§484.1 Basis and Scope

Interpretive Guidelines §484.1

To qualify for a provider agreement as a home health agency under Medicare and Medicaid, an entity must meet and continue to meet all the statutory provisions of §1861(o), 1891 and 1861(z) of the Act, including the Condition of Participation (CoP) requirements.

This, in part, means the HHA:

• is primarily engaged in providing skilled nursing services and other therapeutic services [§1861(o)(1) of the Act; 42 CFR 484.105, Organization and administration of services];

• has policies to govern the services which it provides and provides for supervision of such services [§1861(o)(2) of the Act; 42 CFR 484.75, Skilled professional services and § 484.65 Quality assessment and performance improvement (QAPI). See also 82 FR 4542];

• maintains clinical records on all patients [§1861(o)(3) of the Act; 42 CFR 484.110, Clinical records];

• for any HHA in a state or local jurisdiction with a law that requires agencies or organizations like HHAs to be licensed, is licensed pursuant to such law, or is approved, by the State or local agency responsible for licensing agencies or organizations of this nature, as meeting the standards established for such licensing [§1861(o)(4) of the Act; 42 CFR 484.100, Compliance with Federal, State and local laws and regulations related to health and safety of patients];

• has in effect an overall plan and budget [§1861(o)(5) of the Act; 42 CFR 484.105, Organization and administration of services];

• meets the conditions of participation specified in section 1891(a) and such other conditions of participation as the Secretary may find necessary in the interest of the health and safety of individuals who are furnished services by such agency or organization [§1861(o)(6) of the Act; 42 CFR 484.1, Basis and Scope, et seq.];

• provides the Secretary with a surety bond [§1861(o)(7) of the Act; 42 CFR Part 489, Subpart F];

• meets such additional requirements (including conditions relating to bonding or establishing of escrow accounts as the Secretary finds necessary for the financial security of the program) as the Secretary finds necessary for the effective and efficient operation of the program [§1861(o)(8) of the Act; 42 CFR 484.1, Basis and Scope, et seq.];

• except that for purposes of part A “home health agency” shall not include any agency or organization which is primarily for the care and treatment of mental diseases. The Secretary may waive the requirement of a surety bond under paragraph (7) in the case of an agency or organization that provides a comparable surety bond under State law [§1861(o) of the Act; 42 CFR 484.1, Basis and Scope, et seq.].

CMS is required to determine whether an HHA is complying substantially with the Medicare participation requirements established by the Act and regulations. Section 1866(b)(2)(B) of the Act states in part that a provider’s participation agreement may be terminated if CMS determines that “the provider fails substantially to meet the applicable provisions of section 1861.” To remain a Medicare participating HHA, the HHA must remain in substantial compliance with all conditions of participation.