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Bass, Berry & Sims
On May 9, the Department of Justice's (DOJ) Antitrust Division announced the creation of a new task force, the Task Force on Health Care Monopolies and Collusion (HCMC), focusing on antitrust enforcement...
Barnes & Thornburg
In this episode of AHLA's Speaking of Health Law podcast, John E. Kelly, Partner, Barnes & Thornburg LLP, and Kim H. Looney, Partner, K&L Gates LLP, discuss the current dynamics...
Davis Wright Tremaine
Aetna recently announced that it is rolling out a national protocol under which it will be reviewing both physician and hospital emergency department claims that include Level 4 or 5 evaluation ...
Ankura Consulting Group LLC
In the latest episode of the Ankura podcast, Michelle Mader, Ankura Healthcare Strategy expert, and Ray Anderson, Chief Strategy Officer of Trinity Health offer their insight...
Arnold & Porter
The Federal Trade Commission (FTC) recently announced a proposed order settling charges that online alcohol addiction treatment service provider Monument, Inc. deceived users of its services...
Arnold & Porter
Life Sciences & Healthcare Regulatory practice co-chair Mahnu Davar was quoted in the Bloomberg Law article, "FDA Lab Test Authority Set for Compliance Hurdles, Legal Fights." The article discusses the U.S. Food...
Winston & Strawn LLP
The IRS recently released Rev. Proc. 2024-25, which provides the inflation-adjusted limits related to health savings accounts, high deductible health plans, and excepted benefit health reimbursement ...
Arnold & Porter
In our blog post on 22 February 2024 we reported on the Medicines and Healthcare products Regulatory Agency (MHRA) announcement that it intended to launch a regulatory sandbox for software and AI medical devices called the "AI-Airlock".
Manatt, Phelps & Phillips LLP
On May 8, the House Committee on Ways and Means (W&M) held a markup to consider six health-related bills. All of the bills were reported favorably out of the committee.
Arnold & Porter
On May 6, 2024, the FDA published its highly anticipated final rule, which was formally published in the Federal Register on May 6, revising the regulatory definition of an IVD product to explicitly capture IVDs manufactured by laboratories.
Crowell & Moring LLP
On April 26, 2024, the Federal Trade Commission ("FTC") announced a final rule ("Final Rule") modifying the Health Breach Notification Rule
On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR) Program (2024 Final Rule).
K&L Gates
On 16 February 2024, the Supreme Court of Alabama published its opinion, "Supreme Court of Alabama, SC-2022-0515,"1 regarding whether embryos located outside the biological uterus...
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
Foley & Lardner
Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site...
Venable LLP
Employer group health plans must make an annual disclosure of the plan's prescription drug and healthcare spending to the Centers for Medicare & Medicaid Services (CMS).
Pierson Ferdinand
If your business provides a self-funded health insurance plan to its employees, that health plan covers "medically necessary" services, and you're not keen on defending sex discrimination claims...
Manatt, Phelps & Phillips LLP
As artificial intelligence (AI) continues to permeate the health care industry (and every other part of American life), the industry should be attentive to the risk of anticompetitive...
Dickinson Wright PLLC
Dickinson Wright attorney Kim Ruppel recently participated in The Risky Health Care Business Podcast...
Goodwin Procter LLP
As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz's denosumab biosimilars of Amgen's PROLIA and XGEVA...
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