ML Strategies

Mintz/ML Strategies’ 4th Annual Pharmacy & Pharmaceutical Industry Summit has been scheduled for Thursday, May 2, 2019 – mark your calendars! People from across the industry will gather for one day to share insights about issues that the players in this complex marketplace are tackling.

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

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.

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. CARE adds premiums and cost sharing, healthy behavior incentive programs, and flexible spending accounts, called CARE Accounts, for certain adults in the expansion population. The program is approved to run through September 30, 2021.

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. With the first health care hearings of 2019 beginning next week, we should get a sense of the level of oversight the Administration will be facing this Congress. We cover this and more in this week's health care preview.

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.

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 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.

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. 

Congress has two weeks to finish up a partial spending deal. For many health care stakeholders, the focus is on finishing the reauthorization of the Money Follows the Person program and passing the ACE Kids Act. While there are other legislative items in the health care space still pending, the current thinking is that policy changes around the doughnut hole or the medical device tax will be left unaddressed.

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

On November 26, 2018 the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. This proposed rule is the Trump Administration’s latest action to curb prescription drug prices. The proposed rule outlines a number of provisions to for lowering drug prices and reducing out-of-pocket costs in the Part D program that build off the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.

On November 20, 2018, Virginia submitted an application to CMS for a Section 1115 demonstration program entitled Virginia COMPASS (Creating Opportunities for Medicaid Participants to Achieve Self-Sufficiency). The application comes after Virginia voted in June 2018 to expand its Medicaid program to cover newly eligible non-disabled, non-pregnant adults ages 19 to 64 with income up to 138 percent of the federal poverty level (FPL), on the condition that the expansion include a work requirement and other measures. This waivers implements work requirements and other provisions linked to the state’s Medicaid expansion.

This week, Congress is expected to pass a two-week extension to avoid a partial government shutdown.

As we previously discussed, in October the Trump Administration issued guidance related to 1332 waivers. This guidance outlines how the Trump Administration interprets the ACA 1332 waiver guardrails. On November 29th, CMS built off that guidance and outlined four concepts that states can utilize in 1332 waivers. Below is a discussion of these concepts and their potential effects. 

This week, Congress returns to Washington with 10 working days to prevent a partial government shutdown by December 7th. Reaching an agreement on funding is the highest priority of the Lame Duck, and it could prove contentious given some controversial issues lurking around the corner. Also this week, the Senate will continue to look at health care costs in its ongoing hearing series and, will consider several legislative items.

This week, Congress returns to Washington for its lame duck session with uncertain expectations for what gets done between now and the next funding deadline of December 7, 2018. There are a number of legislative items that passed one chamber and not the other, and watch to see which bills make it across the finish line.