Health Care

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.

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.

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. 

This week, Congress will dive into rising prescription drug costs with a hearing in the Senate Finance Committee. The hearing will feature seven top drug manufacturer executives and will focus on rising drug prices and transparency, among other topics.

In our “FDA 2018 Year in Review (and a Few Thoughts on 2019)” post and recent webinar, we observed that we may look back at 2018 as the beginning of the end for the 510(k) program as it has existed since the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. The 510(k) pathway has been scrutinized for years and among the most damning criticisms leveled against it is that it is a loophole that lets unsafe products on the market by allowing manufacturers to, in most cases, avoid clinical testing.

Congress and the Administration are staring down the prospect of another government shutdown, with talks breaking down over the weekend on a border funding deal. Democrats in the House continue to aggressively pursue drug pricing legislation, and are also touting reforms to the ACA to counteract actions taken by the Administration.

Mintz/ML Strategies’ 4th Annual Pharmacy & Pharmaceutical Industry Summit has been scheduled for Thursday, May 2, 2019 – mark your calendars!

This week, we explore the Administration's proposed rule related to AKS safe harbors and what it means for the drug pricing debate. On Capitol Hill, Democrats in both chambers are beginning to examine behaviors by various companies in an effort to drive home the need for additional oversight. It's clear that drug pricing is going to be a hot topic for this Congress. What's unclear is whether both sides can find consensus in proposals that lower drug costs

The shutdown fight is over for now and Congress is ready to get the work of the 116th Congress underway. This week, there will be four relevant hearings to health care stakeholders, two of which will center around prescription drug pricing. The other two will look at pre-existing conditions and community health center related policies. On the regulatory side, we wait and see if the Administration will be putting forth any regulations in this space, in particular the discount safe harbor rule.

While Congress is still mired in a partial government shutdown, the Administration is continuing to put out relevant health care regulations and approving new Medicaid work requirements.

In 2014, Arizona expanded Medicaid to the new adult group. Following the expansion, Arizona submitted, and CMS approved, an 1115 waiver extension to create the Choice, Accountability, Responsibility, Engagement (CARE) program.

With the recent scoop from Politico that the Trump Administration is considering giving states the ability to implement Medicaid block grants, there has been considerable speculation on what the Administration is planning. Although we don’t know exactly what the Administration has in mind, there increasing skepticism on the legality of this move. So we are laying out the fundamentals and past history as we await the final guidance.

While Congress and the Administration are dug in entering the third week of a partial government shutdown, both branches of government are looking to shape other policy areas in 2019. The Administration is reportedly looking at reforming the Medicaid program and Congress is ramping up its oversight of prescription drug prices.

We cover this and what it will mean for this Congress in this week's preview.

The partial government shutdown is on its 17th day with no end in sight. In this week's preview, we discuss how reaching a solution is challenging for both sides and implications for legislating going forward. We also cover some of the latest polling on health care issues, which may offer a preview into messaging in this space over the next two years.

On Friday, December 14th, Judge O’Connor, a Texas Federal District Court Judge, ruled on the case Texas vs. Azar. As background, Texas vs. Azar was filed by 20 Republican state attorneys general and governors. The plaintiffs challenge the constitutionality of the individual mandate in the Affordable Care Act (ACA) and argue that since the individual mandate has been repealed, or more technically zeroed out, the rest of the ACA must be struck down. They argue that the individual mandate cannot be severed from the ACA given its key structural role in the law. The Department of Justice agreed with some, but not all parts, of this argument, and sixteen states and DC are defending the ACA.

This week, Congress is in session for what should be the last week of the 115th Congress. However, the spending fight that has been raging since the last continuing resolution is no closer to being wrapped up than it was a month ago. Additionally, we watch to see if the IMPROVE Act can be finalized this week.

On December 11, 2018, the House of Representatives passed the IMPROVE Act in a vote of 400-11. The bill is currently moving to the Senate. Our summary of the major provisions of the IMPROVE Act can be found...

As of December 2018, 37 states (including D.C.) have adopted Medicaid expansion. Of the remaining 14 states, some are considering expanding Medicaid. States with recent activity relating to Medicaid expansion include: Florida, Idaho, Maine, Missouri, Nebraska, New Hampshire, North Carolina, and Utah. States continue to explore different opportunities as it relates to Medicaid expansion.