Slide 1 - Ambulatory Surgery Center Association

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					    Changes to Medicare’s
   Conditions for Coverage

               ASCs 2009
              Nashville, TN

     Dawn Q. McLane RN, MSA, CASC, CNOR
Lakeshore Surgicare (NRG Managed) – Administrator

         Jonathan Beal –ASC Association
              Overview of Changes

 Conditions for Coverage (CfC) = the requirements that ASCs
  have to meet to participate in Medicare (CFR sec. 416)
 Must meet requirements for all patients not just Medicare
 Changes finalized November 18, 2008 (73 FR 68502 et. seq.)
 Effective date: May 18, 2009
 Currently 10 Conditions with 16 Standards
 New: 13 Conditions with 35 Standards
 Interpretive guidelines
 - redlined version
  of the CfC
             Summary of Changes
Conditions                           Change?
 Standard
State Law                            No Change
Governing Body and Management        Revised
 Contract Services
 Hospitalization
 Disaster Preparedness Plan
Surgical Services                    Revised
 Anesthetic Risk and Evaluation
 Administration of Anesthetic
 State Exemption
Quality Assessment and Improvement   Revised
 Program Scope
Program Data
Program Activities
Performance Improvement Projects
Governing Body Requirements
 Summary of Changes Continued…
Environment                No Change
Physical Environment
Safety from Fire
Emergency Equipment
Emergency Personnel

Medical Staff              No Change
Membership and Clinical
 Other practitioners
Nursing Services           No Change
Organization and Staff
Medical Records            No Change
Form and Content
Pharmaceutical Services    No Change
Administration of Drugs
  Summary of Changes Continued…
Laboratory and Radiologic Services                        Revised
Laboratory Services
Radiologic Services
Patient Rights                                            New
Notice of Rights
Advance Directives
Submission and Investigation of Grievences
Exercise of Rights and Respect for Property and Person
Privacy and Safety
Confidentially of Clinical Records
Infection Control                                         New
Sanitary Environment
Infection Control Program
Patient Admission, Assessment and Discharge               New
Admission and Pre-Surgical Assessment
Post- Surgical Discharge
    Change in Definition of an ASC
 a distinct entity that operates exclusively
  for the purpose of providing surgical
  services to patients not requiring
 the expected duration of services would
  not exceed 24 hours following admission
 must have agreement with CMS and meet
 the CfC
    Governing Body and Management
 responsible for policies governing
 Oversight and accountability for QAPI
 Develops and maintains disaster
  preparedness plan
 ASC has transfer agreement with CMS
  hospital or physicians performing surgery
  have admitting privileges at hospital (that
  meets CMS requirements)
  Governing Body and Management
 Disaster preparedness plan
   written plan
   provides for emergency care of patients,
   staff and others in the facility in the event of
   fire, natural disaster, functional failure of
   equipment or other unexpected events that
   would threaten the health and safety of those
   in the ASC
   coordinates the plan with state and local
   authorities, as appropriate
   conducts drills at least annually & completes
   written evaluation of drill, promptly
   implementing corrections
                Quality Improvement
 Develop, implement, and maintain
an ongoing, data-driven QAPI program
 Standard - Scope:
    demonstrates measurable improvement in patient
    improves patient safety – use of quality indicators,
    performance measures or reduced medical errors
    measure, analyze and track quality indicators, adverse
    patient events, infection control and other aspects of
 Standard - Data:
    must incorporate data to:
       monitor the effectiveness of services and quality of care
       identify areas for improvement and changes in patient
              Quality Improvement
 Standard - Program Activities: Set priorities
  for PI activities
   focus on high risk, high volume, and problem-
   prone areas
   consider incidence, prevalence and severity of
   affect health outcomes, patient safety and
   quality of care
   track adverse pt events, examine cause,
   implement improvement and ensure improvement is
   implement preventative strategies targeting
   adverse patient events and assure staff is familiar
                  Quality Improvement
 Standard – PI projects
    number and scope of projects reflects scope and complexity
    of the organization
    document projects being conducted – including (minimum)
    reason for implementing the project and a description of the
    project’s results
 Standard – GB responsibilities – ensure that the QAPI
    defined, implemented, and maintained
    addresses the ASC’s priorities and all improvements are
    evaluated for effectiveness
    clearly establishes expectations for safety
    adequately allocated sufficient staff time, information
    systems and training to implement the program
Patient Rights
 4 CfC expressed rights
   Right to make informed decisions regarding
    the patients care
   Right to exercise his or her rights without
    being subjected discrimination or reprisal
   Voice grievances regarding treatment or
    care that is (or fails to be) furnished
   To be fully informed about a treatment or
    procedure and the expected
                Patient Rights

 ASC must inform the patient of patient’s
 rights and must protect and promote the
 exercise of such rights
   Notice of rights
      provide patient verbal and written notice of
       patient’s rights
      in advance of the date of the procedure
      in a language and manner that the patient
                 Patient Rights
 Post the written notice of rights in place(s) where it
  will be noticed by patients waiting for treatment,
    name, address, phone of State agency where patient can
    report complaint
      o CDC (
    website for Office of the Medicare Beneficiary
    Ombudsman (
 Disclose physician financial interests or ownership in
  the ASC
    in writing
    In advance of the date of the procedure
    In accordance with the ―intent‖ of part 420 of this sub
Part 420 of this subchapter
42 Code of Federal Regulations Sec. 420
 Subpart A—General Provisions

 § 420.1 Scope and purpose.
 § 420.3 Other related regulations.

 Subpart B [Reserved]

 Subpart C—Disclosure of Ownership and Control Information

 § 420.200   Purpose.
 § 420.201   Definitions.
 § 420.202   Determination of ownership or control percentages.
 § 420.203   Disclosure of hiring of intermediary's former employees.
 § 420.204   Principals convicted of a program-related crime.
 § 420.205   Disclosure by providers and part B suppliers of business transaction information.
 § 420.206   Disclosure of persons having ownership, financial, or control interest.

 Subpart D—Access to Books, Documents, and Records of Subcontractors

 § 420.300   Basis, purpose, and scope.
 § 420.301   Definitions.
 § 420.302   Requirement for access clause in contracts.
 § 420.303   HHS criteria for requesting books, documents, and records.
 § 420.304   Procedures for obtaining access to books, documents, and records.
Part 420 of this subchapter
42 Code of Federal Regulations
Sec. 420
 (a) Information that must be disclosed. A
  disclosing entity must submit the following
  information in the manner specified in paragraph
  (b) of this section:
 (1) The name and address of each person with an
  ownership or control interest in the entity or in
  any subcontractor in which the entity has direct
  or indirect ownership interest totaling 5 percent
  or more. In the case of a part B supplier that is a
  joint venture, ownership of 5 percent or more of
  any company participating in the joint venture
  should be reported. Any physician who has been
  issued a Unique Physician Identification Number
  by the Medicare program must provide this
                   Patient Rights
 Advanced Directives
   Provided the patient in advance of the date of the
      information concerning policies on advanced directives
      description of applicable state health and safety laws
         o Ascension Health
      And if requested, official state advanced directives form
         o US Living Will Registry      (

      Inform patient of right to make informed decisions
       regarding their care
   Document in MR whether or not the patient has
    executed an advanced directive
                Patient Rights
 Submission and investigation of
   grievance policy documenting existence,
   submission, investigation and disposition of a
   patient’s written or verbal grievance to ASC
   related to mistreatment, neglect, verbal,
   mental sexual or physical abuse
      document grievance
      reported immediately to person in authority
      if substantiated, reported to state and/or local
      specify timeframe for review and response
                  Patient Rights
    investigate all alleged grievances about care provided
    document how grievance was addressed and written
     notice of decision to patient including
       o   name of contact person at ASC
       o   steps taken to investigate
       o   results of grievance process
       o    date grievance process completed
 Respect for property and person
    no discrimination or reprisal
    voice grievances regarding treatment
    be fully informed about treatment / procedure and
    expected outcomes prior to procedure
    if incompetent, rights of patient exercised by person
    appointed to act on behalf of patient
              Patient Rights
 Privacy and safety
    receive care in a safe setting
    free from all forms of abuse or harassment
 Confidentiality of clinical records
    comply with HIPAA related to privacy and security
    of PHI
              Infection Control
 ASC maintains ongoing program to
 prevent, control, and investigate
 infections and communicable diseases:
   include documentation that ASC is following
   nationally recognized infection control
   Program is:
      under direction of designated and qualified
      professional with specialized training in infection
      integral part of QAPI program
      responsible for providing plan of action for
      preventing, identifying and managing infections and
      communicable diseases and immediately
      implementing corrective and preventative measures
      resulting in improvement
 Pt admission, assessment and discharge
 ASC ensures patient has appropriate
  pre-surgical and post-surgical
 all elements of discharge requirements
  are met
 Pre-surgical H&P
   not more than 30 days before date of
   comprehensive medical H&P completed by a
   physician or other qualified practitioner
   (state defined)
Pt admission, assessment and discharge
 Upon admission
    pre-surgical assessment completed by a physician or
    other qualified practitioner
    includes:
       updated medical record entry documenting an exam for
       any changes in the patient’s condition since the H&P
       patient allergies to drugs and biologicals
    placed in MR prior to surgical procedure
 Post surgical assessment
    condition must be assessed and documented in the
    MR by a physician or other qualified practitioner or
    RN with post –op experience
    post surgical needs must be assessed and included in
    the discharge notes
Pt admission, assessment and discharge
 Discharge – ASC must:
   provide patient with written discharge instructions
   and overnight supplies
   make FY appointment with physician when appropriate
   either prior to procedure or before discharge,
      prescriptions
      post-op instructions
      Physician contact information for follow-up care
   ensure patient has discharge order signed by the
    physician who performed the procedure
   ensure patients are discharged in the company of a
   responsible adult, except patients exempted by the
   attending physician
Thank You !