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Mental Health Parity Under the Trump Administration: Where DOL Is Headed and What Congress Is Doing About It
October 14, 2026| Blog
Analysis of Trump-era mental health parity enforcement, DOL's narrowed MHPAEA focus, pending litigation, and bipartisan congressional action.
Departments Finalize Transparency in Coverage Rules: What Health Plans and Issuers Need to Know
October 13, 2026| Blog
On October 5, 2026, the Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) announced changes to the Transparency in Coverage (TIC) final rules, overhauling the 2020 regulatory framework for group health plans and health insurance issuers. The changes aim to standardize the TIC machine-readable files (MRFs) for greater accuracy and accessibility. The rules take effect December 7, 2026, with requirements phased in through July 2028.
340B Rebate Pilot — The Clock Starts NowTen Plans, 18 Drugs, One Deadline
October 7, 2026| Blog
HRSA’s 340B rebate pilot starts Jan. 1, 2027. Learn the approved plans, litigation risks, and readiness steps for health systems.
Banning Corporate Medicine: The Costs Congress Isn't Pricing In
October 5, 2026| Blog
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.
The 340B Squeeze: Academic Medical Centers and Large Health Systems Have the Most to Lose
September 28, 2026| Blog
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.
FemTech's Real Test: Can Innovation Solve Rural America's Maternal Health Crisis?
September 14, 2026| Blog
Can FemTech help solve rural America’s maternal health crisis? Explore innovations, policy barriers, reimbursement, telehealth and access gaps.
The OPO Rule and Your Hospital's Business ModelWhat Transplant and Donor Hospitals Need to Know as CMS Finalizes the Organ Procurement Organization Rule
August 18, 2026| Article
Learn how OPTN modernization, CMS OPO reforms, and new transplant policies will impact donor hospitals, transplant centers, compliance, and planning.
340B Rebates 2.0HRSA Revives Its Pilot Program — and Sets Up a Collision Course With Congress
August 17, 2026| Blog
HRSA revives its 340B rebate pilot as the SUSTAIN 340B Act challenges the model, forcing health systems to prepare for three reform paths.
Women's Health at a Turning Point: What Federal Policy Changes Mean for the FemTech Industry
August 4, 2026| Blog
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.
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.
2026 US Health Care Policy Outlook: Affordability Pressures, TrumpRx, and ACA Uncertainty
February 5, 2026| Article
2026 U.S. health policy outlook exploring affordability pressures, TrumpRx, ACA uncertainty, drug pricing reforms, and key Medicare–Medicaid extender changes.
Health Law Diagnosed – The 2024 Election and Health Care Policy
January 22, 2025| Podcast
Host Of Counsel Bridgette Keller is joined by Alex Hecht, ML Strategies Executive Vice President & Director of Operations, Washington, DC, as they dive into potential health care policy changes on the horizon following the 2024 election and what stakeholders can expect in 2025.
Crunch Time for BIOSECURE Act
December 3, 2024| Alert
Read about the BIOSECURE Act, its legislative path, and the broader context of critical end-of-year negotiations shaping the priorities of the 118th Congress.
PBM Policy and Legislative Update — Fall 2024
November 22, 2024| Article
Building upon prior issues and summarizing activity from July through September, the Fall 2024 PBM Update highlights federal legislative activity and oversight, state legislative activity and oversight, and other noteworthy events and trends affecting the PBM industry.
Congress Intensifies Tampon Safety Efforts and FDA Takes Steps to Respond
September 25, 2024| Blog
In its August 2024 issue, the journal Environmental International published an article called Tampons as a Source of Exposure to Metal(loid)s. The article reports on the results of a recent study by researchers from Columbia, UC Berkeley, and Michigan State that evaluated the presence of metals in different tampons. The research team evaluated 60 samples of tampons, representing 30 unique products from 24 different brands, for the presence of 16 different metals. The researchers found that all the tampons evaluated contained measurable concentrations of each of the 16 metals, including toxic metals such as lead, arsenic, and zinc.
2024 Pre-Election Analysis: Health Care Issues
August 26, 2024| Advisory
Read about different health care priorities that may be pursued by the presidential candidates Donald Trump and Kamala Harris in the latest edition of our 2024 Pre-Election Analysis series on how the November 2024 election will impact the legislative and regulatory landscape.
CMS Issues Final Notice on Program for Breakthrough Device Reimbursement but Industry Looks to Congress for More Inclusive Solution
August 19, 2024| Blog
CMS’s failure to address stakeholder proposals to modify the TCET program has increased interest and advocacy around Congress’s consideration of the Ensuring Patient Access to Critical Breakthrough Products Act. We explore both the shortcomings of the TCET pathway and the possible legislative solutions to its perceived gaps below.
Washington Shake-Up: Vice President Harris to Lead Democratic Nomination for 2024 Presidency
July 25, 2024| Alert
Read about President Biden’s recent withdrawal from the 2024 presidential election and his endorsement of Vice President Kamala Harris as the Democratic nominee, including her stance on technology, climate change, health care, and tax policy.
New Biden Executive Order Emphasizes Women’s Health
March 27, 2024| Alert
On March 18, President Biden signed an executive order (EO) that contributes to the administration’s objective to create solutions to long-lasting women’s health issues that have been historically understudied and under-evaluated.
FTC Hosts Panel and Launches Public Inquiry with DOJ and HHS on Private Equity and Health Care
March 6, 2024| Alert
Read about the FTC’s March 5, 2024 workshop on private equity (PE) investments in the health care industry and a joint request for information on the effects of PE transactions in the health care industry issued by the FTC, DOJ, and HHS.
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