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
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
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
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
Congress — Big Agenda & Little Time -
With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more
1/12/2024
/ Artificial Intelligence ,
China ,
DEA ,
Department of Energy (DOE) ,
Department of Health and Human Services (HHS) ,
Department of Transportation (DOT) ,
Environmental Protection Agency (EPA) ,
FCC ,
Federal Aviation Administration (FAA) ,
Federal Highway Administration ,
Federal Trade Commission (FTC) ,
FERC ,
Food and Drug Administration (FDA) ,
Healthcare ,
Labor Shortage ,
Legislative Agendas ,
NHTSA ,
Notice of Proposed Rulemaking (NOPR) ,
Popular ,
Primary Elections ,
Proposed Legislation ,
Regulatory Agenda ,
Research and Development ,
Tariffs ,
Tax Incentives ,
U.S. Commerce Department ,
U.S. Treasury
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
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
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
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
10/12/2021
/ Base Erosion and Anti-Abuse Tax (BEAT) ,
Biden Administration ,
Capital Gains ,
Controlled Foreign Corporations ,
Estate Tax ,
Gift Tax ,
GILTI tax ,
Green Book ,
Income Taxes ,
International Tax Authority ,
OECD ,
Qualified Business Income ,
SALT ,
Tax Cuts and Jobs Act ,
Tax Rates ,
Tax Reform ,
Taxation ,
U.S. Treasury ,
Ways and Means Committee
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
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
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
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
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
11/24/2020
/ Affordable Care Act ,
Biden Administration ,
California v Texas ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Healthcare Reform ,
Lame Duck Session ,
Legislative Agendas ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
Trump Administration
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
11/11/2020
/ Biden Administration ,
CFIUS ,
China ,
Joe Biden ,
Legislative Agendas ,
Presidential Elections ,
State and Local Government ,
Tariffs ,
Trade Relations ,
Trade Representatives ,
Trump Administration
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
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
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
In response to the coronavirus pandemic, Congress and President Trump have taken the following actions...more
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
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