42 C.F.R. § 411.353 Prohibition on certain referrals by physicians and limitations on billing.
Title 42 - Public Health
(a) Prohibition on referrals. Except as provided in this subpart, a physician who has a direct or indirect financial relationship with an entity, or who has an immediate family member who has a direct or indirect financial relationship with the entity, may not make a referral to that entity for the furnishing of DHS for which payment otherwise may be made under Medicare. A physician's prohibited financial relationship with an entity that furnishes DHS is not imputed to his or her group practice or its members or its staff; however, a referral made by a physician's group practice, its members, or its staff may be imputed to the physician, if the physician directs the group practice, its members, or its staff to make the referral or if the physician controls referrals made by his or her group practice, its members, or its staff. (b) Limitations on billing. An entity that furnishes DHS pursuant to a referral that is prohibited by paragraph (a) of this section may not present or cause to be presented a claim or bill to the Medicare program or to any individual, primary payer, or other entity for the DHS performed pursuant to the prohibited referral. (c) Denial of payment. Except as provided in paragraph (e) of this section, no Medicare payment may be made for a designated health service that is furnished pursuant to a prohibited referral. (d) Refunds. An entity that collects payment for a designated health service that was performed under a prohibited referral must refund all collected amounts on a timely basis, as defined in §1003.101 of this title. (e) Exception for certain entities. Payment may be made to an entity that submits a claim for a designated health service if— (1) The entity did not have actual knowledge of, and did not act in reckless disregard or deliberate ignorance of, the identity of the physician who made the referral of the designated health service to the entity; and (2) The claim otherwise complies with all applicable Federal and State laws, rules, and regulations. (f) Exception for certain arrangements involving temporary noncompliance. (1) Except as provided in paragraphs (f)(2), (f)(3), and (f)(4) of this section, an entity may submit a claim or bill and payment may be made to an entity that submits a claim or bill for a designated health service if— (i) The financial relationship between the entity and the referring physician fully complied with an applicable exception under §411.355, §411.356, or §411.357 for at least 180 consecutive calendar days immediately preceding the date on which the financial relationship became noncompliant with the exception; (ii) The financial relationship has fallen out of compliance with the exception for reasons beyond the control of the entity, and the entity promptly takes steps to rectify the noncompliance; and (iii) The financial relationship does not violate the anti-kickback statute (section 1128B(b) of the Act), and the claim or bill otherwise complies with all applicable Federal and State laws, rules, and regulations. (2) Paragraph (f)(1) of this section applies only to DHS furnished during the period of time it takes the entity to rectify the noncompliance, which must not exceed 90 consecutive calendar days following the date on which the financial relationship became noncompliant with an exception. (3) This paragraph (f) may only be used by an entity once every 3 years with respect to the same referring physician. (4) This paragraph (f) does not apply if the exception with which the financial relationship previously complied was §411.357(k) or (m).
Title 42: Public Health
PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT
Subpart J—Financial Relationships Between Physicians and Entities Furnishing Designated Health Services
§ 411.353 Prohibition on certain referrals by physicians and limitations on billing.
