Section 6409 of the Patient Protection and Affordable Care Act (ACA) was signed into law on March 23, 2010. Section 6409(a) of the ACA required the Secretary of the Department of Health and Human Services, in cooperation with the Inspector General of the Department of Health and Human Services, to establish a Medicare self-referral disclosure protocol that sets forth a process to enable providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute.

Health care providers of services and suppliers are required to submit all information necessary for CMS, on behalf of the Secretary, to analyze the actual or potential violation of Section 1877 of the Social Security Act (the Act). Beginning June 1, 2017, providers of services and suppliers must use the forms included in the OMB-approved collection instrument entitled CMS Voluntary Self-Referral Disclosure Protocol (SRDP) in order to utilize the SRDP. For disclosures of noncompliant financial relationships with more than one physician, the disclosing entity must submit a separate Physician Information Form for each physician. The CMS Voluntary Self-Referral Disclosure Protocol document contains one Physician Information Form. Additional stand-alone Physician Information Forms can be found in the links below.

The SRDP is intended to facilitate the resolution of only matters that, in the disclosing party’s reasonable assessment, are actual or potential violations of the physician self-referral law. Thus, a disclosing party should make a submission under the SRDP with the intention of resolving its overpayment liability exposure for the conduct it identified. As provided in the physician self-referral law, no payment may be made for designated health services that are provided in violation of the physician self-referral law. Section 6409(b) of the ACA gives the Secretary of HHS the authority to reduce the amount due and owing for violations of Section 1877 of the Act.

For further information about the SRDP and its requirements, see the links below.  After reviewing the material below, if you have additional questions please contact the CMS Physician Self-Referral Call Center by e-mail at 1877CallCenter@cms.hhs.gov.

Special Instructions for Submissions to the CMS Voluntary Self-Referral Disclosure Protocol for Physician-Owned Hospitals and Rural Providers that Failed to Disclose Physician Ownership on any Public Website and in any Public Advertisement

CMS has provided special instructions for submissions to the CMS Voluntary Self-Referral Disclosure Protocol (SRDP) involving solely noncompliance with 42 CFR § 411.362(b)(3)(ii)(C) (requiring physician-owned hospitals and rural providers to disclose on any public website for the hospital and in any public advertisement that the hospital is owned or invested in by physicians).  The special instructions are available at  Physician Self-Referral Disclosure Protocol – Special Instructions for Violations of 42 C.F.R. section 411.362(b)(3)(ii)(C) [PDF, 56KB] . Disclosures involving noncompliance with any other provision of the physician self-referral law, including disclosures involving mixed noncompliance with § 411.362(b)(3)(ii)(C) and noncompliance with any other provision of the physician self-referral law, should continue to follow the standard SRDP instructions.

Lookback Period for Disclosures

On February 12, 2016, CMS published a final rule for the reporting and returning of overpayments (the “final overpayment rule”). See 81 FR 7653. The effective date for this rule was March 14, 2016. Among other things, the final overpayment rule established a 6-year lookback period for the reporting and returning of overpayments under regulations at 42 CFR 401.305(f). Prior to March 14, 2016, CMS used the time frame established under the reopening regulations at 42 CFR 405.980(b) as a guide to determine the time frame of the SRDP. As such, the time frame of the SRDP was limited to 4 years from the date that the disclosing party submitted the disclosure to the SRDP, unless reliable evidence of fraud or similar fault existed. Self-referral overpayments reported to CMS in accordance with the SRDP prior to March 14, 2016 are not governed by the 6-year lookback period specified in the final overpayment rule. This includes both overpayments reported and returned (via compromise and settlement) as well as those reported and still in the process of being reviewed through the SRDP. Providers and suppliers that reported self-referral overpayments to the SRDP prior to March 14, 2016 are not expected to return overpayments from the fifth and sixth years. Providers and suppliers reporting overpayments to the SRDP on or after March 14, 2016 are subject to the 6-year lookback period specified in the final overpayment rule.

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