ML Strategies

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. 

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.

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.

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.

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.

You might have missed it but Congress averted a government shutdown last week. While several appropriations bills passed on time for the first time in years, several agencies, including the FDA, were funded on a continuing resolution (CR). The CR provides funding until December 7th and will need to be addressed again by that time. However, the House is now in recess and won’t be back in town until after the midterm elections. So the lame duck session will have a few ‘must dos’ on the list.

This week, Congress is off and running with two emerging priorities to complete before members head off to campaign. With the midterms just 50 days away, the longer issues like opioids and appropriations remain unsolved the more likely they are to get punted until after the midterms.

This week, the House is looking at advancing several health care tax proposals, including permanent repeal of the medical device tax. They will also consider a proposal to delay the health insurance tax by two years.

Congress is in session this week with six important health care hearings, including hearings on Medicare fraud, mental health, and Stark reform. Meanwhile, the Administration continues to put forth new proposed rules and guidance that will impact many stakeholders between now and the end of the year.

This week, Congress returns from recess to another four-week work period. The dynamics of the next four weeks might be in flux now that President Trump has nominated Brett Kavanaugh to the U.S. Supreme Court.

This week, focus turns to the Senate as the House overwhelmingly passed its opioid package known as H.R. 6 last week (see our previous coverage here). The Senate will look to combine its various proposals into one package for floor consideration and what passes will provide a timeline for reconciling the House and Senate packages.

The government is focusing on opioids.  Whether it be program policies, enforcement, or legislation, combating the opioid epidemic continues to be a major focus for government officials.  It is also a major piece of the health care legislation moving in both the House and the Senate.

On June 19,  the Health Policy Consensus Group, which is a group led by former Sen. Rick Santorum (R-PA) and composed of several conservative think tanks, released a white paper proposal to repeal and replace the Affordable Care Act (ACA).

It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s  Request for Information (RFI) on the Blueprint.  We previously posted about the Blueprint’s focus on the 340B Drug Discount Program.

Welcome to the third week of this four week stretch. This week, the House will continue to vote on a number of proposals to address the opioid crisis.

This week the Senate Finance Committee will mark up its opioid package. Additionally, the HELP Committee will hear from Secretary Azar on the Administration's effort to lower prescription drug prices. For our complete review and what else to watch for this week.

To date, 34 states (including D.C.) have adopted Medicaid expansion. Of the remaining 17 states, some are considering expanding Medicaid.

Congress is back in session for a four week work period. With the focus on opioids, there's the potential that meaningful legislation gets done. We will also continue monitoring state action as it relates to work requirements and other initiatives via 1115 waivers.

In a previous blog, we reviewed pending and approved 1115 waivers in 11 states. These reviews provide an overview of 1115 waiver applications, including a focus on work requirements, lock-outs, changes in coverage structures, repealing the Medicaid IMD exclusion, and other behavioral health initiatives.  

This week, the House is set to vote on Right to Try legislation which has gained the support of FDA Commissioner Scott Gottlieb. In the Senate, the HELP Committee will review the Pandemic and All-Hazards Preparedness and Advancing Innovation Act, or PAHPA, along with rural health care issues, which the Senate Finance Committee also happens to be looking at this week.