The Office of Inspector General (“OIG”) recently issued a revised provider self-disclosure protocol (“SDP”) that replaces the initial 1998 SDP and subsequent Open Letters issued in 2006, 2008 and 2009. The revised SDP, released April 17, 2013, provides new guidance on reporting dealings with individuals who appear on the OIG’s List of Excluded Individuals and Entities (“LEIE”), how to report potential violations with specificity and the standard calculation of penalties.

When a Provider May Use the SDP

Any health care provider, supplier or other individuals or entities who are subject to the OIG’s Civil Monetary Penalties (“CMP”) authority may use the SDP to disclose potential violations of the Federal anti-kickback statute (“AKS”) or any other Federal criminal, civil or administrative law for which CMPs are authorized. A person or entity may not use the SDP to disclose potential liability under the Physician Self-Referral Law (the “Stark Law”) unless the same arrangement also involves potential liability under the AKS. In making a disclosure, the disclosing party must acknowledge that the conduct is a potential violation and explicitly identify which laws were potentially violated. Ultimately, it is up to the OIG to determine whether an arrangement is appropriate for resolution with the SDP.

Submission Content

Though all disclosures must contain the same basic information, the revised SDP contains detailed guidance regarding additional information required depending on the type of violation being reported.

False Claims

For matters related to false claims or billing, the disclosing party must estimate the monetary damages at issue. This may be calculated by either reviewing all of the claims affected by the disclosed matter for the relevant period, or by taking a statistically valid sample of the claims that can be projected to the population of claims affected by the matter for the relevant period. The revised SDP did not provide new guidance for this group of submissions except to require that in a sampling, the sample size must be at least 100 items.

Conduct Involving Excluded Persons

For disclosures related to dealings with individuals who appear on the OIG’s LEIE, the OIG has provided new guidance relating to the specific information that must be disclosed. In addition to the basic information required of every submission, the OIG now requires specific information regarding the identity of the excluded individual and details regarding the involvement with such individual, an explanation as to why screening processes in place failed to identify the excluded individual, and what corrective action was implemented to prevent future hiring of excluded individuals.

Conduct Involving the Anti-Kickback Statute and the Stark Law

For matters involving the AKS and the Stark Law, the submission must explain the relevant context and the features of the arrangement that raise potential AKS or both AKS and Stark Law liability. The OIG has provided new illustrations of such context and features that should be disclosed. Some of the examples include:

  • How fair market value was determined and why it is now in question;
  • Why the arrangement was arguably not commercially reasonable;
  • Whether payments were made for services not performed or documented; and
  • Whether referring physicians received payments from Designated Health Services entities that varied with, or took into account, the volume or value of referrals without complying with a Stark Law exception.

Resolution

The OIG’s general practice, when a disclosing party has fully cooperated with the OIG’s review, is to require a minimum multiplier of 1.5 times the single damages. Additionally, the revised SDP has imposed new minimum settlement amounts for self-disclosed matters. For kick-back related matters, the OIG will require a minimum $50,000 settlement amount to resolve the matter. For all other matters settled under the SDP, the OIG will require a minimum $10,000 settlement amount to resolve the matter.

The revised SDP also addresses a disclosing party’s inability to pay settlement amounts. If a disclosing party asserts its inability to pay a settlement amount, the OIG will require extensive financial information and an assessment of how much the disclosing party believes it can afford to pay.