42 CFR §485.719

1. (a)Conditions. If an organization provides outpatient physical therapy or speech pathology services under an arrangement with others, the services are to be furnished in accordance with the terms of a written contract, which provides that the organization retains of professional and administrative responsibility for, and control and supervision of, the services.
2. (b)Standard: Contract provisions. The contract—
   1. (1)Specifies the term of the contract and the manner of termination or renewal;
   2. (2)Requires that personnel who furnish the services meet the requirements that are set forth in this subpart for salaried personnel; and
   3. (3)Provides that the contracting outside resource may not bill the patient or Medicare for the services. This limitation is based on section 1861(w)(1) of the Act, which provides that—
      1. (i)Only the provider may bill the beneficiary for covered services furnished under arrangements; and
      2. (ii)Receipt of Medicare payment by the provider, on behalf of an entitled individual, discharges the liability of the individual or any other person to pay for those services.