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Food and Drug Administration (FDA) Pharmaceutical Industry Medicaid

Alston & Bird

Health Care Week in Review: House Energy & Commerce Committee Held a Markup of 16 Bills; HRSA Demands Johnson & Johnson Cease 340B...

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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 Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor...

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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: Biden Administration Announces $100 Million for ACA Marketplace Navigators and $81.3 Million 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

Alston & Bird

Health Care Week in Review: CMS Finalizes the TCET Pathway for Breakthrough Technologies; HRSA Awards Health Centers Funding 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

Alston & Bird

Health Care Week in Review: CMS Finalizes FY 2025 Payment Rules for Inpatient Hospitals, Inpatient Rehab Facilities, Inpatient...

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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 Releases Final Medicare Prescription Payment Plan Part 2 Guidance

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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

ArentFox Schiff

The 2025 Proposed Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need...

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Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more

Alston & Bird

Health Care Week in Review: Senate Democrats Released Draft Legislation to Prevent Labor and Delivery Unit Closures; CMS Announced...

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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: House Held Oversight Hearing on the 340B Program and HHS Expanded Certified Community Behavioral...

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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

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

Alston & Bird

Health Care Week in Review: CMS Issues Rules on FY 2025 Payment Rates; Medicaid Enrollment; and Short-Term, Limited Duration...

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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: Biden Administration Released FY2025 Budget; Bill Introduced to Make Telehealth Permanent

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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

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: CMS Finalizes Medicaid DSH Rule and House Launches Bipartisan AI Task Force

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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

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #2

This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more

Alston & Bird

Health Care Week In Review: House Passes the SUPPORT Act and Lower Cost, More Transparency Act, HHS Releases Final Rule on Health...

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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: House E&C Committee Held Mark-Up of 44 Bills, Biden Administration Announced Actions to Lower...

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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

Troutman Pepper

Navigating the Future of Pharmacy Law: Key Takeaways From the 2023 American Society of Pharmacy Law Conference

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Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more

McGuireWoods Consulting

Washington Healthcare Update - November 2023 #3

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This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth...more

ArentFox Schiff

Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies

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Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more

Alston & Bird

Health Care Week in Review: New House Speaker Elected; HRSA Issued a Notice on 340B Drug Pricing Program Requirements

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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 Releases Updates on Center for Medicare and Medicaid Innovation Center (CMMI) Initiatives to...

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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

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