Health Care

This week, Congress is working towards passage of a continuing resolution that would fund the government through the middle of November. This will give policymakers and appropriators enough time to hash out differences in funding priorities as well as work on policies addressing drug pricing, surprise billing, and funding for public health programs. The surprise billing issue is really heating up with outside stakeholder groups weighing in and Congress carefully considering its next steps

Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the Senators introduced their much-anticipated proposal to lower drug prices: a chairman’s mark called the Prescription Drug Pricing Reduction Act (PDPRA) of 2019.

This week, the Senate is expected to vote on a budget deal that would also suspend the debt limit for two years. This clears a major hurdle come September when both chambers of Congress will be in session with a laundry list of policies and programs to address, including appropriations.

This week, the House is set to vote on repeal of the Cadillac tax, which is a forty-percent tax on high-cost health plans established by the Affordable Care Act. While its prospects for passage in the Senate are not entirely clear, passage out of the House clears an important hurdle. In other news, we are continuing to monitor the evolving drug pricing debate which is still expected to ramp up in the coming weeks with action from the Administration and Senate.

This week, the Affordable Care Act (ACA) is back in the news with oral arguments set to begin before the U.S. Court of Appeals for the Fifth Circuit. The court will decide whether to uphold a federal district court's ruling that struck down the ACA. This case has the potential to reshape the political landscape in 2020 if it reaches the Supreme Court. On Capitol Hill, policymakers are working hard to bring forth a drug pricing package before the August recess

This week, the House is poised to take action on drug pricing by passing two pieces of legislation. As the House moves the bills through final passage, focus will shift to the Senate, which will unveil a legislative package around lowering costs for consumers in the coming weeks. The scope of this package is still unclear, but it should include a number of proposals that could pass on a bipartisan basis. We cover this and more in this week's preview, which you can find by clicking here.

Following the two week recess, Congress is back in session and will have several high profile hearings this week. For starters, the Energy & Commerce Health subcommittee will continue reviewing prescription drug costs, this time focusing in on Medicare. In the Rules Committee, which does not typically host high profile hearings, they will hold the first committee hearing on H.R. 1384, one of the "Medicare for All" proposals. 

This week, Congress will continue to look at lowering health costs. The House has been focused on both drug costs and overall health care costs, advancing packages to strengthen the individual market in addition to a series of bipartisan drug pricing bills.

This week, House Democrats are pressing forward with a health care package designed to lower drug costs and strengthen the Affordable Care Act (ACA). This package will provide a platform for Democrats to tout legislation that stabilizes the ACA or counteracts actions taken by the Administration. While this legislative package is sure to get a lot of attention following the Department of Justice announcement regarding Texas v. Azar, it's unclear how much support it will garner in the Senate.

In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory developed tests (LDTs) and other in vitro diagnostics (IVDs). The proposed approach would create an entirely new category of medical product separate from medical devices known as in vitro clinical tests (IVCTs).

On March 5, 2019, FDA Commissioner Scott Gottlieb announced his resignation. The physician and venture capitalist, ​for whom this was ​a second stint at the FDA, intends to leave the agency in about a month to spend more time with his family. In this post, Aaron Josephson reflects on Dr. Gottlieb's time leading the FDA and its future after his departure.

As Congress continues its oversight of prescription drug prices, the Senate Finance Committee will also examine abuse and neglect at nursing homes. Meanwhile, the House of Representatives is looking at ways to lower health care costs as it keeps it eye on lowering drug costs as well. The focus and intensity around drug pricing is not expected to diminish anytime soon.

On Tuesday, executives from seven of the largest pharmaceutical companies testified before the Senate Finance Committee on rising prescription drug prices. While the hearing was expected to be packed with fireworks as Senators of both parties grilled the nation's top pharmaceutical executives, it was largely uneventful. 

In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program. FDA also recently issued a proposed regulation for the De Novo program and linked that proposed regulation to 510(k) modernization efforts as part of a broader strategy to improve device safety.