ML Strategies

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of the individual mandate in the Affordable Care Act (ACA) and argue that since the individual mandate has been repealed, or more technically zeroed out, the rest of the ACA must be struck down.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.

All eyes are on Tuesday and what the midterm elections mean broadly and in the health care space. The implications are far reaching, from the House to the Senate, and even the gubernatorial races. Read the full post for links to our weekly preview and coverage of the elections.

On Wednesday, October 25th President Trump, along with HHS Secretary Alex Azar, introduced the administration’s new proposal to lower drug prices through Medicare Part B. The announcement follows ASPE’s morning release of a report comparing U.S. drug prices to international drug prices. The report, which used Medicare Part B payment numbers, stated that the U.S. has about 1.8 times higher ex-manufacturer prices for top drugs than other countries, and the new proposal intends to align U.S. prices with those abroad. The proposal that President Trump discussed will use CMS authority to test three new measures. One will use international pricing as a metric, one will develop a new competitive acquisition program (CAP), and one would alter the average sales price (ASP) model already in effect. Comments on the proposals are due December 31, 2018.

Open Enrollment is fast approaching and the landscape with be notably different than in years past. From the introduction of short-term plans and association health plans to proposals to allow for greater use of health reimbursement arrangements, the strength of the Marketplace will be tested and will inform future policy considerations. We cover this and more in this week's health care preview.

On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year. The list includes nearly 200 rules, 23 of which are already posted on the Office of Information and Regulatory Affairs (OIRA) dashboard. The bulk of the rules on the Agency Rule List for Fall are under the purview of CMS or the FDA (63 and 77 rules, respectively). Also, earlier in October, FDA’s device center released a list of draft and final guidance documents it plans to publish in FY 2019. Many of these rules or guidance documents touch on issues top of mind and we expect that the administration will be moving forward with many of these priorities in the coming months. 

The Massachusetts Health Policy Commission (“HPC”) held its annual Health Care Cost Trends Hearing on October 16-17, 2018. The hearing covered a wide range of topics affecting the health care industry here in the Commonwealth and across the country. Here are some key takeaways and a legislative outlook.

While Congress is in full campaign-mode, the Administration is continuing its regulatory push in the health space. On Monday, the Administration put forth new guidance on Section 1332 waivers. These waivers were created by the Affordable Care Act as a way for states to seek additional flexibility to pursue avenues for providing high quality and affordable health coverage. Today's guidance will put the Administration out front on interpreting state proposal's to drive innovation. We cover this and more in this week's health care preview.

This October 3rd marked the 10-year anniversary of the passage of the Mental Health Parity and Addiction Equity Act (MHPAEA). Now, 10 years later, the question is whether the law has changed the playing field to ensure greater access to care and more equitable financial parameters. Although the passage of this legislation created a pathway for change, there are still challenges to address. Hopefully our path forward will continue address these issues of implementation, so we approach the day when those living with mental health and substance use disorders will be seen as having a condition or disease that deserves prevention strategies, supports and treatment services, and civil rights protections similar to all other medical conditions.

While the House is out on recess, the Senate continues to be in session. This week the Senate has some non-health care related hearings scheduled as well as nomination hearings. We are looking for signals for a deal to finish work and send vulnerable Senators home to campaign. However, while legislative action may begin to cool down, regulatory activity at OIRA could be heating up.

On September 25, 2018, House and Senate negotiators agreed on a final legislative package to address the opioid crisis. Following this agreement, the House passed the opioid package on September 28, 2018. The Senate is expected to pass the package in the weeks ahead, and the President is expected to sign the package into law. ML Strategies has created a chart tracking the provision of the final opioid package.