News & Analysis as of

Final Rules Office of Management and Budget

McDermott+

CY 2026 MA and Part D Final Reg: Policies Under Consideration

McDermott+ on

Last week, the contract year (CY) 2026 Medicare Advantage (MA) and Part D final reg entered the clearance process at the Office of Management and Budget (OMB). As mentioned in a previous Regs & Eggs blog post, OMB’s review is...more

Akin Gump Strauss Hauer & Feld LLP

Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative (Trump EO Tracker)

The Director of the OMB Director shall submit a plan to reduce the size of the Federal Government, requiring that agencies may hire no more than one employee for every four employees that depart. Agency heads must adhere to...more

Holland & Knight LLP

Holland & Knight Health Dose: January 29, 2025

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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....more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Wiley Rein LLP

FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations

Wiley Rein LLP on

The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): •Standardized test methods to detect...more

McDermott+

Hospitals, Take Note: CMS Adopts Changes to Medicare Rural Designations

McDermott+ on

Under Medicare, a plethora of policies directly correlate to whether the patient or provider is located in an urban or rural area when the service is delivered. These policies range from rules that limit coverage of...more

Benesch

Pulse on AI + Healthcare: An Introduction to Healthcare AI Innovation in an Evolving Regulatory Landscape

Benesch on

The expansion of artificial intelligence (“AI”) applications in healthcare (“Healthcare AI”) has made recent headlines, from the transformation of clinical diagnostics with increased accuracy, to use of personalized medicine...more

Benesch

The FMC’s Final Rule on Detention and Demurrage Billing Requirements Takes Effect Despite Pending Litigation

Benesch on

On February 26, 2024, the FMC issued its final rule on detention and demurrage billing requirements. On February 27, 2024, our team outlined the practical impact that the Final Rule will have in the article: “A Whole New...more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

Bradley Arant Boult Cummings LLP

Now That It Appears Marijuana Is Being Rescheduled, How Does That Process Work?

As we at Budding Trends reported last week, the DEA is set to finally accept the recommendation of the U.S. Department of Health and Human Services (HHS) to reschedule marijuana from Schedule I to Schedule III under the...more

Bradley Arant Boult Cummings LLP

DEA Poised to Reschedule Marijuana

Cue the Ron Paul “It’s Happening” gif and shout it from the rooftops: DEA will reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act, per a report from the AP. The United States federal...more

Pillsbury Winthrop Shaw Pittman LLP

Revised Uniform Grants Guidance Reduces Burdens While Encouraging Accessibility and Transparency

On April 4, 2024, the White House released a pre-publication final rule substantially updating the Office of Management and Budget (OMB) Uniform Grants Guidance, which sets the foundational requirements for agencies in making...more

Lathrop GPM

EPA Poised to Expand Federal Superfund to Include Key PFAS

Lathrop GPM on

On April 12, 2024, two days after EPA issued a final rule setting standards for certain per- and polyfluoroalkyl substances (PFAS) in public drinking water, the White House Office of Management and Budget (OMB) concluded its...more

Holland & Knight LLP

Holland & Knight Health Dose: April 9, 2024

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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....more

Lathrop GPM

EPA On the Cusp of Issuing First-Ever Federal Enforceable Drinking Water Standard for Certain PFAS

Lathrop GPM on

On March 27, 2024, the White House Office of Management and Budget (OMB) concluded its review of EPA’s final rule establishing a national drinking water regulation to limit concentrations of certain per- and polyfluoroalkyl...more

Holland & Knight LLP

Federal Maritime Commission Announces Demurrage and Detention Final Rule

Holland & Knight LLP on

Following its Feb. 23, 2024, release of a pre-publication draft, the Federal Maritime Commission (FMC)'s Final Rule on Demurrage and Detention Billing Requirements (Final Rule) was published on Feb. 26, 2024, in the Federal...more

Goodwin

FDA’s Laboratory Developed Test (LDT) Final Rule Under OIRA Review

Goodwin on

On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory...more

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 2024

Holland & Knight LLP on

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. ...more

Pillsbury Winthrop Shaw Pittman LLP

DoD Publishes Final Rule Implementing Executive Order 14005

The rule conforms applicable DFARS clauses to the final FAR rule that was published on March 7, 2022. Contractors must comply with increasing U.S. and qualifying country content thresholds for manufactured end products—65...more

McDermott+

Healthcare Preview for the Week of: January 29, 2024

McDermott+ on

APPROPRIATIONS PROCESS MOVES FORWARD - Over the weekend, negotiators in Congress agreed to certain spending allocations in order to fund various government agencies through most of the year. With both bodies in session...more

Proskauer - Law and the Workplace

White House Clears Independent Contractor Final Rule

On January 2, 2024, the Office of Information and Regulatory Affairs (OIRA) completed its review of the U.S. Department of Labor’s final rule on independent contractor classification under the Fair Labor Standards Act. The...more

Pillsbury Winthrop Shaw Pittman LLP

Department of Labor Finalizes Rule to Provide Service Employees Right of First Refusal under Successor Contracts

To avoid displacement of current service employees, the final rule will require contractors and their subcontractors to offer qualified employees a right of first refusal of employment under successor contracts. President...more

Holland & Knight LLP

Snitches Don't Get Stitches: New Rule Requires Supply Chain Disclosures

Holland & Knight LLP on

The Federal Acquisition Regulatory Council (FARC) issued a new final interim rule requiring contractors to review their supply chain to ensure no companies, products or services they are providing the federal government or...more

Sheppard Mullin Richter & Hampton LLP

Top 10 Takeaways from OMB’s “Build America, Buy America” Guidance for Infrastructure Projects

On August 23, 2023, the White House’s Office of Management and Budget (“OMB”) issued its notification of final guidance implementing Title IX of the Infrastructure Investment and Jobs Act (“IIJA”) – the Build America, Buy...more

Faegre Drinker Biddle & Reath LLP

OMB Issues Final Guidance on BABA Domestic Sourcing Requirements

On August 14, 2023, the Office of Management and Budget (OMB) released final guidance on implementing the statutory requirements of the Build America, Buy America Act (BABA) provisions of the Infrastructure Investment and...more

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