News & Analysis as of

Centers for Medicare & Medicaid Services (CMS) Office of Management and Budget

McDermott+

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

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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

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

King & Spalding

CMS Issues Hospice Proposed Payment Rule

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Last week, CMS issued a proposed rule (Proposed Rule) for fiscal year (FY) 2025 aiming to update Medicare hospice payments and aggregate cap amount in accordance with existing statutory and regulatory requirements. The...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

Mintz

Mintz IRA Update — Demystifying the IRA’s Small Biotech Exception

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On August 29, 2023, CMS selected the first 10 high-expenditure, single source, Medicare Part D drugs subject to negotiation under the IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”). In...more

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 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

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

McDermott+

Regs During an Election Year: What’s on the Menu?

McDermott+ on

Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more

McDermott+

McDermottPlus Check-Up: January 5, 2024

McDermott+ on

Congress Returns Next Week to Face Imminent Funding Deadlines. The Senate will return to session on January 8, and the House will return on January 9. Lawmakers face an immediate time crunch on FY 2024 appropriations, as the...more

Holland & Knight LLP

Holland & Knight Health Dose: December 12, 2023

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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

McDermott+

A Government Shutdown Is Likely on the Horizon: Will the Regulatory Process Also Hit Pause?

McDermott+ on

Passing the 12 annual appropriations bills that fund the federal government for the next fiscal year (which starts on October 1), or enacting a stopgap continuing resolution in the interim, seems to come down to the wire...more

Wiley Rein LLP

The IRA’s Negotiation Process ICR and Revised Negotiation Program Guidance

Wiley Rein LLP on

On July 25, 2023, the Centers for Medicare & Medicaid Services (CMS) republished its Drug Price Negotiation Process Information Collection Request (Negotiation Process ICR). The Negotiation Process ICR, which was originally...more

Baker Donelson

CMS Approves New Group Information Form under Self-Referral Disclosure Protocol

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Following the comment period that ended on August 8, 2022, the Centers for Medicare and Medicaid Services (CMS) recently finalized changes to the Self-Referral Disclosure Protocol (SRDP) for physician practices to disclose...more

Goodwin

CMS Issues First Request for Public Comments on the Medicare Drug Price Negotiation Program “Small Biotech” Exception - Due March...

Goodwin on

The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...more

DirectEmployers Association

OFCCP Week In Review - December 2022 #2

Monday, December 5, 2022: EEOC’s Union Settled Allegations Re Post-Pandemic Return to Work in the Office Policy - Republican Legislators Voiced Concern that EEOC’s Strategic Plan Did Not Address Return to Work in the Office...more

Morrison & Foerster LLP - Government...

Another Ticking Clock: Additional District Court Preliminarily Enjoins EO 14042 | Increasing Need For OMB Update On Ga Court...

On January 27, 2022, the U.S. District Court for the District of Arizona joined the growing list of courts that have preliminarily enjoined Executive Order 14042 (which imposes COVID safety protocols on government...more

DirectEmployers Association

OFCCP Week In Review: January 2022 #4

The DE OFCCP Week in Review (WIR) is a simple, fast and direct summary of relevant happenings in the OFCCP regulatory environment, authored by experts John C. Fox, Candee Chambers and Jennifer Polcer. In today’s edition, they...more

DirectEmployers Association

OFCCP Week In Review: January 2022 #2

The DE OFCCP Week in Review (WIR) is a simple, fast and direct summary of relevant happenings in the OFCCP regulatory environment, authored by experts John C. Fox, Candee Chambers and Jennifer Polcer. In today’s edition, they...more

Foley & Lardner LLP

OMB Publishes Guidance Regarding Enforcement of Federal Contractor Vaccine Mandate in Light of Recent Court Injunctions

Foley & Lardner LLP on

As we previously reported, two federal courts, one in Kentucky and the other in Georgia, collectively have enjoined the government from enforcing the vaccine mandate for federal contractors and subcontractors set forth in...more

MoFo Life Sciences

Biden Administration Executive Order On Promoting Competition In The American Economy: Drug Pricing And Healthcare Industry...

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On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2021 #2

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PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more

ArentFox Schiff

Senate Finance Committee Holds Confirmation Hearing For Top Biden HHS Nominees

ArentFox Schiff on

Deputy Secretary and CMS Administrator Picks Would Fill Two Critical Policy Positions - On Thursday, the Senate Finance Committee held a confirmation hearing for two of the most important health policy officials nominated...more

McGuireWoods Consulting

Washington Healthcare Update - March 2021 #5

Congress - House - Representatives Propose a Permanent Extension of CHIP Funding - The House Energy and Commerce Committee is looking at ways to strengthen the Affordable Care Act (ACA) and expand Medicaid coverage. A...more

McGuireWoods Consulting

Senate Acts to Avert Medicare Sequester Payment Reductions — House Needs to Act

In the nick of time, the U.S. Senate passed legislation on March 25, 2021, to delay a 2 percent across-the-board cut to Medicare through the rest of 2021. The vote was 90 to 2. Without the delay, all Medicare providers would...more

McGuireWoods Consulting

Washington Healthcare Update - November 2020 #1

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This week in Washington: Washington’s focus has been on the presidential and Senate races....more

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