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CMS Issues Final Notice on Program for Breakthrough Device Reimbursement but Industry Looks to Congress for More Inclusive...

Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders....more

New Biden Executive Order Emphasizes Women’s Health

Following an initial funding announcement last month, the Biden administration has kept its foot on the gas to build out the White House Initiative on Women’s Health Research. Last month, we wrote about ARPA-H’s $100 million...more

ARPA-H Commits $100 Million to Accelerate Women’s Health Research through Sprint for Women’s Health

On February 21, 2024, the Advanced Research Projects Agency for Health (ARPA-H) announced a $100 million commitment to research and development in women’s health through Sprint for Women’s Health, a first-of-its-kind effort....more

House Energy Committee Leadership Post Opens as Top Republican Announces Retirement

Start of Election Season Triggers Many Retirements - With the elections nine months away, 43 members of the House have announced they will not seek reelection. An additional three seats will need to be filled due to...more

Post-Election 2022: A Look into the Next Congress

There are plenty of politics to discuss at the table this Thanksgiving, whether family is grateful for that or not. After weeks of tabulations, the midterm election results are largely known. While some individual races...more

Look Ahead: Upcoming Congressional Work Period – July 2022

The next three weeks will be full of activity in Washington D.C., as the House of Representatives and Senate are working to push their legislative agendas to garner support from their constituents ahead of an August recess...more

Massachusetts for ARPA-H

The Advanced Research Projects Agency for Health (ARPA-H) is now a reality. President Biden first pitched the concept in his first address to a joint session of Congress just over a year ago. In March, ARPA-H came to...more

House Democrats Weigh Major Tax Changes for Businesses, Funds, and Individuals

In May 2021, President Biden’s administration released a $6 trillion budget proposal for the coming fiscal year (Budget), including $3.6 trillion of tax increases over 10 years and generous tax credits to incentivize clean...more

Look Ahead: Fall Preview of Key Biden Administration Initiatives

The second half of 2021 will be a busy stretch for Congress. In addition to the typical must-pass legislation, Democrats controlling both chambers and the White House are committed to several big spending bills, too. What...more

House Republicans Reverse Course on Earmarks, Congressionally Directed Spending is Back

Since the Democrats reclaimed control of the House of Representatives in 2018, barrels of ink have been spilled on the topic of “congressionally-directed spending”. Better known as earmarks, this funding mechanism allows...more

As Walsh Awaits Confirmation Vote, DOL Priorities Take Shape

Last week, the Senate Committee on Health, Education, Labor, and Pensions voted 18-4 to advance Boston Mayor Marty Walsh’s nomination for labor secretary. The bipartisan approval signals a non-controversial confirmation vote...more

Transportation & Infrastructure: What to Expect from the Biden Administration & 117th Congress

With Democratic majorities in the U.S. House and U.S. Senate, Congress and President Biden’s new administration are working to quickly advance proposals to provide for economic relief as the nation continues to reel from the...more

Post-Election 2020 - Health Care Preview

With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy. President-elect Biden has been clear that he wants to...more

MLS Election Update: Impact on Trade

Although – barring an incredible, unforeseen reversal in the courts – we now know the outcome of the presidential election, we will have to wait until January to learn whether Republicans or Democrats control the Senate...more

Executive Compensation Practices in Pharma – Insight into Congressional Oversight

In an exchange which has now gone viral, freshman U.S. Representative Katie Porter (D-Calif.) questioned former Celgene CEO Mark Alles about his 2017 compensation structure last week. Rep. Porter, who is now famous for...more

Senate & House Advance PPP Extension: Setting Stage for Next COVID-19 Stimulus Package

Just hours ahead of the June 30 deadline for small business owners to submit applications to the CARES Act Paycheck Protection Program (PPP), the U.S. Senate passed by unanimous consent bipartisan legislation to extend the...more

Congress and the White House Continue Efforts to Respond to Coronavirus

The response to the coronavirus situation is fluid and fast-moving – particularly by Congress’ standards. In response to the coronavirus pandemic, the following legislation has been considered in Congress: Phase I: ...more

Update from Washington – Coronavirus Response

In response to the coronavirus pandemic, Congress and President Trump have taken the following actions...more

Congress Acts to Mitigate COVID-19 Impact

To our friends and clients: Below is an update on legislative efforts by Congress and the White House to address the coronavirus pandemic, prepared by our D.C. colleagues at ML Strategies, who are closely following these...more

Federal Response to COVID-19

In response to the ongoing coronavirus epidemic, the federal government has taken several actions in recent days. The most consequential are: the Coronavirus Preparedness and Response Supplemental Appropriations Act (signed...more

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