Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)) unless otherwise indicated.
(a)
(1) Sections 1861(o) and 1891 establish the conditions that an HHA must meet in order to participate in Medicare.
(2) Section 1861(z) specifies the Institutional planning standards that HHAs must meet.
(3) Section 1895 provides for the establishment of a prospective payment system for home health services covered under Medicare.
(b) This part also sets forth additional requirements that are considered necessary to ensure the health and safety of patients.
As used in this part, unless the context indicates otherwise—
(1) Serves patients in a geographic area different from that of the parent agency; and
(2) Must independently meet the conditions of participation for HHAs because it is too far from the parent agency to share administration, supervision, and services on a daily basis.
Staff required to meet the conditions set forth in this part are staff who meet the qualifications specified in this section.
(a) Is a licensed physician; or
(b) Is a registered nurse; or
(c) Has training and experience in health service administration and at least 1 year of supervisory or administrative experience in home health care or related health programs.
(a) Meets the education and experience requirements for a Certificate of Clinical Competence in audiology granted by the American Speech-Language-Hearing Association; or
(b) Meets the educational requirements for certification and is in the process of accumulating the supervised experience required for certification.
(a)(1) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the State in which practicing, unless licensure does not apply;
(2) Graduated after successful completion of an occupational therapist education program accredited by the Accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA), or successor organizations of ACOTE; and
(3) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT).
(b) On or before December 31, 2009—
(1) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the State in which practicing; or
(2) When licensure or other regulation does not apply—
(i) Graduated after successful completion of an occupational therapist education program accredited by the Accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA) or successor organizations of ACOTE; and
(ii) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc., (NBCOT).
(c) On or before January 1, 2008—
(1) Graduated after successful completion of an occupational therapy program accredited jointly by the committee on Allied Health Education and Accreditation of the American Medical Association and the American Occupational Therapy Association; or
(2) Is eligible for the National Registration Examination of the American Occupational Therapy Association or the National Board for Certification in Occupational Therapy.
(d) On or before December 31, 1977—
(1) Had 2 years of appropriate experience as an occupational therapist; and
(2) Had achieved a satisfactory grade on an occupational therapist proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service.
(e) If educated outside the United States, must meet all of the following:
(1) Graduated after successful completion of an occupational therapist education program accredited as substantially equivalent to occupational therapist entry level education in the United States by one of the following:
(i) The Accreditation Council for Occupational Therapy Education (ACOTE).
(ii) Successor organizations of ACOTE.
(iii) The World Federation of Occupational Therapists.
(iv) A credentialing body approved by the American Occupational Therapy Association.
(2) Successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT).
(3) On or before December 31, 2009, is licensed or otherwise regulated, if applicable, as an occupational therapist by the State in which practicing.
(a) Meets all of the following:
(1) Is licensed, unless licensure does not apply, or otherwise regulated, if applicable, as an occupational therapy assistant by the State in which practicing.
(2) Graduated after successful completion of an occupational therapy assistant education program accredited by the Accreditation Council for Occupational Therapy Education, (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA) or its successor organizations.
(3) Is eligible to take or successfully completed the entry-level certification examination for occupational therapy assistants developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT).
(b) On or before December 31, 2009—
(1) Is licensed or otherwise regulated as an occupational therapy assistant, if applicable, by the State in which practicing; or any qualifications defined by the State in which practicing, unless licensure does not apply; or
(2) Must meet both of the following:
(i) Completed certification requirements to practice as an occupational therapy assistant established by a credentialing organization approved by the American Occupational Therapy Association.
(ii) After January 1, 2010, meets the requirements in paragraph (a) of this section.
(c) After December 31, 1977 and on or before December 31, 2007—
(1) Completed certification requirements to practice as an occupational therapy assistant established by a credentialing organization approved by the American Occupational Therapy Association; or
(2) Completed the requirements to practice as an occupational therapy assistant applicable in the State in which practicing.
(d) On or before December 31, 1977—
(1) Had 2 years of appropriate experience as an occupational therapy assistant; and
(2) Had achieved a satisfactory grade on an occupational therapy assistant proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service.
(e) If educated outside the United States, on or after January 1, 2008—
(1) Graduated after successful completion of an occupational therapy assistant education program that is accredited as substantially equivalent to occupational therapist assistant entry level education in the United States by—
(i) The Accreditation Council for Occupational Therapy Education (ACOTE).
(ii) Its successor organizations.
(iii) The World Federation of Occupational Therapists.
(iv) By a credentialing body approved by the American Occupational Therapy Association; and
(2) Successfully completed the entry-level certification examination for occupational therapy assistants developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT).
(a)(1) Graduated after successful completion of a physical therapist education program approved by one of the following:
(i) The Commission on Accreditation in Physical Therapy Education (CAPTE).
(ii) Successor organizations of CAPTE.
(iii) An education program outside the United States determined to be substantially equivalent to physical therapist entry-level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or an organization identified in 8 CFR 212.15(e) as it relates to physical therapists; and
(2) Passed an examination for physical therapists approved by the State in which physical therapy services are provided.
(b) On or before December 31, 2009—
(1) Graduated after successful completion of a physical therapy curriculum approved by the Commission on Accreditation in Physical Therapy Education (CAPTE); or
(2) Meets both of the following:
(i) Graduated after successful completion of an education program determined to be substantially equivalent to physical therapist entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or identified in 8 CFR 212.15(e) as it relates to physical therapists.
(ii) Passed an examination for physical therapists approved by the State in which physical therapy services are provided.
(c) Before January 1, 2008—
(1) Graduated from a physical therapy curriculum approved by one of the following:
(i) The American Physical Therapy Association.
(ii) The Committee on Allied Health Education and Accreditation of the American Medical Association.
(iii) The Council on Medical Education of the American Medical Association and the American Physical Therapy Association.
(d) On or before December 31, 1977 was licensed or qualified as a physical therapist and meets both of the following:
(1) Has 2 years of appropriate experience as a physical therapist.
(2) Has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service.
(e) Before January 1, 1966—
(1) Was admitted to membership by the American Physical Therapy Association; or
(2) Was admitted to registration by the American Registry of Physical Therapists; or
(3) Has graduated from a physical therapy curriculum in a 4-year college or university approved by a State department of education.
(f) Before January 1, 1966 was licensed or registered, and before January 1, 1970, had 15 years of full-time experience in the treatment of illness or injury through the practice of physical therapy in which services were rendered under the order and direction of attending and referring doctors of medicine or osteopathy.
(g) If trained outside the United States before January 1, 2008, meets the following requirements:
(1) Was graduated since 1928 from a physical therapy curriculum approved in the country in which the curriculum was located and in which there is a member organization of the World Confederation for Physical Therapy.
(2) Meets the requirements for membership in a member organization of the World Confederation for Physical Therapy.
(a)(1) Graduated from a physical therapist assistant curriculum approved by the Commission on Accreditation in Physical Therapy Education of the American Physical Therapy Association; or if educated outside the United States or trained in the United States military, graduated from an education program determined to be substantially equivalent to physical therapist assistant entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or identified at 8 CFR 212.15(e); and
(2) Passed a national examination for physical therapist assistants.
(b) On or before December 31, 2009, meets one of the following:
(1) Is licensed, or otherwise regulated in the State in which practicing.
(2) In States where licensure or other regulations do not apply, graduated on or before December 31, 2009, from a 2-year college-level program approved by the American Physical Therapy Association and, effective January 1, 2010 meets the requirements of paragraph (a) of this definition.
(c) Before January 1, 2008, where licensure or other regulation does not apply, graduated from a 2-year college-level program approved by the American Physical Therapy Association.
(d) On or before December 31, 1977, was licensed or qualified as a physical therapist assistant and has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service.
(1) Has a baccalaureate degree in social work, psychology, sociology, or other field related to social work, and has had at least 1 year of social work experience in a health care setting; or
(2) Has 2 years of appropriate experience as a social work assistant, and has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service, except that these determinations of proficiency do not apply with respect to persons initially licensed by a State or seeking initial qualification as a social work assistant after December 31, 1977.
(a) Is licensed as a speech-language pathologist by the State in which the individual furnishes such services; or
(b) In the case of an individual who furnishes services in a State which does not license speech-language pathologists:
(1) Has successfully completed 350 clock hours of supervised clinical practicum (or is in the process of accumulating such supervised clinical experience);
(2) Performed not less than 9 months of supervised full-time speech-language pathology services after obtaining a master's or doctoral degree in speech-language pathology or a related field; and
(3) Successfully completed a national examination in speech-language pathology approved by the Secretary.
The patient has the right to be informed of his or her rights. The HHA must protect and promote the exercise of these rights.
(a)
(2) The HHA must maintain documentation showing that it has complied with the requirements of this section.
(b)
(2) The patient's family or guardian may exercise the patient's rights when the patient has been judged incompetent.
(3) The patient has the right to have his or her property treated with respect.
(4) The patient has the right to voice grievances regarding treatment or care that is (or fails to be) furnished, or regarding the lack of respect for property by anyone who is furnishing services on behalf of the HHA and must not be subjected to discrimination or reprisal for doing so.
(5) The HHA must investigate complaints made by a patient or the patient's family or guardian regarding treatment or care that is (or fails to be) furnished, or regarding the lack of respect for the patient's property by anyone furnishing services on behalf of the HHA, and must document both the existence of the complaint and the resolution of the complaint.
(c)
(i) The HHA must advise the patient in advance of the disciplines that will furnish care, and the frequency of visits proposed to be furnished.
(ii) The HHA must advise the patient in advance of any change in the plan of care before the change is made.
(2) The patient has the right to participate in the planning of the care.
(i) The HHA must advise the patient in advance of the right to participate in planning the care or treatment and in planning changes in the care or treatment.
(ii) The HHA complies with the requirements of subpart I of part 489 of this chapter relating to maintaining written policies and procedures regarding advance directives. The HHA must inform and distribute written information to the patient, in advance, concerning its policies on advance directives, including a description of applicable State law. The HHA may furnish advance directives information to a patient at the time of the first home visit, as long as the information is furnished before care is provided.
(d)
(e)
(i) The extent to which payment may be expected from Medicare, Medicaid, or any other Federally funded or aided program known to the HHA;
(ii) The charges for services that will not be covered by Medicare; and
(iii) The charges that the individual may have to pay.
(2) The patient has the right to be advised orally and in writing of any changes in the information provided in accordance with paragraph (e)(1) of this section when they occur. The HHA must advise the patient of these changes orally and in writing as soon as possible, but no later than 30 calendar days from the date that the HHA becomes aware of a change.
(f)
The HHA and agent acting on behalf of the HHA in accordance with a written contract must ensure the confidentiality of all patient identifiable information contained in the clinical record, including OASIS data, and may not release patient identifiable OASIS information to the public.
(a)
(b)
(1) The name and address of all persons with an ownership or control interest in the HHA as defined in §§ 420.201, 420.202, and 420.206 of this chapter.
(2) The name and address of each person who is an officer, a director, an agent or a managing employee of the HHA as defined in §§ 420.201, 420.202, and 420.206 of this chapter.
(3) The name and address of the corporation, association, or other company that is responsible for the management of the HHA, and the name and address of the chief executive officer and the chairman of the board of directors of that corporation, association, or other company responsible for the management of the HHA.
(c)
Organization, services furnished, administrative control, and lines of authority for the delegation of responsibility down to the patient care level are clearly set forth in writing and are readily identifiable. Administrative and supervisory functions are not delegated to another agency or organization and all services not furnished directly, including services provided through subunits are monitored and controlled by the parent agency. If an agency has subunits, appropriate administrative records are maintained for each subunit.
(a)
(b)
(c)
(d)
(e)
(f)
(1) Patients are accepted for care only by the primary HHA.
(2) The services to be furnished.
(3) The necessity to conform to all applicable agency policies, including personnel qualifications.
(4) The responsibility for participating in developing plans of care.
(5) The manner in which services will be controlled, coordinated, and evaluated by the primary HHA.
(6) The procedures for submitting clinical and progress notes, scheduling of visits, periodic patient evaluation.
(7) The procedures for payment for services furnished under the contract.
(g)
(h)
(i)
(1)
(2)
(ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health and Crippled Children's Services) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following:
(A) Whether the proposed capital expenditure is required to comform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Intellectual Disability Facilities and Community Mental Health Centers Construction Act of 1963.
(B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations.
(C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency.
(3)
(4)
(j)
(2) If the HHA chooses to refer specimens for laboratory testing to another laboratory, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements of part 493 of this chapter.
A group of professional personnel, which includes at least one physician and one registered nurse (preferably a public health nurse), and with appropriate representation from other professional disciplines, establishes and annually reviews the agency's policies governing scope of services offered, admission and discharge policies, medical supervision and plans of care, emergency care, clinical records, personnel qualifications, and program evaluation. At least one member of the group is neither an owner nor an employee of the agency.
(a)
Patients are accepted for treatment on the basis of a reasonable expectation that the patient's medical, nursing, and social needs can be met adequately by the agency in the patient's place of residence. Care follows a written plan of care established and periodically reviewed by a doctor of medicine, osteopathy, or podiatric medicine.
(a)
(b)
(c)
HHAs must electronically report all OASIS data collected in accordance with § 484.55.
(a)
(b)
(c)
(1) For all completed assessments, transmit OASIS data in a format that meets the requirements of paragraph (d) of this section.
(2) Successfully transmit test data to the State agency or CMS OASIS contractor.
(3) Transmit data using electronics communications software that provides a direct telephone connection from the HHA to the State agency or CMS OASIS contractor.
(4) Transmit data that includes the CMS-assigned branch identification number, as applicable.
(d)
The Home Health Agency (HHA) must comply with all applicable Federal, State, and local emergency preparedness requirements. The HHA must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a)
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment.
(3) Address patient population, including, but not limited to, the type of services the HHA has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the HHA's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.
(b)
(1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at § 484.55.
(2) The procedures to inform State and local emergency preparedness officials about HHA patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment.
(3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact.
(4) A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.
(5) The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
(c)
(1) Names and contact information for the following:
(i) Staff.
(ii) Entities providing services under arrangement.
(iii) Patients' physicians.
(iv) Volunteers.
(2) Contact information for the following:
(i) Federal, State, tribal, regional, or local emergency preparedness staff.
(ii) Other sources of assistance.
(3) Primary and alternate means for communicating with the HHA's staff, Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the HHA's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).
(6) A means of providing information about the HHA's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.
(d)
(1)
(i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles.
(ii) Provide emergency preparedness training at least annually.
(iii) Maintain documentation of the training.
(ii) Demonstrate staff knowledge of emergency procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If
(ii) Conduct an additional exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based.
(B) A tabletop exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.
(e)
(1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.
(2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.
(3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance with the program.
(4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following:
(i) A documented community-based risk assessment, utilizing an all-hazards approach.
(ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.
(5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.
At 81 FR 64033, Sept. 16, 2016, § 484.22 was added, effective Nov. 15, 2016.
The HHA furnishes skilled nursing services by or under the supervision of a registered nurse and in accordance with the plan of care.
(a)
(b)
Any therapy services offered by the HHA directly or under arrangement are given by a qualified therapist or by a qualified therapy assistant under the supervision of a qualified therapist and in accordance with the plan of care. The qualified therapist assists the physician in evaluating level of function, helps develop the plan of care (revising it as necessary), prepares clinical and progress notes, advises and consults with the family and other agency personnel, and participates in in-service programs.
(a)
(b)
If the agency furnishes medical social services, those services are given by a qualified social worker or by a qualified social work assistant under the supervision of a qualified social worker, and in accordance with the plan of care. The social worker assists the physician and other team members in understanding the significant social and emotional factors related to the health problems, participates in the development of the plan of care, prepares clinical and progress notes, works with the family, uses appropriate community resources, participates in discharge planning and in-service programs, and acts as a consultant to other agency personnel.
Home health aides are selected on the basis of such factors as a sympathetic attitude toward the care of the sick, ability to read, write, and carry out directions, and maturity and ability to deal effectively with the demands of the job. They are closely supervised to ensure their competence in providing care. For home health services furnished (either directly or through arrangements with other organizations) after August 14, 1990, the HHA must use individuals who meet the personnel qualifications specified in § 484.4 for “home health aide”.
(a)
(i) Communications skills.
(ii) Observation, reporting and documentation of patient status and the care or service furnished.
(iii) Reading and recording temperature, pulse, and respiration.
(iv) Basic infection control procedures.
(v) Basic elements of body functioning and changes in body function that must be reported to an aide's supervisor.
(vi) Maintenance of a clean, safe, and healthy environment.
(vii) Recognizing emergencies and knowledge of emergency procedures.
(viii) The physical, emotional, and developmental needs of and ways to work with the populations served by the HHA, including the need for respect for the patient, his or her privacy and his or her property.
(ix) Appropriate and safe techniques in personal hygiene and grooming that include—
(A) Bed bath.
(B) Sponge, tub, or shower bath.
(C) Shampoo, sink, tub, or bed.
(D) Nail and skin care.
(E) Oral hygiene.
(F) Toileting and elimination.
(x) Safe transfer techniques and ambulation.
(xi) Normal range of motion and positioning.
(xii) Adequate nutrition and fluid intake.
(xiii) Any other task that the HHA may choose to have the home health aide perform.
“Supervised practical training” means training in a laboratory or other setting in which the trainee demonstrates knowledge while performing tasks on an individual under the direct supervision of a registered nurse or licensed practical nurse.
(2)
(A) Out of compliance with requirements of this paragraph (a) or paragraph (b) of this section;
(B) To permit an individual that does not meet the definition of “home health aide” as specified in § 484.4 to furnish home health aide services (with the exception of licensed health professionals and volunteers);
(C) Has been subject to an extended (or partial extended) survey as a result of having been found to have furnished substandard care (or for other reasons at the discretion of the CMS or the State);
(D) Has been assessed a civil monetary penalty of not less than $5,000 as an intermediate sanction;
(E) Has been found to have compliance deficiencies that endanger the health and safety of the HHA's patients and has had a temporary management appointed to oversee the management of the HHA;
(F) Has had all or part of its Medicare payments suspended; or
(G) Under any Federal or State law within the 2-year period beginning on October 1, 1988—
(
(
(
(
(
(ii)
(3)
(b)
(2)
(ii) The HHA must complete a performance review of each home health aide no less frequently than every 12 months.
(iii) The home health aide must receive at least 12 hours of in-service training during each 12-month period.
(3)
The in-service training may be offered by any organization.
(ii)
(iii)
(4)
(ii) A home health aide is not considered to have successfully passed a competency evaluation if the aide has an “unsatisfactory” rating in more than one of the required areas.
(5)
(6)
(c)
(2)
(d)
(2) The registered nurse (or another professional described in paragraph (d)(1) of this section) must make an on-site visit to the patient's home no less frequently than every 2 weeks.
(3) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy or speech-language pathology services, the registered nurse must make a supervisory visit to the patient's home no less frequently than every 60 days. In these cases, to ensure that the aide is properly caring for the patient, each supervisory visit must occur while the home health aide is providing patient care.
(4) If home health aide services are provided by an individual who is not
(i) Ensuring the overall quality of the care provided by the aide;
(ii) Supervision of the aide's services as described in paragraphs (d)(1) and (d)(2) of this section; and
(iii) Ensuring that home health aides providing services under arrangements have met the training requirements of paragraphs (a) and (b) of this section.
(e)
(2)
An HHA that wishes to furnish outpatient physical therapy or speech pathology services must meet all the pertinent conditions of this part and also meet the additional health and safety requirements set forth in §§ 485.711, 485.713, 485.715, 485.719, 485.723, and 485.727 of this chapter to implement section 1861(p) of the Act.
A clinical record containing pertinent past and current findings in accordance with accepted professional standards is maintained for every patient receiving home health services. In addition to the plan of care, the record contains appropriate identifying information; name of physician; drug, dietary, treatment, and activity orders; signed and dated clinical and progress notes; copies of summary reports sent to the attending physician; and a discharge summary. The HHA must inform the attending physician of the availability of a discharge summary. The discharge summary must be sent to the attending physician upon request and must include the patient's medical and health status at discharge.
(a)
(b)
The HHA has written policies requiring an overall evaluation of the agency's total program at least once a year by the group of professional personnel (or a committee of this group), HHA staff, and consumers, or by professional people outside the agency working in conjunction with consumers. The evaluation consists of an overall policy and administrative review and a clinical record review. The evaluation assesses
(a)
(b)
Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment that accurately reflects the patient's current health status and includes information that may be used to demonstrate the patient's progress toward achievement of desired outcomes. The comprehensive assessment must identify the patient's continuing need for home care and meet the patient's medical, nursing, rehabilitative, social, and discharge planning needs. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. The comprehensive assessment must also incorporate the use of the current version of the Outcome and Assessment Information Set (OASIS) items, using the language and groupings of the OASIS items, as specified by the Secretary.
(a)
(2) When rehabilitation therapy service (speech language pathology, physical therapy, or occupational therapy) is the only service ordered by the physician, and if the need for that service establishes program eligibility, the initial assessment visit may be made by the appropriate rehabilitation skilled professional.
(b)
(2) Except as provided in paragraph (b)(3) of this section, a registered nurse must complete the comprehensive assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status.
(3) When physical therapy, speech-language pathology, or occupational therapy is the only service ordered by the physician, a physical therapist, speech-language pathologist or occupational therapist may complete the comprehensive assessment, and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. The occupational therapist may complete the comprehensive assessment if the need for occupational therapy establishes program eligibility.
(c)
(d)
(1) The last five days of every 60 days beginning with the start-of-care date, unless there is a—
(i) Beneficiary elected transfer;
(ii) Significant change in condition; or
(iii) Discharge and return to the same HHA during the 60-day episode.
(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests;
(3) At discharge.
(e)
(a)
(b)
As used in this subpart—
(a)
(1) A low-utilization payment adjustment (LUPA) of a predetermined per-visit rate as specified in § 484.230.
(2) A partial episode payment (PEP) adjustment due to an intervening event
(3) An outlier payment is determined in accordance with § 484.240.
(b)
(1)
(2)
(c)
(d)
(2) The PEP adjustment will not apply in situations of transfers among HHAs of common ownership. Those situations will be considered services provided under arrangement on behalf of the originating HHA by the receiving HHA with the common ownership interest for the balance of the 60-day episode. The common ownership exception to the transfer PEP adjustment does not apply if the beneficiary moves to a different MSA or Non-MSA during the 60-day episode before the transfer to the receiving HHA. The transferring HHA in situations of common ownership not only serves as a billing agent, but must also exercise professional responsibility over the arranged-for services in order for services provided under arrangements to be paid.
(3) If the intervening event warrants a new 60-day episode payment and a new physician certification and a new plan of care, the initial HHA receives a partial episode payment adjustment reflecting the length of time the patient remained under its care. A partial episode payment adjustment is determined in accordance with § 484.235.
(e)
To calculate the national prospective 60-day episode payment, CMS uses the following:
(a) Medicare cost data on the most recent audited cost report data available.
(b) Utilization data based on Medicare claims.
(c) An appropriate wage index to adjust for area wage differences.
(d) The most recent projections of increases in costs from the HHA market basket index.
(e) OASIS assessment data and other data that account for the relative resource utilization for different HHA Medicare patient case-mix. An HHA must submit to CMS the OASIS data described at § 484.55(b)(1) and (d)(1) in order for CMS to administer the payment rate methodologies described in §§ 484.215, 484.230 and 484.235.
(a)
(b)
(c)
(d)
(1) By computing the mean national cost per visit.
(2) By computing the national mean utilization for each discipline.
(3) By multiplying the mean national cost per visit by the national mean utilization summed in the aggregate for the six disciplines.
(4) By adding to the amount derived in paragraph (d)(3) of this section, amounts for nonroutine medical supplies, an OASIS adjustment for estimated ongoing reporting costs, an OASIS adjustment for the one time implementation costs associated with assessment scheduling form changes and amounts for Part B therapies that could have been unbundled to Part B prior to October 1, 2000. The resulting amount is the unadjusted national 60-day episode rate.
(e)
(1) The cost data described in paragraph (a) of this section to remove the effects of geographic variation in wage levels and variation in case-mix;
(2) The cost data for geographic variation in wage levels using the hospital wage index; and
(3) The cost data for HHA variation in case-mix using the case-mix indices and other data that indicate HHA case-mix.
CMS adjusts the national prospective 60-day episode payment rate to account for the following:
(a) HHA case-mix using a case-mix index to explain the relative resource utilization of different patients. To address changes to the case-mix that are
(1) For CY 2008, the adjustment is 2.75 percent.
(2) For CY 2009 and CY 2010, the adjustment is 2.75 percent in each year.
(3) For CY 2011, the adjustment is 3.79 percent.
(4) For CY 2012, the adjustment is 3.79 percent.
(5) For CY 2013, the adjustment is 1.32 percent.
(6) For CY 2016, CY 2017, and CY 2018, the adjustment is 0.97 percent in each year.
(b) Geographic differences in wage levels using an appropriate wage index based on the site of service of the beneficiary.
(a) CMS updates the unadjusted national 60-day episode payment rate on a fiscal year basis (as defined in section 1895(b)(1)(B) of the Act).
(b) For 2007 and subsequent calendar years, in accordance with section 1895(b)(3)(B)(v) of the Act, in the case of a home health agency that submits home health quality data, as specified by the Secretary, the unadjusted national prospective 60-day episode rate is equal to the rate for the previous calendar year increased by the applicable home health market basket index amount.
(c) For 2007 and subsequent calendar years, in accordance with section 1895(b)(3)(B)(v) of the Act, in the case of a home health agency that does not submit home health quality data, as specified by the Secretary, the unadjusted national prospective 60-day episode rate is equal to the rate for the previous calendar year increased by the applicable home health market basket index amount minus 2 percentage points. Any reduction of the percentage change will apply only to the calendar year involved and will not be taken into account in computing the prospective payment amount for a subsequent calendar year.
An episode with four or fewer visits is paid the national per-visit amount by discipline updated annually by the applicable market basket for each visit type. The national per-visit amount is determined by using cost data set forth in § 484.210(a) and adjusting by the appropriate wage index based on the site of service for the beneficiary. For 2008 and subsequent calendar years, an amount will be added to low-utilization payment adjustments for low-utilization episodes that occur as the beneficiary's only episode or initial episode in a sequence of adjacent episodes. For purposes of the home health PPS, a sequence of adjacent episodes for a beneficiary is a series of claims with no more than 60 days without home care between the end of one episode, which is the 60th day (except for episodes that have been PEP-adjusted), and the beginning of the next episode.
(a) CMS makes a PEP adjustment to the original 60-day episode payment that is interrupted by an intervening event described in § 484.205(d).
(b) The original 60-day episode payment is adjusted to reflect the length of time the beneficiary remained under the care of the original HHA based on the first billable visit date through and including the last billable visit date.
(c) The partial episode payment is calculated by determining the actual days served by the original HHA as a proportion of 60 multiplied by the initial 60-day episode payment.
(a) CMS makes an outlier payment for an episode whose estimated cost exceeds a threshold amount for each case-mix group.
(b) The outlier threshold for each case-mix group is the episode payment amount for that group, or the PEP adjustment amount for the episode, plus a fixed dollar loss amount that is the same for all case-mix groups.
(c) The outlier payment is a proportion of the amount of estimated cost beyond the threshold.
(d) CMS imputes the cost for each episode by multiplying the national per-visit amount of each discipline by the number of visits in the discipline and computing the total imputed cost for all disciplines.
(e) The fixed dollar loss amount and the loss sharing proportion are chosen so that the estimated total outlier payment is no more than 2.5 percent of total payment under home health PPS.
(f) The total amount of outlier payments to a specific home health agency for a year may not exceed an amount equal to 10 percent of the total payments to the specific agency under home health PPS for the year.
(a)
(1) The OASIS data described at § 484.55(b)(1) and (d)(1) for CMS to administer the payment rate methodologies described in §§ 484.215, 484.230, and 484.235, and to meet the quality reporting requirements of section 1895(b)(3)(B)(v) of the Act.
(2) The Home Health Care CAHPS survey data for CMS to administer the payment rate methodologies described in § 484.225(c), and to meet the quality reporting requirements of section 1895(b)(3)(B)(v) of the Act.
(b)
(c)
(1) CMS approves an HHCAHPS survey vendor if such applicant has been in business for a minimum of 3 years and has conducted surveys of individuals and samples for at least 2 years.
(i) For HHCAHPS, a “survey of individuals” is defined as the collection of data from at least 600 individuals selected by statistical sampling methods and the data collected are used for statistical purposes.
(ii) All applicants that meet these requirements will be approved by CMS.
(2) No organization, firm, or business that owns, operates, or provides staffing for a HHA is permitted to administer its own Home Health Care CAHPS (HHCAHPS) Survey or administer the survey on behalf of any other HHA in the capacity as an HHCAHPS survey vendor. Such organizations will not be approved by CMS as HHCAHPS survey vendors.
(3) Approved HHCAHPS survey vendors must fully comply with all HHCAHPS oversight activities, including allowing CMS and its HHCAHPS program team to perform site visits at the vendors' company locations.
An HHA is not entitled to judicial or administrative review under sections 1869 or 1878 of the Act, or otherwise, with regard to the establishment of the payment unit, including the national 60-day prospective episode payment rate, adjustments and outlier payments. An HHA is not entitled to the review regarding the establishment of the transition period, definition and application of the unit of payments, the computation of initial standard prospective payment amounts, the establishment of the adjustment for outliers, and the establishment of case-mix and area wage adjustment factors.
This subpart is established under sections 1102, 1115A, and 1871 of the Act (42 U.S.C. 1315a), which authorizes the Secretary to issue regulations to operate the Medicare program and test innovative payment and service delivery models to improve coordination, quality, and efficiency of health care services furnished under Title XVIII.
As used in this subpart—
(1) For CY 2018, 3-percent.
(2) For CY 2019, 5-percent.
(3) For CY 2020, 6-percent.
(4) For CY 2021, 7-percent.
(5) For CY 2022, 8-percent.
(1) That has or have a current Medicare certification; and,
(2) Is or are being paid by CMS for home health care delivered within any of the states specified in § 484.310.
(a)
(b)
(a) Competing home health agencies will be evaluated using a starter set of quality measures.
(b) Competing home health agencies in selected states will be required to report information on New Measures, as determined appropriate by the Secretary, to CMS in the form, manner, and at a time specified by the Secretary.
(c) Competing home health agencies in selected states will be required to collect and report such information as the Secretary determines is necessary for purposes of monitoring and evaluating the HHVBP Model under section 1115A(b)(4) of the Act (42 U.S.C. 1315a).
A competing home health agency's Total Performance Score for a model year is calculated as follows:
(a) CMS will award points to the competing home health agency for performance on each of the applicable measures in the starter set, excluding the New Measures.
(b) CMS will award points to the competing home health agency for reporting on each of the New Measures in the starter set, worth up to ten percent of the Total Performance Score.
(c) CMS will sum all points awarded for each applicable measure excluding the New Measures in the starter set, weighted equally at the individual measure level, to calculate a value worth 90-percent of the Total Performance Score.
(d) The sum of the points awarded to a competing HHA for each applicable measure in the starter set and the points awarded to a competing HHA for reporting data on each New Measure is the competing HHA's Total Performance Score for the calendar year.
CMS will determine a payment adjustment up to the maximum applicable percentage, upward or downward, under the HHVBP Model for each competing home health agency based on the agency's Total Performance Score using a linear exchange function. Payment adjustments made under the HHVBP Model will be calculated as a percentage of otherwise-applicable payments for home health services provided under section 1895 of the Act (42 U.S.C. 1395fff).
(a)
(b)
(c)