Moving the HME Industry Forward

General Healthcare

OIG Self Disclosure Protocol – Part 1 of 3

April 20, 2015

AMARILLO, TX – Today’s DME supplier is highly regulated. It must abide by a plethora of federal anti-fraud laws, including (but not limited to) the Medicare anti-kickback statute and the federal False Claims Act. Because the day-to-day operations of a DME supplier are complicated, because the documentation requirements the DME supplier must meet are complex, and because federal anti-fraud laws are broadly written, it is not uncommon for the supplier to unwittingly cross into fraud territory.

If a DME supplier discovers that it is engaging in activities that violate one or more federal anti-fraud laws, the question becomes:  What should the supplier do?  One course of action is for the supplier to utilize the OIG’s Self-Disclosure Protocol (“SDP”).

Part 1 gives an overview of the SDP. Part 2 will discuss the information that should be contained in the narrative that is submitted to the OIG. Part 3 will discuss the SDP requirements for conduct involving false billings.

OIG Self-Disclosure Protocol
Eligible Entities – All health care providers/suppliers that are subject to the OIG’s Civil Monetary Penalty (“CMP”) authorities are eligible to use the SDP.

Eligible Conduct – The SDP is available to facilitate the resolution of matters that, in the disclosing party’s reasonable assessment, potentially violate federal criminal, civil or administrative laws for which CMPs are authorized (e.g., the False Claims Act).1 In making a disclosure, a disclosing party must acknowledge unequivocally that the conduct is a potential violation and must explicitly identify the law(s) that were potentially violated. The OIG reserves the right to determine if an arrangement is appropriate for resolution in the SDP.

Potential Benefits of SDP
A) The OIG has instituted a presumption against requiring corporate integrity agreements in exchange for a release of the OIG’s permissive exclusion authority.

B) Under the SDP, the OIG typically requires a minimum multiplier of 1.5 times the single damages (i.e., the amount of overpayment) instead of the typical multiplier of 2 times the single damage. However, the OIG reserves the right to set the multiplier on a case-by-case basis.

C) CMS has proposed suspending the obligation to return overpayments until a settlement agreement is entered or the supplier withdraws or is removed from the SDP.  Otherwise, a supplier is required to report and refund a Medicare or Medicaid overpayment by the later of (1) the date that is 60 days after the date on which the overpayment was identified2 or (2) the date any corresponding cost report is due, if applicable.

D) The OIG has also indicated that it may be less inclined to intervene in a whistleblower (“qui tam”) False Claims Act lawsuit when the defendant has self disclosed. Nevertheless, the OIG reserves the right to intervene in such suits. The benefit to not having the government intervene is that some whistleblowers may be less inclined to pursue a qui tam lawsuit without government intervention because of the high litigation costs.

Potential Risks of SDP
A) The SDP includes a mandatory requirement for an unequivocal acknowledgement that the conduct in question is a potential violation of the False Claims Act, notwithstanding that the facts may not support this conclusion.3  

B) Self disclosures may subject the DME supplier to additional scrutiny by CMS, the OIG and the Department of Justice.

C) Self disclosures are available to the public under the Freedom of Information Act (FOIA).  Disclosing parties must identify to the OIG any portion of a submission that they believe are trade secrets or are commercial, financial, privileged, or confidential and therefore potentially exempt from disclosure under the FOIA. The OIG makes the final determination of exemption and such determination does not unconditionally protect the information from disclosure.

D) Private payers and the public may become aware of the supplier’s self disclosure and exert additional scrutiny, requiring the expenditure of resources to respond to inquiries and audits.

Corrective Action – Prior to disclosing, the disclosing party should ensure that the conduct has ended.  Additionally, all other necessary corrective action should be complete and effective at the time of disclosure.  

Requirements for All Disclosures – The disclosing party is expected to conduct an internal investigation and report its findings to the OIG in its submission. If the disclosing party is unable to complete its internal investigation before sending its submission, the disclosing party must certify in its submission that it will complete the internal investigation within 90 days of its initial submission.

AAHomecare’s Educational Webinar – Aggressive Marketing While Avoiding Legal Pitfalls
Presented by: Jeffrey S. Baird, Esq., Brown & Fortunato, P.C.
Thursday, April 23, 2015
2:30-4:00 p.m. EASTERN TIME
The DME industry today is a totally different animal from yesterday. Now more than ever, in order to succeed the supplier must have an innovative marketing program and enter into strategic joint ventures and business arrangements. This program will discuss the legal parameters that must be followed when implementing a marketing program and entering into joint ventures and arrangements with referral sources. Among other issues, the program will discuss the Medicare anti-kickback statute, the Stark physician self-referral statute, the beneficiary inducement statute, the telephone solicitation statute, safe harbors, and OIG fraud alerts.


Contact Ika Sukh at if you experience any difficulties registering.

Member: $99.00 Non-Member: $129.00 

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato PC, a law firm based in Amarillo, Tex. Jill S. Vogel, JD, is an attorney with the Health Care Group at Brown & Fortunato PC. They represent pharmacies, HME companies, and other health care providers throughout the United States. Baird and Vogel are Board Certified in Health Law by the Texas Board of Legal Specialization. Baird can be reached at (806) 345-6320 or and Vogel can be reached at (806) 345-6343 or