CMS Conditions of Participation for Hospitals

The Centers for Medicare and Medicaid Services (CMS) Conditions of Participation (CoPs) establish the minimum health and safety requirements that healthcare facilities must meet to participate in Medicare and Medicaid programs. These federal regulations, codified at 42 CFR Part 482, are essential for hospital operations and directly impact patient care quality, safety, and reimbursement eligibility.

Overview of Conditions of Participation

CMS CoPs serve as the baseline standards for hospital operations. Compliance is mandatory for hospitals seeking Medicare certification and Medicaid participation.

Regulatory Framework

Regulation	Scope	Enforcement
42 CFR 482	Hospital CoPs	CMS State Operations Manual
42 CFR 483	Long-Term Care CoPs	CMS State Operations Manual
42 CFR 484	Home Health CoPs	CMS State Operations Manual
42 CFR 485	Rural Health, CAH, ASC	CMS State Operations Manual
42 CFR 486	Specialized Providers (OPO, etc.)	CMS State Operations Manual

Deemed Status and Accreditation

Hospitals may achieve Medicare certification through:

• State Survey: Direct survey by State Agency on behalf of CMS
• Deemed Status: Accreditation by CMS-approved accrediting organization

CMS-approved accrediting organizations with deeming authority for hospitals:

• The Joint Commission (TJC)
• Det Norske Veritas Healthcare (DNV GL Healthcare)
• Center for Improvement in Healthcare Quality (CIHQ)
• Healthcare Facilities Accreditation Program (HFAP)

Patient Rights (§482.13)

Hospitals must inform patients of their rights and ensure these rights are protected during the care process.

Core Patient Rights

• Notice of Rights: Patients must be informed of their rights in advance of care
• Informed Consent: Patients have the right to participate in care decisions and give informed consent
• Privacy and Confidentiality: Personal privacy and confidential handling of medical records
• Grievance Process: Right to file complaints and have them investigated
• Advance Directives: Right to formulate advance directives
• Restraint and Seclusion: Use only to ensure immediate physical safety with specific requirements
• Visitation Rights: Right to designate visitors including same-sex domestic partners

Restraint and Seclusion Requirements

Requirement	Behavioral Health	Medical/Surgical
Order Required	Yes, by physician/LIP	Yes, by physician/LIP
Time Limit (Adults)	4 hours	24 hours (but must renew)
Time Limit (9-17 years)	2 hours	24 hours
Time Limit (<9 years)	1 hour	24 hours
Face-to-Face Evaluation	Within 1 hour	Within time frame per policy
Continuous Monitoring	Required	Required

Governing Body (§482.12)

The hospital must have an effective governing body legally responsible for the conduct of the hospital.

Governing Body Responsibilities

• Hospital Operation: Overall responsibility for hospital operation and compliance
• Medical Staff Oversight: Appointment and reappointment of medical staff, privileging
• Quality Program: Responsibility for hospital-wide QAPI program
• Patient Safety: Ensure patient safety and quality improvement
• Contracted Services: Oversight of services provided under contract
• CEO Accountability: Appointment and oversight of CEO/administrator
• Compliance Programs: Operating a compliance and ethics program

Medical Staff (§482.22)

The medical staff must be organized in accordance with the hospital’s bylaws and must be accountable to the governing body for the quality of medical care.

Medical Staff Requirements

• Bylaws: Adopted bylaws, rules, and regulations governing medical staff activities
• Credentialing: Process for appointment and reappointment based on qualifications
• Privileging: Delineation of clinical privileges based on competency
• Peer Review: Ongoing professional practice evaluation (OPPE) and focused professional practice evaluation (FPPE)
• Leadership: Medical staff officers and committee structure
• History and Physical: Completed within 24 hours of admission or 30 days prior with update

Nursing Services (§482.23)

Hospitals must have an organized nursing service that provides 24-hour nursing services to patients.

Nursing Service Requirements

• Director of Nursing: Registered nurse responsible for nursing services operation
• Adequate Staffing: Sufficient number of licensed and non-licensed nursing personnel
• RN Supervision: Registered nurse supervision of all nursing care
• Care Planning: Nursing care plan developed for each patient
• Medication Administration: Drugs and biologicals prepared and administered per orders
• Blood Transfusion: Safe administration with patient identification and monitoring

Infection Prevention and Control (§482.42)

Hospitals must have an active program for the prevention, control, and investigation of infections and communicable diseases.

Infection Control Program Elements

• Infection Control Officer: Qualified individual(s) designated as infection control professional
• Infection Control Committee: Oversight of infection prevention activities
• Surveillance: System for identifying and investigating infections
• Policies and Procedures: Evidence-based infection prevention practices
• Antibiotic Stewardship: Program to promote appropriate antibiotic use
• Employee Health: Screening, immunizations, and work restrictions
• Reporting: Compliance with public health reporting requirements

Antibiotic Stewardship Requirements

Element	Requirement
Leadership Commitment	Governing body oversight, dedicated resources
Accountability	Physician leader for stewardship activities
Drug Expertise	Pharmacist with training in antimicrobial stewardship
Actions	Prospective audit, preauthorization, tracking
Tracking	Monitor prescribing, resistance patterns, outcomes
Reporting	Regular reports to medical staff and leadership
Education	Ongoing education for prescribers and staff

Quality Assessment and Performance Improvement (§482.21)

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

QAPI Program Requirements

• Program Scope: Include all departments, contracted services, and medical staff activities
• Data Collection: Collection and analysis of quality indicator data
• Performance Improvement Projects: Focused projects based on data analysis
• Governing Body Oversight: Regular reports to and approval by governing body
• Resource Allocation: Adequate resources for QAPI activities
• Integration: Coordination with patient safety and risk management programs

Required QAPI Elements

1. Indicators measuring patient health outcomes
2. Indicators measuring healthcare-associated infections
3. Indicators measuring adverse patient events including analysis of root causes
4. Actions to improve performance in identified areas
5. Tracking of improvement over time

Emergency Services (§482.55)

If the hospital offers emergency services, they must meet specific requirements for organization, staffing, and patient care.

Emergency Services Requirements

• Medical Staff Direction: Qualified physician responsible for emergency services
• Physician Availability: Physician available to emergency department 24/7
• Adequate Personnel: Qualified nursing and ancillary support staff
• Emergency Equipment: Appropriate equipment for emergency care
• EMTALA Compliance: Medical screening exam and stabilization requirements
• Integration: Coordination with hospital departments and services

Physical Environment (§482.41)

The hospital must be constructed, arranged, and maintained to ensure patient and staff safety. Compliance with NFPA 99 and building codes is essential for meeting physical environment requirements.

Physical Environment Standards

• Life Safety Code: Compliance with NFPA 101 Life Safety Code
• Healthcare Facilities Code: Compliance with NFPA 99
• Maintenance: Program for maintaining equipment and environment
• Emergency Preparedness: Facilities to support emergency operations
• Infection Control: Facilities designed to minimize infection transmission
• Utilities: Emergency power, medical gas systems, HVAC requirements

Survey and Enforcement

Survey Process

Survey Type	Purpose	Frequency
Initial Certification	New Medicare/Medicaid participation	One-time
Recertification	Ongoing compliance verification	Every 3-6 years
Validation	Verify deemed status compliance	5% sample annually
Complaint Investigation	Respond to complaints/incidents	As needed
Life Safety Code	Fire safety compliance	Every 3 years

Enforcement Actions

• Plan of Correction: Required response to cited deficiencies
• Civil Money Penalties: Financial penalties for non-compliance
• Denial of Payment: For new admissions until compliance achieved
• State Monitor: On-site monitoring for serious deficiencies
• Termination: Removal from Medicare/Medicaid program
• Immediate Jeopardy: Accelerated timeline for serious patient safety issues

Related Resources

For additional information on healthcare regulations and compliance, explore these resources:

• Compliance Standards Hub – Regulatory requirements and guidelines
• Joint Commission Accreditation Standards
• NFPA 99 Healthcare Facilities Code
• Infection Control and Prevention
• Knowledge Base Hub – Healthcare equipment guides