1. ASCs 2009 Nashville, TN Dawn Q. McLane RN, MSA, CASC, CNOR Lakeshore Surgicare (NRG Managed) – Administrator Jonathan Beal –ASC Association Changes to Medicare’s Conditions for Coverage

2. 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 patients  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  www.ascassociation.org/cfcredline.pdf - redlined version of the CfC

3. Summary of Changes Conditions  Standard Change? State LawNo Change Governing Body and Management  Contract Services  Hospitalization  Disaster Preparedness Plan Revised Surgical Services  Anesthetic Risk and Evaluation  Administration of Anesthetic  State Exemption Revised Quality Assessment and Improvement  Program Scope  Program Data  Program Activities  Performance Improvement Projects  Governing Body Requirements Revised

4. Summary of Changes Continued… Environment  Physical Environment  Safety from Fire  Emergency Equipment  Emergency Personnel No Change Medical Staff  Membership and Clinical  Reappraisals  Other practitioners No Change Nursing Services  Organization and Staff No Change Medical Records  Organization  Form and Content No Change Pharmaceutical Services  Administration of Drugs No Change

5. Summary of Changes Continued… Laboratory and Radiologic Services  Laboratory Services  Radiologic Services Revised Patient Rights  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 New Infection Control  Sanitary Environment  Infection Control Program New Patient Admission, Assessment and Discharge  Admission and Pre-Surgical Assessment  Post- Surgical Discharge  Discharge New

6. Change in Definition of an ASC  a distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization  the expected duration of services would not exceed 24 hours following admission  must have agreement with CMS and meet the CfC

7. Governing Body and Management  responsible for policies governing operations  Oversight and accountability for QAPI program  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)

8. 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

9. Quality Improvement  Develop, implement, and maintain an ongoing, data-driven QAPI program  Standard - Scope:  demonstrates measurable improvement in patient outcomes  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 care  Standard - Data:  must incorporate data to: monitor the effectiveness of services and quality of care identify areas for improvement and changes in patient care

10. 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 problems  affect health outcomes, patient safety and quality of care  track adverse pt events, examine cause, implement improvement and ensure improvement is sustained  implement preventative strategies targeting adverse patient events and assure staff is familiar

11. 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 program:  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

12. 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

13. 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 understands

14. Patient Rights  Post the written notice of rights in place(s) where it will be noticed by patients waiting for treatment, including: name, address, phone of State agency where patient can report complaint oCDC (www.cdc.gov/mmwr/international/relres.html) website for Office of the Medicare Beneficiary Ombudsman ( www.cms.hhs.gov/center/ombudsman.asp)  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 chapter

15. 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.

16. 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 number.

17. Patient Rights  Advanced Directives  Provided the patient in advance of the date of the procedure: information concerning policies on advanced directives description of applicable state health and safety laws oAscension Health (www.ascensionhealth.org/ethics/public/issues/ADR_StatebyState_5305.pdf) And if requested, official state advanced directives form oUS Living Will Registry (www.uslivingwillregistry.com/forms.shtm) Inform patient of right to make informed decisions regarding their care  Document in MR whether or not the patient has executed an advanced directive

18. Patient Rights  Submission and investigation of grievances  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 authority specify timeframe for review and response

19. Patient Rights investigate all alleged grievances about care provided document how grievance was addressed and written notice of decision to patient including oname of contact person at ASC osteps taken to investigate oresults 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

20. 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

21. 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 guidelines  Program is: under direction of designated and qualified professional with specialized training in infection control 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

22. Pt admission, assessment and discharge  ASC ensures patient has appropriate pre-surgical and post-surgical assessments  all elements of discharge requirements are met  Pre-surgical H&P  not more than 30 days before date of surgery  comprehensive medical H&P completed by a physician or other qualified practitioner (state defined)

23. 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

24. 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, provide 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

25. Thank You ! Questions ?