Advertisement HHS OGC Weighs in On Sub-Regulatory Guidance in Advisory Opinion: What It Might Mean for False Claims Acts Cases After Azar v. Allina Health Services Friday, December 18, 2020 Azar v. Allina Health Services 1 effectively curtailed the enforceability of certain Medicare policies established without notice-and-comment rulemaking. As a result, health care fraud cases brought under the False Claims Act (FCA), which are predicated on sub-regulatory guidance, face heightened scrutiny after Allina. 2 In a recent Advisory Opinion, the Health and Human Services Office of the General Counsel (HHS-OGC) provided its interpretation of Allina and how violations of sub-regulatory guidance affect the ability of governmental enforcement agencies and relators to bring and support FCA actions moving forward.