42 CFR Part 484 — Home Health Services

PART 484—HOME HEALTH SERVICES Authority: 42 U.S.C. 1302 and 1395hh. Source: 54 FR 33367, Aug. 14, 1989, unless otherwise noted. Subpart A—General Provisions Source: 82 FR 4578, Jan. 13, 2017, unless otherwise noted. § 484.1 Basis and scope. (a) Basis. (1) Sections 1861(o) and 1891 of the Act, which establish the conditions that an HHA must meet in order to participate in the Medicare program and which, along with the additional requirements set forth in this part, are considered necessary to ensure the health and safety of patients; and (2) Section 1861(z) of the Act, which specifies the institutional planning standards that HHAs must meet. (b) Scope. § 484.2 Definitions. As used in subparts A, B, and C, of this part— Allowed practitioner Branch office Clinical note Clinical nurse specialist In advance Nurse practitioner Parent home health agency Physician Physician assistant Primary home health agency Proprietary agency Pseudo-patient Public agency Quality indicator Representative Simulation Subdivision Summary report Supervised practical training Verbal order [82 FR 4578, Jan. 13, 2017, as amended at 84 FR 51825, Sept. 30, 2019; 85 FR 27627, May 8, 2020] Subpart B—Patient Care Source: 82 FR 4578, Jan. 13, 2017, unless otherwise noted. § 484.40 Condition of participation: Release of patient identifiable OASIS information. The HHA and agent acting on behalf of the HHA in accordance with a written contract must ensure the confidentiality of all patient identifiable information contained in the clinical record, including OASIS data, and may not release patient identifiable OASIS information to the public. § 484.45 Condition of participation: Reporting OASIS information. HHAs must electronically report all OASIS data collected in accordance with § 484.55. (a) Standard: Encoding and transmitting OASIS data. (b) Standard: Accuracy of encoded OASIS data. (c) Standard: Transmittal of OASIS data. (1) For all completed assessments, transmit OASIS data in a format that meets the requirements of paragraph (d) of this section. (2) Transmit data using electronic communications software that complies with the Federal Information Processing Standard (FIPS 140-2, issued May 25, 2001) from the HHA or the HHA contractor to the CMS collection site. (3) Transmit data that includes the CMS-assigned branch identification number, as applicable. (d) Standard: Data Format. [82 FR 4578, Jan. 13, 2017, as amended at 85 FR 70356, Nov. 4, 2020; 90 FR 55619, Dec. 2, 2025] § 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. (a) Standard: Notice of rights. (1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. (iii) An OASIS privacy notice to all patients for whom the OASIS data is collected. (2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. (3) [Reserved] (4) Provide written notice of the patient's rights and responsibilities under this rule and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit. (b) Standard: Exercise of rights. (2) If a state court has not adjudged a patient to lack legal capacity to make health care decisions as defined by state law, the patient's representative may exercise the patient's rights. (3) If a patient has been adjudged to lack legal capacity to make health care decisions under state law by a court of proper jurisdiction, the patient may exercise his or her rights to the extent allowed by court order. (c) Standard: Rights of the patient. (1) Have his or her property and person treated with respect; (2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; (3) Make complaints to the HHA regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA; (4) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to— (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. (5) Receive all services outlined in the plan of care. (6) Have a confidential clinical record. Access to or release of patient information and clinical records is permitted in accordance with 45 CFR parts 160 and 164. (7) Be advised, orally and in writing, of— (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). (8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. (9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. (10) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging, (ii) Center for Independent Living, (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. (11) Be free from any discrimination or reprisal for exercising his or her rights or for voicing grievances to the HHA or an outside entity. (12) Be informed of the right to access auxiliary aids and language services as described in paragraph (f) of this section, and how to access these services. (d) Standard: Transfer and discharge. (1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; (2) The patient or payer will no longer pay for the services provided by the HHA; (3) The transfer or discharge is appropriate because the physician or allowed practitioner who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with § 484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner who is responsible for the home health plan of care agree that the patient no longer needs the HHA's services; (4) The patient refuses services, or elects to be transferred or discharged; (5) The HHA determines, under a policy set by the HHA for the purpose of addressing discharge for cause that meets the requirements of paragraphs (d)(5)(i) through (d)(5)(iii) of this section, that the patient's (or other persons in the patient's home) behavior is disruptive, abusive, or uncooperative to the extent that delivery of care to the patient or the ability of the HHA to operate effectively is seriously impaired. The HHA must do the following before it discharges a patient for cause: (i) Advise the patient, the representative (if any), the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is being considered; (ii) Make efforts to resolve the problem(s) presented by the patient's behavior, the behavior of other persons in the patient's home, or situation; (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and (iv) Document the problem(s) and efforts made to resolve the problem(s), and enter this documentation into its clinical records; (6) The patient dies; or (7) The HHA ceases to operate. (e) Standard: Investigation of complaints. (i) Investigate complaints made by a patient, the patient's representative (if any), and the patient's caregivers and family, including, but not limited to, the following topics: (A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; and (B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. (ii) Document both the existence of the complaint and the resolution of the complaint; and (iii) Take action to prevent further potential violations, including retaliation, while the complaint is being investigated. (2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. (f) Standard: Accessibility. (1) Persons with disabilities, including accessible Web sites and the provision of auxiliary aids and services at no cost to the individual in accordance with the Americans with Disabilities Act and Section 504 of the Rehabilitation Act. (2) Persons with limited English proficiency through the provision of language services at no cost to the individual, including oral interpretation and written translations. [82 FR 4578, Jan. 13, 2017, as amended at 84 FR 51825, Sept. 30, 2019; 85 FR 27628, May 8, 2020; 86 FR 62421, Nov. 9, 2021] § 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. (a) Standard: Initial assessment visit. (2) When rehabilitation therapy service (speech language pathology, physical therapy, or occupational therapy) is the only service ordered by the physician or allowed practitioner who is responsible for the home health plan of care, the initial assessment visit may be made by the appropriate rehabilitation skilled professional. For Medicare patients, an occupational therapist may complete the initial assessment when occupational therapy is ordered with another qualifying rehabilitation therapy service (speech-language pathology or physical therapy) that establishes program eligibility. (b) Standard: Completion of the comprehensive assessment. (2) Except as provided in paragraph (b)(3) of this section, a registered nurse must complete the comprehensive assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. (3) When physical therapy, speech-language pathology, or occupational therapy is the only service ordered by the physician or allowed practitioner, a physical therapist, speech-language pathologist, or occupational therapist may complete the comprehensive assessment, and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. For Medicare patients, the occupational therapist may complete the comprehensive assessment when occupational therapy is ordered with another qualifying rehabilitation therapy service (speech-language pathology or physical therapy) that establishes program eligibility. (c) Standard: Content of the comprehensive assessment. (1) The patient's current health, psychosocial, functional, and cognitive status; (2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; (3) The patient's continuing need for home care; (4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; (5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. (6) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; (7) The patient's representative (if any); (8) Incorporation of the current version of the Outcome and Assessment Information Set (OASIS) items, using the language and groupings of the OASIS items, as specified by the Secretary. The OASIS data items determined by the Secretary must include: clinical record items, demographics and patient history, living arrangements, supportive assistance, sensory status, integumentary status, respiratory status, elimination status, neuro/emotional/behavioral status, activities of daily living, medications, equipment management, emergent care, and data items collected at inpatient facility admission or discharge only. (d) Standard: Update of the comprehensive assessment. (1) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a— (i) Elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. (2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner-ordered resumption date; (3) At discharge. [82 FR 4578, Jan. 13, 2017, as amended at 85 FR 27628, May 8, 2020; 86 FR 62421, Nov. 9, 2021; 90 FR 55619, Dec. 2, 2025] § 484.58 Condition of participation: Discharge planning. (a) Standard: Discharge planning. (b) Standard: Discharge or transfer summary content. (2) The HHA must comply with requests for additional clinical information as may be necessary for treatment of the patient made by the receiving facility or health care practitioner. [84 FR 51883, Sept. 30, 2019] § 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. (a) Standard: Plan of care. (2) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. (3) All patient care orders, including verbal orders, must be recorded in the plan of care. (b) Standard: Conformance with physician or allowed practitioner orders. (2) Influenza and pneumococcal vaccines may be administered per agency policy developed in consultation with a physician, physician assistant, nurse practitioner, or clinical nurse specialist, and after an assessment of the patient to determine for contraindications. (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed practitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. (c) Standard: Review and revision of the plan of care. (2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. (3) Revisions to the plan of care must be communicated as follows: (i) Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and all physicians or allowed practitioners issuing orders for the HHA plan of care. (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioners issuing orders for the HHA plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any). (d) Standard: Coordination of care. (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. (2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. (3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. (4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. (5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. (e) Standard: Written information to the patient. (1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. (2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. (3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. (4) Any other pertinent instruction related to the patient's care and treatments that the HHA will provide, specific to the patient's care needs. (5) Name and contact information of the HHA clinical manager. [82 FR 4578, Jan. 13, 2017, as amended at 85 FR 27628, May 8, 2020] § 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 HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. (a) Standard: Program scope. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. (b) Standard: Program data. (2) The HHA must use the data collected to— (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. (c) Standard: Program activities. (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. (2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. (3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. (d) Standard: Performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. (e) Standard: Executive responsibilities. (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. [82 FR 4578, Jan. 13, 2017, as amended at 82 FR 31732, July 10, 2017] § 484.70 Condition of participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. (a) Standard: Prevention. (b) Standard: Control. (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. (c) Standard: Education. [82 FR 4578, Jan. 13, 2017, as amended at 86 FR 61621, Nov. 5, 2021; 88 FR 36510, June 5, 2023] § 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in § 409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in § 409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. (a) Standard: Provision of services by skilled professionals. (b) Standard: Responsibilities of skilled professionals. (1) Ongoing interdisciplinary assessment of the patient; (2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); (3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; (4) Patient, caregiver, and family counseling; (5) Patient and caregiver education; (6) Preparing clinical notes; (7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; (8) Participation in the HHA's QAPI program; and (9) Participation in HHA-sponsored in-service training. (c) Supervision of skilled professional assistants. (2) Rehabilitative therapy services are provided under the supervision of an occupational therapist or physical therapist that meets the requirements of § 484.115(f) or (h), respectively. (3) Medical social services are provided under the supervision of a social worker that meets the requirements of § 484.115(m). [82 FR 4578, Jan. 13, 2017, as amended at 85 FR 27628, May 8, 2020] § 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. (a) Standard: Home health aide qualifications. (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of § 483.151 through § 483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. (2) A home health aide or nurse aide is not considered to have completed a program, as specified in paragraph (a)(1) of this section, if, since the individual's most recent completion of the program(s), there has been a continuous period of 24 consecutive months during which none of the services furnished by the individual as described in § 409.40 of this chapter were for compensation. If there has been a 24-month lapse in furnishing services for compensation, the individual must complete another program, as specified in paragraph (a)(1) of this section, before providing services. (b) Standard: Content and duration of home health aide classroom and supervised practical training. (2) A minimum of 16 hours of classroom training must precede a minimum of 16 hours of supervised practical training as part of the 75 hours. (3) A home health aide training program must address each of the following subject areas: (i) Communication skills, including the ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff. (ii) Observation, reporting, and documentation of patient status and the care or service furnished. (iii) Reading and recording temperature, pulse, and respiration. (iv) Basic infection prevention and control procedures. (v) Basic elements of body functioning and changes in body function that must be reported to an aide's supervisor. (vi) Maintenance of a clean, safe, and healthy environment. (vii) Recognizing emergencies and the knowledge of instituting emergency procedures and their application. (viii) The physical, emotional, and developmental needs of and ways to work with the populations served by the HHA, including the need for respect for the patient, his or her privacy, and his or her property. (ix) Appropriate and safe techniques in performing personal hygiene and grooming tasks that include— (A) Bed bath; (B) Sponge, tub, and shower bath; (C) Hair shampooing in sink, tub, and bed; (D) Nail and skin care; (E) Oral hygiene; (F) Toileting and elimination; (x) Safe transfer techniques and ambulation; (xi) Normal range of motion and positioning; (xii) Adequate nutrition and fluid intake; (xiii) Recognizing and reporting changes in skin condition; and (xiv) Any other task that the HHA may choose to have an aide perform as permitted under state law. (xv) The HHA is responsible for training home health aides, as needed, for skills not covered in the basic checklist, as described in paragraph (b)(3)(ix) of this section. (4) The HHA must maintain documentation that demonstrates that the requirements of this standard have been met. (c) Standard: Competency evaluation. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. (4) A home health aide is not considered competent in any task for which he or she is evaluated as unsatisfactory. An aide must not perform that task without direct supervision by a registered nurse until after he or she has received training in the task for which he or she was evaluated as “unsatisfactory,” and has successfully completed a subsequent evaluation. A home health aide is not considered to have successfully passed a competency evaluation if the aide has an “unsatisfactory” rating in more than one of the required areas. (5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met. (d) Standard: In-service training. (1) In-service training may be offered by any organization and must be supervised by a registered nurse. (2) The HHA must maintain documentation that demonstrates the requirements of this standard have been met. (e) Standard: Qualifications for instructors conducting classroom and supervised practical training. (f) Standard: Eligible training and competency evaluation organizations. (1) Was out of compliance with the requirements of paragraphs (b), (c), (d), or (e) of this section; or (2) Permitted an individual who does not meet the definition of a “qualified home health aide” as specified in paragraph (a) of this section to furnish home health aide services (with the exception of licensed health professionals and volunteers); or (3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or (4) Was assessed a civil monetary penalty of $5,000 or more as an intermediate sanction; or (5) Was found to have compliance deficiencies that endangered the health and safety of the HHA's patients, and had temporary management appointed to oversee the management of the HHA; or (6) Had all or part of its Medicare payments suspended; or (7) Was found under any federal or state law to have: (i) Had its participation in the Medicare program terminated; or (ii) Been assessed a penalty of $5,000 or more for deficiencies in federal or state standards for HHAs; or (iii) Been subjected to a suspension of Medicare payments to which it otherwise would have been entitled; or (iv) Operated under temporary management that was appointed to oversee the operation of the HHA and to ensure the health and safety of the HHA's patients; or (v) Been closed, or had its patients transferred by the state; or (vi) Been excluded from participating in federal health care programs or debarred from participating in any government program. (g) Standard: Home health aide assignments and duties. (2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. (3) The duties of a home health aide include: (i) The provision of hands-on personal care; (ii) The performance of simple procedures as an extension of therapy or nursing services; (iii) Assistance in ambulation or exercises; and (iv) Assistance in administering medications ordinarily self-administered. (4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. (h) Standard: Supervision of home health aides. (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. (ii) The supervisory assessment must be completed onsite (that is, an in person visit), or on the rare occasion by using two-way audio-video telecommunications technology that allows for real-time interaction between the registered nurse (or other appropriate skilled professional) and the patient, not to exceed 1 virtual supervisory assessment per patient in a 60-day episode. (iii) If an area of concern in aide services is noted by the supervising registered nurse or other appropriate skilled professional, then the supervising individual must make an on-site visit to the location where the patient is receiving care in order to observe and assess the aide while he or she is performing care. (iv) A registered nurse or other appropriate skilled professional must make an annual on-site visit to the location where a patient is receiving care in order to observe and assess each aide while he or she is performing care. (2)(i) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech language pathology services— (A) The registered nurse must make an onsite, in person visit every 60 days to assess the quality of care and services provided by the home health aide and to ensure that services meet the patient's needs; and (B) The home health aide does not need to be present during this visit. (ii) Semi-annually the registered nurse must make an on-site visit to the location where each patient is receiving care in order to observe and assess each home health aide while he or she is performing non-skilled care. (3) If a deficiency in aide services is verified by the registered nurse or other appropriate skilled professional during an on-site visit, then the agency must conduct, and the home health aide must complete, retraining and a competency evaluation for the deficient and all related skills. (4) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. (5) If the home health agency chooses to provide home health aide services under arrangements, as defined in section 1861(w)(1) of the Act, the HHA's responsibilities also include, but are not limited to: (i) Ensuring the overall quality of care provided by an aide; (ii) Supervising aide services as described in paragraphs (h)(1) and (2) of this section; and (iii) Ensuring that home health aides who provide services under arrangement have met the training or competency evaluation requirements, or both, of this part. (i) Standard: Individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit. [82 FR 4578, Jan. 13, 2017, as amended at 84 FR 51825, Sept. 30, 2019; 85 FR 27628, May 8, 2020; 86 FR 62421, Nov. 9, 2021] Subpart C—Organizational Environment Source: 82 FR 4578, Jan. 13, 2017, unless otherwise noted. § 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed. (a) Standard: Disclosure of ownership and management information. (1) The names and addresses of all persons with an ownership or controlling interest in the HHA as defined in § 420.201, § 420.202, and § 420.206 of this chapter. (2) The name and address of each person who is an officer, a director, an agent, or a managing employee of the HHA as defined in § 420.201, § 420.202, and § 420.206 of this chapter. (3) The name and business address of the corporation, association, or other company that is responsible for the management of the HHA, and the names and addresses of the chief executive officer and the chairperson of the board of directors of that corporation, association, or other company responsible for the management of the HHA. (b) Standard: Licensing. (c) Standard: Laboratory services. (2) If the HHA refers specimens for laboratory testing, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements of part 493 of this chapter. § 484.102 Condition of participation: Emergency preparedness. The Home Health Agency (HHA) must comply with all applicable Federal, State, and local emergency preparedness requirements. The HHA must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan. (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment. (3) Address patient population, including, but not limited to, the type of services the HHA has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. (b) Policies and procedures. (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at § 484.55. (2) The procedures to inform State and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. (4) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records. (5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency. (c) Communication plan. (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. (2) Contact information for the following: (i) Federal, State, tribal, regional, or local emergency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means for communicating with the HHA's staff, Federal, State, tribal, regional, and local emergency management agencies. (4) A method for sharing information and medical documentation for patients under the HHA's care, as necessary, with other health care providers to maintain the continuity of care. (5) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). (6) A means of providing information about the HHA's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. (d) Training and testing. (1) Training program. (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the HHA must conduct training on the updated policies and procedures. (2) Testing. (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. (e) Integrated healthcare systems. (1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program. (2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered. (3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program. (4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following: (i) A documented community-based risk assessment, utilizing an all-hazards approach. (ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach. (5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively. [82 FR 4578, Jan. 13, 2017, as amended at 84 FR 51825, Sept. 30, 2019] § 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, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. (a) Standard: Governing body. (b) Standard: Administrator. (i) Be appointed by and report to the governing body; (ii) Be responsible for all day-to-day operations of the HHA; (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. (2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. (3) The administrator or a pre-designated person is available during all operating hours. (c) Clinical manager. (1) Making patient and personnel assignments, (2) Coordinating patient care, (3) Coordinating referrals, (4) Assuring that patient needs are continually assessed, and (5) Assuring the development, implementation, and updates of the individualized plan of care. (d) Standard: Parent-branch relationship. (2) The parent HHA provides direct support and administrative control of its branches. (e) Standard: Services under arrangement. (2) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. (3) The primary HHA is responsible for patient care, and must conduct and provide, either directly or under arrangements, all services rendered to patients. (f) Standard: Services furnished. (2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. (g) Standard: Outpatient physical therapy or speech-language pathology services. (h) Standard: Institutional planning. (1) Annual operating budget. (2) Capital expenditure plan. (ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health Services Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following: (A) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963. (B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations. (C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency. (3) Preparation of plan and budget. (4) Annual review of plan and budget. (i) HHA acceptance-to-service. (1) Develop, implement, and maintain through an annual review, a patient acceptance-to-service policy that is applied consistently to each prospective patient referred for home health care, which addresses criteria related to the HHA's capacity to provide patient care, including, but not limited to, all of the following: (i) Anticipated needs of the referred prospective patient. (ii) Case load and case mix of the HHA. (iii) Staffing levels of the HHA. (iv) Skills and competencies of the HHA staff. (2)(i) Make available to the public accurate information regarding the services offered by the HHA and any limitations related to types of specialty services, service duration, or service frequency. (ii) Review the information specified in paragraph (i)(2)(i) of this section as frequently as the services are changed, but no less often than annually. [82 FR 4578, Jan. 13, 2017, as amended at 89 FR 88485, Nov. 7, 2024] § 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. (a) Standard: Contents of clinical record. (1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; (2) All interventions, including medication administration, treatments, and services, and responses to those interventions; (3) Goals in the patient's plans of care and the patient's progress toward achieving them; (4) Contact information for the patient, the patient's representative (if any), and the patient's primary caregiver(s); (5) Contact information for the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA; and (6)(i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. (b) Standard: Authentication. (c) Standard: Retention of records. (2) The HHA's policies must provide for retention of clinical records even if it discontinues operation. When an HHA discontinues operation, it must inform the state agency where clinical records will be maintained. (d) Standard: Protection of records. (e) Standard: Retrieval of clinical records. [82 FR 4578, Jan. 13, 2017, as amended at 85 FR 70356, Nov. 4, 2020] § 484.115 Condition of participation: Personnel qualifications. HHA staff are required to meet the following standards: (a) Standard: Administrator, home health agency. (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. (b) Standard: Audiologist. (1) Meets the education and experience requirements for a Certificate of Clinical Competence in audiology granted by the American Speech-Language-Hearing Association; or (2) Meets the educational requirements for certification and is in the process of accumulating the supervised experience required for certification. (c) Standard: Clinical manager. (d) Standard: Home health aide. (e) Standard: Licensed practical (vocational) nurse. (f) Standard: Occupational therapist. (1)(i) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the state in which practicing, unless licensure does not apply; (ii) Graduated after successful completion of an occupational therapist education program accredited by the Accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA), or successor organizations of ACOTE; and (iii) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). (2) On or before December 31, 2009— (i) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the state in which practicing; or (ii) When licensure or other regulation does not apply— (A) Graduated after successful completion of an occupational therapist education program accredited by the accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA) or successor organizations of ACOTE; and (B) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc., (NBCOT). (3) On or before January 1, 2008— (i) Graduated after successful completion of an occupational therapy program accredited jointly by the Committee on Allied Health Education and Accreditation of the American Medical Association and the American Occupational Therapy Association; or (ii) Is eligible for the National Registration Examination of the American Occupational Therapy Association or the National Board for Certification in Occupational Therapy. (4) On or before December 31, 1977— (i) Had 2 years of appropriate experience as an occupational therapist; and (ii) Had achieved a satisfactory grade on an occupational therapist proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. (5) If educated outside the United States, must meet both of the following: (i) Graduated after successful completion of an occupational therapist education program accredited as substantially equivalent to occupational therapist entry level education in the United States by one of the following: (A) The Accreditation Council for Occupational Therapy Education (ACOTE). (B) Successor organizations of ACOTE. (C) The World Federation of Occupational Therapists. (D) A credentialing body approved by the American Occupational Therapy Association. (E) Successfully completed the entry level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). (ii) On or before December 31, 2009, is licensed or otherwise regulated, if applicable, as an occupational therapist by the state in which practicing. (g) Standard: Occupational therapy assistant. (1) Meets all of the following: (i) Is licensed or otherwise regulated, if applicable, as an occupational therapy assistant by the state in which practicing, unless licensure does apply. (ii) Graduated after successful completion of an occupational therapy assistant education program accredited by the Accreditation Council for Occupational Therapy Education, (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA) or its successor organizations. (iii) Is eligible to take or successfully completed the entry-level certification examination for occupational therapy assistants developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). (2) On or before December 31, 2009— (i) Is licensed or otherwise regulated as an occupational therapy assistant, if applicable, by the state in which practicing; or any qualifications defined by the state in which practicing, unless licensure does not apply; or (ii) Must meet both of the following: (A) Completed certification requirements to practice as an occupational therapy assistant established by a credentialing organization approved by the American Occupational Therapy Association. (B) After January 1, 2010, meets the requirements in paragraph (f)(1) of this section. (3) After December 31, 1977 and on or before December 31, 2007— (i) Completed certification requirements to practice as an occupational therapy assistant established by a credentialing organization approved by the American Occupational Therapy Association; or (ii) Completed the requirements to practice as an occupational therapy assistant applicable in the state in which practicing. (4) On or before December 31, 1977— (i) Had 2 years of appropriate experience as an occupational therapy assistant; and (ii) Had achieved a satisfactory grade on an occupational therapy assistant proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. (5) If educated outside the United States, on or after January 1, 2008— (i) Graduated after successful completion of an occupational therapy assistant education program that is accredited as substantially equivalent to occupational therapist assistant entry level education in the United States by— (A) The Accreditation Council for Occupational Therapy Education (ACOTE). (B) Its successor organizations. (C) The World Federation of Occupational Therapists. (D) By a credentialing body approved by the American Occupational Therapy Association; and (E) Successfully completed the entry level certification examination for occupational therapy assistants developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). (ii) [Reserved] (h) Standard: Physical therapist. (1)(i) Graduated after successful completion of a physical therapist education program approved by one of the following: (A) The Commission on Accreditation in Physical Therapy Education (CAPTE). (B) Successor organizations of CAPTE. (C) An education program outside the United States determined to be substantially equivalent to physical therapist entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or an organization identified in 8 CFR 212.15(e) as it relates to physical therapists. (ii) Passed an examination for physical therapists approved by the state in which physical therapy services are provided. (2) On or before December 31, 2009— (i) Graduated after successful completion of a physical therapy curriculum approved by the Commission on Accreditation in Physical Therapy Education (CAPTE); or (ii) Meets both of the following: (A) Graduated after successful completion of an education program determined to be substantially equivalent to physical therapist entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or identified in 8 CFR 212.15(e) as it relates to physical therapists. (B) Passed an examination for physical therapists approved by the state in which physical therapy services are provided. (3) Before January 1, 2008 graduated from a physical therapy curriculum approved by one of the following: (i) The American Physical Therapy Association. (ii) The Committee on Allied Health Education and Accreditation of the American Medical Association. (iii) The Council on Medical Education of the American Medical Association and the American Physical Therapy Association. (4) On or before December 31, 1977 was licensed or qualified as a physical therapist and meets both of the following: (i) Has 2 years of appropriate experience as a physical therapist. (ii) Has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. (5) Before January 1, 1966— (i) Was admitted to membership by the American Physical Therapy Association; (ii) Was admitted to registration by the American Registry of Physical Therapists; or (iii) Graduated from a physical therapy curriculum in a 4-year college or university approved by a state department of education. (6) Before January 1, 1966 was licensed or registered, and before January 1, 1970, had 15 years of fulltime experience in the treatment of illness or injury through the practice of physical therapy in which services were rendered under the order and direction of attending and referring doctors of medicine or osteopathy. (7) If trained outside the United States before January 1, 2008, meets the following requirements: (i) Was graduated since 1928 from a physical therapy curriculum approved in the country in which the curriculum was located and in which there is a member organization of the World Confederation for Physical Therapy. (ii) Meets the requirements for membership in a member organization of the World Confederation for Physical Therapy. (i) Standard: Physical therapist assistant. (1)(i) Graduated from a physical therapist assistant curriculum approved by the Commission on Accreditation in Physical Therapy Education of the American Physical Therapy Association; or if educated outside the United States or trained in the United States military, graduated from an education program determined to be substantially equivalent to physical therapist assistant entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or identified at 8 CFR 212.15(e); and (ii) Passed a national examination for physical therapist assistants. (2) On or before December 31, 2009, meets one of the following: (i) Is licensed, or otherwise regulated in the state in which practicing. (ii) In states where licensure or other regulations do not apply, graduated before December 31, 2009, from a 2-year college-level program approved by the American Physical Therapy Association and after January 1, 2010, meets the requirements of paragraph (h)(1) of this section. (3) Before January 1, 2008, where licensure or other regulation does not apply, graduated from a 2-year college level program approved by the American Physical Therapy Association. (4) On or before December 31, 1977, was licensed or qualified as a physical therapist assistant and has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. (j) Standard: Physician. (k) Standard: Registered nurse. (l) Standard: Social Work Assistant. (1) Has a baccalaureate degree in social work, psychology, sociology, or other field related to social work, and has had at least 1 year of social work experience in a health care setting; or (2) Has 2 years of appropriate experience as a social work assistant, and has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service, except that the determinations of proficiency do not apply with respect to persons initially licensed by a state or seeking initial qualification as a social work assistant after December 31, 1977. (m) Standard: Social worker. (n) Standard: Speech-language pathologist. (1) Is licensed as a speech-language pathologist by the state in which the individual furnishes such services; or (2) In the case of an individual who furnishes services in a state which does not license speech-language pathologists: (i) Has successfully completed 350 clock hours of supervised clinical practicum (or is in the process of accumulating supervised clinical experience); (ii) Performed not less than 9 months of supervised full-time speech-language pathology services after obtaining a master's or doctoral degree in speech-language pathology or a related field; and (iii) Successfully completed a national examination in speech-language pathology approved by the Secretary. [82 FR 4578, Jan. 13, 2017, as amended at 82 FR 31732, July 10, 2017] Subpart D [Reserved] Subpart E—Prospective Payment System for Home Health Agencies Source: 65 FR 41212, July 3, 2000, unless otherwise noted. § 484.200 Basis and scope. (a) Basis. (b) Scope. § 484.202 Definitions. As used in this subpart— Case-mix index Discipline Furnishing Negative Pressure Wound Therapy (NPWT) using a disposable device HHCAHPS HH QRP Home health market basket index Rural area Urban area [70 FR 68142, Nov. 9, 2005, as amended at 81 FR 76796, Nov. 3, 2016; 83 FR 56628, Nov. 13, 2018; 84 FR 60644, Nov. 8, 2019; 88 FR 77878, Nov. 13, 2023] § 484.205 Basis of payment. (a) Method of payment. (b) Unit of payment Episodes before December 31, 2019. (2) Periods on or after January 1, 2020. (c) OASIS data. (d) Payment adjustments. (1) A low-utilization payment adjustment (LUPA) of a predetermined per-visit rate as specified in § 484.230. (2) A partial payment adjustment as specified in § 484.235. (3) An outlier payment as specified in § 484.240. (e) Medical review. (1) Beneficiary eligibility. (2) Medical necessity determinations. (3) Case-mix group assignment. (f) Durable medical equipment (DME) and disposable devices. (g) Split percentage payments. (1) Split percentage payments for episodes beginning on or before December 31, 2019 Initial and residual final payments for initial episodes on or before December 31, 2019. (B) The residual final payment for initial episodes is paid at 40 percent of the case-mix and wage-adjusted 60-day episode rate. (ii) Initial and residual final payments for subsequent episodes before December 31, 2019. (B) The residual final payment for subsequent episodes is paid at 50 percent of the case-mix and wage-adjusted 60-day episode rate. (2) Split percentage payments for periods beginning on or after January 1, 2020 through December 31, 2020 HHAs certified for participation on or before December 31, 2018 (B) The residual final payment for all 30-day periods is paid at 80 percent of the case-mix and wage-adjusted 30-day payment rate. (ii) HHAs certified for participation in Medicare on or after January 1, 2019. (3) Split percentage payments for periods beginning on or after January 1, 2021 through December 31, 2021. (4) Payments for periods beginning on or after January 1, 2022. (h) Requests for anticipated payment (RAP) for 30-day periods of care starting on January 1, 2020 through December 31, 2020. (i) After the OASIS assessment required at § 484.55(b)(1) and (d) is complete, locked or export ready, or there is an agency-wide internal policy establishing the OASIS data is finalized for transmission to the national assessment system. (ii) Once a physician or allowed practitioner's verbal orders for home care have been received and documented as required at §§ 484.60(b) and 409.43(d) of this chapter. (iii) A plan of care has been established and sent to the physician or allowed practitioner as required at § 409.43(c) of this chapter. (iv) The first service visit under that plan has been delivered. (2) A RAP is based on the physician or allowed practitioner signature requirements in § 409.43(c) of this chapter and is not a Medicare claim for purposes of the Act (although it is a “claim” for purposes of Federal, civil, criminal, and administrative law enforcement authorities, including but not limited to the following: (i) Civil Monetary Penalties Law (as defined in 42 U.S.C. 1320a-7a(i)(2)). (ii) The Civil False Claims Act (as defined in 31 U.S.C. 3729(c)). (iii) The Criminal False Claims Act (18 U.S.C. 287)). (iv) The RAP is canceled and recovered unless the claim is submitted within the greater of 60 days from the end date of the appropriate unit of payment, as defined in paragraph (b) of this section, or 60 days from the issuance of the RAP. (3) CMS has the authority to reduce, disprove, or cancel a RAP in situations when protecting Medicare program integrity warrants this action. (i) Submission of RAPs for CY 2021 General. (2) Criteria for RAP submission for CY 2021. (i) Once physician or allowed practitioner's written or verbal orders that contain the services required for the initial visit have been received and documented as required at §§ 484.60(b) and 409.43(d) of this chapter. (ii) The initial visit within the 60-day certification period must have been made and the individual admitted to home health care. (3) Consequences of failure to submit a timely RAP. (i) Medicare does not pay for those days of home health services based on the “from date” on the claim to the date of filing of the RAP; (ii) The wage and case-mix adjusted 30-day period payment amount is reduced by 1/30th for each day from the home health based on the “from date” on the claim until the date of filing of the RAP; (iii) No LUPA payments are made that fall within the late period; (iv) The payment reduction cannot exceed the total payment of the claim; and (v)(A) The non-covered days are a provider liability; and (B) The provider must not bill the beneficiary for the non-covered days. (4) Exception to the consequences for filing the RAP late. (ii) CMS determines if a circumstance encountered by a home health agency is exceptional and qualifies for waiver of the consequence specified in paragraph (i)(3) of this section. (iii) A home health agency must fully document and furnish any requested documentation to CMS for a determination of exception. An exceptional circumstance may be due to, but is not limited to the following: (A) Fires, floods, earthquakes, or similar unusual events that inflict extensive damage to the home health agency's ability to operate. (B) A CMS or Medicare contractor systems issue that is beyond the control of the home health agency. (C) A newly Medicare-certified home health agency that is notified of that certification after the Medicare certification date, or which is awaiting its user ID from its Medicare contractor. (D) Other situations determined by CMS to be beyond the control of the home health agency. (j) Submission of Notice of Admission (NOA) For periods of care that begin on and after January 1, 2022. (2) Criteria for NOA submission. (i) Once a physician or allowed practitioner's written or verbal orders that contains the services required for the initial visit have been received and documented as required at §§ 484.60(b) and 409.43(d) of this chapter. (ii) The initial visit must have been made and the individual admitted to home health care. (3) Consequences of failure to submit a timely Notice of Admission. (i) Medicare does not pay for those days of home health services from the start date to the date of filing of the notice of admission; (ii) The wage and case-mix adjusted 30-day period payment amount is reduced by 1/30th for each day from the home health start of care date until the date of filing of the NOA; (iii) No LUPA payments are made that fall within the late NOA period; (iv) The payment reduction cannot exceed the total payment of the claim; and (v)(A) The non-covered days are a provider liability; and (B) The provider must not bill the beneficiary for the non-covered days. (4) Exception to the consequences for filing the NOA late. (ii) CMS determines if a circumstance encountered by a home health agency is exceptional and qualifies for waiver of the consequence specified in paragraph (j)(3) of this section. (iii) A home health agency must fully document and furnish any requested documentation to CMS for a determination of exception. An exceptional circumstance may be due to, but is not limited to the following: (A) Fires, floods, earthquakes, or similar unusual events that inflict extensive damage to the home health agency's ability to operate. (B) A CMS or Medicare contractor systems issue that is beyond the control of the home health agency. (C) A newly Medicare-certified home health agency that is notified of that certification after the Medicare certification date, or which is awaiting its user ID from its Medicare contractor. (D) Other situations determined by CMS to be beyond the control of the home health agency. [83 FR 56628, Nov. 13, 2018, as amended at 84 FR 60644, Nov. 8, 2019; 85 FR 27628, May 8, 2020] § 484.215 Initial establishment of the calculation of the national, standardized prospective payment rates. (a) Determining an HHA's costs. (b) Determining HHA utilization. (c) Use of the market basket index. (d) Calculation of the unadjusted national average prospective payment amount for the 60-day episode. (1) By computing the mean national cost per visit. (2) By computing the national mean utilization for each discipline. (3) By multiplying the mean national cost per visit by the national mean utilization summed in the aggregate for the six disciplines. (4) By adding to the amount derived in paragraph (d)(3) of this section, amounts for nonroutine medical supplies, an OASIS adjustment for estimated ongoing reporting costs, an OASIS adjustment for the one time implementation costs associated with assessment scheduling form changes and amounts for Part B therapies that could have been unbundled to Part B prior to October 1, 2000. The resulting amount is the unadjusted national 60-day episode rate. (e) Standardization of the data for variation in area wage levels and case-mix. (1) The cost data described in paragraph (a) of this section to remove the effects of geographic variation in wage levels and variation in case-mix; (2) The cost data for geographic variation in wage levels using the hospital wage index; and (3) The cost data for HHA variation in case-mix using the case-mix indices and other data that indicate HHA case-mix. (f) For periods beginning on or after January 1, 2020, a national, standardized prospective 30-day payment rate applies. The national, standardized prospective 30-day payment rate is an amount determined by the Secretary, as subsequently adjusted in accordance with § 484.225. [65 FR 41212, July 3, 2000, as amended at 83 FR 56629, Nov. 13, 2018] § 484.220 Calculation of the case-mix and wage area adjusted prospective payment rates. CMS adjusts the national, standardized prospective payment rates as referenced in § 484.215 to account for the following: (a) HHA case-mix using a case-mix index to explain the relative resource utilization of different patients. To address changes to the case-mix that are a result of changes in the coding or classification of different units of service that do not reflect real changes in case-mix, the national, standardized prospective payment rate will be adjusted downward as follows: (1) For CY 2008, the adjustment is 2.75 percent. (2) For CY 2009 and CY 2010, the adjustment is 2.75 percent in each year. (3) For CY 2011, the adjustment is 3.79 percent. (4) For CY 2012, the adjustment is 3.79 percent. (5) For CY 2013, the adjustment is 1.32 percent. (6) For CY 2016, CY 2017, and CY 2018, the adjustment is 0.97 percent in each year. (b) Geographic differences in wage levels using an appropriate wage index based on the site of service of the beneficiary. (c) Beginning on January 1, 2023, CMS applies a cap on decreases to the home health wage index such that the wage index applied to a geographic area is not less than 95 percent of the wage index applied to that geographic area in the prior calendar year. The 5-percent cap on negative wage index changes is implemented in a budget neutral manner through the use of wage index budget neutrality factors. [72 FR 49879, Aug. 29, 2007, as amended at 80 FR 68717, Nov. 5, 2015; 83 FR 56629, Nov. 13, 2018; 87 FR 66886, Nov. 4, 2022] § 484.225 Annual update of the unadjusted national, standardized prospective payment rates. (a) CMS annually updates the unadjusted national, standardized prospective payment rate on a calendar year basis (in accordance with section 1895(b)(1)(B) of the Act). (b) For 2007 and subsequent calendar years, in accordance with section 1895(b)(3)(B)(v) of the Act, in the case of a home health agency that does not submit home health quality data, as specified by the Secretary, the unadjusted national, standardized prospective rate is equal to the rate for the previous calendar year increased by the applicable home health market basket index amount minus 2 percentage points. Any reduction of the percentage change will apply only to the calendar year involved and will not be taken into account in computing the prospective payment amount for a subsequent calendar year. (c) For CY 2020, the national, standardized prospective 30-day payment amount is an amount determined by the Secretary. CMS annually updates this amount on a calendar year basis in accordance with paragraphs (a) and (b) of this section. [80 FR 68717, Nov. 5, 2015, as amended at 83 FR 56629, Nov. 13, 2018; 84 FR 60645, Nov. 8, 2019] § 484.230 Low-utilization payment adjustments. (a) For episodes beginning on or before December 31, 2019, an episode with four or fewer visits is paid the national per-visit amount by discipline determined in accordance with § 484.215(a) and updated annually by the applicable market basket for each visit type, in accordance with § 484.225. (1) The national per-visit amount is adjusted by the appropriate wage index based on the site of service of the beneficiary. (2) An amount is added to the low-utilization payment adjustments for low-utilization episodes that occur as the beneficiary's only episode or initial episode in a sequence of adjacent episodes. (3) For purposes of the home health PPS, a sequence of adjacent episodes for a beneficiary is a series of claims with no more than 60 days without home care between the end of one episode, which is the 60th day (except for episodes that have been PEP-adjusted), and the beginning of the next episode. (b) For periods beginning on or after January 1, 2020, an HHA receives a national 30-day payment of a predetermined rate for home health services, unless CMS determines at the end of the 30-day period that the HHA furnished minimal services to a patient during the 30-day period. (1) For each payment group used to case-mix adjust the 30-day payment rate, the 10th percentile value of total visits during a 30-day period of care is used to create payment group specific thresholds with a minimum threshold of at least 2 visits for each case-mix group. (2) A 30-day period with a total number of visits less than the threshold is paid the national per-visit amount by discipline determined in accordance with § 484.215(a) and updated annually by the applicable market basket for each visit type, in accordance with § 484.225. (3) The national per-visit amount is adjusted by the appropriate wage index based on the site of service for the beneficiary. (c) An amount is added to low-utilization payment adjustments for low-utilization periods that occur as the beneficiary's only 30-day period or initial 30-day period in a sequence of adjacent periods of care. For purposes of the home health PPS, a sequence of adjacent periods of care for a beneficiary is a series of claims with no more than 60 days without home care between the end of one period, which is the 30th day (except for episodes that have been partial payment adjusted), and the beginning of the next episode. [83 FR 56629, Nov. 13, 2018] § 484.235 Partial payment adjustments. (a) Partial episode payments (PEPs) for episodes beginning on or before December 31, 2019. (2) The PEP adjustment does not apply in situations of transfers among HHAs of common ownership. (i) Those situations are considered services provided under arrangement on behalf of the originating HHA by the receiving HHA with the common ownership interest for the balance of the 60-day episode. (ii) The common ownership exception to the transfer PEP adjustment does not apply if the beneficiary moves to a different MSA or Non-MSA during the 60-day episode before the transfer to the receiving HHA. (iii) The transferring HHA in situations of common ownership not only serves as a billing agent, but must also exercise professional responsibility over the arranged-for services in order for services provided under arrangements to be paid. (3) If the intervening event warrants a new 60-day payment and a new physician or allowed practitioner certification and a new plan of care, the initial HHA receives a partial episode payment adjustment reflecting the length of time the patient remained under its care based on the first billable visit date through and including the last billable visit date. The PEP is calculated by determining the actual days served as a proportion of 60 multiplied by the initial 60-day payment amount. (b) Partial payment adjustments for periods beginning on or after January 1, 2020. (2) The partial payment adjustment does not apply in situations of transfers among HHAs of common ownership. (i) Those situations are considered services provided under arrangement on behalf of the originating HHA by the receiving HHA with the common ownership interest for the balance of the 30-day period. (ii) The common ownership exception to the transfer partial payment adjustment does not apply if the beneficiary moves to a different MSA or Non-MSA during the 30-day period before the transfer to the receiving HHA. (iii) The transferring HHA in situations of common ownership not only serves as a billing agent, but must also exercise professional responsibility over the arranged-for services in order for services provided under arrangements to be paid. (3) If the intervening event warrants a new 30-day payment and a new physician or allowed practitioner certification and a new plan of care, the initial HHA receives a partial payment adjustment reflecting the length of time the patient remained under its care based on the first billable visit date through and including the last billable visit date. The partial payment is calculated by determining the actual days served as a proportion of 30 multiplied by the initial 30-day payment amount. [83 FR 56629, Nov. 13, 2018, as amended at 85 FR 27628, May 8, 2020] § 484.240 Outlier payments. (a) For episodes beginning on or before December 31, 2019, an HHA receives an outlier payment for an episode whose estimated costs exceeds a threshold amount for each case-mix group. The outlier threshold for each case-mix group is the episode payment amount for that group, or the PEP adjustment amount for the episode, plus a fixed dollar loss amount that is the same for all case-mix groups. (b) For periods beginning on or after January 1, 2020, an HHA receives an outlier payment for a 30-day period whose estimated cost exceeds a threshold amount for each case-mix group. The outlier threshold for each case-mix group is the 30-day payment amount for that group, or the partial payment adjustment amount for the 30-day period, plus a fixed dollar loss amount that is the same for all case-mix groups. (c) The outlier payment is a proportion of the amount of imputed cost beyond the threshold. (d) CMS imputes the cost for each claim by multiplying the national per-15 minute unit amount of each discipline by the number of 15 minute units in the discipline and computing the total imputed cost for all disciplines. [83 FR 56630, Nov. 13, 2018] § 484.245 Requirements under the Home Health Quality Reporting Program (HH QRP). (a) Participation. (b) Data submission. (i) Data— (A) Required under section 1895(b)(3)(B)(v)(II) of the Act, including HHCAHPS survey data; and (B) On measures specified under sections 1899B(c)(1) and 1899B(d)(1) of the Act. (ii) Standardized patient assessment data required under section 1899B(b)(1) of the Act. (iii) For purposes of HHCAHPS survey data submission, the following additional requirements apply: (A) Patient count. (B) Survey requirements. (C) CMS approval. ( 1 ( 2 (D) Disapproval by CMS. (E) Compliance with oversight activities. (2)(i) Data submission requirements. (ii) Data completion thresholds. (B) A home health agency must meet or exceed the data submission compliance threshold described in paragraph (b)(2)(ii)(A) of this section to avoid receiving a 2-percentage point reduction to its annual payment update for a given fiscal year described under § 484.225(b). (3) Measure removal factors. (i) Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. (ii) Performance or improvement on a measure does not result in better patient outcomes. (iii) A measure does not align with current clinical guidelines or practice. (iv) The availability of a more broadly applicable (across settings, populations, or conditions) measure for the particular topic. (v) The availability of a measure that is more proximal in time to desired patient outcomes for the particular topic. (vi) The availability of a measure that is more strongly associated with desired patient outcomes for the particular topic. (vii) Collection or public reporting of a measure leads to negative unintended consequences other than patient harm. (viii) The costs associated with a measure outweigh the benefit of its continued use in the program. (c) Exceptions and extension requirements. (2) An HHA may request an exception or extension within 90 days of the date that the extraordinary circumstances occurred by sending an email to CMS HHAPU reconsiderations at [email protected] (i) HHA CMS Certification Number (CCN). (ii) HHA Business Name. (iii) HHA Business Address. (iv) CEO or CEO-designated personnel contact information including name, title, telephone number, email address, and mailing address (the address must be a physical address, not a post office box). (v) HHA's reason for requesting the exception or extension. (vi) Evidence of the impact of extraordinary circumstances, including, but not limited to, photographs, newspaper, and other media articles. (vii) Date when the HHA believes it will be able to again submit data under paragraph (b) of this section and a justification for the proposed date. (3) Except as provided in paragraph (c)(4) of this section, CMS does not consider an exception or extension request unless the HHA requesting such exception or extension has complied fully with the requirements in this paragraph (c). (4) CMS may grant exceptions or extensions to HHAs without a request if it determines that one or more of the following has occurred: (i) An extraordinary circumstance, such as an act of nature, affects an entire region or locale. (ii) A systemic problem with one of CMS's data collection systems directly affects the ability of an HHA to submit data under paragraph (b) of this section. (d) Reconsiderations. (ii) An HHA may request reconsideration no later than 30 calendar days after the date identified on the letter of non-compliance. (2) Reconsideration requests may be submitted to CMS by sending an email to CMS HHAPU reconsiderations at [email protected] (i) HHA CCN. (ii) HHA Business Name. (iii) HHA Business Address. (iv) CEO or CEO-designated personnel contact information including name, title, telephone number, email address, and mailing address (the address must be a physical address, not a post office box). (v) CMS identified reason(s) for non-compliance as stated in the non-compliance letter. (vi) Reason(s) for requesting reconsideration, including all supporting documentation. (3) CMS does not consider a reconsideration request unless the HHA has complied fully with the submission requirements in paragraphs (d)(1) and (2) of this section. (4)(i) CMS notifies the HHA, in writing, of its final decision regarding any reconsideration request through at least one of the following methods: (A) CMS designated data submission system. (B) The United States Postal Service. (C) Email from the CMS Medicare Administrative Contractor (MAC). (ii) CMS grants a timely request for reconsideration, and reverses an initial finding of non-compliance, only if CMS determines that the HHA was in full compliance with the HH QRP requirements for the applicable program year. (5)(i) An HHA may request, and CMS may grant, an extension to file a reconsideration request if, during the period to request a reconsideration as set forth in paragraph (d)(2) of this section, the HHA was affected by an extraordinary circumstance beyond the control of the HHA (for example, a natural or man-made disaster). (ii) HHAs must submit the reconsideration extension request no later than 30 calendar days from the date of the written notification of noncompliance. (iii) The reconsideration extension request must— (A) Be submitted to CMS via email to CMS HHAPU reconsiderations at [email protected] (B) Contain all the following information: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 (6) CMS notifies the HHA in writing of its final decision regarding the HHA's request for an extension to file a reconsideration of noncompliance request via an email from CMS. (e) Appeals. [84 FR 60645, Nov. 8, 2019, as amended at 87 FR 66886, Nov. 4, 2022; 88 FR 77878, Nov. 13, 2023; 90 FR 55619, Dec. 2, 2025] § 484.250 OASIS data. An HHA must submit to CMS the OASIS data described at § 484.55(b) and (d) as is necessary for CMS to administer the payment rate methodologies described in §§ 484.215, 484.220, 484.230, 484.235, and 484.240. [84 FR 60646, Nov. 8, 2019] § 484.260 Limitation on review. An HHA is not entitled to judicial or administrative review under sections 1869 or 1878 of the Act, or otherwise, with regard to the establishment of the payment unit, including the national 60-day prospective episode payment rate, adjustments and outlier payments. An HHA is not entitled to the review regarding the establishment of the transition period, definition and application of the unit of payments, the computation of initial standard prospective payment amounts, the establishment of the adjustment for outliers, and the establishment of case-mix and area wage adjustment factors. § 484.265 Additional payment. An additional payment is made to a home health agency in accordance with § 476.78 of this chapter for the costs of sending requested patient records to the QIO in electronic format, by facsimile, or by photocopying and mailing. [85 FR 59026, Sept. 18, 2020] Subpart F—Home Health Value-Based Purchasing (HHVBP) Models Source: 80 FR 68718, Nov. 5, 2015, unless otherwise noted. HHVBP Model Components for Competing Home Health Agencies Within State Boundaries for the Original HHVBP Model § 484.300 Basis and scope of subpart. This subpart is established under sections 1102, 1115A, and 1871 of the Act (42 U.S.C. 1315a), which authorizes the Secretary to issue regulations to operate the Medicare program and test innovative payment and service delivery models to improve coordination, quality, and efficiency of health care services furnished under Title XVIII. § 484.305 Definitions. As used in this subpart— Applicable measure (1) Twenty home health episodes of care per year for the OASIS-based measures; (2) Twenty home health episodes of care per year for the claims-based measures; or (3) Forty completed surveys for the HHCAHPS measures. Applicable percent (1) For CY 2018, 3-percent. (2) For CY 2019, 5-percent. (3) For CY 2020, 6-percent. (4) For CY 2021, 7-percent. Benchmark Competing home health agency or agencies (1) That has or have a current Medicare certification; and, (2) Is or are being paid by CMS for home health care delivered within any of the states specified in § 484.310. Home health prospective payment system (HH PPS) Larger-volume cohort Linear exchange function New measures Payment adjustment Performance period Selected state(s) Smaller-volume cohort Total Performance Score Value-based purchasing [80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 82 FR 51752, Nov. 7, 2017; 86 FR 62422, Nov. 9, 2021] § 484.310 Applicability of the Home Health Value-Based Purchasing (HHVBP) Model. (a) General rule. (b) Selected states. § 484.315 Data reporting for measures and evaluation and the public reporting of model data under the Home Health Value-Based Purchasing (HHVBP) Model. (a) Competing home health agencies will be evaluated using a set of quality measures. (b) Competing home health agencies in selected states will be required to report information on New Measures, as determined appropriate by the Secretary, to CMS in the form, manner, and at a time specified by the Secretary, and subject to any exceptions or extensions CMS may grant to home health agencies for the Public Health Emergency as defined in § 400.200 of this chapter. (c) Competing home health agencies in selected states will be required to collect and report such information as the Secretary determines is necessary for purposes of monitoring and evaluating the HHVBP Model under section 1115A(b)(4) of the Act (42 U.S.C. 1315a). [80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 84 FR 60646, Nov. 8, 2019; 85 FR 27628, May 8, 2020; 86 FR 62422, Nov. 9, 2021] § 484.320 Calculation of the Total Performance Score. A competing home health agency's Total Performance Score for a model year is calculated as follows: (a) CMS will award points to the competing home health agency for performance on each of the applicable measures excluding the New Measures. (b) CMS will award points to the competing home health agency for reporting on each of the New Measures worth up to ten percent of the Total Performance Score. (c)(1) For performance years 1 through 3, CMS will sum all points awarded for each applicable measure excluding the New Measures, weighted equally at the individual measure level to calculate a value worth 90 percent of the Total Performance Score. (2) For performance years 4 and 5, CMS will sum all points awarded for each applicable measure within each category of measures (OASIS-based, claims-based and HHCAHPS) excluding the New Measures, weighted at 35 percent for the OASIS-based measure category, 35 percent for the claims-based measure category, and 30 percent for the HHCAHPS measure category when all three measure categories are reported, to calculate a value worth 90 percent of the Total Performance Score. (d) The sum of the points awarded to a competing HHA for each applicable measure and the points awarded to a competing HHA for reporting data on each New Measure is the competing HHA's Total Performance Score for the calendar year. [80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 83 FR 56630, Nov. 13, 2018] § 484.325 Payments for home health services under Home Health Value-Based Purchasing (HHVBP) Model. CMS will determine a payment adjustment up to the maximum applicable percentage, upward or downward, under the HHVBP Model for each competing home health agency based on the agency's Total Performance Score using a linear exchange function. Payment adjustments made under the HHVBP Model will be calculated as a percentage of otherwise-applicable payments for home health services provided under section 1895 of the Act (42 U.S.C. 1395fff). § 484.330 Process for determining and applying the value-based payment adjustment under the Home Health Value-Based Purchasing (HHVBP) Model. (a) General. (b) Calculation of the value-based payment adjustment amount. (c) Calculation of the payment adjustment percentage. § 484.335 Appeals process for the Home Health Value-Based Purchasing (HHVBP) Model. (a) Requests for recalculation Matters for recalculation. (i) Interim performance scores. (ii) Annual total performance scores. (iii) Application of the formula to calculate annual payment adjustment percentages. (2) Time for filing a request for recalculation. (3) Content of request. (ii) The basis for requesting recalculation to include the specific quality measure data that the HHA believes is inaccurate or the calculation the HHA believes is incorrect. (iii) Contact information for a person at the HHA with whom CMS or its agent can communicate about this request, including name, email address, telephone number, and mailing address (must include physical address, not just a post office box). (iv) The HHA may include in the request for recalculation additional documentary evidence that CMS should consider. Such documents may not include data that was to have been filed by the applicable data submission deadline, but may include evidence of timely submission. (4) Scope of review for recalculation. (5) Recalculation decision. (b) Requests for reconsideration Matters for reconsideration. (2) Time for filing a request for reconsideration. (3) Content of request. (ii) The basis for requesting reconsideration to include the specific quality measure data that the HHA believes is inaccurate or the calculation the HHA believes is incorrect. (iii) Contact information for a person at the HHA with whom CMS or its agent can communicate about this request, including name, email address, telephone number, and mailing address (must include physical address, not just a post office box). (iv) The HHA may include in the request for reconsideration additional documentary evidence that CMS should consider. Such documents may not include data that was to have been filed by the applicable data submission deadline, but may include evidence of timely submission. (4) Scope of review for reconsideration. (5) Reconsideration decision. [81 FR 76796, Nov. 3, 2016] HHVBP Model Components for Competing Home Health Agencies (HHAs) for HHVBP Model Expansion—Effective January 1, 2022 Source: 86 FR 62422, Nov. 9, 2021, unless otherwise noted. § 484.340 Basis and scope of this subpart. This subpart is established under sections 1102, 1115A, and 1871 of the Act (42 U.S.C. 1315a), which authorizes the Secretary to issue regulations to operate the Medicare program and test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care furnished to individuals under Titles XVIII and XIX of the Act. § 484.345 Definitions. As used in this subpart— Achievement threshold Applicable measure (1) Twenty home health episodes of care per year for each of the OASIS-based measures. (2) Twenty home health episodes of care per year for each of the claims-based measures. (3) Forty completed surveys for each component included in the HHCAHPS survey measure. Applicable percent Benchmark Competing home health agency or agencies (HHA or HHAs) (1) Has or have a current Medicare certification; and (2) Is or are being paid by CMS for home health care services. HHA baseline year Home health prospective payment system (HH PPS) Improvement threshold Larger-volume cohort Linear exchange function Model baseline year Nationwide Payment adjustment Payment year Performance year Pre-Implementation year Smaller-volume cohort Total Performance Score (TPS) [86 FR 62422, Nov. 9, 2021, as amended at 87 FR 66887, Nov. 4, 2022] § 484.350 Applicability of the Expanded Home Health Value-Based Purchasing (HHVBP) Model. (a) General rule. (b) New HHAs. (1) The HHA baseline year is the first full calendar year of services beginning after the date of Medicare certification. (2) The first performance year is the first full calendar year following the HHA baseline year. (c) Existing HHAs. [86 FR 62422, Nov. 9, 2021, as amended at 87 FR 66887, Nov. 4, 2022] § 484.355 Data reporting for measures and evaluation and the public reporting of model data under the expanded Home Health Value-Based Purchasing (HHVBP) Model. (a) Competing home health agencies will be evaluated using a set of quality measures. (1) Data submission. (i) Data on measures specified under the expanded HHVBP model. (ii) HHCAHPS survey data. For purposes of HHCAHPS Survey data submission, the following additional requirements apply: (A) Survey requirements. (B) CMS approval. (C) Definition of survey of individuals. (D) Administration of the HHCAHPS survey. (E) Compliance by HHCAHPS survey vendors. (F) Patient count exemption. (2) [Reserved] (b) Competing home health agencies are required to collect and report such information as the Secretary determines is necessary for purposes of monitoring and evaluating the expanded HHVBP Model under section 1115A(b)(4) of the Act (42 U.S.C. 1315a). (c) For each performance year of the expanded HHVBP Model, CMS publicly reports applicable measure benchmarks and achievement thresholds for each cohort as well as all of the following for each competing HHA that qualified for a payment adjustment for the applicable performance year on a CMS website: (1) The Total Performance Score. (2) The percentile ranking of the Total Performance Score. (3) The payment adjustment percentage. (4) Applicable measure results and improvement thresholds. (d) CMS may grant an exception with respect to quality data reporting requirements in the event of extraordinary circumstances beyond the control of the HHA. CMS may grant an exception as follows: (1) A competing HHA that wishes to request an exception with respect to quality data reporting requirements must submit its request to CMS within 90 days of the date that the extraordinary circumstances occurred. Specific requirements for submission of a request for an exception are available on the CMS website. (2) CMS may grant an exception to one or more HHAs that have not requested an exception if CMS determines either of the following: (i) That a systemic problem with CMS data collection systems directly affected the ability of the HHA to submit data. (ii) That an extraordinary circumstance has affected an entire region or locale. § 484.358 HHVBP Measure removal factors. CMS may remove a quality measure from the expanded HHVBP Model based on one or more of the following factors: (a) Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made (that is, topped out). (b) Performance or improvement on a measure does not result in better patient outcomes. (c) A measure does not align with current clinical guidelines or practice. (d) A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available. (e) A measure that is more proximal in time to desired patient outcomes for the particular topic is available. (f) A measure that is more strongly associated with desired patient outcomes for the particular topic is available. (g) Collection or public reporting of a measure leads to negative unintended consequences other than patient harm. (h) The costs associated with a measure outweigh the benefit of its continued use in the program. (i) It is not feasible to implement the measure specifications. [88 FR 77878, Nov. 13, 2023, as amended at 90 FR 55619, Dec. 2, 2025] § 484.360 Calculation of the Total Performance Score. A competing HHA's Total Performance Score for a performance year is calculated as follows: (a) CMS awards points to the competing home health agency for performance on each of the applicable measures. (1) CMS awards greater than or equal to 0 points and less than 10 points for achievement to each competing home health agency whose performance on a measure during the applicable performance year meets or exceeds the applicable cohort's achievement threshold but is less than the applicable cohort's benchmark for that measure. (2) CMS awards greater than 0 but less than 9 points for improvement to each competing home health agency whose performance on a measure during the applicable performance year exceeds the improvement threshold but is less than the applicable cohort's benchmark for that measure. (3) CMS awards 10 points to a competing home health agency whose performance on a measure during the applicable performance year meets or exceeds the applicable cohort's benchmark for that measure. (b) For all performance years, CMS calculates the weighted sum of points awarded for each applicable measure within each category of measures (OASIS-based, claims-based, and HHCAHPS Survey-based) weighted at 35 percent for the OASIS-based measure category, 35 percent for the claims-based measure category, and 30 percent for the HHCAHPS survey measure category when all three measure categories are reported, to calculate a value worth 100 percent of the Total Performance Score. (1) Where a single measure category is not included in the calculation of the Total Performance Score for an individual HHA, due to insufficient volume for all of the measures in the category, the remaining measure categories are reweighted such that the proportional contribution of each remaining measure category is consistent with the weights assigned when all three measure categories are available. Where two measure categories are not included in the calculation of the Total Performance Score for an individual HHA, due to insufficient volume for all measures in those measure categories, the remaining measure category is weighted at 100 percent of the Total Performance Score. (2) When one or more, but not all, of the measures in a measure category are not included in the calculation of the Total Performance Score for an individual HHA, due to insufficient volume for at least one measure in the category, the remaining measures in the category are reweighted such that the proportional contribution of each remaining measure is consistent with the weights assigned when all measures within the category are available. (c) The sum of the weight-adjusted points awarded to a competing HHA for each applicable measure is the competing HHA's Total Performance Score for the calendar year. A competing HHA must have a minimum of five applicable measures to receive a Total Performance Score. § 484.365 Payments for home health services under the Expanded Home Health Value-Based Purchasing (HHVBP) Model. CMS determines a payment adjustment up to the applicable percent, upward or downward, under the expanded HHVBP Model for each competing HHA based on the agency's Total Performance Score using a linear exchange function that includes all other HHAs in its cohort that received a Total Performance Score for the applicable performance year. Payment adjustments made under the expanded HHVBP Model are calculated as a percentage of otherwise-applicable payments for home health services provided under section 1895 of the Act (42 U.S.C. 1395fff). § 484.370 Process for determining and applying the value-based payment adjustment under the Expanded Home Health Value-Based Purchasing (HHVBP) Model. (a) General. (b) Calculation of the value-based payment adjustment amount. (c) Calculation of the payment adjustment percentage. (1) The applicable percent as defined in § 484.345. (2) The competing HHA's Total Performance Score divided by 100. (3) The linear exchange function slope. [86 FR 62422, Nov. 9, 2021, as amended at 87 FR 66887, Nov. 4, 2022] § 484.375 Appeals process for the Expanded Home Health Value-Based Purchasing (HHVBP) Model. (a) Requests for recalculation Matters for recalculation. (i) Interim performance scores. (ii) Annual total performance scores. (iii) Application of the formula to calculate annual payment adjustment percentages. (2) Time for filing a request for recalculation. (3) Content of request. (ii) The basis for requesting recalculation to include the specific data that the HHA believes is inaccurate or the calculation the HHA believes is incorrect. (iii) Contact information for a person at the HHA with whom CMS or its agent can communicate about this request, including name, email address, telephone number, and mailing address (must include physical address, not just a post office box). (iv) The HHA may include in the request for recalculation additional documentary evidence that CMS should consider. Such documents may not include data that was to have been filed by the applicable data submission deadline, but may include evidence of timely submission. (4) Scope of review for recalculation. (5) Recalculation decision. (b) Requests for reconsideration Matters for reconsideration. (2) Time for filing a request for reconsideration. (3) Content of request. (ii) The basis for requesting reconsideration to include the specific data that the HHA believes is inaccurate or the calculation the HHA believes is incorrect. (iii) Contact information for a person at the HHA with whom CMS or its agent can communicate about this request, including name, email address, telephone number, and mailing address (must include physical address, not just a post office box). (iv) The HHA may include in the request for reconsideration additional documentary evidence that CMS should consider. The documents may not include data that was to have been filed by the applicable data submission deadline, but may include evidence of timely submission. (4) Scope of review for reconsideration. (5) Reconsideration decision. (A) Renders a final determination reversing or modifying the reconsideration decision; or (B) Does not review the reconsideration decision within 14 days of the request. (ii) An HHA may request that the CMS Administrator review the reconsideration decision within 7 calendar days of the decision. (iii) If the CMS Administrator receives a request to review, the CMS Administrator must do one of the following: (A) Render a final determination based on his or her review of the reconsideration decision. (B) Decline to review a reconsideration decision made by CMS. (C) Choose to take no action. (iv) If the CMS Administrator does not review an HHA's request within 14 days (as described in paragraph (b)(5)(iii)(B) or (C) of this section), the reconsideration official's written reconsideration decision is final. [86 FR 62422, Nov. 9, 2021, as amended at 88 FR 77879, Nov. 13, 2023]

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