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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. 87
"in FY2011. - S_C PDQ"