News & Analysis as of

Medicaid Life Sciences Pharmaceutical Industry

Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with... more +
Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with children.  less -
Bass, Berry & Sims PLC

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

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On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

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Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Alston & Bird

Health Care Week in Review: HHS Finalizes Rule Prohibiting Disability Discrimination; FDA Finalizes LDT Rule; Senate Finance...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: CMS Finalizes Rules on Nursing Home Staffing Standards and Medicaid Access and Quality; FTC Bans Most...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas...more

Quarles & Brady LLP

The Lower Costs More Transparency Act of 2023

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The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more

McDermott Will & Emery

Trending in Telehealth: November 8 – 14, 2023

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Manatt, Phelps & Phillips, LLP

Accessing Cell and Gene Therapies: Insights on Coverage, Reimbursement and Emerging Models

Editor’s Note: In a new white paper, summarized below, Manatt Health discusses emerging reimbursement models for cell and gene therapies. The paper provides an overview of current Medicaid, Medicare and commercial coverage,...more

Manatt, Phelps & Phillips, LLP

Accessing Cell and Gene Therapies : Insights on Coverage, Reimbursement and Emerging Models

Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q3 2023 and Beyond

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As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - November 2022 #2

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Health Reform and Midterm Results: In the wake of the midterm elections, leadership changes of key committees are underway. Commentators note that while both parties may agree on problems in the pharmaceutical and healthcare...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

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2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - September 2022

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Inflation Reduction Act: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022. Republican leaders on the House Energy & Commerce and...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - July 2022

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Latham’s Government Price Reporting Team covers general developments, the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, Medicare Part B, and state law developments. Drug Pricing Initiatives: Congress and...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2022 #2

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Drug Pricing Initiatives: Congress and stakeholders continue to discuss drug pricing reform measures, including those that were originally part of H.R. 5376 (the Build Back Better Act, or BBBA). In a related development,...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2022

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2022 Medicaid & Government Pricing Congress Concludes: The annual Medicaid & Government Pricing Congress took place in Philadelphia from May 23-25 and virtually from June 1-2. On May 25, Latham partner Christopher H. Schott...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2022 #2

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Drug Pricing Initiatives: Discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the Build Back Better Act, or BBBA). ...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - April 2022

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Biden Administration Releases FY 2023 Budget - The Biden Administration’s proposed Budget of the U.S. Government for FY 2023 (see also the accompanying fact sheet) includes proposals relevant to drug manufacturers....more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - March 2022 #2

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Drug Pricing Initiatives: Senators and stakeholders continue to discuss some of the drug price reform measures that were originally part of H.R. 5376 (the Build Back Better Act, or BBBA), such as imposing price caps on...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - February 2022

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Drug Pricing Initiatives: Discussion continues regarding pathways to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA). Potential approaches include a reduced or modified version of the BBBA, although details...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - January 2022 #3

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Drug Pricing Initiatives: The pathway to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA) remains unclear. President Biden has suggested splitting up the BBBA and individually passing those provisions that...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - January 2022 #2

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340B PROGRAM - Further State Legislation Seeks to Regulate PBMs in Relation to 340B: Florida, Kentucky, Missouri, Nebraska, and New Hampshire recently introduced legislation aiming to regulate pharmacy benefit managers...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - January 2022

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Drug Pricing Initiatives: The pathway to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA) is unclear, following Senator Joe Manchin’s withdrawal of his support for the measure. The BBBA is an approximately...more

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