My Policy Hub

Improving health is our policy

ACA Now

6409 - Medicare Self-Referral Disclosure Protocol

 
Implementation Status 
Statutory Text 

Summary

Directs the Secretary of HHS to, in cooperation with the OIG, establish by September 23, 2010, a protocol – the self-referral disclosure protocol (SRDP) – to enable health care providers and suppliers to disclose an actual or potential violation of Medicare physician self-referral law.  Such information on how to disclose via the SRDP is required to be publicly posted on the Internet.  Authorizes the Secretary to reduce the amount due and owing for all violations to a lesser amount.  Requires the Secretary to submit by March 23, 2012 a report to Congress on the implementation of this section.

Implementation Status

 
Summary 
Statutory Text 

2010

HHS published a notice in the fall of 2010, announcing the delegation of the authority granted to the Secretary of HHS pursuant to this provision to CMS.  In the spring of 2011, CMS published an information collection request pertaining to the SRDP process.  For more information about the SRDP, including links to the report to Congress, the revised protocol, and so forth, visit CMS’ webpage dedicated to this initiative.  To access an overview of the various settlements under this provision, see here.

2013

In a related event, on July 9, HHS OIG announced an online portal whereby providers may voluntary disclose potential fraud under the existing Self-Disclosure Protocol (SDP).

2014

On Feb. 24, CMS posted a notice pertaining to the agency’s revision to an existing information collection pertaining to the SRDP.

On May 2, CMS issued an information collection revising certain aspects of the Medicare Self-Referral Disclosure Protocol. Comments are due by June 2.

2015

On July 8, CMS posted the Calendar Year (CY) 2016 Medicare Physician Fee Schedule (MPFS) proposed rule, which delineates payment policies impacting physicians and other practitioners paid under the MPFS each year (see fact sheet here). Citing the latest doc fix (P.L. 114-10), the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), CMS effectuates the statutory 0.5% increase. The proposed rule addressed this provision of the ACA. Comments are due Sept. 8.

2016

On Sept. 9, CMS published a notice seeking approval to revise its currently approved information collection request regarding the Medicare SRDP.  The new request includes a required form for SRDP submissions. Comments are due Oct. 11.

2019

HHS announced highly-anticipated proposed reforms to the Physician Self-Referral Law (the “Stark Law”) and the Federal Anti-Kickback Statute (AKS), including relevant civil monetary penalty (CMP) provisions, the latter of which prohibit inducements to beneficiaries. Comments will be due in 75 days, on approximately Dec. 31st. The proposed changes are delineated in a pair of rules issued by the Centers for Medicare and Medicaid Services (CMS) (proposed rule; fact sheet) (Stark Law) and the Office of Inspector General (OIG) (proposed rule; fact sheet) (AKS and CMP).

Statutory Text

 
Implementation Status 
Summary 

SEC. 6409 ø42 U.S.C. 1395nn note¿. MEDICARE SELF-REFERRAL DISCLOSURE PROTOCOL. (a) DEVELOPMENT OF SELF-REFERRAL DISCLOSURE PROTOCOL.— (1) IN GENERAL.—The Secretary of Health and Human Services, in cooperation with the Inspector General of the Department of Health and Human Services, shall establish, not later than 6 months after the date of the enactment of this Act, a protocol to enable health care providers of services and suppliers to disclose an actual or potential violation of section 1877 of the Social Security Act (42 U.S.C. 1395nn) pursuant to a self-referral disclosure protocol (in this section referred to as an ‘‘SRDP’’). The SRDP shall include direction to health care providers of services and suppliers on— (A) a specific person, official, or office to whom such disclosures shall be made; and (B) instruction on the implication of the SRDP on corporate integrity agreements and corporate compliance agreements. (2) PUBLICATION ON INTERNET WEBSITE OF SRDP INFORMATION.—The Secretary of Health and Human Services shall post information on the public Internet website of the Centers for Medicare & Medicaid Services to inform relevant stakeholders of how to disclose actual or potential violations pursuant to an SRDP. (3) RELATION TO ADVISORY OPINIONS.—The SRDP shall be separate from the advisory opinion process set forth in regulations implementing section 1877(g) of the Social Security Act. (b) REDUCTION IN AMOUNTS OWED.—The Secretary of Health and Human Services is authorized to reduce the amount due and owing for all violations under section 1877 of the Social Security Act to an amount less than that specified in subsection (g) of such section. In establishing such amount for a violation, the Secretary may consider the following factors: (1) The nature and extent of the improper or illegal practice. (2) The timeliness of such self-disclosure. (3) The cooperation in providing additional information related to the disclosure. (4) Such other factors as the Secretary considers appropriate. (c) REPORT.—Not later than 18 months after the date on which the SRDP protocol is established under subsection (a)(1), the Secretary shall submit to Congress a report on the implementation of this section. Such report shall include— (1) the number of health care providers of services and suppliers making disclosures pursuant to the SRDP; (2) the amounts collected pursuant to the SRDP; (3) the types of violations reported under the SRDP; and (4) such other information as may be necessary to evaluate the impact of this section.

Contact Us

Impact Health Policy Partners 1301 K Street, NW, Suite 300W
Washington, D.C. 20005

(202) 309-0796
Contact Us