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Medicaid › Medicare Part D › Food and Drug Administration (FDA)

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 -
McDermott+

McDermott+ Check-Up: September 20, 2024

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Senate Judiciary Human Rights and the Law Subcommittee Holds Hearing on Georgia Abortion Ban. The field hearing examined how Georgia’s abortion ban impacts women’s health, and featured patient and physician witnesses. ...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: CMS Finalizes Rules for Medicare Advantage, Part D, and Affordable Care Act (ACA) Marketplaces

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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

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

Foley Hoag LLP

HHS Issues Report Outlining Three New Drug Models for Testing by CMMI

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On February 14, 2023, and in response to Executive Order 14087 (“Lowering Prescription Drug Costs for Americans”), the Secretary of Health and Human Services (HHS) issued a report announcing the selection of three models that...more

Goodwin

U.S. Senate Passes Significant Drug Pricing Reform in the Inflation Reduction Act of 2022

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​​​​​​​On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more

Hogan Lovells

Demy-Colton panel explains importance of U.S. market access planning ahead of Phase III trials

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Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms, providing companies that are new to the U.S. market, or looking to launch in the...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2021 #2

Alston & Bird on

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

McGuireWoods Consulting

Washington Healthcare Update - February 2020 #3

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This week in Washington: The House and Senate will be in recess the week of Feb. 17 in observation of Presidents Day....more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

BakerHostetler

Capitol Hill Healthcare Update

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Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: shutdown risk increases as talks stall; Gottlieb’s Hill testimony postponed; more bills...more

BakerHostetler

Capitol Hill Healthcare Update

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Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: With the shutdown over (for now), the FDA is back in business; two hearings spotlight drug...more

BakerHostetler

Capitol Hill Healthcare Update

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Highlights this week: Gottlieb warns FDA’s funds running low as shutdown continues; House Dems launch sweeping probe on drug prices, Senate approves Medicaid measures, and more....more

Holland & Knight LLP

Healthcare Law Update: May 2018

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Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Drug Pricing Blueprint: Overview and Analysis

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• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more

BakerHostetler

Capitol Hill Healthcare Update

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CONGRESS WORKS TO PASS BUDGET BEFORE FRIDAY’S SHUTDOWN DEADLINE - House leaders are pushing to schedule a vote this week on a $1.3 trillion budget agreement that would give the Senate enough time to pass it before a Friday...more

Baker Donelson

President's Budget on Health Care: Entitlement Reform, Opioid Funding, and Cuts to Health Programs

Baker Donelson on

Note: All fiscal estimates cited over a ten-year budget window refer to the Fiscal Year 2019-2028 budget window. The President's fiscal year 2019 (FY19) budget proposal for the Department of Health and Human Services (HHS)...more

Holland & Knight LLP

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

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The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

Holland & Knight LLP

White House Unveils Proposal on Drug Pricing

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On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Baker Donelson

Trump Administration Releases Fiscal Year 2018 Budget Proposal

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On Tuesday, May 23, the White House released the President's fiscal year 2018 (FY18) budget, launching a contentious and consequential debate that is expected to last through the end of the fiscal year and possibly beyond....more

BakerHostetler

Capitol Hill Healthcare Update

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Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: MedPAC votes on changes in Part D... Senate HELP Committee reports five “Cures” bills... One report shows uninsured number decreasing... Another says, but we still need the safety net. ...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

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