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Traci L. Vitek

Senior Vice President

[email protected]

+1.202.434.7445

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Traci advises health care organizations and innovative technology companies, including hospitals, health systems, biotechnology and medical technology (MedTech) companies, digital health companies, and wearable device manufacturers, on federal health care policy, legislative strategy, and executive branch engagement. She brings over two decades of experience across Congress, federal agencies, and the private sector to help organizations navigate regulatory environments, secure federal market access, and advance their health care priorities.

Her work encompasses federal market access, Medicare and Medicaid reimbursement, laboratory policy, the 340B Drug Pricing Program, rural health, telehealth, health information technology and interoperability, aging policy, adoption policy, and organ procurement and transplantation policy, with matters touching the US Department of Health and Human Services, CMS, FDA, HRSA, SAMHSA, NIH, ONC/ASTP, ACL, and ACF.

At HHS, Traci served nearly a decade in senior roles, including Deputy Assistant Secretary for Legislation, overseeing legislative portfolios for multiple agencies. She advised the HHS Secretary on the 340B Drug Pricing Program, organ procurement and transplantation reform, rural health, telehealth, health information technology, and aging and adoption policy, including passage of legislation reauthorizing the Older Americans Act.

Previously, she served as attorney advisor at the HHS Office of Inspector General and as Republican professional staff on the US House Committee on Energy & Commerce, where she co-authored provisions of the landmark 21st Century Cures Act and contributed to the Medicare Access and CHIP Reauthorization Act (MACRA).

She also advised health care and technology clients in private practice and consulting roles on Medicare and Medicaid reimbursement, FDA policy, laboratory policy and physician self-referral (Stark Law) matters, and federal program compliance.

viewpoints

A Discussion on What's Shaping the Future of FemTech

Key Takeaways on Policy, FDA Oversight, Privacy, and Investment

October 9, 2026 | Webinar | By Traci L. Vitek, Daniel Cody, Benjamin Zegarelli

Explore key FemTech trends shaping the industry, from FDA oversight and privacy laws to policy shifts, investment readiness, and innovation.

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340B Rebate Pilot — The Clock Starts Now

Ten Plans, 18 Drugs, One Deadline

October 7, 2026 | Blog | By Traci L. Vitek, Emmett R. Jamieson, Theresa Carnegie

HRSA’s 340B rebate pilot starts Jan. 1, 2027. Learn the approved plans, litigation risks, and readiness steps for health systems.

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Banning Corporate Medicine: The Costs Congress Isn't Pricing In

October 5, 2026 | Blog | By Traci L. Vitek, Deborah Daccord, Daniel Cody

Senators Warren, Wyden, and Merkley, along with Representatives Hoyle, Ocasio-Cortez, and Subramanyam, have introduced the Stop Corporate Takeovers of Physicians Act. The bill would establish the corporate practice of medicine doctrine, rooted in more than a century of law in about half of the states, as a federal baseline. The bill would require that licensed physicians be majority owners and controlers of medical practices and place limitations upon management services organizations. Its rationale is straightforward: a prior Senate bill titled the Break Up Big Medicine Act asserted that more than 75% of U.S. physicians now work for corporate employers and the sponsors want clinical decisions made by doctors rather than shareholders.

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The 340B Squeeze: Academic Medical Centers and Large Health Systems Have the Most to Lose

September 28, 2026 | Blog | By Traci L. Vitek, Theresa Carnegie, Brent Henry

Most of the 340B debate centers on rural hospitals and community health centers. The biggest dollars, however, sit with academic medical centers (AMCs) and large health systems, and that is where Washington’s next three moves converge.

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FemTech's Real Test: Can Innovation Solve Rural America's Maternal Health Crisis?

September 14, 2026 | Blog | By Traci L. Vitek, Daniel Cody

Can FemTech help solve rural America’s maternal health crisis? Explore innovations, policy barriers, reimbursement, telehealth and access gaps.

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Learn how OPTN modernization, CMS OPO reforms, and new transplant policies will impact donor hospitals, transplant centers, compliance, and planning.

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HRSA revives its 340B rebate pilot as the SUSTAIN 340B Act challenges the model, forcing health systems to prepare for three reform paths.
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AI: The Washington Report — August 2026 Edition

August 7, 2026 | Article | By Alexander Hecht, Traci L. Vitek, Erek Barron, John McEachern

A comprehensive review of July 2026 AI policy actions, including GOLD EAGLE cybersecurity efforts, FTC AI guidance, congressional proposals, clinical AI benchmarking, and state AI legislation.

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Women's Health at a Turning Point: What Federal Policy Changes Mean for the FemTech Industry

August 4, 2026 | Blog | By Traci L. Vitek, Theresa Carnegie, Karen Lovitch, Daniel Cody

For decades women's health has too often been treated as a narrow policy category, despite affecting roughly half the population. That is changing. There is now an emerging category of medicine built around regulated software, biomarker-based decision-making, and new regulatory and reimbursement pathways. FemTech now spans menstrual health, fertility, pregnancy and postpartum care, pelvic and sexual health, menopause, contraception, and conditions that affect women differently or disproportionately. 

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On June 25, 2026, Senate HELP Committee Chairman Bill Cassidy (R-LA) released a sweeping legislative discussion draft titled the 340B Drug Pricing Integrity and Affordability for Patients Act. This proposal represents the most significant proposed overhaul of the 340B Drug Pricing Program in more than 15 years—and if enacted, it would have profound implications for every hospital, health system, and safety-net provider currently participating in the program.

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Recognition & Awards

  • Five HHS OIG Exceptional Achievement Awards (2012 – 2017)

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