Affordable Care Act, Medicare Part B, Prescription Drugs

Recent Developments in Pharmacy-Related Legislation and Regulations

Wiley Rein LLP on 5/15/2024

Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more

CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

McDermott Will & Emery on 4/26/2024

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more

The Inflation Reduction Act of 2022: Healthcare Provisions

McDermott Will & Emery on 9/9/2022

After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more

Benefits-Related Provisions of the Inflation Reduction Act of 2022

Groom Law Group, Chartered on 8/31/2022

On August 16, President Biden signed into law the Inflation Reduction Act of 2022 (P.L. 117-169; the “Act”). Although the Act differs considerably from the wide-ranging domestic economic package Democrats had initially...more

With Inflation Reduction Act Signed, Other Health Policy Issues Ahead for Congress

Holland & Knight LLP on 8/17/2022

Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more

Healthcare & Life Sciences: Drug Pricing Digest - July 2022 #2

Latham & Watkins LLP on 7/20/2022

Drug Pricing Initiatives: Democrats renewed their efforts to pass drug pricing reform measures in the form of a revised H.R. 5376 (the Build Back Better Act, or BBBA). Democrats intend to adopt the BBBA as part of the budget...more

Alston & Bird Health Care Week in Review - April 2022 #2

Alston & Bird on 4/11/2022

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

Senate Lays Groundwork for Fall Health Care Negotiations Before Recessing This Month

Manatt, Phelps & Phillips, LLP on 8/17/2021

The Big Picture - Before leaving for its August recess, the Senate made progress on two major Biden Administration priorities by passing bipartisan infrastructure legislation and a fiscal year (FY) 2022 budget resolution....more

The Fate of the Trump Administration’s Controversial Most Favored Nation Drug Pricing Model Is Unclear Given Mounting Legal...

Polsinelli on 12/10/2020

On November 27, 2020, CMS published its Most Favored Nation (MFN) Model Interim Final Rule (IFR) that seeks to lower the amount paid for 50 high-cost Medicare Part B drugs to the lowest price that drug manufacturers receive...more

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on 11/24/2020

Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

New Risks, New Rewards, New Exposure

King & Spalding on 6/24/2020

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Capitol Hill Healthcare Update

BakerHostetler on 2/5/2019

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: Trump will discuss healthcare and drug costs in this week’s State of the Union address;...more

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

Holland & Knight LLP on 2/19/2018

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

340B Update: CMS Proposes to Reduce 340B Drug Reimbursement; Draft Executive Order Could Mean Further Changes to the 340B Program

K&L Gates LLP on 7/14/2017

The Trump administration is considering significant changes relating to the 340B Drug Pricing Program (“340B Program”), which allows certain categories of safety net providers to access discounted pricing on covered...more

OIG Work Plan: A Roadmap to Identify Health Care Compliance Risk

McDermott Will & Emery on 9/7/2016

Each year, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues a Work Plan that summarizes new and ongoing OIG reviews and areas of focused attention for the coming year and beyond....more

OIG Mid-Year Updated Provides Insight To Its Concerns

Hinshaw & Culbertson LLP on 6/20/2016

The Office of Inspector General (OIG) recently released its mid-year update of its Fiscal Year Work Plan for 2016. The Work Plan summarizes new and ongoing reviews and activities that the OIG plans to pursue. Not...more

A&B Healthcare Week in Review

Alston & Bird on 4/28/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more

Washington Healthcare Update

McGuireWoods LLP on 4/12/2016

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

A&B Healthcare Week in Review

Alston & Bird on 3/11/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more

Health Care Update - February 2016 #5

Mintz - ML Strategies on 3/2/2016

Congress Expected to Vote on Opioid Legislation - This week, Congress will consider the Comprehensive Addiction and Recovery Act (CARA). CARA would be the first step the Senate has taken in 2016 to address the opioid...more

A&B Healthcare Week in Review

Alston & Bird on 2/26/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

Health Update - December 2015

Manatt, Phelps & Phillips, LLP on 12/22/2015

Lessons from Hawaii's Trailblazing ACA 1332 Waiver Proposal - Editor's Note: On September 9, Hawaii became the first state to post a draft 1332 waiver proposal for public comment. While Hawaii's proposal focuses on the...more

Health Care Update - November 2015

Mintz - ML Strategies on 11/4/2015

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Health Care Update - October 2015

Mintz - ML Strategies on 10/29/2015

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

Washington Healthcare Update

McGuireWoods LLP on 7/28/2015

This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

Patient Protection and Affordable Care Act (PPACA) › Medicare Part B › Prescription Drugs

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