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Life Sciences Centers for Medicare & Medicaid Services (CMS) Medicaid

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

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

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

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

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

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

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 - 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 - 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

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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 - September 2021 #2

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Drug Pricing Initiatives: Democrats are continuing to debate the reconciliation package that contains many of President Biden’s domestic policy initiatives, including with respect to drug pricing. The budget reconciliation...more

Latham & Watkins LLP

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

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$1 Trillion Infrastructure Bill Includes Two Drug Pricing Provisions: On Aug. 10, 2021, the Senate passed H.R. 3684, the Investing in a New Vision for the Environment and Surface Transportation in America Act, or the INVEST...more

Latham & Watkins LLP

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

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CMS Releases Proposed Physician Fee Schedule for 2022: On July 13, 2021, the Centers for Medicare and Medicaid Services (CMS) released the proposed Physician Fee Schedule (PFS) for 2022 (link). Among other issues, the PFS...more

Latham & Watkins LLP

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

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Supreme Court Upholds Affordable Care Act: On June 17, 2021, the Supreme Court ruled 7 to 2 to dismiss for lack of standing a challenge to the Affordable Care Act (ACA) brought by Texas and other states. The states had...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021

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Biden Releases Federal Budget Proposal for 2022: On May 28, 2021, President Biden released the proposed budget for fiscal year 2022, which would increase health spending by 23%. The proposal urges Congress to enact drug...more

Sheppard Mullin Richter & Hampton LLP

Day 3 Notes at the 2020 J.P. Morgan Healthcare Conference

CMI, CMMI, and Changing the Consumer Experience in the U.S. and China - Case Mix Index: Sitting in multiple hospital, payor and physician organization presentations at the J.P. Morgan healthcare conference this year, it is...more

King & Spalding

Congress Acts to Eliminate MDRP Misclassification

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President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more

McDermott Will & Emery

Administration Offers Up New Proposals to Cut Drug Costs

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On November 26, CMS released a notice of proposed rulemaking, “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses,” which includes provisions that aim to reduce overall drug...more

McDermott Will & Emery

CMS Requests Comment on Potential International Pricing Index Model for Part B Drugs

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On October 25, 2018, the Centers for Medicare and Medicaid Services (CMS) announced an Advance Notice of Proposed Rulemaking with Comment (ANPRM) proposing to implement an international pricing index (IPI) model for Medicare...more

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

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