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Healthcare Patient Access

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

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

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

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

Quarles & Brady LLP

HIPAA Reproductive Health Rule Vacated Nationally

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A federal judge in Texas has vacated almost all of the 2024 HIPAA Rule to Support Reproductive Health Care Privacy that created special protections for reproductive health care information, finding that the U.S. Department of...more

Seyfarth Shaw LLP

Time to Revisit Your HIPAA Documents After Reproductive Health Privacy Rule Vacated

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In the wake of a recent federal District Court decision, the reproductive health care HIPAA Privacy rules finalized during the Biden Administration have been vacated and plan sponsors should re-evaluate the language included...more

Seyfarth Shaw LLP

Supreme Court Upholds Tennessee Transgender Care Ban

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In a widely awaited for decision, the Supreme Court in a 6-3 opinion authored by Justice Roberts held that a Tennessee law which prohibits certain medical treatments (puberty blockers and hormones) for transgender minors,...more

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Jones Day

Medicare's Innovation Center Charts New Direction: Part 2 – Digital Health and AI

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the second of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding digital...more

Seyfarth Shaw LLP

States Seeking Remedies for the Rising Costs of Prescription Drugs

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As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney...

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In this powerful episode, hosts Heather and Matthew are joined by Sydney Severance, a young woman and former competitive athlete whose life changed dramatically when she unexpectedly became wheelchair-bound. After a...more

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

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Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Hinshaw & Culbertson - Health Care

OIG Advisory Opinion 25-02 Integrates Community Health Center Social Support Services with Primary Care Referral Programs

The U.S. Department of Health and Human Services (HHS) Office of Inspector General ("OIG") issued Advisory Opinion No. 25-02 ("Opinion") on April 4, 2025, regarding a Health Center proposal to link social support services to...more

Quarles & Brady LLP

Departments Will Not Enforce 2024 Final Rule under MHPAEA

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The Trump Administration has just announced that it will pause enforcement of the September 2024 final rule (“Final Rule”) under the Mental Health Parity and Addiction Equity Act (“MHPAEA”)....more

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