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Recent Compliance Updates & Tips

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Do’s and Don’ts for Compliance Officers

Provider-Self-Disclosure-Protocol-on-ComplianceThe Department of Health and Human Services (HHS) Office of Inspector General (OIG) has a process for health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving Federal health care programs. The Provider Self-Disclosure Protocol (SDP), established in 1998, provides guidance on how to investigate conduct and quantify damages. The SDP also provides guidance on how providers can make disclosures in an effort to resolve liability under OIG’s civil monetary penalty (CMP) authorities. There have been upwards of 1,000 disclosures since the SDP’s inception, resulting in recoveries approaching a half billion dollars cumulatively. Currently, the OIG reports that it receives an average of 100 SDPs a year, resulting in nearly $100 million in settlements each year.

There are three main categories of cases that the OIG acts on for SDP settlements: i) False Claims, ii) employment of excluded individuals, and iii) Stark/Anti-Kickback Statute (AKS) violations. Some EMTALA cases are resolved through SDP annually as well. For 2016, False Claims cases resulted in the largest recoveries, totaling nearly 40% of all SDP settlements. This was followed by settlements involving the employment of excluded individuals, totaling nearly 30% of settlements, and the balance relating to Stark/AKS violations and a sparing number of EMTALA cases.

Benefits of Filing and Settling Claims with the SDP

The OIG instituted the SDP with benefits to encourage provider use of the process.  Benefits include a presumption against requiring a Corporate Integrity Agreement (CIA) and releasing the entity from being excluded from Federal health care programs. Providers who file the SDP and cooperate with the OIG during the SDP process will pay a lower multiplier on single damages (generally 1.5 times the single damage) than would normally be required in a Government-initiated investigation. Another SDP benefit promoted by the OIG is that use of the SDP may mitigate potential exposure to Medicare or Medicaid.  When the OIG reports receipt of a submission through the SDP, the OIG may suspend the obligation to report overpayments on the matter.

In the case of False Claims being submitted, the total amount of those claims must be presented in the SDP. For matters involving AKS, disclosing parties must also specify the total amount of remuneration involved in an arrangement. Disclosing parties must specify this total regardless of whether a portion of that remuneration was not in violation. Referrals involving excluded individuals must include: a) the identity of those parties, b) any provider ID number, c) job duties, d) dates employed or under contract, e) description of any background checks completed before and/or during the time employed or under contract, f) description of the provider’s screening process, g) circumstances leading the engagement of the excluded individual, h) description of how the situation was discovered, i) a description of corrective action taken, and j) the total amount claimed and paid by Federal health care programs for services of the excluded party.

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Expert Advice on Disclosing Self-Discovered Evidence and Following the Provider Self-Disclosure Protocol

Tom Herrmann, JD has 20 years experience in the Office of Counsel to the Inspector General. He advises that once an organization makes the decision to submit a SDP, they need to be prepared to follow the protocol posted on the OIG website carefully. Failing to follow the protocol guidelines can easily lead to an aggravation of matters. The OIG has made it clear that it does not want to see SDP submissions for errors or overpayments with no potential violation of CMP, or to request an opinion on whether a potential violation exists. Nor will it accept any Stark-only potential violations. Further, the OIG is also not interested in settlements under $10,000, or $50,000 in cases related to AKS. SDPs related to Stark/AKS must acknowledge that the disclosed arrangement “constitutes a potential violation of those statutes.” Establishing the exact conduct being disclosed is critical to making the process of SDP submission work. The process requires a thorough and timely investigation of all the facts related to the situation and a final report certifying the investigation was completed within 90 days. The key to this step is establishing a proper scope for the investigation.  The scope should include evaluating potential exposure of damages. Once facts are known, a proper determination can be made as to the manner best to resolve the matter. The OIG posts individual settlements on its website. It is worthwhile reviewing results of others using the protocol. The final point of advice about using the SDP is that the OIG is not interested in litigation or legal arguments about the submission. The OIG is very clear that the submission must follow the protocol exactly. The OIG will act upon what is provided without attorneys trying to influence the analysis or decisions of settlement amounts. The SDP process is not a place to negotiate or litigate issues.

OIG Self-Disclosure Protocol Tips

  1. Don’t insist, in the initial disclosure or at settlement, that there is no fraud.
  2. Don’t disclose until you have investigated thoroughly and have all the facts.
  3. Don’t submit a SDP for a Stark law violation only.
  4. Don’t file a SDP and then refuse to pay the multiplier determined by the OIG.
  5. Don’t argue damages decided upon by the OIG.
  6. Do make sure you have quantified the damages accurately.
  7. Do identify the potential laws violated at the time of disclosure.
  8. Do cooperate fully after filing a SDP, this is not a place to argue or litigate issues.

Mr. Herrmann noted that matters often brought to his attention could result in resolution through a number of channels, depending on the factual circumstances, with SDP being just one potential channel. In some cases, resolution may simply involve refunding an overpayment received in error. CMS Self-Referral Disclosure Protocol (SDRP) is another resolution channel to be considered, as well as making a disclosure to a State Medicaid program. Then, of course, in the case of criminal wrongdoing by individuals or the organization, there are channels through the Department of Justice.

Have Compliance Questions? Contact Our Experts

Strategic Management Services has healthcare compliance experts with years of experience evaluating compliance programs. If you have questions regarding the OIG Self-Disclosure Protocol or about your compliance program, give us a call at (703) 683-9600 or contact us online.

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