The Voluntary Self-Referral Disclosure Protocol (SRDP) recently released by the Centers for Medicare and Medicaid Services (CMS) looks remarkably familiar. The new SRDP permits hospitals and other providers who believe that they are or might be providing services in violation of the federal Stark physician self-referral law (42 U.S.C. § 1395nn) to disclose such actual or potential violation to CMS in the hopes of resolving the matter as favorably as possible. Required by the health care reform law, the SRDP is specifically limited to reports of actual or potential violations of the Stark self-referral law, so-called Stark-only violations. In contrast, the Self Disclosure Protocol used by the Office of Inspector General (OIG) of Health and Human Services should be used to disclose potential violations that are based, at least in part, on the anti-kickback statute, False Claims Act, or civil monetary penalties.
The table in this article shows the comparison between the Self-Referral Disclosure Protocol and the Self Disclosure Protocol.
Comparison Between the Self-Referral Disclosure Protocol and the Self-Disclosure Protocol
To see table please click here.
Considerations Before Self-Disclosure
The decision of whether to disclose an actual or potential violation of any federal law is one that should be made in consultation with qualified legal counsel after a full internal investigation of the facts and circumstances giving rise to a disclosure. A few points to consider before disclosing a matter are:
- Will the disclosure resolve all the potential fraud and abuse violations involving the disclosing party? If not, what other laws and regulations are implicated and how can these violations be resolved? Disclosure may give other agencies a heads-up that they ought to take a closer look at you and your business partners.
- Have you thoroughly investigated your business’s compliance with applicable laws and regulations to ferret out all potential issues and implemented corrective action with ongoing monitoring for any areas of noncompliance?
- Disclosing actual or potential violations means facing substantial civil penalties and fines, even if the final settlement amount is reduced from treble damages (to some other agreed-upon amount), and you have invited the government into your home to have a look around.
- Voluntary disclosures may adversely affect relations with business partners or health plans, as well as potentially result in termination from the state Medicaid program and/or termination of business agreements.
- Voluntarily providing otherwise privileged or confidential information undermines the protection of this information, making it discoverable by others.
- Substantial expenses are involved in the disclosure process and post-disclosure monitoring, separate and apart from any fines and penalties.
- A provider must consider whether the provider has (or can obtain) the financial and other records (going back six years or as far as required) to do the analysis necessary to determine the extent of violations and damages (or penalties) owed.
- Further complexities are added to the decision when clinical staff has changed, as disclosure implicates a privilege waiver and has other serious considerations. Disclosure may potentially impact former and new staff members in a number of ways.
The determination that a disclosure is or is not in the best interest of you and your business requires careful and deliberate analysis of the benefits and the risks involved. Disclosure is a process that, once begun, cannot be undone and requires a detailed legal and financial picture of your business.