Health Care Self-Disclosure Protocols

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Project Overview

• Health Care Self-Disclosure ProtocolsPresenter
  Name

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• In recent years the federal government has
  aggressively investigated and prosecuted
  pharmaceutical companies and health care
  providers for possible violations of anti-fraud,
  anti-kickback and other laws. These efforts have
  resulted in massive fines and financial
  penalties.
• In the face of these dangers, participants in the
  health care market need to consider various ways
  to forestall or at least mitigate possibly
  crippling sanctions.  One important means is to
  investigate and voluntarily disclose wrongdoing
  before the start of an investigation of course,
  in the hope of convincing the authorities to
  forego charges altogether or at least
  substantially reduce the penalties that would
  otherwise be sought and imposed.

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• As logical as this approach seems, the results of
  self-reporting often fall short of expectations.
  In Dilemma of Self-Reporting  The FCPA
  Experience, Elkan Abramowitz and I describe how
  federal authorities seek to give companies an
  incentive to self-report misconduct.  But, with
  the possible exception of the Department of
  Justice, Antitrust Divisions Leniency Program
  and the Internal Revenue Services Offshore
  Voluntary Disclosure Program, the benefit of
  self-reporting remains uncertain in many
  contexts.
• The benefits of self-reporting are certainly
  similarly uncertain in the health care context,
  in which the U.S. Department of Health and Human
  Services, Office of Inspector General (OIG) and
  the Centers for Medicare and Medicaid Services
  (CMS) have established protocols that offer
  incentives to health care providers that
  self-report.

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• The Voluntary Self-Referral Disclosure Protocol
  (SRDP) established by CMS in 2010 in response
  to a Congressional mandate in the Affordable Care
  Act sets forth a process for Medicare services
  providers and suppliers to self-disclose actual
  or potential violations of the physician
  self-referral statute, commonly knows as the
  Stark Law.  That law prohibits physicians from
  making referrals for certain health services
  payable by Medicare to an entity in which the
  physician or a member of the physicians family
  has a financial relationship.  In exchange for a
  potential reduction in overpayments and
  penalties, the SRDP requires detailed
  disclosures, including an explanation of why the
  violation occurred and a complete legal
  analysis.  Yet, the SRDP makes no guarantees. 
  It lists factors that CMS may consider in
  reducing the amounts owed by a disclosing party,
  but states  CMS is not obligated to reduce any
  amounts due and owing.  CMS also may refer
  disclosed matters to the OIG or the Department of
  Justice for further investigation and possible
  prosecution.

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• The OIG Provider Self-Disclosure Protocol
  (SDP), issued in April 2013, sets forth the
  process for health care providers to voluntarily
  disclose self-discovered evidence of potential
  fraud involving federal health care programs,
  which, according to OIG gives providers the
  opportunity to avoid the costs and disruptions
  associated with a Government-directed
  investigation and civil or administrative
  litigation.  The SDP offers several benefits,
  including a presumption against requiring
  corporate integrity agreements because good-faith
  self-disclosure is an indication of a robust and
  effective compliance process.  OIG generally
  imposes a lower damages multiplier on
  self-disclosing parties, although it determines
  in individual cases whether a higher multiplier
  may be warranted.  And, participation suspends
  the obligation to return Medicare or Medicaid
  overpayments.