ML Strategies

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. We cover this and more in this week's preview, which you can find by clicking here.

With less than a year to go until the end of formal sessions on July 31, 2020, Massachusetts legislators are back in action this month to begin tackling a robust policy agenda. We are poised to see action on both new and pending legislation this fall on a number of priority policy areas.

As August recess gets underway for the House and the Senate, ML Strategies has prepared a summary of the status of this summer’s key cybersecurity issues. ML Strategies will continue to track these and other cybersecurity priorities before Congress and the Administration through August and beyond.

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. We cover this and more in this week's preview, which you can find by clicking here. 

On Monday, July 22nd the Massachusetts Legislature finalized the Fiscal Year 2020 Budget and delivered it to Governor Baker’s desk for approval. The Legislature’s Budget Conference Committee, led by Chairmen Representative Aaron Michlewitz (D- Boston) and Senator Michael Rodrigues (D- Somerset), authorizes $43.1 billion in state spending for this fiscal year and included the largest annual increase for K-12 education in the state’s history, a $269 million dollar lift.

Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, Pre-Cert involves a premarket evaluation of a software developer’s culture of quality and organizational excellence and continual, real-time postmarket analyses to assure software meets the statutory standard of reasonable assurance of safety and effectiveness.

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. They will also have to balance the Administration's efforts, which is expected to issue an executive order this month on lowering drug costs. We cover this and more in this week's preview. 

This week, the House Energy & Commerce Committee is voting on seven more drug pricing bills. The Senate is going to be unveiling its cost-containment package in the coming weeks (if not days) and should include most, if not all, of the House-passed drug pricing bills. This action will set the stage for the summer work period, which is expected to focus heavily on drug pricing and other cost-containment measures, such as surprise medical bills. At CMS, the agency published a final rule last week that touched on several noteworthy drug pricing issues. We cover this and more in this week's preview, which you can find by clicking here. 

Congress is circling an issue that is not black and white in terms of the stakeholders it could impact and how interests will align. The leaders of the Senate Health, Education, Labor, and Pensions Committee and the Senate Finance Committee are poised to release a cost-containment package in the coming weeks which will touch on surprise billing issues, drug pricing, and other access and transparency issues. While there is intense bipartisan interest in addressing some of these issues, it is unclear how exactly this package will reach the President's desk given the current political climate.

This week, the House is poised to take action on drug pricing by passing two pieces of legislation. As the House moves bills through final passage, focus will shift to the Senate which will in the coming weeks unveil a legislative package around lowering costs for consumers. 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.


The House is poised to pass several noteworthy drug pricing bills this work period, as well as legislation to strengthen the Affordable Care Act. Once the House votes on these bills, the question will then become what is the Senate able to pass and what is their appetite for taking it on this summer. We cover this and more in this week's preview.

Connie Garner discusses the future of long term care and long term services and supports in the United States.

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. We cover this and more in this week's preview.

Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI’s Cosmetics & Personal Care Products conference on March 28, 2019. Attendees asked many questions about legitimate uses of and claims for CBD, but definite answers were in short supply due to the current confusion over the legality of CBD as a product itself or other products, such as food or cosmetics, with CBD added.

When asked a direct question about FDA’s perspective on and plans for CBD regulation, Dr. Linda Katz, Director of FDA’s Office of Cosmetics and Colors and Acting Chief Medical Officer for Food Safety and Applied Nutrition, did not comment directly but referred all attendees to an upcoming public meeting on CBD in April 2019. It is possible that the public meeting could be the start of an FDA rulemaking process for CBD regulations. Even though Dr. Katz was unable to comment, there was still plenty of CDB advice to share with industry attendees.

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. For our complete health care preview...

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.

The proposed De Novo regulation, issued December 5, 2018, would codify into regulation many of the policy and programmatic features of the De Novo program that are currently outlined in guidance documents. Because guidance is nonbinding, FDA is seeking through the proposed regulation to provide structure, clarity, and transparency to the De Novo process in a way that would be binding on De Novo submitters.