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					                      DEPARTMENT OF HEALTH & HUMAN SERVICES
                              Centers for Medicare and Medicaid Services

                                            Survey and Certification Group
                                  Center for Medicaid and State Operations
                                                   7500 Security Boulevard
                                                Baltimore, MD 21244-1850




Quality Assurance for the Medicare & Medicaid Programs


        FY2011 Mission & Priority Document (MPD)




                 Survey and Certification




                      September 3, 2010
                                            Table of Contents

Section                                           Topic                                    Page
ONE       INTRODUCTION                                                                     4
TWO       SPECIAL CHALLENGES                                                               7
THREE     SPECIAL NOTES and SUMMARY OF MAJOR CHANGES from PRIOR YEARS                      13
FOUR      MAJOR PRIORITIES FOR S&C WORKLOAD                                                19
             Long Term Care (LTC) Facilities                                               19
             Home Health Agencies (HHAs)                                                   21
             Intermediate Care Facilities for the Mentally Retarded (ICFs/MR)              23
             Accredited, Deemed Hospitals – Representative Sample Validation Surveys       24
             Accredited, Deemed Critical Access Hospitals (CAHs) – Representative Sample   24
             Validation Surveys
             Complaints in Accredited, Deemed Hospitals and CAHs – Validation of           25
             Complaint Investigations
             Non-Deemed & Non-Accredited Hospitals and CAHs                                25
             Inpatient Prospective Payment System (IPPS) - Excluded Hospitals/Units        26
             Religious Non-Medical HealthCare Institutions (RNHCI)                         27
             Psychiatric Hospitals                                                         27
             Organ Transplant Centers                                                      28
             End-Stage Renal Disease (ESRD) Facilities                                     32
             Psychiatric Residential Treatment Facilities (PRTFs)                          35
             Ambulatory Surgical Centers (ASCs)                                            36
             Recertification Surveys of Other Types of Facilities                          38
             Comprehensive Outpatient Rehabilitation Facilities (CORFs)                    38
             Outpatient Physical Therapy (OPT) and Speech Pathologist (SP)                 39
             Portable X-rays                                                               39
             Rural Health Clinics (RHCs)                                                   39
             Federally Qualified Health Centers (FQHCs)                                    40
             Hospices                                                                      40
             Deemed Hospices                                                               40
             Swing Beds                                                                    41
             CMHCs                                                                         41
             Complaint and Facility Self-Reported Incident Investigations                  41
FIVE      INITIAL SURVEYS                                                                  44
             Tier 2                                                                        44
             Tier 3                                                                        44
             Tier 4                                                                        45
             Conversions                                                                   46
             Priority Exception Requests                                                   46
             Accreditation Requests                                                        47
             Special Provisions for IPPS Exclusion                                         47
SIX       CORE INFRASTRUCTURE – STANDARD REQUIREMENT – MUST BE DONE                        50
             Surveyor Training                                                             50
             OSCAR/ASPEN Data Entry                                                        51
             CMS Quality Initiative                                                        51
             Performance Measurement Activities                                            52
             Nurse Aide Registry                                                           53
         HHA Toll-Free Hotline and Investigative Unit                            53
         Resident Assessment Instrument (RAI)/Minimum Data Set (MDS)             53
         OASIS                                                                   55
         MDS/OASIS Automation and Related Activities                             56
         MDS/OASIS Costs                                                         57
         Quality Improvement and Evaluation System (QIES)                        58
         QIES/SB-MDS/MDS/OASIS State Systems Support                             59
         Emergency Preparedness                                                  64
         Energy Productivity                                                     66
         Alignment with State Performance Standards System (SPSS)                67
         Other Tier 4 Workload                                                   67
SEVEN BUDGET FORMULATION GUIDELINES                                              68
      App 1    Table of Survey Frequencies and Priorities                        73
      App 2    FY2011 State S&C Projected Budget Allocations                     79
      App 3    FY2011 Projected Validation Survey Workload                       81
      App 4    Affordable Care Act – Nursing Home Transparency and Improvement   82
      ATTACHMENTS
      Training Program Mission Letter - Issued Separately




                                                                                 3
                                        SECTION ONE: INTRODUCTION

The mission of the survey and certification (S&C) program is to assure basic levels of quality and
safety for Medicare (1) and Medicaid (2) beneficiaries.

Survey and certification is the only system that provides onsite, objective and outcome-based
verification by knowledgeable and trained individuals to assure that basic standards of quality are
being met by healthcare providers across the nation or, if not met, that appropriate remedies are
promptly applied and implemented effectively. More than 200,000 providers, suppliers and
laboratories are subject to survey & certification, with more than 70,000 being visited through
onsite surveys on a periodic basis. These include:

    Ambulatory Surgical Centers  Hospices                                                       ICFs-MR
    Comprehensive Outpt Rehab  Hospitals – Acute                                                Nursing Homes
    Dialysis (ESRD) Facilities   Hospitals – Rehabilitation, LTCHs,                             Outpatient Phys. Therapy
                                               Psychiatric
    Clinical Laboratories                    Hospitals – Critical Access                        Portable X-Ray
    Home Health Agencies                     Hospitals – Organ Transplant                       Rural Health Clinics

The Centers for Medicare & Medicaid Services (CMS) accomplishes these vital quality assurance
functions under specific direction from the Social Security Act (the Act) and in concert with
States, accrediting organizations (AOs) and various contracts with qualified organizations.

When significant problems are determined, through onsite observation during regularly-scheduled
surveys or complaint investigations, CMS is backed by legislated authority to impose remedies on
the provider or supplier. Failure to implement appropriate remedial action for serious deficiencies
on the part of any provider can result in termination of the Medicare and Medicaid provider
agreements (which also terminates funding from those sources).

In the case of clinical laboratories, failure to implement corrective action may also result in
cessation of any type of moderate or high complexity human specimen testing used for healthcare
purposes, as delineated in the Clinical Laboratory Improvement Amendments of 1988 (3).

1 Medicare is a Federal insurance program providing a wide range of benefits for specific periods of time through providers and
suppliers participating in the program. The Federal Government makes payment for services through designated fiscal
intermediaries (FIs) and carriers to the providers and suppliers. Section 1864(a) of the Act directs the Secretary to use the help of
State health agencies or other appropriate agencies when determining whether health care entities meet Federal standards.

2 Medicaid is a State program that provides medical services to clients of the State public assistance program and, at the State's
option, other needy individuals, as well as augments hospital and nursing facility (NF) services that are mandated under Medicaid.
When services are furnished through institutions that must be certified for Medicare, the institutional standards must be met for
Medicaid as well. In general, the only types of institutions participating solely in Medicaid are NFs, Psychiatric Residential
Treatment Facilities (PRTF), and Intermediate Care Facilities for the Mentally Retarded (ICFs/MR). Medicaid requires NFs to
meet virtually the same requirements that skilled nursing facilities participating in Medicare must meet. ICFs/MR must comply
with special Medicaid standards. Section 1902(a)(33)(B) requires that the State uses the agency utilized for Medicare or, if such
agency is not the State agency responsible for licensing health institutions, the State use the agency responsible for such licensing
to determine whether institutions meet all applicable Federal health standards for Medicaid participation, subject to validation by
the Secretary.

3 Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all
laboratories testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was
performed. A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the
purpose of providing information for the diagnosis, prevention, treatment of disease, or the impairment of, or assessment of health.
 CLIA is user-fee funded; therefore, all costs of administering the program must be covered by the regulated facilities, including
certificate and survey costs. CMS is charged with the implementation of CLIA, including laboratory registration, fee collection, 4
The Act mandates the establishment of minimum health and safety standards that must be met by
providers and suppliers participating in the Medicare and Medicaid programs. For laboratories,
Section 353 of the Public Health Service Act is the impetus for such standards. The Secretary of
the Department of Health and Human Services (DHHS) has designated CMS to administer the
standards compliance aspects of these programs.

Agreements between the Secretary and the various States, territories and the District of Columbia
stipulate that State Survey Agencies (SAs) designated by the Governors are responsible for the
performance of the certification functions created by §1864 of the Act, that the designated agencies
will keep necessary and appropriate records to be furnished as required by delegates of the
Secretary and that they will employ management methods, personnel procedures, equal
opportunity policies and merit systems procedures in accordance with agreed upon or established
practices.

The Secretary agrees to provide funds for the reasonable and necessary costs to the States to
perform the functions authorized by the agreements. Payments to States under §1864 of the Act
are made from the Federal Hospital and Supplementary Medical Insurance Trust Funds to cover
the costs of services performed under the agreement as authorized by §1864 of the Act. However,
expenditures from the Trust Funds for S&C functions are authorized only through the regular
appropriation process of Congress.

To the extent the SA is performing Medicaid certification activities pursuant to an approved State
Plan, the Federal financial grant mechanisms are used to pay the State for a percentage of the cost
of those activities during each quarter of the year. The matching grants come from appropriated
general revenues of the United States. The Secretary is authorized to pay a percentage against
these costs for the proper and efficient administration of the State Plan. Whereas the Title XVIII
trust funds are controlled under terms of the State agreement, the grant funds are controlled by the
established rules of Federal grant laws and regulations. Among the responsibilities of the parties
to the §1864 agreements are obligations imposed upon the Federal government (delegated to
CMS) dealing with the States‘ program administration, which include:

•   Setting policy and providing policy interpretations on the provider and supplier certification
    program standards;
•   Providing consultation to agencies involved in administering the Federal requirements;
•   Paying the appropriate and allowable costs of the SA functions relating to administration of
    regulations and provisions of the agreement and State Plan;
•   Making determinations of allowable State costs to submit for Federal payment;
•   Controlling payment of Federal trust funds (and grant awards) to appropriate SAs for S&C costs
    incurred in administering Title XVIII and Title XIX programs; and
•   Training and qualifying Federal and State personnel for conducting Medicare and Medicaid
    provider certification.




surveys, surveyor guidelines and training, enforcement, approvals of proficiency testing providers, accrediting organizations and
exempt States. A separate budget process exists for operating the CLIA program.

                                                                                                                                    5
                     Major Survey & Certification Functions - Examples



    S&C Major                  Focus                              Frequency – CMS Policy
     Function
1 Comprehensive     A survey of all the major       Nursing Homes – average every year
  (―Standard‖)      requirements for quality that   Home Health – every 3 years, every provider
  Surveys           are specified in regulation.    Hospitals – every 3 years, on average
                                                    Dialysis Facilities – every 3 years, on average
                                                    Others – 3-6 year averages, depending on provider type.
2 Complaint         Investigation of a complaint    Frequency varies by provider type. In FY2009 approx.
  Investigations    & the provider‘s compliance     47,000 nursing home and 5,800 hospital/CAH complaints
                    with CMS requirements.          were investigated.
3 Minimum Data      Monitoring assessments that nursing homes are required to conduct for every nursing
  Set (MDS)         home resident and educating providers. Use of assessment data to inform and target
  (Nursing          oversight of nursing homes and for the Five-Star Star Nursing Home Quality Rating
  Homes)            System. On-going.
4 Outcome &         Monitoring assessments that home health agencies are required to conduct for every
  Assessment        adult, Medicare or Medicaid patient receiving skilled services and educating providers.
  Information Set   Use of assessment data to inform and target oversight of home health agencies. On-
  (OASIS)           going.
5 Validation of     Validation surveys are designed to verify the accuracy of State or AO surveys. Two main
  State Surveys     types of validation surveys are done: (a) comparative surveys, in which a CMS team or
                    contractor conducts an independent survey within 60 days of the State survey (to compare
                    results) and (b) observational surveys, in which a CMS team or contractor accompanies
                    the State team to observe the process of the State team. Sample size varies with provider
                    type, from 5% in nursing homes, to 1% for all other provider types.
6 Validation of     Two main types of representatively sampled validation surveys are done: (a) comparative
  Accreditation     surveys, in which the SA conducts a survey within 60 days of the AO survey and (b)
  Organizations     ―mid-cycle‖ validation surveys that are not tied to the timing of an AO survey but are
  (AOs)             designed to assess the continuity of provider compliance, usually after earlier deficiency
                    corrections. Sample size varies according to the budget and provider/supplier type. CMS
                    must report annually to Congress on the performance of all CMS-approved national
                    accreditation programs in assuring the compliance with Medicare health and safety
                    standards of accredited providers/suppliers. In addition, complaint surveys are conducted
                    in response to substantial allegations of deficiencies in accredited facilities.
7 Accreditation     CMS reviews the applications of organizations for initial approval or renewal of deeming
  Organization      authority for the approval of providers/suppliers meeting health and safety standards
  Approvals &       under Medicare. The statute requires that the AO standards be at least equivalent to
  Oversight         CMS‘ and that the qualifications of the surveyors and conduct of the surveys be adequate.
                    Providers accredited by CMS-approved AOs in most cases are deemed to meet CMS
                    certification requirements (some exceptions apply). Validation surveys (#6 above)
                    represent an important aspect of CMS on-going AO oversight once CMS approval has
                    been granted.
8 Public            CMS and States provide high quality content on public websites regarding a variety of
  Information       provider types. For example, CMS‘ Five-Star Quality Rating System offers consumers
                    easy-to-understand information about the quality of care in the nation‘s nursing homes,
                    conveniently available on the CMS Nursing Home Compare website. The website
                    contains key information about quality measures, staffing and survey results. As a service
                    to the public, the website improves the ability of consumers to make informed decisions
                    and to ask pertinent questions of providers. As a tool for quality, the website provides
                    incentives for nursing homes to improve their quality.                                6
                          SECTION TWO: SPECIAL CHALLENGES

A. New Responsibilities

Congress and the public continue to look to CMS and State survey agencies to take on new
responsibilities designed to protect vulnerable populations and ensure the quality of healthcare for
Medicare and Medicaid beneficiaries. Examples include:

A.1 Affordable Care Act (ACA): The newly passed Affordable Care Act (ACA) contains many
elements designed to improve quality in the U.S. health care system. Those requiring action by
State survey agencies include:

      Posting 2567s and PoCs on State Websites (Section 6103): States are required to maintain
       a consumer-oriented website providing useful information to consumers regarding all
       skilled nursing facilities and all nursing facilities in the State, including for each facility the
       Form 2567 inspection reports, complaint investigation reports and facility‘s plan of
       correction.

      Independent IDRs (Section 6111): States will be required to offer the opportunity for an
       independent informal dispute resolution (independent IDR) to nursing homes for which a
       civil monetary penalty has been imposed, effective in FY2011;

      Background Checks (Section 6201): States are being invited to participate in a CMS
       matching grant program to improve their background check systems for potential long term
       care employees. Grants are due to be awarded at the end of FY2010 and in early FY2011,
       for a three year program;

      New Regulations: New regulations will be forthcoming in many areas that will require
       State implementation activities, including:
           o Section 6101– Ownership Disclosure
           o Section 6102 – Quality Assurance Improvement (QAPI)
           o Section 6102 – Ethics & Compliance Program
           o Section 6111 – Independent IDR,
           o Section 6111 – CMPs (a notice or proposed rule-making was published on July 12,
               2010)
           o Section 6113 – Notification of Facility Closure
           o Section 6121 - Dementia and abuse prevention training for nurse aides,

See Appendix 4 for more information regarding the Affordable Care Act.

A.2 Healthcare Acquired Infections (HAI) Initiatives: States are in the forefront of many
initiatives to reduce the incidence of healthcare associated infections, including:

      Ambulatory Surgical Centers: In order to prevent healthcare associated infections, States
       conducted more frequent and comprehensive surveys of ASCs in FY2010 using a new
       infection control surveyor worksheet, more surveyors and tracer methodology. In FY2011
       this initiative is being incorporated into the standard ASC survey process, with about 25%
       of all non-deemed ASCs being surveyed. In addition, special funding has been made
       available from the American Recovery and Reinvestment Act (ARRA) for those States that
       will survey more than 25% of their non-deemed ASCs in FY 2011 (see Memorandum
                                                                                                  7
         S&C 10-31)

        Hospital HAI Initiative: In FY2011 we expect to solicit volunteer States to pilot test an
         infection control survey worksheet for hospital settings.
        New ESRD Initiative: A collaborative effort between State Survey Agencies and ESRD
         Networks to address healthcare associated infections in ESRD facilities is in the planning
         stage.

A.3 MDS 3.0: A change in the RAI process through the revision of the MDS assessment tool
(currently MDS Version 2.0) will require Long Term Care (LTC) facilities to begin using the MDS
Version 3.0 (MDS 3.0) in the beginning of FY2011. The changes will affect LTC providers,
vendors, ROs and the SAs as changes to the RAI and survey processes, including the SOM,
QM/QI and survey reports and the RAI User‘s Manual, will be necessary.

A.4 OASIS C: The revised OASIS instrument, OASIS C was implemented January 1, 2010. The
new instrument will provide process measures results in the Fall of 2010, a new concept for
HHAs. In addition revised Outcome Reports will be available in Spring 2011. This change
requires training of all providers, State Agencies and surveyors. It will also require a change to the
HHA survey process and reports. The changes will affect HHA providers, vendors, ROs and the
SAs as changes to the OASIS process, the SOM and the CASPER User‘s Manual, will be
necessary.

B. Continuing Challenges

B.1 State Personnel Barriers: In response to budget challenges in 2009 and 2010, most States
adopted across-the-board hiring freezes and other limitations. States generally applied these
restrictions to survey & certification personnel despite the fact most funds in most States for survey
& certification is derived from Federal rather than State funds4. Approximately 15 States have also
enacted furloughs5. These limitations have compounded the pre-existing personnel challenges
facing State Survey Agencies that derive from recruitment and hiring inflexibilities in State
personnel systems, difficulty in competing for personnel in the healthcare marketplace and State-
imposed limitations on training. Such pre-exisiting barriers caused the Government Accountability
Office to cite State personnel challenges as a risk factor in the proper oversight of the nation‘s
healthcare facilities6. To address these challenges, in part, CMS has separated out additional
training-travel funds as a distinct cost category. Unused funds will be redeployed to other States for

4 For example, the GAO reported that of those States in their interview sample that had not spent their entire Medicare
allocation, 88% ―identified hiring freezes or vacancies as the primary reason.‖ GAO-09-64, p. 34.
5 Based on a survey conducted in June 2009 by the Association of Health Facilities Survey Agencies.
6 GAO-09-64, ―CMS Needs to Reexamine Its Approach for Funding State Oversight of Health Care Facilities,‖
February 2009. For example, the GAO reported that ―…many of the 28 states we contacted told us that an unstable
workforce had affected their ability to meet CMS survey priorities over the past several years. The workforce
instability arises mostly from noncompetitive salaries, which result in the hiring of less qualified candidates, and hiring
freezes. Salary levels, minimum qualifications, and decisions about when to hire or not hire surveyors are the result of
state personnel policies that affect surveyor positions as well as positions for other state employees. According to
AHFSA and state officials, staff retention issues among states can be attributed primarily to noncompetitive salaries
for RNs—the profession that comprises the largest proportion of surveyors nationally. In fiscal year 2006, the surveyor
attrition rate among the 28 states we contacted ranged from 0 percent to about 46 percent, and 17 of these states
reported attrition rates of 10 percent or higher. Officials from one state told us that the starting salary for their RN
surveyors ranged from $30,000 to $35,000 and that trained RNs typically leave surveyor positions after a few years to
seek jobs in the private sector for higher salaries.‖ (p. 33)
                                                                                                                         8
emergency preparedness and one-time expenses. The FY2011 allocations will also be adjusted
downward for States whose furlough programs or hiring restrictions limit their ability to
accomplish the full Medicare workload consistent with available funds.

B.2 More Providers: There is a
consistent increase in the number of
providers that must be surveyed. This
is one of the strongest drivers of the
Medicare survey & certification
budget, since more providers will
stretch out the average time between
surveys unless additional resources are
available. The following graph
illustrates the total cumulative effect of
increased numbers of all types of
providers that are subject to Medicare
and Medicaid survey and certification
requirements, excluding clinical
laboratories.

Certain types of healthcare providers,
however, are growing in number faster than others. Of particular concern are home health
agencies, ambulatory surgical centers and end-stage renal disease facilitates (ESRD).

                                                             The graph to the left, for example, shows the
                                                            change in home health agencies (HHAs) HHAs,
                                                            declining from 7,216 at the end of FY2000 to a
                                                            low point of 6,904 at the end of FY2001 and then
                                                            increasing recently by 48.9% from FY2002 to
                                                            FY20097.

                                                            The number of ambulatory surgical centers
                                                            (ASCs) has been increasing at about 10% a year on
                                                            average. This graph shows the total number of
                                                            ambulatory surgical centers growing from 3,094 at
                                                            the end of FY2000 to 5,233 at the end of FY2009,
                                                            a 69.1% increase. As more and more ASCs were
developed, the average survey frequency
declined to about once every ten years. CMS
therefore made ASC surveys a special focus
beginning in FY2008. In FY2010 States
and CMS are surveying about 33% of all
ASCs, and 25% in FY2011.

End-stage renal disease (ESRD) facilities
are also growing significantly in number.
The following graph portrays the rise in


7. 10,363 facilities for FY2009 through 10/01/2009 (OSCAR 10 report).                                          9
                                                                                8
ESRD facilities from 3,957 in FY2000 to 5,433 in FY2009, a 37.3% increase.

To address these challenges, in FY2010 the
President requested ―catch-up‖ funds that would
significantly improve the States‘ ability to
address the large increase in Medicare
participating providers, including the backlog of
providers newly seeking Medicare participation.
 The FY2011 budget request continues to make
survey & certification a national priority to
ensure adequate public protections and quality of
care.

B. 3 Sustaining Improved Survey Coverage: Federal and State efforts to improve efficiency,
provide clearer guidance, implement State performance standards and accomplish other
improvements have resulted in a survey
system that is both improved and more
reliable. The graph on this page, for
example, shows the percentage of nursing
homes surveyed at least every 15 months
reached 99.97% in 2009 compared with
96.3 % in 1999.

 Similar improvements have been made in
the area of home health, with the percent of
home health agencies surveyed at least
every three years (a statutory requirement)
increasing from 89.7% in 1999 to 99.7 % in
2006 and 99.95% in 2009.
 Unfortunately, resource constraints have
not permitted the same level of
improvement in non-long term care (NLTC) areas and in some such areas (such as ASCs and
ESRDs) the greater number of providers meant that average survey frequency was reduced to
levels that gave us great concern.

                                                                In FY2007 the State Performance
                                                                Standards System (SPSS) was
                                                                expanded to include more provider
                                                                types and a more comprehensive
                                                                view of the total value of the survey
                                                                process for promoting quality
                                                                assurance. The SPSS expansion
                                                                allowed CMS to better track
                                                                performance in the non-LTC area.
                                                                With that baseline, CMS made
                                                                ESRD and ASC surveys a priority
                                                                beginning in 2008.


8. Facilities for FY2009 through 10/1/2009 (OSCAR 10 report.)                                      10
B.4 Sustaining More Complaint Investigations: CMS, State and Congressional emphasis on
responses to direct patient/resident complaints has resulted in definite improvements in the quality
assurance system. Onsite complaint investigations
permit a timely and targeted insight into the quality
of care of a provider. The number of onsite
complaint investigations increased after FY2001,
then declined during the period of severe S&C
budget challenges and more recently increased to
an all-time high. The following graph portrays the
3.8% increase in completed complaint
investigations from FY2001 to FY2009 (including
life-safety code complaint investigations).


B.5 National S&C Medicare Budget Trends: For four consecutive years (2005-2008) Congress
was not able to fully fund the President‘s Medicare S&C budget request. However, CMS Acting
Administrator Kerry Weems allocated
additional one-time CMS funds to S&C in
order to bring the Medicare quality assurance                     S&C Medicare Budget
budget closer to the President‘s full 2008                as Percent of Total Medicare Budget
requested level. Congress also supported the
President‘s 2009 budget request and the           0.11%
FY2010 request that provided some ―catch-         0.10%
up‖ funds. These actions halted the downward 0.09%
trend in the proportion of Medicare funds
                                                  0.08%
devoted to Medicare quality assurance. This
graph portrays the national trend in the          0.07%
proportion of total Medicare expenditures         0.06%
devoted to quality assurance, declining from      0.05%
about 0.10% in FY2001 to 0.06% in FY2007
                                                          99
                                                          00
                                                          01
                                                          02
                                                          03
                                                          04
                                                          05
                                                          06
                                                          07
                                                          08
                                                          09
                                                          10
                                                          11
and then increasing slightly.
                                                       19
                                                       20
                                                       20
                                                       20
                                                       20
                                                       20
                                                       20
                                                       20
                                                       20
                                                       20
                                                       20
                                                       20
To promote the highest achievable State                20
survey performance, CMS adapted to fiscal constraints by placing a priority on state survey
activities and taking a number of other activities including:

•   CMS Central Office Reductions: Reducing CMS central office contracts and functions so that
    more funds could be provided to States;
•   Efficiency Initiatives: Adding tools to increase efficiency and effectiveness (such as the ASPEN
    suite of information system tools);
•   Data Drivers for Outcome-Based and Risk-Adjusted Survey Protocols: Increasing efforts to
    develop survey protocols that reflect information from data on outcomes and risks among the
    different providers (such as the tier II targeted surveys);
•   Delaying Improvements: Postponing or slowing planned improvements (such as slowing
    implementation of the new QIS survey process for nursing homes) and
•   Prioritization: Prioritizing work through the ―Tier system‖ of priorities and taking action to
    promote consistent national application of those priorities.
                                                                                                   11
The President‘s proposed FY2011 budget for S&C would enable States and CMS to continue to
recover and restore the delayed initiatives to improve quality and ensure adequate protections for
Medicare and Medicaid beneficiaries. This includes restoring the schedule of implementation for
the nursing home Quality Indicator Survey (QIS) and reducing or eliminating the backlog of
surveys for providers newly seeking participation in Medicare. The FY2011 budget also permits
CMs and States to continue the improved survey process for ambulatory surgical centers that
enables a more effective focus on healthcare associated infections, together with greater frequency
of ASC surveys.




                                                                                                12
     SECTION THREE: SPECIAL NOTES and SUMMARY OF MAJOR CHANGES
                          from PRIOR YEARS

In this section we describe some of the notable changes from the FY2010 MPD. We also repeat,
for purposes of emphasis, some changes made in recent years. Changes made in 2010 and
continued in 2011 without further change are noted at the end of each paragraph.

Entirely New in FY2011

A. Affordable Care Act (ACA): Appendix 4 contains a description of some of the major parts of
the ACA that require implementation activities by the State survey agencies.

B. Hospital Infection Control Pilot: We plan to issue a solicitation for FY2011 to identify
States that would be interested in pilot-testing an infection control survey instrument in the
hospital setting.

C. Transplant Program Survey Priorities: For FY2011, complaint investigations remain as a
Tier 1 priority for IJ Complaints and Tier 2 for all other complaints. Three types of surveys will
remain as Tier 2 priorities (a) completion of any remaining initial surveys under the new
Conditions of Participation, (b) mandatory surveys as described in the transplant regulation, (c) a
targeted list of programs identified by CMS. Re-approval surveys in FY2011 that are not
identified as Tier 2 priorities will move to Tier 3. Most transplant surveys conducted in FY2011
will be re-approval surveys. Additional details about the survey priorities in each tier are
described more fully in Section Four.

D. New ESRD Infection Control Initiative: In conjunction with AHRQ and CDC, the Survey
and Certification Group will be conducting a new ESRD Infection Control Initiative to reduce
healthcare associated infections in ESRD facilities. State Survey Agencies and ESRD Networks
will collaborate on this initiative. Details including volunteer opportunities for States, will be
issued later in FY 2011 via S&C Memorandum.


Continued from the Recent Past

E. Ambulatory Surgical Centers (ASCs): In FY 2011 all States that have non-deemed ASCs are
required to survey at least 25% of their non-deemed ASCs using the enhanced survey process.
States that have only 4 or fewer non-deemed ASCs must survey at least 1 facility in FY 2011
unless all such ASCs were surveyed in FY2010.

To implement a GAO recommendation, the ASC surveys in FY2011 must also include those
specific ASCs that have been selected as part of a random sample by CMS. We plan to issue the
list in September 2010. States must also continue to send to a CMS contractor the completed
Infection Control Surveyor Worksheet for each survey to enable CMS and CDC to analyze the
nationwide findings. See Section Four for more details.

Similar to FY2010, funding for the ASC surveys is broken out separately in the S&C Medicare
budget (see Appendix 2) and will require some special reporting on the form CMS 435. Further,
in accordance with AdminInfo 10-31, the performance period for recovery Act grants will be
extended for states that:
      May need more time to complete their FY 2010 workload of recertification surveys for at
        least 33% of their non-deemed ASCs; and/or
      Apply and are approved for Recovery Act funds to perform more than 25% of their non-
        deemed ASCs in FY 2011.

For these States:
    As in FY 2010separate reporting on the Recovery Act website will continue until they
       complete all Recovery Act funded survey workload, or they draw down all of their
       Recovery Act grants, whichever comes first;
    Unlike FY 2010, Recovery Act funds must be used first before drawing down funds
       identified in the ASC column of the State‘s S&C Medicare budget (in Appendix 2).

For all other States, funds identified in the ASC column of the State‘s S&C Medicare budget (in
Appendix 2), which are not needed by the State to meet the 25% survey requirement, may be used
for other CMS S&C priorities.

F. Travel Training: A portion of the Medicare funding for FY 2011 will continue to be
separately available to defray State costs involved in traveling to attend CMS‘ tuition-free training
events for surveyors. Such funds are separately indentified in Appendix 2. Funds left by States
that do not use their full allocation to support State staff to attend the training will be redistributed
to other States. During FY 2011 we will review with each State the status of planned and actual
use of federal travel funds and begin any redistribution that is advisable. States must use their
standard allocation for training expenses that exceed the amounts identified in the special column
of Appendix 2. See Section Seven for a description of the accounting process for these funds.

G. Budget Adjustments for Furloughs and State Hiring Limitations: For FY2011 allocations,
CMS will review the status of any staff furlough programs and other personnel limitations that may
affect the State‘s ability to accomplish the Federal workload. CMS will adjust downward the
allocations for States whose furlough programs or hiring restrictions limit their ability to accomplish
the full Medicare workload consistent with available funds. To the extent that performance is
negatively affected despite the availability of Federal funds, CMS will review performance under the
1864 agreement or under Medicaid law to determine if longer term actions are warranted.
Downword adjustments in the baseline or other budget columns in Appendix 2 for FY2011 will
apply only for FY2011 and the funds not allocated to the affected States will be made available to
other States as one-time budget allocations. We will conduct one such review and reallocation in the
December – February time period and a second review in March – July 2011.

H. Special Focus Facilities (SFFs): As indicated in the FY2010 MPD, we are increasing the
number of SFFs by approximately 20% and increasing the candidate list from which States
recommend final selections to CMS. The increase will be phased in, with a 10% increase in
FY2011, and the remaining increase in FY2012. This increase will primarily affect the larger
States. A separate S&C Memorandum will be issued detailing the changes.

I. Transplant Center Surveys: As we implemented the three-year phase-in of transplant center
surveys, we fully honored State preferences as to whether they wished to survey transplant
programs themselves or have our national contractor conduct the surveys. Near the end of FY
2010 we will complete the three-year phase-in of initial surveys and begin the re-approval surveys
for programs certified earlier under the transplant Conditions of Participation. Starting in FY
2011, we will also begin the process of ensuring that all States with 5 or more transplant hospitals
                                                                                                  14
conduct transplant center surveys even if they had not previously done so. See Section Four for
those additional States that will need to begin to conduct transplant center surveys and that should
ensure that the appropriate surveyors participate in the FY 2010 transplant program training
(scheduled for September 2010).

J. One-Time Funding Opportunities: We suggest that States conduct a clear analysis of one-
time investments that may raise productivity or otherwise lead to a reduction in the rate of growth
in future expenses. Such analysis will position the State to take advantage of funds that may be
reallocated from other States that are not equipped to make effective use of the monies (see item F
above). We particularly request that States analyze their State‘s transportation policies to
determine the extent to which the State may be able to take advantage of one-time opportunities to
decrease reliance on fossil fuels and increase fuel efficiency.

K. High Impact Fraud Areas: Certain provider or supplier types in high-impact + fraud areas
identified by CMS will require CMS RO approval before federal funds are used to conduct initial
surveys. See Section Five C. 3.

L. Core Infrastructure: Consistent with changes begun in FY2007 and FY2008, certain
functions have been clarified as a core requirement, since they simply must be done. Prompt data
entry and maintenance of the information system databases are examples. No direct S&C
activities are considered complete until the survey data are entered into OSCAR/ASPEN
databases. Other examples include the nurse aide registry, MDS and OASIS coordination and
education and maintenance of the home health hotline. No changes were made for FY 2011.

M. Validation Surveys for Accrediting Organizations: Validation surveys of providers
deemed to meet Federal requirements for certain accredited provider/supplier types remain a Tier 1
priority. The first 1% samples for deemed hospitals as well as 5% for deemed critical access
hospitals and one home health agency survey must be budgeted within the State‘s baseline budget.
Beginning in FY 2008 we added the possibility for supplemental funding (above the baseline) for
ASCs and certain other providers, as summarized in the following table.

For FY2011 approximately one third of all hospital validation surveys will be surveys of a
randomly selected sample of long term care hospitals. These surveys will not be tied to an AO
survey, but instead may be conducted at the SA‘s discretion, so long as they are completed during
the Fiscal Year. CMS will notify states selected to conduct LTCH validation surveys prior to the
start of the Fiscal Year.

Since the results of validation surveys for all deemed provider/supplier types must be included in
the statutorily expanded annual Report to Congress, for FY2011 we are treating all validation
surveys as a Tier 1 priority; previously only hospital validation surveys were required to be
addressed in the Report to Congress, but with the statutory expansion of our reporting
obligations, it is appropriate to categorize all accreditation organization validation surveys as
Tier 1.




                                                                                                  15
                     Table: Validation Surveys for Accrediting Organizations
                Accredited, Deemed Provider Type                    Included in      Supplemental (Added to
                                                                     Standard         Standard Allocation)
                                                                     Allocation
    Deemed Home Health Agency Validation Surveys                  Yes – the first    Yes – only for surveys
                                                                   survey in each       after the first one
                                                                        State
    Deemed Hospice Validation Surveys                                   No                    Yes
    Deemed Ambulatory Surgical Center Validations                       No                    Yes
    Deemed Hospitals – Standard First Sample 1% (see CMS table)        Yes                    No
    Deemed Hospitals – Targeted Add‘l Sample (second sample %)          No                    Yes
    Deemed Critical Access Hospitals – 5%                              Yes                    No

N. Tier 2 Targeted Sampling: the ASC Tier II targeted surveys are reduced from 33% in FY2010
to 25% in FY2011 for all States, as noted in ―A‖ above, but special Recovery Act funds have been
made available for States that volunteer to survey more than the 25% of ASCs in FY 2011. As
recommended by the GAO, we will also select a random sample for some ASC surveys in order to
produce a representative sample of completed ASC infection control instruments for subsequent
analysis of ASC infection control practices by CMS and CDC. Targeted samples (or at least 1
provider, whichever is greater) for certain other providers, such as HHAs and ESRDs, remain at
the FY2010 levels.

As in the past, the work of a higher priority Tier may contribute toward fulfilling the work of a
lower priority Tier. For example, some (but not all) of the ESRD facilities surveyed for the Tier 2
targeted sample may also be ones that are due for a survey to fulfill Tier 3.

Note: See the paragraph below entitled ―Alignment with State Performance Standards” for
additional information regarding Tier 2. Any State that has fewer than 7 non-deemed providers in
the applicable provider class is not required to conduct a targeted survey except for ASCs. For
example, a State that has only 2 OPT providers, will not be expected to do a Tier 2 targeted sample
for OPTs.

O. Tier 2 Statistical Conventions: For all Tier 2 targeted surveys of non-deemed providers and
suppliers, we apply the following conventions for SPSS tracking purposes:
        Small Numbers Exemption: Tier 2 targeted sampling requirements do not apply for
          most provider/supplier types for which fewer than 7 non-deemed Medicare-participating
          providers exist in the State. This exemption does not apply to validation samples of
          accredited providers, or to ASC targeted surveys in FY2011.
        Percentages Not Rounded: Meeting the sample size requires meeting the percentage
          without resorting to ―rounding up‖ (e.g., 4.8% would not fully meet a 5% requirement).

P. Tier 2 Targeted Samples and Alignment with Budget Processes: Consistent with S&C
Administrative Information Memorandum 08-22:
   1. Analysis of Results: Each spring we will analyze the Tier 2 targeted sample results for the
       prior Federal fiscal year and forward the data for discussion with the applicable State;
   2. Sequester: We will identify the dollar value of the surveys in the targeted samples that
       were not performed and sequester those funds when the budget allocations are made to
       States pursuant to enactment of the final fiscal year Federal budget (generally in March of
       each year).
   3. Remediation Plan and Release of Funds: We will allocate the sequestered funds to the
                                                                                                 16
      applicable State if, within 60 days of CMS‘ notice to the State, an acceptable action plan is
      received and approved by CMS for the State‘s conduct of targeted surveys for the fiscal
      year in question.
   4. Alternative Re-assignment of Resources: If an acceptable action plan is not in place
      within 60 days, we will release the sequestered funds to other States.
   5. Applicability: These procedures apply to targeted samples of ASCs, ESRDs, non-
      accredited hospitals and hospices.

Q. Accredited IPPS-Excluded Rehabilitation Hospitals/IPPS-Excluded Rehabilitation and
Psychiatric Units of IPPS Hospitals: Until IPPS-exclusion requirements are codified as
Conditions of Participation, we are continuing to suspend the requirement that accredited IPPS-
excluded rehabilitation hospitals or IPPS-excluded rehabilitation or psychiatric units in accredited
IPPS hospitals be validated for compliance with exclusion criteria at least once every six years via
onsite surveys. Instead, such hospitals will be part of the pool of IPPS-excluded hospitals/units
from which the State draws a 5% sample for onsite verification.

R. New IPPS-Excluded Rehabilitation Hospitals/IPPS-Excluded Rehabilitation and
Psychiatric Units of IPPS Hospitals: We are continuing the policy first provided via S&C-08-03
(dated November 5, 2007) to suspend the requirement for States to conduct first time onsite
verification surveys of all new rehabilitation hospitals/excluded rehabilitation units and all new
excluded psychiatric units seeking exclusion from IPPS. Such hospitals/units newly seeking IPPS
exclusion are instead required to self-attest to their compliance with the exclusion criteria. Once
approved, the newly-approved hospitals and units are placed by the State into the pool of existing
IPPS-excluded hospitals and units from which the annual 5% onsite verification sample is drawn.
The provider should return a completed certification packet, along with all other requested
materials, to the SA no less than 90 days prior to the start of the facility‘s first or next cost
reporting period, as applicable, in order for the RO to have sufficient time to make a determination
to approve or deny the provider‘s IPPS exclusion status. If the provider submits the application
less than 90 days in advance, CMS will continue to process the application, but the provider
assumes the risk that the RO review may not be completed in time for payment at the excluded
rate to start with the first or next cost reporting period (See Section Five for more detail about the
certification packet).

S. Pre-Requisites for LSC Training: We are providing advance notice of FY2011 pre-requisites
for life-safety code surveyors. See the beginning of Section Six.

T. Training & Support of Staff: Survey work requires high levels of expertise, knowledge and
training. Staff turnover adds to the challenge. In FY2011 CMS will continue to work with States
to develop more long term strategies for addressing ongoing challenges such as the training
required as a result of staff turnover and succession.

CMS will be expanding its support of State Agency training functions by actions such as:
   LMS: Conversion to a new Learning Management System (LMS) that will enhance the
     automation of student enrollment and increase the accuracy of training transcripts, which
     are required by statute.
   Distance Learning: Testing whether distance learning tools such as the Blackboard Course
     Management System (or virtual classroom) can be extended to State Agencies for their use
     in meeting their statutory requirement to the conduct of training and personnel
     development for their staffs.
                                                                                              17
      Expanding Online: Expanding the number of courses offered using online resources,
       where such media will produce an equal or better learning outcome.
      Credits: Upgrading the capability of CMS training to be better retained by students through
       accreditation of CMS training by the International Association for Continuing Education
       and Training (IACET).
      Pre-requisites: Requiring the completion of prerequisite preparation before student
       surveyors can be enrolled in a course.
      New Curricula: Developing a needs assessment that will inform our longer term efforts to
       create a Complaint Investigation curriculum that can strengthen the abilities of States to
       more quickly address demand for the numbers of such survey-types.

Additional training challenges arise from system improvements being made to the survey process
and survey tools, as well as the new survey responsibilities mentioned above. Examples include:

       Quality Indicator Survey (QIS): In FY 2007 CMS concluded its five-State demonstration
       of the new survey process for nursing homes. CMS is proceeding with national
       implementation of the QIS using contractors to provide training State-by-State. All States
       currently implementing the QIS, including those that began implementation in FY 2009,
       are expected to participate in a webinar (live, interactive, web-based training session)
       which will cover changes in the QIS, due to its programming into the CMS data systems.
       This is expected to take place during fall, 2010 and will consist of both surveyor training
       and IT training webinars. See the LTC discussion in Section 4 of this document for more
       details.

       ESRD Training: An updated series of technical, hands-on training courses, incorporating
       the new regulations and new training materials, will be conducted during FY 2011. New
       training materials on infection control will be developed during the fiscal year. We will
       also continue the national roll-out of the automated ESRD survey system, Surveyor
       Technical Assistant for Renal Disease (STAR) system during FY2011. The STAR system
       is being revised to follow the new regulations and we will continue to train surveyors on
       the use of the system.

       MDS 3.0: A change in the RAI process through the revision of the MDS assessment tool
       will require changes to the RAI and survey processes, including the SOM, QM/QI and
       survey reports and the RAI User‘s Manual. CMS is implementing the new MDS 3.0on
       October 1, 2010, and we have provided in-person training for RAI coordinators this past
       Spring. States are expected to provide information to providers regarding this revised tool
       and to answer questions throughout FY2011.

       OASIS C: A change in the OASIS process through the revision of OASIS assessment tool
       and measures will require changes to the HHA survey process, including SOM and the
       Surveyor worksheets. The OASIS Education Coordinators are super users of the revised
       OASIS User‘s Manual. As CMS moves toward the implementation of process measures in
       2010, we will be working with the SAs to develop and refine an OASIS C training module
       to support effective OASIS C implementation.

       HHA Survey Process Enhancement: The survey protocols are being revised in response
       to the GAO report, building clarity on what constitutes a condition level deficiency.
       Comprehensive surveyor training will undergo significant revisions in FY2011.
                                                                                             18
     SECTION FOUR: MAJOR PRIORITIES for S&C WORKLOAD and PROGRAM
                           REQUIREMENTS

Survey activities for FY2011 must be scheduled and conducted in accordance with the S&C
priority ranking provided in this document. The four priority Tiers reflect statutory mandates and
program emphases. Planning for lower-tiered items presumes that the State will accomplish
higher-tiered workloads. For example, States must assure that Tiers 1 and 2 will be completed as a
pre-requisite to planning for subsequent Tiers. It is not necessary to complete Tier 1 or Tier 2
work before beginning Tier 3 if the multi-tier work has been included in the State‘s submission,
has been approved by CMS and the higher Tier work will be completed by the end of the FY. In
addition to prioritizing work between Tiers 1-4, we suggest States prioritize their work within
Tiers and to consult with the ROs in the prioritizing process. States must track their workload
quarterly by Tier and report the results to the RO 45 days after the close of the quarter and also
report for the full fiscal year 60 days after the close of the fiscal year. As part of their oversight and
trouble-shooting responsibilities, ROs will monitor and work with States on the performance of
the Tiered workload.

A. Long-Term Care (LTC) Facilities
All skilled nursing facilities (SNFs) and nursing facilities (NFs) are subject to a standard survey
not later than 15.9 months after the previous standard survey, with a statewide average between
standard surveys of 12.9 months.

    1. NHOIP: Nursing Home Oversight Improvement Program (NHOIP) expectations continue
       to apply even though separate budgeting and reporting of those expenditures is no longer
       required. NHOIP expectations are delineated in the SOM and in various S&C numbered
       memoranda. With the added funding that NHOIP provides, States will also continue to be
       expected to: continue their more intense review of nursing homes‘ abilities to prevent
       pressure ulcers, dehydration and malnutrition as part of the annual survey process; fund the
       additional costs associated with imposing immediate sanctions on nursing homes with a
       substantiated second violation of harming residents; fund the additional costs associated
       with the special focus facility initiative and conduct surveys on repeat offenders with
       serious violations; and fund the costs associated with staggering a set number of nursing
       home inspections (to be started mornings, evenings and/or weekends). In FY 2011 we are
       increasing the number of special focus facilities (see #A.5 below).

        States must secure the necessary Medicaid State share for funding those NHOIP activities
        attributable to Medicaid facilities or dually-certified facilities.

    2. Oversight: With respect to LTC enforcement, CMS supports State surveyors in citing
       instances of non-compliance with program standards. In FY2011 CMS will review each
       State‘s enforcement data for recent years to ensure conformance with CMS policy and
       statutory requirements. CMS enforcement policy does not support a quota program under
       which States are encouraged to cite more deficiencies than necessary, but does support
       appropriate and full remedial action. For nursing homes, if it is determined that there is
       substandard quality of care, an extended or partial extended survey must be conducted, in
       accordance with Appendix P of the SOM.


        When conducting nursing home surveys, LTC surveyors should report to the SA which
                                                                                                      19
         nursing home facilities provide hospice services to residents and any concerns they have
         about the provision of hospice services in a specific facility. SAs are expected to follow up
         and initiate enforcement action against a hospice when they identify hospice non-
         compliance issues associated with care to nursing home residents who have elected the
         hospice benefit.

                                       NURSING HOMES - Priority
                         Tier 1                                          Tier 2                  Tier 3   Tier 4
   15.9 Month Max. Interval: No more than 15.9             NH Oversight & Improvement
    months elapses between surveys for any particular        Program (NHOIP): All aspects of
    nursing home.                                            the nursing home improvement
   12.9 Month Avg: All nursing homes in the State are       program are sustained (e.g., off-
    surveyed, on average, once per year. The Statewide       hour surveys, special focus
    average between consecutive standard surveys must        facilities, etc.)
    be 12.9 months or less.

     3. QIS: CMS will continue to move forward with implementation of the QIS to achieve
        national implementation. CMS is using a train-the-trainer approach to build staff expertise
        in a sustainable manner. State trainers will conduct training of their respective survey staff
        ultimately leading to statewide QIS implementation in the State. CMS will notify a State
        when it is selected and what its implementation schedule will be. The process to be
        followed by a State selected to implement the QIS is outlined in Chapter 4 of the State
        Operations Manual.

         The priority listing of the order in which CMS will begin implementation of the QIS in
         each State that has not already begun or completed implementation was communicated
         through S&C-09-50, dated August 7, 2009.

         If a State wishes to begin QIS implementation earlier than its allotted schedule, we will
         consider moving this State up on the list. Please notify your CMS regional office.

     4. MDS 3.0: CMS is also moving forward with the national implementation of the MDS 3.0
        on October 1, 2010. CMS has provided to State RAI coordinators a train-the-trainer class
        so that providers and surveyors could be trained in the MDS 3.0.

         States will be responsible for assuring that their survey and certification staff members are
         trained in the use of the RAI process, including the new MDS 3.0, as well as the changes to
         the SOM and survey processes as a result of the MDS 3.0 implementation. This will
         ensure that surveyors and State RAI Coordinators have the necessary skills to perform their
         roles.

         The MDS 3.0 implementation has an effect on both the Traditional and QIS survey
         processes. We will release a major change to the Traditional survey process via Survey
         and Certification memorandum to address the loss of the Quality Measures for
         approximately a year or more, as well as changes to the Roster/Sample Matrix due to new
         MDS fields. This will be released in draft form prior to the scheduled October 1st
         implementation. A PowerPoint train-the-trainer product will accompany the draft and all
         States that are using the Traditional survey process are expected to train their surveyors so
         they may conduct surveys under the revised process starting October 1st. The QIS process
         software will undergo changes to accommodate the MDS 3.0 implementation, since some
         residents in the database will have a 2.0 and others a 3.0 MDS during the transition        20
       phase. Training will be provided on the changes unless the adjustment is incorporated into
       the major changes to the QIS planned for this Fall. There will also be revisions to
       Appendix PP to update language in the Resident Assessment section and to correct
       outdated references to MDS 2.0 in various locations.

   5. Special Focus Facilities: We are increasing the number of SFFs by approximately 20%
      and increasing the candidate list from which States recommend final selections to CMS.
      The increase will be phased in over two years, with about half of the increase (10%) in
      FY2011 and the remaining increase in FY2012. This increase will primarily affect the
      larger States. A separate S&C Memorandum will be issued detailing the changes.

B. Non-Accredited, Non-Deemed Home Health Agencies (HHAs)
Under Section 1891(b) of the Act, the Secretary is responsible for assuring that Conditions of
Participation (CoPs) and the resulting enforcement are adequate to protect the health and safety of
individuals under the care of an HHA and to promote the effective and efficient use of Medicare
funds. In accordance with Sections 1861(o), 1864 and 1891(c) of the Act, SAs generally conduct
surveys of HHAs to determine whether they are complying with the CoPs.

HHAs must be surveyed via a standard survey at least every 36.9 months. This is not an average
of 36.9 months; it is a maximum interval between surveys for any one particular HHA. The
Medicare statute established the 36-month interval commensurate with the need to assure the
delivery of quality home health services. Comprehensive State performance standards for
compliance with the 36.9-month statutory requirement continue to apply.

For FY2011, we continue to make an exception to instructions in Section 2195E of the SOM in
favor of what we believe will be a simpler and better method. For FY2011, we are also making an
exception to instructions in Section 2195.1 of the SOM. It will be optional for States to encode
into ASPEN the ―A-B-C-D‖ categorization of HHAs by which frequency of survey has been
determined in the past. The SOM is scheduled for updates to take place in FY2011.

Each SA will conduct surveys on a 5% targeted sample of non-deemed HHAs each year. Based on
an analytical program developed by the University of Colorado under contract with CMS, we will
generate a list of HHAs for which available data indicate higher-than-average risk of quality
problems. We will again provide survey lists for targeted surveys. In addition, we will provide a list
of agencies who were non compliant with OASIS submission requirements under the Pay for
Reporting structure. States will then apply their additional knowledge and professional judgment to
select a subset of agencies from the CMS list that will then comprise a final sample equal in number
to 5% of all HHAs in the State. In this manner we hope to target increasingly scarce Medicare
resources most effectively.

In Tier 4 we promote additional surveys (beyond Tier 1 and Tier 2) sufficient to ensure that,
ultimately, 50% of HHAs are surveyed each year, on average. The additional surveys needed to
reach the 50% level (beyond those already done in Tiers 1and 2) are prioritized for FY2011 in the
lower Tier 4 priority, due to budget limitations.

Use of newly enhanced HHA survey protocols and the identification and monitoring of HHA
branch locations will continue. Branch office reports were made available beginning December
2006 and supply surveyors with branch specific OASIS reports to assist with the survey process.
Additionally, we are continuing our efforts to improve the HHA survey protocols.
                                                                                               21
With respect to HHA branch identification, RO‘s must apply a unique identification number to
every branch of a parent or subunit. All new HHA branches must continue to be assigned CMS
identification numbers. Each branch is numbered with the same Federally-assigned provider
number as the parent or subunit with two modifications. There is a ―Q‖ between the State code
and four-digit provider designation plus three more digits for a 10-character branch identifier. The
last three digits will allow a maximum of 999 branches to be assigned to one parent or subunit
HHA. ROs must enter these identification numbers into a branch identification field in ASPEN
and maintain an accurate database of branch identification numbers from this point on. HHAs are
required to report the branch number on the OASIS assessments.

SAs should continue to follow the direction in Section 2182 of the SOM when reviewing an
HHA‘s request for a branch office.

Before any State or Federal surveyor may serve on a survey team (except as a trainee) for an HHA
survey, he/she must attend the Basic HHA course (see S&C-03-05 that clarifies the intent of
Section 4009C of the SOM). In addition, all HHA surveyors must have received training on the
enhanced HHA survey protocols, now incorporated into SOM Section 2200 and included in the
Home Health Basic Surveyor training.

                                             HOME HEALTH AGENCIES
                  Tier 1                                  Tier 2                  Tier 3             Tier 4
  36.9-Month   Max. Interval: No more         5%  Add’l Targeted Sample:                  24.9 Month Avg: Add‘l
   than 36.9 months elapses between            States annually survey 5% of the             surveys (beyond Tiers 1-3)
   surveys for any particular agency.          HHAs, selected from a CMS list               done based on State
  Surveys Pursuant to Complaints:             that identifies those agencies               judgment regarding HHAs
   Extended surveys are required after         more at risk of providing poor               more at risk of providing
   each complaint investigation that finds     care. Surveys in the targeted                poor care so all HHAs are
   substantiated CoPs out of compliance        sample may count toward the                  surveyed on avg. every 24.9
   (both deemed & not deemed HHAs).            36.9-month interval requirement.             mos. (all surveys divided by
                                                                                            total agencies ≤ 24.9 mos.)

CMS completed the national implementation of the OASIS C in early FY2010. Implementation
support included:

       Providing comprehensive instruction to RO and OASIS Educational Coordinators (OECs)
        so that these individuals can successfully manage provider and surveyor inquiries and
        issues related to the OASIS process and the OASIS C. States should budget for the travel
        for this conference (assume a Baltimore conference).

       Providing training and educational products for the SAs and surveyors so that these
        individuals can successfully understand the changes to the OASIS instrument and
        implement changes to the survey process. States should budget for the travel for this
        training.

States will be responsible for assuring that their survey staff members are trained in the use of the
new protocols and worksheets based on the changes to the SOM and survey processes as a result
of OASIS C implementation. This will ensure that surveyors and State OASIS Coordinators have
the necessary skills to perform their roles. Each SA will be responsible for sending its OASIS
Education Coordinator(s) to the OASIS Coordinators‘ Conference and ensuring that OASIS
Coordinator(s) and survey staff members attend all mandatory training sessions related to the
OASIS Process and/or OASIS C.
                                                                                                    22
C. Accredited, Deemed Home Health Agencies
CMS has a statutory responsibility to report annually to Congress on the performance of the
national accreditation organizations whose programs have been recognized for Medicare
participation purposes, including HHA deemed accreditation programs. States will continue to be
responsible for conducting complaint surveys related to HHAs and validation surveys of 5%
(sample will be selected by CMS based on the accreditation survey schedule) of deemed HHAs
that are surveyed by accreditation organizations (AOs) in FY2011. Surveys must be completed
within 60 days of completion of the AO survey. Each SA should budget for one validation
survey of its deemed HHAs from its standard allocation, unless it does not have any deemed
HHAs located in its State.

Depending on the AOs‘ actual survey schedules, there may be States with deemed HHAs for
which no validation survey can be assigned in FY2011. CMS receives monthly updates from the
AOs on surveys scheduled for the next 60 days. Each month a sample of these surveys is selected
for validation and we will inform the SAs promptly if they have been assigned a validation survey.
 A small number of States with large numbers of deemed facilities may be designated to perform
more of these validation surveys once they have completed the one validation survey provided for
in the standard allocation. For these States, a supplemental budget allocation will be made for
surveys completed beyond the first validation survey.

                      ACCREDITED, DEEMED HOME HEALTH AGENCIES
                 Tier 1                                    Tier 2                       Tier 3   Tier 4
 5% Validation Surveys: States annually
 survey a representative sample of
 deemed HHAs specified by CMS during
 the year. At least 1 deemed HHA is
 surveyed in each State, unless the State
 has no deemed HHAs, or unless CMS
 makes no assignment, based on AO
 survey schedules. (Each State surveys 1
 HHA within its standard budget
 allocation; additional surveys are
 budgeted via supplemental allocation)
 Surveys Pursuant to Complaints:
 Extended surveys are required after each
 complaint investigation that finds
 substantiated CoPs out of compliance
 (both deemed & not deemed HHAs).

D. Intermediate Care Facilities for the Mentally Retarded (ICFs/MR)
States have a statutory obligation to conduct annual surveys of ICFs/MR in order to renew their
annual agreement. In addition, if the SA is unable to conduct the survey before the expiration date,
the SA must give the State Medicaid Agency written notice to extend the time-limited agreement and
the recertification must occur before the expiration of the extension. Beginning in FY2002 CMS
adopted a comprehensive State performance standard to monitor to what extent States are recertifying
ICFs/MR before the expiration date of the facilities‘ time-limited agreements.

The President‘s budget requests Federal funds for the Medicaid portion of LTC survey &
certification activities, including recertification surveys and related revisits of ICFs/MR once per
year. States are reminded to secure the necessary Medicaid State share for funding those LTC
survey and certification activities attributable to Medicaid facilities and dually-certified
                                                                                                   23
facilities.

Before any State or Federal surveyor may serve on a survey team (except as a trainee) for an
ICF/MR survey, he/she must attend the Basic ICF/MR course (reference: see S&C-03-05, which
clarified the intent of Section 4009C of the SOM).

                                          ICFs/MR - Priority
                   Tier 1                                        Tier 2                  Tier 3   Tier 4
  12Month Max. Interval: No more than 12.9      Extended  Surveys Pursuant to
  months elapses between surveys for any         Complaints: Extended surveys are
  particular ICF/MR, except for those ICFs/MR    required after each complaint
  for which a short extension is granted.        investigation in which there are
                                                 substantiated CoPs out of compliance.

E. Accredited, Deemed Hospitals – Representative Sample Validation Surveys
CMS has a statutory responsibility to report annually to Congress on the performance of the
national accreditation organizations whose programs have been recognized for Medicare
participation purposes, including hospital deemed accreditation programs. The following
represents CMS policy:

    1. Each State will conduct validation surveys on approximately 1% of accredited, deemed
       hospitals (or at least 1 in each State, whichever is greater) as part of the State‘s baseline
       budget. CMS has attempted to estimate which hospitals the AOs will survey in FY2010
       based on accreditation renewal dates and will select the sample. The projected number of
       surveys for each State is shown in Appendix 3. Each State should budget for the number
       of validation surveys indicated in Appendix 3 from its standard allocation.

    2. Selected States will conduct validation surveys on a second targeted sample (an
       additional 1-5%). The expected number of supplemental hospital surveys for each State
       is shown in Appendix 3. We will notify each affected State as supplemental validation
       surveys are assigned for this ―second sample%.‖

CMS receives monthly updates from the AOs on surveys scheduled for the next 60 days. Each
month a sample of these surveys are selected for validation and we will inform the SAs promptly if
they have been assigned a validation survey. However, for FY 2011, approximately one third of
hospital validation surveys will be surveys of a representative sample of long term care hospitals
(LTCHs) and will not necessarily be based on the AOs‘ survey schedules.

F. Accredited, Deemed CAHs – Representative Sample Validation Surveys
CMS has a statutory responsibility to report annually to Congress on the performance of the
national accreditation organizations whose programs have been recognized for Medicare
participation purposes, including critical access hospital deemed accreditation programs. Each
State should budget for validation surveys of 5% of its accredited, deemed CAHs (or at least one
survey, whichever is greater) unless it does not have any deemed CAHs located in its State. States
with very small numbers of deemed CAHs may not have any that are surveyed by an AO during
2011, but we will not be able to determine this fact until well into the fiscal year. Nonetheless, all
States should tentatively plan for at least one such validation survey. CMS receives monthly
updates from the AOs on surveys scheduled for the next 60 days. Each month a sample of these
surveys is selected for validation and we will inform the SAs promptly if they have been assigned
a validation survey.
                                                                                                    24
G. Complaints in Accredited, Deemed Hospitals and CAHs – Validation of Complaint
Investigations
Complaint investigations of accredited hospitals and CAHs are prioritized with all other
complaints (Tier 2), unless the RO authorizes an investigation of a complaint that it has
determined would, if substantiated, pose an immediate jeopardy (IJ) to patients. Such potential IJ
complaints are prioritized as Tier 1. In addition, full surveys of accredited, deemed hospitals and
CAHs conducted pursuant to a complaint investigation that substantiates condition-level
deficiencies in a deemed hospital or CAH are prioritized as Tier 1.

       ACCREDITED, DEEMED HOSPITALS AND CAHS – VALIDATION SURVEYS
                                Tier 1                                                 Tier 2      Tier 3   Tier 4
  First  (1%) Sample: All States perform at least one survey and           Non-IJ   Complaints
   selected States perform additional surveys of the States‘ accredited,
   deemed hospitals, designed to validate the surveys of accredited
   organizations, with CMS identifying the hospitals to be surveyed in
   each State (“first 1%” sample funded via the State’s regular
   budget).
  Targeted Second (Add’l) Sample: Some States conduct add‘l
   surveys from a second sample identified by CMS. (Second
   sample% budgeted separately and allocated as supplemental
   funding during the year)
  5% CAH Validation Surveys: States annually survey a
   representative sample of accredited, deemed CAHs specified by
   CMS during the year (5% of surveys conducted by accrediting orgs,
   or at least 1 survey, whichever is greater.) (Entirely funded out of
   each State’s regular budget).
  Complaint surveys: authorized and prioritized by the RO. IJ
   complaints are to be initiated within 2 days of authorization and are
   Tier 1 priority. All others are to be initiated within 45 days and
   represent a Tier 2 priority. The on-site portion of EMTALA
   surveys must be completed within 5 days of RO authorization.
  Surveys Pursuant to Complaints: Full surveys are required after
   each complaint investigation that finds substantiated CoPs out of
   compliance for accredited, deemed hospitals and CAHs.

H. Non-Accredited, Non-Deemed Hospitals and CAHs
CMS policy is to achieve a national recertification coverage level that ultimately achieves 33%
coverage for non-accredited, non-deemed hospitals and CAHs. To accommodate resource
limitations, we have spread that expectation across multiple tiers rather than just one tier. In
addition to all non-accredited short term acute care hospitals and CAHs, the CMS coverage policy
applies to specialty hospitals, such as long term care, rehabilitation and psychiatric hospitals and to
rehabilitation and psychiatric units within accredited short term acute care hospitals. The priorities
apply to recertification surveys, associated revisits of non-accredited hospitals or CAHs and initial
surveys.


Critical Access Hospitals (CAHs)
A conversion survey is required for each new non-accredited, non-deemed CAH. Generally, all
prospective CAHs must first be certified and enrolled as a hospital and may then seek conversion
to CAH status. Requests from a hospital to be certified as a CAH are therefore not treated as
initial surveys but as conversions and may be surveyed as a Tier 2, 3, or 4, priority at State option.

                                                                                                              25
I. Inpatient Prospective Payment System (IPPS) - Excluded Hospitals/Units

   1. Sampling Surveys for Existing IPPS-Excluded Hospitals/Units: States will also be
      responsible for conducting an onsite re-verification of IPPS exclusion criteria for at least
      5% (but not less than 2 hospitals) of rehabilitation hospitals and rehabilitation and
      psychiatric units within short-term acute care hospitals, when those units have already
      qualified for IPPS exclusion. This requirement applies regardless of whether the hospital
      participates via deemed accreditation status or not, since AOs do not have the authority to
      deem hospitals in compliance with IPPS exclusion criteria. These surveys must be
      scheduled at least 90 days prior to the beginning of the hospital cost reporting period.
   2. New IPPS-Exclusion Applications: Based on guidance provided via S&C-08-03 (dated
      November 5, 2007), the requirement for States to conduct first time onsite verification
      surveys of all new rehabilitation hospitals and or all new rehabilitation or psychiatric units
      of short term acute care hospitals seeking exclusion from IPPS will continue to be waived.
       Such hospitals newly seeking IPPS exclusion will instead be required to self-attest to their
      compliance with the exclusion criteria. These first-time attestations must be processed
      prior to the beginning of the hospital cost reporting period. Once approved, the newly-
      approved hospitals/units are placed by the State into the pool of existing IPPS-excluded
      hospitals/units from which the annual 5% onsite verification sample is drawn.

We continue to suspend the requirement that accredited IPPS-excluded rehabilitation
hospitals/excluded units be validated for compliance with exclusion criteria at least once every six
years with surveys scheduled at least 90 days prior to the end of the hospital cost reporting period.
The suspension will continue until such time as the IPPS requirements may be codified in the
Conditions of Participation.

NOTE: IPPS-exclusion verifications or re-verifications may always be conducted concurrently
with a regular hospital survey, as long as the cost-reporting period timeframes are observed.




                                                                                                  26
                 NON-ACCREDITED, NON-DEEMED HOSPITALS and CAHs and
                        IPPS-Excluded Hospitals/Units – All Hospitals
Tier                 Tier 2                                       Tier 3                                        Tier 4
 1
           5% Targeted Sample:                   4.0-Year Interval: No more than 4.0               3.0-Year Avg: Add‘l
            States survey at least 1 but           years elapse between surveys for any               surveys are done (beyond
            not less than 5% of the                particular non-accredited hospital or              Tiers 2+3), based on State
            short-term, acute care non-            CAH                                                judgment regarding the non-
            accredited hospitals and              New IPPS: All new rehabilitation                   accredited hospitals and
            5% of non-accredited                   hospitals/ units & new psychiatric                 CAHs that are most at risk
            CAHs in the state. These               units seeking exclusion from IPPS (9),             of providing poor care, such
            are selected from CMS lists            as well as existing providers newly                that all non-accredited
            that identify those hospitals          seeking such exclusion. The SA does                hospitals or CAHs in the
            and CAHs more at risk of               not need to conduct an on-site survey              State are surveyed, on avg,
            providing poor care. Some              for verification of the exclusion                  every 3.0 years (i.e., total
            targeted surveys may                   requirements, but instead may process              surveys divided by total
            qualify to count toward                an attestation of compliance by the                non-accredited
            Tier 3 + 4 priorities.                 hospital.                                          hospitals/CAHs is not more
            Targeted sample                       IPPS Exclusion Verification                        that 3.0 years; separate
            requirements do not apply              (Existing excluded hospitals/units):               calculation for hospitals and
            to States with fewer than 7            5% (but at least 2 per State) of                   CAHs). Targeted surveys
            non-accredited hospitals or            providers already IPPS-excluded.                   may count toward the 3.0-yr
            CAHs. Separate                         These are rehabilitation hospitals,                avg.
            calculation for hospitals              rehabilitation units and psychiatric
            and CAHs.                              units that have attested to continued
                                                   compliance with the IPPS exclusion
                                                   requirements (10). These surveys
                                                   verify that the hospital/unit continues
                                                   to meet IPPS exclusion criteria.

J. Religious Non-Medical Healthcare Institutions (RNHCI)
The RNHCI provider is responsible for meeting the Conditions of Coverage to qualify as a
Medicare provider and that portion of the Conditions of Coverage that define an RNHCI. The
Boston Regional Office has the primary responsibility for the approval and certification process to
ensure and verify that the RNHCI conforms to specific Conditions of Coverage and all of the
Conditions of Participation.

K. Surveys of Psychiatric Hospitals
Currently, no accrediting organizations have been granted deeming authority for the two special
psychiatric CoPs under 1861(f) of the Social Security Act and 42 CFR, Section 482.61 and 482.62.
 While SAs were formally designated responsibility for surveying the two special psychiatric
CoPs, CMS recognized many SAs do not maintain the psychiatric expertise necessary to assess
compliance with the two special CoPs. As a result, CMS continues to maintain (under contract) a
panel of psychiatric consultant surveyors to conduct initial and recertification surveys of the two
special conditions.

CMS policy is to conduct recertification surveys of 25% - 33% of psychiatric hospitals each year
for the two special psychiatric conditions for those psychiatric hospitals that elect PPS exemption.
Working with the CMS ROs, CMS Central Office directs the contract surveyors to conduct initial
and recertification surveys and to conduct complaint investigations, upon direction from the CMS
Central Office, for the two special psychiatric conditions. On occasion, a survey of the two special

9 Onsite verifications are to be completed no later than 90 days prior to the beginning of the hospital‘s cost reporting period.
10 Onsite verifications are to be completed no later than 90 days prior to the beginning of the hospital‘s cost reporting period.   27
psychiatric conditions may indicate that a survey of the general hospital conditions is required. In
such instances, the appropriate State and RO are consulted for the necessary action. States that
require assistance in reviewing the two special psychiatric conditions, or have recommendations of
hospitals for surveys should contact their RO.

Effective October 1, 2010, when deficiencies are indentified in initial or recertification surveys of
the two psychiatric conditions, CMS central office will authorize up to two revisits by CMS
contract surveyors if recommended by the CMS Regional Office. A third revisit may be
conducted only if recommended by the CMS Regional Office and conducted either by the State or
the RO survey staff. CMS will provide a Basic training course (via Blackboard technology) to
assist those State and Regional surveyors who either have not surveyed psychiatric hospitals for an
extended period of time or have been unable to attend an on-site training course.

In addition, for those States that have the requisite professional resources available and wish to
assume the responsibility for the survey of psychiatric hospitals in their State, CMS will make
contractor staff available upon request for either on-site training or a partnership survey. A budget
adjustment, similar to the one provided for States performing transplant hospital surveys, would be
made for initial and recertification surveys conducted by the State Agency. In order to conduct
these surveys, surveyors must have experience in the psychiatric hospital setting (psychiatric nurse,
psychiatrist and psychologist). If a State assumes responsibility for the two special conditions for
psychiatric hospitals in their State, it must adhere to the time interval between surveys (3-4 years)
as stated in this document and survey 25-33% of psychiatric hospitals each year.

                                      Psychiatric Hospitals
   Tier 1        Tier 2                          Tier 3                               Tier 4
                           N/A – Performed by CMS National Contractor

L. Organ Transplant Programs
On March 30, 2007, the final regulation establishing new survey and certification requirements for
organ transplant programs was published in the Federal Register. This regulation took effect June
28, 2007. Transplant programs that were Medicare approved as of June 28, 2007 were required to
apply for survey and certification, under the new regulations, by December 26, 2007 (180 days
from the regulation‘s effective date).

We expect all transplant programs to be surveyed under the new Conditions of Participation to be
completed by October 2010.

Programs that participated in Medicare prior to June 28, 2007 have been able to continue to
participate in Medicare under the aegis of the current National Coverage Determination (NCD) or
ESRD Conditions for Coverage. New transplant programs that start after the new rule‘s effective
date (June 28, 2007) may only participate in Medicare pursuant to the new rules and require an
onsite survey prior to such participation.

Overall Responsibilities: States and a CMS Contractor are responsible for conducting initial, re-
approval, certification, complaint and associated revisit surveys of transplant programs. We are
distributing the transplant surveys over multiple tiers:

Tier 1:
          Complaint Investigations – IJ: Investigation of complaints that are potential immediate
                                                                                                28
          jeopardy.

Tier 2
   (a) Initial Surveys: Initial surveys of transplant programs under the new Conditions of
       Participation
   (b) Mandatory Re-Approval Surveys- Re-approval surveys for transplant programs that are
       due for re-approval in this fiscal year for which one or more of the following criteria apply
       (and are described in 42 CFR 482.82):
           ● Average data submission of OPTN forms falls below 95%;
           ● Average clinical experience (volume) over the past 3 years is less than 10 transplants
             per year (if the program must meet such requirements); or
           ● Patient and graft survival outcomes are significantly lower than expected to such an
             extent that it exceeds the regulatory thresholds.

          CMS will generate the list of these transplant programs annually for distribution to the
          SAs;

   (c) Targeted Surveys- CMS will distribute a targeted list that identifies transplant programs
       that have had significant programmatic changes or where there are indicators of poor
       performance at the beginning of the fiscal year. Targeted surveys continue strong federal
       oversight of all organ transplant programs while making effective and efficient use of
       federal and state resources. The targeted list will vary by state, depending on the risk
       factors that are evident (such as key personnel changes, extended periods of inactivity,
       mergers, nearby programs closing, poor risk-adjusted outcomes). For planning purposes, it
       would be reasonable for States with 5 or more transplant programs to anticipate a 20%
       targeted sample. No percentage estimate is appropriate for other states due to the very low
       number of programs. The targeted re-approval survey list is confidential for use only within
       the specific State survey agency.

   (d) Complaint Investigations- Non-IJ: Investigation of complaints not categorized as potential
       immediate jeopardy.


Tier 3:
           Maximum Interval- The Tier 3 priority is an interval measure identifying a maximum of
          4.0 years between onsite surveys for any one particular transplant program (see Appendix
          1). Targeted surveys under Tier 2 may count toward the Tier 3 priority.

Review of All Transplant Programs within a Transplant Hospital

If a transplant program within a hospital must be surveyed as part of the mandatory or targeted
sample, we expect that all transplant programs within the same hospital that have applied for
Medicare certification will be reviewed at the same time. The CMS Regional Office may grant
exemptions to this policy on a case-by-case basis. Such exemption does not change the
requirements established under the Tier structure described above. Surveying all transplant
programs within a given hospital will simplify the approval and accountability process and dates,
and will generally be more efficient than returning to the hospital on several occasions to survey
different programs. Note: this paragraph does not apply to complaint investigations.

                                                                                                     29
Please note that the information used to determine whether or not a transplant program be included
in the targeted sample is updated frequently (e.g., national data is provided quarterly or semi-
annually). CMS CO and RO will work with the SA on a case-by-case basis if there is a need to
substitute, add, or remove onsite surveys recognizing that the SA survey schedule is often
established months in advance.

For FY2011, we plan for a mix of State surveys for transplant programs and national contractor
surveys. Based on feedback we received, 22 States and the District of Columbia expressed a
desire to survey organ transplant programs. Initial surveys of transplant centers in the remaining
24 States and Puerto Rico will be surveyed by CMS‘ Contractor. Four States (AK, ID, MT and
WY) do not currently have any transplant programs; if any transplant programs apply from those
States, we will discuss this at that time with the respective State.

As we implemented the three-year phase in of transplant center surveys, we have fully honored
State preferences as to whether they wished to survey transplant programs themselves or have our
national contractor conduct the surveys. Near the end of FY2010 we will complete the three year
phase-in and will begin the process of all States with 5 or more transplant hospitals conducting
transplant center surveys. In FY2010, we required just those States with 7 or more hospitals to
begin conducting transplant center surveys. In FY2011, States with 5 or more transplant centers
will be conducting these surveys. The FY2011 additional States, that will begin to conduct
transplant center surveys are identified in italics and marked with and asterisk in the table below
and should ensure that the appropriate surveyors attend the transplant hospital training in mid-
September 2010 so that they are prepared to conduct transplant center surveys starting in FY 2011.

For States and the District of Columbia that will be surveying organ transplant programs, the table
below also outlines the number of surveys that were completed in FY2009 and the expected
number and schedule of initial onsite and re-approval surveys of transplant hospitals for FY2010
through FY2011. This table is intended to assist in overall workload planning. Additional
information about the specific transplant programs that have applied and the priority of each
program will be provided to the ROs and the States in future communications.

Surveys that may arise from complaints and initial surveys for transplant hospitals that have not
applied to CMS for approval as of May 2010, are not included in this table and represent
additional SA responsibilities in those States surveying transplant centers. We expect that the
current process for handling complaint surveys will not change. States that have not elected to
survey transplant centers will still need to conduct complaint investigations in transplant centers
when the allegations involve implication for hospital Conditions of Participation or ESRD
Conditions for Coverage.




                                                                                                  30
    Table: Estimated Workload for SA Onsite Surveys of Organ Transplant Programs


                                  Total Number of Transplant            Number of Re-approval
           States                         Hospitals                           surveys
Arizona                                                             5                           1
California                                                         22                           4
District of Columbia                                                4                           0
Florida                                                            10                           3
Georgia*                                                            5                           2
Illinois                                                            8                           3
Indiana                                                             3                           1
Iowa                                                                3                           1
Kansas                                                              2                           1
Kentucky                                                            3                           2
Maryland                                                            2                           1
Massachusetts                                                       9                           3
Michigan                                                            8                           2
Minnesota                                                           5                           3
Missouri                                                            8                           3
New Jersey*                                                         6                           2
New York                                                           15                           6
North Carolina                                                      4                           2
North Dakota                                                        2                           0
Ohio                                                               10                           3
Oklahoma*                                                           5                           2
Oregon                                                              2                           0
Pennsylvania                                                       16                           7
South Dakota                                                        2                           1
Tennessee                                                           9                           3
Texas                                                              27                           8
Virginia                                                            6                           1
Washington                                                          5                           2
Total                                                                                          67
    * New States to begin transplant hospital surveys in FY2011.

 a. Transplant hospitals generally have multiple programs within each hospital. During the survey, each
    transplant program must be reviewed and approved separately.




                                                                                                     31
                                          Transplant Centers
          Tier 1                             Tier 2                             Tier 3     Tier 4
  Complaint               Initials: Any initial surveys of programs    4.0Yr Max
  Investigations -IJ       Mandatory Re-approval Surveys: The           Interval: No
                            transplant program does not meet the data    more than 4.0
                            submission, clinical experience or           years elapses
                            outcomes requirements.                       between onsite
                           Targeted Sample (5-25%): Surveys of          surveys for any
                            transplant programs from a CMS list that     particular
                            identifies those transplant programs that    transplant
                            have had significant program changes         program.
                            and/or are more at risk of providing poor
                            care. Surveys in the targeted sample may
                            count toward the Tier 3 requirement.
                           Complaint Investigations – Non-IJ




M. End Stage Renal Disease (ESRD) Facilities
Notable aspects of the ESRD survey responsibilities and new developments include:

1. 1. Information and Communications Responsibilities: States are responsible for being
   informed about and communicating with the ESRD programs in the State and as applicable,
   with the appropriate ESRD network.

2. Survey Priorities and Responsibilities:

1. High Safety Risk: ESRD surveys are conducted to protect the health and safety of ESRD
   beneficiaries who face extraordinary technical and clinical risks associated with dialysis
   treatments. The treatments provided in ESRD facilities involve high safety risks because of:
   (1) the complex and varied nature of the dialysis and reuse equipment requires operation by
   knowledgeable staff; (2) the need for water to be treated onsite because it can only contain a
   minimal level of bacteria, endotoxins, or chemicals (since during dialysis treatment,
   contaminated water mixed with acid and bicarbonate, can be toxic for a dialysis patient); and
   (3) the extracorporeal circulation of blood that occurs in the ESRD facility presents a higher
   risk for transmission of infections than in the hospital setting. Many of the potentially life
   threatening procedures associated with dialysis treatments have resulted in individual or
   multiple patient deaths.

2. Minimum Requirements for ESRD Surveyors: The basic requirements for new ESRD
   surveyors were specifically communicated in policy letter S&C-03-05, which clarified the
   intent of Section 4009C of the SOM. CMS expects States to continue to fulfill these
   requirements for FY2011. Specifically, before any State or Federal surveyor may serve on an
   ESRD survey team (except as a trainee), he/she must attend one of the ESRD technical
   courses, i.e., the ESRD Basic Technical Course, or the ESRD Advanced Technical Course.
   Surveyors may choose the courses that best fulfill their needs.

   Because of rapid changes in dialysis technologies, ongoing refinements in clinical measures
   and standards based upon updated data analysis and research and changing patterns of care
   delivery driven by a variety of factors including new payment strategies, CMS expects that
   specialized ESRD surveyors who do ESRD surveys will keep their skills updated and learn
   about new ESRD equipment and technologies including attendance at the ESRD Annual
                                                                                                    32
   Update Course or an ESRD Technical Course at least every other year.

3. State Specialization of ESRD surveyors for a Complex, Technical Survey: States must be
   prepared to survey ESRD facilities for such technically and clinically complex areas as water
   treatment safety, dialyzer reuse safety, specialized infection control and prevention
   precautions, equipment operation and maintenance and staffing qualifications and abilities.
   While the average lifespan of the ESRD beneficiary is 6 years, the ESRD data show that taking
   into account the difference among patients, the practice patterns of facilities can affect that
   lifespan by 20% on average – almost a one year gain in life expectancy directly attributable to
   better quality of care. The emphasis of the ESRD survey process focuses on those practice
   patterns that are known to affect mortality and to provide potential safety risks to patients.
   When States invest in the specialization of their surveyors responsible for ESRD surveys, it
   allows them to build higher levels of expertise in this complex survey process and focus
   training on that smaller group of specialists.

4. Data Reports: CMS has implemented a system of providing facility specific and State-
   specific ESRD Data Reports for use by States as a guide for ESRD surveys. Each State must:
    ● Use the Outcomes List and data profiles to (1) select facilities for survey; and (2) as part of
      the pre-survey activity for every ESRD survey, following the ESRD Survey Protocol.
    ● Use these data reports to better understand and monitor the performance of renal facilities
      during and between surveys.
    ● Use the data reports to help determine the extent of potential citations.
.
       In 2009, the ESRD program initiated a new web-based ESRD data system titled
       CROWNWeb. During 2011, the Survey & Certification Group will begin developing pilot
       models for integrating data from the CROWNWeb system into the facility-specific and
       State-specific Data reports used by providers and States. These data reports will be used to
       address specific areas of the new regulations, including Quality Assessment and
       Performance Improvement, Patient Assessment and Plan of Care. Through its data reports
       and monitoring system, the Survey & Certification Group will play a critical role in the
       rollout of the Quality Initiative Program (QIP) in FY 2011. The QIP is the quality phase of
       the new ESRD bundled payment strategy and the MIPPA-driven payment deduction for
       poor performance.


5. Fistula First: Each State should have an identified person who coordinates the State‘s
   activities regarding the Department‘s Breakthrough Initiative on Vascular Access Improvement
   (i.e., ―Fistula First‖). This State representative should remain current regarding the goals and
   materials available as part of this Breakthrough Initiative. One of the sources of information is
   the website, www.fistulafirst.org. The representative should also ensure that State data
   regarding fistula rates are reviewed and focused surveying occurs in facilities that have low
   fistula rates. We do not expect this to represent a substantial workload, nor require a full-time
   position. The basic requirement is for a point person who can maintain key communications,
   become knowledgeable about fistulas and the national initiative and design internal procedures
   that will advance fistula implementation.


6. New ESRD Conditions for Coverage & New Survey Protocol: Effective October 14, 2008,
   new ESRD regulations to certify and survey ESRD facilities were implemented. There were a
                                                                                          33
number of notable changes in the new ESRD regulations, including:

      New - ESRD Life Safety Code Surveys: Beginning in 2009, applicable ambulatory
       healthcare provisions of the 2000 edition of the Life Safety Code (LSC) of the National
       Fire Protection Association apply to ESRD facilities.

       The LSC component of the ESRD survey will be accomplished according to the
       following schedule:
       1. New Providers: LSC component surveys should occur at the time of their initial
          certification for those initial surveys of providers who meet the definition of a
          ―new‖ provider in the CMS regulation. If the initial certification is for a provider
          who meets the regulations definition as an ―existing‖ provider (e.g., constructed
          before February 9, 2009) then the LSC component should be phased in together
          with the schedule for recertification surveys (see below).
       2. Complaint Surveys: If there is a credible LSC complaint that needs to be
          investigated, schedule and perform the investigation promptly.
       3. Recertification Surveys: LSC component surveys for recertification surveys and
          existing providers will be initiated in late CY 2010. We expect each State to
          survey a portion of their ESRD facilities each year using the ESRD-Specific LSC
          guidance. Additional details will be communicated via S&C Memoranda.

      New – Dialysis Patient Care Technician Certification: By April 15, 2010, all
       dialysis patient care technicians who had been employed for at least 18 months were
       required to be certified either through a CMS-approved national certification
       organization or under a CMS-approved State certification program. Newly-employed
       dialysis patient care technicians have 18 months from their date of hire to be certified.
       Listings of approved programs are available through CMS.

      New – Detailed Infection Control and Water/Dialysate Quality Requirements:
       CMS has incorporated into regulations several sets of detailed recommendations
       established by the Centers for Disease Control and Prevention (CDC) and the
       Association for the Advancement of Medical Instrumentation (AAMI). These
       recommendations are detailed, specific and have the force of regulation.

      New – Patient Assessment and Plan of Care Requirements: The new regulations
       require that a patient assessment and a plan of care for each assessment be completed by a
       specified interdisciplinary team that communicates and plans concurrently. Specific
       standards and measures are referenced in CMS‘ Measures Assessment Tool (MAT).

      Mostly New - QAPI System: The previous requirement for a ―quality assessment and
       performance improvement‖ system has been substantially strengthened and modernized
       to reflect the current state of program improvement science. The regulation obliges
       facilities to have an ongoing, data-driven system to measure and track specific quality
       indicators, as identified and specified in the ESRD Measures Assessment Tool so as to
       achieve measured improvement in outcomes and error reduction. The facility must
       immediately correct any identified problems that threaten the health and safety of
       patients and use the QAPI system to take actions that reduce future incidents. This is
       an important Condition for Coverage in its own right, as well as functioning as an
                                                                                             34
             ―independent but associated‖ requirement in concert with deficiencies in a variety of
             other Conditions.

7. Surveyor Technical Assistant for Renal Disease (STAR) software, PC Tablet Technology,
   and Training: STAR is an automated software program for the ESRD survey process, which is
   utilized on PC Tablets. Throughout the year, CMS will provide STAR training courses that
   teach the STAR software, as well as provide an introduction to PC Tablet technology.

8. ESRD Infection Control Initiative: In conjunction with AHRQ and CDC, we will be
   conducting a new ESRD Infection Control Initiative to reduce healthcare associated infections
   in ESRD facilities. We will communicate additional information via S&C Memoranda later in
   FY 2011 and FY 2012.

9. Initial ESRD Surveys: We encourage initial surveys of ESRD facilities to occur as early as
   possible on the survey schedule because of a combination of unique characteristics of ESRD
   facilities:

         ● Approximately 95% of the beneficiaries in ESRD facilities are supported by Medicare
           insurance.
         ● The statute prevents ESRD facilities from being deemed for certification by any
           accrediting organization.
         ● ESRD beneficiaries represent one of the fastest growing Medicare sub-populations.
         ● Capital construction costs for ESRD facilities are significant and the staff required to
           operate a dialysis treatment facility is specialized.

         For these reasons initial ESRD surveys are prioritized at a higher level than most other
         initial surveys (see category 15 of Appendix 1).

                                              ESRD FACILITIES
Tier 1                Tier 2                                  Tier 3                                  Tier 4
          Targeted    Sample (10%): States    3.5-Year  Interval (42.9 months):         3.0-Year  Avg: Additional
           survey a 10% targeted sample of      Additional surveys are done to ensure     surveys are done (beyond
           ESRD facilities, selected from a     that no more than 3.5 years elapses       Tiers 2-3) sufficient to
           CMS list that identifies those       between surveys for any one particular    ensure that ESRD facilities
           facilities most at risk of           ESRD facility.                            are surveyed with an
           providing poor care. Targeted       Support “Fistula First”                   average frequency of 3.0
           surveys may count toward the        Initial ESRD Surveys.                     years or less.
           requirements in Tiers 3 and 4.      Expansion of stations or services.
          Relocations


N. Psychiatric Residential Treatment Facilities (PRTFs)
An interim final rule establishing standards for the use of restraint and seclusion in PRTFs was
published on January 22, 2001. An amendment and clarification to this rule was published on
May 22, 2001 with an immediate effective date. The interim final rule published on January 22,
2001 and the interim final rule amendment published May 22, 2001 can be accessed on
www.access.gpo.gov under the published date of January 22, 2001 and May 22, 2001.

The PRTF rule establishes a definition of a PRTF as ―a facility other than a hospital, that provides
psychiatric services as described in 42 CFR, Section 441, subpart D, to individuals under age 21,
in an inpatient setting.‖ The rule also establishes one Conditions of Participation (CoP) for the use
of restraint and seclusion that PRTFs must meet in order to continue to provide the Psych Under
                                                                                                  35
21 benefit.

The CoP specifies requirements designed to protect the residents against the improper use of
restraints that include, but are not limited to: parental/guardian notification when
restraints/seclusion are used; reporting of deaths and serious occurrences; staffing requirements for
staff that order the use of restraint and seclusion; requirements for monitoring residents in and
immediately after seclusion; etc.

The rule requires that restraint or seclusion be used only under emergency situations and requires
each facility that provides services under a Medicaid provider agreement to individuals under 21
who are inpatients, to attest in writing to the State Medicaid Agency, that the facility is in
compliance with the standards set forth in this rule.

The PRTF rule further requires the SA to conduct surveys in 20% of the PRTFs to validate the
accuracy of the attestations and investigate complaints. For purposes of budgeting, States should
contact the State Medicaid Agency to obtain the number of PRTFs in their State. States should
assume surveys will be conducted in 20% of the PRTFs annually. Note: State survey costs
(Federal funds) for this activity are provided through mandatory Medicaid funds. States
should enter all PRTF attestations received from the State Medicaid Agency into the ASPEN
system upon receipt.

      PSYCHIATRIC RESIDENTIAL TREATMENT FACILITIES for CHILDREN
 Tier 1   Tier 2                                      Tier 3                                     Tier 4
                    5-Year Interval: Survey visits (Validation and Complaint) of 20% of PRTFs.


O. Ambulatory Surgical Centers (ASCs)
We have improved the process for ASC surveys to enable better identification of infection control
and other compliance problems. The survey process includes (a) use of a special infection control
survey instrument, (b) tracer methodology in which the ASC experience of at least one patient is
followed throughout the course of the patient‘s ASC stay, (c) multiple-person teams. In FY2011
States are expected to survey at least 25% of the non-deemed ASCs in each State (subject to minor
adjustments). (Before commencing their FY 2011 work, States that received Recovery Act grants
must first complete their required FY 2010 ASC recertification survey workload, no later than
December 31, 2010. On a voluntary basis and with CMS approval, States may also use their FY
2010 Recovery Act grants to perform additional non-deemed ASC recertification surveys, beyond
the required 25 %.) In addition, States may receive supplemental funds with 100% Recovery Act
funds to survey more than the 25% of non-deemed ASCs in FY 2011 (a separate S&C
memorandum S&C 10-31 described the details).

In addition to the Tier 3 requirements, we emphasize the following:

   1. Tier 2 Targeted 25% Sample Surveys for Non-Deemed ASCs: SAs will perform surveys
      totaling 25% of all non-accredited, non-deemed ASCs, or at least 1, whichever is greater,
      unless all non-deemed ASCs were surveyed in FY2010. States must convey to CMS‘
      contractor a copy of the completed Surveyor Infection Control Worksheet for each survey,
      to permit a national analysis of infection control issues that can inform education and
      training efforts. With the exception of the subset of randomly selected ASCs discussed in
      #2 below, States will select ASCs for survey, focusing on ASCs that have not been
      surveyed in more than 6 years and/or ASCs that represent a greater risk of having quality
      problems, based on their recent compliance history and any other important factors
                                                                                               36
   known to the SA.

   Note: In contrast to other Tier 2 targeted surveys, the Tier 2 targeted sample
      requirement for ASCs does apply to a State that has fewer than 7 ASCs.

2. Randomly-Selected Subset of the 25%: Within the 25% target, States must include those
   ASCs identified by CMS via random selection of non-deemed ASCs. As in FY2010, this
   representative sample will fulfill a recommendation of the GAO and provide CMS and
   CDC with representative data on ASC infection control practices captured on the ASC
   infection control survey instrument. The facilities to be surveyed as part of the random
   sample will be identified for the SA by CMS prior to the start of the Fiscal Year. SAs may
   schedule the surveys at any time during the fiscal year, so long as they are all completed by
   the end of the federal fiscal year.

3. Deemed ASCs - SAs will perform validation surveys on a 5% - 10% sample of
   accredited, deemed ASCs. Appendix 3 provides a projection of the ASC
   validation workload for each SA. SAs will receive a supplemental allocation for
   these validation surveys. The ASCs to be surveyed will be selected by CMS
   based on the accreditation survey schedule of deemed ASCs that are surveyed by
   accreditation organizations (AOs) in FY2011. Surveys must be completed within
   60 days of completion of the AO survey.

4. Budgeting - Similar to procedures used in FY2010, funding for the ASC surveys
   for FY2011 is broken out separately in the S&C Medicare budget (see Appendix
   2) and will require some special reporting on Form CMS 435.

   Further, in accordance with AdminInfo 10-31, the performance period for Recovery Act
   grants will be extended until March 31, 2011 for States that:

       o May need more time to complete their FY 2010 workload of recertification surveys
         for at least 33% of their non-deemed ASCs; and/or
       o Apply and are approved for Recovery Act funds to perform more than the FY 2011
         workload of recertification surveys for at least 25% of their non-deemed ASCs.

   For these States:
      o As in FY 2010separate reporting on the Recovery Act websitewill continue until
          they complete all Recovery Act funded survey workload, or they draw down all of
          their Recovery Act grants, whichever comes first;
      o Unlike FY 2010, Recovery Act funds must be used first before drawing down funds
          identified in the ASC column of the State‘s S&C Medicare budget (in Appendix 2).

   Funds identified in the ASC column of the State‘s S&C Medicare budget (in Appendix 2),
   which are not needed by the State to meet the 25% survey requirement, may be used for
   other CMS S&C priorities.

   To calculate the FY2011 funding for ASC surveys in FY2011 on a State-by-State
   basis, we multiplied the number of non-deemed ASC surveys in each State times
   25%. This yields the number surveys of non-deemed surveys expected (i.e., we
   expect 25% of all such ASCs to be surveyed). For most states we then multiplied
                                                                                             37
           this number times the actual average hours per survey for FY 2010 surveys
           reported by each State on the CMS Form 670 as of August 2010 (for both the
           health recertification survey and the life-safety code portion of the standard
           survey). This yields the expected total (aggregate) hours of survey time. Finally,
           we multiply the aggregate expected hours by the State-specific average cost per
           hour for non-LTC surveys. We then add a national average expected cost for
           revisits to arrive at the grand total. Two exceptions apply:

                   Low ―n‖ – If the total number of surveys reported for FY2010 was less than 5; we
                    used the greater of (a) the national average number of hours per survey for FY2010
                    or (b) the State-specific average number of hours for FY2009.
                   Outliers: If a State had a significantly anomalous number of average hours for
                    FY2010, we used the national average number of hours per survey for FY2010
                    instead of the State-reported number of hours per survey.


                                 Ambulatory Surgical Centers (ASCs)
           Tier 1                                     Tier 2                               Tier 3          Tier 4
Validations- Deemed ASCs:       Targeted Surveys (25%): The State performs             6.0-Year            N/A for
5% - 10% of deemed ASCs:       surveys totaling 25% of all non-accredited, non-        Interval:           FY2011
States conduct validation      deemed ASCs in the State (or at least 1, whichever is   Additional
surveys of deemed ASCs,        greater unless all non-deemed ASCs were surveyed in     surveys are done
assigned by CMS based on       FY 2011), based on CMS selection of a random            to ensure that no
AO survey schedules.           sample for a portion of the targeted survey volume      more than 6.0
(Budgeted separately via       and, State judgment for those providers more at risk    years elapses
supplemental allocation)       of quality problems for the remainder. The SA-          between surveys
                               selected ASC sample is drawn only from non-             for any one
                               accredited, non-deemed ASCs. Some of the targeted       particular non-
                               surveys may qualify to count toward the Tier            deemed ASC.
                               3priority. States with fewer than 7 ASCs must survey
                               at least 1 ASC unless all non-deemed ASCs were
                               surveyed in FY 2011.

                               Recovery Act funds allocated by CMS for FY 2011
                               work may be used to exceed the above 25% survey
                               level.

 P. Recertification Surveys of Other Types of Facilities
 CMS is targeting national annual recertification coverage priorities for the other non-LTC
 providers, including:

       •   Comprehensive Outpatient Rehabilitation Facilities (CORFs);
       •   Rehabilitation agency providers;
       •   Portable X-ray suppliers; and
       •   Rural Health Clinics (RHCs).

     1. Comprehensive Outpatient Rehabilitation Facilities (CORFs)
        In January 2006, CMS updated Appendix K of the SOM to address recent concerns
        regarding the provision of core services in CORFs. Specifically, there have been a number
        of findings where Medicare-certified CORFs are failing to provide the core services and/or
        a comprehensive rehabilitation program to the patients they serve, as specified in 42 CFR
                                                                                                 38
   §485.58.

   Due to budgetary constraints, many CORF applicants are unable to receive initial surveys.
   CORFs are now requesting to open off-site locations for the provision of therapy
   services. This is creating an additional work load for the SAs as they must evaluate the
   information provided by the CORFs to determine whether or not to recommend approval
   for those offsite locations to the ROs. Currently CMS does not track offsite locations
   separately. SAs should include off-site locations in the survey process whenever possible.

2. Rehabilitation Agencies (Outpatient Physical Therapy (OPT) and Speech-Language
   Therapy Providers)
   Many rehabilitation agencies provide services from extension sites (such as nursing homes
   and assisted living facilities) rather than their primary site of certification. SAs should
   ensure extension locations are incorporated into the survey process. In FY2006 CMS
   began issuing identifiers to rehabilitation agency extension locations to ensure that CMS
   and SAs were aware of the existence of such locations. It is important for the SAs to verify
   that the rehabilitation agencies with extension locations are providing oversight
   (administrative and supervisory) for all their locations.

   Due to the overwhelming number of extension locations that a rehabilitation agency may
   have, there may be a lack of appropriate equipment or modalities available for patient
   treatment which can affect positive patient outcomes. Data indicates there are more
   extension locations than primary sites and a growth of 200 extension locations in a single
   year. Updates to Appendix E and Chapter 2 of the State Operations Manual assist the SA
   in determining whether an extension location should be approved.

   The Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
   Conditions of Participation were updated to make them consistent with changes made to
   the Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
   payment rules in FY2008. The changes were published in the Physician Fee Schedule and
   implemented in January 2009.

3. Portable X-Ray
   Portable X-ray suppliers are also requesting off-site locations. CMS will track these
   requests to see if there is an emerging trend.

4. Rural Health Clinics (RHCs)
   SAs will perform surveys on a 5% targeted sample of RHCs, or at least 1, whichever is
   greater. States will select the sample, focusing on RHCs that have not been surveyed in
   more than 6 years and/or RHCs that represent a greater risk of having quality problems,
   based on their recent compliance history or other factors known to the SA. States should
   use their individual history of growth, in addition to any State and local events/initiatives,
   as a guide to project workloads. This Tier 2 sample is not required for any State that has
   fewer than 7 RHCs.




                                                                                                39
           CORFs, Rehabilitation Agency Providers, Portable X-Ray, Rural Health Clinics
  Tier 1                                 Tier 2                                       Tier 3                  Tier 4
            5% Targeted Surveys: Each year, the State surveys 5% of             7.0-Year  Interval:   6.0-Year Avg:
             CORFs, Rural Health Clinics, and Rehabilitation Agencies            Additional surveys      Add‘l surveys are
             and Portable X-rays (or at least 1 of each type, whichever is       are done to ensure      done (beyond
             greater), based on State judgment for those providers more at       that no more than       tiers 2+3) such
             risk of quality problems. Some of the targeted surveys may          7.0 years elapse        that all providers
             qualify to count toward the Tier 3 and 4 priorities. States with    between surveys         in the State are
             fewer than 7 providers of each type are exempt from this            for any one             surveyed, on
             requirement.                                                        particular provider.    average, every 6
            Complaint investigations                                                                    years. (i.e., total
                                                                                                         surveys divided
                                                                                                         by total providers
                                                                                                         is not less than
                                                                                                         16.7% = 6.0
                                                                                                         years).

5. Federally Qualified Health Centers (FQHCs)
   Certification and recertification surveys are not required for FQHCs. However, CMS
   investigates complaints that make credible allegations of substantial violations of CMS
   regulatory standards for FQHCs. SAs will use the most of the same health and safety
   standards as they do for RHCs when investigating FQHC complaints.

6. Hospices
   Hospice Conditions of Participation were published on June 5, 2008. The regulation was
   effective December 2, 2008. This was the first full-scale revision since the Conditions of
   Participation were originally published in 1983. Training was provided to hospice
   surveyors nationwide (both experienced and new). New survey tools were developed as
   well as updates to the interpretive guidelines and SOM.

   The SA is expected to have a system in place for nursing home surveyors to report to the
   SA those nursing facilities which are providing hospice services to residents and any
   concerns they have about the provision of hospice services in a specific facility. SAs are
   expected to follow-up and initiate enforcement action against a hospice when they identify
   hospice non-compliance issues associated with care to nursing home residents who have
   elected the hospice benefit.

   Before any State or Federal surveyor may serve on a survey team (except as a trainee) for a
   hospice survey, he/she must attend the Basic Hospice course.




                                                                                                                40
                                                       HOSPICE
              Tier 1                                 Tier 2                           Tier 3              Tier 4
 Deemed Providers/Suppliers: 5% Targeted Surveys: Each year, the                 6.5-Year           6.0-Year Avg:
  States conduct validation         State surveys 5% of Hospices based on         Interval:            Add‘l surveys
  surveys of deemed hospices,       State judgment for those providers more       Additional           are done
  according to a list supplied by   at risk of quality problems. The sample is    surveys are done     (beyond Tiers
  CMS, depending on the             drawn only from non-deemed                    to ensure that no    2+3) such that
  accreditation organizations‘      providers/suppliers. Some of the targeted     more than 6.5        all providers in
  survey schedules for FY2011.      surveys may qualify to count toward the       years elapse         the State are
  (Budgeted separately via          Tier 3 and 4 priorities. States with fewer    between surveys      surveyed, on
  supplemental allocation)          than 7 providers of each type are exempt      for any one          average, every
                                    from this requirement.                        particular           6 years. (i.e.,
                                                                                  provider.            total surveys
                                                                                                       divided by total
                                                                                                       providers is not
                                                                                                       less than 16.7%
                                                                                                       = 6.0 years).

    7. Deemed Hospices
       State agencies will perform validation surveys on a sample selected by CMS, based on the
       accreditation survey schedule of deemed hospices. A limited number of States with
       deemed Hospices will be required to perform these validation surveys, for which a
       supplemental allocation will be provided.

Q. Swing Beds
Swing beds will continue to be surveyed as part of a scheduled hospital or CAH survey, but need
not be targeted for a separate, stand-alone survey, unless a hospital or CAH is applying for an
initial swing bed agreement. States should include swing beds during hospital and CAH
recertification surveys. Swing bed hospitals are transitioned to the SNF/PPS starting on the first
day of the hospital‘s first cost reporting period. States must provide technical assistance and
training to providers on both clinical and systems aspects of swing bed assessment submissions.
See Section 5. D for the scheduling of surveys for hospitals or CAHs that wish to add swing beds
as a new service.

R. Community Mental Health Centers (CMHC)
CMS has drafted new regulations for CMHCs which are currently in the clearance process. It is
anticipated that these regulations will be effective in early FY2011. Previously, all survey activity
for CMHCs has been conducted by the CMS Regional Offices. With the implementation of these
new regulations, the State Survey Agencies will assume the responsibility for the surveys. The
survey interval for the CMHCs, utilizing these new regulations, will be every five (5) years. CMS
will provide national training for the survey of the CMHCs under the new regulations in the later
part of FY2011 anticipating that the State surveys will begin surveys in FY2012. The initial
surveys of the CMHCs under the new regulations will be implemented over a 4-5 year period.
Targeted surveys may be assigned to achieve faster application of the new CoPs, (faster than 20%
of the CMHCs completed each year) but we will provide a 3-6 month advance notice in such a
case. CMS will work with the States to develop a methodology for the prioritization of the
existing facilities. The new regulations must be utilized for all initials and complaint
investigations starting in FY2012.

S. Complaint and Facility Self-Reported Incident Investigations
We place continued high priority on complaint investigations. The budget contains funds for
                                                                                                                   41
conducting complaint investigations consistent with expectations contained in Federal regulation
and the SOM, including the use of the ACTS and the timely input of information. In situations
where a determination is made that immediate jeopardy may be present and ongoing, the SA is
required to investigate within two working days of receipt of the information except:

        1) For all Medicare deemed providers/suppliers complaint and incident intakes, the SA
           investigates a complaint within two working days of receipt of the Form CMS-2802,
           Request for Validation of Accreditation Survey, from the RO if the RO determines that
           the complaint involves potential immediate jeopardy to patient health and safety;
        2) For hospital EMTALA complaints, the investigation is completed within five working
           days after receipt of the authorization from the RO;
        3) For restraint/seclusion death reports from hospitals, the SA completes the investigation
           within five working days of receipt of authorization from the RO.
        4) For restraint/seclusion death reports of unexpected deaths of Hospice patients receiving
           inpatient care by a hospice that provides care directly in its own facility, the State
           Agency will complete the investigation within five working days of receipt of
           authorization from the RO.

(Appendix Q of the SOM contains the Guidelines for Determining Immediate Jeopardy.)

All fires in Medicare/Medicaid-certified healthcare facilities that result in serious injury or death must
be entered into ACTS as a complaint or self-reported incident. In these cases, the fire is to be
considered a priority assignment of ―Immediate Jeopardy (IJ).‖

For nursing homes only, if the SA makes the determination that actual harm may be present; the
investigation is to be initiated within 10 working days of its receipt. The initiation of these types of
investigations is generally defined as the SA beginning an onsite survey.

When a nursing home surveyor identifies a resident who is receiving poor quality care from
another provider type (e.g., Medicare hospice providing care in a nursing home, or an ESRD
supplier providing dialysis supplies or service in a nursing home) a complaint should be conveyed
to the appropriate survey component to investigate. Likewise, a hospice surveyor who identifies a
resident of a nursing home who is receiving poor care should refer the situation to the appropriate
survey component to investigate care being provided in the nursing home.

For substantial allegations of noncompliance for non-EMTALA and non-immediate jeopardy
complaints for providers/suppliers with deemed status, an onsite survey is required within 45
calendar days after approval by the RO.

All other Medicare and Medicaid complaint investigations should be conducted promptly,
according to guidance in the SOM, Section 5075.9. If the intake information received requires an
onsite survey and the allegation may involve both Federal and State licensure requirements, at a
minimum, an onsite survey is completed to investigate the Federal requirements.
For all deemed non-LTC provider types for which one or more condition-level deficiencies is
determined to be out of compliance pursuant to a complaint investigation, a full survey must be
performed and this is a Tier 1 priority.

For ICFs/MR, after each complaint investigation in which there are CoPs that are substantiated as
being out of compliance, extended surveys are required. For HHAs in which a complaint
                                                                                                42
investigation finds a CoP to be out of compliance, an extended survey must be conducted. These
are Tier 2 priorities.

For all other non-deemed provider types in which complaint investigations find that CoPs are out
of compliance, surveys should be expanded as necessary in accordance with the SOM. These are
Tier 2 priorities.

To support management operations, the SA must enter required data elements in the ACTS in a
timely manner, as specified by CMS (see Chapter 5 of the SOM).

The level of Federal matching payments for Medicaid complaint survey activity will be sufficient
to meet all CMS expectations. States must secure the necessary Medicaid State share for funding
those complaint investigation activities attributable to Medicaid facilities and/or dually-certified
facilities.




                                                                                                  43
    SECTION FIVE: CMS PRIORITIES for INITIAL SURVEYS of PROVIDERS and
               SUPPLIERS NEWLY ENROLLING in MEDICARE

Below we summarize CMS‘ long-standing policy for Medicare initial surveys. Those long-
standing policies were re-affirmed and further clarified via S&C-08-03 (November 5, 2007) and
08-13 (March 7, 2008). We also clarify special provisions that apply in the case of conversions,
access-to-care issues, reinstatement of terminated providers and distinct part units (see parts D-F
of this section for details).

A. Tier 2 Priority for Initial Surveys
All relocations of existing providers or suppliers are Tier 2 priorities.

B. Tier 3 Priority for Initial Surveys
Most surveys of providers or suppliers newly seeking Medicare participation are prioritized as Tier 4.
However, the provider types below are surveyed as a Tier 3 priority. States may prioritize within Tier
3 to address their unique circumstances and general availability of any one particular provider type.

   1. ESRD Facilities: Due to the unique reliance of dialysis patients on Medicare and the fact
      that there are no deemed accreditation options for ESRD facilities, we accord such
      facilities a higher Tier 3 priority than most other provider or supplier types. We encourage
      initial surveys of ESRD facilities to occur as early as possible on the survey schedule
      because of a combination of unique characteristics of ESRD facilities (see earlier ESRD
      discussion). The Tier 3 priority includes addition of stations or services.

   2. Transplant Programs: Transplant programs are accorded a Tier 2 or Tier 3 priority based
      on a review by CMS. There are no CMS-approved accrediting organizations (AOs) for
      transplant centers; and because the start-up of a transplant program involves significant up-
      front investment. While this may change in the future, CMS has neither received nor
      approved any AO applications for transplant center accreditation to date. In addition,
      transplant patients (and donors) rely on Medicare in ways that other patients do not (such
      as special eligibility provisions for post-operative immunosuppressive drug coverage when
      certain otherwise ineligible individuals receive transplants from a Medicare-certified
      center).

   3. Rural Health Clinics: Given that RHCs serve areas that often involve considerable travel
      distance to access healthcare and there is no current accreditation option for RHCs, we
      believe it is important to raise the priority status for such providers.

   4. Nursing Facilities-Medicaid-Only: Costs for initial surveys of Medicaid-only nursing
      facilities (NFs) are funded through Medicaid without Medicare expenses. They are not
      subject to CMS‘ initials policy of Medicare surveys and may be surveyed at State priority
      discretion. See part D below with respect to potential conversions of Medicaid-certified
      facilities to dually-certified (Medicare and Medicaid) facilities.

   5. Dual Skilled Nursing Facilities-Medicare & Medicaid: There is no accreditation option
      for this provider type and there are few new SNF providers each year (about 30-40
      nationwide, often replacement facilities). Medicare SNFs may therefore be surveyed as a
      Tier 3 priority except for those that do not also participate in Medicaid. See part D of this
      section for the policy on conversion of Medicaid-only NFs to dually-certified facilities.
                                                                                                  44
     6. Excluded Hospitals/Units without an AO Option: Since hospitals have an accreditation
        option, surveys for the health and safety standards represent a Tier 4 priority. However,
        AOs are not currently approved for the verification of compliance with the special
        requirements for psychiatric hospitals and may not be approved for verification of
        compliance with the special requirements for exclusion of rehabilitation hospitals or
        psychiatric or rehabilitation units from the Inpatient Prospective Payment System.

                a. The verification of compliance with the psychiatric special conditions for
                   psychiatric hospitals found at 42 CFR §482.60 through §482.62 is included in the
                   higher Tier 3 priority. The psychiatric hospital would be expected to seek AO
                   accreditation for the basic health and safety requirements and then the CMS
                   contractor will survey for just the special psychiatric conditions.

                b. See part G of this section for the special procedures that apply for rehabilitation
                   hospitals and IPPS-excluded rehabilitation and psychiatric units.

          Note: This process does not apply to CAHs with Distinct Part Psychiatric and/or
          Rehabilitation Units (DPUs), since the exclusion criteria for these units are found in the
          CAH CoPs. Accredited, deemed CAHs are reviewed for compliance with the exclusion
          criteria by their AOs. Non-accredited, non-deemed CAH DPUs are surveyed by the SA as
          part of the standard CAH survey.

SA Directors may consider a variety of factors in setting priorities for initial surveys within Tier 3
and Tier 4 except that new transplant programs and new ESRD facilities (or expansions) should be
top Tier 3 priorities, unless they fall into a high-impact fraud area described in C. 3 below. Such
factors may include unprecedented State growth in specific provider type applicants without
commensurate need or corroborated concerns in your State related to Medicare or Medicaid
program integrity.11

C. Tier 4 Priorities for Initial Surveys

     1. Accreditation Options: Initial certifications of all provider/supplier types that have the
        option to achieve deemed Medicare status by demonstrating compliance with Medicare
        health and safety standards through a survey conducted by a CMS-approved accreditation
        organization is a Tier 4 priority. In light of the Federal Medicare resource constraints, we
        consider the cost of initial surveys to be the lowest priority for the Medicare program for
        those provider and supplier types that have a deemed accreditation option in those States
        unable to complete the higher-priority Tier 1-3 work. These include:
             • Ambulatory Surgical Centers
             • Home Health Agencies
             • Hospices
             • Hospitals
             • Critical Access Hospital Distinct Part Psychiatric or Rehabilitation Units


11 On August 15, 2001, CMS issued S&C-01-22 which outlined new procedures for issuance of the CMS-855A and B. Under these procedures,
Fiscal Intermediaries or Carriers are responsible for distributing, reviewing and recommending approval of CMS-855s. These procedures were
designed to streamline the provider enrollment process and minimize significant time lapses between application and certification.         45
       States may establish priorities within Tier 4, except for certain provider or supplier types
       affected by the high-impact fraud area provided in C. 3 below.

   2. All Others: All other newly-applying providers/suppliers not listed in Tier 3 are Tier 4
      priorities, unless approved on an exception basis by the CMS RO due to serious healthcare
      access considerations or similar special circumstances (see ―Priority Exception Requests‖
      in part E below). The affected Medicare providers/suppliers include:

           •   Comprehensive Outpatient Rehabilitation Facilities
           •   Skilled Nursing Units in Hospitals
           •   Nursing Homes that do not participate in Medicaid
           •   Outpatient Physical Therapy

   3. High-Impact Fraud Areas: In areas that we identify as high-impact fraud areas, surveys of
      providers that newly seek Medicare participation will (a) be a low Tier 4 priority for the
      specific provider or supplier type we have identified as characterized by high fraud rates
      and (b) will require approval from the appropriate CMS RO prior to the use of federal
      funds to conduct the survey. We will issue periodic communications to States regarding
      the high-impact fraud designations.

D. Conversions of Previously Certified Providers
Conversion of an existing provider under the same provider agreement is not considered an initial
application and the priority policy for initials does not apply. The provider/supplier types in this
circumstance are:

      Hospital - CAH: Conversion of a hospital to a CAH or a CAH back to a hospital is a
       conversion (not an initial certification) and at State option may be done as Tier 2, 3, or 4.
       However, the addition of swing beds as a new service in an existing hospital or CAH is a
       Tier 4 priority.

      Medicaid-only Nursing Facility (NF) to Dually-Certified: Conversion of a Medicaid-
       only Nursing Facility (NF) to dual-certification (SNF/NF) does not require an initial
       Medicare certification survey provided (a) the Medicaid survey has been completed within
       the prior six months, (b) the majority of beds in the facility will remain Medicaid-certified
       and (c) the procedures in SOM 7002 are followed. If any of these provisions do not apply,
       the survey is considered an initial survey and subject to the Tier priorities.

      Existing SNF/NF Redesign to Small House Model: Medicare certified nursing homes
       that convert to a Small House certified, resident-centered, culture change environment
       (which requires new construction). A Life Safety Code survey should be completed around
       the time any new or remodeled building is occupied by a participating provider or supplier.

E. Priority Exception Requests

   1. Access to Care Reasons: Providers or suppliers may apply to CMS via the SA requesting
      consideration for an exception to the priority assignment of the initial survey if lack of
      Medicare certification would cause significant access-to-care problems for beneficiaries
      served by the provider or supplier. The SA may choose whether to make a
                                                                                                 46
        recommendation to CMS before forwarding the request to the RO.

        There is no special form required to make a priority exception request. However, the
        burden is on the applicant to provide data and other evidence that effectively establishes
        the probability of serious, adverse beneficiary healthcare access consequences if the
        provider is not enrolled to participate in Medicare. CMS will not endorse any request that
        fails to provide such evidence and fails to establish the special circumstances surrounding
        the provider‘s request. We expect that such exceptions will be infrequent.

    2. Reinstatement of Terminated Providers: CMS may consider a provider‘s request for
       exception to the priority assignment of the initial survey in the case of a provider whose
       previous Medicare participation was terminated (involuntarily) if there is persuasive
       evidence that enduring, high quality of care will be maintained.

    3. Voluntary Termination: Change of Ownership (CHOW) without Assumption of
       Provider/Supplier Agreement: When a CHOW occurs; CMS presumes that the new
       owner assumes the previous owner‘s provider/supplier agreement with Medicare.
       However, some new owners choose to avoid successor liability to Medicare by not
       assuming the provider/supplier agreement. In such cases the seller‘s agreement with
       Medicare is terminated, there is a break in Medicare‘s payment for services between the
       date of termination of the old agreement and the effective date of the new agreement and
       the buyer is treated as an initial applicant. For provider/supplier types for which deemed
       status is not available, the RO may consider a new owner‘s request for exception to the
       priority assignment of the initial survey if the community served by the provider would
       best be served by minimizing the period of the break in Medicare coverage of the
       provider‘s services.

F. Accreditation Requests

SAs should continue to collect and forward to the RO the certification packets12 for facilities
wishing to participate in Medicare through deemed accreditation, including attestation documents
for those hospitals seeking first-time IPPS exclusion.

G. Special Provisions for Compliance with IPPS-Exclusion Requirements

With respect to rehabilitation hospitals and short-term acute care hospitals with excluded
rehabilitation or psychiatric units, please note the following policy refinements:

    1. IPPS-Excluded Rehabilitation Hospitals and IPPS-excluded Rehabilitation or
       Psychiatric Units of a Hospital: As noted in part B, accreditation organizations do not
       have authority to verify a hospital‘s or a hospital excluded unit‘s compliance with the IPPS
       exclusion criteria at 42 CFR 412. Currently, annual re-verification of IPPS-exclusion for
       such excluded hospitals or units in already-certified hospitals is handled by provider self-
       attestation. Until release of S&C-08-03, initial verification for first-time IPPS-exclusion
       was required via onsite certification surveys by the States.



12 Such as the completed provider agreement, applicable civil rights forms, completed worksheets where necessary,
copy of the accreditation letter from the AO, etc.                                                              47
In FY2011 we are continuing the suspension (until further notice) of the requirement for an
onsite IPPS-exclusion survey of all rehabilitation hospitals and short-term acute care
hospitals with units for which they are seeking first-time IPPS-exclusion (SOM Section
3100 - 3108B); except for providers whose IPPS exclusion has previously been removed.
See number 2 below for discussion of providers that lose exclusion status. Instead, such
providers will be required to submit an attestation and completed Form CMS-437, CMS-
437A, or CMS-437B, whichever is applicable, indicating that all CMS exclusion
requirements are met. Note that these attestation procedures apply to all rehabilitation
hospitals and all short-term acute care hospital units that are IPPS-excluded.

In addition to the attestation and applicable Form CMS-437, rehabilitation hospitals and
excluded rehabilitation units must also submit evidence of compliance with the medical
director requirement. Psychiatric units must submit evidence of compliance with patient
assessment and staffing requirements.

For initial certification and annual attestation, the following process is used for IPPS-
exclusion attestation and documentation:

(a) The SA sends to the provider the attestation statement and appropriate CMS-437, along
    with the standard packet of certification forms and documents, within 10 working days
    of the earlier of the following two dates:
     Receipt of the provider‘s letter of intent to open for service and to seek IPPS
        exclusion; or
     Receipt of the Fiscal Intermediary‘s recommendation for approval of the 855
        application.

(b) In the case of rehabilitation hospitals or rehabilitation units, the SA requests that the
    provider attach (to its completed certification packet) documentation that permits
    verification that the provider has a qualified medical director who meets the regulatory
    standards at 42 CFR 412.29(f).

(c) In the case of psychiatric units, the SA will also request that the provider attach to its
    completed certification packet the following information:

      Medical record protocols to permit verification that each patient receives a
       psychiatric evaluation within 60 hours of admission; that each patient has a
       comprehensive treatment plan; that progress notes are routinely recorded; and that
       each patient has discharge planning and a discharge summary.
      A description of the type and number of clinical staff, including a qualified medical
       director of inpatient psychiatric services and a qualified director of psychiatric
       nursing services, registered nurses, licensed practical nurses and mental health
       workers to provide care necessary under their patients‘ active treatment plans.

(d) The provider should return the completed certification packet, along with all other
    requested materials, to the SA no less than 90 days prior to the start of the facility‘s
    first or next cost reporting period, as applicable, in order for the RO to have sufficient
    time to make a determination to approve or deny the provider‘s IPPS exclusion status.
    If the provider submits the application less than 90 days in advance, CMS will continue
    to process the application, but the provider assumes the risk that the RO review may
                                                                                             48
             not be completed in time for payment at the excluded rate to start with the first or next
             cost reporting period.

         (e) The SA will act promptly to review the completed packet and will forward it to the RO
             as soon as possible in order to permit a final certification determination prior to the
             start of the provider‘s cost reporting period.

    2. Psychiatric Unit or Rehabilitation Hospital/Unit IPPS Exclusion Removal: If CMS
       removes the IPPS exclusion status of a psychiatric unit or a rehabilitation hospital or unit,
       the hospital may subsequently seek excluded status again. In such cases the hospital is
       required to operate for at least twelve months under the IPPS while continuing to provide
       the applicable psychiatric or rehabilitation services that comply with the exclusion
       requirements.13 The facility must apply for IPPS exclusion status in the same way as a
       provider seeking first-time exclusion. However, in the case of a hospital or unit that has
       had its IPPS-exclusion status removed, the requirement for onsite verification by the
       SA of compliance with the exclusion criteria for psychiatric or rehabilitation services
       will remain in force and such surveys will be a Tier 4 priority.




13 The twelve month requirement refers to the cost reporting period, and may be found at 42 CFR 412.25(c) and
412.25(f) for IPPS-excluded units of a hospital, and 42 CFR 412.23(h) and 412.23(i) for rehabilitation hospitals.   49
      SECTION SIX: CORE INFRASTRUCTURE – STANDARD REQUIREMENT
                            MUST BE DONE

A. Training of Surveyors: SA responsibilities for training surveyors are communicated in an
Attachment to the main MPD and will be conveyed separately and shortly after this main document.
However, to facilitate SA planning we wish to amend our previous MPD direction concerning the
requirement applicable in FY2011 to implement the use of a new prerequisite to the Basic Life
Safety Code (BLSC) training.

   1. Prerequisite for Basic Life Safety Code (BLSC) training: Beginning no later than
      FY2013, SAs will be required to obtain ―Fire Inspector I Certification‖ for their students
      attending the BLSC training. National Fire Protection Association (NFPA) Standard 1301,
      ―Standards for Professional Qualification for Fire Inspector and Plan Examiners,‖ describes
      the skills and knowledge required by the NFPA and establishes a minimum performance
      standard for those performing fire safety inspections. The Certification includes a test to
      determine whether individuals have the requisite skills and knowledge.

       More than a majority of current students for the BLSC have little background in Fire Safety
       and have difficulty with learning how to apply CMS standards related to the LSC. If
       needed by the student, the NFPA Standard 1301 prescribes knowledge that will help BLSC
       students before arrival at the CMS-sponsored BLSC training, therefore increasing the
       likelihood of success with a revised and more demanding BLSC course. Only the
       completion of the Certification Test is required for such students; it is optional that they
       attend a training to prepare for the Certification Test. By late Summer of Calendar Year
       2010, CMS will inform SAs of specific steps and options that may be explored to assure
       that such certification (or acceptable equivalent source) testing is available to their
       students. CMS will state the acceptable alternative sources for such testing.

       Any person who has already obtained this certification would not be required to take any
       action, except to assure that a copy of the NFPA Certification form is provided to their SA
       and to CMS for recordation in the Learning Management System. SAs that need to
       institute the Fire Inspector I Certification will need to begin planning now to address
       Human Resource matters, hiring procedures, training budget requirements, etc., to assure a
       smooth transition to this requirement.

   2. Requirements for future LSC training: To achieve the objective of upgraded quality of
      the LSC surveyor, students must come prepared with a fundamental knowledge of the
      following:

             Structural fire behavior and its impact on structural integrity;
             Psychology of person-behaviors when involved in fires;
             Comprehension of a systems approach to fire protection;
             Systems commonly used for fire protection and suppression;
             Fundamentals of building materials and strengths;
             Knowledge of how to document code violations in preparation for enforcement
              procedures and substantiation of findings.


                                                                                                50
   3. Key points:
         1. Those SAs that contract with State Fire Marshals will probably not need additional
             training to meet this requirement as most State Fire Marshals already require Fire
             Inspector I Certification before a new person can join their staffs.
         2. Approximately 80% of those coming to the BLSC do not have backgrounds in Fire
             Safety.
         3. Many violations of fire code or the requirements of LSC are facility-wide
             deficiencies
         4. Training/Certification undertaken by The International Fire Service Accreditation
             Congress (IFSAC) and accredited by the NFPA, assures a uniform level of
             acceptable background for those becoming involved in the inspection of healthcare
             facilities.
         5. Those surveyors with a fire background may successfully challenge the
             examination without taking training. Both the course and the examinations are not
             expensive, but should be considered as part of budget planning by SAs, unless SAs
             require certification as prerequisite to hiring.
         6. More information may be found on the following website: http://www.ifsac.org/
             which includes those agencies accredited to provide Fire Inspector I certification.
             Some 38 States have IFSAC facilities available within the State. SAs without in-
             State facilities can contact their State Fire Marshal for more information on how it
             is that they access IFSAC facilities.

   4. How the changes will be phased in: We do not plan to require all existing LSC surveyors attain
      Fire Inspector I Certification or return to the BLSC training to acquire or confirm skills, but we
      would strongly urge SA Directors to consider doing so or provide for succession planning
      related to these issues. All Certifications are to be received by CMS/Training Staff by
      10/31/2013.

B. OSCAR/ASPEN Data Entry of Survey Workload (Completion and Use of the CMS-670)
States should continue to ensure accurate and timely completion of the CMS-670 according to
current ASPEN guidelines and CMS SOM Chapter 2, Section 2705 and evaluate their own
surveyor times.

C. CMS Quality Initiative
In FY2003, CMS began publicly reporting nursing home, ESRD and home health quality measures
and implemented a nationwide quality improvement effort in nursing homes and HHAs by Quality
Improvement Organizations (QIOs). QIOs/ESRD Networks and SA partnerships are critical to the
improvement of nursing home, ESRD and home health quality. In 2011, Networks and State
Agencies will collaborate in two new areas, the Infection Control Initiative and the Involuntary
Discharge Initiative. Networks and State Agencies will continue to work together on the Fistula
First Initiative. In FY2011 Home Health Compare will be revised in both format and content.
QIO‘s however are no longer offering support for each provider type measure.

Effective August 2005, all QIOs were required to work with nursing homes across the country on
efforts to transform nursing homes from institutions into homes which provide a high quality of
care and quality of life services to those who reside there. Beginning August 1, 2008 CMS‘ 9th
Scope of Work for the QIOs set an ambitious 3-year agenda for QIOs to work with nursing homes
that have poor quality, including Special Focus Facilities (SFFs). This involves an increased focus
on resident and staff satisfaction, staff turnover, management of pressure ulcers, decreasing the use
                                                                                                  51
of physical restraints and treating and managing depressive symptoms.

The core infrastructure requirement in FY2011, applicable to all SAs, is focused on the following:

   1. Restraints, Pressure Ulcers and Immunization Rates in Nursing Homes – Our mutual goal
      is to reduce the prevalence of pressure ulcers, reduce the incidents of restraints and increase
      the immunization rates in nursing homes. The SA‘s role is to:

            a. Assure that State surveyors are adequately trained on the regulatory requirements
               and pertinent SOM interpretive guidelines;
            b. Make sure that surveyors follow the survey protocols and processes;
            c. Provide suitable enforcement remedies when nursing homes are cited;
            d. Provide appropriate communications and education for providers regarding the
               importance of these three priority areas, CMS‘ goals and resources available to
               nursing homes; and
            e. Coordinate S&C activities with those of the QIOs, make appropriate referrals to the
               QIOs and encourage systemic quality improvement in nursing home plans of
               correction.

   2. Working with Nursing Homes with Systemic Problems

       a. Meet requirements of the Special Focus Facility (SFF) initiative:
           Select SFF from the candidate list released periodically by CMS;
           Survey SFF facilities twice every 12 months beginning from the date it is selected
             as an SFF;
           Monitor SFF to determine if they meet graduation criteria or require more robust
             enforcement strategies.
       b. Coordinate with QIOs to provide nursing homes which have systemic problems with
          possible tools to assist them.

   3. Staffing Data and Quality Measures (QMs) - With the help of SAs we are striving toward
      improving the adequacy of reported data for nursing home staffing data and QMs. The
      SA‘s role is to:
           Ensure that surveyors follow survey protocols and processes in comparing survey
              and MDS information during the survey; and
           Ensure that the RAI coordinator provides support and technical assistance for
              nursing homes in the coding of the MDS.

Additional emphasis, at State discretion, applies to working with nursing homes and QIOs on
culture change that improves quality of life without compromising quality of care.

D. Performance Measurement Activities
State budget submissions must include thorough and well-structured action plans for effecting
Survey and Certification program goals and objectives. The plans should outline effective
strategies for achieving performance targets and conforming to CMS‘ State performance standards
and priorities. States should also identify how national goals and standards are being translated
into individual performance objectives. If CMS finds that the SA does not meet the performance
standards, the SA will be expected to develop and implement a corrective action plan.

                                                                                                 52
E. Nurse Aide Registry (NAR)/Nurse Aide Training and Competency Evaluation Program
(NATCEP)
States are required to maintain a registry of all individuals who have completed a nurse aide
training course and have passed a competency evaluation test. States must also investigate
allegations of resident neglect and abuse (including misappropriation of personal funds) by a nurse
aide or other individuals.

The State must assure that the nurse aide registry is operated in compliance with the Federal
requirements. This includes assuring that:
   • The SA reports findings of resident abuse, neglect and misappropriation of resident property
      to the registry and these findings are included in the registry within ten working days of the
      findings;
   • In the case of a singular finding of neglect, the State has established a procedure so that a
      nurse aide can petition to have his or her name removed from the registry. (The employment
      and personal history of the nurse aide must not reflect a pattern of abusive behavior or
      neglect and the nurse aide must wait one year from the substantiation of the finding before
      petitioning to have his or her name removed from the registry.)

The allowable costs that can be charged to the Medicare State Certification program are outlined in
Sections 1819(e) (1) and (2) of the Social Security Act. These costs relate to the State
requirements to specify and review nurse aide training and competency evaluation testing
programs together with the establishment and maintenance of the nurse aide registry. States are
required to conduct these activities as part of the 1864 Agreement as authorized by Section
1864(d) of the Social Security Act. The actual training and competency evaluation testing of nurse
aides are not payable as part of this Agreement.

See the General Budget Formulation Guidelines section of this letter for instructions on the
reporting of NAR/NATCEP expenses and associated full-time equivalent amounts.

In September 2003, a final rule was published that creates a category of nursing home employee
who may assist residents in eating and hydration. The SA may be involved with implementation if
the State decides to allow the use of eating and hydration assistants. There may be State costs
associated with implementation of this regulation.

F. Home Health Toll-Free Hotline and Investigative Unit
States must maintain a toll-free hotline to receive complaints and to answer questions about
HHAs. States must also maintain a unit to investigate complaints. CMS only pays for the
maintenance of the hotline and complaint unit and for necessary survey or survey-related activity
to follow-up on complaints regarding Federal home health agency requirements.

With the national implementation of ACTS in FY2004, States must ensure that complaints from
the HHA hotline are effectively captured in ACTS.

G. Resident Assessment Instrument/Minimum Data Set (RAI/MDS)
All certified nursing homes and swing bed hospitals are required to encode and transmit MDS
records to a repository maintained by the State, or for the latter to the CMS National Assessment
Collection Database, in accordance with CMS established record specifications and time frames.
As such, CMS expects the States to continue to provide staff to serve as RAI/MDS educational
and technical resources to the nursing homes and SA in each State during FY2011, States must
                                                                                                53
continue to adequately fund and staff the positions of a RAI coordinator and a RAI/MDS
automation coordinator.

The State RAI coordinator and the RAI/MDS automation coordinators will be responsible for the
following tasks:
• Attending all mandatory training sessions and demonstrating competency and skills in the RAI
   process, including coding and transmitting the MDS (this includes MDS 3.0 in addition to
   MDS 2.0);
• Participating in CMS-sponsored workgroups and training including WebEx conferences, and
   satellite training programs for RAI Coordinators on the RAI process and the MDS (MDS 2.0 &
   MDS 3.0), as well as DAVE2 findings and recommendations;
• Conducting ongoing RAI/MDS education and training and providing technical support to
   SNF/NF and swing bed hospital providers and SA staff that--
        – Addresses the RAI process and proper coding of MDS elements to assist providers in
             meeting OBRA MDS and PPS requirements;
        – Incorporates DAVE2 recommendations and findings;
        – Incorporates information from the MDS Tip Sheets;
        – Incorporates the MDS 3.0, including any changes to the RAI and survey processes.
• Includes at least two provider training courses annually, which may focus on basic RAI training
   for new providers or on topics identified either by the State or CMS as important for existing
   providers; administrative, educational and technical support to providers that will assist in the
   accuracy in coding of resident assessments; and the transmission of MDS data;
• Efficient maintenance of the RAI/MDS State system;
• The collection and housing of MDS data in order that States can develop and test a wide range
   of program improvement initiatives;
• Coordinating with CMS, SAs, FIs, A/B Medicare Administrative Contracts (MACs) and
   associations in their education of SNF/NF and swing bed hospital providers and surveyors
   regarding the MDS (including the MDS 3.0) and changes to the RAI and survey processes;
• Conducting any follow-up training in conjunction with CMS national RAI/MDS educational
   offerings;
• Producing MDS outcome reports;
• Educating providers and SA staff on reports from the data system, MDS outcome reports, RAI
   Manual revisions and any revisions to the RAI process;
• Assist in promoting State-wide consistency with national policies and procedures; and
• Completing semi-annually reporting of the CMS MDS training worksheet in the QIES system
   in order to report the educational offerings that were conducted in the State during the year.

In addition, as CMS moves forward with the national implementation of the MDS 3.0 in early
FY2011, States should note that implementation will include:

•   Providing comprehensive education to RO & SA RAI and nursing home field-surveyor
    preceptors (RAI coordinators‘ conference and MDS 3.0 educational offerings – details to be
    announced in the MPD training addendum) so that these individuals can successfully manage
    provider and surveyor inquiries and issues related to the RAI and survey processes and the
    MDS 3.0. States should budget for the travel for this conference(s). See the MPD training
    addendum for greater detail on the intended audiences, timing and locations of the
                                                                                               54
    educational offerings. The MPD training addendum will be released approximately one month
    after the main body of the MPD is released; and
•   Providing training and training aids for SA and RO training coordinators, field-surveyor
    preceptors and surveyors so that these individuals can successfully understand, interpret and
    implement the changes to the MDS and related survey processes.

As States will be responsible for assuring that their SA staff are trained in the use of the RAI
process, including the new MDS 3.0, as well as the changes to the SOM and survey reports and
processes as a result of the MDS 3.0 implementation, each SA will be responsible for sending its
RAI and Automation Coordinators, as well as a nursing home field-surveyor preceptor, to the RAI
Coordinators‘ Conference and MDS 3.0 educational offerings in FY2011. States will also be
responsible for ensuring that its RAI Coordinator(s) and survey and certification staff members
collaborate in order to ensure that their SA staff are adequately prepared to perform their roles as
surveyors or RAI coordinators. This is particularly important as the MDS 3.0 significantly impacts
both the RAI and survey processes.

Therefore, States must budget for three to four staff members to attend one, five-day train-
the-trainer session and several distance-based sessions, on the MDS 3.0. Once trained, these
trainers will be expected to provide MDS 3.0 education, collaboratively, for SA staff and
nursing home providers. Please also consult the MPD training addendum for details on
additional MDS 3.0 training offerings.

States should note that MDS expenditures are reflected as long-term care Medicare and Medicaid
costs on form CMS-435. For more reporting instructions, please refer to the General Budget
Formulation Guidelines section.

H. HHA/Outcome and Assessment Information Set (OASIS)
States will be required to operate the State OASIS data system and report OASIS data to the
central CMS repository. States should note that OASIS expenditures are reflected as non-LTC
costs on the form CMS-435. For more reporting instructions, please refer to the General Budget
Formulation Guidelines section.

All certified HHAs are required to encode and transmit OASIS records for Medicare and Medicaid
beneficiaries to a repository maintained by States in accordance with CMS-established record
specifications and time frames. States will continue to play an active role in providing HHAs with
Outcome Based Quality Improvement (OBQI) reports, using CMS developed software as well as
interpreting and using the report. In addition, the outcome-based quality monitoring reports and
quality improvement reports (i.e., case mix and potentially avoided event reports) will continue to
be available to HHAs. In FY 2011, the package of available reports will be revised and will
include additional measures and reports - Process Based Quality Improvement (PBQI). HHAs will
use these reports to target care practices for improvement by learning how to correctly read the
reports, identifying potential areas for improvement, developing and using audit tools to evaluate
current care practices and developing plans to improve care practices in areas that have been
targeted for improvement. CMS expects the States to continue to play a key role in providing the
educational and technical resources (CASPER) to the HHAs in each State.

States will continue to fund the positions of the OASIS Educational Coordinator and the OASIS
Automation Coordinator and will continue with the responsibilities outlined in CMS guidance.

                                                                                                 55
OASIS coordinator activities include:
• Educating providers and SA staff on SOM Revisions, Interpretive Guidelines, including any
  new or proposed CoPs relating to OASIS;
• Basic OASIS training for new and existing providers;
• Clarification of OASIS/ activities;
• Educating providers and SA staff on reports from the data system and OASIS outcome reports;
• The masking and encryption process;
• The OASIS survey and enforcement process;
• Provide CMS approved training materials available from CMS or CMS contractors as part of
  training activities for new and existing HHAs;
• Participating in CMS-sponsored workgroups and training upon request; and
• Completing an annual OASIS training worksheet in the QIES system by October 15th of each year.
In addition, CMS has completed the national implementation of OASIS C in January 2010.
Implementation included:

•   Providing comprehensive instruction to RO & SA OASIS Education Coordinators (OEC
    Conference) so that these individuals can successfully manage provider and surveyor inquiries
    and issues related to the OASIS process and the OASIS C;
•   Providing training and educational products for the SAs and surveyors so that these individuals
    can successfully understand the changes to the OASIS instrument and implement changes to the
    survey process; and
•   Each SA will be responsible for sending its OASIS Education Coordinator(s) to the OEC
    Coordinators‘ Conference, and ensuring that it‘s OEC(s) and survey and certification staff
    members attend all mandatory training sessions related to the OASIS C Process and/or OASIS
    C.


I. MDS and OASIS Automation and Related Activities
Overall responsibility for fulfilling requirements to operate the State MDS and OASIS data
systems rests with the SA. However, the SA may enter into an agreement with the State Medicaid
Agency, another component, or a private contractor to perform day-to-day operations of the
system. Prior to entering into an agreement with subcontractors, SAs must receive RO approval if
the State MDS or OASIS system is operated by an entity other than the SA. The State must ensure
that the SA is provided real-time access to this system to fully support all MDS and OASIS driven
functions which will be required of the survey agency (e.g., quality indicator reporting, survey
targeting, etc.). Off-site operation of the MDS and OASIS systems will require high capacity, fault
tolerant network connections to ensure reliable support for the SA‘s daily operations, which will
be affected by this system. The State is also responsible for reporting MDS and OASIS data to a
CMS central repository.

CMS will continue to add software applications to States‘ standardized hardware environments to
support evolving needs for MDS, OASIS and related survey and certification functions in the
States under the QIES initiative discussed below.

CMS will continue to conduct training of State personnel responsible for administrative and
                                                                                                56
technical aspects of the MDS, Swing Bed (SB)-MDS and OASIS system operation. States should
reference the training schedule (Training Program document) for a listing of proposed MDS, SB-
MDS and OASIS conferences and training courses.

In order to assess how information about OASIS, MDS and SB-MDS is disseminated across the
nation, the States will report semi-annually on training and technical assistance that they have
provided. Instructions for reporting training activity using the MDS and HHA Training
Worksheets are found on the secure website: https://www.qtso.com/state/stsprtdownload.php.
The worksheets are accessed via the QIES To Success website and are available to State personnel
who have rights to see the MDS or HHA reports. The information entered on the worksheets is
stored in the National Database. CMS Central and RO personnel can retrieve this data via the
CASPER reports: MDS Training Reports or HHA Training Reports.

With CMS technical support and guidance, States will be expected to continue to work closely with
the provider community and their MDS, SB-MDS and OASIS software vendors to provide
information on specific requirements related to the submission of MDS, SB-MDS and OASIS
assessments especially with the move toward national implementation of the MDS 3.0, to the
appropriate State or CMS repository. CMS expects that a facility's private sector software vendor
will provide primary support to the facility in terms of MDS, SB-MDS and OASIS encoding and
transmission to the State. State personnel, however, will be required to work with facilities and
software vendors to educate them about this process. States no longer need to fund the monthly
line charges associated with installation, maintenance and transmission of the MDS and OASIS
data from the facilities to the State. CMS has converted SNF and HHA providers to a virtual
private network (AT&T Global Network Services) to meet confidentiality and security
requirements. However, each State must have one line accessible by CMS systems maintainers to
ensure their system can be updated. CMS has also established a separate CMS repository for SB-
MDS data. CMS will make this data available to each State system upon request.

State personnel will continue to work with facilities and their software vendors in troubleshooting
any difficulties facilities experience as they transmit records and implement MDS 3.0.

Each State should review its staffing requirements experience for support of State automation
functions and recommend changes as needed. Staffing recommendations for systems support are
listed in the "MDS/SB-MDS/OASIS/QIES System Support" section that follows further in this letter.

Each State should also review its State MDS and OASIS Automation Project Plans submitted with
its prior year budget requests and provide any updates detailing continuing activities such as
facility training, vendor and provider education and technical assistance to providers.

J. Reimbursement for MDS and OASIS Costs
Provider costs for MDS, SB-MDS and OASIS are compensated through the Medicare and
Medicaid programs according to the rules for such reimbursement effective for Medicare and
Medicaid.

CMS will continue to fund any needed upgrades to the State MDS and OASIS systems and related
software, as well as the cost of upgrading client computers needed to access the MDS and OASIS
servers (discussed under Information Systems Hardware). CMS will also continue to fund the cost
of transmitting MDS and OASIS data from the State to the CMS central repository. Provider costs
for hardware and software to maintain and transmit MDS, SB-MDS and OASIS data from their
                                                                                             57
facility to the States will continue to be the provider's responsibility.

However, States are, again, expected to incur some costs associated with operating the MDS, SB-
MDS and OASIS systems, specifically for staff time, training and supplies to support the
automated MDS and OASIS systems.

When States use MDS data in administering the Medicaid program, Federal costs associated with
automating MDS and the operating data system should be apportioned by the States between two
funding sources: the Medicare and Medicaid Survey and Certification program and the Medicaid
program (under administrative costs). States should apportion MDS costs to these programs based
on the States' determination of each program's utilization of the MDS system. Costs charged to the
Medicare and Medicaid Survey and Certification Program will be prorated in terms of the portion
of SNFs and NFs in the States that participate in the Medicare and Medicaid program. Similarly,
costs associated with downloading and transferring SB-MDS data to the Medicaid program should
be apportioned by the State between these two funding sources. The Federal match for the
Medicaid Survey and Certification Program will be 75 percent. Budget estimates should be
prepared and submitted as part of each State's FY2011 Survey and Certification budget request.
Costs related to the publication, dissemination and validation of software vendors' ability to
comply with State specifications for any added MDS, SB-MDS, or OASIS sections or data (i.e.,
that portion of the MDS or OASIS that may be added to the State's RAI or HHA instrument at the
State's discretion) will not be funded through the Survey and Certification budget. To the extent
that a State develops customized applications for information maintained in the MDS or OASIS
database (e.g., to support Medicaid payment), the costs of developing and maintaining these
additional software applications (and any related hardware components) will not be funded
through the Survey and Certification budget.

We do not anticipate that any State will allocate more than a minimal amount of its MDS and
OASIS costs to the Medicaid Program as administrative costs. The Federal match for costs
apportioned as Medicaid administrative costs will be 50 percent and should be reported by the
State on line 14 (Other Financial Participation) of the quarterly form CMS-64. Also, where State
licensure programs benefit from the automation of the MDS and OASIS, the State itself should
also share in the MDS and OASIS automation costs.

K. The Quality Improvement and Evaluation System (QIES)
CMS goals for the standardized MDS/OASIS/SB-MDS system go well beyond providing States
with the ability to collect assessment data from providers and transmit that data to a central
repository for analysis and support of prospective payment systems. CMS has always intended
that the MDS/OASIS/SB-MDS data management system would support a suite of
applications/tools designed to provide States and CMS with the ability to use performance
information to enhance onsite inspection activities, monitor quality in an ongoing manner and
facilitate providers' efforts related to continuous quality improvement. This overall initiative,
known as the Quality Improvement and Evaluation System, also includes:

   Extension of the MDS/OASIS/SB-MDS systems to include new provider types in future years;
   Continued development of the ASPEN suite of products, ASPEN Survey Explorer (ASE),
    ASPEN Central Office (ACO), ASPEN Enforcement Manager (AEM), ASPEN Scheduling
    and Tracking (AST) and ACTS, integrated with State standard systems;
   Further integration of the learning management system that supports most day-to-day
    operations of the survey and certification training program; and
                                                                                        58
     Integration of these functions and systems into a comprehensive information system,
      subsuming the functions of the current OSCAR system and integrating a distributed State
      system with a central repository of assessment and Survey and Certification data linked to
      other vital CMS systems such as the National Provider System, the Provider Enrollment and
      Chain Ownership System and others.

During FY2011, CMS will continue major aspects of the OSCAR redesign phase of QIES with
integration of CLIA laboratories and expanded reporting capabilities. Other significant phases will
begin to further integrate the MDS/OASIS QIES server into day-to-day SA operations.

States must budget for two or three staff members to attend up to two, three-day train-the-
trainer sessions for QIES/ASPEN systems releases and ASPEN. Once trained, these trainers
will be expected to perform comparable, hands-on training for agency staff in each of these
areas.

CMS also plans to conduct one, 3-4 day session focusing on prototyping testing and training for a
new release in Baltimore; including representatives from 10 States (selectees will be announced.)

L. QIES/SB-MDS/MDS/OASIS STATE SYSTEMS SUPPORT
Each State must continue to provide adequate staff for technical systems support based on the
staffing recommendations provided below.
                                              FTE
                      Rank*            FTE            All Provider Types/State
                                                          (Excluding CLIA)
                         1             4.0             <600
                         2             4.5             600-1500
                         3             5.0             >1500
*These ranks may be adjusted upward if the RO believes the volume of a State‘s complaints warrant more staff.

These FTEs should be allocated approximately as follows:
• MDS/SB-MDS/OASIS Automation Coordinator - 1 FTE
• Systems Administrator - 0.5 to 1 FTE
• Technical operations/system management support - 0.5 FTEs
• Technical support/training for providers, vendors and SA staff - 1-3 FTEs
• ASPEN/OSCAR Coordinator - 1 FTE
These estimates reiterate CMS‘ staffing recommendations from prior MPD guidance. They do not
represent new staffing requirements.

States should also examine their privacy and security controls and determine if optimum
protections, as required by federal and State standards, will necessitate any software, hardware,
training, security protocols or budgetary adjustments.

      1. High Speed Internet Access (i.e., DSL, broadband, T1)
         We have received several questions regarding whether high speed access to the internet
         was required. While we do not require it in FY 2011, we certainly do encourage its use
         and include such costs as a legitimate administrative expense under Medicare and
         Medicaid. We wish to advise States that it is probable that high speed internet access will
         be required in the near future and is increasingly a priority in all areas of federal
                                                                                                  59
   endeavor. For example, in the Recovery Act Congress provided $7.2 billion in funds to
   expand high speed internet access in rural areas.

   The amount of data moved during each workday increases each year. Surveyor time is a
   precious asset and the amount of time involved in accessing information electronically is
   directly affected by the type of internet connection available. Back and forth
   communications between servers and clients can consume many megabytes per transaction.
    High speed connections also foster an environment where CMS and the SAs can optimize
   use of future uses of technology to improve survey efficiency, e.g., computer based
   training. Industry studies show that cost benefit analyses favor high speed connections and
   that is the direction in which the industry is progressing.

2. Information Systems Hardware
   The standard MDS/OASIS system and components that will be integrated with it, such as
   ASPEN/QIES, are comprised of technologies that have been selected to deliver the most
   powerful access to a broad range of information related to facility quality monitoring and to
   support State agency survey operations within a user-friendly interface. While the core
   components of the MDS/OASIS/QIES system (i.e., hardware and software) have been or
   will be provided and installed by CMS within each State, additional computers for State
   agency end-users will be required to access this core system. These end-user systems are
   referred to as clients and include computers for users who work onsite within the State
   agency office as well as off-site users including facility survey staff. As the State
   MDS/OASIS/QIES server assumes a larger role in day-to-day State operations, States
   should ensure that it is integrated into their existing systems infrastructure such as State
   LANs.

   SAs currently vary in the number of laptop/notebook systems they have available for field
   surveyors' use in accessing ASPEN. Internally, most agencies provide network based
   computing support for in-house staff managers. Furthermore, over the past few fiscal
   years, many States have included extensive system upgrades as part of their budget
   requests. CMS expects that States will use their existing systems to the fullest extent
   possible to provide client access to the standard system components. To provide users with
   access to the standard system, States should follow one (or a combination) of the following
   approaches:

    a. Existing State machines that meet the minimum requirements, as described below, are
       used to provide user access to the standard system. This includes desktop systems
       connected to an internal network, as well as laptop/tablet systems used mainly for
       ASPEN Survey Explorer.

    b. To the extent that existing State systems do not meet the minimum requirements (e.g.,
       insufficient RAM memory), the State submits a plan and budget request to support
       upgrading of these systems to the recommended performance levels, which includes
       the type of equipment to be purchased and associated costs. Upgrading an existing
       computer can include adding more RAM and disk capacity and purchasing processor
       upgrades. States should also include in the budget those costs associated with
       upgrading current computer operating systems to the prescribed Windows operating
       systems. The costs associated with upgrading equipment should not exceed the cost
       for actual replacement. Finally, it is also appropriate for States to include a budget for
                                                                                               60
            additional staff/contractor costs incurred to manage the computer and operating system
            upgrade process.

       c. To the extent that a State does not possess sufficient systems that are currently capable
          or able to be upgraded to the minimum standard, the State should submit a plan and
          budget request to support the acquisition of the number of new systems that are
          necessary to provide appropriate access. The budget request must include the number
          of each type of machine to be purchased and associated costs.

       d. QIS – This budget note is directed toward States considering a purchase of computers
          for their LTC surveyors and/or States that will be implementing the QIS in FY2011.
          CMS plans to move forward with measured implementation of the QIS during FY2011,
          CMS will communicate with the States currently selected/approved to implement the
          QIS in FY2011 regarding any questions/issues related to equipment procurement.
          Unless the SA has already procured tablet computers for their LTC surveyors, the SA
          will need to submit a budget request for any equipment needed (e.g., the computers).
          For FY2011 QIS implementations, CMS is requiring States to procure Tablet PC
          configuration(s) as part of this process. Moreover, CMS highly recommends that
          States plan for future QIS implementations as part of their hardware procurement
          process recognizing the need for Tablet PC configurations as a future need. The
          hardware that is budgeted by the SA is in addition to the hardware provided as part of
          the startup process, with the understanding that equipment costs will be distributed in
          the usual manner against Medicare/Medicaid/Licensure.

           Costs for equipment purchases that will be used in conjunction with the QIS must be
           included on Form CMS-435 State Survey Agency Budget/Expenditure Report and
           CMS-1466 Survey and Certification State Agency Schedule for Equipment Purchases.

           Equipment purchases for QIS LTC surveyors should include: one Tablet laptop
           (described in the table below, Minimum and Recommended Client Requirements) for
           each surveyor and one portable printer for every three such surveyors. The portable
           printers, which are currently required only for the QIS process, should be lightweight,
           capable of 17 pages or more per minute and capable of running on battery power alone.

       e. Surveyor Technical Assistant for Renal Disease (STAR) - Prior to attending a STAR
          training course, surveyors are expected to have access to specified tablet PCs.
          Surveyors will be able to use the same Tablet equipment for QIS and STAR.

Guidelines for the recommended system configuration and State size based estimates for the
number of systems required are found below. For FY2011 planning purposes, it is expected that at
least 10 client systems will be required for in-office access to the standard system and related
components, based on State size (i.e., small, average, large) as used in the FY2004 Budget Call
Memorandum. In other words, a large State should have 30 client systems that meet the minimum
standards for agency staff. For field systems, States should seek to maintain a ratio of at least one
laptop/tablet system per two surveyors.

Laptops: Please note, for States planning laptop purchases, CMS now requires acquisition of the new
Convertible Tablet PC platform when selecting systems for QIS implementation. Furthermore, CMS
strongly suggests that States start planning immediately for future QIS implementation with respect to
                                                                                                61
the procurement of Tablet PCs. Convertible Tablet laptops work in two configurations: 1)
Traditional configuration with raised screen display, full keyboard and standard mouse pad and 2)
Tablet configuration in which the screen is folded flat, the keyboard hidden and with data capture
performed through a pen-like stylus for rapid form-based entry and direct note-taking via handwriting
recognition technology. When purchasing a Tablet, we recommend the type that is a single unit with
non-detachable screen and keyboard.

These convertible Tablet PCs are fully compatible with current CMS systems, such as ASPEN
Survey Explorer and also provide the advantage of preparing your agency for future ASPEN
survey systems versions, which will utilize the enhanced information capture capabilities of the
Tablet configuration.


   3. Encryption Policy
      CMS‘ encryption policy requires all agency data be protected from unauthorized access.
      There may be various levels of protection for agency data, but for personally identifiable
      information (PII), the policy states that dissemination of such data using any portable
      devices or recordable media, (e.g., CDs, DVDs, Cartridges, Diskettes, Laptops, External
      Hard Drives, USB Memory Sticks or thumb drives, etc.), requires encryption. The whole
      disk encryption of the hard-drive of a Laptop or Tablet PC must be employed. Encryption
      is the process of protecting stored or transmitted information with a password (key) so that
      it is indecipherable until the intended recipient uses the password to access it.

       In accordance with the CMS encryption policy, all QIES components installed on
       workstations must have encryption software installed that meets or exceeds the standards
       set forth in the ―CMS Information Security Acceptable Risk Safeguards (ARS)‖ This
       includes all QIES components installed on Laptop/Tablet PCs as well as any removable
       media used to disseminate PII. Specifically, the following sections of the ARS should be
       referenced:

       •   IA-7 Cryptographic Module Authentication (Specifies acceptable encryption type –FIPS
            140-2 compliant (http://csrc.nist.gov/publications/PubsFIPS.html) NIST validated
            module. (http://csrc.nist.gov/cryptval/)
       •   IA-2 User Identification and Authentication
       •   AC-3 Access Enforcement
       •   AC-4 Information Flow; specifically CMS-2
       •   AC-19 Access Control for Portable and Mobile Systems (encryption requirement only)
       •   MP-5 Media Transport
       •   SC-8 Transmission Integrity
       •   SC-12 Cryptological Key Establishment and Management

           Please note, in addition to these encryption sections, agencies are encouraged to review
           the entire ARS as a guideline for enterprise-wide security practices. States are
           responsible for ensuring that encryption software has the capability of creating
           encrypted files that are self-extracting with a password key. More information on this
           will be forthcoming.

       Additionally, many agencies have home-based staff using QIES software installed on          62
          home workstations. Such home-based systems must be protected with encryption software
          as described above and comply with CMS controls as defined in the ARS.

         Minimum and Recommended Client Requirements: EXISTING or NEW EQUIPMENT
        Component                              Minimum                           Required for QIS Implementation
                                                                                     Recommended for Other

         Processor             Pentium Class (or equivalent) @ 1.2 GHz        Pentium Class (or equivalent) @ 2.0 GHz

      Memory (RAM)                              512 MB                                          2 GB

 Disk Capacity (Free space)                 4 GB (1 GB free)                16 GB ( 4 GB free) at 7200 RPM with Native
                                                                               Command Queuing (NCQ) Capability

          Monitor                           15" Color VGA                          Desktop 19": Color Flat Panel
                                       SVGA for laptop or tablet             >1024x768 screen resolution Flat Panel for
                                                                                         laptop or tablet

    Operating System*              Windows 2000, XP, Vista – 32 bit                     Windows XP – 32 bit
                                                                                            Vista – 32 bit

    Runtime Platform**              Windows .NET Framework 3.5                     Windows .NET Framework 3.5

 Secure Access/Encryption          Required – See Encryption Policy               Required – See Encryption Policy
  (See Encryption Policy)

         Anti-virus                         Current License                                Current License

 Universal Serial Bus Port                        One                                          Three

     Removable Media                           USB Drive                                     USB Drive
   (see Encryption Policy)

      Pointing Device                     Mouse or equivalent                            Mouse or equivalent
                                      (e.g. trackball or touchpad)           (e.g. trackball or touchpad) and Pen/Stylus

  Network Interface Card                          Yes                                            Yes
   (See CMS ARS security         Wireless network cards must support            Wired for network connectivity; and
 guidelines for acceptable              WPA-level encryption                    Wireless network cards must support
  wireless configurations)                                                             WPA-level encryption

       Optical Drive                           CD -ROM                           CD/DVD-ROM (External for tablet)

           Audio                      Standard built-in speakers             Attachable microphone and standard built-
                                                                                            in speakers

 Battery (laptop or tablet)                6-cell lithium-ion                             6-cell lithium-ion

Side-to-Rear Cooling (laptop                 Not required                               Recommended for all
         or tablet)

        Browser***                      Internet Explorer v 7.0                        Internet Explorer v 7.0

 * Microsoft has released a new version of its Windows operating system – Windows 7. CMS systems will not be
 validated on this new operating system during the period covered by this document. States considering
 implementing Windows 7 should carefully evaluate CMS software on this platform before full-scale deployment.
 ** The .NET Runtime is integrated into Windows Vista. A separate install is not necessary for Vista. ASPEN 10.0 will
                                                                                                                   63
automatically install the .NET Runtime when it is not already on the system.
*** Microsoft has released a new version of its browser – Internet Explorer v 8.0. CMS systems will not be validated
with this new browser during the period covered by this document. States considering implementing Internet
Explorer v 8.0 should carefully evaluate CMS software with this browser before full-scale deployment.


M. Emergency Preparedness: SAs operate in a larger context of State emergency preparedness
and often play important roles within a State Incident Command System (ICS) that extend far
beyond Federal survey and certification functions. In such cases States have cost accounting
systems in place to allocate expenses properly and ensure that the cost of non-Federal activities is
not charged against Federal accounts. Nonetheless, some emergency preparedness and emergency
response activities are vital to the effective conduct of Federal quality assurance and, as such, are
properly included in the State‘s S&C mission, priority and budget document.

The items identified below are key elements that have been developed based on the
recommendations of the S&C Emergency Preparedness Stakeholder Communication Forum.
While we realize some States already have very well-developed systems that far exceed the
elements described here, we appreciate that for many States enhanced IT reporting capabilities
require additional time to implement. In September 2007 CMS therefore provided considerable
advance notice for States to establish the electronic tracking and reporting capability no later than
July 1, 2009 that includes the data elements identified under “2. Effective Communication &
Coordination with CMS.”

        1. SA Continuity of Operations (COOP)
        The SA maintains a coordinated, emergency Continuity of Operations Plan (COOP),
        updated at least annually, which is submitted to the CMS RO. The COOP addresses:

            a. Essential S&C business functions, including:
                  Provision of prompt responses to complaints regarding patients/residents who are
                   in immediate jeopardy.
                  Provision of monitoring and enforcement of healthcare providers. Even in
                   widespread or significant disasters where reduced S&C activities may occur, key
                   activities (such as complaint investigations, provider communications,
                   communication with CMS regarding any advisable adjustment to previously-
                   imposed enforcement actions that might impede evacuee placement, etc) will still
                   need to occur in order to ensure the health and safety of patients and residents.
                  Conducting timely surveys or re-surveys in the aftermath of a disaster.
            b. Identification of strategies to ensure maintenance and protection of S&C critical data.
            c. A program of COOP exercises, conducted at least annually by designated staff to
               ensure State, Regional, Tribal and Federal responsiveness, coordination, effectiveness
               and mutual support.

        2. Effective Communication & Coordination with CMS
           a. Point of Contact: A State S&C emergency point of contact (and back-up) is available
              24 hours per day and 7 days per week to the CMS RO when the State declares a
              widespread disaster. The contact:
                 Coordinates State S&C activities with CMS;
                 Addresses questions and concerns regarding S&C essential functions;
                                                                                                                  64
        Provide status reports; and
        Ensures effective communication of federal S&C policy to local constituencies
           (see details below).
       These functions may be fulfilled by a person within the State ICS who has been
       clearly assigned to communicate with CMS and provide data for S&C functions.
  b. Policy Communications: The SA maintains capability for prompt dissemination of
     CMS policy and procedures to surveyors, providers and affected stakeholders.
     During a disaster, the capability is operative 24/7. The SA capability includes back-
     up communication strategies, such as websites and hotlines and emergency capability
     that enable functional communication during energy blackouts. A designated person
     is available for responding to healthcare providers‘ questions and concerns related to
     federal survey and certification. These functions may be performed by a person
     within the State ICS, who has been clearly assigned to perform these functions.
  c. Information and Status Reports: The SA or the State ICS maintains capability and
     operational protocols to provide the CMS RO with (a) State policy actions (such as a
     Governor‘s emergency declarations or waiver of licensure requirements) and (b) an
     electronic provider tracking report, upon request, regarding the current status of
     healthcare providers affected by a disaster. The capability includes:


     Provider Contacts                         Provider Status                    Provider Plans
 Provider‘s name                For profit/ or not-for-profit agency, or        Estimated date
 CMS Certification Number        government agency status                         for restored
  (CCN)                          Provider status (evacuated, closed, damaged)     operations
 National Provider Number       Provider census                                 Source of
  (NPI)                          Available beds                                   information
 Provider type                  Emergency department contact information        Date of the
 Address (Street, City, ZIP      (name, telephone number, FAX number) if          status
  Code, County)                   different than provider contact information      information
 Current emergency contact      Emergency department status (if applicable)
  name                           Loss of power and/or provider unable to be
 Contact‘s Telephone             reached
  number and alternate (e.g.,
  cell phone)
 Contact‘s email address

3. Recovery Functions
Recovery functions will be determined on a case-by-case basis between the SA and the
CMS RO. In the context of survey & certification, recovery functions represent those
activities that are required to ensure that a provider has re-established the environment and
systems of care necessary to comply with Federal certification requirements.

4. Funding
We believe that the types of actions that we are specifying are currently underway or in
place based on State-level initiatives and/or prior informal arrangements between States
and ROs formed on an ad hoc basis. In many of these cases, implementation costs will be
very low. We, therefore, encourage SAs to seek other available sources of emergency
services funding or grants to promote emergency preparedness coordination wherever
possible and to share information and expertise with other States.
                                                                                         65
       To the extent that routine work cannot be accomplished during a significant disaster,
       unobligated S&C funds may be available to provide fiscal resources that otherwise could
       not be budgeted for the above activities. Depending on the nature of the disaster, the CMS
       RO may also authorize expenditures for certain recovery efforts that would not normally be
       covered, when such activities advance the subsequent recovery and the continued or
       resumed certification of providers. An example is the conduct of pre-survey site visits in
       the aftermath of a disaster, prior to the reopening of a healthcare facility, particularly when
       the result of the site visit is a conclusion that a subsequent survey is not required (such as a
       finding that damage is so light that a new life-safety code survey is not needed).

       If a very significant emergency occurs in a State and it calls upon extra SA resources to
       meet the resulting needs, the State can submit a supplemental budget request, which we
       will consider for priority funding depending on the severity and extent of the emergency.

       5. Affected Provider Emergency Exchange (APEEX)
       To assist States to ensure the electronic capability to track provider status in an emergency,
       CMS piloted, with the support of the HHS Agency for Healthcare Research and Quality
       (AHRQ), a template of the Emergency Preparedness Resource Inventory (EPRI) database,
       as a voluntary tool for SAs to meet the CMS provider tracking and reporting requirements.
       An evaluation of the CMS EPRI Pilot findings was issued in the fall of 2009.

       CMS is currently in the process of making available to States the Affected Provider
       Emergency Exchange ‗APEEX‘ and any interested States will be able to utilize the
       software at no cost in the near future. However, regardless of the system used, States are
       still required to submit electronic affected provider status reports to the CMS RO during
       emergency events, which include the data elements identified above. An Affected Provider
       Status Report template is available on the S&C Emergency Preparedness website for this
       purpose:
       http://www.cms.hhs.gov/SurveyCertEmergPrep/Downloads/AffectedProviderReportTool.p
       df.

       6. Relationship to State Performance Standards System
       If a significant emergency occurs in a State that disrupts normal survey and certification
       activity and that is well outside the level that can typically be expected in the State, CMS
       will take such circumstances into account so as to avoid penalizing the State for SA
       Performance issues unavoidably caused by the emergency.

N. Energy Productivity
Consistent with the President‘s policies and executive direction, CMS seeks to improve the energy
productivity of survey & certification operations. Insofar as transportation and fuel costs are
significant items of S&C expense, we encourage States to lease or modernize their automobile
fleets with highly efficient vehicles that meet or exceed 40 miles per gallon in combined
city/highway EPA mileage ratings. An increasing array of vehicles meets this level of efficiency.
In FY 2011 we will continue CMS incentives to enlarge upon transportation and other energy
productivity improvements. In the event that one-time funding becomes available later in the FY,
we suggest that States conduct some advance analysis of what would be feasible to take advantage
of such funds and how the State would accomplish appropriate cost-accounting among affected
funding sources if Medicare one-time funds were available.
                                                                                                    66
O. Alignment with State Performance Standards System (SPSS): States must maintain
documentation and information systems to ensure accurate and timely provision of information on
survey activities, findings, enforcement and surveyor performance. Timely uploading of surveys is
an important aspect of such a system. With regard to performance of surveys within the required
frequencies, most non-LTC provider types continue to be part of the SPSS for frequency of
surveys specified in Tiers 1-3. The SPSS includes all of the following with regard to survey
frequency.

                 Table: Providers for Which Tier 1-3 Performance is Measured by SPSS

           Statutory Providers                                     Other Providers
  Nursing Homes                          Hospitals (all types)       Rural Health   Clinics (RHCs)
  Home Health Agencies                   ESRD facilities             ASCs
  Validations – all types of   deemed    Hospices                    OPTs
   providers/suppliers
  ICFs/MR                                Comprehensive   Outpatient Rehabilitation Facilities (CORFs)


States must track their Tier workload on a quarterly and annual frequency and report the quarterly
results to the Regional Offices during the course of the year by the end of the succeeding quarter.
As part of their oversight and trouble-shooting responsibilities, Regional Offices will be
monitoring and working with the States on the performance of the Tiered workload.

P. Miscellaneous Tier 4 Workload:

Inpatient Rehabilitation Facilities Prospective Payment System (IRF-PPS)
CMS developed a patient-centered assessment instrument (IRF-PAI) to assess short stay patients
for inpatient rehabilitation facilities to support the Prospective Payment System for
reimbursement. IRF-PAI data is collected on all Medicare patients who receive inpatient services
from an inpatient rehabilitation facility (free standing rehabilitation hospital or rehabilitation unit
in an acute care hospital) certified for Medicare payments. SAs will have access to this
information through the CMS system for monitoring quality of care issues. The system is Web-
based and there will be a plug-in that must be downloaded to the workstation. The States are not
responsible for training or technical assistance to providers.




                                                                                                          67
               SECTION SEVEN. BUDGET FORMULATION GUIDELINES

No change is made with regard to the justifications and explanations of the State budget. These
are necessary for RO analysis of the budget and to enable a worthwhile dialogue regarding Federal
expectations and anticipated State performance. Completion of the State activity plan continues to
be required.

   A. Timing: By September 30, 2010, please submit to CMS ROs a proposed budget for
      FY2011 that conforms to the specifications in this letter. The budget should be based on a
      specific dollar amount expected for Medicare funding (rather than a general estimate of
      what the State believes is needed). The budget must include brief, narrative contingency
      plans (higher and lower than the projected baseline budget) as noted in this document,
      since it is highly unlikely that Congress will pass the final budget until well into the
      Federal fiscal year. Although it may be necessary to make some adjustments after
      Congress passes a final budget, our goal is to reduce budget uncertainty for States as much
      as possible.

   B. Projecting Budget Levels: For FY2011, the President‘s proposed budget would provide
      States with an increase in Medicare S&C funds to bring it to levels that better correspond
      with the workload and goals of the Administration. We do not know the extent to which
      Congress will support the requested funding level. To address the budget uncertainty, we
      are adopting the following approach for FY2011.

           1. Projected Baseline Budget: All States should submit an S&C budget that assumes
              an increase in the Medicare portion of the budget that conforms to the baseline
              amounts in Appendix 2. Increases in each State‘s budget baseline are influenced by
              the Budget Allocation Tool (BAT) that measures the State‘s workload compared to
              all other States. The FY2011 BAT has been adjusted for changes in the number of
              Medicare-certified providers in each State that must be surveyed.

           2. Contingency Plans: For the Medicare portion of the budget, all States must
              develop a contingency plan that identifies adjustments that the State could make at
              the mid-point of the fiscal year when we expect final Federal budget figures to be
              available. The contingency plans should be brief, narrative descriptions, not full-
              blown alternative budgets. The contingencies must reflect CMS priorities, but may
              also address State priorities within the CMS priority Tier system. It is not
              necessary to complete the budget forms for the contingency plans. The two
              contingencies are:

              a. Adverse Contingency Adjustment: Actions to accommodate a reduction in
                 funds compared with projected amounts.
              b. Positive Contingency Adjustment: Actions to accommodate budget increases
                 above the projections in this document, based on the State‘s ranking in CMS‘
                 Budget Allocation Tool (BAT), as follows:

Consider the special travel-training funds (separately identified in Appendix 2) to be available
(unchanged) in both the adverse and positive contingency plans. The projected budget, as well as
the contingency plans, should assume full availability of the special travel-training funds in
column G1 of Appendix 2.
                                                                                                 68
              BAT Quintile         Average Baseline             Positive                 Adverse
              in Which the             Increase               Contingency             Contingency
              State is Listed        Projected**             (above baseline         (below baseline
                                                               projection)             projection)
                     1                    5.5%                  + 2.50%                  - 3.75%
                     2                    4.5%                  + 2.25%                  - 3.50%
                     3                    3.5%                  + 2.00%                  - 3.00%
                     4                    2.5%                  + 1.75%                  - 2.50%
                     5                    1.5%                  + 1.50%                  - 1.50%
                *This table is for general information only.
                **For the baseline budget, use the actual dollar amounts for each State‘s baseline budget (rather than
                the above percentage), as provided in Appendix 2.

In the event of favorable action by Congress on the President‘s FY2011 proposed budget, Federal
contingency priorities for FY2011 will focus on fulfilling CMS commitments that implement
recommendations made by the Government Accountability Office (GAO) and that have had to be
delayed as the FY2006 and FY2007 national budgets persisted at levels lower than the FY2005
budget. These include:

•   Improving oversight of accrediting organizations (e.g., for accredited hospitals, CAHs, HHAs,
    hospices and ASCs),
•   Improving ASC, ESRD and Hospice surveys,
•   Improving consistency and effectiveness of State surveys, through actions such as improving
    the number of Federal validation surveys,
•   Continued national implementation of the new Quality Indicator Survey (QIS),
•   Continuation of the pilot for Surveyor Technical Assistant for Renal (STAR),
•   Surveys of transplant centers and
•   Additional improvements in the effectiveness of remedial enforcement actions to protect
    beneficiaries and improve the quality of care.

States also have a responsibility to develop and implement a budget for Federal Medicaid
matching funds sufficient to accomplish the Medicaid quality assurance functions articulated here.

States are to prepare budget requests in accordance with the instructions in Chapter 4 of the SOM -
Program Administration and Fiscal Management. States should review the Budgetary Process
covered in Sections 4600 through 4642, in particular, before preparing their budget requests. The
State budget request for Medicare must be based on the instructions in this document (excluding
one-time allocations, special purpose disbursements, supplemental payments, etc.). Small mid-
year adjustments in the Medicare portion of the budget may need to be made after Congress
finalizes the FY2011 appropriation.

The goal of SA budget-building is to project the highest amount of work that can be completed,
within the priority structure, based upon the total dollar amount assigned to the State. The dollar
amounts appearing on every line of the CMS-435 must be derived from corresponding activity
projections. Slight adjustments to line item figures, using insignificant amounts, are acceptable for
purposes of matching a State‘s assigned bottom line. But in no case should a State enter a figure
on the CMS-435 that has been devised solely to meet the State‘s assigned total amount. This is
                                                                                                                  69
important not only to maintain the integrity of the budget process, but also to allow meaningful
quarterly and annual comparisons of budgeted and expended amounts.

   C. Special Travel-Training Funds: Unless otherwise requested by a State, we will consider
      the special travel-training funds (separately identified in Appendix 2) to be the first dollars
      spent for surveyors attending in-person CMS training courses published in the CMS
      training schedule.

       Example 1: A State is allocated $25,000 in special travel training funds. The State projects
       and budgets for an additional $30,000 as part of its baseline budget, for a total projected
       need and budget of $55,000. The State actually expends $50,000. Since $50,000 is greater
       than the total $25,000 in special travel funds, we will consider the entire $25,000 to be
       spent. In this case the State has $5,000 left over in its baseline budget, which it may then
       transfer to other purposes with CMS RO approval.

       Example 2: With the same projected need and budget as in Example 1, the State actually
       spends only $15,000 in total. In this case, $10,000 is left unspent in the special travel-
       training funds ($25,000 minus $15,000) and will be redeployed to other States. The
       unexpended funds in the States baseline budget ($30,000 minus 0) will remain available to
       the State and may be transferred to other Medicare survey & certification purposes with
       CMS RO approval. Please contact your CMS RO if you have questions.

   D. Budget and Expenditure Reporting Requirements
      States are expected to continue requesting and reporting all NAR/NATCEP costs and FTEs
      on the Miscellaneous line 14A of the form CMS-435. These expenses are not to be
      included in salaries/fringe benefits. States‘ budget requests should be tied to the number of
      nurse aides and/or training programs. CMS will not approve any budgets that fail to
      include NAR/NATCEP associated FTEs and expenses under line 14A (Miscellaneous) on
      the form CMS-435 (columns C and D, respectively).

       NAR/NATCEP and competency evaluation costs incurred for Title XIX-only facilities are
       considered administrative costs and are to be reported on the Quarterly Medicaid Statement
       of Expenditures for the Medical Assistance Program (form CMS-64). There are no
       provisions for covering these expenses in the Medicaid Survey and Certification budgets.

       Costs incurred in joint Titles XVIII/XIX facilities for NAR/NATCEP will be charged and
       reimbursed 50 percent by Medicare and 50 percent by Medicaid (50%-50% split).
       Expenses incurred for Title XVIII should be reported on the form CMS-435; expenses for
       Title XIX on the form CMS-64.

       Each State is required to prepare a ―mini-budget‖ form CMS-435 separately for MDS and
       OASIS, indicating FTEs and proposed costs in the appropriate line items.

       The separate budget request and Excel template sheet for NHOIP Medicare funding is no
       longer required, nor the quarterly NHOIP expenditure report, nor the end-of-year report,
       nor will States be required to track NHOIP expenditures separately on the NHOIP
       Expenditure Report. The State Performance Standards System (SPSS) will pick up on the
       most important results of the NHOIP. This effectively ends the ―NHI Expenditure Report
       Instructions from Central Office dated December 30, 1999.‖
                                                                                               70
   In summary, the budget package should include:
      • Form CMS-435 that captures all projected FY expenditures (including MDS,
         OASIS and the NHOIP) spread across the appropriate lines of the CMS-435;
      • 2 Mini Form CMS-435s (MDS & OASIS);
      • Form CMS-434 (planned workload);
      • Form CMS-1465A (list of personnel);
      • Form CMS-1466 (equipment purchases);
      • Line Item Budget justification
      • Activity Plan
   We also remind States that, under no circumstance, should the costs reported in the training
   line on the form CMS-435 be zero. As discussed in the SOM, this line item includes any
   non-salary costs associated with training.


E. CMS Budget Analysis and Adjustment

   1. Budget Adjustments for Furloughs and State Hiring Limitations: For FY2011
      allocations, CMS will review the status of any staff furlough programs and other
      personnel limitations that may affect the State‘s ability to accomplish the Federal
      workload. CMS will adjust downward the allocations for States whose furlough
      programs or hiring restrictions limit their ability to accomplish the full Medicare
      workload consistent with available funds. To the extent that performance is negatively
      affected despite the availability of Federal funds, CMS will review performance under
      the 1864 agreement or under Medicaid law to determine if longer term actions are
      warranted. Downward adjustments in the baseline or other budget columns in
      Appendix 2 for FY2011 will apply only for FY2011 and the funds not allocated to the
      affected States will be made available to other States as one-time budget allocations.
      We will conduct one such review and reallocation in the October – January time period
      and a second review in March – April 2011.

   2. States with a Pattern of Unexpended Funds: In addition, if a State has had
      unexpended Medicare funds exceeding 3% of its total Medicare baseline allotment (or
      $500,000, whichever is greater) for two or more consecutive years from FY2006 –
      FY2010, the State must submit an explanation as to how the barriers to workload,
      accomplishment have, or are, being removed for FY2011 in order to receive the full
      baseline increase that CMS has otherwise scheduled for the State. If CMS does not
      accept the State‘s plans, then we will make a one-year downward adjustment in the
      State‘s allocation of Medicare funds.

F. Ambulatory Surgical Center Funds
   Similar to FY 2010, funding for the ASC surveys is broken out separately in the S&C
   Medicare budget (see Appendix 2) and will require some special reporting on Form CMS-
   435.
   Further, in accordance with AdminInfo 10-31, the performance period for Recovery Act
   grants will be extended until March 31, 2011 for States that:                        71
             o May need more time to complete their FY 2010 workload of recertification surveys
               for at least 33% of their non-deemed ASCs; and/or
             o Apply and are approved for Recovery Act funds to perform more than the FY 2011
               workload of recertification surveys for at least 25% of their non-deemed ASCs.

       For these States:
          o As in FY 2010separate reporting on the Recovery Act website will continue until
              they complete all Recovery Act funded survey workload, or they draw down all of
              their Recovery Act grants, whichever comes first;
          o Unlike FY 2010, Recovery Act funds must be used first before drawing down funds
              identified in the ASC column of the State‘s S&C Medicare budget (in Appendix 2).

       Funds identified in the ASC column of the State‘s S&C Medicare budget (in Appendix 2),
       which are not needed by the State to meet the 25% survey requirement, may be used for
       other CMS S&C priorities.

To calculate the FY2011 funding for ASC surveys in FY2011 on a State-by-State basis, we
multiplied the number of non-deemed ASC surveys in each State times 25%. This yields the
expected number of non-deemed surveys expected (i.e., we expect 25% of all such ASCs to be
surveyed). We then multiplied this number times the actual average hours per survey for FY2010
surveys reported by each State on the CMS Form 670 as of June 2010 (for both the health
recertification survey and the life-safety code portion of the standard survey). This yields the
expected total (aggregate) hours of survey time. Finally, we multiply the aggregate expected hours
by the State-specific average cost per hour for non-LTC surveys. We then add a national average
expected cost for revisits to arrive at the grand total. Two exceptions apply:

               Low ―n‖ – If the total number of surveys reported for FY2010 was less than 5, we
                used the greater of (a) the national average number of hours per survey for FY2010
                or (b) the State-specific average number of hours for FY2009.
               Outliers: If a State had a significantly anomalous number of average hours for
                FY2010, we used the national average number of hours per survey for FY2010
                instead of the State-reported number of hours per survey.




                                                                                                72
                                                   Appendix 1 - Table of Survey Frequencies & Priorities

                                                                2011 SURVEY FREQUENCY & PRIORITY
 Category                                              Tier 1                                                         Tier 2                     T-3            Tier 4
1. Nursing    15.9-Mo. Max. Interval: No more than 15.9 months elapses between surveys for any      NH Oversight & Improvement
Homes          particular nursing home.                                                                Program (NHOIP): All aspects of
              12.9-Mo. Avg: All nursing homes in the State are surveyed, on average, once per         the nursing home improvement
               year. The Statewide average interval between consecutive standard surveys must be       program are sustained (e.g., off-
               12.9 months or less.                                                                    hour surveys, SFFs, etc.)
2. Home       36.9-Mo. Max. Interval: No more than 36.9 months elapses between surveys for any      5% Add’l Targeted Sample:                         24.9 Mo. Avg: Add‘l
Health         particular agency.                                                                     States annually survey 5% of the                  surveys (beyond tiers 1-
Agencies      Surveys Pursuant to Complaints: Extended surveys are required after each               HHAs, selected from a CMS list                    3) done based on State
               complaint investigation that finds substantiated CoPs out of compliance (both deemed   that identifies those agencies most               judgment regarding
               & non-deemed HHAs).                                                                    at risk of providing poor care.                   HHAs most at risk of
              5% Validation Surveys: States annually survey 5% or at least 1 deemed HHA,             Surveys in the targeted sample may                providing poor care so
               unless the State has no deemed HHAs, or unless CMS makes no assignment, based on       count toward the 36-month interval                all HHAs are surveyed
               AO survey schedules. (Each State surveys 1 HHA within its standard budget              requirement.                                      on avg. every 24 mos.
               allocation; additional surveys are budgeted via supplemental allocation.)                                                                (all surveys divided by
                                                                                                                                                        total agencies ≤ 24.9
                                                                                                                                                        mos.)
3.            12.9Mo. Max. Interval: No more than 12.9 months elapses between surveys for any           Extended       Surveys Pursuant to
ICFs/MR       particular ICF/MR, except for those ICFs/MR for which a short extension is granted.            Complaints: Extended surveys are
                                                                                                             required after each complaint
                                                                                                             investigation in which there are
                                                                                                             substantiated CoPs out of
                                                                                                             compliance.
4.            1% Validation Sample: All States perform surveys for at least 1% of the States‘ deemed                Complaint Investigations
Hospitals      hospitals, designed to validate the surveys of accreditation organizations. CMS identifies the         – Non-IJ, Non-EMTALA
& CAHs-        hospitals to be surveyed by each State. Funded out of each State‘s regular budget.
Accredited    Targeted Add’l Validation Sample: Some States conduct add‘l surveys from a second
and            sample selected by CMS (second sample % budgeted separately and allocated as
Deemed         supplemental during the year).
              5% CAH Validation Surveys: States annually survey a 5% of deemed CAHs specified by
               CMS during the year, or at least 1, whichever is greater. Funded out of each State‘s regular
               budget. If CMS makes no assignment for deemed facilities, then no validation survey is
               required.
              Complaints – IJ & EMTALA: Complaint Surveys authorized and prioritized by the RO as
               potential Immediate Jeopardy. IJ allegations are to be initiated within 2 days of authorization
               and are a Tier 1 priority. All others are to be initiated within 45 days and represent a Tier 2
               priority. The on-site portion of EMTALA surveys must be completed within 5 days of RO
               authorization.
              Standard Surveys Pursuant to Complaints: Full surveys are required after each complaint
               investigation that finds substantiated CoPs out of compliance for accredited, deemed
               hospitals and CAHs.
  Category                                                                             2011 Survey Frequency & Priority
                   Tier 1                                  Tier 2                                                         Tier 3                                       Tier 4
5. Hospitals-&                  5-Year Max. Interval: No more than 5.0 years elapses  Recerts: 4.0-Year Max. Interval: No more than 4.0                  3.0-Year  Avg. Add‘l surveys
CAHs Non-                        between surveys for any non-accredited hospital or              years elapses between surveys for any particular non-     are done (beyond Tiers 2-3),
Accredited and    See            CAH.                                                            accredited hospital or CAH.                               based on State judgment
Non-Deemed        above         5% Targeted Sample: States survey at least 1, but not          New IPPS: All new rehabilitation hospitals/ units &       regarding the non-accredited
(14)                             less than 5% of the short-term, acute care, non-                new psychiatric units seeking exclusion from IPPS         hospitals and CAHs that are
                                 accredited hospitals and 5% of non-accredited CAHS              (15), as well as existing providers newly seeking such    most at risk of providing poor
                                 in the State. These are selected from CMS lists that            exclusion. The SA does not conduct an on-site survey      care, such that all non-
                                 identify those hospitals/CAHs more at risk of providing         for verification of the exclusion requirements but        accredited hospitals/CAHs in
                                 poor care. Some targeted surveys may qualify to count           instead processes an attestation of compliance by the     the State are surveyed, on avg,
                                 toward the Tier 3 and 4 priorities. Targeted sample             hospital.                                                 every 3.0 years (i.e., total
                                 requirements do not apply to States with fewer than 7          IPPS Exclusion Verification (Existing excluded            surveys divided by total non-
                                 non-accredited hospitals or CAHs. Separate                      hospitals/units): 5% (but at least 2 per State) of        accredited hospitals/CAHs is
                                 calculation for hospitals and CAHs.                             providers already IPPS-excluded. These are                not more that 3.0 years;
                                                                                                 rehabilitation hospitals, rehabilitation units and        separate calculation for
                                                                                                 psychiatric units that have attested to continued         hospitals and CAHs).
                                                                                                 compliance with the IPPS exclusion requirements           Targeted surveys may count
                                                                                                 (16). These surveys verify that the hospital continues    toward the 3.0 yr avg.
                                                                                                 to meet IPPS exclusion criteria.
6. Transplant      Compla      Initials: Any initial surveys of programs that applied         4.0 Yr Max Interval: No more than 4.0 years elapses
Centers            ints- IJ:     prior to December 26, 2007.                                     between onsite surveys for any particular transplant
(funded with       Investig     Mandatory Re-approval Surveys: The transplant                   program.
supplemental       ation of      program does not meet the data submission, clinical            Initials: Initial surveys not identified as Tier 2 by
allocation to      potentia      experience or outcomes requirements.                            CMS.
participating      l IJ         Targeted Sample (5-25%): Surveys of transplant
States)            Compla        programs from a CMS list that identifies those
                   ints          transplant programs that have had significant program
                                 changes and/or are more at risk of providing poor care.
                                 Surveys in the targeted sample may count toward the
                                 Tier 3 requirement. Percentage will vary by State,
                                 depending on the CMS issued list.
                                Complaints Non-IJ: Investigation of complaints not
                                 categorized as potential IJ.
7. ESRD                         10% Targeted Sample: States survey a 10% targeted              3.5-Year Interval: Additional surveys are done to        3.0-Year Avg: Additional
                                  sample of ESRD facilities, selected from a CMS list             ensure that no more than 3.5 years elapse between       surveys are done (beyond Tiers
                                  that identifies those facilities most at risk of providing      surveys for any one particular ESRD facility.           2-3) sufficient to ensure that
                                  poor care. Some of the targeted surveys may qualify to  Support “Fistula First”                                        ESRD facilities are surveyed
                                  count toward the Tier 3 and 4 priorities.                     Initial Surveys                                          with an average frequency of
                                Relocations.                                                   Expansion of stations or services                        3.0 years or less.
   Statistical Convention: Whenever standards are expressed in months, 0.9 of the succeeding month is included in order to permit completion of any survey in progress.
   Hence a 12 month average is tracked as 12.9 months. Similarly, a 3.0 year interval is tracked as 36.9 months and a 6.0 year interval is tracked at 72.9 months.

   14 Includes critical access hospitals, rehabilitation hospitals, and psychiatric hospitals. IPPS refers to the Inpatient Prospective Payment System.
   15 Onsite verifications are to be completed no later than 90 days prior to the beginning of the hospital‘s cost reporting period.                                            74
   16 Onsite verifications are to be completed no later than 90 days prior to the beginning of the hospital‘s cost reporting period.
   Category                                                                   2011 Survey Frequency & Priority
                        Tier 1                                     Tier 2                                       Tier 3                                    Tier 4
8. Hospices       States conduct          5% Targeted Surveys: Each year, the State surveys       6.5-Year Interval:                      6.0-Year Avg: Add‘l surveys are
                    validation              5% of the non- deemed hospices in the State (or at        Additional surveys are done             done (beyond tiers 2-3) such that
                    surveys of              least 1, whichever is greater), based on State            to ensure that no more than             all non-deemed hospices in the
                    deemed hospices,        judgment for those hospices more at risk of quality       6.5 years elapse between                State are surveyed, on average,
                    specified by CMS,       problems. Some of the targeted surveys may qualify        surveys for any one particular          every 6 years. (i.e., total surveys
                    during the year,        to count toward the Tier 3 and 4 priorities. States       non-deemed hospice.                     divided by total non-deemed
                    depending on the        with fewer than 7 non- deemed hospices are exempt                                                 hospices is not less than 16.7% =
                    accreditation           from this requirement.                                                                            6.0 years).
                    organizations‘
                    survey schedules
                    for FY2011.
                    (Budgeted
                    separately via
                    supplemental
                    allocation).

9. Outpatient                            5% Targeted Surveys: Each year, the State surveys             7.0-Year Interval:                  6.0-Year Avg: Add‘l surveys are
Physical                                 5% of the providers in the State (or at least 1,                Additional surveys are done          done (beyond tiers 2-3) such that
Therapy                                  whichever is greater), based on State judgment for              to ensure that no more than          all providers in the State are
Providers                                those providers more at risk of quality problems. Some          7.0 years elapse between             surveyed, on average, every 6
                                         of the targeted surveys may qualify to count toward the         surveys for any one particular       years. (i.e., total surveys divided
                                         Tier 3 and 4 priorities. States with fewer than 7               provider.                            by total providers is not less than
                                         providers of this type are exempt from this requirement.                                             16.7% = 6.0 years).


10.                                     5% Targeted Surveys: Each year, the State surveys              7.0-Year Interval:                  6.0-Year Avg: Add‘l surveys are
Comprehensive                             5% of the providers in the State (or at least 1,               Additional surveys are done          done (beyond Tiers 2-3) such
Outpatient                                whichever is greater), based on State judgment for             to ensure that no more than          that all providers in the State are
Rehabilitation                            those providers more at risk of quality problems.              7.0 years elapse between             surveyed, on average, every 6
Facilities                                Some of the targeted surveys may qualify to count              surveys for any one particular       years. (i.e., total surveys divided
                                          toward the Tier 3 and 4 priorities. States with fewer          provider.                            by total providers is not less than
                                          than 7 providers of this type are exempt from this                                                  16.7% = 6.0 years).
                                          requirement.
11. Rural                                  5% Targeted Surveys: Each year, the State surveys           7.0-Year Interval:                  6.0-Year Avg: Add‘l surveys are
Health Clinics                              5% of the RHCs in the State (or at least 1, whichever        Additional surveys are done          done (beyond tiers 2-3) such that
                                            is greater), based on State judgment for those RHCs          to ensure that no more than          all RHCs in the State are
                                            most at risk of quality problems Some of the targeted        7.0 years elapse between             surveyed, on average, every 6
                                            surveys may qualify to count toward the Tier 3 and 4         surveys for any one particular       years. (i.e., total surveys divided
                                            priorities. States with fewer than 7 RHCs of this type       RHC.                                 by total RHCs is not less than
                                            are exempt from this requirement.                                                                 16.7% = 6.0 years).


                                                                                                                                                                      75
Category                                                                               2011 Survey Frequency & Priority
                        Tier 1                                 Tier 2                                        Tier 3                                    Tier 4

12. Ambulatory    5% Deemed ASC           25% Targeted Surveys: The State performs surveys          6.0-Year Interval: Additional        N/A for FY 2011
Surgery Centers   Suppliers: States        totaling 25% of all non-deemed ASCs in the State (or       surveys are done to ensure that
                  conduct validation       at least 1, whichever is greater), based on CMS            no more than 6.0 years elapse
                  surveys of deemed        selection of a random sample for a portion of the          between surveys for any one
                  ASCs specified by        targeted survey volume and, for the remaining              particular non-deemed ASC.
                  CMS, depending on        surveys, State judgment for those ASCs more at risk
                  the accreditation        of quality problems. The SA-selected sample is drawn
                  organizations‘           only from non-deemed ASCs. Some of the targeted
                  survey schedules.        surveys may qualify to count toward the Tier 3
                  (Budgeted                priority. States with fewer than 7 non-deemed ASCs
                  separately via           must survey at least 1 ASC.
                  supplemental
                  allocation               Recovery Act funds allocated by CMS for FY 2011
                                           work may be used to exceed the above 25% survey
                                           level.

13. Psychiatric                                                                                      5.0-Year Interval: Survey
Residential                                                                                           visits (Validation and
Treatment                                                                                             Complaint) of 20% of PRTFs).
Facilities
(Medicaid
Psych < 21)
14. Portable X-                                                                                      7.0-Year Interval: Additional        6.0-Year Avg: Add‘l surveys
Ray Suppliers                                                                                         surveys are done to ensure that       are done (beyond Tiers 2-3) such
                                                                                                      no more than 7.0 years elapse         that all providers in the State are
                                                                                                      between surveys for any one           surveyed, on average, every 6
                                                                                                      particular provider.                  years. (i.e. total surveys divided
                                                                                                                                            by total providers is not less than
                                                                                                                                            16.7% = 6.0 years).




                                                                                                                                                                     76
Category                                             2011 Survey Frequency & Priority
                   Tier                     Tier 2                                      Tier 3                                     Tier 4
                    1

15. New                      Relocations                               Initial certification of the following:    Initial certifications of all provider
Provider-Initial                                                         ESRD Facilities                           types that have a deemed
Surveys                                                                  Transplant centers                        accreditation option: hospitals,
                                                                         RHCs                                      home health, new home health
                                                                         Nursing Homes                             branches, hospice, expansion of
                                                                        Note: Conversion of a hospital to a         inpatient hospice for a currently
                                                                        CAH, or a CAH back to a hospital is         certified hospice, ambulatory
                                                                        a conversion, not an initial                surgical centers. (While CAHs may
                                                                        certification and at State option may       also be deemed, these are
                                                                        be done as Tier 2, 3, or 4. However,        conversions, not initial
                                                                        the addition of swing beds as a new         certifications.)
                                                                        service in an existing hospital or         The addition of home health
                                                                        CAH is a Tier 4 priority.                   branches or hospice multiple
                                                                                                                    locations (not inpatient units) are
                                                                                                                    administrative actions thus not a
                                                                                                                    deeming option. (AOs deem
                                                                                                                    compliance with CoPs, not
                                                                                                                    administrative actions.) Though
                                                                                                                    surveys may not be involved, these
                                                                                                                    actions should remain in the Tier
                                                                                                                    structure as they are often resource
                                                                                                                    intensive.
                                                                                                                   All other newly-applying providers
                                                                                                                    not listed in Tier 3 are Tier 4, unless
                                                                                                                    approved on an exception basis by
                                                                                                                    the CMS RO, due to serious
                                                                                                                    healthcare access considerations or
                                                                                                                    similar special circumstances.



                                                                                                                                                 77
Category                                                                      2011 Survey Frequency & Priority

                                             Tier 1                                                                Tier 2                                       Tier 3   Tier 4

16. Complaint    Complaint Investigations triaged as a high potential for          Complaint Investigations triaged as not likely to be immediate jeopardy.
Investigations   immediate jeopardy.


17. Core          Timely OSCAR/ASPEN data entry of survey workload
Infrastructure    Attendance at mandatory federal surveyor training
                  MDS, OASIS, QIES and IRF-PAI systems activities
                  Maintenance of the nurse aide registry and assessments of nurse aide training and competency evaluation programs
                  Review of the nurse aide registry to assure that it is being operated in compliance with the requirements.
                  Maintenance of a home health hotline
                  Performance Measurement Activities
                  Implement & promote fulfillment of CMS GPRA goals and Quality Initiative, including collaboration with QIOs on       the GPRA goals (pressure ulcer
                   reduction, restraint use reduction).
                  Training of survey & certification staff, including transcript & qualifications maintenance. (See separate Training Mission Letter)
                  Emergency preparedness essential functions




                                                                                                                                                                    78
                                                  Appendix 2 - FY2011State S&C Projected Budget Allocations

A      B         C            D           E           F          G1**       G2**          G3**             H            I           J            K           L            M
                                         FY 11                  FY 11                                 Subtotal FY
                          FY 10 State               FY 11                 FY 11 ASC      All-Other                   Transpla                Addl. FY 11   Non-Del      FY 11
Sta   Quin    FY 10 ASC                  Base-                  State                                   11 Proj.                Validation
                            Budget                 Baseline               Survey $’s   State Budget                     nt                     Alloc.      Deducti    Projected
 te   -tile    Baseline                  line %                Training                               State Budget              Supplmnts
                           Adjusted*              increase $               Baseline      Baseline                    Survey $                Adjmnts.***     on      Total Alloc.
                                        change                  Travel                                  Baseline
CT     3       $41,701    $5,835,063    4.10%     $238,946     $21,000     $66,505      $6,007,504    $6,095,009      ($852)        $                                $6,094,157
ME     4       $17,611    $2,404,508    2.57%      $61,892     $15,800     $14,508      $2,451,892    $2,482,200      ($426)        $                                $2,481,774
MA     3       $19,608    $8,368,766    3.34%     $279,726     $16,000     $69,878      $8,578,614    $8,664,492     $49,492        $                                $8,713,984
NH     1       $47,001    $1,122,407    6.30%      $70,684     $10,000     $43,476      $1,149,614    $1,203,090      ($426)        $                                $1,202,664
RI     4       $10,862    $1,913,212    2.55%      $48,749      $5,000     $12,539      $1,949,422    $1,966,961      ($426)        $                                $1,966,535
VT     2         $0        $847,465     4.41%      $37,373     $11,000       $0         $884,838       $895,838       ($426)        $                                 $895,412
NJ     3      $232,947    $7,391,241    3.54%     $261,280     $23,000    $613,506      $7,039,015    $7,675,521     $37,683        $                                $7,713,204
NY     1      $195,149    $13,857,039   5.28%     $731,652     $128,000   $216,948     $14,371,742    $14,716,690    $92,853        $         $65,460                $14,875,003
PR     5       $26,505     $553,087     2.21%      $12,223      $9,000     $69,950      $495,361       $574,311       ($426)        $                                 $573,885
DE     3       $16,935     $920,316     3.32%      $30,536     $22,000     $70,849      $880,004       $972,853       ($852)        $                                 $972,001
DC     5       $7,718      $880,469     1.87%      $16,465     $27,000     $6,596       $890,338       $923,934        $0           $                                 $923,934
MD     2      $244,312    $3,766,487    4.86%     $183,051     $18,000    $491,389      $3,458,149    $3,967,538     $8,554         $                                $3,976,092
PA     3      $163,860    $10,870,651   3.78%     $410,911     $80,000    $205,377     $11,076,184    $11,361,561    $71,542        $                                $11,433,103
VA     3       $32,402    $3,964,255    3.39%     $134,309     $63,000     $89,700      $4,008,864    $4,161,564     $14,438        $                                $4,176,002
WV     4       $19,914    $2,235,859    2.86%      $63,946     $15,000     $22,786      $2,277,018    $2,314,804      ($426)        $                                $2,314,378
AL     4       $19,280    $4,740,057    3.12%     $147,890     $16,000     $82,821      $4,805,126    $4,903,947      ($426)        $                                $4,903,521
FL     3      $109,133    $11,026,812   3.61%     $397,517     $181,000   $304,843     $11,119,486    $11,605,329    $16,295        $                                $11,621,624
GA     3      $303,719    $5,778,633    3.85%     $222,477     $31,600    $701,247      $5,299,863    $6,032,710     $26,891        $                                $6,059,601
KY     3       $20,220    $4,928,208    3.40%     $167,658     $19,000     $70,371      $5,025,495    $5,114,866     $37,198        $                                $5,152,064
MS     3       $62,649    $2,105,290    3.99%      $84,001     $35,000    $210,320      $1,978,971    $2,224,291      ($426)        $                                $2,223,865
NC     3       $35,161    $7,491,418    3.32%     $248,565     $38,200     $93,181      $7,646,802    $7,778,183     $17,342        $                                $7,795,525
SC     4       $39,019    $2,875,944    2.83%      $81,504     $25,000    $109,507      $2,847,941    $2,982,448      ($426)        $                                $2,982,022
TN     2      $143,399    $4,324,716    4.59%     $198,504     $43,000    $211,865      $4,311,356    $4,566,221     $43,927        $                                $4,610,148
IL     1       $69,401    $13,964,313   5.39%     $752,676     $29,000    $176,178     $14,540,812    $14,745,990    $38,922        $                                $14,784,912
IN     2       $88,001    $7,421,037    4.23%     $313,910     $29,000    $146,701      $7,588,246    $7,763,947     $7,421         $                                $7,771,368
MI     2       $48,565    $9,444,081    4.82%     $454,733     $40,000    $149,392      $9,749,422    $9,938,814     $28,424        $                                $9,967,238
MN     4       $56,573    $8,327,493    2.63%     $218,680     $45,000    $185,746      $8,360,427    $8,591,173     $54,087        $                                $8,645,260
OH     3       $91,711    $15,732,245   3.43%     $539,616     $48,000    $635,859     $15,636,002    $16,319,861    $55,797        $                                $16,375,658
WI     2       $27,337    $6,679,419    4.82%     $321,614     $20,000    $111,076      $6,889,957    $7,021,033     ($1,705)       $                                $7,019,328
AR     3       $61,282    $4,927,706    3.45%     $169,883     $30,000    $103,388      $4,994,201    $5,127,589     ($1,279)       $                                $5,126,310
LA     1       $52,641    $5,569,756    5.23%     $291,020     $22,000    $102,352      $5,758,424    $5,882,776     ($1,705)       $                                $5,881,071
NM     4       $17,195    $2,081,172    2.72%      $56,545     $26,000     $35,913      $2,101,804    $2,163,717      ($852)        $                                $2,162,865
OK     2       $58,321    $5,020,218    5.04%     $253,019     $28,000    $154,919      $5,118,318    $5,301,237     $29,380        $                                $5,330,617
TX     4      $244,425    $32,469,947   2.54%     $824,802     $277,000   $514,436     $32,780,313    $33,571,749    $97,735        $                                $33,669,484


                                                                                                                                                                                    79
    A     B          C             D           E           F            G1**          G2**         G3**              H             I           J            K            L             M
                                              FY 11                                                             Subtotal FY
                              FY 10 State                FY 11       FY 11 State   FY 11 ASC      All-Other                     Transpla                Addl. FY 11                  FY 11
 Sta     Quin    FY 10 ASC                    Base-                                                            11 Proj. State              Validation                  Non-Del
                                Budget                  Baseline      Training     Survey $’s   State Budget                       nt                     Alloc.                   Projected
 te      -tile    Baseline                    line %                                                              Budget                   Supplmnts                  Deduction
                               Adjusted*               increase $      Travel       Baseline      Baseline                      Survey $                Adjmnts.***               Total Alloc.
                                             change                                                              Baseline
    IA    1       $7,795       $3,259,356    6.33%      $206,220      $29,000       $15,370      $3,450,206     $3,494,576       $8,416        $         $48,722                   $3,551,714
    KS    2       $44,665      $4,171,850    4.68%      $195,243      $25,000       $138,107     $4,228,986     $4,392,093       $8,548        $                                   $4,400,641
 MO       3       $84,727     $10,245,486    3.33%      $341,021      $30,000       $251,340    $10,335,167    $10,616,507      $27,557        $                                  $10,644,064
    NE    3       $28,203      $2,705,856    3.59%      $97,262       $22,000       $48,075      $2,755,043     $2,825,118       ($426)        $                                   $2,824,692
 CO       4       $86,449      $4,967,126    2.50%      $123,979      $34,000       $157,149     $4,933,957     $5,125,106      ($1,705)       $                                   $5,123,401
    MT    4       $7,680       $1,864,906    2.48%      $46,306       $20,000       $14,968      $1,896,243     $1,931,211        $0           $                                   $1,931,211
    ND    4       $12,756      $1,435,346    2.60%      $37,319       $12,000       $36,701      $1,435,964     $1,484,665        $0           $                                   $1,484,665
    SD    5       $17,322      $1,425,685    2.04%      $29,084       $30,000       $46,725      $1,408,044     $1,484,769      $14,550        $                                   $1,499,319
    UT    1       $66,525      $1,918,477    5.45%      $104,461      $22,000       $72,167      $1,950,771     $2,044,938      ($1,279)       $                                   $2,043,659
 WY       4       $9,455       $1,047,375    2.63%      $27,504       $13,200       $37,912      $1,036,967     $1,088,079        $0           $                                   $1,088,079
    AZ    4       $89,571      $3,791,908    2.47%      $93,660       $25,000       $194,839     $3,690,729     $3,910,568      $11,947        $                                   $3,922,515
    CA    2      $449,735     $37,974,659    4.94%     $1,877,011     $360,000     $1,219,690   $38,631,980    $40,211,670      $27,295        $                                  $40,238,965
    HI    4       $21,037      $1,099,010    2.73%      $30,003       $20,000       $63,078      $1,065,935     $1,149,013       ($426)        $                                   $1,148,587
    NV    3       $56,542      $1,978,648    2.59%      $51,188       $22,000       $124,844     $1,904,992     $2,051,836       ($426)        $                                   $2,051,410
    AK    4       $29,753      $852,921      2.51%      $21,400       $25,000       $27,239      $847,082        $899,321         $0           $                                   $899,321
    ID    3       $16,562      $1,728,898    3.47%      $59,906       $25,000       $46,664      $1,742,140     $1,813,804        $0           $                                   $1,813,804
 OR       4      $118,431      $3,526,606    2.51%      $88,574       $30,000       $119,008     $3,496,172     $3,645,180        $0           $                                   $3,645,180
 WA       3      $155,497      $6,625,933    3.68%      $243,503      $18,000       $437,315     $6,432,121     $6,887,436      $26,151        $                                   $6,913,587
 Tot
  al
                 $3,927,262   $310,459,335   3.87%     $12,000,000   $2,208,800    $9,145,313   $313,314,022   $324,668,136     $837,104       $         $114,182        $0       $325,619,422




                                                                                   End Notes to Appendix 2

*          FY10 Budget Adjusted includes travel/training and ASC $'s
**         Column G1-G3 is the Breakout of the Total FY11 Baseline budget that appears in column H.
***        One-Time Adjustments, Special projects, etc.
$          Validation supplements to be awarded throughout the fiscal year, estimates are displayed in Appendix 3




                                                                                                                                                                                                 80
                                         Appendix 3 - FY 2011 Projected Validation Survey Workload


            CAHS                       HOSPITALS                        HOME HEALTH AGENCIES                  HOSPICES              AMBULATORY SURGICAL CTRS
                          Total                                            Reg.
         Tot                              Est.                                      Est                       Est.                            Est.
                   Est    Deem    Est              Est. Sup $    Total     Bud                        Total                         Total #
        Deem                              Sup                                      Sup     Est. Sup           Sup        Est. Sup             Sup    Est. Sup
State              Sam     ed #   Sam              Award for    Deemed      get                       Deem                          Deeme
         ed #                             Wk-                                      Wk-     $ Award            Wk-        $ Award              Wk-    $ Award
                    ple   Hospi    ple             Hospitals    # HHAs     Wk-                         ed #                         d ASCs
        CAHs                              load                                     load                       load                            load
                           tals                                            load
CT        0        0       39      1        0         $0           13        1       0        $0         6      0          $0          2       0        $0
MA        3        0       95      1        2       $55,200        20        1       0        $0        13      0          $0         35       2     $17,000
ME        1        0       22      1        0         $0            1        0       0        $0         4      0          $0          2       0        $0
NH        1        0       15      1        0         $0            2        0       0        $0         2      0          $0          7       0        $0
RI        0        0       16      1        0         $0            7        1       0        $0         4      0          $0          4       0        $0
VT        1        0        8      1        0         $0            0        0       0        $0         0      0          $0          1       0        $0
R1        6        0      195      6        2       $55,200        43        3       0        $0        29      0          $0         51       2     $17,000
NJ        0        0       92      1        2       $55,200        12        1       0        $0        19      1        $11,200      93       6     $51,000
NY        6        0      203      3        3       $82,800        11        1       0        $0         5      0          $0         51       3     $25,500
PR        0        0       39      1        0         $0           15        1       0        $0         3      0          $0          1       0        $0
VI        0        0        2      0        0         $0            0        0       0        $0         0      0          $0          0       0        $0
R2        6        0      336      5        5      $138,000        38        3       0        $0        27      1        $11,200     145       9     $76,500
DC        0        0       12      1        0         $0            1        1       0        $0         1      0          $0          0       0        $0
DE        0        0       11      1        0         $0            6        1       0        $0         5      0          $0         13       1      $8,500
MD        0        0       62      1        1       $27,600         5        1       0        $0         4      0          $0          8       0        $0
PA        3        0      200      2        3       $82,800        39        1       0        $0        32      2        $22,400      14       1      $8,500
VA        5        0       90      1        2       $55,200        49        1       1     $12,300      14      0          $0         12       1      $8,500
WV        8        1       41      1        0         $0            2        0       0        $0         0      0          $0          2       0        $0
R3       16        0      416      7        6      $165,600       102        5       1     $12,300      56      2        $22,400      49       3     $25,500
AL        0        0       93      1        2       $55,200         9        1       0        $0         9      0          $0          5       0        $0
FL        7        1      202      2        3       $82,800       677        1      12     $147,600      6      0          $0        129       8     $68,000
GA       21        1      139      1        2       $55,200        12        1       0        $0        19      1        $11,200      24       1      $8,500
KY       18        1       82      1        1       $27,600         8        1       0        $0         2      0          $0          2       0        $0
MS        4        0       61      1        1       $27,600         3        1       0        $0        11      0          $0         10       1      $8,500
NC       19        1       96      1        2       $55,200        44        1       1     $12,300       7      0          $0         12       1      $8,500
SC        3        0       66      1        1       $27,600        28        1       0        $0         9      0          $0         10       1      $8,500
TN       13        1      120      1        2       $55,200        18        1       0        $0        11      0          $0         18       1      $8,500
R4       85        5      859      9       14      $386,400       799        8      13     $159,900     74      1        $11,200     210      13     $110,500
 IL      28        2      151      2        2       $55,200       176        1       3     $36,900      14      0          $0         40       3     $25,500
IN       30        2      117      1        1       $27,600        38        1       0        $0        14      0          $0         38       2     $17,000
MI       21        1      132      2        2       $55,200       483        1       9     $110,700     55      3        $33,600      35       2     $17,000
MN       17        1       61      1        1       $27,600         8        1       0        $0         8      0          $0          7       0        $0
OH       29        2      186      2        2       $55,200       118        1       2     $24,600      28      2        $22,400      96       6     $51,000
WI       35        2       75      1        1       $27,600        15        1       0        $0        13      0          $0         26       2     $17,000
R5      160        10     722      9        9      $248,400       838        6      14     $172,200    132      5        $56,000     242      15     $127,500
AR        6        0       47      1        0         $0            6        0       0        $0         1      0          $0          1       0        $0
LA        9        1      114      1        2       $55,200        11        1       0        $0         6      0          $0         12       1      $8,500
NM        2        0       35      1        0         $0            4        1       0        $0         3      0          $0          5       0        $0
OK        1        0       71      1        1       $27,600        33        1       0        $0        18      0          $0          5       0        $0
TX       13        1      414      3        4      $110,400       755        1      13     $159,900    109      5        $56,000      91       5     $42,500
R6       31        2      681      7        7      $193,200       809        4      13     $159,900    137      5        $56,000     114       6     $51,000
IA        9        1       32      1        0         $0            8        1       0        $0        14      0          $0         16       1      $8,500
KS        3        0       45      1        0         $0           16        1       0        $0        12      0          $0          9       0        $0
MO       11        1       95      1        2       $55,200         4        1       0        $0         5      0          $0         13       1      $8,500
NE        4        0       23      1        0         $0            3        1       0        $0         2      0          $0         10       1      $8,500
R7       27        2      195      4        2       $55,200        31        4       0        $0        33      0          $0         48       3     $25,500
CO        6        0       63      1        1       $27,600        32        1       0        $0        10      0          $0         15       1      $8,500
MT        2        0       11      1        0         $0            3        1       0        $0         2      0          $0          2       0        $0
ND        3        0       12      0        0         $0            1        0       0        $0         0      0          $0          1       0        $0
SD        0        0        8      1        0         $0            0        0       0        $0         2      0          $0          1       0        $0
UT        0        0       33      1        0         $0            7        1       0        $0         9      0          $0          5       0        $0
WY        1        0       13      1        0         $0            0        0       0        $0         0      0          $0          3       0        $0
R8       12        0      140      5        1       $27,600        43        3       0        $0        23      0          $0         27       1      $8,500
AZ        6        0       64      1        1       $27,600        28        1       0        $0        16      1        $11,200      25       2     $17,000
CA       15        1      354      2        4      $110,400       405        1       8     $98,400     129      6        $67,200     286      13     $110,500
HI        2        0       16      1        0         $0            1        1       0        $0         2      0          $0          2       0        $0
NV        3        0       33      1        0         $0           49        1       1     $12,300       8      0          $0         17       1      $8,500
R9       26        1      467      5        5      $138,000       483        4       9     $110,700    155      7        $78,400     330      16     $136,000
AK        5        0       12      1        0         $0            1        0       0        $0         1      0          $0         0        0        $0
ID        4        0       14      1        0         $0            6        1       0        $0         8      0          $0         17       1      $8,500
OR        8        1       33      1        0         $0            2        1       0        $0         4      0          $0         11       1     $8,500
WA        7        1       59      1        1       $27,600         4        1       0        $0         1      0          $0         37       2     $17,000
R10      24        2      118      4        1       $27,600        13        3       0        $0        14      0          $0         65       4     $34,000
Tot.    393        22     4,129   61       52      $1,435,200   3,199      43     50       $615,000   680     21         $235,200    1,281    72     $612,000




                                                                                                                                                     81
            Appendix 4 - Affordable Care Act – Nursing Home Transparency and Improvement

Sec. 6101. Disclosure of Information about Ownership and Additional Disclosable Parties
The provision requires skilled nursing facilities (SNFs) and nursing facilities (NFs) to report information
including the name, title and period of service for each member of the governing body of the facility, officer,
member, partner, trustee, or managing employee of the facility. In addition, the facility must report similar
information about the organizational structure and relationship of each person or entity that is a disclosable party
by virtue of exercising some level of operational control of the facility, leasing or subleasing property, or
providing services to the facility, including consulting or accounting services. Upon enactment, such
information must be available upon request to the Secretary, the Inspector General, the State and the State long-
term care ombudsman. No later than two years after enactment, the Secretary must promulgate final regulations
requiring, within 90 days of publication, a facility to report the information in a standardized format and certify
as a condition of participation and payment under Medicare or Medicaid that such information is accurate and
current.

       The primary role of the Survey & Certification Group in FY 2011 will be to identify user needs, identify
       survey & certification information system adjustments necessary to make the most effective use of the
       data and linking quality of care performance information with ownership data. State SAs should plan to
       coordinate with their State Medicaid Agency colleagues. We advise State Medicaid Agencies to track
       the Medicare developments closely and seek to coordinate the collection of such information between
       Medicaid and Medicare.

Sec. 6102. Ethics & Compliance - Accountability Requirements
The provision requires SNFs and NFs to implement a compliance and ethics program that is effective in
preventing and detecting criminal, civil and administrative violations and in promoting quality of care. This
compliance and ethics program must contain a number of components, including specific individuals within
high-level personnel being assigned overall responsibility to oversee and ensure compliance and the standards
must be consistently enforced with discipline for those that fail to detect an offense. Compliance and ethics
programs must be in operation on or after the date that is 36 months after enactment. The Secretary, working
with the Inspector General, is required to promulgate regulations that may include a model compliance and
ethics program two years after enactment. Three years after promulgation, Secretary must evaluate and submit a
Report to Congress on the program.

Sec. 6102. Quality Assurance & Performance Improvement - Accountability Requirements
The Secretary shall establish standards for a quality assurance and performance improvement (QAPI) programs
in SNFs and NFs and provide technical assistance to facilities on the development of best practices in order to
meet standards. Facilities must submit a plan for meeting the QAPI standards and implementing best practices
not later than one year after regulations for such standards are promulgated. QAPI programs must be
implemented not later than December 31, 2011.



       Survey & Certification will be responsible for implementing the new QAPI regulations. State SAs will
       play a vital role in the effective implementation and fulfillment of the QAPI requirement. CMS, together
       with States and stakeholders, will develop guidance and technical assistance materials in FY 2011. We
       will invite State SA input and ideas to this process. Surveyor training will be scheduled in late FY 2011
       or early FY 2012. CMS may also sponsor a limited demonstration program with volunteer States and
       volunteer nursing homes.


                                                                                                                82
Sec. 6103. Nursing Home Compare Medicare Website
This provision requires the Secretary to include on the Nursing Home Compare website or any successor
website detailed data on:

     Facility staffing levels;
     Links to State websites that include Form 2567 inspection reports and facility‘s plan of correction or
       other response to the report;
     Information to guide consumers in how to interpret and understand the reports,
     Links to a standardized complaint form and
     Summary information on the number, type, severity and outcome of substantiated complaints.

Data on staffing levels must be made available upon implementation of these requirements, while all State data
must be made available within one year of enactment. As part of these efforts, the provision requires States to
submit information to the Secretary on survey and certification activities, including enforcement activities and
the Secretary shall establish a process to review the accuracy, presentation, timeliness and comprehensiveness
of information on the website and modify or revise the information based on the review. These requirements
will be effective one year after the date of enactment.

This provision also codifies the Special Focus Facility program at Section 1819(f) and 1919(f) of the SSA.

The provision further requires facilities, one year after the date of enactment, to have reports involving surveys,
certifications and complaint investigations for the three preceding years available to an individual upon request
and to post notice of their availability in areas of the facility that are prominent and accessible to the public.

Finally, as a requirement enforceable under Medicaid law, this provision requires States to maintain a
consumer-oriented website providing useful information to consumers regarding all skilled nursing facilities and
all nursing facilities in the State, including for each facility:

      Form 2567 inspection reports,
      Complaint investigation reports,
      Facility‘s plan of correction and
      Such other information that the State or the Secretary considers useful in assisting the public to assess
       the quality of long term care options and the quality of care provided by individual facilities.

   State Survey Agencies play a major role in all of these provisions and must coordinate with the State
   Medicaid Agency in the development and maintenance of the required consumer-oriented website. In
   consultation with States and stakeholders, CMS will develop guidance and basic design parameters for the
   display and provision of the required information.


Sec. 6104. Reporting of Expenditures
This provision requires SNFs to separately report expenditures for wages and benefits for direct care staff on the
Medicare cost report for cost reporting periods beginning on or after two years after enactment. Not later than
one year after enactment, the Secretary must redesign the report after consultation with private sector
accountants. Within 30 months of enactment, the provision requires the Secretary in consultation with the
Medicare Payment Advisory Commission (MedPAC), the Medicaid and CHIP Payment and Access
Commission, the Inspector General and other expert parties determined by the Secretary, to categorize
expenditures for each SNF into functional accounts on an annual basis. The provision also requires the
Secretary to establish procedures to make information on expenditures available upon request.

       We do not expect State SAs to have a role in this provision. However, State Medicaid Agencies may 83
       wish to coordinate with the Center for Medicare within CMS as the plan for implementing this provision
       are developed.

Sec. 6105. Standardized Complaint Form
Effective one year after enactment, this provision requires the Secretary to develop a standardized complaint
form for use in filing complaints with the State survey and certification agency and a State long-term care
ombudsman program. The provision also requires the State to establish a complaint resolution process, within
certain parameters spelled out in the statute, to ensure that the legal representative of a resident or other
responsible party is not denied access to the resident or retaliated against if they have complained about the
quality of care or other issues.

       CMS will work with States and stakeholders in the design of a complaint form.

Sec. 6106. Ensuring Staffing Accountability
This provision requires the Secretary, after consulting with long-term care stakeholders, to mandate the
electronic submission of direct care staffing information based on payroll and other verifiable and auditable data
in uniform format to begin no later than two years after the date of enactment. The provision stipulates that the
information must: categorize the work an employee performs, include resident census data and information on
resident case mix, include a regular reporting schedule and include information on employee turnover and
tenure and the hours of care provided per day.

       We will want to coordinate with State Medicaid Agencies as we develop the design for this provision.
       We may solicit volunteer nursing homes to pilot test certain aspects of a prospective system. The
       requirements will be published as a notice of proposed rule-making before being issued in final form.

Sec. 6107. GAO Study and Report on Five-Star Quality Rating System
This provision requires the GAO to study and report to Congress not later than two years after enactment on the
Five-Star Quality Reporting System, including recommendations on how the system is being implemented,
problems associated with implementation and how the system can be improved.

       We do not expect there to be a role for State SAs in this provision except to respond to GAO requests for
       information.

Sec. 6111. Civil Money Penalties
Effective March 23, 2011 (one year after enactment), this provision specifies that:

      Nursing homes for which a civil monetary penalty has been imposed must have the opportunity for an
       independent informal dispute resolution (independent IDR) prior to the collection of the CMP.
      In cases where the facility requests a formal appeal, the Secretary may collect the CMP and place it in
       escrow until the formal appeal is resolved.
      The Secretary may reduce by up to 50% the amount of a CMP where a facility self-reports and promptly
       corrects a deficiency for which a penalty was imposed within 10 calendar days of the date of imposition,
       with two exceptions: 1) the Secretary has reduced a penalty in the preceding year with respect to a repeat
       deficiency; or 2) the penalty is imposed on the facility for a deficiency that is found to result in a pattern
       of harm or widespread harm, immediately jeopardizes the health or safety of a resident or residents, or
       results in the death of a resident.
      The Secretary may retain a portion of the collected CMP funds attributable to Medicare and use such
       funds for the protection and benefit of nursing home residents. Heretofore CMP funds attributable to
       Medicare were all conveyed to the U.S. Treasury (while the funds attributable to Medicaid were
       provided to the State Medicaid Agencies for the protection and benefit of nursing home residents.           84
       The most significant State SA role in this provision will be the establishment and maintenance of an
       effective independent IDR system, which must be in place in FY 2011. For more details, see the notice
       of proposed rule-making we published on July 12, 2010. In addition, State SAs will play a key role in the
       verification of facility self-reports and prompt self-correction that may qualify a facility for the 50%
       CMP reduction in certain cases. CMS itself will make the changes necessary for the collection and
       escrow of CMP funds.

Sec. 6112. National Independent Monitor Demonstration Program
This provision requires the Secretary, acting through ASPE, to establish a two-year demonstration project to
develop, test and implement an independent monitoring program to oversee interstate and large intrastate SNF
and NF chains and subject to funding availability, begin the demonstration within one year of enactment. The
Secretary must evaluate chains selected to participate in the demonstration based on criteria developed by the
Secretary, including where evidence suggests that a number of facilities of the chain are experiencing serious
safety and quality of care problems. A participating chain is required to pay for a portion of the costs of the
demonstration.

An independent monitor under contract is required to perform a number of tasks, including periodic reviews of
the chains, assessing if facilities are in compliance with State and Federal laws and regulations, conducting
sustained oversight and publishing results of reviews, analyses and oversight. No later than 10 days after receipt
of a finding of an independent monitor, a participating chain must submit a report outlining corrective actions,
or indicating that the chain will not implement the recommendations, including reasons why it will not do so.
The independent monitor must finalize its recommendations within 10 days and submit a report to the chain,
Secretary and affected States.

This provision also requires the Inspector General to evaluate the demonstration to determine whether it should
be established on a permanent basis and recommend appropriate procedures and mechanisms for doing so in a
Report to Congress not later than 180 days after completion of the demonstration.

       Insofar as this provision was authorized but there were no funds appropriated, the U.S Department of
       Health and Human Services does not have any immediate implementation plans for this provision.

Sec. 6113. Notification of Facility Closure
Effective one year after the date of enactment, this provision requires any individual who is the administrator of
a facility that is preparing to close to: provide written notification at least 60 days in advance (or in case of a
termination, a date the Secretary determines appropriate) to the Secretary, State long-term care ombudsman,
residents and legal representatives of residents or other responsible parties; ensure that the facility does not
admit new residents on or after the date on which such written notification is submitted; and include in the
notice a plan for the transfer and relocation of residents by a specified date prior to closure. Any individual who
is the administrator of the facility that fails to comply with these requirements is subject to a civil monetary
penalty of up to $100,000 and any other penalties prescribed by law; further, they may also be subject to
program exclusion. The State must ensure that all residents of a facility have been successfully relocated to
another facility or an alternate home and community-based setting prior to closure. The Secretary may continue
to make payments prior to resident relocation.

       CMS will issue a notice of proposed rule-making to implement this provision. State SAs may play an
       important role in determining whether the proper notice was provided.

Sec. 6114. National Demonstration Projects on Culture Change and Use of Information Technology in
Nursing Homes
                                                                                                                85
This provision seeks to implement two facility-based demonstration projects, not to exceed three years, within
one year of enactment. The first demonstration shall focus on best practices in facilities that are involved in the
―culture change‖ movement and the second shall develop best practices in the use of information technology to
improve resident care. Under each demonstration, one or more grants to facility-based settings for the
development of best practices must be awarded on a competitive basis. The Secretary is required to Report to
Congress not later than nine months after completion of the demonstration projects.

Sec. 6121. Dementia Management and Abuse Prevention Training
Effective one year after enactment, this provision requires nurse aide training and competency evaluation
programs to include dementia management training and patient abuse prevention training in initial training and
if the Secretary determines appropriate, in ongoing trainings. The provision also clarifies that a nurse aide
includes individuals who provide services through an agency or under a contract with the facility.

Sec. 6201. Nationwide Program for National and State Background Checks on Direct Patient Access
Employees of Long-Term Care Facilities
Effective upon enactment, this provision requires the Secretary to establish a nationwide program of background
checks on prospective direct patient access employees, in addition to a prohibition on hiring abusive workers
and the authority for States to impose penalties. Under the program, the long-term care facility or provider is
required to obtain State and national criminal history background checks on the prospective employee through
means as the Secretary determinates appropriate, efficient and effective. States are required to describe and test
methods that reduce duplicative fingerprinting, including the development of a ―rap back‖ capability that will
alert State officials and the facility of any subsequent criminal convictions following the initial background
check. Background checks are to remain valid for a period of time determined by the Secretary. The Inspector
General shall conduct an evaluation and Report to Congress not later than 180 days from the completion of the
nationwide program.

The program shall be funded by both the Federal and State governments. A non-Federal contribution made by
the State will be matched at three times such contribution not to exceed $3 million for newly participating States
and $1.5 million for previously participating States. The Secretary must notify the Treasury of the required
appropriation amount for FYs 2010-2012, which is not to exceed $160 million. No more than $3 million of this
amount is reserved for the evaluation.



                           Other Items of Special Note for Survey & Certification

Sec. 6403. Elimination of Duplication Between the Healthcare Integrity and Protection Data Bank and
the National Practitioner Data Bank
This provision requires the Secretary to cease operating the Healthcare Integrity and Protection Data Bank
(HIPDB) and transfer all information to the National Practitioner Data Bank (NPDB) in order to maintain a
national healthcare fraud and abuse data collection program for reporting certain final adverse actions against
healthcare providers, suppliers, or practitioners. Currently HRSA maintains the NPDB and OIG maintain the
HIPDB.

The provision allows the Secretary to establish reasonable fees during the transition period for disclosure of
information, not to exceed the cost of processing the requests for disclosure and providing information. The
provision also requires States to have a reporting system for formal proceedings, as defined by the Secretary,
concluded against a healthcare practitioner or entity by a State licensing or certification agency and requires
States to have a reporting system for any final adverse action taken against a healthcare provider, supplier, or
practitioner by a State law or fraud enforcement agency. The Secretary is required to begin the transition
                                                                                                                   86
process upon enactment. The amendments must be effective either one year after date of enactment or on the
effective date of regulations promulgated by the Secretary.

Section 6703 – National Training Institute
The Act establishes a National training institute to improve the training of surveyors with respect to
investigating allegations of abuse, neglect and misappropriation of property. The institute would evaluate
surveyor competencies, develop and disseminate information on best practices for the investigation of abuse,
neglect and misappropriation of property, assess performance of State intake systems, analyze and report
annually on complaints and conduct a national study of the cost to State agencies of conducting complaint
investigations.

       We hope to implement the new program in collaboration with States to the extent that resources can be
       mobilized. Although funds were not appropriated for this authorized initiative, in FY2011 CMS will
       work with States to better identify the particular training needs that would be most useful and that could
       best inform the development of curricula and other design elements of such a Training Institute.

Section 6703 – Grants to State Survey Agencies
The law provides grants to State survey agencies to design and implement optimal complaint investigation
systems. CMs would implement the new program in collaboration with States. However, as no funds were
appropriated, we are holding this initiative in abeyance.

Section 6703 – National Nurse Aide Registry
The law requires HHS in consultation with stakeholders conduct a study on the establishing a national nurse
aide registry. The primary role of the Survey & Certification Group will be to conduct the study.

Section 6501– Termination of Provider Participation under Medicaid if Terminated under Medicare or
other State Plan

Effective January 1, 2011, this provision allows the Secretary to terminate an individual or entity from
participation in Medicaid if an individual or entity is terminated under Medicare or any other State plan.




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