News & Analysis as of

Proposed Rules Healthcare Pharmaceutical Industry

Alston & Bird

Health Care Week in Review | Draft MAHA Commission Strategy Document Circulated; President Trump Signs EO Aiming to Fill Drug...

Alston & Bird on

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 | HHS Cancels mRNA Vaccine Development Projects Under BARDA; President Trump Signs EO to Increase...

Alston & Bird on

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

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

Latham & Watkins LLP on

The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more

Holland & Knight LLP

CMS Releases CY 2026 Outpatient Prospective, ASC Payment System Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on July 15, 2025, issued the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems proposed rule, which proposes updates to the...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

Alston & Bird on

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

Goodwin

Health Headlines: March 2025

Goodwin on

Welcome to the third issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

Bass, Berry & Sims PLC

CMS CY 2026 Parts C and D Proposals Focus on Informed Choice

Bass, Berry & Sims PLC on

On December 10, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule, which, if finalized as proposed, has potentially significant implications for Medicare Advantage (MA) plans and Medicare...more

DLA Piper

CMS Releases New Proposed Rule for Medicare Advantage and Part D

DLA Piper on

On December 10, 2024, the Centers for Medicare and Medicaid Services (CMS) released a Proposed Rule for revisions to the regulations governing the Medicare Advantage (MA) program, Medicare Prescription Benefit (Part D),...more

Troutman Pepper Locke

2024 Mid-Year Review: State AGs Shaping Regulatory Landscapes

Troutman Pepper Locke on

In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

Quarles & Brady LLP on

On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

McDermott Will & Schulte

FDA Publishes Proposed Rule on Sections 503A and 503B Compounding

On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

Polsinelli on

Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

McDermott Will & Schulte

Trending in Telehealth: January 4 – 15, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

McDermott+

McDermottPlus Check-Up: October 6, 2023

McDermott+ on

THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Issues Long-Awaited Proposed Rule To Regulate Laboratory-Developed Tests

On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule that would end its long-standing policy of enforcement discretion with respect to regulation of laboratory-developed tests (LDTs) (the...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

McDermott Will & Schulte

Trending in Telehealth: September 19 – 25, 2023

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott+

McDermottPlus Check-Up: September 8, 2023

McDermott+ on

CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...more

Polsinelli

CMS Proposes $9B in Relief for 340B Hospitals

Polsinelli on

340B Covered Entities (CEs) are getting a glimpse into what they can expect to be repaid due the fallout from CMS’ unlawful 340B payment reduction that was struck down by the U.S. Supreme Court in June 2022.  CMS discussed a...more

McDermott+

McDermottPlus Check-Up: April 28, 2023

McDermott+ on

Congress was in session, and it was a busy healthcare week at the committee level, with six hearings focused specifically on health issues. On the House floor, Republicans passed the Limit, Save, Grow Act—a bill that raises...more

McDermott+

Healthcare Preview for the Week of: May 1, 2023

McDermott+ on

Lots of Healthcare Activity in Congress - Activity in Congress focusing on healthcare issues has increased over the last few weeks and is not slowing down anytime soon. This week, the Senate Health, Education, Labor, and...more

Polsinelli

DEA Announces Permanent Flexibilities for the Prescribing of Controlled Substances via Telemedicine

Polsinelli on

On February 24, 2024, the Drug Enforcement Administration (“DEA”) released a long-anticipated proposed rule that aims to permanently extend controlled substance prescribing flexibilities beyond the COVID-19 Public Health...more

29 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide