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.

In the Senate, the Judiciary Committee advanced five bills relating to the opioid crisis, and the HELP Committee advanced the “Opioid Crisis Response Act of 2018,” which has over 40 measures relating to opioids. Most recently (6/12), the Senate Finance Committee unanimously approved the Helping To End Addiction And Lessen (HEAL) Substance Use Disorders Act Of 2018.  That Act includes the expansion of the Physician Payment Sunshine Act to include payments to mid-level providers, as we previously blogged about here.  Click here for a summary of all Senate bills.

On the House side, over the last two weeks, the House passed over 50 bills to combat the opioid crisis and have received bipartisan support. Additional opioid related bills have been introduced and passed out of committee. On June 20, the House voted and passed three additional opioid bills (HR 5925, HR 9797, and HR 6082). Two of these bills were considered controversial. H.R. 5797, The IMD CARE Act, repeals the Medicaid IMD exclusion for individuals with opioid use disorders. H.R. 6082, The Overdose Prevention and Patient Safety Act, amends 42 CFR Part 2 confidentiality protections pertaining to substance use disorder patient records.  Continue Reading Opioids Have Our Attention

In early January, Idaho Governor Butch Otter signed an executive order (EO) directing the state’s Department of Insurance (DOI) to “seek creative options” to expand “access” to health insurance coverage for Idahoans. The EO essentially deemed to allow health carriers in the state to offer plans on the health insurance exchanges created by the Affordable Care Act (ACA) “even if not all [ACA] requirements are met.”[1]  For many spectators, the most significant aspect about the order was not that it instructed a state agency to ignore federal law, but that it left open the question whether the Centers for Medicare & Medicaid Services (“CMS”), under the direction of Trump Administration appointee Seema Verma, would step in to enforce the ACA.  CMS’s response in early March was that it would enforce the ACA’s penalties against carriers that attempted to sell non-compliant plans, which was a rare instance of the Administration defending a law that it has otherwise attempted to eliminate. Continue Reading What Lessons Can We Take From The Administration’s Refusal to Allow Idaho to Dismantle the ACA Marketplaces?

Although the options for accelerated FDA pathways have recently expanded, the current political climate has increased scrutiny of expedited approvals. Next week, my colleague Bethany Hills will be moderating a panel discussion in our Boston office about the realities of pursuing an accelerated pathway. Panelists from J&J Innovation, Synlogic, and Analysis Group will focus on the risks and potential rewards of the shorter time to market.

Topics to be covered include:

  • When to consider an alternative pathway to approval
  • Risks – including the chance of FDA denial
  • Market perceptions — increased value, rising stock prices
  • Realities of the pathways
  • Clinical and data risks
  • Pairing exclusivity and accelerated pathways
  • Finance theory on risk and stock pricing

The event will take place next Thursday, March 29th at 5:00 PM in our Boston office (registration starts at 4:30). For more information or to register or the event, please click here.

This week, Congress returns to Washington with 11 days to finalize a government spending bill. Standing in the way are a number of unresolved health care issues, including drug pricing and market stabilization. There are a number of moving parts that will begin to come together this week. Also on our radar screen is the ongoing marketplace issues in the state of Idaho, where the federal government is urging the state to consider short-term limited duration insurance plans. We cover this and more in the health care preview, which you can find here.

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D  Proposed Rule (Proposed Rules) by setting out a framework for Part D plans to monitor and reduce the potential misuse of frequently abused prescription drugs. (Those interested in a high-level overview of the Proposed Rules should see our post from last month). Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

Last week, ML Strategies released an Advisory providing a comprehensive review of the Republican’s efforts this past year to repeal and replace the Affordable Care Act.   The Advisory, published September 22, 2017, walks through the evolution of the Republican’s efforts beginning with the American Health Care Act and ending with an analysis of the Graham-Cassidy bill, which died in the Senate earlier this week.  With the Republican’s commitment to get something called “repeal and replace” passed, we expect these efforts will continue.  Understanding this evolution may provide insight on where we could be headed.

 

This week, in their “Future of the Affordable Care Act” series on our Employment Matters blog, my colleagues Alden Bianchi and Edward Lenz provided an analysis of the major provisions of the American Health Care Act (“AHCA”).

Introduced on March 6, 2017, the AHCA is the first concrete legislative proposal detailing the initial provisions designed to repeal and replace the Affordable Care Act.  As Alden and Ed discuss, the bill currently is the subject of widespread media scrutiny and intense criticism.  The bill is not final and will likely face numerous changes, including the last minute proposals changes of the past 48 hours.  The March 6th version offers an outline of Republican priorities in the regulation of health and health care financing, which include a strong bias in favor of market-based solutions and aversion to most (but not all) government intervention in the health care markets.

Check out their full analysis on The Future of the Affordable Care Act Week 7: The American Health Care Act, here. Continue Reading Future of the Affordable Care Act and the American Health Care Act

ML Strategies has published its Washington Outlook for 2017, with a collection of materials covering what to expect from the 115th Congress, spanning multiple issues and industries.

For Health Care stakeholders, ML Strategies considers priorities that have been identified by the Trump Administration and the Republican-controlled Congress, and forecasts possible legislative and administrative actions to move their agendas along. We all know that the ACA is a target, and whether the chosen path forward is repeal and replace, or repair and rebuild, there are some key components of the law that are vital to a healthy marketplace.  ML Strategies outlines some strategies and tactics we might see in the coming weeks.

In addition to ACA repeal, the Health Care Outlook also discusses key Administration appointees for HHS, CMS and FDA, as well as potential policy advisors. There are also a number of Congressional acts up for reauthorization – the “UFAs” for FDA, CHIP and Medicare outpatient therapy caps – each important in its own right, but which also creates opportunities for ‘ride-along’ policy initiatives.

Finally, ML Strategies looks to what may happen to the ACA cost-sharing reductions with the House v. Burwell litigation, and considers whether Telemedicine might provide an opportunity for this new Congress to work together, across party lines.

Access the ML Strategies 2017 Outlook: Health Care here.

Access the comprehensive ML Strategies Washington Outlook for 2017 here.

 

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward with the demo.

The demonstration was intended to test new reimbursement methods for Medicare Part B drugs and to promote value-based and cost-effective drug purchasing.  Despite its intentions, major patient, pharmaceutical, and physician groups criticized the scope of the rule and the speed in which CMS was implementing it.  Many worried it would restrict or limit access to certain drugs.  It also drew sharp criticism from several members of Congress, including President-elect’s nominee for the Secretary of Health and Human Services, Rep. Tom Price. Continue Reading The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger