Fridays are for fraud and abuse news-related releases, yet again.  Last Friday, the HHS Office of the Inspector General (OIG) released a notice (Notice) informing the public that it has delayed the release of a final rule regarding applicable fraud and abuse law waivers for ACOs participating in the Medicare Shared Savings Program (MSSP).  Accordingly, the OIG extended the application of the waivers from the fraud and abuse laws stated in the November 2011 Interim Final Rule (IFR) for another year (until Nov. 2, 2015).  The waivers from the IFR essentially allow ACOs participating in the MSSP to test out innovative relationships among participating providers with a “pass” from the OIG and Centers for Medicare & Medicaid Services (CMS) with regard to their authority to enforce the Physician Self-Referral Law, the Anti-Kickback Statute(AKS), the Gainsharing Civil Monetary Penalty Law (CMP), and the Beneficiary Inducement CMP.

In the Notice, the OIG has acknowledged that it “would benefit from additional input from stakeholders” on the following four topics:

  1. How and to what extent ACOs are using the IFR’s waivers;
  2. Whether the IFR’s waivers currently serve the needs of ACOs and the Medicare program;
  3. Whether the IFR’s waivers “adequately protect the Medicare program and beneficiaries from the types of harms associated with referral payments or payments to reduce or limit services;” and
  4. Whether there are new or changed considerations that should inform the development of additional notice and comment rulemaking.

The OIG has not established a deadline for receiving stakeholder comments.

My colleagues Tom CraneKaren Lovitch, and Brian Dunphy profiled the IFR in depth when the OIG initially released it in a BNA Health Care Fraud Report Article (subscription required).   Of relevance to the third and fourth items in the above list of topics is that the OIG has already made key changes to applicable fraud and abuse regulations.  As we profiled here on the blog, in April 2013, the OIG and CMS extended the Electronic Health Records (EHR) Donation safe harbor sunset date to December 31, 2016.  And earlier this month, the OIG released proposed additions and modifications to rules governing the AKS safe harbors, the Gainsharing CMP, and the Beneficiary Inducement CMP.   Thus, although the IFR remains applicable, the underlying statutes and regulations affected under the IFR continue to evolve.  These changes will affect how ACOs may experiment with innovative provider relationships and payment mechanisms under the MSSP and in non-MSSP activities.

The Notice, along with the other aforementioned recent regulatory changes, should prompt ACOs and their participants to review their activities involving the following issues to determine whether their health care coordination activities remain lawful.:

  • EHR donations;
  • Referral services;
  • Cost-sharing waivers (including under Medicare Part D);
  • Free transportation services; and
  • Coupons, rebates, and retailer reward programs.

Moreover, participating ACOs should also review whether such arrangements that the IFR exempted from fraud and abuse enforcement may subject the ACO providers to risk if (or when) they no longer participate in the MSSP.