Conditions of Participation · 42 CFR Part 484
§484.105 Condition of participation: Organization and administration of services.
The regulation text and CMS’s interpretive guidelines for every survey tag under this condition, quoted from the State Operations Manual, Appendix B (Rev. 245).
CMS lists these tags as Level 1 standards (SOM Appendix B, Part I.C, Table 1):
A partial extended survey is conducted when noncompliance is identified in any Level 1 standard.
§484.105 Condition of participation: Organization and administration of services.
On the 2567: Organization And Administration Of Services
The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished.
CMS’s guidance for this tag
Interpretive Guidelines §484.105
The roles of the governing body, administrator and clinical manager may not be delegated. In other words, an HHA must ensure that the responsibilities of the governing body, administrator and clinical manager (for the day-to-day operation of the HHA) are not relinquished to another person or organization on an on-going basis. This does not apply to periodic “acting” employees in the absence of the administrator or clinical manger. In addition, the use of payroll services, OASIS transmission contractors, and personnel training programs are not considered to be delegation of administrative and supervisory functions; these are service contracts that the agency may use to optimize administrative and supervisory efficiencies.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(a) Standard: Governing body.
On the 2567: 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.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(a)
An HHA may establish a governing body composed of individuals of its choosing. The individuals that comprise the governing body are those who have the legal authority to assume responsibility for assuring that management and operation of the HHA is effective and operating within all legal bounds (as noted in 82 FR 4548).
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(b)(1) Standard: Administrator. The administrator must:
On the 2567: Administrator Appointed By Governing Body
(i) Be appointed by and report to the governing body;
CMS’s guidance for this tag
Interpretive Guidelines §484.105(b)(1)(i)
The administrator is actively involved in the daily responsibilities of running the HHA. The administrator must be appointed by and accountable to the governing body; acting as a liaison between the daily functions of the HHA and the governing body (as noted in 82 FR 4548).
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(b)(1)
On the 2567: Responsible For All Day-To-Day Operations
[§484.105(b)(1) The administrator must:]
(ii) Be responsible for all day-to-day operations of the HHA;
CMS’s guidance for this tag
Interpretive Guidelines §484.105(b)(1)(ii)
The HHA administrator is required, among other things, to be responsible for all day-to-day operations of the HHA and to be available to patients, representatives, and caregivers to receive complaints (§ 484.50(a)(1)(ii) and (c)(3)). The administrator should be actively involved in the daily responsibilities of running the HHA, and each HHA should be able to demonstrate such involvement upon survey (as noted in 82 FR 4548).
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(b)(1)
On the 2567: Ensure Clinical Manager Is Available
[§484.105(b)(1) The administrator must:]
(iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours;
CMS’s guidance for this tag
Interpretive Guidelines §484.105(b)(1)(iii)
“Operating hours” include all hours which the HHA is open and providing care to patients.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(b)(1)
On the 2567: Ensure That Hha Employs Qualified Personnel
[§484.105(b)(1) The administrator must:]
(iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(b)(2)
On the 2567: Ensures Qualified Pre-Designated Person
§484.105(b)(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.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(b)(2)
“Pre-designation” means that the individual who is responsible for fulfilling the role of the administrator in his/her absence is established in advance and approved by the governing body.
Pre-designation needs to be by both the administrator and the governing body. The goal of this requirement is to provide management continuity within the HHA to the greatest degree possible. HHA staff should know and be able to verbalize upon interview who the pre-designated individual(s) is/are for this role (82 FR 4549).
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(b)(3)
On the 2567: Available During All Operating Hours
§484.105(b)(3) The administrator or a pre-designated person is available during all operating hours.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(b)(3)
“Available” means physically present at the agency or able to be contacted via telephone or other electronic means.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(c) Standard: Clinical manager.
On the 2567: Clinical Manager
One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-
- The CFR reads: “(c) Clinical manager.”
Logicly’s note, not CMS text
the manual labels this paragraph a Standard; the CFR heading does not
CMS’s guidance for this tag
Interpretive Guidelines §484.105(c)
§484.115(c) provides that a clinical manager must be a licensed physician, physical therapist, speech-language pathologist, occupational therapist, audiologist, social worker, or a registered nurse.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.105(c) Standard: Clinical manager…Oversight must include the following-]
On the 2567: Make Patient And Personnel Assignments,
(1) Making patient and personnel assignments,
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.105(c) Standard: Clinical manager…Oversight must include the following-]
On the 2567: Coordinate Patient Care
(2) Coordinating patient care,
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.105(c) Standard: Clinical manager…Oversight must include the following-]
On the 2567: Coordinate Referrals;
(3) Coordinating referrals,
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.105(c) Standard: Clinical manager…Oversight must include the following-]
On the 2567: Assure Patient Needs Are Continually Assessed
(4) Assuring that patient needs are continually assessed, and
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
[§484.105(c) Standard: Clinical manager…Oversight must include the following-]
On the 2567: Assure Implementation Of Plan Of Care
(5) Assuring the development, implementation, and updates of the individualized plan of care.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(d) Standard: Parent-branch relationship.
On the 2567: Report All Branch Locations To Sa
(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.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(d)(1)
A “branch” is an approved location or site (physically separate from its parent’s location) from which an HHA provides services within a portion of the total geographic area served by the parent agency. A branch provides services under the same CMS certification number (CCN) as its parent agency. See Chapter 2 of the State Operations Manual for additional information on HHA Branch CMS Certification Numbers.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
G0974
On the 2567: Direct Support And Administrative Control
(2) The parent HHA provides direct support and administrative control of its branches.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(d)(2)
The parent location must provide supervision and administrative control of its branches daily to the extent that the branches depend upon the parent’s supervision and administrative functions to meet the CoPs, and could not do so as independent entities. The parent agency must be available to meet the needs of any situation and respond to issues that could arise with respect to patient care or administration of a branch. A violation of a CoP in a branch would apply to the entire HHA. Therefore, it is essential for the parent to exercise adequate control, supervision, and guidance for all branches under its leadership.
“Direct support and administrative control” of a branch includes that the parent agency maintains responsibility for:
• The governing body oversight of the branch; • Any branch contracts for services; • The branch’s quality assurance and performance improvement plan; • Policies and procedures implemented in the branch; • How and when management and direct care staff are shared between the parent and branch, particularly in the event of staffing shortfalls or leave coverage; • Human resource management at the branch; • Assuring the appropriate disposition of closed clinical records at the branch; and • Ensuring branch personnel training requirements are met.
Survey Procedures §484.105(d)(2)
HHAs must demonstrate compliance through evidence of established policies and procedures to ensure adequate control, supervision, and guidance for all branches under an HHA’s leadership.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(e) Standard: Services under arrangement.
On the 2567: 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)).
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(e)(2)
On the 2567: Must Have A Written Agreement
§484.105(e)(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.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(e)(3)
On the 2567: Primary Hha Is Responsible For Patient Care
§484.105(e)(3) The primary HHA is responsible for patient care, and must conduct and provide, either directly or under arrangements, all services rendered to patients.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(e)
The HHA retains overall responsibility for all services provided, whether provided directly by the HHA or through arrangements (i.e., under contract). For example, in contracting for a service such as physical therapy, an HHA may require the contracted party to do the day-to-day professional evaluation component of the therapy service. The HHA may not, however, delegate its overall administrative and supervisory responsibilities (see also §484.105(d)). All HHA contracts for services should specify how HHA supervision will occur.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(f) Standard: Services furnished.
On the 2567: Skilled 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.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(f)
The HHA must provide skilled nursing services and at least one other therapeutic service. However, only one service must be provided directly by the HHA.
An HHA is considered to provide a service “directly” when the persons providing the service for the HHA are HHA employees. An individual who works for the HHA on an hourly or per-visit basis may be considered an HHA employee if the HHA is required to issue a form W-2 on the individual’s behalf with no intermediaries. An HHA is considered to provide a service “under arrangements” when the HHA provides the service through contractual or affiliation arrangements with other agencies or organizations, or with an individual(s) who is not an HHA employee.
Contracted staffing may supplement, but may not be used in lieu of, HHA staffing for services provided directly by the HHA. In addition, the use of contracted staff in a service provided directly by the HHA may occur only on a temporary basis to provide coverage for unexpected HHA staffing shortages, or to provide a specialized service that HHA employees cannot provide.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(f)(2)
On the 2567: In Accordance With Current Clinical Practice
§484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(f)(2)
Accepted standards of practice include guidelines or recommendations issued by nationally recognized organizations with expertise in the field. Clinical practice guidelines and accepted professional standards of practice may be found in, but are not limited to: − State practice acts; − Standards established by national organizations, boards, and councils (e.g., the American Nurses’ Association standards); and − The HHA’s own policies and procedures.
HHAs should consider identifying the clinical practice guideline or standard of practice used when developing and updating care policies and procedures.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(g) Standard: Outpatient physical therapy or speech-language pathology services.
On the 2567: Outpatient Therapy 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.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(g)
In general, this guidance is for situations where a patient would be coming to the premises of the HHA for outpatient therapy services. The patient would not be receiving HHA services and OPT services at the same time and therefore not all the HHA CoPs would apply. For example, the patient could have a total joint operation and be discharged home to get HHA services inclusive of therapy. Then when the patient is doing better, they could transition to outpatient services provided by the HHA on the premises of the HHA where the HHA has a therapy gym.
If an HHA provides outpatient physical therapy services or speech-language pathology services it must also meet the conditions of the regulations summarized below, among others, as applicable:
§485.711 Condition of participation: Plan of care and physician involvement: For each patient in need of outpatient physical therapy or speech pathology services, there is a written plan of care established and periodically reviewed by a physician, or by a physical therapist or speech pathologist respectively.
§485.713 Condition of participation: Physical therapy services: If the HHA offers physical therapy services, it provides an adequate program of physical therapy and has an adequate number of qualified personnel and the equipment necessary to carry out its program and to fulfill its objectives.
§485.715 Condition of participation: Speech pathology services: If speech pathology services are offered, the HHA provides an adequate program of speech pathology and has an adequate number of qualified personnel and the equipment necessary to carry out its program and to fulfill its objectives.
§485.719 Condition of participation: Arrangements for physical therapy and speech pathology services to be performed by other than salaried organization personnel The following two CoPs, §485.723 and §485.727, are applicable when specialized rehabilitation space and equipment is owned, leased, operated, contracted for, or arranged for at sites under the HHA’s control and when the HHA bills the Medicare/Medicaid programs for services rendered at these sites.]
§485.723 Condition of participation: Physical environment. The building housing the HHA is constructed, equipped, and maintained to protect the health and safety of patients, personnel, and the public and provides a functional, sanitary, and comfortable environment.
§485.727 Condition of participation: Emergency preparedness. The HHA must establish and maintain an emergency preparedness program.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(h) Standard: Institutional planning.
On the 2567: 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.
(Rev. 219; Issued: 04-12-24; Effective: 04-12-24; Implementation: 04-12-24)
§484.105(i) Standard: 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.
- The CFR reads: “(i) HHA acceptance-to-service.”
Logicly’s note, not CMS text
the manual labels this paragraph a Standard; the CFR heading does not (G990 and G992 both carry this heading; the manual also prints "acceptance to service" without hyphens)
CMS’s guidance for this tag
Interpretive Guidelines §484.105(i)(1):
Admission to HHA services is a critical step in ensuring patients receive timely, appropriate care to meet their needs. As part of this process, agencies must develop, implement, and maintain a patient acceptance-to-service policy that is applied equally and consistently when evaluating each prospective patient referred for home health care.
The acceptance-to-service policy includes four minimum requirements related to the HHA’s capacity to provide patient care that are clinical factors that influence whether an HHA should accept or decline a referral, ensuring the health and safety of the referred patient by matching HHA services to patient needs. The policy must be reviewed annually and include, at a minimum, the following information:
• the anticipated needs of the referred prospective patient; • the HHA’s case load and case mix, which generally means the number (volume) and types of patients (complexity) of patients currently receiving care at the HHA which informs what the HHA expects it can reasonably care for at any time; • the HHA’s staffing levels; and • the skills and competencies of the HHA staff.
These elements inform an HHA's assessment of its capacity and determine its suitability to meet the anticipated needs of the prospective patient referred for HHA services. Within this structure, HHAs may tailor their policy to address additional concerns, procedural delays, and challenges that they typically face in the referral and acceptance process. It is the responsibility of the HHA to work with its referral sources by educating them on the HHA's acceptance-to-service policy and the services it offers, with the goal of minimizing communication gaps (see the related requirement at G992).
While all of a prospective patient's needs may not be known at the time of referral, general information regarding the patient's diagnosis and recent hospitalization (as appropriate), and specific orders from the patient's medical provider should provide a reasonable basis for HHAs to anticipate the overall needs of the patient and determine whether, in light of the described elements that must be present in the policy, the prospective patient is or is not appropriate for the HHA to accept for service.
• Surveyors must review the HHA’s acceptance to service policy to ensure it meets all the elements within this regulation. • Surveyors should confirm the HHA’s acceptance to service policy includes at a minimum the four criteria listed in this requirement:
o Anticipated needs of the referred prospective patient. o Case load and case mix of the HHA. o Staffing levels of the HHA. o Skills and competencies of the HHA staff. This policy is HHA-specific and separate and distinct from the patient’s individualized plan of care at §484.60.
(Rev. 245; Issued: 08-05-26; Effective: 08-05-26; Implementation:08-05-26)
§484.105(i) Standard: HHA acceptance to service.
[An HHA must do both of the following: ...]
(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.
CMS’s guidance for this tag
Interpretive Guidelines §484.105(i)(2):
HHAs must make the specified information available to the public; however, CMS does not specify a method for public availability (89 FR at 88455 (Nov. 7, 2024)). HHAs provide information regarding their services in multiple formats (for example, Care Compare, agency websites, brochures). To ensure that the information presented to the public is accurate, we are requiring HHAs to review publicly facing information whenever services are changed, but no less often than annually. We expect HHAs to update information on the services they provide and any service limitations if they anticipate not having a service available for 3 to 6 months. Changing a service means the HHA has formally altered the services it offers, whether by adding, discontinuing, temporarily pausing, or restricting a service. For example, a change in service may include an employee taking an extended leave of absence (that is, care for a family member, recovery from a serious illness or procedure, maternity leave) or the addition of a new contract employee that provides speech language pathology services, which an HHA may not have provided before.
CMS extracts information about an HHA’s services offered (including whether they provide Skilled Nursing Care, Physical Therapy, Occupational Therapy, Speech Therapy, Medical Social Worker Services, and Home Health Aides) from the CMS-1572 survey report form, where the “Services Provided” information is captured directly from facility staff. The information from this form is entered into the CMS iQIES database and serves as the source for certain CMS public reporting, such as the CMS Care Compare website. This form is completed and updated during a CMS initial and recertification survey.
States may also create these forms outside a survey cycle. HHAs should ensure this information is completed in PECOS, then outreach to their OASIS Education Coordinator or OASIS Automation Coordinator to request that their data in iQIES be updated.
Surveyors should note that updates to home health agency provider demographic information do not occur in real time and may take up to six months to appear on Care Compare. Therefore, as long as the HHA can provide you with evidence that they requested corrections/updates, this would not trigger a citation if Care Compare was incorrect.
(Rev. 245; Issued: 08-05-26; Effective: 08-05-26; Implementation:08-05-26)
Current CFR text, 42 CFR 484.105 as revised 2025-10-01 (govinfo)
§ 484.105 Condition of participation: Organization and administration of services.
The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished.
(a) Standard: Governing body. 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.
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Source: State Operations Manual, Appendix B - Guidance to Surveyors: Home Health Agencies (Rev. 245, issued 08-05-26), text extracted from the PDF with pdftotext, retrieved 2026-10-09, and 42 CFR Part 484, annual edition revised as of October 1, 2025 (govinfo XML granules). Works of the US Government are in the public domain.
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