Medicare CoPs and Interpretive Guidelines

 
What Is This?
It is important for CRNAs to know and have access to federal regulations that impact nurse anesthesia practice and reimbursement.
 
Medicare conditions of participation, or CoP, are federal regulations with which particular healthcare facilities must comply in order to participate – that is, receive funding from – the Medicare and Medicaid programs, the largest payors for healthcare in the U.S. CoP are published in the Code of Federal Regulations or CFR; one may identify or “cite” them by their title in the CFR and their section or paragraph by number. The importance of the CoP for CRNAs is straightforward: The Medicare hospital CoP for anesthesia services, for example, provides both the federal requirement that CRNAs in Medicare hospitals be supervised by an operating practitioner or anesthesiologist, and the process by which a state may opt-out of that requirement.
 
Medicare interpretive guidelines are used by sate survey agencies (also known as SAs, which are usually state departments of health) to ascertain healthcare facilities’ compliance with the CoP. Such SAs survey healthcare facilities on two conditions: to determine the facility’s eligibility to participate in the Medicare program if it is not otherwise accredited by a “deemed status” entity such as the Joint Commission on the Accreditation of Hospital Organizations (JCAHO), and to audit healthcare facilities already accredited. According to the Government Accountability Office (GAO), SAs survey about 5 percent of a state’s hospitals in a given year. Medicare has provided SAs such interpretive guidelines for many years; however, CMS’ action to publish them online in May 2004 has brought increased scrutiny to the guidelines by AANA, CRNAs and hospitals. The importance of the interpretive guidelines to CRNAs is that at a practical level SA surveyors use them to ascertain facilities’ compliance with the CoP. Interpretive guidelines are identified either by the citation of their respective CoP in the Code of Federal Regulations, or by their heading or “Tag” number under which they appear in their respective CMS manual or appendix.
 
CMS is the Centers for Medicare & Medicaid Services, the federal agency that administers these important federal programs. Its website is http://www.cms.hhs.gov.
 
CMS has described its compliance relationships with healthcare facilities as follows (from 70 FR 15267, 3/25/2005):
 
The CoPs are the requirements that hospitals must meet to participate in the Medicare and Medicaid programs. The CoPs are intended to protect patient health and safety and to ensure that high quality care is provided to all patients.
 
Sections 1861(e)(1) through 1861(e)(8) of the Act define the term "hospital"' and list the requirements that a hospital must meet to be eligible for Medicare participation. Section 1861(e)(9) of the Act specifies that a hospital must also meet such other requirements as the Secretary of Health and Human Services (the Secretary) finds necessary in the interest of the health and safety of the hospital's patients. Under this authority, the Secretary has established in regulations, at Part 482, the requirements that a hospital must meet to participate in the Medicare program.
 
Compliance is determined by State survey agencies (SAs) or accreditation organizations. The SAs, in accordance with section 1864 of the Social Security Act (the Act), survey hospitals to assess compliance with the CoPs. The SAs conduct surveys using the State Operations Manual (SOM) (Centers for Medicare & Medicaid Services (CMS) Publication No. 7). The SOM contains the regulatory language of the CoPs as well as interpretive guidelines and survey procedures that give guidance on how to assess provider compliance. Under Sec. 489.10(d), the SAs determine whether a hospital meets the CoPs and make corresponding recommendations to us about a hospital's certification, (that is, whether a hospital has met the standards required to provide Medicare and Medicaid services and receive Federal and State reimbursement).
 
Under section 1865 of the Act, hospitals that are accredited by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the American Osteopathic Association (AOA), and other national accreditation programs approved by us are deemed to meet the requirements in the CoPs. Therefore, accredited hospitals are not routinely surveyed by SAs for compliance with the CoPs but are deemed to meet most of the hospital CoPs based on their accreditation. (See 42 CFR Part 488, ``Survey Certification, and Enforcement Procedures''). However, all Medicare- and Medicaid-participating hospitals are required to be in compliance with our CoPs regardless of their accreditation status.
 
Hospitals
  • Medicare Hospital Condition of Participation:  Anesthesia Services (42 CFR §482.52)
  • Hospital Conditions of Participation: Anesthesia Services Interpretive Guidelines. Medicare State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals
  • Previous Medicare Hospital Conditions of Participation: Anesthesia Services Interpretive Guidelines. Medicare State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals (Rev. 1 05-21-04).
  • State Operations Manual, pages 275-281 only address anesthesia services
  • Interim guidelines published April 29, 2005, on matters relating to supervision, supersede the portion of the above guidelines under the heading (“Tag”) A-417. These interim guidelines include new or moved language in underline.
     
Critical Access Hospitals (CAH)
  • Medicare Critical Access Hospital (CAH) Condition of Participation: Surgical services (42 CFR §485.639(b), (c), (d) and (e)).
  • Medicare Critical Access Hospital (CAH) Condition of Participation: Surgical Services Interpretive Guidelines (42 CFR §482.52). Medicare State Operations Manual, Appendix W – Survey Protocol, Regulations and Interpretive Guidelines for Critical Access Hospitals (CAHs) and Swing-Beds in CAHs – (Rev. 05-21-04).
    • State Operations Manual, pages 130-143 only address anesthesia issues specifically.
    • Interim guidelines published April 29, 2005. To the extent that CMS’ hospital and CAH conditions of participation are identical, so too are their respective interpretive guidelines. Thus, CMS states the updated guideline affecting practice of nurse anesthesia in CAHs at 42 CFR §485.639(c)(2), tag #C-0323, is the same guideline as for hospitals.
       
Ambulatory Surgical Centers (ASCs)
  • Medicare Ambulatory Surgical Center Condition of Participation: Surgical services. (42 CFR §416.42).
  • Medicare State Operations Manual, Appendix L – Guidance to Surveyors: Ambulatory Surgical Services– (Rev. 56, 12-30-09).