Conditions of Participation: Specialized Providers

Basis and scope.

This subpart sets forth the conditions that facilities must meet to be certified as comprehensive outpatient rehabilitation facilities (CORFs) under section 1861(cc)(2) of the Social Security Act and be accepted for participation in Medi...

Basis and scope.

This provision outlines the requirement for the Secretary to establish conditions for rural emergency hospitals to participate in Medicare to ensure patient health and safety.

Definitions.

As used in this subpart, rural emergency hospital or REH means an entity that operates for the purpose of providing emergency department services, observation care, and other outpatient medical and health services specified by the Secret...

Basic requirements.

Participation as an REH is limited to facilities that—

Designation and certification of REHs.

CMS certifies a facility as an REH if the facility was, as of December 27, 2020—

Condition of participation: Compliance with Federal, state, and local laws and regulations.

This provision requires rural emergency hospitals to comply with applicable health and safety laws and maintain state licensure or approval.

Definition.

As used in this subpart, unless the context indicates otherwise, “comprehensive outpatient rehabilitation facility”, “CORF”, or “facility” means a nonresidential facility that—

Condition of participation: Governing body and organizational structure of the REH

There must be an effective governing body, or responsible individual or individuals, that is legally responsible for the conduct of the REH.

Condition of participation: Medical staff.

The REH must maintain an organized medical staff responsible for the quality of medical care, operating under governing body-approved bylaws and credentialing processes.

Condition of participation: Provision of services.

The REH must furnish health care services in accordance with written policies developed by professional staff, including emergency services and post-acute care needs.

Condition of participation: Emergency services.

The REH must provide the emergency care necessary to meet the needs of its patients in accordance with acceptable standards of practice.

Condition of participation: Laboratory services.

The REH must provide basic laboratory services essential to the immediate diagnosis and treatment of the patient consistent with nationally recognized standards of care for emergency services, patient population, and services offered.

Condition of participation: Radiologic services.

The REH must maintain, or have available, diagnostic radiologic services.

Condition of participation: Pharmaceutical services.

The REH must have pharmaceutical services that meet the needs of its patients.

Condition of participation: Additional outpatient medical and health services.

If the REH provides outpatient medical and health services in addition to providing emergency services and observation care, the medical and health services must be appropriately organized and meet the needs of the patients in accordance...

Condition of participation: Infection prevention and control and antibiotic stewardship programs.

The REH must have active facility-wide programs for the surveillance, prevention, and control of healthcare-associated infections (HAIs) and other infectious diseases, and for the optimization of antibiotic use through stewardship.

Condition of participation: Staffing and staff responsibilities.

This provision establishes the staffing requirements, professional responsibilities, and clinical performance review standards for Rural Emergency Hospitals.

Condition of participation: Nursing services.

The REH must have an organized nursing service that is available to provide 24-hour nursing services for the provision of patient care.

Condition of participation: Discharge planning.

An REH must have an effective discharge planning process that focuses on the patient's goals and treatment preferences and includes the patient and their caregivers/support person(s) as active partners in the discharge planning for post-...

Condition of participation: Patient's rights.

An REH must protect and promote each patient's rights.

Condition of participation: Quality assessment and performance improvement program.

The REH must develop, implement, and maintain an effective, ongoing, REH-wide, data-driven quality assessment and performance improvement (QAPI) program.

Condition of participation: Agreements.

The REH must have in effect an agreement with at least one certified hospital that is a level I or level II trauma center for the referral and transfer of patients requiring emergency medical care beyond the capabilities of the REH that is—

Condition of participation: Compliance with State and local laws.

The facility and all personnel who provide services must be in compliance with applicable State and local laws and regulations.

Condition of participation: Medical records.

The Rural Emergency Hospital must maintain a comprehensive, secure, and organized medical records system, including electronic notification requirements for patient transfers and discharges.

Condition of participation: Emergency preparedness.

The REH must comply with all applicable Federal, state, and local emergency preparedness requirements.

Condition of participation: Physical environment.

The REH must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special services appropriate to the needs of the community.

Condition of participation: Skilled nursing facility distinct part unit.

This provision mandates that any skilled nursing facility services provided in a distinct part unit of an REH must be separately licensed and certified under long-term care requirements.

Condition of participation: Governing body and administration.

The facility must have a governing body that assumes full legal responsibility for establishing and implementing policies regarding the management and operation of the facility.

Condition of participation: Comprehensive rehabilitation program.

The facility must provide a coordinated rehabilitation program that includes, at a minimum, physicians' services, physical therapy services, and social or psychological services.

Condition of participation: Clinical records.

The facility must maintain clinical records on all patients in accordance with accepted professional standards and practice.

Basis and scope.

This section defines the statutory basis and scope for the designation of Critical Access Hospitals (CAHs) under the Social Security Act.

Rural health network.

A rural health network is an organization that meets the following specifications:

Personnel qualifications.

Staff that furnish services in a CAH must meet the applicable requirements of this section.

Designation and certification of CAHs.

This section outlines the criteria for state designation and CMS certification of facilities as Critical Access Hospitals.

Condition of participation: Compliance with Federal, State, and local laws and regulations.

The CAH and its staff are in compliance with applicable Federal, State and local laws and regulations.

Condition of participation: Status and location.

This provision establishes the eligibility criteria for Critical Access Hospital status, including rural location requirements, distance from other facilities, and rules for relocation and co-location.

Condition of participation: Compliance with hospital requirements at the time of application.

This provision mandates that a facility must hold a Medicare provider agreement as a hospital at the time it applies for designation as a Critical Access Hospital.

Condition of participation: Patient's rights.

A CAH must protect and promote each patient's rights.

Condition of participation: Agreements.

This provision mandates that Critical Access Hospitals maintain written agreements for network participation, quality assurance, and the credentialing and privileging of telemedicine practitioners.

Condition of participation: Emergency services.

The CAH provides emergency care necessary to meet the needs of its inpatients and outpatients.

Condition of participation: Physical environment.

The facility must provide a physical environment that protects the health and safety or patients, personnel, and the public.

Condition of participation: Number of beds and length of stay.

This provision defines the operational limits for Critical Access Hospitals regarding the maximum number of inpatient beds and the average length of stay.

Condition of participation: Physical plant and environment.

This provision sets requirements for the construction, maintenance, and life safety of the facility, including adherence to NFPA codes and fire safety protocols.

Condition of participation: Emergency preparedness.

The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements.

Condition of participation: Organizational structure.

This provision establishes the requirement for a governing body or individual to assume legal responsibility for the operation and quality of care in a Critical Access Hospital.

Condition of participation: Staffing and staff responsibilities.

This provision outlines the requirements for professional health care staff, medical direction, clinical privileges, and the structure of a unified medical staff in a Critical Access Hospital.

Condition of participation: Provision of services.

This provision mandates the development of patient care policies and defines the scope of clinical services, including laboratory, radiology, nursing, and rehabilitation, that a Critical Access Hospital must provide.

Conditions of participation: Clinical records.

This provision establishes requirements for the maintenance, protection, retention, and electronic notification capabilities of clinical records systems in critical access hospitals.

Condition of participation: Surgical services.

If a CAH provides surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the CAH in accordance w...

[Reserved]

This provision is currently reserved and contains no substantive regulatory requirements.

Condition of participation: Infection prevention and control and antibiotic stewardship programs.

The CAH must have active facility-wide programs, for the surveillance, prevention, and control of HAIs and other infectious diseases and for the optimization of antibiotic use through stewardship.

Condition of participation: Quality assessment and performance improvement program.

The CAH must develop, implement, and maintain an effective, ongoing, CAH-wide, data-driven quality assessment and performance improvement (QAPI) program.

Condition of participation: Discharge planning.

A Critical Access Hospital (CAH) must have an effective discharge planning process that focuses on the patient's goals and treatment preferences and includes the patient and his or her caregivers/support person(s) as active partners in t...

Condition of participation: Organ, tissue, and eye procurement.

The CAH must have and implement written protocols that:

Special requirements for CAH providers of long-term care services (“swing-beds”)

A CAH must meet the following requirements in order to be granted an approval from CMS to provide post-CAH SNF care, as specified in § 409.30 of this chapter, and to be paid for SNF-level services, in accordance with paragraph (c) of thi...

Condition of participation: psychiatric and rehabilitation distinct part units.

Critical Access Hospitals operating distinct part units for psychiatric or rehabilitation services must comply with specific hospital-level requirements and bed count limitations.

Condition of participation: Obstetrical services.

If the CAH offers obstetrical services, the services must be well organized and provided in accordance with nationally recognized acceptable standards of practice for the health care (including physical and behavioral health) of pregnant...

Condition of participation: Utilization review plan.

The facility must have in effect a written utilization review plan that is implemented annually, to assess the necessity of services and promotes the most efficient use of services provided by the facility.

Condition of participation: Emergency preparedness.

This provision mandates that Comprehensive Outpatient Rehabilitation Facilities establish and maintain a comprehensive emergency preparedness program, including risk assessments, policies, communication plans, and training.

Personnel qualifications.

This section sets forth the qualifications that must be met, as a condition of participation, under § 485.58, and as a condition of coverage of services under § 410.100 of this chapter.

Basis and scope.

This provision outlines the legal basis and regulatory scope for outpatient physical therapy and speech pathology services under the Social Security Act.

Definitions.

This section provides the official definitions for terms used throughout the subpart, including clinic, rehabilitation agency, and supervision.

Personnel qualifications.

This provision establishes the licensure, certification, and educational requirements for personnel providing outpatient physical therapy, occupational therapy, and speech-language pathology services.

Condition of participation: Compliance with Federal, State, and local laws.

The organization and its staff are in compliance with all applicable Federal, State, and local laws and regulations.

Condition of participation: Administrative management.

The clinic or rehabilitation agency has an effective governing body that is legally responsible for the conduct of the clinic or rehabilitation agency.

Condition of participation: Plan of care and physician involvement.

For each patient in need of outpatient physical therapy or speech pathology services, there is a written plan of care established and periodically reviewed by a physician, or by a physical therapist or speech pathologist respectively.

Condition of participation: Physical therapy services.

If the organization offers physical therapy services, it provides an adequate program of physical therapy and has an adequate number of qualified personnel and the equipment necessary to carry out its program and to fulfill its objectives.

Condition of participation: Speech pathology services.

If speech pathology services are offered, the organization provides an adequate program of speech pathology and has an adequate number of qualified personnel and the equipment necessary to carry out its program and to fulfill its objecti...

Condition of participation: Rehabilitation program.

This condition and standards apply only to a rehabilitation agency's own patients, not to patients of hospitals, skilled nursing facilities (SNFs), or Medicaid nursing facilities (NFs) to which the agency furnishes services.

Condition of participation: Arrangements for physical therapy and speech pathology services to be performed by other than salaried organization personnel.

This provision mandates that services provided under contract must be governed by a written agreement that ensures the organization retains professional and administrative responsibility.

Condition of participation: Clinical records.

The organization maintains clinical records on all patients in accordance with accepted professional standards, and practices.

Condition of participation: Physical environment.

The building housing the organization is constructed, equipped, and maintained to protect the health and safety of patients, personnel, and the public and provides a functional, sanitary, and comfortable environment.

Condition of participation: Infection control.

The organization that provides outpatient physical therapy services establishes an infection-control committee of representative professional staff with responsibility for overall infection control.

Condition of participation: Emergency preparedness.

The Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (“Organizations”) must comply with all applicable Federal, State, and local emergency pre...

Condition of participation: Program evaluation.

The organization has procedures that provide for a systematic evaluation of its total program to ensure appropriate utilization of services and to determine whether the organization's policies are followed in providing services to patien...

Appeal rights.

This provision establishes that the appeal procedures in part 498 apply to entities participating or seeking to participate in the Medicare program as a CORF.

Basis and scope.

This provision outlines the statutory basis and regulatory scope for community mental health centers providing partial hospitalization and intensive outpatient services.

Definitions.

As used in this subpart, unless the context indicates otherwise—

Condition of participation: Personnel qualifications.

This provision establishes the required qualifications, licensure, and experience standards for professionals providing services at Community Mental Health Centers.

Condition of participation: Client rights.

The client has the right to be informed of his or her rights.

Condition of participation: Admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client.

The CMHC must ensure that all clients admitted into its program are appropriate for the services the CMHC furnishes in its facility.

Condition of participation: Treatment team, person-centered active treatment plan, and coordination of services.

The CMHC must designate an interdisciplinary treatment team that is responsible, with the client, for directing, coordinating, and managing the care and services furnished for each client.

Condition of participation: Quality assessment and performance improvement.

Community Mental Health Centers are required to implement a data-driven quality assessment and performance improvement program to monitor and improve behavioral health outcomes and client safety.

Condition of participation: Organization, governance, administration of services, partial hospitalization services, and intensive outpatient services.

The CMHC must organize, manage, and administer its resources to provide CMHC services, including specialized services for children, elderly individuals, individuals with serious mental illness, and residents of its mental health service...

Condition of participation: Emergency preparedness.

The Community Mental Health Center (CMHC) must comply with all applicable Federal, State, and local emergency preparedness requirements.