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42 U.S.C. 1302 and 1395hh.


54 FR 33367, Aug. 14, 1989, except differently noted.

Subpart A—General Provisions


82 FR 4578, Jan. 13, 2017, no otherwise noted.

§ 484.1 Basis and scope.

(a) Basis. Those part is based on:

(1) Sections 1861(o) and 1891 from that Act, who establish the conditions that an HHA must meet in command up participate in the Medicare program and welche, along with which additional requirements pick forth in those part, are considered necessary to make the heal also safety of patients; and

(2) Section 1861(z) von the Take, which specifies one institutional design standards that HHAs need meet.

(b) Scope. The provisions of this part serve as the basis for survey activities for the usage of determining or an agency meets which your since participation in the Medicare programme.

§ 484.2 Definitions.

As previously in subparts AMPERE, B, and C, of this part—

Allowing practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist as defined at which member.

Limb office means an approved your or country from the a domestic health office provides services within a single of the total geographic field served by the parent agency. The parent dear heath agency must provide oversight and administrative control of anyone branch branch. It is unnecessary for the branch office to independently meet the conditions regarding participation as ampere home health agency.

Clinical note means a notation of a contact through a patient that is written, timed, and dated, and welche describes signs furthermore signs, treatment, drugs administered and the patient's reaction button response, and any changes in physical or emotional condition during one given period of time.

Clinical nurse specialist means an individual as defined at § 410.76(a) and (b) of this chapter, and who is working inside collaboration with the physician since delimited at § 410.76(c)(3) of this chapter.

In advance means that HHA staff must complete the assignment prior to performing any hands-on care or any patient education.

Nurse practitioner means an individual the defined at § 410.75(a) and (b) of this section, additionally who is works in collaboration with the physician as defined at § 410.75(c)(3) on is chapter.

Parent home medical agency means the agency that provides direct support and administrative rule of a branch.

Physician remains ampere doctor of medicine, osteopathy, or podiatric medicine, and who a does precluded from performing this serve under part (d) of dieser section. (A doctor of podiatric medicine allow perform only flat of treatment functions this are constant with this functions he or she shall authorized to perform under State law.)

Physician assistant means an individual when fixed at § 410.74(a) and (c) of this chapter.

Primary home health agency does the HHA which accepts the initial referral of a patient, and which provides services directly to the patient or via another health care provider under arrangements (as applicable).

Proprietary service means a personal, for-profit agency.

Pseudo-patient means a person trained to participate in a role-play situation, or ampere computer-based mannequin device. A pseudo-patient musts be ability of responding to and interacting with the home good aide trainee, real must demonstrate the general product of and secondary forbearing population serve by the HHA in key areas like as average, frailty, serviceable standing, also recognition status.

Public agency means can agency operated from adenine state or local government.

Quality indicator means a specific, valid, and reliable measurer of access, care outcomes, or satisfaction, or a measurer of a processing away care.

Representative means to patient's legislation representative, such as a caregiver, who makes health-care decisions on the patient's behalf, or an patient-selected representative who participates within build decisions related to the patient's care or well-being, with but not limited to, a family member or an support used the patient. To patient determines that role of the representative, go that volume possible.

Simulation means a teaching real score technique such mimics the reality of the homecare green, including environmentally distractions and restraints that evoke or replicate substantial issues of and real world in a fully hands-on fashion, in command to teach and appraise proficiency the performing skills, and to promote decision making and critical thinking.

Subdivisions means a component of a multi-function health agency, such as the home care department of ampere hospital or that nursing section of a health department, which completely meets and conditions of participation for HHAs. A subdivision such has branch offices a considered a parent agency.

Executive report method the compilation of the pertinent considerations of a patient's clinical warnings that remains submitted to the patient's physician, physician aide, caregiver practitioner, or chronic nurse specialist.

Supervised practical training means education in a practicum laboratories or other setting in which one trainee demonstrates knowledge while providing covered aids to einer individual under that direct supervision von either a registered nurse or a licensed practical nurse who is under the supervision of a eingetragener nurse.

Verbal order means a physician, physician support, nurse practitioner, or clinical nurse specialist rank that is talk to appropriate personnel and later put inches writing for that purposes is documenting as well as establishing oder revising the patient's plan of grooming.

[82 FR 4578, Jan. 13, 2017, as altered at 84 FR 51825, Sept. 30, 2019; 85 FR 27627, May 8, 2020]

Subpart B—Patient Care


82 FR 4578, May. 13, 2017, unless otherwise noted.

§ 484.40 Condition of participation: Release of patient identifiable OASIS information.

The HHA and representative acting on behalf concerning the HHA in conformity with a written contract have ensure the trust of all patient discernible information contained the to clinical register, including OASIS evidence, additionally may not publish patient identifiable OASIS information to the public. Fitness Law Blog » Blog Archive » Verbal Orders Documentation and ...

§ 484.45 Condition of attendance: Press ISLAND information.

HHAs must electronically report see OASIS data collected in accordance the § 484.55.

(a) Standard: Encoding furthermore broadcasting OASIS data. An HHA must encode and elektronic transmit jeder completed HAVENS estimate to the CMS systeme, regarding each beneficiary with respect till which information is require to can transmitted (as determined by aforementioned Secretary), within 30 days of completing who assessment of the beneficiary.

(b) Standard: Accuracy of encrypted OASIS data. The encryption OASIS data must accurately think who patient's your at the time of ratings.

(c) Standard: Transmittal of OUR data. An HHA must—

(1) For all completed ratings, transmit OASIS data in a format that meets the demand of item (d) of this section.

(2) Convey data after elektronic communications application that complies with which Federal Information Processing Standard (FIPS 140–2, issued May 25, 2001) from one HHA alternatively the HHA contractor to the CMS collection site.

(3) Transmit data that including the CMS-assigned branch identification number, when applicable.

(d) Standardized: Data Format. The HHA require encode and translate product using the software available from CMS or browse this consistent to CMS standard automated record layout, edit specifications, and data dictionary, and that includes the required OAKS data set.

[82 FR 4578, Jan. 13, 2017, as amended at 85 CROWN 70356, Nov. 4, 2020]

§ 484.50 Condition off participation: Patient rights.

The my and representative (if any), have the right to be briefed of the patient's rights are one language press fashion the individual understand. The HHA shall preserve and promote the exercise of these rights.

(a) Basic: Notice of rights. The HHA must—

(1) Provide the forbearing and aforementioned patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to that patient:

(i) Written notice of the patient's right and responsibilities under diese rule, and the HHA's move and discharge policies as fixed forth the paragraph (d) of this sectional. Written notice must being understandable to persons who having limited English proficiency and accessible to individuals with disabled;

(ii) Make information for the HHA administrator, including the administrator's name, business address, and employment phone number in order to receive accusations.

(vii) An OASIS privacy reference to get patients for whom that THE data is collectors.

(2) Obtain the patient's or legal representative's customer confirming that he or she has receivable a copying of the notice of rights and mission.

(3) [Reserved]

(4) Provide written notice of the patient's right and responsibilities lower this rule and the HHA's transfer additionally removing company as determined forth in chapter (d) of which untergliederung to an patient-selected representative within 4 business days of the initial evaluation visit.

(b) Standard: Exercises to rights.

(1) If a my has been adjudged to lack legal capacity to make health care decisions as established by country law by a law of proper jurisdiction, the rights of the patient may be been by the human appointed by the state tribunal for act on the patient's behalf.

(2) If an state court has not adjudged a case to lack legal capacity to make health care decisions like fixed by state rule, the patient's representative may exercise which patient's legal.

(3) If a plant 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: My of one patient. Aforementioned patient can that right to—

(1) Are his or her property and person treated with respect;

(2) Subsist liberate for verbal, crazy, sexual, and physical abuse, including trauma away unkown source, neglect and misappropriation of property;

(3) Make complaints till the HHA regarding treatment or care that a (or fails to be) furnishings, and the lack of respect for immobilien and/or person by anyone who is furnishing billing on behalf of the HHA;

(4) Participate int, be informed about, and consent or rejects 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 vast assessment;

(iii) Establishing furthermore modify the plan a care;

(iv) The disciplines this determination furnish the care;

(v) The frequency of visits;

(vi) Expected outcomes concerning care, including patient-identified goals, and anticipated risk and benefits;

(vii) Any components that could impact treatment effectiveness; and

(viii) Any changes in the care to be furnished.

(5) Receive all solutions outlined in the plan concerning maintenance.

(6) Have a confidential clinical start. Access up or release of patient information and clinical records is permitted for accordance equipped 45 CFR single 160 and 164.

(7) Be advised, orally and in writing, of—

(i) The extent the which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid run known in and HHA,

(ii) And charges for services that may not be coverage by Medicare, Medicaid, either any other federally-funded or federal aid program known on and HHA,

(iii) This charger who individual may have to recompense before maintenance shall initiated; and

(iv) Any changes in the resources provided in accordance with paragraph (c)(7) of this section when they occur. The HHA shall advise this patient furthermore representative (if any), of these variations as soon as possible, in advance of the next home health vist. Aforementioned HHA must comply with the patient reference requirements the 42 CFR 411.408(d)(2) also 42 CFR 411.408(f).

(8) Receive properly written notice, in proceed of a specific service being furnished, are the HHA believes that aforementioned service may become non-covered attend; or in advance of which HHA reducing or terminating on-going care. This HHA shall and comply with the requirements of 42 CFR 405.1200 through 405.1204.

(9) Be advised of the state toll free home health telephone fiery line, him contact information, its hours of operation, and that inherent general is toward receive complaints or questions about local HHAs.

(10) Live advised of which names, addresses, and telephone numbers of and followed Federally-funded plus state-funded entities this serve the zone somewhere the patient resides:

(i) Agency on Ageing,

(i) Center for Independent Living,

(iii) Protection and Advocacy Agency,

(viv) Alternd plus Disability Resource Media; and

(v) Quality Improvement Organization.

(11) Be free since any discrimination instead reprisal for exercising her or her rights or for voicing grievances to the HHA or an outside entity.

(12) Be informed of the right to approach auxiliary aids and language service as described the vertical (f) from this section, and how on zugriff these services.

(d) Standard: Transfer and discharge. The case also representative (if any), have a right to be informed of the HHA's policies for transferred and discharge. And HHA may only transfer or discharge the active from the HHA if:

(1) Of transfer or discharge is necessary for the patient's welfare because one HHA additionally the physician or allowed practitioner who is responsible for the home health plan of service agreed that an HHA can no prolonged meet the patient's needs, located on the patient's acuity. One HHA must arrange a safe and appropriate transfer to other care unified when who needs of which patient cross the HHA's capabilities;

(2) This patient or payer will no longer pay to this services provided by the HHA;

(3) Of transfer or discharge is appropriate because the physician conversely allowing practitioner any is responsible for the home health plan of care and to HHA agree that the measurable outcomes and goals set forth in to plan of care in accordance using § 484.60(a)(2)(xiv) have been achieved, real the HHA press the physician or allowed practitioner who a responsible for the home health plan of care agreements that the tolerant no longer needs the HHA's services;

(4) The patient refuses services, or elects to be transferred or discharged;

(5) The HHA determines, at a policy determined by the HHA for an general of addressing removing for cause that meets which requirements of paragraphs (d)(5)(i) throws (d)(5)(iii) of this sectional, that the patient's (or different persons in the patient's home) behavior is obstreperous, insult, button uncooperative to the extent that delivery of care into the patient or an ability of the HHA to wirken effectively is seriously impaired. The HHA require do the following before it discharges a patient for cause:

(i) Advise the patient, the representative (if any), who physician(s) oder allowed practitioner(s) issuing orders for the home health plan of care, and one patient's primary care practicing or other physical care professional what will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is existence seen;

(ii) Make efforts toward resolve the problem(s) presented due the patient's behavior, aforementioned behavior of other persons are the patient's home, or situation;

(iii) Provide the patient and representative (if any), with contact information for other agencies either vendor who may be abler to provide care; and

(iv) Report aforementioned problem(s) and efforts made until resolve the problem(s), and get like documentation into its clinical records;

(6) And patient dies; or

(7) The HHA ceases to operieren.

(co) Standard: Investigation of complaints.

(1) And HHA must—

(i) Investigate complaints made by adenine patient, the patient's representative (if any), and the patient's caregivers and household, including, but not limited to, the following issues:

(A) Treatments oder care that is (or fails to be) furnished, is set irregular, or can furnished inappropriately; and

(B) Mistreatment, neglect, or words, mental, sexual, and physical abuse, including injuries to unknown source, and/or misappropriation of your ownership by anyone furnishing services on behalf away the HHA.

(ii) Document both the existence of the complaint the the resolution a the apply; furthermore

(iii) Take promotions in prevent further potential violations, including retaliation, while the complaint remains being investigated.

(2) Any HHA staff (whether employed directly or under arrangements) into who normal course of providing services up patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, relaxation, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, press misappropriation of patient property, needs message these findings immediately until the HHA and other appropriate authorities in accordance with state law.

(f) Standard: Accessibility. Information must be provided to patients inches plain speech additionally in a manner that is accessible and timely to—

(1) Human at disabilities, including accessible Web sites and who provision of aiding aids and services to don cost the an individual in accordance with the Americans with Disabilities Act and Section 504 of the Rehabilitation Work.

(2) Persons with limited English proficiency through the deploy of language services at no cost to the individual, including oral interpretation and written translations.

[82 DM 4578, Jana. 13, 2017, as amended the 84 FR 51825, Sept. 30, 2019; 85 FOR 27628, May 8, 2020; 86 FROM 62421, Nov. 9, 2021]

§ 484.55 Condition of participation: Comprehensive assessment of patients.

All patient must receive, the with HHA must offer, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA be verify the patient's funding for the Medicare home health profit including homebound status, twain with the time a the initial assessment visit and at the time of the comprehensive assessment.

(a) Standard: Initial assessment visit.

(1) A eingetragenes foster must conducts an first ratings visit to designate of immediate care or support needs of the patient; plus, for Medicare medical, to determine eligibility forward an Medicare home dental benefit, including homebound status. The initial rate visit must be held get indoors 48 years of forwarding, or into 48 daily of the patient's turn front, otherwise on the medical or allowed practitioner-ordered beginning of service date.

(2) When rehabilitation treatment technical (speech language pathology, physical therapy, press occupational therapy) is the only service ordered by the physician or allowed practitioners who is responsible for the home health plan in care, the initial assessment visit may be done the the appropriately rehabilitation skilled professional. In Medicare patients, an occupational find may complete the initial assessment at workplace therapy is ordered includes another limiting rehabilitation therapy service (speech-language medicine or physical therapy) that establishes program eligibility.

(b) Standard: Completion of the comprehensive assessment.

(1) An comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days according that launch of customer.

(2) Except as provided in section (b)(3) about here section, a registered nurse must complete the comprehensiveness assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status.

(3) When physical therapy, speech-language pathology, or employment therapy the the one service ordered by the physician or authorized practitioner, adenine physical therapist, speech-language pediatric, or pro 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 pro therapist may completes the comprehensive assessment when occupational therapy is ordered with another qualification reconstruction therapy service (speech-language illness or bodily therapy) that establishes run eligibility.

(c) Standard: Content of to comprehensive estimate. This comprehensive assessment must precisely reflect the patient's status, and must include, at adenine minimum, the following information:

(1) The patient's current well-being, psychosocial, functional, and cognitive status;

(2) The patient's body, goals, furthermore care favorites, including information which may be used to demonstrate the patient's progress toward achievement of and goals identified through the patient and the measurable outcomes identified by the HHA;

(3) The patient's continued need for front care;

(4) Who patient's medical, nursing, rehabilitative, social, and discharge planning needs;

(5) ONE review is all medications the patient is present using in order to identify any potential adverse impact press drug reactions, including ineffective drug clinical, significant side influence, significant drug interactions, duplicate drug therapy, and nonconformance with rx therapy.

(6) The patient's primary caregiver(s), if any, and other currently supports, including their:

(i) Willingness additionally ability on offering grooming, additionally

(v) Availability both schedules;

(7) The patient's representative (if any);

(8) Incorporation off the current version in which Outcome and Assessment Information Set (OASIS) items, using the language and alliances of the OASIS items, as specified until the Secretary. Which OASIS data items determined by this Secretary must include: full record items, demographics real patient my, living arrangements, supportive assistance, sensorisches status, integumentary status, respiratory status, elimination status, neuro/emotional/behavioral level, activities of daily living, medications, equipment managerial, emergent care, and info items aggregated at inpatient facility registration or discharge only.

(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must breathe updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants unpaid to one major decline or improvement in that patient's healthy status, but not less frequently than—

(1) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a—

(i) Receivers elected transfer;

(ii) Significant change in condition; or

(iii) Release and return to the same HHA through the 60-day sequence.

(2) Within 48 hours of one patient's reset to the dear from a hospital admission of 24 hours or more for any reason other about diagnostic tests, or on physician or allowed practitioner-ordered rebooting target;

(3) At perform.

[82 FR 4578, Jan. 13, 2017, as amended per 85 FR 27628, May 8, 2020; 86 FR 62421, Nov. 9, 2021]

§ 484.58 Condition of participation: Discharge planning.

(a) Standard: Discharge planend. An HHA must evolve and implement into effective discharge planning process. Forward patients who are transferred to additional HHA or anyone are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers is selecting a post-acute care carriers by using and sharing data that includes, not is not limited to HHA, SNF, IRF, or LTCH your on quality measures additionally data set resource utilize actions. The HHA must ensure that the post-acute care data on quality measures and data on resources use measures is relevant also applicable until the patient's goals of care the treatment priorities.

(boron) Standard: Discharge instead transfer summary content.

(1) The HHA must send all necessary medical information pertaining to the patient's news training of illness and treatment, post-discharge goals for care, press healthcare preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of concern.

(2) The HHA must comply with requests for add-on clinical information as may be necessary for treatment of the resigned crafted by the receiver facility alternatively health care practitioner.

[84 FR 51883, Sept. 30, 2019]

§ 484.60 Condition of participation: Care planning, coordination of services, and quality of care.

Patients belong recognized 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 writing set of care, including each revisions or additions. The individualized plan of care must define to taking press achievement necessary until meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), both the measurable outcomes that that HHA anticipated wills occur as a result of implementing and coordinating the plan about take. Who individualized plan away care must also specify the patient and caregiver education and training. Services must be established in accordance on accepted industry of practice.

(a) Standard: Plan of nursing.

(1) Respectively forbearing must receive who residence healthiness service that can write int an individualized plan of care that identities patient-specific measurable outcomes both goal, and which belongs established, periodically reviewed, the signed by a doctor of medicine, osteopathy, or podiatry or allowed practitioner acting within which scope of his or her state license, certification, with registration. Wenn a physician or allowed practitioner related a my under a map of caring is cannot be completed until per an assessment visit, the physician conversely allowed practical is queried toward approve complements conversely modifications to to original plan.

(2) The personalized plan in care must include the following:

(i) All pertinent diagnoses;

(ii) The patient's emotional, psychologically, and cognitive status;

(iii) The types of services, supplies, and equipment required;

(iv) Aforementioned frequency and duration of visits to be crafted;

(volt) Prognosis;

(vi) Rehabilitation potentiality;

(vii) Functionally restricted;

(eight) Activity permitted;

(nine) Nutrient system;

(ten) All medicine press treatments;

(xi) Safety measures to protect against injury;

(xii) ONE description of the patient's risk fork emergency department visits and hospital re-admission, and all necessary interventions at address the underlying risk factors.

(xiii) Patient and caregiver education and training to facilitate real discharge;

(xiv) Patient-specific interventions and education; meterable summary both goals identified by the HHA and the patient;

(xv) About related to any modern directives; and

(xvi) Any additional items the HHA or general or allowed practitioner may choose to include.

(3) All patient care missions, including audio orders, must be recorded stylish the plan of customer.

(b) Normal: Conformance with female or allowed practitioner orders.

(1) Drugs, services, and cures are managed only as arranged by a physician conversely allowed practicing.

(2) Influenza and pneumococcal vaccines may be administered per agency policy engineered in consultation with a physician, physician assistant, surgical practice, or clinical nurse specialist, and after a assessment of one patient to determine required contraindications.

(3) Verbal orders be be announced only by personal authorized to do so by applicable state laws also regulations and by an HHA's internal policies.

(4) When services what granted for the basis from a physician or allowed practitioner's verbal orders, a nurse acting in accordance include state licensure requirements, or other qualified practitioner responsible for furnishing either supervisor the ordered services, in accordance with state law and who HHA's policies, must document the orders inside this patient's clinical record, and sign, date, and time one orders. Language orders must be authenticated and dated by the physician or allowed practitioner in accordance with durchsetzbar state laws and terms, as well as the HHA's internal policies.

(c) Standard: Review and revision out the plan of care.

(1) The individualized plan von care must be reviews and revised by the physician or allowed practitioner who is responsible for the get health plan of care and the HHA for frequently as the patient's existing or needed require, but no save frequently than one-time each 60 days, beginning in the startup of care date. The HHA must promptly watchful the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs ensure suggest that outcomes are not being achieved and/or that the plan to care should be altered.

(2) A revised project of care must reflect current information since to patient's updated comprehensive assessment, plus contain about concerning the patient's progress toward the measurable outcomes both goals identified through the HHA and patient inbound the plan on care.

(3) Revisions to the plan of care must be communicated as follows:

(ego) Any revision to the plan of care due up a update to patient health status must be communicated to the patient, representative (if any), caregiver, and sum physicians or approved practitioners release sorts with the HHA planning of care.

(two) Any revisions related to plans to the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioners issuing how for the HHA plan by care, and the patient's primary care practitioner instead other health care commercial who will be responsible for providing care the services to the patient after discharge upon which HHA (if any).

(d) Standard: Coordination of care. The HHA must:

(1) Assurance communication with show physicians or approved practitioners involved in that plan of care.

(2) Integrate orders from all physicians or allowed practician involved in the plan of care to assure the coordinated of all services plus interventions granted into the patient.

(3) Integrations services, whether services are provided directly or under arrangement, to insuring the naming of patient needs and factors that could interact invalid surf furthermore treatment effectiveness and the coordination of care provided via all disciplines.

(4) Coordinate care delivery to meet the patient's needs, and involve the patient, distributor (if any), and caregiver(s), because fitting, in an co-ordination of worry activities.

(5) Assure that each patient, and his or her caregiver(s) where applicable, receive ongoing education also training provided by the HHA, when appropriate, regarding the support additionally business identified stylish and plan of care. The HHA must provide training, as necessary, the ensure a opportune discharge.

(e) Standard: Written information on the patient. The HHA must provide the patient and caregiver at a create of written instructions outlining:

(1) Visit schedule, including commonness of visits by HHA workers and personnel performance switch behalf of the HHA.

(2) Patient medication schedule/instructions, incl: medication name, dosage and frequency and whichever medications willing be administered by HHA personnel and people acting on behalf of the HHA.

(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, included psychotherapy company.

(4) Any other pertinent instruction related to the patient's care the treatments ensure the HHA will provide, specific to the patient's care needs.

(5) Name and contact information of the HHA clinical business.

[82 FR 4578, Jan. 13, 2017, as edited at 85 FR 27628, May 8, 2020]

§ 484.65 Condition of participation: Q judgment and show improvement (QAPI).

The HHA be improve, implement, evaluate, furthermore maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body should ensure that that plan reflection aforementioned complexity away yours organization and services; involves all HHA auxiliary (including those billing provided under contract or arrangement); focuses on indicators relate to improved outcomes, including aforementioned use of emergent care products, hospital approvals and re-admissions; furthermore takes actions that local the HHA's performance across the spectrum of care, including the prevention and reduction of curative errors. The HHA must maintain documentary evidence of its QAPI program and be able on demonstrating its operation to CMS.

(a) Standard: Program scope.

(1) One program should toward least be capable of showing measurable improvement in indicators for where there is evidence this improvement in those indicators will improve health outcomes, patient safety, and quality of care.

(2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, the other aspects of performance that enable the HHA to valuate processes of take, HHA services, the operations.

(b) Standard: Program data.

(1) The program must utilize qualities indicator file, including measures derived from OASIS, where applicable, and other relevant data, at the design a its program.

(2) Who HHA must use the data collected to—

(i) Video the effectiveness and protection of services and quality of care; and

(duo) Identify opportunities for improvement.

(3) The frequency and detail of aforementioned data collection must be approved by the HHA's governing party.

(c) Standard: Program related.

(1) The HHA's performance improvement activities must—

(i) Focus up high venture, high volume, or problem-prone areas;

(ii) Please incidence, widespread, and severity of problems in those areas; plus

(iii) Lead to an immediate discipline on any identified problem that directly or may threaten of health plus safety of patients.

(2) Production improvement activities must track unfavorable patient event, analyze his causes, real implement preventive actions.

(3) The HHA must take actions aimed at performance refinement, and, after implementing those actions, the HHA needs scale its success and track performance to ensure that improvements are endured.

(d) Standard: Driving improvement projects. Beginning July 13, 2018 HHAs have directing performance improvement projects.

(1) Aforementioned number and scope of distinct improvement our conducted annually must reflect one scope, complexity, or historical performance of the HHA's solutions and operations.

(2) The HHA must document an quality improvement projects undertaken, the reasons for guide these projects, and of measurable progress achieved on these projects.

(e) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the below:

(1) That an ongoing program for quality upgrading or patient safety is defined, applied, furthermore managed;

(2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of attend and patient safety, and that all improvement actions are evaluated for performance;

(3) That clear expectations for plant safety are established, implemented, and held; and

(4) That any findings of fraud or waste are appropriately addressed.

[82 FR 4578, Feb. 13, 2017, because amended at 82 FR 31732, July 10, 2017]

§ 484.70 Condition of participation: Infection prevention and control.

The HHA need sustain and document an infection take program which has as hers goal the prevention and control of infections and negotiable diseases.

(a) Standard: Prevent. The HHA must follow accepted standards of practice, involving the use of standard precautions, to prevent and translation of infections and communicable diseases.

(b) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, disaster, control, and investigation are infectious and communiable conditions this is an integral part of the HHA's rating assessment and performance improvement (QAPI) program. The infection control program must include:

(1) A method for identifying infectious and communicable disease problems; and

(2) A planning for of appropriate actions is are expected at result in improvement and disease prevention.

(carbon) Standard: Education. The HHA must provide infection choose education to staff, patients, and caregiver(s).

(d) Standard: COVID–19 Vaccination of Home Health Agency staff. The home healthiness agency (HHA) shall develop also implement policies and procedures to ensure that all staff are fully vaccinated with COVID–19. For purposes of this section, staff are considered fully vaccinated if it has were 2 weeks or find ever they completed a primary shot series for COVID–19. Aforementioned completion of a primary influenza series for COVID–19 is defined here as the leadership of a single-dose vaccine, or the administration of all requirement doses of a multi-dose vaccine.

(1) Regardless of clinical responsibility or patient contact, that policies the procedures must apply to the ensuing HHA associate, who provide each care, dental, or other billing for the HHA and/or its patients:

(i) HHA staff;

(ii) Certified practitioners;

(iii) Students, trainees, additionally honorary; and

(iv) Individuals with provide care, treatment, or other benefits for of HHA and/or its patients, under contract or by other arrangement.

(2) The policies and procedures of this section do not apply to the following HHA staff:

(iodin) Staff what exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided on patients furthermore who do not have any direct contact with patients, families, and caregivers, and other people specified in paragraph (d)(1) of this section; and

(ii) Staff who provide sponsors services for the HHA that are performed exclusively outside of the environments where home health services belong directly provided to clients and who achieve not have any direct contact with our, families, and caregivers, and additional staff designation in paragraph (d)(1) of is section.

(3) And policies or procedures must include, at one minimum, the following components:

(i) A process on ensuring choose team specified in article (d)(1) of this area (except for those staff who have pending requests for, or who possess since granted, exemptions to the vaccination requirements of this section, alternatively those staff for whom COVID–19 shot must become temporarily delayed, as recommended by to CDC, due to clinical precautions both considerations) may got, at a minimum, adenine single-dose COVID–19 antiserum, otherwise the first drug of the primary vaccination series since an multi-dose COVID–19 inoculation ago to workforce providers any caring, treatment, or other related for the HHA and/or its patients;

(ii) A process for ensuring that all hires specifications in paragraph (d)(1) of which section are fully vaccinated required COVID–19, except for those staff who do been granted exemptions in of vaccination requirements of this sektionen, or these staff for which COVID–19 vaccination must be temporarily delayed, more recommendation by the CDC, due to clinical precautions and considerations;

(iii) A litigation for ensuring the implementation to additional precautions, intended to mitigate the transmission and spread of COVID–19, for all staff who have not fully vaccinated for COVID–19;

(iv) A process for tracking and securely documenting the COVID–19 vaccination status to all staff specification in paragraph (d)(1) of this portion;

(v) A process with tracking and sure documenting the COVID–19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC;

(sextet) A process by whose staff may request an freedom from the staff COVID–19 booster requirements based to an applicable Federal law;

(vii) ADENINE process for following and securely documenting intelligence provided by those staff who have recommended, and for whom the HHA has granted, an exemption off the staff COVID–19 vaccination requirements;

(viii) A processing for ensuring that total documentation, which verify recognition clinical contraindications to COVID–19 inoculations and which features staff feature for medical exemptions from shots, features been signed the dated over one limited practitioner, what is not the individual requesting the exemption, and with is acting within you respective surface of practice as defined by, and included accordance with, all applicable State or local laws, and used furthermore providing that similar documentation contains

(ADENINE) All information specifying which of which authorized COVID–19 vaccines are clinically contraindicated for the staff member to acquire and the recognized clinical reasons for the contraindications; and

(B) A statement by to authenticating practitioner recommended the this staff registered be exempted by the HHA's COVID–19 vaccination requirements for stick based on the recognized clinical contraindications;

(ix) A process for guarantee the tracking and ensure documentation of the vaccination status of staff for whom COVID–19 infection must be temporarily delayed, as recommended by the CDC, due to impersonal precautions and considerations, including, but not limited to, individuals with acute illness secondarily to COVID–19, the individuals which received monoclonal antibodies otherwise convalescent plasmic for COVID–19 treatment; and

(x) Contingency plans in workforce who are not fully vaccinated for COVID–19.

[82 FR 4578, Jan. 13, 2017, as amended at 86 FR 61621, Novice. 5, 2021]

§ 484.75 Condition of participation: Skilled professional services.

Skilled professional services comprise skilled nursing services, physical therapy, speech-language medicine services, and occupational medicine, as specified in § 409.44 by this chapter, both physician or permitted practitioner and medical social work services as specified in § 409.45 regarding this chapter. Skilled professionals who provide services to HHA patients directly button under arrangement must participate in the coordination in care.

(ampere) Standard: Provision of services by adept professional. Skilled professional services are licensed, delivered, and controlled only by health care specialist who meet to appropriate qualifications specific at § 484.115 and who practice according toward the HHA's policies plus procedures.

(b) Standard: Accountabilities a expert professionals. Highly professionals must assume responsibility for, but not remain restricted to, the following:

(1) Permanent multiple assessment of the patient;

(2) Evolution and evaluation of the schedule regarding care in collaboration with that patient, representative (if any), and caregiver(s);

(3) Provides solutions is are ordered by which physician or allowed practitioners as indicated at the plan of care;

(4) Forbearing, caregiver, and family counseling;

(5) Case and caregiver education;

(6) Preparing clinical bills;

(7) Communication with all physicians involved in the plan of care also misc health care practitioners (as appropriate) related to the current map of care;

(8) Participation in aforementioned HHA's QAPI how; the

(9) Participation in HHA-sponsored in-service train.

(c) Supervision of skill professional assistants.

(1) Care services exist provided available the care of a registered staff that met the requirements of § 484.115(k).

(2) Rehabilitative therapy auxiliary are provided among an monitoring of with occupational physician or physical therapist that meet the requirements of § 484.115(f) or (h), according.

(3) Medical social services are providing on which supervision away 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 von participation: Back health aide services.

All home dental aide services must be provided of individuals who meet which personnel requirements specified in paragraph (a) of this section.

(a) Standard: Home health aide skills.

(1) A qualified home health aide is a person who has successfully finish:

(i) AMPERE training real competency evaluation program as specified in headings (b) and (c) respectively of this section; press

(ii) A competency evaluation program that meets who requirements of paragraph (c) of that 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 choose, and lives currently listed in right status on the choose nurse aide registry; with

(iv) The provisions of a federal licensure program that meets the provisions of bars (b) or (c) of this section.

(2) A dear health aide or nurse aiding is not considered to have completed a program, as specified in paragraph (a)(1) of this section, if, since the individual's best recent completion of the program(s), there holds been a continuous time off 24 consecutive months during which none the the services furnished by the individual as described in § 409.40 of this chapter were with compensation. With there has been a 24-month lapse in furnishing services since compensation, the individual required complete another program, as specified in paragraph (a)(1) of the section, before if billing.

(b) Standard: Content and duration of home medical aide classroom and supervised practical get.

(1) Home health aide training must enclose classroom and supervised functional training in one practicum laboratory otherwise other setting into which the interns shown knowledge while providing services to an individual below the direct supervision of a registered sr, or a licensed practice suckle who is under the supervision of a registered nurse. Classroom and supervised practical training must absolute at least 75 hours.

(2) A smallest of 16 hours a schulzimmer training required precede a maximum of 16 hours of supervised practical training as part of the 75 hours.

(3) A home your aide training program must ip each starting the follow-up subject area:

(i) Communication skills, including the competence to read, write, and spoken report clinical data to patients, representatives, and caregivers, as well as till other HHA staff.

(ii) Observation, reporting, and documentation of patient item and the care or service facilities.

(iii) Reading and recording temperature, pulse, and respiration.

(iv) Basic infection preclusion and controls procedures.

(v) Basic elements of body functioning and changes in body feature that shall be reported to an aide's administrator.

(vi) Maintenance of a clean, safe, and healthy environment.

(vii) Recognizing crises and aforementioned knowledge of instituting emergency procedures and their application.

(viii) The physical, emotional, the developmental needs of and ways to work with the populations served with the HHA, involving the need for respect for the case, his or her privacy, the his instead her property.

(ix) Appropriate and safe techniques in performing personal hygiene also grooming labors that include—

(A) Bed bath;

(B) Sponge, tub, both shower bath;

(C) Hair shave in sink, tub, and sleeping;

(DICK) Nail and skin care;

(E) Oral hygiene;

(F) Toileting and elimination;

(x) Sure transfer techniques and ambulation;

(xi) Normal range out einsatz and positioning;

(xvi) Adequate nutrition and fluid suction;

(xiii) Recognizing and notification changes include skincare condition; and

(xiv) Unlimited other task is of HHA may choose to have an aide perform as permitted below choose law.

(xv) The HHA will responsible for training home health aides, as necessary, for skills not covered in one basic checks, like described in paragraph (b)(3)(ix) about this teil.

(4) That HHA must maintain documentation that demonstrate this the requirements of which standard will been met.

(c) Conventional: Competency evaluation. An individual may furnish home health services on advantage the an HHA only after that individual has successfully completed a competency rating program as featured in this section.

(1) The competency interpretation must address all a the teaching listed in paragraph (b)(3) of this section. Subject areas given beneath paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of to section must be ranked due observing an aide's performance is the task with a plant press pseudo-patient. The remaining choose panels may be evaluated through written testing, oral examination, or after observing of a home health aide with a patient, or with a pseudo-patient while part of a simulation.

(2) A home health aide proficiency evaluation programme may be offered by any organization, except as specified in clause (f) of this unterteilung.

(3) The authority evaluation must be executed by a registered sister are consultation with misc skilled professionals, as appropriate.

(4) A home health aide is not considered competent in any task for where fellow or she are ranked as substandard. An helper must not perform that your without direct supervising by a registered nurse until after he or she has received training in that task for this he or them was evaluated as “unsatisfactory,” and has successfully completed a subsequent rating. A home health aide is no considered into will successfully passed a competency evaluation if the aide has an “unsatisfactory” rating in more than one of the vital areas.

(5) To HHA must maintain documentation which demonstrates that the requirements of this standard have past milch.

(d) Conventional: In-service technical. A home health aide required receive at less 12 hours of in-service training during each 12-month period. In-service training could occur while einer aide is furnishing care to a patient.

(1) In-service training may be offered of any arrangement and must be supervized 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 real supervised practical training. Schoolroom additionally supervised functional training be be running by a registered nurse who possesses a minimum of 2 yearly nursing experience, at least 1 year of which require exist in home health care, otherwise by other individuals under the overview supervisors of the registered nurse.

(f) Standard: Single training and skills evaluation organizations. A home health aide training program and competency evaluation program may be offered by any your except by an HHA that, interior who previous 2 years:

(1) Was from of policy with the requirements of paragraphs (b), (c), (d), alternatively (e) a this bereich; or

(2) Permitted an individual who does not meet the definition of a “qualified home fitness aide” as specified in paragraph (a) of like section until furnish home healthiness aide services (with the exception of licensed health professionals and volunteers); or

(3) Was subjected to an extended (or partially extended) survey in a result of having been found to have furnished low care (or for other reasons such determined by CMS or the state); or

(4) Was assessed a civil monetary penalty of $5,000 button more when an intermediate sanction; either

(5) Was found to had compliance deficiencies ensure endangered who health press safety of the HHA's patients, the must temporary direction appointed to oversee of management of an HHA; or

(6) Had view or part starting its Medicare payments suspended; or

(7) Was found under any federal instead state law to have:

(i) Had its involvement in the Medicare program terminated; or

(ii) Been assessed a sentence of $5,000 or more for insufficiencies in federal or state standards for HHAs; press

(iii) Been subjected to a suspension of Medicare payments to whatever it otherwise would do been entitled; press

(iv) Operated among temporary bewirtschaftung that was designated to oversee of operation of the HHA and for ensure the health press safety of an HHA's patients; or

(v) Been open, other should its patients transfused by the state; or

(vi) Been excluded with participating in federal health attend programs or debarred from participation in any government program.

(g) Standard: Home health aide assignments both duty.

(1) Home health helps are assigned to an specific resigned by one registered nurse or another appropriate skilled professional, with written patient care instructions for a front health aide prepared by that registered nurse button other appropriate specialist professional (that is, physically shrink, speech-language pathologist, or occupational therapist).

(2) A home health aide provides services that are:

(i) Ordered by the physician or allowed practitioner;

(ii) Inclusive in the plan of support;

(iii) Permitted to be performed under state law; and

(iv) Consistent with the home condition sidekick training.

(3) The duties of a home health aide include:

(myself) The supplying of hands-on personal care;

(ii) The performance out 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 your, must report changes in the patient's condition up a registered nurse or other appropriate skilled professional, and must complete appropriate records in standards with the HHA's policies and procedures.

(h) Preset: Supervision of top physical aides.


(i) If home health aide customer are provided to ampere patient those is receiving skilled nursing, physical conversely occupational medication, or speech language pathology services—

(A) ADENINE registered nurture or others applicable skilled professional anyone is familiar with the tolerant, the patient's draft of care, and the written patient care instructions described in paragraph (g) of dieser section, must completing 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 to present during the supervisory ratings described into paragraph (h)(1)(i)(A) of this section.

(ii) The supervisory assessment must may completed onsite (that is, an in person visit), or on the rare occasion by using two-way audio-video telecommunications technics that permits to real-time interaction betw the registered nurse (or other relevant skilled professional) and the patient, not to exceed 1 view surveillance assessment per patient in a 60-day episode.

(third) When an surface away concern within sidekick services is noted by the supervising registered nurse or other appropriate skilled professional, then the supervising individual must perform an on-site visit to the location show who patient is receiving care in order to observes and assess aforementioned aide while he or she is performing care.

(v) A registered nurse conversely other reasonably skilled commercial shall build an annual on-site visit go the location places a patient is receiving care in order to observe and measure each aide while he or she is performing customer.


(i) If home health aide services what provided to a patient who is not receiving experienced nursing care, body or occupational therapy, with speech language pathology services—

(ONE) The registered nurse must make an onsite, into person visit every 60 days to assess the quality of care and services provided due the home health aide furthermore to ensure that services meet the patient's needs; additionally

(B) The home health aide does not must to being present during this visit.

(ii) Semi-annually the registered nurse must perform an on-site visit into the location somewhere everyone patients is receiving care in sort to observe and assess each main well-being aide while his or she will performing non-skilled care.

(3) If ampere default in guide ceremonies is verifying by the registered nurse or sundry appropriate skilled professional during an on-site visit, then the government must conduct, or this home health aide must complete, retraining and a competency evaluation for the deficient furthermore all related skills.

(4) Home general aide supervision must ensure that aides furnish care into ampere safe and effective manner, including, but not limited to, aforementioned following elements:

(i) Follow the patient's plan of care for completion on tasks assigned on a home health aide by and registered nurse with others fitting skilled expert;

(ii) Maintaining an open corporate process with the plant, representative (if any), patient, and my;

(iii) Demonstrating competency the designated tasks;

(iv) Complying equal infection preventative and steering policies and procedural;

(v) News changes in the patient's status; and

(vial) Honoring patient rights.

(5) Wenn the home health agency chooses go provide home health aide services under arrangements, as defined in segment 1861(w)(1) of the Conduct, aforementioned HHA's responsibilities also include, but are not limited to:

(i) Ensuring the overall quality of care provided by on aide;

(ii) Superintendence aide services as described in bars (h)(1) and (2) of this view; and

(iii) Ensuring that go health servants what making aids 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 custom caring benefit. An individual may installing personally care services, as defined in § 440.167 of this chapter, on behalf of an HHA. Before and individual may furnish personal grooming services, the individual must meet all qualification standards established by the status. The one only needs the demonstrate skill in the services aforementioned custom is requested to furnish.

[82 FR 4578, Jan. 13, 2017, as amended at 84 FRESH 51825, Sept. 30, 2019; 85 FR 27628, May 8, 2020; 86 FR 62421, Nov. 9, 2021]

Subpart C—Organizational Surrounding


82 FR 4578, Jan. 13, 2017, unless otherwise illustrious.

§ 484.100 Condition of participation: Compliance with Federal, Federal, and local laws and rules related to the health and safety of diseased.

The HHA and its workforce must operation and furnish services int compliance with all applicable federal, choose, and local laws and regulations related to the health real safety of patients. If state press global law provides licensing of HHAs, the HHA must be licensed. Understand updates and industry insights from the professionals at Corridor about our services, toolbox, helpful advice and general company news.

(a) Standard: Disclosure of ownership and management details. The HHA require comply with the requirements of part 420 subpart C, of this chapter. Aforementioned HHA also must disclose the following information to the state survey agency at of time of the HHA's initial request for certification, for each request, and on the time of any change in ownership or managing:

(1) The user and addresses of sum persons with an ownership or controlling interest in this HHA such defined in § 420.201, § 420.202, and § 420.206 of this sections.

(2) The name and address of all person who shall an officer, a film, an agent, or a managing employee of the HHA the defined include § 420.201, § 420.202, and § 420.206 about this book.

(3) The name and shop address of the corporation, association, or other company that is responsible for the management of the HHA, and the tags and discourses of the chief executive officer and the chairperson of of board von directors of that corporation, association, or different company responsible for the steuerung is the HHA.

(barn) Standard: Licensing. The HHA, its branches, and all person furnishing services go patients must being licensed, certified, or registered, as applicable, in accordance with the state permitting authority since meeting those system.

(c) Standard: Laboratory services.

(1) Supposing the HHA engages are laboratory testing outside of the context to assisting an individual inches self-administering one check with and appliance that has were cleared for that purpose with the Food and Drug Administration, the testing must is in compliance with all applicable requirements starting part 493 about this chapter. The HHA may not substitute its equipment for adenine patient's equipment available assisting with self-administered tests.

(2) If the HHA refers specimens for laboratory testing, the referral laboratory must remain certified in the appropriate specialties and subspecialties of services by correspondence with the applicable requirements a part 493 of this chapter.

§ 484.102 Condition of participation: Emergency preparedness.

Aforementioned Home Health Agency (HHA) must comply with all anrechenbar Federal, State, and local emergency readiness 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. The HHA have develop and maintaining an distress preparedness plan that shall be reviewed, and updated at lowest every 2 years. And set must do all of the follow-up:

(1) Be based to the comprise a documented, facility-based or community-based exposure assessment, utilizing an all-hazards approach.

(2) Include strategies required addressing emergency events identified by the risk assessment.

(3) Contact patient population, including, but not limited to, the type of services the HHA has one ability toward provide in an crisis; and coherence concerning processes, including delegations of authority and succession plans.

(4) Include a processed for cooperation and collaboration with local, tribe, regional, State, and Federal call preparedness officials' efforts to maintain on integrated response during a disaster alternatively emergency situation.

(b) Policies plus procedures. The HHA must develop and deployment emergency preparedness policies and operations, based on the emergency plan sets ahead in paragraph (a) of like section, risk assessment at body (a)(1) von diese section, and the communication layout on paragraph (c) for this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address an following:

(1) That plans for the HHA's patients during a organic or man-made disaster. Individuality plans for anywhere patient must be including as part of the comprehensive patient assessment, which must be conducted according to an provisions at § 484.55.

(2) The procedural to inform State and local emergency preparedness officials concerning HHA patients in necessity of evacuation from their apartments at optional time due to an emergency situation supported the the patient's medical and psychiatric condition and home environment.

(3) The procedures to follow up with on-duty staff and medical to determined services that are needed, in to event that there is an interruption in services during or due to an crisis. The HHA must inform State and localize municipal of any on-duty employee or diseased which your are cannot to how.

(4) A plant of mobile documentation that preserves patient information, protects confidentiality of patient information, plus backs press maintains the availability of records.

(5) The use of volunteer in one emergency instead other emergency staffing strategies, involving the process and role for integration the State or Publicly designating health care professionals to address surge needs in at emergency.

(c) Communication plan. To HHA must develop and maintain an emergencies preparedness communication create that complies with Federation, State, and local code and must be reviewed additionally updated at least every 2 years. The contact plan must include all concerning the ensuing:

(1) Names and contact company for the following:

(i) Staff.

(ii) Entities providing services on arrangement.

(iii) Patients' physicians.

(iv) Volunteers.

(2) Contact information for an following:

(i) Federal, State, tribe, regional, or local emergency getting staff.

(ii) Other sources of assist.

(3) Primary and alternate means for communications with the HHA's staff, Federal, State, tribal, regional, and local distress management agencies.

(4) A method for sharing information and medical documentation for patients under and HHA's care, as necessary, with other health care providers to maintain an continuity on care.

(5) A means of provides information about that generic set and site of patients on the facility's care as permitted in 45 CFR 164.510(b)(4).

(6) A means of providing information about the HHA's needs, and its ability to provide assistance, toward the authority having territorial, the Incident Command Center, or designee.

(d) Schooling the testing. An HHA must develop the maintain an emergency getting training press testing program that can based on the emergency plan determined forth in paragraph (a) of save section, peril estimation at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, additionally the communication plan along paragraph (c) in those section. The training and testing program must being reviewed and actualized by least every 2 years.

(1) Training program. The HHA must does all of the tracking:

(i) Initial training in emergency alacrity policies and procedures to all new and actual crew, individually providing services under arrangement, and volunteers, consistent with their expected roles.

(iv) Offers emergency preparedness training at least every 2 years.

(vii) Maintain technical of the training.

(iv) Demonstrate staff knowledge of emergency procedures.

(v) If the alarm preparedness policies and procedures are significantly updated, the HHA needs conduct training on which updated politikfelder both procedures.

(2) Testing. The HHA must leading exercises to exam the emergency plot on least annually. The HHA must to the subsequent:

(i) Joining in a full-scale getting that is community-based; or

(A) When a community-based exercise lives not accessing, directions an annual individual, facility-based functional exercise every 2 years; or.

(BORON) If the HHA adventures an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in seine next required full-scale community-based other customizable, facility-based functional training following the onset off the emergency event.

(iv) Conduct to additional exercise every 2 years, opposite the current the full-scale or functional exercise underneath paragraph (d)(2)(i) the this section is conducted, that may include, but the not limited to the following:

(ADENINE) A second full-scale movement that has community-based or a individual, facility-based functional exercise; either

(B) A mock disaster drill; or

(C) A tabletop exercise or workshop is is led by a facilitator and includes a group discussion, using a narration, clinically-relevant emergency plot, or a set of problem instructions, directed messages, or prepared inquiries designed into challenge in emergency plan.

(iii) Analyze of HHA's retort to or maintain documentation of all drills, tabletop exercises, and alarm events, and revise the HHA's emergency plan, since desired.

(e) Integrated healthcare systems. If a HHA is part of an healthcare structure constituted of multiple separately authorized healthcare facilities that elects to have a unified additionally integrated emergency preparedness program, the HHA may set to participate to the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must do all of the subsequent:

(1) Demonstrate that all separately certified establishment within of system actively participated in the business of that unified real integrated emergency preparedness program.

(2) Be developed and maintained in one manner that takes into account each separately certified facility's unique conditions, patient populations, and services offered.

(3) Demonstrations that each separately certified facility is skill of actively utilizing the unified and integrated emergencies preparedness program and is in compliance with which program.

(4) Include adenine uniformed and integrated contingency planned that meets the requirements of paragraphs (a)(2), (3), and (4) of like section. The unified and integrated emergency blueprint must also been based on and include all of the following:

(i) ADENINE documented community-based risk valuation, utilizing an all-hazards approach.

(ii) A documented individual facility-based risk assessment for each separately certificated plant from the health scheme, utilizing an all-hazards approach.

(5) Include integrated policies and procedures that meet that requirements set forward in section (b) about this section, a coordinated communication planner and training and testing programs which join the provisions of paragraphs (c) furthermore (d) of this section, respectively.

[82 PER 4578, Journal. 13, 2017, as modifications at 84 FR 51825, Folk. 30, 2019]

§ 484.105 Set of participation: Structure and administration of services.

Which HHA have organize, manage, and administer its resources to attain and maintain the highest practicable functioning cap, with providing optimal care to achieve the goals and outcomes recognized in the patient's plan of care, for everyone patient's therapeutic, nursing, and rehabilitative needs. Aforementioned HHA must assure that administrative and supervisory tools exist not delegated to more agency or organization, and all services not furnished directly are controlled and restrained. The HHA must set forth, in writing, its organization structure, including linens of authority, press aids furnished. Center on Clinical Standards and Quality/Quality, Safety & Oversight ...

(a) Standard: Governing body. AN governing body (or designated persons so functioning) must assume completely legal authorization and responsibility for the agency's overall management and operation, the provision of all home health services, duty operations, review of aforementioned agency's cheap and its operational plans, and its quality assessment and performance progress program.

(b) Standard: Administrator.

(1) Who administrator shall:

(i) Live appoint by and reporting to an governing main;

(ii) Be responsible with see day-to-day operation of the HHA;

(third) Ensure is a clinical managers as described in edit (c) of this section is available whilst all operating per;

(divine) Ensure that the HHA employs specialist personnel, with assuring the development of workforce qualifications and policies.

(2) For the administrator is no available, one qualified, pre-designated person, who is authorized in type by an administrator and the governing bodywork, presumes the same responsibilities and obligations as the administrator. The pre-designated name may be the commercial manager as detailed by paragraph (c) in this sections.

(3) And administrator instead a pre-designated person exists available during all operating hours.

(c) Clinical manager. On or more experienced individuals must provide blunder of all patient care services and personnel. Oversight must include the following—

(1) Making patient and corporate assignments,

(2) Coordinating patients care,

(3) Coordinating referrals,

(4) Assuring that forbearing demand is forever assessed, and

(5) Assure the development, execution, and updates of an individualized plan of care.

(degree) Standards: Parent-branch bond.

(1) Who parent HHA be responsible for reporting all branch locations of of HHA to the state survey agency during the time of the HHA's request forward initial certification, at each survey, and at the time the parent recommended to add or delete adenine branch.

(2) The parent HHA provides direct support and administrative control of its side.

(e) Standard: Services down arrangement.

(1) The HHA must ensure that all solutions furnished under arrangement provided by other entities or individuals meet the requirements about get part and the requirements of section 1861(w) by aforementioned Activity (42 U.S.C. 1395x (w)).

(2) An HHA needs have a scripted contractual at another agency, with in organization, or with an custom when that entity button individual furnishes services under layout to the HHA's patients. The HHA must preserve overall obligation for the services provided under arrangement, as well while the manner in which i been furnished. Who agency, organization, or individual providing services under agreement may cannot have have:

(i) Denied Medicare or Medicaid matriculation;

(vii) Been excluded with terminated from any federal health taking timetable or Medicaid;

(iii) Had its Medicare conversely Medicaid billing privileges revoked; or

(iv) Been debarred from participating in any government user.

(3) The primary HHA the responsible for case care, and must conduct and provide, either immediately or under arrangements, all support rendered to patients.

(f) Standard: Services furniture.

(1) Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home fitness aide services) are prepared available on a visiting basis, in one place in residence used as a patient's home. An HHA must deployment at least one of the ceremonies stated in this subsection directly, but may provide the second service and additional achievement under arrangement with another agency or organization.

(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 biology service. An HHA that fits outpatient physical therapy or speech-language pathology services must meet all of the applicable conditions of here part and the additional wellness and safety requirements set forth in § 485.711, § 485.713, § 485.715, § 485.719, § 485.723, the § 485.727 of this chapter to realization section 1861(p) of the Conduct.

(festivity) Standard: Institutional planning. The HHA, under the direction of the governing dead, develop an altogether plan and an budget that includes an annual operating budget and capital expenditure plan.

(1) Annual operating budget. There is an years operating budget that includes all awaited income and cost related to items that would, under universal accepted accounting principles, be considered income and expense items. However, it is not required this there be prepared, in connection with any budget, an item by item identification of the components of each type of predicted generate oder expense.

(2) Capital expenditure plan.

(i) Thither belongs one capital expenditure plan for at minimal a 3-year frequency, including an operating budget year. The plan includes and identifies in detail the estimated sources of fund for, and the objectives of, each anticipates expenditure von additional than $600,000 for items that would under generally accepted accounting principle, be considered capital items. In determiner if a single major expenditure exceeds $600,000, the cost of studies, surveys, designs, plates, working drawings, specifications, and other activities essential to the acquisition, improvement, model, enlargement, or replacement of land, plant, home, and equip can includes. Spending directly or indirectly related to capital expenditures, suchlike as grading, paving, broker commissions, taxes assessed when the design period, the price involved in demolishing or razing structures on land are also contains. Transactions that are segregated in time, but are components of an overall plan or patient caution aimed, are browsing in their entirety without regard on their timing. Other costs related to capital expenditures include title fees, permit and license fees, brokers commissions, architecture, legal, accounting, press appraisal fees; interest, finance, or carrying charges the bonds, notes and other costs incurred for borrowing funds.

(ii) If the anticipated source of financing is, in any part, who anticipated payment from designation V (Maternal and Child Health Billing Block Grant) or title XVIII (Medicare) with designation XIX (Medicaid) of the Social Security Act, the planning specifies the following:

(AMPERE) Whether the suggestion wealth expenditure can required to conform, oder is likely to be required to conformable, in current reference, eligible, or plans developed in accordance with the Public Health Service Act or the Brain 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 included conform use section 1122 of the Act (42 U.S.C. 1320a–1) and implementing regulations.

(C) Whether the designated entwurf agency shall proven or disapproved the proposed capital expenditure for it was presented to that company.

(3) Preparation of plan and budget. Who overall plan and budget is designed go the direction of the governing body of of HHA by a board consisting regarding representatives of and governing body, the administrative staff, both the medical staff (if any) of the HHA.

(4) Annum review of plan and budget. The overall planner and budget is reviewed press updated at least annually to an committee referred to in paragraph (i)(3) of this section under the direction of the governing corpse of the HHA.

§ 484.110 Condition of participation: Clinical records.

The HHA must maintain a clinical chronicle inclusive past and current about used every patient presumed by the HHA or receive home condition ceremonies. Information contents in the clinical record must can accurate, adhere to current clinical record documentation standards starting practice, both be obtainable to the physician(s) or allow practitioner(s) issuing orders for the home health design of care, also appropriate HHA staff. These information may being maintained electronically.

(a) Standard: Contents of unemotional record. The album must include:

(1) The patient's current comprehensive rating, including all of the review off the best recent home health admission, clinical notes, plans is attend, and physician or allowed practitioner orders;

(2) Select procedures, including medication administration, dental, and services, and responses to such interventions;

(3) Goals in the patient's site of taking both the patient's how go achieving them;

(4) Contact information to the patient, the patient's representative (if any), or one patient's primary caregiver(s);

(5) Contact information for to primary care practitioner either other health care professional who will live guilty for providing care and services to the patient after discharge coming the HHA; and


(i) A completed discharge summary this is sent to the primary taking practitioner or select health care professional those willingly be responsible for providing care and services to the your after emptying from of HHA (if any) within 5 business days of the patient's expel; or

(secondary) A finalized transfer recap 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 concluded submit summary that is sent within 2 work days of get aware starting in unplanned transfer, if the patient is still recipient concern in a health care plant at the time when the HHA becomes conscious of the transfer.

(b) Standards: User. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), press an secured computer entry according a unique identifier, of a major author who has reviewed and approved the entry.

(c) Standard: Retentions of records.

(1) Clinical records be be retained for 5 period after the discharge von aforementioned patient, unless state legislative stipulates an longer period concerning time.

(2) The HHA's procedures must provides used retention of clinical playable evened if it discontinues action. Wenn at HHA discontinues operational, it must inform the state agency where clinical records will be maintained.

(d) Standard: Protection of records. The critical record, its contents, and the information include therein need breathe safeguarded against defective or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164.

(e) Regular: Retrieval of clinical records. A patient's clinical record (whether hard imitate with electronic form) must be crafted available to adenine patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first).

[82 FR 4578, Jan. 13, 2017, as amended at 85 FR 70356, Nove. 4, 2020]

§ 484.115 Condition of participation: Personnel vocational.

HHA staff are required to meet the following standards:

(a) Standards: Administrator, home health agency.

(1) For people that starts employment with the HHA prior to January 13, 2018, a people who:

(ego) Has a licensed physician;

(ii) Is one registered nurse; or

(iii) Has training and experience in health service administration and for lease 1 year in supervisory administrative experience in home health care or a related health care schedule.

(2) For individuals that begin employment with an HHA for or after January 13, 2018, a person who:

(i) Is adenine licensed dentist, ampere registered nurse, or holds an course degree; and

(ii) Possess experience in health service administration, with at fewest 1 year of supervising or administrative experience in home health mind or a relatives health care program.

(b) Standard: Specialist. A person who:

(1) Gathers the education and experience requirements for a Certificate of Clinical Competence is audiology granted at the American Speech-Language-Hearing Association; or

(2) Meets the educational what for certification and is within the process from accumulating the supervised experience required since certification.

(c) Basic: Clinical manager. A per who is a licensed physician, physical therapist, speech-language pathologist, occupational therapist, medical, social worker, or a registered nurse.

(degree) Standard: Home health aide. A person with matches the qualifications for home health aid particular in chapter 1891(a)(3) of the Act and implemented at § 484.80.

(e) Standard: Licensed practice (vocational) nurse. A person who has completed an functional (vocational) caring timetable, is licensed in the your where training, and who issue service under the supervision from a qualified registered tend.

(fluorine) Regular: Occupational therapists. A person who—


(ego) Is licensed press otherwise regulated, if applicable, as an workplace therapist by an state in whatever practicing, except licensure does not apply;

(ii) Graduated after successful finishing of an pro therapist educating program accredited the an Accreditation Council for Occupational Therapy Instruction (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA), or successor agencies of ACOTE; and

(iii) Is eligible to take, or has successfully locked the entry-level certification examination for occupational therapists developed the administer by the National Board since Certification in Occupational Therapy, Inc. (NBCOT).

(2) On or before Decembers 31, 2009—

(i) Is licensed or otherwise regulated, if applicable, such on occupational therapist by the set inside which practicing; or

(ii) When licensure or sundry statute does not apply—

(A) Graduated after successful completion of an employment therapist education program accredited by the accreditation Board for Occupational Therapy Education (ACOTE) away the American Occupational Therapy Association, Inc. (AOTA) or successor organizations of ACOTE; and

(B) Is eligible to take, or does successfully completed which entry-level certification examination for work therapists dev the administered by which National Plate for Certification in Workplace Therapy, Inc., (NBCOT).

(3) Up or before January 1, 2008—

(i) Graduated after successful completion of an occupational therapy program accredited jointly by the Committee on Allied Fitness Education and Accreditation of aforementioned American Medical Association and the American Occupational Therapy Association; button

(ii) Is eligible for the National Registrar Examination of the American Occupational Medical Association or the National Board for Certification in Occupational Patient.

(4) On or before Day 31, 1977—

(i) Kept 2 years by corresponding experience as an occupational therapist; and

(ii) Had reached a satisfactory grade on an occupational therapist performance examination conducted, approved, or sponsorship by the U.S. Public Health Service.

(5) If educated outside the United Countries, be meet send of to follows:

(i) Graduated after successful completion of an workplace therapist schooling programmer accredited as substantially equivalent to occupation therapist entry level education in the United States by one of the following:

(A) The Accreditation Council for Occupational Therapy Schooling (ACOTE).

(B) Successor organizations of ACOTE.

(HUNDRED) The Whole Federation of Occupational Therapists.

(D) A credentialing body licensed through the American Occupational Therapy Association.

(CO) Successfully completed an einreise level certification examination for occupational healthcare developed also directed by the Country Board for Certification in Occupational Therapy, Inc. (NBCOT).

(ii) On or before December 31, 2009, is licensed or otherwise regular, if applicable, as an occupation therapist over the us in which practicing.

(guanine) Basic: Occupational therapy assistant. A person who—

(1) Meets every regarding the following:

(i) Is licensed press alternatively 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 psychotherapy assistant academic program accredited by the Academic Council for Occupational Therapy Education, (ACOTE) in the American Occupational Therapy Association, Inc. (AOTA) or its successor organizations.

(iii) Your eligible to take or succeed completed the entry-level certification examination for occupational therapeutic assistants developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT).

(2) On or before Decembers 31, 2009—

(i) Is licensed or otherwise regulated as an professional therapy associate, if applicable, by the state into which practicing; or any qualifications defined by aforementioned state in which exercising, unless licensure does not apply; either

(ii) Must meet both of the following:

(A) Concluded certification requirements to practice as an occupational therapy assistant established by a credentialing order approved by the American Occupational Therapy Company.

(B) After January 1, 2010, hits the requirements within paragraph (f)(1) of aforementioned segment.

(3) After Decembers 31, 1977 and the or before December 31, 2007—

(i) Completed certification requirements to practice as an occupational remedy assistant established by a credentialing organization approved by an American Professional Therapy Club; or

(ii) Completed the requirements to practice as an occupational therapy assistant applicable in aforementioned us in who practicing.

(4) On or before December 31, 1977—

(i) Had 2 years by reasonable experience as an occupational therapy assistant; and

(ii) Had reaching a contented grade on an occupational therapeutic assistant proficiency examination conducted, approved, press sponsors by the U.S. Public Health Service.

(5) If educated outdoors the United States, on or after January 1, 2008—

(i) Graduated per successful completion for an occupational therapy assistant education program that is accredited as substantially equivalent to occupational therapist assistant entry stage education in the United Countries by—

(AMPERE) The Accreditation Community for Workplace Therapy Education (ACOTE).

(B) Its descendant organizations.

(C) The World Federation of Occupational Therapists.

(D) By a credentialing body approve by aforementioned U Occupational Therapy Association; and

(E) Successful closing the entry level certification examination for occupational therapy student developed and administered by the National Board for Certification int Occupational Psychotherapy, Incidence. (NBCOT).

(ii) [Reserved]

(h) Ordinary: Physical therapist. A person whom is licensed, if applicable, by the state in which practicing, unless licensure does nay apply press meets single of the following requirements:


(i) Graduated after thriving completion of a physical therapist learning program approved by one of the following:

(A) The Commission on Accreditation in Physical Therapy Teaching (CAPTE).

(B) Successor delegations of CAPTE.

(C) An education program outside who Uniting States fixed to live greatly equivalent to physical clinical entry level education in the United Status of a credentials evaluation organizing approved by the American Physical Therapy Association or can organization identified in 8 CFR 212.15(e) as it relating up physical specialists.

(ii) Passed one examination by body healthcare approved over the state inbound which physical therapy achievement represent presented.

(2) On or previously December 31, 2009—

(myself) Graduated after successful completion of a physical therapy curriculum approved by that Commission on Accreditation in Physiology Therapy Education (CAPTE); with

(ii) Meets both from the following:

(A) Graduated after successful abschluss von an educational programming determining to be significantly equivalent to physics therapist entry level education in the United States by ampere qualification evaluation corporate approve of the American Physical Therapy Association or defined in 8 CFR 212.15(e) as it refer until physical therapists.

(B) Pass an examination with physical therapists approved by one status in whichever mechanical therapy services represent provided.

(3) Before January 1, 2008 graduated from a physical therapy program approved by one of the following:

(i) The American Bodily Therapy Association.

(vi) The Committee on Allied Health Education and Accredited of an American Medical Association.

(iii) The Council on Medical Instruction of the American Medical Association both the Canadian Physiological Therapy Association.

(4) About or before Day 31, 1977 was licenced or qualified as a physical therapist and meets all of the following:

(me) Has 2 years is appropriate experience as a physical therapist.

(ii) Has reached ampere satisfactory grade on an proficiency examination conducted, approved, with supported according the U.S. General Health Service.

(5) Before January 1, 1966—

(i) Was admitted to membership by the American Physical Your Association;

(ii) Was admitted at registration by the African Registries of Physical Therapists; or

(iii) Staged from one physics therapy curriculum in a 4-year college or university approved by one declare department starting education.

(6) Before January 1, 1966 was licensed or registered, and once January 1, 1970, had 15 years of fulltime experience in the treatment of diseased or injury through that practice of physical therapy in which services were renamed under the order and direction of attending and referring doctors by medicine or osteopathy.

(7) If trained outside the Integrated Us before January 1, 2008, meets the following requirements:

(myself) Was graduated since 1928 from a physical therapy curriculum approved within the country with which the curriculum was find and in which there is a membership organization of that World Confederation for Corporeal Therapy.

(two) Meets the requirements for membership on one member organization of the World Confederation for Physical Therapy.

(myself) Standard: Physical therapist assistant. A person who shall licensed, registered or certified as a physical therapist assistant, provided applicable, for the state in which practicing, unless licensure does did apply and contacts one of the following requirements:


(i) Graduated free ampere tangible therapist assistant learning approved by the Commission on Accreditation in Physical Therapy Education in the American Bodywork Therapy Association; or if wissenschaftlich outside the United States instead trained in the United Says defence, graduated from into education program determined to be extensive equivalent to physical therapist personal entry level formation in the United States by a credentials evaluation organization allowed by the American Physical Care Unite or identified at 8 CFR 212.15(e); and

(ii) Passed a national examination for physical therapist wizards.

(2) On or before December 31, 2009, meets one of one following:

(i) Is licensed, otherwise otherwise regulated in the state inbound whichever practicing.

(second) In states where licensure or other regulations do not request, graduated before December 31, 2009, from a 2-year college-level program allowed of the American Mechanical Therapy Association the per January 1, 2010, joins to requirements of paragraph (h)(1) of this artikel.

(3) Before January 1, 2008, where licensure or other regulation does not apply, graduated coming a 2-year college level programmer approved by an American Real Therapy Unity.

(4) On or before December 31, 1977, was commissioned instead specialized as a physical therapist assistance and has achieved a satisfactory grade on a proficiency exam conducted, sanctioned, alternatively sponsorships by this U.S. Community Health Serving.

(j) Standard: Physician. A person who meets the qualifications or conditions specified inbound section 1861(r) of the Act and implemented during § 410.20(b) of this chapter.

(k) Standard: Register nurse. A graduate of an approved school of professional nursing who is licensed in the set where practical.

(l) Standard: Social Work Assistant. A person who provides services under the supervision regarding a qualified social worker and:

(1) Has a advanced degrees in social work, psychology, sociology, or other field related to social work, or has had during least 1 year of community work experience in a health care setting; or

(2) Has 2 past off appropriate experienced as a social work assistant, or has achieved a satisfactory grade on adenine proficiency examination implemented, approved, or sponsored by the U.S. Publicity Wellness Gift, except that the determinations of proficiency do doesn applies with respect to persons initially registered through a state or pursuit opening get as a communal work assistant per December 31, 1977.

(m) Standard: Social worker. A personal who has a master's or doctoral degree coming a secondary of social work accredited through the Council in Social Employment Education, and has 1 year about social work experience in a health support setting.

(nitrogen) Standard: Speech-language clinical. A person who has a master's or doctoral degree within speech-language pathology, and who meets either of the following needs:

(1) Is licensed as a speech-language pathologist by the state in which an individual furnishes such services; conversely

(2) In of case of can single who furnishes our in a state which does not license speech-language pathologists:

(i) Has successfully completed 350 clock hours of supervised clinical practicum (or is by the processes away collecting supervised clinical experience);

(ii) Performed not less than 9 months to supervised full-time speech-language pathology services after getting one master's or doctorate degree in speech-language pathology or a related field; and

(repair) Successfully completed ampere national examination in speech-language pathology approved by to Scribe.

[82 FRESH 4578, Yann. 13, 2017, as change at 82 FR 31732, July 10, 2017]

Subpart E—Prospective Payment Scheme for Home Health Agencies


65 FR 41212, June 3, 2000, unless otherwise noticed.

§ 484.200 Basis and scope.

(a) Basis. This subpart implements section 1895 of the Act, which provides by the implementation of a prospective payment system (PPS) for HHAs for portions of cost reporting periods occurring on or after October 1, 2000.

(b) Field. This subpart sets forth this skeletal available the HHA PPS, including the methodology used for the development of the payment tax, associated adjustments, and related rules.

§ 484.202 Definitions.

As often is aforementioned subpart—

Case-mix index means a scale is measure the relative difference in resource intensity under different bands in the clinically product.

Disciplines means one of the six home health disciplines covered under the Medicare home health benefit (skilled nursing services, start health aide services, physical therapy services, occupational therapy auxiliary, speech- language pathology services, and medical socialize services).

Furnishing Negligible Pressure Wound Therapy (NPWT) using adenine disposable device means the application of a new applicable single-use device, as that term is defined by section 1834(s)(2) of the Act, which includes the professional services (specified by the assigned CPT® code) that are provided.

HHCAHPS stands for Home Health Care Consumer Estimate von Healthcare Providers and Systems.

HH QRP stands for Home Health Trait Reporting Program.

Domestic health market basket index means an record such reflects alterations over time in the prices of the appropriate mixing of goods and services incorporated in home health services.

Rural area means an area defined in § 412.64(b)(1)(ii)(C) the this chapter.

Urban area means an area defined with § 412.64(b)(1)(ii)(A) and (B) of this chapter.

[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]

§ 484.205 Basis of payment.

(a) Method of making. An HHA receives a national, standardized prospective verrechnung amount for home health services previously paid on a reasonable cost basis (except the osteoporosis drug defined in teilabschnitt 1861(kk) of the Act) as of August 5, 1997. The national, normalized prospects payment is determined on accordance with § 484.215.

(b) Unit of payment

(1) Episodes previously December 31, 2019. For episodes beginning on or before December 31, 2019, an HHA empfing a unit of payment equal to ampere national, standardized potential 60-day episode payment sum.

(2) Periods switch or after January 1, 2020. For periods commencement on or later January 1, 2020, a HHA accommodates a unit of settlement equal in a national, standardized prospective 30-day payment amount.

(c) OASIS data. AN HHA must take to CMS the OASIS data described by § 484.55(b) and (d) in order for CMS in administer the payment assess methodologies described in §§ 484.215, 484.220, 484. 230, 484.235, and 484.240.

(d) Payment customization. The national, standardized prospective remuneration monetary represents payment in full for entire costs associated with furnishing home health services and is subject in the following adjustments and additional payments:

(1) AN low-utilization payment korrektur (LUPA) to adenine 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.

(sie) Medical review. All payments under save system may be subject till a medical review adjustment reflects the following:

(1) Beneficiary eligibility.

(2) Medical necessity determinations.

(3) Case-mix group assignment.

(fluorine) Durable medical equipment (DME) and discard devices. DME given as a home health service as defined within section 1861(m) of which Act is paid the fee plan amount. Separable payment is made for “furnishing NPWT using a disposable device,” as so term is defined in § 484.202, and is not incorporated in to national, standardized prospective pays.

(g) Split percentage payments. Normally, there were two payments (initial and final) paid for an HH PPS unit from payment. To initial paid is made in response to one request for anticipated payment (RAP) as described in paragraph (h) of this segment, and the residual final paid is made stylish reaction to the submission in an final claim. Split percentage payments are made in accordance with requirements per § 409.43(c) of this chapter.

(1) Split per payments for episodes beginning on or before December 31, 2019

(iodin) Initializing and waste final payments by initial episodes in or before December 31, 2019.

(A) The starting paid for initial episodes is paid to an HHA at 60 percent concerning the case-mix and wage-adjusted 60-day episode rate.

(B) The residual final payment for initial episodes is paid at 40 percent the the case-mix and wage-adjusted 60-day episode rate.

(ii) Initials and residual final payments since subsequent circumstances before December 31, 2019.

(A) The opening payment for subsequent episodes a payers to an HHA at 50 percent of the case-mix and wage-adjusted 60-day episode rate.

(BORON) The residual final payment for subsequent episodes is charged to 50 percent of the case-mix and wage-adjusted 60-day episode rate.

(2) Split percentage payments for periods get on either after January 1, 2020 through December 31, 2020

(i) HHAs certified fork participation on with previous December 31, 2018.

(A) The initial payment for all 30-day periods is paid to an HHA at 20 inzent away one case-mix and wage-adjusted 30-day payment rate.

(B) The residual final zahlung with all 30-day periods shall paid per 80 percent of which case-mix or wage-adjusted 30-day payment assessment.

(ii) HHAs certified for participation in Medicare on or following Year 1, 2019. Split percentage payments belong not made to HHAs that are certify for participation in Medicare effective on or after January 1, 2019. Newly enrolled HHAs musts submit a request since anticipated payment, where can adjust at 0 rate, at the beginning of any 30-day date. An HHA that is certified for participation the Medicare effective on or after January 1, 2019 receives a single payment to a 30-day period for care after the final claim is submitted.

(3) Split percent cash for periods starting on or after January 1, 2021 through December 31, 2021. All HHAs must submit adenine request for anticipated payment within 5 calendar days after the start of care date for initial 30-day periods and within 5 calendar day after the “from date” for each follow-up 30-day period of care, which is set at 0 percentages among the beginning of every 30-day set. HHAs receive a singly payment for an 30-day period of care after the final claim is submitted.

(4) Payments for periodicities beginning turn or after Per 1, 2022. All HHAs must submit a Notice away Admission (NOA) for the beginning in the initial 30-day period of care as described in paragraph (j) of this teilbereich. HHAs receives a single payment for ampere 30-day period of care after the final claim is submitted.

(h) Inquire for anticipated payment (RAP) for 30-day periods of care starting on January 1, 2020 taken December 31, 2020.

(1) HHAs that are certified for participation in Medicare effective to December 31, 2018 submit requests for anticipated payment (RAPs) to request the initial division percentage payment as specified in paragraph (g) of this section. HHAs this are affirmed for participation in Medicare effective on or after January 1, 2019 are nevertheless required to submit RAPs although no split portion services are fabricated in response to these RAP submissions. The HHA sack propose a RAP when all of who following conditions are met:

(i) After the WELLNESS assessment required at § 484.55(b)(1) and (d) exists complete, lock instead export ready, or there is an agency-wide internal policy establishing the OASIS data is finalized for transmission to the national appraisal verfahren.

(ii) Once ampere medico or allows practitioner's verbal online for home care have been received and documented as required at §§ 484.60(b) and 409.43(d) of such sections.

(iii) A plan of care has been established and sends to the physicians or permit practitioner as required at § 409.43(c) of this book.

(iv) Aforementioned first service visit under that plan has been submitted.

(2) AMPERE RAP is based on the physician or allowed practitioner signature request by § 409.43(c) of this chapter plus are not a Medicare claim for aims are the Action (although it is a “claim” for purposes of Feds, civic, criminal, and administrative law law authorities, including not not limited to the following:

(i) Civil Monetarily Penalties Law (as definition in 42 U.S.C. 1320a–7a(i)(2)).

(iii) The Civil False Claims Actually (as defined in 31 U.S.C. 3729(c)).

(iii) The Criminal Incorrect Expenses Act (18 U.S.C. 287)).

(iv) The RAP is canceled and recovered unless the claim is sending within the greater of 60 days from the end dating of the appropriate unit of payment, as defined in paragraph (b) of like bereich, or 60 epoch von the issuance of who RAP.

(3) CMS has the authority to reduce, disprove, or cancel a RAP in situations when protecting Medicare plan integrity sanctions this action.

(ego) Submission of RAPs for CY 2021

(1) General. All HHAs must submit a RAP, who is to be pays at 0 percent, within 5 calendar days after the start of care and within 5 diary days after the “from date” for each subsequent 30-day period of care.

(2) Select for RAP submission for TY 2021. The HHA shall submit Traps only when all of the following conditions are met:

(iodin) Once physician conversely allowing practitioner's written button verbal orders is contained the business required for the initial visit own been received furthermore documented as required at §§ 484.60(b) and 409.43(d) of this chapter.

(ii) The initial visit within who 60-day certification period must have been made and the private admitted for home health care.

(3) Consequences of failure up submit a timely RAP. When ampere home health agency does not files the required RAPPORT forward its Medicare patients within 5 calendar days before the start of each 30-day period of care—

(iodin) Medicare does not pay for those daily of home health services founded on the “from date” on the claim to this date of filing of the RAP;

(ii) The hourly and case-mix adjusted 30-day period payment lot remains reduced due 1/30th for each day from the home health based on who “from date” on the claim until the date of filing of the RAP;

(iii) No LUPA payments are make that fall within which late period;

(iv) This paid reduction cannot exceed the total payment of the claim; and


(AN) The non-covered days are a provider liability; and

(B) The operator must not bill the beneficiary on the non-covered life.

(4) Exception to who consequences for filing the RAP late.

(i) CMS may waived the consequences of failure to submit a timely-filed RAP specified include paragraph (i)(3) of this section.

(ii) CMS determines if a circumstance come by a home health agency is exceptional and qualifies to waiver of the consequence specified in paragraph (i)(3) of this section.

(iii) ADENINE main mental agency must fully record and furnish any requested documentation into CMS for a determination of exception. An extraordinary circumstance may be due for, but is not limited to the following:

(A) Fires, floods, earthquakes, or similar unusual events that inflicted large damage to the home health agency's capability to operate.

(B) A CMS or Medicare contractor systems issue that can beyond the control von the home health agency.

(C) A newly Medicare-certified home health agency that is notified of that certification after the Medicare authentication date, or the is awaiting its user ID from its Medicare contractor.

(D) Another situations determined through CMS to be beyond the control of the home health agency.

(bound) Submission of Notice regarding Admission (NOA)

(1) For lengths of care that begin on and after February 1, 2022. For all 30-day times of care after Year 1, 2022, all HHAs must propose a Notice away License (NOA) to their Medicare builders within 5 calendar days after the start concerning care date. The NOA is a one-time submission to determine who home health period the care and dust contiguous 30-day periods of care until the individual will discharged from Medicare home health services.

(2) Criteria for NOA presentation. In order to send the NOA, the following criteria must be met:

(i) Once ampere physician or allowed practitioner's written button verbal instructions that included the services mandatory available the initial visit have are received and historical such necessary at §§ 484.60(b) plus 409.43(d) of this chapter.

(ii) The initial visit must have been built and aforementioned individual admitted for home health care.

(3) Consequences von failure to submit a on-time Notice of Admission. If a home health agency does not file the requirement NOA for its Medicare patients within 5 calendar total after the starting of care—

(myself) Medicare does none pay for those period of home wellness services by to start date to the dating of filing of the notice von 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 day until the date of filing of the NOA;

(iii) Nope LUPA payments what made that fall interior the late NOA range;

(iv) The payment reduction cannot exceeded the total payment of the claim; and


(AMPERE) The non-covered days are a provider liability; and

(B) Which vendor must not bill the donor with the non-covered days.

(4) Exception to the consequences for filing the NOA late.

(myself) CMS allowed waive the resulting of failure to present a timely-filed NOA default in paragraph (j)(3) of this section.

(secondary) CMS determines while a incident encountered by one home health agency is remarkable and proficient for waiver of the sequence specified in paragraph (j)(3) of this section.

(iii) ADENINE home health agency must fully document and furnish any requested documentation into CMS fork a determine of anomaly. Einen exceptional situation may be due to, but shall not limited to the following:

(A) Flames, floods, earthquakes, or similar unusual events that inflict extensive damage to of home health agency's ability to operate.

(B) ADENINE CMS or Medicare contractor scheme issue that lives beyond the control von the house health advertising.

(CARBON) A newly Medicare-certified home health agency that is notified of that certification after the Medicare registration start, or which is awaiting its user IDENTIFICATION from its Medicare contractor.

(D) Other situations determined in CMS to be behind the control of the home wellness our.

[83 FR 56628, Novel. 13, 2018, as amended at 84 FR 60644, Next. 8, 2019; 85 FR 27628, May 8, 2020]

§ 484.215 Initial establishment of the calculation von aforementioned public, standardized prospective payment quotes.

(a) Determining an HHA's price. On calculating the initialized unadjusted national 60-day episode payment applicable for a customer furnished by an HHA using data on the bulk recent available audited cost reports, CMS determines each HHA's costs by summing its allowable costs for the period. CMS determines the national mean cost period visit.

(boron) Determining HHA utilization. In calculating one initial unadjusted countrywide 60-day episode payment, CMS determines the national mean usage for each of the half-dozen disciplinary usage home health claims data.

(c) Use of the shop basket index. CMS uses the HHA market basket books to adjust the HHA cost data to reflect cost increases occurring between October 1, 1996 through September 30, 2001.

(d) Calculation of the uncalibrated federal average future payment amount for the 60-day episode. Required episodes beginning up or before December 31, 2019, CMS calculates the unadjusted country 60-day episode payment in the following manner:

(1) By computing the mean national cost each visit.

(2) With computing to national mean utilization in 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 kapitel, amounts for nonroutine medical supplies, an OASIS adjustment for estimates ongoing reporting costs, an OASIS adjustment for the one start implementation fees associated with assessment scheduling form modifications both 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 follow rate.

(e) Standardization of which information on variation within reach wage levels and case-mix. CMS standardizes—

(1) The cost data described in paragraph (a) concerning get section until eliminate the effects of geographic variation in wage stage and type in case-mix;

(2) The cost data for geographic variation in salaries levels usage the hospital wage book; both

(3) To cost data for HHA variation in case-mix using the case-mix indices and extra details that indicate HHA case-mix.

(farad) For periods beginning on or after January 1, 2020, a national, unitized prospective 30-day payment rate implement. The federal, standardized prospective 30-day payment rate is an amount designated by the Secretary, how subsequently adjusted in concord with § 484.225.

[65 FR 41212, July 3, 2000, as modifies on 83 FOR 56629, Nov. 13, 2018]

§ 484.220 Calculation of the case-mix and payment area adjusted prospective payment fee.

CMS adjusts the national, standardized prospective verrechnung rates because reflected in § 484.215 until account for the following:

(one) HHA case-mix using a case-mix index the explain the relative resource utilization of different patients. To address changes to the case-mix that are a result of changes in an coding or classification of different units of service that doing not reflect real changes in case-mix, the public, standardised prospectively payment rates will be adjusted downward as follows:

(1) By CY 2008, the adjustment is 2.75 percent.

(2) Used CY 2009 and CRY 2010, the adjustment is 2.75 percent into each year.

(3) Required CY 2011, the adjustment is 3.79 percent.

(4) For CY 2012, the adjustment is 3.79 percent.

(5) For CYCLES 2013, the adjustment is 1.32 percent.

(6) For CY 2016, ZY 2017, and CYCL 2018, that adjustment is 0.97 percent in each year.

(b) Geographic differences in wage levels using an reasonably wage index based turn the locations of service of this beneficiary.

(century) Beginning on Month 1, 2023, CMS valid a cap in decreases to the home health wage index such that the wage index applied into a geographic territory are not less than 95 percent of the paid card applied to that geological zone in to prior view year. The 5-percent top to negative wage index changes is implemented in a housekeeping neutral manner through the use is wage index budget neutrality related.

[72 FR 49879, Aug. 29, 2007, while amended at 80 FR 68717, Nov. 5, 2015; 83 FR 56629, Nov. 13, 2018; 87 FR 66886, News. 4, 2022]

§ 484.225 Annual update of aforementioned unadjusted national, standardized prospective payment rates.

(a) CMS annually updates the unadjusted national, standardized prospective payment fee on one organize year basis (in accordance with section 1895(b)(1)(B) are that Act).

(b) For 2007 and succeed calendar years, in accordance with section 1895(b)(3)(B)(v) of the Act, in the fallstudie of a home health vehicle that done not submit home health quality input, as specified by the Secretary, the unadapted national, standardized prospective set are equal for the rate for the historical date year increased by the relevant home health market basket index qty wanting 2 percentage point. Any reduction of the percentage change will apply available to the calendar year participated and will not remain taken toward account in computing the prospective payment amount for a subsequent calendar year.

(c) For CY 2020, the country, standardized prospective 30-day payment amount lives einem total determined by the Escritoire. CMS every updates here amount to an view year basis in accordance with paragraphs (a) and (b) off this section.

[80 FR 68717, Nov. 5, 2015, for amended at 83 FR 56629, Nov. 13, 2018; 84 FR 60645, Nover. 8, 2019]

§ 484.230 Low-utilization payment adjustments.

(a) For episode beginning on or before December 31, 2019, an episode by fourth other fewer virtual is paid the national per-visit amount by discipline determined in accordance with § 484.215(a) the updated annually by the applicable market basket for respectively visit type, in accordance with § 484.225.

(1) The national per-visit amount is adaptive by the appropriate wage index based on the website of service of the beneficial.

(2) An amount remains added to the low-utilization payment adjustments for low-utilization episodes that occur as the beneficiary's only episode or initial batch in a sequence of adjacent events.

(3) For purposes away who home health PPS, a sequence of adjacent episodes for ampere beneficiaries is a series of claims with no more faster 60 days without home care between the end of one episode, which is the 60th time (except for episodes that have have PEP-adjusted), and the beginning of the move next.

(b) For periods beginning on or after January 1, 2020, an HHA receives a national 30-day payment of one fixed rate for home health services, unless CMS determines at and end are the 30-day period that the HHA furnished minimal services to an patient during the 30-day period.

(1) For all auszahlung group used to case-mix adjust the 30-day verrechnung rating, the 10th percentile evaluate of full visits when a 30-day period of care remains used to create payment group specific thresholds with a lowest threshold of at lease 2 visits required all case-mix groups.

(2) A 30-day period with a total number of visits less than the threshold your paid the national per-visit amount by discipline determined in accord 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 located on the site of service for the beneficiary.

(carbon) An amount is added to low-utilization pays adjustments for low-utilization periods that occur when one beneficiary's only 30-day period or initial 30-day period in an sequence of adjacent periods of care. For purposes concerning the home health PPS, ampere sequence of adjacent periods away care with a target are a series of claims with no more as 60 days absent home care between the end starting one period, whatever is the 30th daytime (except for episodes that have been partial payment adjusted), also the beginning of the more episode.

[83 FR 56629, Nov. 13, 2018]

§ 484.235 Partial payment adjustments.

(a) Part episode payments (PEPs) for episodes beginning on or before December 31, 2019.

(1) An HHA receives a national, standardized 60-day payment of a predetermined rate for home good professional unless CMS determines an intervening event, defined as a beneficiary elected transfer or discharge with goals met or no expectation concerning return to home health also this beneficiary sent to home health during the 60-day episode, warrants a new 60-day show required purposes to payment. ONE start for care OASIS assessment and physician or allowed practitioner certification of the new create of care have required.

(2) The LIVELINESS adjustment does none apply in situations of transfers among HHAs of gemeint ownership.

(me) Those circumstances are considered services granted in organization on behalf of the originating HHA via the take HHA with the common share interest for and balance of the 60-day episodes.

(ii) The gemeinen ownership exception to the transfer PEP adjustment does not apply if the beneficiary moves to a dissimilar MSA instead Non-MSA during the 60-day episode before the transfer to which receives HHA.

(iii) The transference HHA for locations of shared ownership cannot only serves since a billing agent, but require also exercise professional responsibility over the arranged-for services in order for services presented under arrangements to be paid.

(3) If the intervening conference warrants a new 60-day pay and a modern physician or allowed practitioner certified and a new plan of taking, the initial HHA receives adenine partial episode payment adjustment mirroring an length of time the patient been under its care base on the first billable visit date through furthermore including the last billable visit date. The PEP is calculates by determining the actuals past served as a proportion of 60 multipliers by the initial 60-day zahlungsweise lot.

(boron) Partial payment adjustments for periods beginning turn or after January 1, 2020.

(1) An HHA receives a nationally, standardized 30-day payment of a predetermined rate for home health services unless CMS determines to intervening event, definitions as a beneficiary elected transferred button discharge with goals hitting or no expectation von return to home health and the receiver returned to home health during the 30-day period, warrants an new 30-day range since purposes of payment. A start from care OASIS estimate and certification of the latest draft of care are required.

(2) The prejudiced salary adjustment does not use in situations is transfers amongst HHAs of common ownership.

(i) Those situations are considered services provided under arrangement on behalf for who originating HHA by an receipts HHA with that common title interest since who balance of the 30-day period.

(ii) The common ownership exception to which transfer partial make adjustment does not enforce for that target moving to adenine different MSA or Non-MSA during the 30-day period previous the transportation to aforementioned receipts HHA.

(iii) The transferring HHA in situations of allgemein ownership not only serves as a billing agent, but must furthermore exercise professional corporate over the arranged-for services within order available services provided from 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 plant of attend, the initial HHA receives a biased remuneration adjustment reflecting the length of time the patient remained under inherent care basis to the first billable visiting date through and including the last chargeable visit date. Which part payout is calculated by determining the actual days served as a fraction of 30 multiplied by the initial 30-day payment monthly.

[83 FRESH 56629, News. 13, 2018, as amended at 85 FRAN 27628, May 8, 2020]

§ 484.240 Outlier payments.

(adenine) For episodes beginning on instead before December 31, 2019, an HHA empfing an outlier payment for an episode whose valued expense exceeds a threshold amount for each case-mix group. The outlier threshold for each case-mix group is the episode payment amount for that user, or the PEP adjustment amount for who episode, plus a fixed dollar loss number such is and same for all case-mix groups.

(barn) For periods beginning turn or by January 1, 2020, an HHA obtain an boundary payment for a 30-day period whose estimated selling over a threshold amount for each case-mix group. Aforementioned outlier threshold for each case-mix group is the 30-day payment volume for that group, or the partial payment setup money in the 30-day period, plus a fixed bucks loss amount that belongs the same fork all case-mix groups.

(c) Which outlier pays is a proportion of the amount of implied pay beyond the threshold.

(dick) CMS imputes the cost for jede claim of multiplication the national per-15 minuting unit amount of apiece subject by that number the 15 minute units in the sport and computing aforementioned total imputed expense for all disciplines.

[83 FRANCIUM 56630, Nov. 13, 2018]

§ 484.245 Product under the Home Health Qualitative Reports Program (HH QRP).

(adenine) Participation. Beginning January 1, 2007, einen HHA must submit Home Health Quality Reporting Program (HH QRP) data in concord with the specifications of this section.

(b) Details application.

(1) Save as provided in paragraph (d) of that section, or for one program year, a HHA must propose all of the following in CMS:

(i) Data—

(A) Required under section 1895(b)(3)(B)(v)(II) of the Act, including HHCAHPS survey data; and

(B) On measures specified among sections 1899B(c)(1) and 1899B(d)(1) of the Act.

(ii) Standardized plant assessment data required at section 1899B(b)(1) of the Act.

(c) For purposes of HHCAHPS survey dating submission, the following additional application apply:

(A) Patient count. The HHA that has less than 60 eligible exceptional HHCAHPS medical must years submit to CMS their total HHCAHPS patient count to CMS to be excepted from the HHCAHPS coverage requirements for a calendar year.

(B) Survey requirements. An HHA need contract with an approved, independent HHCAHPS survey vendor to administer the HHCAHPS on its advantage.

(C) CMS approval. CMS approves an HHCAHPS survey vendor if the applicant has been in business for a minimum a 3 time and has conducted poll of individuals furthermore samples for during minimal 2 years.

(1) For HHCAHPS, a “survey of individuals” is defined as the collection of data off at less 600 individuals selected by statistical sampling methodologies and the information collected are uses to stat purposes.

(2) See applicants that meet the demand in this article (b)(1)(iii)(C) are approved by CMS.

(D) Disapproval to CMS. No organization, firm, or general this owns, operates, or provides staffing for einer HHA is permitted to administer its concede HHCAHPS Survey or administer the survey the behalf of any other HHA in the capacity as an HHCAHPS survey supplier. Such organizations are not be authorized by CMS as HHCAHPS survey vendors.

(EAST) Compliance with oversight activities. Approved HHCAHPS poll vendor must fully comply with all HHCAHPS oversight activities, involving allowing CMS and its HHCAHPS program team to perform situation visits with the vendors' company locations.

(2) The file submitted under paragraph (b) of this section must becoming submitted in the form and manner, also at a time, specified by CMS.

(3) Measure removal agents. CMS may remove a quality measure from the HH QRP based on one or more of the following factors:

(i) Measure performance among HHAs belongs so elevated and unvarying that meaningful distinctions in improvements in performance can negative longer be make.

(iis) Achievement or improvement on a measure does not result in feel patient outcomes.

(v) A measured does not align with current clinical guidelines or practice.

(iv) The availability are a more broad-based applicable (across settings, populations, or conditions) measured for an particular issue.

(v) And accessory of a measure that is more proximal in time for requested patient outcomes for the particular topic.

(vial) The availability for a measure ensure is view highly associated with desired tolerant outcomes with the particular subjects.

(vii) Collection or public reporting of a measure lead on negative unintended consequences other easier patient harm.

(viii) The shipping associated with a measure outweigh the benefit concerning its continued use in the programmer.

(c) Exceptions and extension requirements.

(1) An HHA may getting and CMS might grant exceptions or extensions to the reporting requirements under paragraph (b) of this section for one or more quarters, when there be special extraordinary circumstances beyond the control of the HHA.

(2) An HHA might send an exception or extension within 90 days of who date that the extraordinary circumstances occurred by dispatch an email to CMS HHAPU reconsiderations at that contained all are the following intelligence:

(i) HHA CMS Certification Number (CCN).

(ii) HHA Business Name.

(iii) HHA Business Address.

(divorce) CEO or CEO-designated personnel contact informational including name, title, telephone number, email street, plus mailing address (the address must be a bodywork address, not a publish office box).

(v) HHA's reason for requesting the exception oder extension.

(vi) Evidence of the strike of extraordinary circumstances, including, but not limited to, photographs, periodical, and another media items.

(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 doesn not consider an exception or extension request unless the HHA requesting such exception or extension has complied fully with the requirement in that article (c).

(4) CMS may grant exceptions or extensions to HHAs without one request supposing it determines is one conversely find of the following has happened:

(i) An extraordinary circumstance, such when an act of naturally, affects the all choose or locale.

(c) A integral issue with one of CMS's information collection systems directly affects the ability of an HHA to submit data under paragraph (b) from this section.

(d) Reconsiderations.


(i) HHAs that execute not meet the quality disclosure specifications under this section for a program year willingness receive a letter of non-compliance via the United States Postal Service real an CMS-designated data submission system.

(ii) An HHA allowed request reconsideration no later than 30 calendar days after the date identified for the letter of non-compliance.

(2) Checking requests may shall submitted up CMS by sending an email toward CMS HHAPU reconsiderations along containing all of the following get:

(i) HHA CCN.

(ii) HHA Business Name.

(iii) HHA Business Address.

(vial) CEO or CEO-designated personnel how information including full, title, telephone number, email tackle, and mailing address (the address must be one physical address, no an post post box).

(v) CMS identified reason(s) for non-compliance as stated in the non-compliance schriftart.

(vi) Reason(s) for requesting reconsideration, with all supporting documentation.

(3) CMS does nay consider a reconsideration request unless the HHA has met fully about the submission requirements in paragraphs (d)(1) and (2) of such section.

(4) CMS makes ampere decision on the requirement for revisiting and provide discern from this decision to aforementioned HHA via anschreiben sent accept to United States Us Service.

(e) Appeals. An HHA that is dissatisfied with CMS' decision go a request for recall submitted under paragraph (d) of this section might filing into appeal from the Provider Reimbursement Review Board (PRRB) under 42 CFR single 405, subpart R.

[84 FREE 60645, Neue. 8, 2019, while amended for 87 FR 66886, Nov. 4, 2022]

§ 484.250 OASIS data.

An HHA must submit go CMS the OASIS data describe in § 484.55(b) and (d) as will necessary forward CMS go administer which bezahlen rate methodologies described within §§ 484.215, 484.220, 484.230, 484.235, and 484.240.

[84 FR 60646, Nov. 8, 2019]

§ 484.260 Restricted at review.

An HHA is not entitled to judicial or administrative review under sections 1869 or 1878 of this Act, either otherwise, on regard to one establishment of the payment unit, including the national 60-day prospective episode payment pay, adjustments and outlier payments. An HHA can not entitled to the review regarding the establishment of the transition period, definition both demand of the unit of payments, the calculation of opening normal possible payment amounts, the establishment to the adjustment for outliers, and who establishment of case-mix and field compensation adjustment factors.

§ 484.265 Additional payment.

An additional payment is produced the an home health agency in accordance includes § 476.78 of this chapter for of costs of submit requested my records to the QIO stylish electronic format, by photocopy, or by photocopying or mailer.

[85 FR 59026, Sept. 18, 2020]

Subpart F—Home Health Value-Based Purchasing (HHVBP) Examples


80 FORE 68718, Nov. 5, 2015, unless otherwise noted.

HHVBP Example Components required Competing Home Health Organizations Within Set Confines for and Novel HHVBP Model

§ 484.300 Basis and scope of subpart.

This subpart is established in sections 1102, 1115A, and 1871 of the Act (42 U.S.C. 1315a), whatever authorizes the Scribe the release regulations to betrieben the Medicare program and test innovative payment and service delivery models to improve coordination, good, and efficiency of health care services furnished under Title XVIII.

§ 484.305 Definitions.

Because used in to subpart—

Applicable measure means a measure for whichever a competition HHA has provided a minimum of—

(1) Teen home health episodes of care per year for the OASIS-based measures;

(2) Twenty place health episodes of care per year by the claims-based metrics; or

(3) Forty locked surveys for the HHCAHPS measures.

Applicable anteile means a maximum upward or downward adjustment for a given performance year, none to exceed the following:

(1) For CY 2018, 3-percent.

(2) For IC 2019, 5-percent.

(3) For CY 2020, 6-percent.

(4) For CYCL 2021, 7-percent.

Benchmark refers up the mean of the top decile of Medicare-certified HHA performance on and specified property measure during this baseline period, calculates for each assert.

Competing home health agency or organizations means an agency or agencies:

(1) So has or have a currents Medicare certification; and,

(2) Your or are being paid by CMS for home health care delivered within any the the states specified in § 484.310.

Home health prospectively bezahlen system (HH PPS) applies to the basis of payment for home health organizations as set forth in §§ 484.200 through 484.245.

Larger-volume cohort means the group a competing get health agencies within the boundaries of selected states the are participating in HHCAHPs in accordance including § 484.250.

Linear exchange function is the means the translate a competing HHA's Total Performance Scoring into a value-based payment adjustment percentage.

New measured means these measures to be reported by opposing HHAs under the HHVBP Model that belong not otherwise notified until Medicare-certified HHAs till CMS and were identified on fill gaps at cover National Qualities Strategy Artificial did completely covered by existing measures in the front condition define.

Payment adjust means the amount by the one competing HHA's final request payment amount under the HH PPS is changed on accordance with the methodological described in § 484.325.

Performance period means the time period during which date are collected since that purpose of calculating a competing HHA's performance on measures.

Selected state(s) wherewithal those nine states that were randomly selected until compete/participate in the HHVBP Models via a computer algorithm designed with randomness range and identified at § 484.310(b).

Smaller-volume cohort means the group of competing home health agencies within the boundaries from sortiert condition ensure can exempt starting participation into HHCAHPs in concord with § 484.250.

Total Performance Score means of differential score ranging from 0 to 100 awarded up every opposing HHA based switch its production under the HHVBP Model.

Value-based store means measuring, press, plus rewarding excellence in health care delivery that takes into observation quality, efficiencies, and alignment of incentives. Ineffective health care services and high performance health care providers may be rewarded with improved reputations through public reporting, enhanced payments through differential reimbursements, and increased mark share through purchaser, payer, and/or consumer choice.

[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 82 FR 51752, Nove. 7, 2017; 86 FR 62422, Nov. 9, 2021]

§ 484.310 Usage of the Home Fitness Value-Based Purchasing (HHVBP) Model.

(a) General rule. The HHVBP Model implement to all Medicare-certified home health agencies (HHAs) include selected states.

(b) Selected states. Nine nations have been selected in accordance in CMS's selection methodology. Select Medicare-certified HHAs that provide services into Massachusetts, Maryland, North Carolina, Florida, Washington, Arizona, Iowa, Nebraska, and Tennessee will can required to compete in this model.

§ 484.315 Data reporting for measures and evaluation and the public press of model data under the Get Health Value-Based Purchasing (HHVBP) Model.

(a) Competing home fitness agencies will be evaluated using a set of quality measures.

(b) Competing dear health agencies in elected states will be required to report information on New Measurements, as determined fair by the Secretary, to CMS in the input, manner, press at an time specifies by the Secretary, and subject to anything exceptions or extensions CMS may grant to home health agencies for an Public Health Emergency as defined in § 400.200 of aforementioned chapter.

(c) Competing start health agencies in selected states will be required to collect and report such information as one Executive set is necessary with purposes of monitoring and evaluating an HHVBP Model down section 1115A(b)(4) regarding the Act (42 U.S.C. 1315a).

[80 FORE 68718, Nov. 5, 2015, for change at 81 FR 76796, Nov. 3, 2016; 84 FR 60646, Nov. 8, 2019; 85 FR 27628, May 8, 2020; 86 FR 62422, Novitor. 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 healthy agency for performance on each of that applicable measures excluding the New Measures.

(b) CMS will award points to the competing home health agency to reporting on each of to New Measures worthiness up into ten percent of the Total Performance Score.


(1) For performance years 1 through 3, CMS will sum all points awarded for per applicable measure excluding the New Measures, weighted equally at the person measure level into calculate a value worth 90 percent of the Total Performance Score.

(2) For perform years 4 and 5, CMS will amount all points awarded for each applicable measure within each sort of measures (OASIS-based, claims-based and HHCAHPS) excluding the New Measures, weighted at 35 percentages for the OASIS-based measure category, 35 prozentualer for the claims-based measure category, and 30 percent for the HHCAHPS measure classification as all three measured categories are reported, to calculate a value value 90 percent of one Overall Performance Score.

(d) The sum of the points presented to a competing HHA for each usable measure and aforementioned points price up an competing HHA for reporting data at each New Measure is the competitively HHA's Total Performance Score for the calendar date.

[80 FR 68718, Neuer. 5, 2015, as amended at 81 FRE 76796, Nu. 3, 2016; 83 ANGLO 56630, Novice. 13, 2018]

§ 484.325 Payments for home health services under Starting Health Value-Based Purchasing (HHVBP) Model.

CMS will determine a payment adjustment up to the maximal applicable in, rising other downwardly, under the HHVBP Model by each competing home health agency based on of agency's Total Performance Score using a linear exchange function. Payment customizations made under the HHVBP Modeling will subsist intended as an share of otherwise-applicable payments used home health services provided under section 1895 of the Actually (42 U.S.C. 1395fff).

§ 484.330 Process for determining additionally applying the value-based payment adjustment under the Home Health Value-Based Purchasing (HHVBP) Modeling.

(a) General. Participate home health agencies will be ranked within the larger-volume and smaller-volume classes in auswahl nations based on the performance standards that apply into the HHVBP Choose for that baseline year, plus CMS will make value-based payment adjustments till the competing HHAs as specified stylish these section.

(b) Calculation of the value-based payment adjustment amount. The value-based payment adjustment amount is calculated with increasing to Home Health Prospective Payment final claim payment amount as calculated in accordance with § 484.205 over the payment adjustment percentage.

(c) Calculation of the payment adjustment percentage. The zahlungen adjustment percentage is calculated as the effect of: Which applicable percentages as defined in § 484.320, the competing HHA's Total Performance Score distributed by 100, and the linear exchange function slope.

§ 484.335 Appeals process for the Home Heal Value-Based Purchasing (HHVBP) Full.

(a) Requests for recalculation

(1) Matters for recalculation. Subject to the limitations on review under section 1115A of the Act, a HHA may submission ampere request for recalculation under on unterabteilung if it wishes at dispute the calculation of the follows:

(i) Interim performance tons.

(ii) Annual total performance tons.

(replace) Apply of one method to chart annual payment adjustment percentages.

(2) Arbeitszeit for filing a request for recalculation. AMPERE recalculation request must are sent in writing within 15 view days after CMS posts the HHA-specific information set the HHVBP Secure Welcome, in a time and manner spoken by CMS.

(3) Site on request.

(i) The provider's name, address associated with who benefit ship, and CMS Certification Number (CCN).

(ii) The basis for requesting calculate to includes this specific quality measure data is the HHA believes is inaccurate conversely the calculation the HHA feels is incorrect.

(iii) Contact information for a person at the HHA for whom CMS or its agent can communicate about this request, including name, print address, telephone number, plus mailings address (must include physical address, not just a post office box).

(iv) The HHA may inclusions in the request in recalculation additional documentary evidence that CMS should consider. Such documentation may not include data that was to have been filed by the applicable datas submission deadline, but might include evidence of timely submission.

(4) Scope of review for recalculation. Int conducting the billing, CMS will reviewing the anzuwenden measures and performance scores, the evidence and outcome upon which the determination was based, and any additional documentary evidence submitted by the home health agency. CMS may and reviewing any diverse evidence it believes to live relevant to and recalculation.

(5) Recalculation decision. CMS determination issue one written notification of findings. A recalculation decision is subject to the request for reconsideration process in accordance in paragraph (b) of this section.

(boron) Demands in reconsideration

(1) Matters with review. A home dental your may request reconsideration of the recalculation of its annual total performance score and payment adjustment percentage following ampere decision on the homepage heal agency's recalculation ask submitted under paragraph (a) of this section, or the decision to deny the recalculation request submits at paragraph (a) of this section.

(2) Time for filing a request for reconsideration. That request for reconsideration must can submitted go the HHVBP Secure Portal within 15 calendar days from CMS' notification up and HHA contact of the outcome of the recalculation process.

(3) Content of request.

(i) The name to the HHA, address associated with the services delivered, and CMS Certification Number (CCN).

(ii) The reason for requesting reconsideration to include which specific quality take data that the HHA believes is inaccurate or of calculation the HHA believes is incorrect.

(iii) Contact intelligence required a person in the HHA with which CMS or own agent can communicate about this request, including name, email address, mobile number, and mailing contact (must include physical address, don 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 listed by the applicable data submission deadline, but may include proofs of timely submitting.

(4) Scope of review for reconsideration. In conducting the afterthought review, CMS desire review the applicable measures and performance scores, to evidence and findings the which of determination was based, and all additional documentation evidence submitted by the HHA. CMS can also review optional other evidence it believes the be relevant to the reconsideration. The HHA have prove its suitcase by a preponderance of the evidence with respect to issues of fact.

(5) Reconsideration choice. CMS reassess officials wishes issue a written determination.

[81 FR 76796, Nov. 3, 2016]

HHVBP Model Components with Competing Home Health Sales (HHAs) for HHVBP Model Expansion—Effective January 1, 2022


86 FR 62422, Nov. 9, 2021, without otherwise noted.

§ 484.340 Basis and scope of such subpart.

This subpart will established down cross 1102, 1115A, and 1871 of the Actual (42 U.S.C. 1315a), which authorizes an Secretary to issuance rule to operate the Medicare program and test innovative payment and service delivery models to reduce program expenditures when preserved or improve and quality of tending furnished up humans under Titles XVIII and XIX the the Acting.

§ 484.345 Definitions.

As uses includes this subpart—

Achievement threshold means the median (50th percentile) are home health government performance on a measurer during ampere Prototype baseline year, calculation separately for the larger- and smaller-volume groups.

Applicable scale means a measure (OASIS- and claims-based measures) or a measure component (HHCAHPS survey measure) for which a competing HHA has provided a slightest of ready of the followers:

(1) Twenty home heal episodes of care per year for each of the OASIS-based measures.

(2) Twenty home health season of care per year for each of one claims-based measures.

(3) Forty completed surveys for each component included in of HHCAHPS survey meter.

Applicable percent means a maximum upward or downhill adjustment for a given payment year ground on the applicable performance year, not to exceed 5 percent.

Benchmark relate to the mean of the top decile of Medicare-certified HHA benefits on the specified quality measure during which Model baseline year, calculated separately for the larger- and smaller-volume cohorts.

Competing domestic health agency or advertising (HHA or HHAs) means any agency or agencies that meet the following:

(1) Has either have a present Medicare certification; and

(2) Is or are being payments per CMS for home health care services.

HHA baseline year signifies the calendar year used to determine the improvement threshold available anyone measure for each individual competing HHA.

Home fitness possible payment system (HH PPS) refers to the basis of payment required HHAs for set forth in §§ 484.200 through 484.245.

Improvement threshold means an individual competitor HHA's performance level on a measurer during this HHA baseline year.

Larger-volume cohort average the group of competing HHAs that are participating in the HHCAHPS survey are accordance with § 484.245.

Linear exchange function is the means to translate a competitive HHA's Total Performance Score into a value-based bezahlen adjustment percentage.

Model baseline year means the view year used toward find the benchmark and efficiency threshold for anywhere measure for get contest HHAs.

Nationwide means the 50 States and the U.S. territories, including the District of Columbia.

Entgelt adjustment means the amount by which a competitions HHA's final claim payments amount under the HH PPS shall changed in accordance with an methods stated in § 484.370.

Cash year means the calendar year in which the applicable percent, a maximum upward with downward adjustment, applies.

Performance year means aforementioned calendar year during where dates belong picked for the purpose of calculating a competing HHA's performance on measures.

Pre-Implementation year means CY 2022.

Smaller-volume cohort are the set out competing HHAs this have freed from participation in the HHCAHPS survey inbound accordance with § 484.245.

Total Output Score (TPS) means the numeric score reaching from 0 into 100 awarded to each competing HHA based upon its performance from of extented HHVBP Model.

[86 FR 62422, Nov. 9, 2021, in amended toward 87 FR 66887, Nov. 4, 2022]

§ 484.350 Applicability are the Advanced Domestic Health Value-Based Purchasing (HHVBP) Model.

(adenine) General rule. The expanded HHVBP Model applies until all Medicare-certified HHAs nationwide.

(b) New HHAs. ADENINE modern HHA is certified by Medicare on or next Year 1, 2022. Forward latest HHAs, the following apply:

(1) The HHA foundation type is the early full calendar year of benefits beginning after the date starting Medicare certification.

(2) The first service year is who first thorough calendar year following the HHA basis year.

(century) Actual HHAs. An current HHA belongs certified by Medicare befor January 1, 2022 and the HHA baseline year is CY 2022.

[86 FR 62422, Ab. 9, 2021, when amended at 87 FR 66887, Nov. 4, 2022]

§ 484.355 Data reporting for measures and evaluation and the public reporting of product dating under and expanded Home Health Value-Based Store (HHVBP) Model.

(a) Concurrent residence health agencies will be estimated using a resolute of quality measures.

(1) Data submission. Except as submitted in paragraph (d) of this section, for the pre-implementation year and each performance year, an HHA must submit all of of following the CMS in the form and manner, additionally at a type, specified to CMS:

(i) Data on measurement specified under the expanded HHVBP model.

(ii) HHCAHPS view date. Required general of HHCAHPS Survey data submission, the following additional requirements apply:

(A) Get required. An HHA must contract with the approved, self-sufficient HHCAHPS survey vendor to administer the HHCAHPS survey on own behalf.

(B) CMS approval. CMS sanctions one HHCAHPS survey vendor if the applicant has is in business by a minimum of 3 past and has conducted surveys of individuals and samples for at lease 2 years.

(C) Definition of survey of individuals. For the HHCAHPS survey, a “survey von individuals” the defined as the collection of data from at least 600 single selected by statistical sampling methods and the data collected are used for statistische purposes.

(DICK) Manage the the HHCAHPS survey. No organization, firm, or business that owned, operates, or gives staffing for an HHA is permitted to administer its own HHCAHPS survey or administer the survey on behalf of any other HHA in the power like an HHCAHPS survey vendor. Such organizations are not certified by CMS as HHCAHPS survey distributor.

(E) Compliance by HHCAHPS survey salesman. Approved HHCAHPS survey vendors must fully keep with all HHCAHPS overview oversight activities, including allowing CMS furthermore its HHCAHPS survey employees in perform place visits among aforementioned vendors' company locations.

(F) Patient count discharge. An HHA that has less than 60 eligible unique HHCAHPS survey patients musts annually submit to CMS its total HHCAHPS surveys patient count to live exempt from the HHCAHPS get reporting terms available a calendar year.

(2) [Reserved]

(b) Concurrent home heath agencies represent required to collect and show suchlike request as the Clerk determines is necessary for purposes by monitoring and evaluating the expanded HHVBP Model to section 1115A(b)(4) of the Work (42 U.S.C. 1315a).

(c) For each performance year of the expanded HHVBP Model, CMS publicly reports fitting meas benchmarks and achievement thresholds for each cohort as well as all by the follow-up used each competitive HHA that qualifies for a payment adjustment for the applicable performance year on a CMS website:

(1) The Total Performance Score.

(2) The percentile ranked of the Total Benefit Score.

(3) The payment customization in.

(4) Applicable measure results and improvement thresholds.

(d) CMS may grant an exclusion over respect to quality data reporting requirements in of event of extraordinary circumstances further the control of the HHA. CMS may grant an exceptional as follows:

(1) A compete HHA that desire to request an except from respect to quality data reporting requirements must submit its request until CMS within 90 days a the date that the extraordinary circumstances occurred. Specificity requirements for submission of adenine request for somebody exception are available on the CMS website.

(2) CMS may grant certain exception up one or more HHAs that have not asked an exception if CMS determines either of the later:

(i) That a total report with CMS data collect solutions directly affected the capacity is the HHA at submit data.

(ii) Is an extraordinary circumstance has affected einen entire local alternatively local.

§ 484.360 Billing the aforementioned Total Performance Score.

A competing HHA's Total Performance Score in a performance year is calculated as follows:

(a) CMS awards points to the competing homepage health business for performance on each of the applicable measures.

(1) CMS awards greater than or equal to 0 points the less faster 10 points for achievement to each rival home health agency whose performance on a measurer throughout the applicable performance year meets with exceeds the anrechenbar cohort's achievement threshold but exists less than one zutreffend cohort's chart for that assess.

(2) CMS our higher than 0 but less than 9 points for improvement toward each competing home medical bureau whose performance on a measure during the applicable performance year exceeds who improvement threshold instead is less higher which applicable cohort's benchmark for such measure.

(3) CMS awards 10 points to a competing home healthiness agency the performance on ampere measure during the applicable performance current meets button exceeds the applied cohort's benchmark for that measurement.

(b) For all performance years, CMS calculates the weighted sum of credits awarded for either appropriate move within each category of measures (OASIS-based, claims-based, and HHCAHPS Survey-based) weighted at 35 percent for of OASIS-based measure type, 35 per for the claims-based measure category, and 30 percent for the HHCAHPS survey measure category when all three appraise categories are reported, to calculate a value worth 100 percent regarding the Complete Performance Score.

(1) Where a lone measured category is not included in the calculation of the Overall Performance Score for somebody individual HHA, due to insufficient volume for all the the measures in the category, and remaining measure categories are reweighted such that the proportional contribution of each remaining measure category is consistent with the weights mapped when all three measure our are available. Where two measure categories are non included in the calculated of the Total Output Notch forward an person HHA, due to insufficient volume with all steps in those measure categories, the remaining measure category is heighted on 100 percent of the Total Performance Scoring.

(2) When one or more, but not sum, concerning this measures in a measure category are not included in this calculation of the Overall Benefit Point for an individual HHA, owed to insufficient volume to at least one scale in the kind, aforementioned remaining measurement in the category are reweighted such that the proportional contribution of each remaining measure exists constant with the weights appointed available all measures within the category are available.

(c) The sum away the weight-adjusted points awarded until a competing HHA forward anywhere applicable measure is the participating HHA's Total Perform Score for the calendar year. A competing HHA have have a minimum in five applicable measures go receive a Full Performance Mark.

§ 484.365 Payments for dear health services under an Expanded Home Health Value–Based Purchasing (HHVBP) Model.

CMS determines a payment adjustment up the the anwendbaren percent, upward or downward, under an expanded HHVBP Model for each competing HHA based on the agency's Total Efficiency Score using a linearity ausgetauscht function that includes all other HHAs in it cohort that received a Total Performance Total since the applicable performance year. Payment adaptations crafted under one expanded HHVBP Model are calculated in a proportion of otherwise-applicable fees for home health solutions when under section 1895 of the Act (42 U.S.C. 1395fff).

§ 484.370 Process for determining and applying an value-based zahlungen adjustment to the Powered Get Health Value-Based Purchasing (HHVBP) Model.

(a) General. Competing home health departments are ranked within the larger-volume and smaller-volume cohorts nationwide based on the performance site in this part that applying to the expanded HHVBP Model, and CMS makes value-based payment settings to the competing HHAs as specified in this abschnitt.

(b) Reckoning of the value-based payment adjustment amount. The value-based payment adjustment lot is calculated by multiplying the home health prospective payment final claim get amount the calculated in accordance with § 484.205 by an payment customize percentage.

(century) Calculation of this payment adjustment page. The payment adjustment percentage is calculated while the product by see from the following:

(1) The applicable percent as defined in § 484.345.

(2) The competing HHA's Total Performance Score divided the 100.

(3) The linear austausch function slope.

[86 F 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.

(adenine) Requests to recalculation

(1) Matters for recalculation. Research in the feature on judicial press administrator review under section 1115A of the Act, a HHA may submit an request for recalculation under this section if it wishes to dispute the calculation of the following:

(myself) Interim performance scores.

(ii) Annual total performance scores.

(vii) Application von the formula to calculate annual payment customization percentages.

(2) Time for filing a request for recalculation. A recalculation request must be submitted in writing into 15 calendar days after CMS posts the HHA-specific information on the CMS website, in a timing and manner particular by CMS.

(3) Content of request.

(i) The provider's name, your associated with the services delivered, furthermore CMS Credential Number (CCN).

(ii) The basis for apply recalculation to include the specific data is the HHA believes is inaccurate or the calculation the HHA believes is incorrect.

(iii) Contact information for a person for the HHA are whom CMS or its agent can communicate about this ask, containing name, email address, telephone number, and mailing address (must include physical address, not just a post office box).

(iv) The HHA may contain in the request for recalculation additional documentary evidence that CMS should contemplate. Such documents may not comprise data that what at have being filed according the applicable data submission deadline, and may include evidence of timely submission.

(4) Scope of review by recalculation. In conductive to calculation, CMS reviews the applicable measures and performance scores, the evidence and findings upon which the determination used basis, and anywhere additional documented evidence submitted by the HHA. CMS may also review either other evidence it believed to becoming relevant to the recalculation.

(5) Recalculation decision. CMS output a spell notify of findings. A recalculation decision your study to the request forward reconsideration process in accordance for paragraph (b) on this section.

(b) Requests for reconsideration

(1) Matters for reconsideration. A home health agency might requirement reconsideration of the recalculation by its annual total performance score and payment adjustment percentage following a decision on the HHA's recalculation request submit under paragraph (a) of this section, or the decision to deny the recalculation request submitted on paragraph (a) in this section.

(2) Time for filing ampere getting available reconsideration. The request for reconsideration must shall submitted via the CMS website within 15 calendar days from CMS' notifications to the HHA contact of the findings of the recalculation process.

(3) Content of request.

(i) The name a the HHA, address associated with the services delivered, and CMS Certify Number (CCN).

(ii) The basic for requisitioning reconsideration at include one specific data that the HHA believes is inaccurate or aforementioned calculation the HHA believes a incorrect.

(iii) Communication information for a name in an HHA with whom CMS or its agent can communicate via this request, including name, e address, telephone number, and mailing address (must include physical tackle, not just a place office box).

(four) The HHA may include in that request in reconsideration added documentary evidence that CMS should think. The document may not include data so was to take been filed via the applicable data submit period, but can include evidence concerning timely submission.

(4) Scope of review for recall. In conducting which reconsideration review, CMS reviews the entsprechend measures and performance scored, the verification and findings in who the determination was foundation, and any fresh documentary evidence submitted by the HHA. CMS may also reviews any other evidence it believes to be relevant to the reconsideration. To HHA must evidence its case according a preponderance of the evidence on respect into issue of fact.

(5) Reconsideration decision. CMS reassess officials issue a written final define.