To qualify for Medicare certification and reimbursement, providers and suppliers of health services must comply with minimum health and safety standards. These standards are termed “Conditions of Participation” (“CoPs”) or “Conditions for Coverage” (“CfCs”), depending on the type of Medicare-participating entity. They are embodied in Title XVIII of the Social Security Act (“SSA”) and other regulations that the Secretary of the Department of Health and Human Services (“DHHS”) find to be necessary and in the interest of the health and safety of individuals who receive services in the institution, as authorized by SSA.
History of CoPs in the Medicare Program
As early as 1916, the American College of Surgeons (“ACS”) undertook a survey of hospitals in the United States and Canada to examine the quality of service in these institutions. See John W. Cashman, M.D., et al., The "Why" of Conditions of Participation in the Medicare Program 83 Public Health Reports 9, 714 (1968), available at http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1891865&blobtype=pdf. Covering over 2,700 hospitals, the survey and its findings were never published. In fact, the survey committee ordered the reports destroyed when the results indicated that only 89 of nearly 700 hospitals with more than 100 beds could meet any reasonable healthcare standards. ACS did respond, however, by adopting a set of minimum standards to which hospitals could voluntarily commit.
It was not until 1946, when Congress passed the Hill-Burton Hospital Survey and Construction Act, that widespread application of healthcare standards occurred. In order to receive Hill-Burton funding, states were required to license entities to ensure that hospital facilities adhered to several quality of service requirements. With the enactment of Medicare and Medicaid in 1965, Congress again had to determine whether control of the quality of care provided by individual hospitals ought to be based on uniform federal standards or remain under state supervision and control. Ultimately, Congress chose to establish uniform minimum national standards to be certified by state agencies. See http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1891865&blobtype=pdf.
- Title XVIII of the Social Security Act
Today, Medicare-participating providers that are subject to CoPs include:
- Hospitals (42 C.F.R. Part 482)
- Critical Access Hospitals (42 C.F.R. Part 485, Subpart F)
- Home Health Agencies (Soc Sec. Act § 1891 and 42 C.F.R. Part 484)
- Hospices (Soc. Sec. Act § 1861(dd) and 42 C.F.R. Part 418)
- Comprehensive Outpatient Rehabilitation Facilities (Soc. Sec. Act § 1861(cc) and 42 C.F.R. Part 485 Subpart B)
- Rehabilitation Agencies, Clinics, and Public Health Agencies operating as providers of outpatient physical therapy or speech pathology services (Soc. Sec. Act § 1861(p)(4) and 42 C.F.R. Part 485 Subpart H)
- Intermediate Care Facilities for Persons with Mental Retardation (42 C.F.R. Part 483 Subpart I)
- Religious Nonmedical Health Care Institutions (42 C.F.R. §§ 403.730 through 403.746)
Medicare-participating suppliers subject to CfCs include:
- Portable X-ray Services (42 C.F.R. Part 486 Subpart C)
- End-Stage Renal Disease Facilities (42 C.F.R. Part 494)
- Occupational Therapists in Independent Practice (42 C.F.R. Part 485 Subpart H)
- Ambulatory Surgical Centers (Soc. Sec. Act § 1832(a)(2)(F)(i) and 42 C.F.R. Part 416)
- Federally Qualified Health Centers (Soc. Sec. Act § 1861(aa)(3) and 42 C.F.R. Part 491)
- Organ Procurement Organizations (42 C.F.R. Part 486 Subpart G).
- Skilled nursing facilities (SNFs) (Soc. Sec. Act § 1819) and rural health clinics (Soc. Sec. Act § 1861(aa)(2) and 42 C.F.R. Part 491) are subject to “requirements for SNFs” and “conditions for certification” respectively, rather than CoPs and CfCs (See 42 C.F.R. § 488.10).
Determination that a particular healthcare organization is in compliance with CoPs or CfCs is made in one of two ways. First, state survey agencies under contract with DHHS recommend whether an organization meets the applicable CoPs or CfCs. If the organization meets certification standards, the Secretary may approve the state agency’s recommendation. See 42 C.F.R. §§ 488.10 through 488.12. These decisions may be appealed if a provider or supplier is found not to meet the requisite requirements (42 C.F.R. § 488.24) and are subject to periodic review (42 C.F.R. § 488.20).
Second, some organizations (e.g., hospitals) may also receive certification by obtaining accreditation from an accrediting body approved by the Centers for Medicare and Medicaid Services (“CMS”). Accredited institutions are deemed to meet all of the Medicare CoPs, except (i) the requirement for utilization review (42 C.F.R. § 488.5(a)(1)); (ii) the additional special staffing and medical records requirements necessary for psychiatric hospitals (42 C.F.R. § 488.5(a)(2)); and (iii) any requirement established by the Secretary that CMS identifies as being higher or more precise than the requirements for accreditation (42 C.F.R. § 488.5(a)(3)). Currently, for hospitals, CMS-approved accrediting bodies include the Joint Commission, the American Osteopathic Association and Det Norske Veritas Healthcare, Inc. See CMS-Approved Accreditation Organization Contact Information, available at http://www.cms.hhs.gov/SurveyCertificationGenInfo/Downloads/AOContactInformation.pdf.
In both of the above situations—investigations made by the state survey agencies and investigations made by the designated accreditation organization—the reviewing institutions follow guidelines issued by CMS in the State Operations Manual (CMS Pub. 100-07) to make recommendations as to whether a particular provider is compliant with relevant CoPs or CfCs.
CoPs and CfCs differ depending on the type of entity, but there are several common criteria that exist. Examples of common conditions include (i) a governing body responsible for effectively governing affairs of the institution (see, e.g., 42 C.F.R. § 482.12); (ii) a quality assurance program to evaluate entity-wide patient care (see, e.g., 42 C.F.R. § 482.21); (iii) medical record service responsible for medical records (see, e.g., 42 C.F.R. § 482.24); (iv) a utilization review that reviews the services furnished by the entity and its staff (see, e.g., 42 C.F.R. § 482.30); and (v) a facility constructed, arranged and maintained according to a life safety code that ensures patient safety and the deliverance of services appropriate to the needs of the community (see, e.g., 42 C.F.R. § 482.41).
Areas in the Spotlight
CMS has several ongoing priority activities involving the CoPs and CfCs for certain health care providers. CMS currently designates the following activities as the most important:
- Sprinklers in nursing facilities (life safety code)
- Alcohol based hand sanitizers and nursing facility smoke alarms (life safety code)
- Anesthesia supervision
- Final rule: requirements for history and physical examinations; authentication of verbal orders; securing medications; and postanesthesia evaluations
- Restraint and seclusion in hospitals
- Immunizations (flu and pneumococcal) of nursing facility residents
- Proposed revision to end stage renal disease facilities
- Proposed CoPs for transplant hospitals
- Critical access hospitals – necessary provider (NP) relocations
- Proposed revision to hospice CoPs
- Final organ procurement organization CfCs
See CMS Conditions for Coverage (CfCs) & Conditions of Participations (CoPs) Spotlight available at http://www.cms.hhs.gov/CFCsAndCoPs/02_Spotlight.asp.
To participate in the Medicare program, health service providers and suppliers must meet certain statutory and regulatory requirements promulgated under Title XVIII of the Social Security Act. These requirements, generally termed CoPs or CfCs, vary based on the type of entity and are subject to change through CMS’s rulemaking process. It is important for Medicare-participating entities to remain compliant with these requirements because deficiencies in one or more of the conditions can result in denial of payment and may lead to exclusion from Medicare if not corrected.
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