Section 484.105 - [Effective 1/1/2025] Condition of participation: Organization and administration of servicesThe HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished.
(a)Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program.(b)Standard: Administrator.(1) The administrator must:(i) Be appointed by and report to the governing body;(ii) Be responsible for all day-to-day operations of the HHA;(iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours;(iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies.(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section.(3) The administrator or a pre-designated person is available during all operating hours.(c)Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following- (1) Making patient and personnel assignments,(2) Coordinating patient care,(3) Coordinating referrals,(4) Assuring that patient needs are continually assessed, and(5) Assuring the development, implementation, and updates of the individualized plan of care.(d)Standard: Parent-branch relationship.(1) The parent HHA is responsible for reporting all branch locations of the HHA to the state survey agency at the time of the HHA's request for initial certification, at each survey, and at the time the parent proposes to add or delete a branch.(2) The parent HHA provides direct support and administrative control of its branches.(e)Standard: Services under arrangement.(1) The HHA must ensure that all services furnished under arrangement provided by other entities or individuals meet the requirements of this part and the requirements of section 1861(w) of the Act (42 U.S.C. 1395x (w) ).(2) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been:(i) Denied Medicare or Medicaid enrollment;(ii) Been excluded or terminated from any federal health care program or Medicaid;(iii) Had its Medicare or Medicaid billing privileges revoked; or(iv) Been debarred from participating in any government program.(3) The primary HHA is responsible for patient care, and must conduct and provide, either directly or under arrangements, all services rendered to patients.(f)Standard: Services furnished.(1) Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services 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 pathology services. An HHA that furnishes outpatient physical therapy or speech-language pathology services must meet all of the applicable conditions of this part and 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.(h)Standard: Institutional planning. The HHA, under the direction of the governing body, prepares an overall plan and a budget that includes an annual operating budget and capital expenditure plan. (1)Annual operating budget. There is an annual operating budget that includes all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items. However, it is not required that there be prepared, in connection with any budget, an item by item identification of the components of each type of anticipated income or expense.(2)Capital expenditure plan.(i) There is a capital expenditure plan for at least a 3-year period, including the operating budget year. The plan includes and identifies in detail the anticipated sources of financing for, and the objectives of, each anticipated expenditure of more than $600,000 for items that would under generally accepted accounting principles, be considered capital items. In determining if a single capital expenditure exceeds $600,000, the cost of studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the acquisition, improvement, modernization, expansion, or replacement of land, plant, building, and equipment are included. Expenditures directly or indirectly related to capital expenditures, such as grading, paving, broker commissions, taxes assessed during the construction period, and costs involved in demolishing or razing structures on land are also included. Transactions that are separated in time, but are components of an overall plan or patient care objective, are viewed in their entirety without regard to their timing. Other costs related to capital expenditures include title fees, permit and license fees, broker commissions, architect, legal, accounting, and appraisal fees; interest, finance, or carrying charges on bonds, notes and other costs incurred for borrowing funds.(ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health Services Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following:(A) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963.(B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1 ) and implementing regulations.(C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency.(3)Preparation of plan and budget. The overall plan and budget is prepared under the direction of the governing body of the HHA by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff (if any) of the HHA.(4)Annual review of plan and budget. The overall plan and budget is reviewed and updated at least annually by the committee referred to in paragraph (i)(3) of this section under the direction of the governing body of the HHA.(i)HHA acceptance-to-service. An HHA must do both of the following: (1) Develop, implement, and maintain through an annual review, a patient acceptance-to-service policy that is applied consistently to each prospective patient referred for home health care, which addresses criteria related to the HHA's capacity to provide patient care, including, but not limited to, all of the following: (i) Anticipated needs of the referred prospective patient.(ii) Case load and case mix of the HHA.(iii) Staffing levels of the HHA.(iv) Skills and competencies of the HHA staff.(2)(i) Make available to the public accurate information regarding the services offered by the HHA and any limitations related to types of specialty services, service duration, or service frequency.(ii) Review the information specified in paragraph (i)(2)(i) of this section as frequently as the services are changed, but no less often than annually. 82 FR 4579 , 1/13/2017; 89 FR 88385 , 1/1/2025