Health Law Scan

The US Department of Health and Human Services (HHS) Office of General Counsel (OGC) offered the healthcare industry the benefit of its legal analysis of the recent US Supreme Court opinion in Azar v. Allina Health Services (Allina) with respect to its impact on Medicare payment rules, sharing its Memorandum to the Principal Deputy Administrator & Director of the Center for Medicare dated October 31, 2019 (OGC Memo) with the public.

We hosted a very informative Fast Break session last week on complex FCA issues. If you weren't able to join, the session was led by Katie McDermott and Matt Hogan, who are both authorities in False Claims Act (FCA) litigation.

Paired with the recent decision in Azar v. Allina, the healthcare industry in particular can hope for a greater voice in the regulatory process in the wake of the US Supreme Court’s directives. With Allina’s requirement that all statements of policy or guidance with substantive legal effect must proceed through notice and comment rulemaking, and Kisor’s instructions for greater judicial diligence with respect to interpreting agency rules, the healthcare industry may have increased confidence that the courts can provide a meaningful role in protecting regulated parties from unchecked agency authority. This is of great value in an era of rapidly changing and thoroughly regulated healthcare delivery systems.

In an opinion with significant implications for the healthcare industry, the US Supreme Court has held that information that is both customarily and actually treated as private by its owner—and that is provided to the government under an assurance of privacy—is exempt from disclosure under the Freedom of Information Act (FOIA).

In an opinion of significant importance to the administration of the Medicare program, the US Supreme Court issued a 7–1 decision requiring the Centers for Medicare & Medicaid Services (CMS) to follow notice and comment rulemaking when adopting a “statement of policy” that establishes or changes a “substantive legal standard.”

The US Supreme Court issued its decision on May 13 in Cochise Consultancy v. United States ex rel Hunt, unanimously holding that the three-year tolling provision in 31 U.S.C. 3731 (b)(2) applies in favor of relators in declined FCA cases. This decision resolves a three-way split in the circuits on whether relators may have up to 10 years to pursue allegations in declined whistleblower cases.