U.S. HHS Workplace of Common Counsel Assertion of Group Suggests Potential Consolidation, Enlargement of Authority

On March 14, 2025, the U.S. Division of Well being and Human Companies (HHS) issued a revised Assertion of Group for the Workplace of the Common Counsel (HHS-OGC).¹ Modifications embrace a return to an organizational construction extra just like the early days of the primary Trump administration for the legal professionals advising the Meals and Drug Administration (FDA), in addition to the closing of sure regional HHS-OGC places of work. Further modifications might probably sign an effort to consolidate and increase HHS-OGC’s authority, particularly with respect to issues at present opined upon by legal professionals advising the HHS Workplace of Inspector Common (HHS-OIG). Stakeholders ought to take into account alternatives to interact with HHS in mild of the modifications introduced within the March 2025 Assertion of Group.

Sure modifications to HHS-OGC’s group had been previewed by HHS-OGC in an internet site posting final week.² With respect to FDA, within the latter a part of the primary Trump administration, HHS-OGC merged the roles of the FDA Chief Counsel and the HHS Deputy Common Counsel for Meals and Medication. Probably the most just lately introduced modifications return to the separate positions construction from the early a part of the primary Trump administration and provides extra duty to the Deputy Common Counsel. The Deputy Common Counsel is now generally known as the “Deputy Common Counsel/Chief Counsel for Meals, Analysis, and Medication” and oversees the Meals and Drug Division of HHS-OGC (generally known as FDA’s “Workplace of the Chief Counsel” at FDA) in addition to the Nationwide Institutes of Well being Department of OGC. The FDA Chief Counsel (also referred to as the “Affiliate Common Counsel, Meals and Drug Division,” because it was within the early a part of Trump 1) will report back to the Deputy Common Counsel/Chief Counsel for Meals, Analysis, and Medication.

As well as, HHS-OGC is closing six of its ten regional places of work, a transfer characterised as a consolidation effort to “decrease working prices.”³ HHS-OGC regional places of work have had a broad vary of duties, usually involving surveys/inspections of suppliers and enforcement actions regarding privateness and civil rights legal guidelines. Within the near-term, the closures could lead to delays for issues dealt with by regional places of work and a much bigger position for the principle workplace of HHS-OGC.

The March 2025 Assertion of Group additionally makes a number of different notable modifications:

• “Binding” authorized recommendation: HHS-OGC’s “Mission” assertion has been up to date to state that HHS-OGC’s authorized recommendation “shall be binding on the Division until overturned by the Secretary.” Traditionally HHS-OGC’s authorized recommendation was not uniformly seen as binding by policymaking parts of HHS.
• Relationship between HHS-OGC and the Workplace of Counsel to the Inspector Common (OCIG): HHS-OIG has its personal authorized division, OCIG, that sits outdoors of the HHS-OGC organizational construction and has no political appointees. OCIG advises HHS-OIG on all of its work, starting from conventional Inspector Common duties as set out within the Inspector Common Act of 1978 to work HHS has delegated to HHS-OIG, equivalent to interpretation and enforcement of the Anti-Kickback Statute. Prior iterations of the HHS-OGC Assertion of Group acknowledged that HHS-OIG “is permitted to have its personal Workplace of the Counsel to the Inspector Common.” Nevertheless, the March 2025 Assertion of Group says that HHS-OIG is permitted to have its personal counsel “with respect to issues solely inside the OIG’s jurisdiction.” Equally, the HHS-OGC description of duties beforehand acknowledged that HHS-OGC “[s]upervises all authorized actions of the Division and its working and workers divisions, besides the OIG.” That language has been up to date to say “besides with respect to sure issues inside the jurisdiction of the OIG.” HHS-OGC could start taking the place that sure authorized points OCIG at present advises on usually are not “solely inside” HHS-OIG’s jurisdiction and thus are the province of HHS-OGC, not OCIG. For instance, the Inspector Common Act of 1978 requires every federal company to ascertain an Workplace of Inspector Common however prohibits companies from “transferr[ing] to such workplace any program working duties.”⁴ HHS-OGC could take the place that sure areas on which OCIG at present opines, together with probably areas involving enforcement of the Anti-Kickback Statute, implicate program working duties and can’t by regulation be inside the sole jurisdiction of HHS-OIG or OCIG. Healthcare firms confronted with HHS-OIG enforcement actions could want to take into account whether or not HHS-OGC’s newly articulated place ought to inform their protection methods.
• HHS-OGC now conducts inside investigations: The March 2025 Assertion of Group signifies that the Nationwide Complicated Litigation and Investigation Division—a brand new division HHS-OGC created throughout the first Trump administration to deal with a rising tide of advanced litigation—will “conduct inside investigations on the request of the Secretary, Deputy Secretary, or Common Counsel.” The scope and subject material of such inside investigations shouldn’t be clear. HHS-OGC has not traditionally performed inside investigations, which might typically be carried out by HHS-OIG.
• New “Civil Rights and Well being, Privateness, and Expertise Division”: HHS-OGC moved the authorized crew advising the Assistant Secretary for Expertise Coverage and Workplace of the Nationwide Coordinator for Well being Info Expertise (ASTP/ONC) outdoors of the Facilities for Medicare & Medicaid Companies (CMS) Division and into the Civil Rights and Well being Division (CRD), which is now referred to as the Civil Rights and Well being, Privateness, and Expertise Division. This new division includes two branches, the Civil Rights Department and the Well being Info Privateness and Expertise Department, every of which is headed by a Deputy Affiliate Common Counsel. Obligations embrace “offering authorized recommendation on all civil rights, well being coverage, privateness, and associated coverage and enforcement issues within the Division, aside from defending claims filed by workers of HHS.” CRD already had duty for Well being Insurance coverage Portability and Accountability Act enforcement, and this transfer consolidates privateness and technology-related work inside HHS-OGC at a time of speedy digital transformation within the well being sector, together with from synthetic intelligence innovation.
• Modifications to remaining regional workplace caseload: The March 2025 Assertion of Group removes the next CRD-related work from the duties of the now-four regional places of work: “offering authorized providers to the Workplace for Civil Rights, together with recommendation and illustration in administrative and judicial litigation with respect to the enforcement of civil rights legal guidelines and the Well being Insurance coverage and Portability and Accountability Act of 1996.” The priorities of the HHS Workplace for Civil Rights usually swing dramatically between modifications in administration, and this transfer could also be designed to make sure enough political oversight over civil rights issues.
• Doubtlessly larger HHS-OGC involvement in FDA-related enforcement actions: FDA’s Workplace of Chief Counsel (also referred to as the Meals and Drug Division of HHS-OGC (FDD)) advises the Commissioner of Meals and Medication and offers authorized providers to FDA and HHS officers on issues involving FDA-regulated merchandise. FDD refers civil and prison enforcement circumstances to the Division of Justice (DOJ), and it really works intently with DOJ on these enforcement issues and on defending challenges to provisions of the Federal Meals, Drug, and Beauty Act (FDCA), the implementing rules, and FDA insurance policies, initiatives, and selections. Though the Deputy Common Counsel and Common Counsel of HHS sometimes usually are not concerned in OCC/FDD’s referrals of enforcement issues to DOJ, this administration has signaled that they could take a extra energetic position. The March 2025 Assertion of Group explains that “all prison prosecutions, investigations, and civil issues could also be referred to the Division of Justice solely by means of or in session with the Chief Counsel, acceptable Deputy Common Counsel or the Common Counsel.”
• HHS-OGC advisory opinion authority: Through the first Trump administration, HHS-OGC started issuing advert hoc advisory opinions saying its place on authorized points. HHS posted the advisory opinions to the HHS Steering Portal.⁵ HHS-OGC below the Biden administration continued this apply. The March 2025 Assertion of Group memorializes as an HHS-OGC duty “[i]ssu[ing] all Advisory Opinions besides these regarding the Anti-Kickback Act (SSA 1128B(b)), the Anti-Inducement Act (SSA 1128A(a)(5)), and the Ethics in Affected person Referral Act of 1989,” i.e., the Stark Legislation. HHS-OIG points advisory opinions regarding the Anti-Kickback Act and Anti-Inducement Act, and CMS points advisory opinions regarding the Stark Legislation. Stakeholders can anticipate to proceed to see HHS-OGC subject advisory opinions on different matters and should take into account alternatives to interact with HHS-OGC on acceptable topics for advisory opinions.

This publish is as of the posting date acknowledged above. Sidley Austin LLP assumes no responsibility to replace this publish or publish about any subsequent developments having a bearing on this publish.