News & Analysis as of

Life Sciences Medicare Medicaid

Alston & Bird

Health Care Week in Review: Congress Passed a Continuing Resolution (CR); CMS Released Guidance on Coverage Requirements for...

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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

Fenwick & West LLP

Update on the BioSecure Act

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The BioSecure Act is a bipartisan bill introduced in both the U.S. House of Representatives and Senate earlier this year that would effectively stop companies that are doing business with the U.S. government from using...more

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

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

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 187: South Carolina Hospitals and Healthcare Industry...

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For episode 187, Heather and Matthew welcome back a favorite recurring guest of the show, Thornton Kirby, President of the South Carolina Hospital Association. Thornton shares exciting updates on recent SCHA initiatives,...more

Whiteford

New CMS Guidance on Use of Algorithms and AI in Prior Authorizations and Utilization Management

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Use of algorithms and artificial intelligence (AI) in prior authorization and utilization management is facing growing criticism and litigation. Notable lawsuits include alleged automatic authorization denials for tests that...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

Alston & Bird

Health Care Week In Review: HRSA Releases List of Health Professional Shortage Areas, Biden Bolsters HHS Authority to Address Drug...

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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

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

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

Mintz - Health Care Viewpoints

OIG Issues Favorable Advisory Opinion on Gift Cards to Incentivize Patients to Return Samples for At-Home Colorectal Cancer...

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more

Fenwick & West Life Sciences Group

A Complex Regulatory Landscape Emerges for Telemedicine

Every year, Rock Health surveys the digital health landscape, noting the changing trends related to adoption by providers, patients and payers of these innovative new technologies....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

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

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Drug Pricing Initiatives: The Senate is expected to vote on a revised version of H.R. 5376 (the Build Back Better Act, or BBBA), now styled as the Inflation Reduction Act of 2022 (IRA). The House originally passed H.R. 5376...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 - 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 - May 2022

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Drug Pricing Initiatives: In advance of the midterm elections in November, discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the...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

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - November 2021

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Drug Pricing Initiatives: Late on Nov. 5, 2021, the House of Representatives passed H.R. 3684 (the Infrastructure Investment and Jobs Act). This $1 trillion infrastructure bill, which was passed earlier by the Senate, is part...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - October 2021 #2

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2021 Medicaid Drug Rebate Program Conference Concludes: The conference took place in New Brunswick, N.J., Oct. 11-13 and virtually Oct. 18-20. Christopher H. Schott spoke in person as part of the “Fireside Chat: External...more

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