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A Pivotal Week for Pharmaceutical Policy: Trump Administration Advances Tariff and Drug Pricing Initiatives
October 7, 2025 | Blog | By Theresa Carnegie, Stephnie John, Hassan Shaikh, Attiya S. Khan, Grace Callander, Sneha Shenoy
The first week of October 2025 marked a significant shift in U.S. drug pricing policy as the Trump administration unveiled a series of sweeping actions to deliver on his promise to lower drug prices. From President Trump’s announcement of a 100% tariff on imported branded drugs to the Trump administration’s landmark pricing deal with Pfizer and the rollout of the TrumpRx.gov direct-to-consumer (DTC) platform, last week marked an escalation in the White House’s efforts to drive down prescription drug costs and bring pharmaceutical manufacturing back to U.S. soil. Below, we provide an overview of the Trump administration’s new policies and the stakeholder responses already reshaping the broader pharmaceutical landscape.
Beyond the Clinical Setting: OCR’s Settlement with Cadia Further Demonstrates OCR’s Focus on HIPAA Compliance in the Digital World
October 6, 2025 | Blog | By Kate Stewart, Cassandra Paolillo, Madison Castle
On September 30th, 2025, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Cadia Healthcare Facilities for potential violations of the HIPAA Privacy and Breach Notification Rules. Cadia Healthcare Facilities (Cadia) is a group of five providers that specialize in rehabilitation, skilled nursing, and long-term care services in Delaware. This settlement follows an OCR investigation of Cadia in which Cadia posted a “success story” of a patient to its public website without first receiving a valid HIPAA authorization from the patient. The success story post included PHI such as the patient’s name, their photograph, and information regarding their condition, treatment, and recovery. OCR’s investigation further revealed that, through their “success story” program, Cadia compromised the PHI of 150 total patients.
The RADV Odyssey: Extrapolation Vacated
October 1, 2025 | Blog | By Tara E. Dwyer
Telehealth Update: We’re Going to Need Congressional Approval
September 25, 2025 | Blog | By Cassandra Paolillo, Kate Stewart, Daniel Cody, Stephnie John, Madison Castle
As we’ve covered again and again over the past five years, providers are once more facing the prospect of a telehealth “cliff” if Congress does not take action to extend the Medicare flexibilities for telehealth services that have been in place since March of 2020. While news is focused on the pending government shutdown, providers and Medicare beneficiaries who have come to rely on the COVID-era waivers and other flexibilities that greatly increased the availability of telehealth are facing the prospect of significantly reduced access to virtual care as of October 1, 2025. Here is a quick review of what telehealth providers and their patients stand to lose if Congress does not act to extend coverage:
Summer Roundup: OIG Issues Multiple Advisory Opinions Relevant to Manufacturers
September 23, 2025 | Blog | By Rachel Yount
Over the 2025 summer, the Department of Health and Human Services’ Office of Inspector General (OIG) issued four advisory opinions—two favorable and two unfavorable—that provide valuable guidance for medical device companies and pharmaceutical manufacturers navigating the federal Anti-Kickback Statute (AKS). These opinions address warranty reimbursements, vendor access fees, physician ownership, and exclusion screening costs. Below is a summary of each.
FDA in Flux — September 2025 Newsletter
September 17, 2025 | Article | By Joanne Hawana, Benjamin Zegarelli
The September 2025 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.
Mintz IRA Update — 340B Roundup: Senate HELP Committee’s Long-Awaited 340B Report Highlights Ongoing Problems but Provides Few Solutions
September 15, 2025 | Article | By Lauren Moldawer, Xavier Hardy, Abdie Santiago, Jordyn Flaherty
Senate HELP Committee releases 340B report urging transparency, oversight, and reforms amid uncertainty over future federal legislative action.
Mintz IRA Update — Redesigning Part D for CY 2026
September 15, 2025 | Article | By Tara E. Dwyer, Samantha Hawkins
CMS finalizes 2026 Medicare Part D changes under the IRA, including new cost limits, subsidy guidance, and updated creditable coverage rules.
Mintz IRA Update — PhRMA’s 2025 Policy Agenda and the Industry’s Crossroads with the IRA and Drug Pricing Reform
September 15, 2025 | Article | By Theresa Carnegie, Hassan Shaikh
PhRMA’s 2025 agenda pushes back on drug pricing reforms, calling for innovation-friendly policies, 340B reform, and PBM accountability.
Mintz IRA Update — The Uncertain State of Affairs for GLP-1s
September 15, 2025 | Article | By Theresa Carnegie, Hassan Shaikh, Samantha Hawkins
GLP-1 receptor agonists (GLP-1s) such as semaglutide, and dual agonists like tirzepatide, are transforming obesity treatment and reshaping the US health care landscape.
Mintz IRA Update — 340B Roundup: HRSA Launches 340B Rebate Model Pilot Program Amid Ongoing Legal and Regulatory Shifts
September 15, 2025 | Article | By Lauren Moldawer, Xavier Hardy, Abdie Santiago, Jordyn Flaherty
HRSA launches 340B rebate pilot tied to Medicare drug negotiations, signaling major program shifts amid legal rulings and stakeholder concerns.
Mintz IRA Update — IRA Medicare Drug Price Negotiation Program Updates for Q3 2025
September 15, 2025 | Article | By Rachel A. Alexander, Stephnie John, Samantha Hawkins, Hassan Shaikh
On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for the third cycle of the IRA’s Medicare Drug Price Negotiation Program (Negotiation Program).
Mintz IRA Update — Under Pressure: The Trump Administration’s Drug Pricing Executive Orders
September 15, 2025 | Article | By Theresa Carnegie, Xavier Hardy, Hassan Shaikh, Abdie Santiago
President Trump issues executive orders and letters to curb drug costs, promote MFN pricing, and reform Medicare’s Negotiation Program.
Mintz IRA Update — Disrupting the Pharmaceutical Supply Chain: The Era of the DTC Model
September 15, 2025 | Article | By Theresa Carnegie, Stephnie John
While the pharmaceutical industry has reacted negatively to President Trump’s May 12 “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order), manufacturers appear to be leveraging one of Trump’s directives in the Executive Order, accelerating the industry’s shift toward a new model of drug delivery: direct-to-consumer (DTC) programs.
Mintz IRA Update — 340B Roundup: CMS Proposes Steeper OPPS Clawbacks, Launches Drug Cost Survey with Public Comment
September 15, 2025 | Article | By Lauren Moldawer, Xavier Hardy, Abdie Santiago, Jordyn Flaherty
CMS proposes OPPS payment cuts and a drug cost survey, signaling major 340B reimbursement shifts and renewed scrutiny of hospital payment rates.
Mintz IRA Update — Still Undefeated: Government Notches Three More Victories in Negotiation Program Lawsuits
September 15, 2025 | Article | By Theresa Carnegie, Mitchell Clough, Xavier Hardy, Hassan Shaikh
Federal courts continue to uphold the Medicare Drug Price Negotiation Program, with multiple rulings emphasizing the voluntary nature of manufacturer participation. Key legal challenges from AstraZeneca, Boehringer Ingelheim, PhRMA, and others face setbacks as the government remains undefeated.
Mintz IRA Update — 340B Roundup: States and Manufacturers Continue to Battle over 340B Contract Pharmacies
September 15, 2025 | Article | By Lauren Moldawer, Xavier Hardy, Abdie Santiago, Jordyn Flaherty
States and manufacturers clash over 340B contract pharmacy laws as litigation mounts and courts weigh in on the future of pharmacy access protections.
Mintz IRA Update — Medicare Part B Physician Fee Schedule Guidance and Its Potential Implications for Medicare Part D
September 15, 2025 | Article | By Theresa Carnegie, Tara E. Dwyer, Rachel Yount, Hassan Shaikh
The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare Part B drugs.
OCR Releases New HIPAA Security Risk Assessment Tool
September 10, 2025 | Blog | By Kate Stewart, Cassandra Paolillo
In a move that underscores the growing urgency around healthcare cybersecurity, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has released version 3.6 of its Security Risk Assessment (SRA) Tool. The SRA Tool is a free resource designed to help covered entities and business associates conduct HIPAA-compliant risk assessments. It is particularly focused on small and medium providers and can be a useful tool for any smaller entity subject to HIPAA. Non-provider entities, including business associates, may need to make modifications to the tool to fit their operations and security infrastructure.
Recent Criminal Convictions Highlight Risks in Offering Gift Cards to Patients
September 9, 2025 | Blog | By Rachel Yount
In a cautionary tale for health care entities, the U.S. Attorney’s Office for the Eastern District of North Carolina recently announced the convictions of two health care executives who admitted to orchestrating a multi-year kickback scheme involving the use of gift cards to incentivize Medicaid patients to attend counseling sessions and submit urine drug tests. Although the Department of Health and Human Services’ Office of Inspector General (OIG) has issued multiple Advisory Opinions green-lighting other programs that include gift card distributions, these convictions underscore the importance of structuring patient incentives in strict accordance with OIG guidance.
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