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CMS Gets New Exclusion Authority: A New Enforcement Risk for Life Sciences Companies

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We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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In a Federal Register notice published October 14, 2026 and effective immediately, HHS Secretary Robert F. Kennedy, Jr. delegated authority to the Centers for Medicare & Medicaid Services (CMS) to exclude certain individuals and entities from participation in federal healthcare programs under Section 1128(b) of the Social Security Act. Although the scope and operation of this authority remain to be seen, the delegation opens the door for CMS to independently impose exclusion, even after a life sciences company has resolved exclusion with the HHS Office of Inspector General (OIG).Read the <a href="https://lifesciences.mofo.com/topics/261026-cms-gets-new-exclusion-authority" target="_blank">full blog post</a>.

CMS Gets New Exclusion Authority: A New Enforcement Risk for Life Sciences Companies

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.As the lead of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks. In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA). </li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs. Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Partner

Demme Doufekias is a trial attorney whose practice focuses on matters involving complex government and internal investigations. As a member of the firm’s Investigations + White-Collar Defense practice, individuals and corporations seek Demme’s counsel through all phases of investigations and litigation, from proactive compliance counseling and due diligence through the simultaneous defense of criminal investigations, administrative proceedings, and civil litigation. She successfully defends clients in civil and criminal matters in federal and state trials.Demme’s global investigations practice encompasses a number of substantive areas, including the Foreign Corrupt Practices Act and other anticorruption regimes, anti-money laundering, and criminal antitrust and securities violations. She has represented clients in cross-border investigations, including FCPA investigations and the U.S. Department of Justice’s (DOJ) investigations of price-fixing in the auto parts and generic drug industries. She also counsels clients in creating global anti-corruption compliance programs and in due diligence matters related to healthcare and anti-corruption laws.Demme regularly represents pharmaceutical, biotechnology, and medical device companies and has extensive experience with healthcare investigations and regulatory matters. She defends companies and executives in federal investigations conducted by DOJ, the Department of Health and Human Services, and the Food and Drug Administration. Her experience includes counseling and defending clients in matters related to the Food, Drug, and Cosmetic Act; other federal health care laws; and transparency laws such as the federal Physician Payments Sunshine Act. When required, Demme has successfully defended her healthcare clients at trial, including, obtaining a complete defense victory on behalf of a former pharmaceutical sales executive charged with violations of the federal Anti-Kickback statute in a two-week jury trial in U.S. District Court for the District of Massachusetts (U.S. v. Bruens, et al).Demme was most recently named to Global Investigations Review’s “Women in Investigations” 2018 survey, which recognizes the top 100 leading female investigations specialists from around the world.In addition to her investigations and healthcare practices, Demme maintains a robust civil litigation practice. Her experience includes conducting investigations and litigating on behalf of creditors’ committees and other constituents in federal bankruptcy matters and representing clients in state and federal civil trials.Prior to law school, Demme worked in the White House Counsel’s Office during the Clinton administration, where she worked on various investigations by the Office of Independent Counsel, including Whitewater, campaign finance, presidential impeachment, and the activities of various Cabinet members. She is admitted to practice in Virginia and the District of Columbia.<h4>Representative Experience</h4><h5>Criminal Investigations and Matters</h5><ul><li>Represents Fortune 500 multinational pharmaceutical company in DOJ and SEC investigations of potential FCPA violations.</li><li>Represented numerous executives of Japanese auto parts manufacturers in connection with DOJ investigation of price-fixing in the auto parts industry.</li><li>Represented Fortune 500 technology company on various FCPA matters in multiple emerging markets.</li><li>Represented software creator in connection with grand jury investigation of WikiLeaks.</li><li>Represented global power company in connection with FERC investigation of gas-trading practices.</li><li>Represented the former chairman and chief executive officer of Kansas public utility in DOJ and IRS investigations, related shareholder litigation and arbitration proceedings, resulting in two criminal trials, with the first ending in a hung jury and the second in a conviction later reversed on appeal and subsequently dismissed.</li></ul><h5>Health Care Fraud And False Claims Act Matters</h5><ul><li>Represents executive of generic drug manufacturer in connection with DOJ price-fixing investigation.</li><li>Represented former compliance director and marketing director of global pharmaceutical company in criminal investigation of marketing and promotion of arthritis pain medication.</li><li>Represented former president of a global medical device company indicted as “responsible corporate officer” in criminal investigation concerning off-label promotion of prosthetic bone cement.</li><li>Represented former senior executive of a Fortune 500 health care and pharmaceutical company during investigation of company’s good manufacturing practices (GMP) and related product recall.</li><li>Represented executive of large regional retina practice in qui tam litigation concerning Medicare and Medicaid reimbursement violations.</li></ul><h5>Bankruptcy And Other Litigation Matters</h5><ul><li>Conducted investigations on behalf of the official committee of unsecured creditors in various bankruptcy matters in the coal industry, including Murray Energy, Westmoreland Coal Company, Patriot Coal Corporation, Peabody Energy, Inc., and Armstrong Energy, Inc.</li><li>Conducted investigation on behalf of the official committee of unsecured creditors for international telecom company Avaya Inc. and its affiliated debtors.</li><li>Conducted investigation, on behalf of Chapter 11 Trustee, into collapse of global financial broker MF Global and brought suit against former officers and directors for breaches of various duties.</li><li>Represented government contractor specializing in technologies for national security and aerospace programs in trade secrets litigation, including at trial in state court litigation and winning a partial defense verdict.</li><li>Obtained defense judgment for a national law firm in a $226 million state legal malpractice suit.</li></ul>

Demme Doufekias

Megan focuses her practice on healthcare regulatory, operational, and transactional matters. As a member of the FDA + Healthcare Regulatory and Compliance Group, Megan provides guidance to participants in and across the healthcare industry, including digital health companies, healthcare systems, and healthcare startups. She helps companies develop, evaluate, and implement innovative business strategies in consideration of the complex, multijurisdictional regulatory requirements governing the healthcare industry.Megan also helps guide companies through various transactions, including corporate acquisitions, integrations, and affiliations, establishing management service organizations, and drafting professional services arrangements. She provides valuable guidance on issues pertaining to the Corporate Practice of Medicine, HIPAA compliance, day-to-day operational matters, issues concerning Medicare, Medicaid, and commercial payor reimbursement, drug-pricing, as well as licensure, certification, and scope of practice requirements. She counsels companies on issues pertaining to fraud and abuse concerns, including compliance with the Physician Self-Referral Law (the Stark Law), the Anti-Kickback Statute (AKS), the Eliminating Kickbacks in Recovery Act (EKRA), and the False Claims Act (FCA).Prior to joining Morrison Foerster, Megan practiced at full-service firms in D.C., as well as at a boutique healthcare firm in Virginia. Megan received her J.D. from the Emory University School of Law and earned her B.A. from the University of Virginia. She is an active member of the American Health Lawyers Association and has been recognized in Best Lawyers: Ones to Watch® in America since 2021.