Conditions of Participation and Conditions for Coverage Spotlight

CMS has several ongoing priority activities involving the Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) for certain health care providers. Below you will find key information about our most important activities.

Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations.  Final Rule, Public Comment Period, and Delay of Effective Date: CMS-3380-F and CMS-3380-F2

On March 30, 2021, the Centers for Medicare & Medicaid Services’ (CMS) organ procurement organization final rule entitled “Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations; Final rule” (85 FR 77898) went into effect.  The December 2020 final rule revises the Organ Procurement Organizations (OPO) Conditions for Coverage to increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures and increasing competition for open donation service areas. The effective date of the final rule was temporarily delayed in a notice published on February 2, 2021 to give Department officials the opportunity for further review of the issues of fact, law, and policy raised by this rule (86 FR 7814). Following review of the public comments, the March 30, 2021 effective date of the rule remained unchanged and the policies that went into effect contained no changes from the final rule that published December 2, 2020.

Community Mental Health Centers Conditions of Participation: CMS-3202-F

A final rule was published on October 29, 2013.  This final rule establishes a formal set of community mental health center (CMHC) Conditions of Participation (CoPs), which are the health and safety regulations Medicare providers must meet to participate in the Medicare program.  The Community Mental Health Center benefit was established by OBRA in 1990.  Initially, a CMHC was approved to participate in Medicare solely based on its attestation that it met the definition of a CMHC, and provided certain services as identified in the Social Security Act (the Act).  Presently, a CMHC is approved to participate when a CMS regional office determines that the CMHC meets the definition of a CMHC and provides certain services as identified in the Act.

The new Conditions of Participation will help raise standards for the 100 CMHCs that participate in Medicare and ensure high quality and safe care for the more than 13,000 Medicare beneficiaries they serve.  CMHCs must continue to follow already-existing Medicare program integrity and payment regulations and are still required to comply with applicable provisions of the Public Health Service Act.

A 2012 report by the Department of Health and Human Services' Inspector General concluded that Conditions of Participation would strengthen Medicare's ability to oversee the quality, effectiveness, and safety of care provided by CMHCs.  In addition to delineating rights and safety protections that must be provided to all clients of Medicare-participating CMHCs, this final rule adopts contemporary standards of practice for the community behavioral health setting, and incorporates public recommendations made by national associations.

Under the new Conditions of Participation, all clients will have a treatment team, an active treatment plan, and coordination of services providing individualized client care.  Clients must be provided with an initial evaluation, a comprehensive assessment, and a discharge or transfer plan that identifies each client's needs and how those needs will be met on a timely basis.  In addition, CMHCs must use outcome and client satisfaction data to identify specific program needs and improve the quality of care provided to clients.  The regulations also promote continuity of care by emphasizing the need for communication with other service providers regarding client needs at the time of discharge or transfer.

To ensure that the mental health centers are meeting the new health and safety requirements, CMS will survey community mental health centers at least once every 5 years, although surveys may occur more frequently if a complaint is received by CMS or the state survey agency.

The final rule publication date was October 29, 2013, with an effective date of October 29, 2014.

Effective date: October 29, 2014

CFR section numbers: 42 CFR 485.900 - 485.918 et al. (final rule)

CFR section descriptions: 42 CFR Part 485

Brief description of document(s): The final rule, CMS 3202-F, a formal set of community mental health center (CMHC) Conditions of Participation, which are the health and safety regulations Medicare providers must meet to participate in the Medicare program.

Downloads:

Regulation: http://www.gpo.gov/fdsys/search/pagedetails.action?granuleld=2013-24056&packageld=FR-2013-10-29&acCode=FR

Related links: None

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013: CMS-1590-FC

On November 16, 2012, the Centers for Medicare & Medicaid Services (CMS) published a final rule to expand the Conditions for Coverage (CfCs) at §486.106 to allow Medicare to pay for Portable X-ray Services ordered by physicians and non-physician practitioners acting within the scope of their Medicare benefit and state law (77 FR 69372), and in accordance with the ordering policies for other diagnostic services under §410.32(a) (77 FR 69009).  The revision expanded the list of non-physician practitioners to include: "a nurse practitioner, clinical nurse specialist, physician assistant..." (77 FR 69009).  CMS believes non-physician practitioners have become an increasingly important component of clinical care.

The final rule became effective January 2013.

Reform of Hospital and Critical Access Hospital Conditions of Participation: CMS-3244-F

On May 16, 2012, the Centers for Medicare & Medicaid Services (CMS) published a final rule, "Reform of Hospital and Critical Access Hospital Conditions of Participation." This final rule was developed through a retrospective review of existing regulations called for by President Obama's January 18, 2011 Executive Order 13563, to “modify, streamline, or repeal” regulations which impose unnecessary burdens, including on hospitals and other providers that must comply with requirements under Medicare.

The CoPs are federal health and safety requirements ensuring high quality care for all patients.  Hospitals and CAHs must meet these conditions to participate in the Medicare and Medicaid programs.  The final rule is designed to reduce the regulatory burden on hospitals by the following:

•  Requiring that all eligible candidates, including APRNs and PAs, must be reviewed by the medical staff for potential appointment to the hospital medical staff and then allowing for the granting of all the privileges, rights, and responsibilities accorded to appointed medical staff members.
• Supporting and encouraging patient-centered care, through such changes such as allowing a patient or his or her caregiver/support person to administer certain medications (both those brought from the patient’s home and those dispensed by the hospital), and by allowing hospitals to use a single, interdisciplinary care plan that supports coordination of care through nursing services.
• Encouraging the use of evidence-based pre-printed and electronic standing orders, order sets, and protocols that ensure the consistency and quality of care provided to all patients by allowing nurses the ability to implement orders that are timely and clear.
• Allowing hospitals to determine the best ways to oversee and manage outpatients by removing the unnecessary requirement for a single Director of Outpatient Services.
• Increasing flexibility for hospitals by allowing one governing body to oversee multiple hospitals in a single health system.
• Allowing CAHs the flexibility to affiliate with other providers, as well as using temporary entities, to address efficiencies and alleviate work force shortages so that they can provide safe and timely delivery of care to their patients.

Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction: CMS-9070-F

On May 16, 2012, the Centers for Medicare & Medicaid Services (CMS) published a final rule of CMS regulations that have been identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries. This final rule would increase the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing the delivery of quality patient care.

This rule would help reduce unnecessary burdens on health care providers, allowing them to dedicate more resources to improving patient care. Some of the more than two dozen regulatory changes include:

• Revising which End Stage Renal Disease (ESRD) facilities are required to comply with National Fire Protection Agency Life Safety Code requirements. CMS estimates that this revision could save an estimated $108.7 million for the ESRD providers. 
• Eliminating the specific list of emergency equipment Ambulatory Surgical Centers must have on hand, and allowing facilities, in conjunction with medical staff and their governing bodies, to develop policies and procedures that specify emergency equipment appropriate to the services they provide.
•  Revising the definition of “donor document” to clarify that a valid donor document is any documented indication of an individual’s choice regarding his or her wishes concerning organ and/or tissue donation that was made by that individual or another authorized individual in accordance with any applicable State law.  This revision recognizes that individuals can express specific wishes concerning organ and/or tissues donation and are not limited to a decision to donate or not donate their organs and/or tissues after their deaths.  It also recognizes that the donor document must comply with any applicable State law.  It also recognizes that other individuals, such as a parent of a minor child, may make the donation decision for another individual, if it is in accordance with any applicable State law.

The final rule will be effective on July 16, 2012.

Long Term Care Facilities: Hospice Services: CMS-3140

On October 22, 2010, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule, "LTC Facilities: Hospice Services." This proposed rule would require a specific written agreement between LTC facilities and Medicare-certified hospice providers serving the LTC facility's residents who elect hospice care. By requiring this written agreement, the role of each provider will be better understood by both parties, resulting in better quality of care. This proposed rule corresponds with the requirements for hospices found at 42 CFR §418.112, entitled  "Hospices that provide hospice care to residents of a SNF/NF or ICF/MR", published as part of the hospice final rule, CMS-3844-F, Hospice Care Conditions of Participation, in June of 2008.

This proposed rule would help to ensure that LTC facilities and hospice providers work together to coordinate resident care by requiring a written agreement.  The final rule is expected to publish in early 2012.

Hospital and Critical Access Hospital Telemedicine: CMS-3227-F

We published a final rule in May 2011.  This final rule revised the CoPs for both hospitals and CAHs. These revisions allow for a new credentialing and privileging process for physicians and practitioners providing telemedicine services.

The purpose of the rule was to revise the credentialing and privileging process for telemedicine providers in hospitals and CAHs. Based on feedback from hospitals, CAHs, and other organizations, we concluded that our previous credentialing and privileging process requirements for telemedicine providers was duplicative and burdensome for physicians, practitioners, and hospitals. It was particularly burdensome for small hospitals, which often lack the resources to fully carry out the traditional credentialing and privileging process for all of the physicians and practitioners that might be able to provide telemedicine services for their patients.

Hospital and Critical Access Hospital Visitation: CMS-3228-F

CMS published a final rule on November 17, 2010. This final rule revised the Medicare conditions of participation for hospitals and critical access hospitals (CAHs) to ensure visitation rights for all patients. Specifically, Medicare- and Medicaid-participating hospitals and CAHs are now required to have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restrictions or limitations that the hospital or CAH might need to place on such rights as well as the reasons for the clinical restrictions or limitations.

Requirements for Long Term Care Facilities: Notice of Facility Closure: CMS-3230

CMS published an interim final rule (IFC) with comment period, "LTC Facilities: Notice of Facility Closure" in January 2011.  This IFC implements Section 6113 of the Affordable Care Act (P.L. 111-148).  One of the requirements in section 6113 states, that in the case of a LTC facility closure, any individual who is the administrator of the facility provides written notification of the closure and a plan for the relocation of residents at least 60 days prior to the impending closure or, if the Secretary terminates the facility's participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate.

Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers: CMS-3178

In response to concern about the ability of healthcare providers across the United States to plan for and respond to emergencies, the CMS is in the process of developing a proposed rule with emergency preparedness conditions of participation (CoP) and conditions for coverage (CfC) for all Medicare/Medicaid certified providers and suppliers ("providers"), excluding Community Mental Health Centers (CMHCs).  Thus, the proposed rule would apply to Hospitals; Religious Nonmedical Health Care Institutions (RNHCIs); Ambulatory Surgical Centers (ASCs); Hospice;  Psychiatric Residential Treatment Facilities (PRTFs); Programs of All-Inclusive Care for the Elderly (PACE); Transplant Centers; Long-Term Care (LTC) Facilities; Intermediate Care Facilities for Persons w/ Mental Retardation (ICFs/MR); Home Health Agencies (HHAs); Comprehensive Outpatient Rehabilitation Facilities (CORFs); Critical Access Hospitals (CAHs);  Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; Organ Procurement Organizations (OPOs);  Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs); and End-Stage Renal Disease (ESRD) Facilities. Our goals are to address systemic gaps, such as those identified after the Gulf hurricanes, and to provide a regulatory framework to ensure that every provider has in place a comprehensive, coordinated emergency preparedness process that will provide consistency in meeting the needs of patients, residents, and clients  across Federal, State, tribal, regional, and local emergency preparedness systems. The proposed rule is scheduled for publication in early 2012.

Condition of Participation: Community Mental Health Centers (CMHC):  CMS-3202

CMS published a proposed rule on June 17, 2011. This proposed rule establishes Conditions of Participation (CoP) for community mental health centers (CMHC).  CMHC care is a comprehensive combination of mental health care services, which includes physician services, psychiatric nursing, counseling and social services. Under the proposed rule, the CMHC Conditions of Participation provide requirements for quality and safety, and focuses attention on meeting the specific needs of individual clients.

Ambulatory Surgical Centers (ASC): Conditions for Coverage: Same Day Services: CMS-3217

On October 24, 2011, the Centers for Medicare & Medicaid Services (CMS) published an ASC Final Rule that will update the conditions for coverage regulations for Ambulatory Surgical Centers (ASCs), based on a proposed rule CMS issued in April 2010. This new final rule simplifies requirements that ASCs must follow in notifying patients about their rights. Specifically, the final rule will allow ASCs to provide the patient, the patient's representative, or the patient's surrogate with patient rights information prior to the start of the surgical procedure. Before today's final rule, ASCs were required to notify patients in advance of the date of the procedure. This caused particular logistical problems and inconveniences for patients who needed ASC services on the same day they received a physician referral.

Changes in Conditions of Participation and Payment for Rural Health Clinics and Federally Qualified Health Centers (RHC/FQHC): CMS-1910

On June 27, 2008, CMS published a proposed rule entitled, Changes in Conditions of Participation Requirements and Payment Provisions; Rural Health Clinics and Federally Qualified Health Centers that would require changes in conditions for certification and coverage (CfC) for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).  This proposed rule would require RHCs to establish a quality assessment and performance improvement (QAPI) program that would enable the facility to review its operating systems and processes of care to identify and implement opportunities to improve the quality of patient care.  This proposed rule would also add the following requirements for RHCs and FQHCs:  maintain and document an infection control process, update the requirements under the emergency services standard and patient health records to reflect advancements in technology and treatment, update the regulations pertaining to waivers to the staffing requirements, and establish location requirements for new and existing RHCs.

Anesthesia Supervision

Effective November 13, 2001, CMS established an exemption for Certified Registered Nurse Anesthetists (CRNAs) from the physician supervision requirement.  This exemption recognized a Governor's written request to CMS attesting that he or she is aware of the State's right to an exemption of the requirement and that is in the best interests of the State's citizens to exercise this option.

As of November 2020, nineteen States and the U.S. Territory Guam have chosen to opt-out of the CRNA physician supervision regulation.  The States are: California, Iowa, Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota, Washington, Alaska, Oregon, South Dakota, Wisconsin, Montana, Colorado, Kentucky, Arizona, and Oklahoma.