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Articles by Amanda Johnston
DOJ Fraud Division Prioritizes Health Care
DOJ Health Care Fraud Priorities for FDA-Regulated Companies The U.S. Department of Justice (DOJ) has made health care one of five enforcement priorities for its new National Fraud Enforcement Division (Fraud Division). An August 13, 2026, memorandum also identified corporate misconduct as a separate priority and promised more resources, data analytics, and technology for health care fraud enforcement. Medical product and life sciences companies should pay particular attention.
RAPID Promises Faster Medicare Coverage, With Limits | JD Supra
The Centers for Medicare & Medicaid Services (CMS) has now provided the details behind its proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway , an effort designed to bring Medicare coverage planning much earlier into medical device development. The pathway remains proposed. CMS will respond to public comments in a subsequent final notice and has indicated that RAPID is expected to become effective upon publication of that final notice.
Veloxis Resolution Highlights Payment and Reporting Risks
On August 10, 2026, the Department of Justice announced a coordinated criminal and civil resolution with Veloxis Pharmaceuticals Inc. involving kickbacks to healthcare professionals (HCPs) and specialty pharmacies relating to Envarsus XR, a kidney transplant immunosuppression drug. Veloxis entered into a 36-month deferred prosecution agreement (DPA) in connection with a criminal Information charging the company with conspiracy to commit violations of the federal Anti-Kickback Statute (AKS).
CMS Proposes Stronger Enforcement Tools for Open Payments Audits
The Physician Payments Sunshine Act, a.k.a., the Open Payments Program, is changing, again. A proposed rule included within the Centers for Medicare and Medicaid Services' (CMS) Interoperability Standards and Prior Authorization for Drugs rulemaking (CMS-2026-1255) would significantly strengthen the agency's ability to compel participation in Open Payments audits. The public comment period closed on June 15, 2026, and medical products companies should evaluate audit readiness now.
FTC Turns Up the Heat on Healthcare: Key Implications for Medtech, Pharma, & Biotech Companies
The Federal Trade Commission (“FTC”) recently announced the formation of a Healthcare Task Force under Chairman Andrew N. Ferguson. As outlined in the memorandum, the Task Force is intended to strengthen coordination across the FTC’s competition, consumer protection, and economic policy functions to address issues in healthcare markets. While the initiative does not create new legal obligations, it signals a more coordinated and potentially more active enforcement posture.
DOJ Reports Record Fiscal Year 2025 False Claims Act Recoveries | JD Supra
On January 16, 2026, the U.S. Department of Justice announced that False Claims Act (FCA) settlements and judgments for Fiscal Year 2025 exceeded $6.8 billion, the highest annual total in the statute’s history. Recoveries more than doubled FY 2024 results, driven overwhelmingly by healthcare enforcement.
FDA’s 2026 CDS and General Wellness Guidance Updates | JD Supra
For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates provide important clarification on how certain products may fall within, or outside, FDA oversight. On January 6, 2026, FDA issued revised guidance addressing Clinical Decision Support (CDS) Software and General Wellness: Device Policy for Low Risk Devices.
FDA Sends 100 Cease-and-Desist Letters: A Warning to Industry | JD Supra
On September 9, 2025, the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) dropped a regulatory bombshell: the FDA issued approximately 100 cease-and-desist letters and thousands of letters to industry targeting direct-to-consumer (DTC) drug ads. This sweeping action is being interpreted as the start of a broader shift in FDA’s oversight of promotional content—particularly in digital and broadcast media.
[Hybrid Event] Navigating What’s Next: AI, Compliance, and Regulation in Life Sciences - November 6th, Mountain View, CA | JD Supra
Discounted lodging is available through this link. Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time. This is an exclusive, in-person and live-streamed cross-border legal and regulatory forum held in collaboration with international law firm Fieldfisher.
TCET—A Medicare Coverage Option for Breakthrough Devices | JD Supra
For many device makers, the biggest commercial hurdle isn’t FDA authorization—it’s the long wait for Medicare to decide on coverage. Historically, the gap between FDA market authorization and a National Coverage Determination (NCD) has stretched several years, delaying access for seniors and slowing commercial adoption. The Transitional Coverage for Emerging Technologies (TCET) pathway, finalized by CMS in August 2024, is a new voluntary process designed to close that gap.
Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries | JD Supra
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the product lifecycle. Managing these changes effectively requires a robust and well-documented change control process. This process is essential not only for ensuring product quality and safety but also for meeting FDA regulatory requirements.
LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains | JD Supra
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s decades-long policy of enforcement discretion and bring LDTs under the same regulatory framework as other in vitro diagnostics (IVDs). The move was met with controversy, and many industry stakeholders predicted litigation. They were right.
FDA Goes All In on AI: What It Means for Your Submissions | JD Supra
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and it’s already scaling the technology across all centers. FDA Commissioner Dr. Martin Makary has directed each product center (drugs, devices, biologics, and others) to begin immediate deployment of generative AI tools.
Can Companies Fund Diagnostic Testing for Conditions Their Product Treats? | JD Supra
Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important compliance considerations under the Anti-Kickback Statute and other healthcare laws. The Office of Inspector General (OIG) recently issued two advisory opinions (AO 22-06 and AO 24-12) addressing pharmaceutical company-sponsored diagnostic testing programs.
Federal court blocks transgender military ban in GLAD Law and NCLR case Talbott v. Trump - GLAD Law
“The Court’s unambiguous factual findings lay bare how this ban specifically targets and undermines our courageous service members who have committed themselves to defending our nation. Given the Court’s clear-eyed assessment, we are confident this ruling will stand strong on appeal,”said GLAD Law’s Jennifer Levi WASHINGTON, DC—U.S. District Court Judge Ana Reyes today issued a nationwide preliminary injunction in Talbott v.
Streamlining Device Changes with Predetermined Change Control Plans (PCCPs) | JD Supra
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved modifications without submitting a 510(k) or PMA supplement for each change. By leveraging PCCPs, manufacturers can increase efficiency, accelerate innovation, and allocate resources more strategically.
CMS Auditing Companies for Sunshine Compliance: Are You Ready? | JD Supra
Are you prepared for a Sunshine Act audit? Reporting entities are subject to Sunshine Act compliance audits by HHS, CMS, and/or the OIG to ensure that reported data is accurate, complete, and submitted on time. Civil monetary penalties (CMPs) of up to $1,150,000, as adjusted annually, may be imposed on reporting entities for violations.
FDA Intensifies Efforts on LDT Regulation | JD Supra
FDA has set its sights on April 2024 for the release of the Final Rule, as indicated by the Agenda of Regulatory and Deregulatory Actions. This expedited timeline underscores the FDA’s commitment to LDT oversight.
Court Affirms Criminal Convictions for Device Execs Under the FDCA | JD Supra
Overview The Food, Drug and Cosmetic Act imposes several restrictions and prohibitions on the marketing of medical devices and other products regulated by the U.S. Food and Drug Administration (FDA). While many enforcement actions under the FDCA are civil in nature, the statute also includes provisions for criminal enforcement. Notably for purposes of this case, the “introduction or delivery for introduction into interstate commerce of any . . . device . . .
Compliance Considerations in High-Tech Healthcare | JD Supra
Amanda Johnston presented on Compliance Considerations in High-Tech Healthcare at a recent CLE program that Gardner Law and Fieldfisher hosted in Huntington Beach, California. If you don't have time to watch the session recording, please see the summary of key topics below. Cutting-edge technology is desirable to consumers for its ability to deliver innovative solutions, improved efficiency, enhanced user experiences, and the promise of staying ahead in an ever-evolving digital landscape.
[Hybrid Event] Mastering Tomorrow's Tech: A Cutting-Edge Approach to Compliance, Privacy, and Regulation - November 9th, Huntington Beach, CA | JD Supra
Join Gardner Law and Fieldfisher live from Huntington Beach, CA for this complimentary CLE event.
Beyond Paperwork: Assessing the Effectiveness of a Compliance Program | JD Supra
June 13, 2023 To embed, copy and paste the code into your website or blog: In the world of FDA-regulated companies, compliance with regulatory requirements is not just a matter of paperwork. It is a critical aspect that can significantly impact mergers and acquisitions (M&A) and the overall success of your business.
FDA Violations and the Park Doctrine Threat | JD Supra
Did you know… As a leader at an FDA-regulated company, you could be held criminally liable for misdemeanor FDA violations even if you did not know about the activities leading to the violation. If you are an executive at an FDA-regulated company, you should be aware of the Park Doctrine, also known as the Responsible Corporate Officer (“RCO”) Doctrine.
Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley | JD Supra
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies.
Anti-Fraud & Sunshine Update | JD Supra
Since the definition of “covered recipient” was expanded under the Open Payments Program in 2020, manufacturers may have noticed that there are fewer payments and transfers of value to report to states such as Connecticut, Massachusetts, Washington D.C., Minnesota, Nevada, and Vermont under state transparency reporting requirements. This is largely due to the doctrine of preemption, which is based on the Supremacy Clause of the U.S. Constitution.
Are you Submission Ready? FDA Medical Device Submission Tips & Tricks | JD Supra
FDA's Pre-Sub Program Is a Pre-Sub really necessary? This is a common question that we receive. We find that companies vary in their perspective on the answer to this question and how they view the value of FDA’s Pre-Sub Program. Some companies treat it as a mandatory step, while others completely avoid it.
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