The Conditions of Participation are not a licensure track of their own. Medicare certification under 42 CFR Part 484 is a status the agency obtains after the State Survey Agency (or a CMS-approved Accrediting Organization — ACHC, CHAP, or The Joint Commission) inspects the agency, finds it in substantial compliance with every CoP and Standard in Part 484, and recommends certification to CMS through the State Agency. The certification is paired with a CMS Certification Number (CCN) and provider enrollment under CMS-855A. A state license — wherever the state requires one — is a separate filing under the state's Department of Health. In states like Ohio, Pennsylvania, California, and New York, the federal certification and the state license run in parallel through partly overlapping document sets surveyed by partly overlapping reviewers; missing either filing stalls the agency. For the state-by-state mechanics, our deep dives on Ohio ODH certification, Pennsylvania Chapter 601, California CDPH Form 5000-A, and New York Article 36 walk the state filings against the federal CoP backbone described here.

This article is for founders preparing for an initial certification survey, established operators preparing for a recertification or complaint survey, and compliance leads building or auditing a policy-and-procedure manual. For the broader question of whether a Medicare-certified track makes sense for the business model at all, start with our complete guide to starting a home health agency. For the payment side that turns Medicare certification into revenue, the PDGM walkthrough is the companion read.

How the CoPs Interact with State Licensure

The relationship is simple in concept and frequently muddled in practice. Section 1861(o) of the Social Security Act defines a "home health agency" as a public agency or private organization that is primarily engaged in providing skilled nursing services and other therapeutic services, and that meets the conditions of participation specified in the Act and in 42 CFR Part 484. To bill Medicare or Medicaid for skilled home health services, the agency has to be Medicare-certified — there is no state-only path to Medicare reimbursement. To furnish services to anyone in the state, the agency has to comply with whatever state licensure law the state has enacted, which in most states includes a state-issued home health license, a state survey, and a state-imposed scope of practice that may be narrower than the federal scope.

Surveyors typically work through both regimes in a single visit. In Ohio, the same Bureau of Long Term Care Quality survey team inspects the agency against 42 CFR Part 484 (on CMS's behalf, under the State Agency contract) and against OAC 3701-60 (the state license). In California, CDPH's Licensing & Certification district office runs the federal CoP survey using SOM Appendix B and the state inspection under 22 CCR Chapter 6 in the same on-site visit. In New York, the federal CoP survey for a CHHA is performed by the New York State Department of Health on CMS's behalf — but New York's LHCSA (the non-Medicare home care license) sits outside the federal CoP framework entirely and is governed only by 10 NYCRR Parts 765 and 766. Knowing which regime a particular requirement comes from is the first compliance skill an operator has to learn, because survey findings cite a specific regulatory section, and the corrective-action plan has to address the cited authority.

The post-2018 Part 484 is the version of the federal rule a 2026 applicant is operating against. CMS published a comprehensive rewrite of the CoPs in the January 13, 2017 final rule (82 FR 4504), with most provisions effective January 13, 2018, and a delayed effective date of July 13, 2018 for the QAPI and HHA training/competency provisions. The 2017 rewrite reorganized Part 484, replaced clinically prescriptive standards with patient-centered and outcome-based language, and introduced the integrated care planning and QAPI requirements that define the modern CoP framework. Subsequent annual Home Health Final Rules — through the CY 2026 rule effective January 1, 2026 — have layered payment, quality reporting, and incremental CoP refinements on top of the 2017 framework rather than rewriting it. The CoP structure described below is the 2017-as-amended version; older policy manuals predating the 2017 rule are out of date and need to be retired before a survey, not edited around.

Subpart A — General Provisions and Definitions (§§ 484.1, 484.2)

Subpart A is short but load-bearing. It establishes the basis and scope of the regulation and defines the terms every other Subpart uses.

§ 484.1 — Basis and scope. Part 484 is issued under sections 1861(o), 1891, and 1895 of the Social Security Act. The CoPs apply to all home health agencies as defined in § 484.2 — public, voluntary nonprofit, and proprietary alike. The Subpart also makes clear that the CoPs do not preempt state licensure laws that impose additional requirements, with limited exceptions where federal law specifically supersedes.

§ 484.2 — Definitions. Definitions an applicant has to internalize:

  • Branch office. A location or site from which an HHA provides services within a portion of the total geographic area served by the parent agency. The branch is part of the HHA, shares administration, supervision, and services with the parent, and is not separately certified. The geographic and oversight criteria CMS uses to determine whether a location is a branch (and not a separately certifiable site) are described in CMS's Survey & Certification policy and are surveyed against during the initial CoP survey.
  • Parent home health agency. The agency that develops and maintains administrative controls of subunits or branch offices.
  • Subunit. A semi-autonomous organization that serves patients in a geographic area different from that of the parent agency. A subunit, unlike a branch, must independently meet the CoPs and is separately certified — the distinction matters because a multi-state or multi-region operator that misclassifies a subunit as a branch is operating an unlicensed satellite.
  • Primary home health agency. The agency that is responsible for the services furnished to patients and for implementation of the plan of care.
  • Clinical note. A notation of a contact with the patient that is written and dated by a member of the health care team, and that describes signs and symptoms, treatment, drugs administered, the patient's reaction or response, and any changes in the physical or emotional condition.
  • Quality indicator. A specific, valid, and reliable measure of access, care outcomes, or satisfaction, or a measure of a process of care.
  • Representative. The patient's legal representative — guardian, person designated by the patient under a written advance directive, or, in the absence of those, the patient's family member or other person authorized under state law to make health care decisions for the patient.

The branch versus subunit distinction trips up applicants who plan multi-county or multi-region rollouts. If the satellite location operates with its own clinical leadership and serves a geographic area materially different from the parent's, CMS will treat it as a subunit, and the satellite needs its own CCN, its own certification survey, and its own enrollment. Plan the footprint accordingly before submitting the CMS-855A. The full enrollment walkthrough — 855A section by section, the 42 CFR Part 489 Subpart F surety bond, the § 489.28 capitalization rule, MAC jurisdictions, and state Medicaid enrollment — is in our Medicare and Medicaid payer enrollment reference.

Subpart B — Patient Care (§§ 484.40 through 484.80)

Subpart B is where the patient-facing CoPs live. The numbering jumps from 484.2 to 484.40 because the 2017 final rule eliminated the older Subpart B numbering and renumbered the substantive CoPs into the 484.40-series. Each CoP in Subpart B is structured as a Condition followed by one or more Standards; surveyors deficiency-tag at the Standard level, and a pattern of Standard-level deficiencies can be elevated to a Condition-level deficiency that triggers an enforcement remedy under the § 488 Subpart I framework.

§ 484.40 — Release of patient identifiable OASIS information. The HHA may not release patient-identifiable Outcome and Assessment Information Set (OASIS) data to the public; it must protect the data consistent with the Privacy Act and HIPAA. Internal use for QAPI and care planning is permitted; external release without authorization is not. The HIPAA framework that overlays this CoP — 45 CFR Parts 160 and 164, the Privacy Rule, the Security Rule, the § 164.504(e) Business Associate Agreement requirements, the 60-day breach notification clock, and the December 2024 OCR Security Rule NPRM — is described in our HIPAA compliance walkthrough for home health agencies.

§ 484.45 — Reporting OASIS information. The HHA must electronically report all OASIS data collected on each patient to CMS in accordance with CMS-published specifications. The current OASIS instrument as of the CY 2026 effective date is OASIS-E1, which incorporated standardized assessment data elements driven by the IMPACT Act and replaced OASIS-E effective January 1, 2025, with OASIS-E2 finalized for January 1, 2027 in the CY 2026 Home Health Final Rule; verify the version current at your survey date because CMS publishes version updates with each annual rule cycle. The data is the foundation of HH QRP reporting, the Home Health Value-Based Purchasing program, the Home Health Compare star ratings, and case-mix grouping under PDGM. For the section-by-section walkthrough of the OASIS-E1 instrument, the SOC/ROC/Recert/Transfer/Discharge timepoints, the iQIES submission process, and the HH QRP measures derived from OASIS data, see our OASIS-E documentation guide; for the Care Compare star calculation that consumes the OASIS data, including the measure set, the calculation methodology, the HHCAHPS administration rules, and the operational moves that lift a 3-star agency to 4 stars, see our Home Health Compare star ratings guide.

§ 484.50 — Condition of participation: Patient rights. The patient rights CoP is the most frequently surveyed CoP in initial certification. The agency must provide the patient with a verbal notice of rights in the patient's primary language, in the form and manner the patient understands, no later than the second visit. A written notice of rights must be provided in advance of furnishing patient care, with information including the right to participate in the plan of care, the right to receive all services in the plan, the right to confidentiality, the right to be advised of the agency's policies and procedures for receiving complaints, the toll-free state Home Health Hotline phone number and hours of operation, the contact information for the protection-and-advocacy network, and the OASIS privacy notice. The patient or representative must sign and date the receipt of the notice; the agency retains the signed acknowledgment in the clinical record. Standards within § 484.50 also cover transfer and discharge, the patient's right to access their medical record, and the right to be free from mistreatment, neglect, and verbal, mental, sexual, and physical abuse.

§ 484.55 — Condition of participation: Comprehensive assessment of patients. Each patient must receive a patient-specific comprehensive assessment that accurately reflects the patient's current health, psychosocial, functional, and cognitive status; the patient's strengths, goals, and care preferences; the patient's continuing need for home care; the patient's medical, nursing, rehabilitative, social, and discharge planning needs; a review of all medications the patient is currently using; the patient's primary caregiver, if any; and the patient's representative, if any. The initial assessment visit must be completed within 48 hours of the referral, within 48 hours of the patient's return home, or on the physician-ordered start-of-care date. The comprehensive assessment must be completed within five calendar days after the start of care. Reassessment must occur at least every 60 days, in conjunction with significant change in condition, and at discharge. OASIS data collection is required for skilled Medicare and Medicaid patients aged 18 and older, excluding maternity patients, and is integrated into the comprehensive assessment.

§ 484.58 — Condition of participation: Discharge planning. The HHA must develop and implement an effective discharge planning process. The discharge plan must be patient-specific, address goals of care and treatment preferences, and include a discharge summary sent to the receiving facility or practitioner within prescribed timeframes (within two business days of a planned discharge or transfer, and within two business days of becoming aware of an unplanned discharge). The IMPACT Act compliance burden — sending the discharge summary within the post-acute care continuum — sits inside this CoP.

§ 484.60 — Condition of participation: Care planning, coordination of services, and quality of care. Each patient must be accepted for treatment on the reasonable expectation that the HHA can meet the patient's medical, nursing, rehabilitative, and social needs in their place of residence. The plan of care, established and periodically reviewed by a doctor of medicine, osteopathy, or podiatry — or, since the CARES Act of 2020, a nurse practitioner, clinical nurse specialist, or physician assistant working in accordance with state law — must specify the care and services necessary to meet the patient-specific needs identified in the comprehensive assessment. The plan must be reviewed and revised by the responsible practitioner and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start-of-care date. The agency is responsible for coordination of care, communication of changes, and ensuring that all members of the care team are informed of the patient's plan of care.

§ 484.65 — Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The Standards within § 484.65 require the program to use quality indicator data, including measures derived from OASIS, to design and implement performance improvement projects; to focus on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions, and the prevention and reduction of medical errors; to address adverse patient events; and to take actions aimed at performance improvement and to track the actions taken to ensure that improvements are sustained. The governing body is responsible for ensuring that an ongoing QAPI program is defined, implemented, maintained, and evaluated annually. QAPI is the most frequently elevated Standard-to-Condition-level deficiency in initial certification surveys when the agency cannot produce documentation of governing-body oversight, measurable indicators, or completed performance improvement projects.

§ 484.70 — Condition of participation: Infection prevention and control. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. The agency must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's QAPI program. Patients, caregivers, and staff must be educated on current infection prevention and control practices. The COVID-19 vaccination education and offer requirement for HHA staff, added through interim final rules and codified at the § 484.70 Standard level, sits inside this CoP and remains in effect through the CY 2026 rule.

§ 484.75 — Condition of participation: Skilled professional services. Skilled professional services — skilled nursing, physical therapy, speech-language pathology, occupational therapy, and medical social work — must be authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified in § 484.115 and who practice according to the HHA's policies and procedures. Each skilled professional is responsible for providing services in accordance with the plan of care, providing ongoing interdisciplinary assessment, developing and evaluating the plan of care in partnership with the patient and representative, providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care, patient and caregiver education, communication with the physician, preparation of clinical and progress notes, and participation in the HHA's QAPI program.

§ 484.80 — Condition of participation: Home health aide services. The CoP that drives the largest single workforce-compliance burden in most agencies. Standards within § 484.80 cover home health aide qualifications (the federal 75-hour minimum training program with at least 16 hours of supervised practical training, the competency evaluation, and the annual 12-hour in-service requirement); placement on a state's home health aide registry where applicable; the requirement that aide services be furnished only by an aide who has successfully completed a training and competency evaluation program that meets the requirements of § 484.80(b) and (c) and that is approved by CMS or the state; supervision by a registered nurse at least every 14 days when the aide is furnishing services to a skilled care patient (and at least every 60 days for personal care services in the absence of skilled services); and supervision documentation. The 2017 final rule changed the supervisory cadence from 14 days while the patient is on skilled service to a 14-day on-site visit by an RN, with off-cycle supervisory visits required when an aide-only patient is identified. The aide registry verification step trips up new agencies that hire an aide without confirming current registry status — an aide who has lapsed off the state registry is not a qualified home health aide, and visits furnished by that aide during the lapsed period are non-compliant.

Subpart C — Organizational Environment (§§ 484.100 through 484.115)

Subpart C is the institutional and infrastructure CoP set. Where Subpart B governs the patient relationship, Subpart C governs the organization that wraps around it.

§ 484.100 — Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA must operate and provide services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. Standards include licensure and licensing of staff (every staff member furnishing services that require licensure must be licensed, certified, or registered under applicable laws), and the agency's own licensure where state law requires it. The Standard is the regulatory hook that pulls state licensure into federal CoP compliance — an agency operating without a required state license is non-compliant with § 484.100 even if every other CoP is satisfied.

§ 484.102 — Condition of participation: Emergency preparedness. Cross-referenced from the all-provider emergency preparedness rule at 42 CFR 482 and 484. Each HHA must develop and maintain an emergency preparedness program that meets the requirements of paragraphs (a) through (e) of the cross-referenced rule, including a written risk assessment using an all-hazards approach, written policies and procedures based on the risk assessment, a written communication plan that complies with federal and state law, and a training and testing program that includes initial training of all new and existing staff at hire and annually thereafter, and the conduct of two exercises per year (at least one full-scale community-based exercise, with the second being either a full-scale exercise or a tabletop exercise). The most recent annual exercise documentation must be in the file at the time of the certification survey.

§ 484.105 — Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity for each patient. Standards include:

  • Governing body. A governing body, or designated persons functioning as a governing body, that assumes full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget, and the agency's quality assessment and performance improvement program.
  • Administrator. A qualified administrator who is appointed by and reports to the governing body. The administrator is responsible for all day-to-day operations, including ensuring the availability of services, administering the budget, ensuring compliance with federal and state laws, and ensuring that a clinical manager is available during operating hours.
  • Clinical manager. One or more qualified individuals who provide oversight of all patient care services and personnel. The clinical manager is responsible for making patient and personnel assignments, coordinating patient care, coordinating referrals, ensuring that patient needs are continually assessed, and ensuring the development, implementation, and updates of the individualized plan of care. The clinical manager role is the single most consequential clinical hire after the administrator.
  • Parent-branch and parent-subunit responsibilities. The parent HHA is responsible for the actions of its branches and subunits and must conduct ongoing oversight to ensure CoP compliance.
  • Services furnished. The HHA must furnish skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, occupational therapy, medical social services, or home health aide services) directly through agency staff. Other services may be furnished under arrangement, but the agency must provide at least one service directly by employees of the HHA.
  • Outpatient physical therapy or speech-language pathology services. If the HHA furnishes outpatient physical therapy or speech-language pathology services, those services must meet the additional CoPs at § 485.711 through § 485.725.

§ 484.110 — Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient that is accepted by the HHA and receiving home health services. Standards address record content (the comprehensive assessment, the plan of care, all interventions, all progress notes, contact information for the patient, the patient's representative, the patient's primary caregiver, and the patient's primary care practitioner, and discharge or transfer summary documentation), authentication (every entry signed and dated by the practitioner who authored it), retention (at least five years after the discharge of the patient unless state law stipulates a longer period), and protection from loss, damage, and unauthorized use. The clinical record requirements increasingly intersect with Office of the National Coordinator interoperability rules and the agency's electronic health record system; the CoP itself is technology-agnostic but the operational reality is that the clinical record lives in the EHR and the EHR's data export, audit log, and access control configurations are the artifacts a surveyor reviews.

§ 484.115 — Condition of participation: Personnel qualifications. The omnibus qualifications CoP. The Standards specify minimum qualifications for the administrator (since July 13, 2018, an administrator who is licensed or registered in accordance with state laws and regulations governing administrators of HHAs, with a degree or training and experience requirements specified in the Standard), the audiologist, the clinical manager, the home health aide (the federal 75-hour training program and competency evaluation), the licensed practical or vocational nurse, the medical social worker, the occupational therapist and assistant, the physical therapist and assistant, the registered nurse, and the speech-language pathologist. The Standard for each role specifies the credential, the supervisory or training pathway, and the documentation the personnel file must contain.

Subparts E, F, and G — Payment, Home Infusion Therapy, and HIT Suppliers

Beyond the operational CoPs in Subparts A through C, Part 484 also contains the payment regulations and the home infusion therapy provider framework that operators have to be aware of.

Subpart E — Prospective Payment System for Home Health Agencies (§§ 484.200 through 484.245). The implementing regulations for the home health prospective payment system (HH PPS), including the case-mix methodology, the wage index adjustment, the labor-related share, the LUPA (low-utilization payment adjustment) thresholds, the outlier methodology, and the conditions for payment. Since January 1, 2020, HH PPS has operated under the Patient-Driven Groupings Model (PDGM), which moved from a 60-day episode and 120-visit therapy-threshold model to a 30-day payment period using clinical grouping, comorbidity adjustment, functional impairment, and admission source. The CY 2025 and CY 2026 rules continued the multi-year process of applying the budget-neutrality "behavioral assumption" recalibration that CMS uses to keep PDGM aggregate payments equivalent to what the prior 60-day system would have paid. For operators, the most important Subpart E details are in our PDGM walkthrough; for purposes of CoP compliance, Subpart E sits in the background as the rules that determine what the agency is paid for the services Subparts B and C require it to deliver.

Subpart F — Covered Items and Services for Home Infusion Therapy. Effective January 1, 2021, Subpart F implements the home infusion therapy benefit established by the 21st Century Cures Act. The subpart specifies which infusion drugs are covered and the conditions under which professional services for home infusion therapy are payable. Home infusion therapy is paid as a Part B benefit and is a separate benefit from the home health benefit, even though it is often furnished in the same household by overlapping clinicians.

Subpart G — Conditions of Participation for Home Infusion Therapy Suppliers. The CoPs that apply to home infusion therapy suppliers — a separate Medicare-enrolled supplier type (CMS-855B), distinct from the home health agency, that must accredit through a CMS-approved AO. An HHA may also enroll separately as an HIT supplier, but the two enrollments are separate filings and are surveyed against separate rules.

The CY 2025 and CY 2026 Home Health Final Rules

The annual Home Health Final Rule cycle is the principal mechanism CMS uses to update PDGM, refine the HH QRP, and incrementally amend the CoPs. The two most recent rules a 2026 operator has to be current on:

CY 2025 Home Health Final Rule. Published in the Federal Register on November 7, 2024 (89 FR 89844), with most provisions effective January 1, 2025. The rule applied the next phase of the permanent behavioral adjustment to PDGM base rates, updated the LUPA thresholds and case-mix weights, refined the 30-day payment rate calculation, and made HH QRP updates including the addition of four new measures (the Discharge Function Score, the COVID-19 Vaccination Coverage among Healthcare Personnel measure, and the two Transfer of Health Information measures) and the removal of certain OASIS-based measures. The rule also finalized policies on home health value-based purchasing (HHVBP) and updated the HHCAHPS survey methodology. CoP-side changes in the CY 2025 rule were modest, with refinements to the patient rights notice and to the QAPI documentation standards rather than a structural rewrite.

CY 2026 Home Health Final Rule. Published in the Federal Register in November 2025 with provisions effective January 1, 2026. Continued the multi-year permanent and temporary behavioral adjustment recalibration under PDGM, updated the wage index and the labor-related share, and made further HH QRP refinements including measure-set revisions, the IMPACT Act-driven assessment data element updates, and the OASIS instrument updates. Operators should read the rule against their existing P&P manual sections on patient rights, QAPI, and HH QRP reporting and update language to match the rule's effective-date provisions. Because the CY 2026 rule's full text and corrections cycle continue to evolve through publication, every operator should verify the rule current on the agency's survey date directly from the Federal Register.

The cadence to plan against: the Proposed Rule typically publishes in late June, the public comment window runs through August or early September, the Final Rule publishes in late October or early November, and the rule takes effect on January 1 of the following year. A compliance lead who reads only the final rule each November and ignores the summer proposed-rule comment window has limited ability to influence the Standard-level changes that show up in the final rule. NAHC — now operating as part of the National Alliance for Care at Home following the NAHC/NHPCO merger — and state home care associations submit consolidated comments each cycle that sophisticated operators read alongside their own.

Home Health Quality Reporting Program (HH QRP)

The HH QRP is the federal pay-for-reporting program established under section 1895(b)(3)(B)(v) of the Social Security Act. An HHA that does not submit required quality data is subject to a 2 percentage point reduction in the annual market basket update. The HH QRP measure set as of the CY 2026 rule includes the following categories:

OASIS-based measures. Process and outcome measures derived from OASIS data, including:

  • Improvement in Ambulation/Locomotion
  • Improvement in Bathing
  • Improvement in Bed Transferring
  • Improvement in Management of Oral Medications
  • Improvement in Dyspnea
  • Discharge Function Score (added effective FY 2025)
  • Application of Functional Assessment / Care Plan
  • Drug Regimen Review with Follow-up for Identified Issues

Claims-based measures. Measures calculated from Medicare claims data:

  • Acute Care Hospitalization During the First 60 Days of Home Health
  • Emergency Department Use Without Hospitalization
  • Discharge to Community — Post-Acute Care
  • Potentially Preventable 30-Day Post-Discharge Readmission
  • Total Estimated Medicare Spending Per Beneficiary

Patient experience measures (HHCAHPS). Composite scores from the Home Health Consumer Assessment of Healthcare Providers and Systems survey, including Care of Patients, Communication Between Providers and Patients, Specific Care Issues, and the Overall Rating of Care.

Standardized assessment data elements. The IMPACT Act-driven cross-setting standardized patient assessment data elements covering cognitive function, special services, treatments, interventions, medical conditions, comorbidities, and impairments, and the social determinants of health (SDOH) elements. The CY 2025 and CY 2026 rules continued the phased rollout of SDOH-related elements.

COVID-19 Vaccination Coverage among HCP. The structural measure that requires HHAs to report the share of staff who received a complete COVID-19 vaccination series for the relevant reporting period.

Transfer of Health Information measures. The TOH-Provider and TOH-Patient measures track whether a current reconciled medication list is provided at transfer or discharge to a subsequent provider and to the patient, family, or caregiver, respectively.

Each measure has a specific reporting threshold, a data submission deadline, and a public reporting timeline that flows through Care Compare. Verify the current measure set on the CMS HH QRP page at your reporting deadline, because measures are added and retired with each annual rule cycle and missing a single submission deadline costs the agency 2 points off the next year's market basket update.

State Operations Manual Appendix B — What Surveyors Actually Use

The CoPs are the regulation. The State Operations Manual Appendix B is the survey instrument the State Agency or AO actually walks through when on-site. Appendix B — "Guidance to Surveyors: Home Health Agencies" — sits inside CMS Pub. 100-07, the State Operations Manual, and is updated through periodic transmittals as the underlying CoPs change. Surveyors use Appendix B to map each Standard to a set of probes, observations, record reviews, and interviews. The survey result — the CMS-2567 Statement of Deficiencies — cites the specific § and Standard, references the Appendix B interpretive guidance, and assigns a deficiency a Scope and Severity rating from A (isolated, no actual harm with potential for minimal harm) through L (widespread, immediate jeopardy to patient health or safety). The Scope and Severity grid is the same one used in nursing home and ESRD surveys and is the trigger for the § 488 Subpart I enforcement remedies that range from directed plans of correction to termination from the Medicare program.

Appendix B is publicly available, and operators should read it as if it were the rule, because the survey writes against it. Agencies that build their P&P manual against the regulation alone — without crossing each policy to the corresponding Appendix B probe — frequently produce policies that satisfy the Standard but fail the surveyor's review path. The most useful preparation a new HHA can do before its initial certification survey is to walk every Appendix B probe against the corresponding policy, the corresponding clinical record example, and the corresponding personnel file example, and confirm that a surveyor opening to that page would find the artifact the probe asks for.

The initial certification survey is conducted unannounced after the agency has admitted the minimum number of patients required by CMS's tasking guidance (typically the agency must have furnished services to a minimum number of skilled patients before the State Agency will schedule the survey, with the precise threshold and timing described in current CMS Survey & Certification policy). The recertification survey cycle for Medicare-certified HHAs runs every 36 months under the standard cycle, with shorter cycles for agencies with prior condition-level deficiencies or with complaint-driven findings.

Common Initial-Survey and Recertification Deficiencies

Patterns CMS Quality, Safety, and Oversight reports and State Agency aggregate deficiency reports show recurring across the country. The clusters below are summarized here; for the deficiency-by-deficiency walk with the Appendix B probe path, the operational fix, the mock-survey methodology, the Day-1 documentation set, and the Plan of Correction structure CMS will accept, see our Home Health Survey Prep — Top 10 G-Tag Deficiencies reference.

§ 484.50 — Patient rights documentation gaps. The single most cited CoP. Agencies miss the timing of the verbal notice (must be no later than the second visit), the patient signature on the written rights acknowledgment, the OASIS privacy notice, or the state Home Health Hotline number. The fix is a one-page intake packet structured against § 484.50(c) standard-by-standard with the clinical record cross-reference baked in.

§ 484.55 — Comprehensive assessment timing. The five-day completion clock, the 48-hour initial assessment visit clock, and the 60-day reassessment cadence are all specific timing rules and all frequently slip. The fix is an EHR-based start-of-care workflow that surfaces the deadline and blocks chart closure until the timely assessment is on the record.

§ 484.60 — Plan of care content and signature. Plans of care that lack signed orders from the responsible practitioner, that omit specific frequency-and-duration language for each discipline, or that fail to reflect changes from the most recent reassessment. Pair the EHR plan-of-care template with a pre-signature checklist against § 484.60(a) and (b) standard elements.

§ 484.65 — QAPI documentation. Surveyors look for evidence that the QAPI program is operating: a written program description approved by the governing body, a current set of measurable indicators tied to OASIS and claims data, at least one performance improvement project (PIP) in process, evidence of governing-body review, and minutes documenting the annual evaluation. New agencies that pass the regulation but cannot produce the artifacts get tagged at Standard level, and patterns of QAPI deficiencies elevate fast to Condition level.

§ 484.70 — Infection control surveillance and education documentation. Aggregate infection logs, patient and caregiver education records, staff competency on standard precautions, and the COVID-19 vaccination education and offer documentation are the artifacts an Appendix B reviewer expects. Many agencies have the practice and lack the documentation; the documentation is what the survey scores.

§ 484.80 — Aide supervision cadence and training file. The 14-day RN supervisory visit when a skilled patient is on aide service, the on-site RN supervisory visit at least every 60 days for aide-only patients (with the post-2017 supervisory rules carefully read), the aide's annual 12-hour in-service total, and the personnel file documentation of the 75-hour training and competency evaluation program with skills checklist completion. The aide registry verification step is the most easily missed pre-hire control and the most easily fixed.

§ 484.102 — Emergency preparedness training and exercise records. The annual training of all staff, the two annual exercises (one full-scale or community-based, plus a tabletop or second exercise), and the post-exercise after-action report. Many agencies run the exercises and never produce the after-action report; surveyors deficiency-tag the missing documentation.

§ 484.105 — Governing body minutes and clinical manager continuity. Governing body minutes that reflect oversight of QAPI, budget, and compliance; a designated clinical manager whose tenure is documented in the personnel file; and continuity arrangements when the clinical manager is unavailable. Vacancies in the clinical manager role that are not bridged in the file are direct survey findings.

§ 484.110 — Clinical record retention and authentication. Five-year retention with a documented backup-and-recovery process, signed and dated entries from each clinician, and an EHR audit-log capability that the surveyor can request. New agencies running paper records or hybrid systems frequently miss the authentication and retention rules; mature agencies on a single EHR rarely do.

§ 484.115 — Personnel file completeness. The credential, the license, the competency evaluation (for aides), the orientation, the annual in-service hours (where applicable), the health screening, the criminal background check (where required by state law), and the supervision documentation. Missing items in even one personnel file generate a Standard-level finding; patterns across files elevate. The federal-plus-state background screening stack the personnel file is supposed to evidence — OIG LEIE, SAM.gov, State Nurse Aide Registry verification under 42 CFR § 483.156, the state criminal-history and abuse-registry layers, and the FCRA disclosure-and-authorization wrapper — is walked in our background check compliance reference.

P&P Manual Structure That Maps to Every Subpart

The most efficient policy-and-procedure manual is structured to mirror the surveyor's review path: organized by CoP §, cross-referenced to Appendix B probes, and tagged to the artifact (clinical record, personnel file, governance file) that demonstrates compliance. A workable section structure:

  • Section 1 — General provisions. Mission, scope, governance structure, and the agency's organizational chart. Maps to § 484.1 and the governing body Standard at § 484.105.
  • Section 2 — Definitions. The agency's working definitions, aligned to § 484.2, plus state-specific definitions where state law overlays.
  • Section 3 — Patient rights and intake. The notice-of-rights workflow, the patient bill of rights, the OASIS privacy notice, the state hotline number, the patient and representative acknowledgment, and the protection-and-advocacy contact. Maps to § 484.50.
  • Section 4 — Comprehensive assessment. The intake assessment workflow, the OASIS data collection process, the reassessment cadence, and the medication review process. Maps to § 484.55.
  • Section 5 — Plan of care and care coordination. The plan-of-care template, the practitioner ordering process, the 60-day review, the case conference cadence, and the transfer/discharge summary process. Maps to § 484.60 and § 484.58.
  • Section 6 — QAPI program. The written program description, the indicator set, the PIP roster, the governing-body review schedule, and the annual evaluation template. Maps to § 484.65.
  • Section 7 — Infection prevention and control. The standard precautions policy, the surveillance and reporting workflow, the patient and staff education materials, and the COVID-19 vaccination education and offer policy. Maps to § 484.70.
  • Section 8 — Skilled professional services. Discipline-specific service descriptions, supervision policies, and documentation expectations for nursing, PT, OT, SLP, and MSW. Maps to § 484.75.
  • Section 9 — Home health aide services. The aide training and competency evaluation program, the aide registry verification step, the supervisory visit cadence, and the in-service training calendar. Maps to § 484.80.
  • Section 10 — Compliance with laws. State licensure status, professional licensure verification, and the agency's compliance program. Maps to § 484.100.
  • Section 11 — Emergency preparedness. The risk assessment, the emergency plan, the communication plan, the training program, and the exercise schedule with after-action report templates. Maps to § 484.102.
  • Section 12 — Organization and administration. The governing body charter, the administrator job description, the clinical manager job description, the parent-branch oversight workflow, and the services-furnished policy. Maps to § 484.105.
  • Section 13 — Clinical records. The record content rules, the authentication policy, the retention schedule, and the EHR security and audit-log configuration. Maps to § 484.110.
  • Section 14 — Personnel qualifications. Per-role qualification grids, the personnel file content list, the orientation curriculum, and the annual evaluation cycle. Maps to § 484.115.
  • Section 15 — HH QRP and OASIS. The OASIS submission workflow, the HH QRP measure roster, the HHCAHPS vendor relationship, and the data integrity controls.
  • Section 16 — Billing and corporate compliance. The Medicare and Medicaid claims process, the documentation-to-billing reconciliation, the False Claims Act compliance program, and the Stark Law / Anti-Kickback Statute training.

The most efficient version of this manual is one document with the regulatory citation in the section header and the Appendix B probe number in the margin. Surveyors who can match a probe to a section in seconds run faster surveys, and faster surveys with traceable artifacts are the surveys that close cleanly.

When the CoPs Apply — and When They Do Not

One source of confusion in the home care market is the assumption that every "home health" or "home care" agency operates under the CoPs. They do not.

Medicare-certified HHAs. Subject to the full Part 484 framework, surveyed by the State Agency or AO under SOM Appendix B, paid under PDGM. The CoPs apply to every patient the agency serves, not only Medicare patients — once the agency is certified, the operating standards apply uniformly.

State-licensed home care agencies that are not Medicare-certified. Operate under state licensure rules only. New York's Licensed Home Care Services Agency, Pennsylvania's Chapter 611 home care agency, Texas's Personal Assistance Services HCSSA category, and California's Home Care Organization under the Home Care Services Consumer Protection Act are examples. Part 484 does not apply to these agencies; the state rules do. A state-licensed agency that wants to bill Medicare must add a Medicare certification on top of the state license, which adds the full Part 484 compliance burden.

Hospice agencies. Operate under a separate CoP framework at 42 CFR Part 418 with its own SOM Appendix M survey instrument. A hospice that wants to operate as both hospice and home health needs two separate Medicare enrollments and complies with both Part 418 and Part 484.

Home infusion therapy suppliers. Operate under the Subpart G CoPs at § 484.300 et seq. with their own AO accreditation. Distinct enrollment from the home health agency.

Founders evaluating which model fits the business plan should make this choice before submitting any application. The CoPs are a substantially heavier compliance load than most state-licensure-only regimes, and the trade-off is access to Medicare reimbursement and to the broader payer market that follows Medicare certification. For agencies that intend to serve only private-pay clients or only Medicaid HCBS waiver patients, the state-licensure-only path is often the right answer; for agencies that intend to bill Medicare for skilled home health, the Part 484 burden is unavoidable.

Authoritative Sources

The primary regulatory and official sources every Medicare-certified HHA should bookmark and check at each survey cycle:

Verify the version current at your agency's survey or filing date. CMS updates eCFR continuously, transmittals against the State Operations Manual appear on a rolling cadence, and the annual Final Rule is the principal mechanism through which payment rates and HH QRP measures change. A compliance lead who reads only the regulation as it existed at the date of certification and does not track annual updates is operating against a stale rulebook.

The Bottom Line

The CMS Conditions of Participation are the federal layer that overlays every state home health regime. Subpart A defines the entity, Subpart B governs the patient relationship and the QAPI program, Subpart C governs the organization and the personnel, and Subparts E through G govern payment and the parallel home infusion therapy supplier framework. The annual Home Health Final Rule cycle adjusts payment, measures, and the occasional Standard, but the structure of the CoP framework is stable and a P&P manual built against the post-2018 Part 484 numbering is durable.

Operators who succeed at the CoPs treat Part 484 as the survey rulebook, walk every Appendix B probe against their own policies and artifacts, build a QAPI program that produces governing-body-reviewed evidence, document everything they already do for infection control and emergency preparedness rather than discovering at survey that the practice is in place but the documentation is not, and verify HHA training and aide registry status before the first home visit. Operators who stumble are usually the ones who treated the CoPs as a checklist for the initial survey rather than the operating framework, and who let documentation drift between the certification survey and the first recertification cycle.

If you want a structured way to assess your CoP readiness against the same logic a State Survey Agency or AO surveyor uses, start with our compliance readiness assessment. It walks the same Subpart B and Subpart C Standards a surveyor would, scores your gaps, and produces an action list ordered by deficiency-tag risk. For the day-by-day operational build between state license issuance and a clean initial certification survey — staff hiring sequence, P&P implementation, CMS-855A timing, the first patient admission, the state and Medicare survey windows, and the six-month operating runway every new agency has to plan against — see our First 90 Days operational playbook. For the upstream model decision — whether the agency should pursue Medicare-certified skilled home health under Part 484 at all, versus a non-medical home care license that operates outside the federal CoP framework — see our skilled vs non-medical disambiguation and our model comparison guide. For the state-specific overlays that sit on top of Part 484, our deep dives on California CDPH licensure, Texas HCSSA licensure, Florida Rule 59A-8, Ohio ODH certification, Pennsylvania Chapter 601, and New York Article 36 describe how the federal rule and the state rule are surveyed in practice. Once your packet is in and the CoP survey is on the calendar, the workforce side begins — and our resources on reducing caregiver turnover, becoming an employer of choice, and the credentialing compliance checklist describe the post-certification operating reality every Medicare-certified HHA inherits.