Conditions of Participation: Specialized Providers

Basis and scope.

This provision establishes the conditions for facilities to be certified as comprehensive outpatient rehabilitation facilities and participate in Medicare.

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.

This provision defines a rural emergency hospital as an entity providing emergency and outpatient services with an average length of stay not exceeding 24 hours.

Basic requirements.

This provision specifies that participation as a rural emergency hospital requires meeting definitions, holding a provider agreement, and complying with conditions of participation.

Designation and certification of REHs.

This provision outlines the criteria for CMS to certify a facility as a rural emergency hospital based on its status 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.

This provision defines a comprehensive outpatient rehabilitation facility as a nonresidential facility established for diagnostic, therapeutic, and restorative services.

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

This provision mandates that an REH have an effective governing body responsible for medical staff oversight, contracted services, and quality of care.

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 emergency care services that are organized, integrated, and staffed by qualified personnel to meet patient needs.

Condition of participation: Laboratory services.

The REH must provide basic laboratory services essential for immediate diagnosis and treatment, either directly or through a certified contractual agreement.

Condition of participation: Radiologic services.

The REH must maintain diagnostic radiologic services that are safe for patients and personnel, with qualified staff and documented records.

Condition of participation: Pharmaceutical services.

The REH must maintain pharmaceutical services that meet patient needs, including secure drug storage, medication administration policies, and accurate record-keeping for controlled substances.

Condition of participation: Additional outpatient medical and health services.

The REH must organize outpatient services, including surgical and anesthesia procedures, according to established standards of practice and qualified personnel requirements.

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

This provision mandates that Rural Emergency Hospitals maintain active, facility-wide infection prevention and control and antibiotic stewardship programs, including specific requirements for leadership, reporting, and staff vaccination.

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.

This provision mandates that Rural Emergency Hospitals maintain an organized, 24-hour nursing service supervised by a registered nurse.

Condition of participation: Discharge planning.

This provision outlines the requirements for an effective discharge planning process that incorporates patient goals, treatment preferences, and transition to post-acute care.

Condition of participation: Patient's rights.

This provision establishes the comprehensive patient rights for Rural Emergency Hospitals, including notice of rights, grievance processes, informed decision-making, confidentiality, restraint and seclusion standards, and visitation rights.

Condition of participation: Quality assessment and performance improvement program.

The Rural Emergency Hospital must maintain an ongoing, data-driven quality assessment and performance improvement program to improve health outcomes and reduce medical errors.

Condition of participation: Agreements.

The Rural Emergency Hospital must maintain a transfer agreement with at least one certified hospital that is a level I or level II trauma center for emergency care beyond the facility's capabilities.

Condition of participation: Compliance with State and local laws.

The facility and its personnel must comply with all applicable state and local laws, including licensure requirements for the facility and staff.

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.

This provision mandates that Rural Emergency Hospitals establish and maintain a comprehensive emergency preparedness program, including risk assessments, policies, communication plans, training, testing, and emergency power systems.

Condition of participation: Physical environment.

This provision establishes requirements for the physical plant, emergency power, safety, and fire protection standards for Rural Emergency Hospitals.

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.

This provision outlines the responsibilities of the governing body, administrator, and professional personnel in managing facility operations, patient care policies, and institutional budgets.

Condition of participation: Comprehensive rehabilitation program.

This provision sets requirements for the provision of coordinated rehabilitation services, including physician oversight, treatment planning, and laboratory service standards.

Condition of participation: Clinical records.

The facility must maintain clinical records on all patients that are documented accurately, organized systematically, and safeguarded against unauthorized use or loss.

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 defined as an organization including at least one CAH and one acute care hospital with agreements for patient referral, communication, and quality assurance.

Personnel qualifications.

Staff providing services in a CAH, including clinical nurse specialists, nurse practitioners, and physician assistants, must meet specific licensure, certification, and educational requirements.

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.

Critical Access Hospitals and their staff must comply with all applicable federal, state, and local laws, including those related to licensure, registration, and patient health and safety.

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.

This provision establishes the comprehensive rights of patients in a Critical Access Hospital, including grievance processes, informed decision-making, privacy, confidentiality, restraint and seclusion standards, and visitation 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.

This provision requires the facility to maintain a safe, sanitary, and accessible physical environment, including fire safety, infection control, and equipment maintenance programs.

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.

Critical Access Hospitals must develop and maintain a comprehensive emergency preparedness program, including a risk assessment, policies and procedures, a communication plan, and a training and testing program.

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.

This provision outlines the requirements for surgical services, including practitioner qualifications, anesthesia administration, risk evaluation, and discharge procedures.

[Reserved]

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

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

This provision mandates the implementation of facility-wide infection prevention and antibiotic stewardship programs, including surveillance, reporting, and leadership responsibilities.

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.

Critical Access Hospitals must implement an effective discharge planning process that involves patients and caregivers to ensure safe transitions and reduce readmissions.

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

Critical Access Hospitals must maintain written protocols for organ, tissue, and eye procurement, including collaboration with designated procurement organizations and donor family notification.

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

Critical Access Hospitals providing swing-bed services must meet specific eligibility, payment, and quality requirements, including compliance with various skilled nursing facility standards.

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.

Critical Access Hospitals offering obstetrical services must ensure services are well-organized, appropriately staffed, and supported by evidence-based protocols and staff training.

Condition of participation: Utilization review plan.

Critical Access Hospitals must implement a written utilization review plan to assess the necessity and efficiency of services provided.

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 defines the specific licensure, education, and experience requirements for clinical personnel, including physicians, nurses, and therapists, as a condition of participation.

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.

This provision requires that the organization and its staff maintain compliance with all applicable Federal, State, and local laws, including facility and personnel licensure requirements.

Condition of participation: Administrative management.

This provision outlines the responsibilities of the governing body, the appointment of an administrator, and the requirement for written personnel and patient care policies.

Condition of participation: Plan of care and physician involvement.

This provision mandates that a written plan of care be established and reviewed for each patient receiving outpatient physical therapy or speech pathology services, and requires emergency procedures.

Condition of participation: Physical therapy services.

This provision sets standards for an adequate physical therapy program, including requirements for equipment, facilities, and the supervision of physical therapist assistants.

Condition of participation: Speech pathology services.

This provision outlines the requirements for an adequate speech pathology program, including necessary equipment, facilities, and qualified personnel.

Condition of participation: Rehabilitation program.

This provision specifies that rehabilitation agencies must ensure therapy services are furnished by qualified individuals, whether directly or under contract.

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.

This provision mandates that organizations maintain organized, accurate, and confidential clinical records for all patients, including specific content requirements and retention schedules.

Condition of participation: Physical environment.

This provision requires that the facility be constructed, equipped, and maintained to ensure the health and safety of patients, staff, and the public.

Condition of participation: Infection control.

This provision requires the establishment of an infection-control committee and the implementation of policies for preventing and controlling infections within the organization.

Condition of participation: Emergency preparedness.

This provision requires organizations to establish and maintain a comprehensive emergency preparedness program, including risk assessment, policies, communication plans, and training.

Condition of participation: Program evaluation.

This provision requires a systematic evaluation of the organization's total program, including clinical record reviews and statistical analysis, to ensure quality and policy compliance.

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.

This provision defines key terms used in the regulation of Community Mental Health Centers, including active treatment plans, assessments, restraint, and seclusion.

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.

This provision mandates that Community Mental Health Centers protect and promote client rights, including requirements for notice of rights, grievance procedures, abuse reporting, restraint and seclusion protocols, staff training, and death reporting.

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

Community Mental Health Centers must conduct timely initial evaluations and comprehensive assessments for all admitted clients and maintain specific procedures for discharge or transfer.

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

Community Mental Health Centers must designate an interdisciplinary treatment team to develop and implement a person-centered active treatment plan 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.

This provision establishes the organizational, governance, and service delivery requirements for Community Mental Health Centers, including standards for professional management, staff training, and physical environment.

Condition of participation: Emergency preparedness.

This provision mandates that Community Mental Health Centers establish and maintain a comprehensive emergency preparedness program, including risk assessment, communication plans, and staff training.