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Patient Access

Quarles & Brady LLP

Massachusetts Law Permitting Pharmacies and Pharmaceutical Manufacturers to Offer Drug Discounts to Consumers Extended to January...

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The Massachusetts law permitting pharmacies and pharmaceutical manufacturers to offer drug discounts to consumers, which was set to expire on January 1, 2026, has recently been extended to January 1, 2031....more

Morgan Lewis

US Administration Ups the Ante for Gender-Affirming Care Providers With Legislative Proposal

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The US Department of Justice has proposed legislation to the US Congress that would, if enacted, create a private right of action against healthcare professionals who provide gender-affirming care to children. The proposal...more

Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

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The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more

Rivkin Radler LLP

NY Insurer Fined $250,000 for Mental Health “Ghost Network”

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The New York Attorney General’s office recently announced an agreement with MVP Health Care under which the insurer will pay $250,000 in penalties, fees, and costs to the state for maintaining an inaccurate mental health...more

Cozen O'Connor

NY AG Puts Mental Health Ghost Network to Rest

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New York AG Letitia James has announced an agreement with MVP Health Plan (MVP) following an investigation that found systemic problems with the insurer’s mental health provider network. The investigation revealed that MVP’s...more

Jones Day

Bill Seeks to Restrict 30-Month Stay in Hatch-Waxman Litigation to One Patent

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Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 248: Fighting Addiction and Expanding Access to...

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This week on the podcast, Lynnsey and Lauren are joined by Sara Howe and Morgan Coyner of Addiction Professionals of North Carolina (APNC) for a powerful conversation about substance use treatment, patient brokering, and the...more

McDermott Will & Schulte

New Illinois law updates physical therapy standards for telehealth providers

On August 15, 2025, Illinois enacted Senate Bill (SB) 2153, which became effective on the date of signature. The legislation amends the Illinois Physical Therapy Act to remove various provisions that previously limited the...more

King & Spalding

White House and CMS Announce Health Technology Ecosystem Initiative

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On July 30, 2025, CMS issued a press release announcing its Health Tech Ecosystem initiative, a voluntary, patient-centric initiative aimed at utilizing technology to improve the patient experience. The main goals of the...more

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

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On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

Jones Day

HHS Pilot Program to Evaluate 340B Drug Pricing Program Rebate Models

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The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more

Benesch

Dialysis & Nephrology Digest - August 2025

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An investigation highlighted concerns about for-profit dialysis clinics in the U.S., which are linked to worse patient outcomes and reduced transplant access. DaVita and Fresenius, controlling over 60% of dialysis centers,...more

Carlton Fields

Agency Actions, Trade Deals, and Other Initiatives to Further Executive Order Goals for the Pharma Industry

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The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more

Quarles & Brady LLP

Risks and Regulations with the Use of AI in Behavioral Health

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As some studies estimate that nearly 23% of the adult population lives with a mental illness, the integration of artificial intelligence (AI) into mental health care has transformative potential in terms of accessibility,...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Wilson Sonsini Goodrich & Rosati

CMS Announces Creation of Health Tech Ecosystem for Improving Access to Patient Data

During a “Make Health Tech Great Again” event on July 30, 2025 at the White House, the Centers for Medicare & Medicaid Services (CMS) announced its intent to create a digital health ecosystem, in partnership with private...more

Troutman Pepper Locke

Second FTC and DOJ Listening Session Focuses on Formulary and Benefit Practices and Regulatory Abuse in the Pharmaceutical...

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On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more

Quarles & Brady LLP

A Prescription for Caution: Senators Release Investigative Report on Direct-To-Consumer Telehealth Models

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On July 17, the offices of Senators Durbin (D. IL.), Warren (D. MA.), Sanders (I. VT.), and Welch (D. VT.) (collectively, “Senators”) released a report summarizing the results of a nine month investigation into...more

Troutman Pepper Locke

Congressional Briefing Highlights Growing Bipartisan Consensus on the Need for Federal Clarity in Hemp-Derived Cannabinoid...

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On July 17, the U.S. House Committee on Agriculture hosted a closed-door roundtable briefing focused on the regulatory gray areas surrounding hemp-derived cannabinoid products. The session, convened in response to ongoing...more

Pullman & Comley - Connecticut Health Law

A Progress Report on Psychedelic Drug Legislation in Connecticut and Nearby States

The burgeoning field of psychedelic medicine, which suffered a major setback last year when the Food and Drug Administration (FDA) rejected an application to approve the use of midomafetamine (MDMA) to treat post-traumatic...more

Jones Day

CMS Updates Kidney Care Choices Model

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The Center for Medicare and Medicaid Innovation ("CMMI") announced sweeping changes to the Kidney Care Choices Model ("KCC Model"), a key set of value-based programs....more

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

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On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

Seyfarth Shaw LLP

SCOTUS on ACA Challenge: Seriously Guys, We’re Doing This Again?

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In a closely watched decision, the Supreme Court has upheld the authority of the U.S. Preventive Services Task Force (Task Force), preserving the Affordable Care Act’s (ACA) requirement that health plans cover preventive...more

Troutman Pepper Locke

Virginia's Protection of Reproductive Health Information Law – Part One, Scope, Applicability, and Penalties

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In Part One of this FAQ series, we break down Virginia's Senate Bill 754, Consumer Protection Act; prohibited practices, etc., reproductive or sexual health information (Act), which amends the Virginia Consumer Protection Act...more

Troutman Pepper Locke

U.S. Supreme Court Holds Medicaid’s Any-Qualified-Provider Provision Does Not Confer Enforceable Rights

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The U.S. Supreme Court, in a 6-3 decision, ruled that the Medicaid Act’s any-qualified-provider provision does not confer individual rights enforceable under 42 U.S.C. §1983. This decision reverses the Fourth Circuit’s...more

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