Congress’s opioids package and the politics of the IMD exclusion

At the end of September, the Senate passed a final version of an expansive legislative package designed to tackle the United States opioid epidemic. The package contains a broad range of policy approaches to the crisis, including enhanced tracking of fentanyl in the U.S. mail system, improved access to Medication Assisted Treatment and addiction specialists, and lifted restrictions on telemedicine and inpatient addiction treatment. The package, which now sits on President Trump’s desk, is widely expected to be signed into law.

The legislative effort has been lauded as a rare act of bipartisanship in an otherwise-polarized Washington.

The Washington Post called the set of bills “one of the only major pieces of legislation Congress is expected to pass this year.” A Time headline declared that “Opioid Bill Shows Congress Can Still Work Together.” Praise of this across-the-aisle effort is merited: the Senate voted for the set of bills 98-1, and the House voted for it 393-8.

While critics have rightfully pointed out that the package does not provide for enough increased spending to address the crisis, with more than 72,000 people dying from drug overdoses in 2017, the time is ripe for a collaborative approach to the opioid crisis, and any effort helps.

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Mary Mayhew: The New Anti-Medicaid Head of Medicaid

Mary Mayhew, a fierce opponent of Medicaid Expansion under the Affordable Care Act, was announced on October 15 as the new Deputy Administrator and Director of the U.S. Center for Medicaid and CHIP [Children’s Health Insurance Program] Services. As the House Ways and Means Committee Democrats put it in a recent tweet, the Trump Administration’s choice “is like hiring an arsonist to be a city’s fire chief.”

Mayhew spent years as commissioner of Maine’s Department of Health and Human Services under outgoing Governor Paul LePage. She stepped down in May 2017. After her time as commissioner, Mayhew pursued an unsuccessful race for Governor of Maine, coming in third in the Republican Primary this past June.

The Maine Department of Health and Human Services’ approach to Medicaid under Mayhew’s leadership does not exactly suggest she will take an expansive approach to Medicaid in her new role. According to the ACLU of Maine, enrollment in MaineCare, Maine’s Medicaid program, decreased by 37 percent during her time in office, eliminating coverage for about 80,000 people.

The state also dropped from 10th to 22nd in national health rankings.

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image showing a line of voting booths, with legs showing

Medicaid Expansion Goes to the Polls

With the 2018 midterm elections fast approaching, there are key some voter propositions with important health implications.

Most notably, this November, voters in three conservative states — Idaho (Proposition 2), Utah (Proposition 3), and Nebraska (Initiative 427) — will be deciding on whether to expand Medicaid. In addition, voters in Montana will decide whether to permanently extend their state’s Medicaid expansion. This is coming at the heels of the closely watched November 2017 referendum where Mainers decisively supported Medicaid expansion 59 percent  to 41 percent.

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waiting in line

A status update on the Medicaid work requirement landscape

Earlier this week, Michigan submitted a proposal to the Trump administration requesting approval to impose work requirements on Medicaid expansion beneficiaries. Michigan’s proposal was submitted through the Medicaid Act’s section 1115 waiver program, which allows states to introduce experimental projects that “further the objectives” of the Act. (For a more in-depth discussion of the function of section 1115 waivers in the Medicaid scheme, see Carmel Shachar’s Bill of Health post from earlier this summer.)

Work requirement waivers garnered a rush of attention after the Trump administration issued guidance indicating that it would begin approving such requests. Michigan is now one of twelve states that have submitted a work requirement proposal, with four of those states having successfully received approval from HHS.

This recent development in Michigan provides an opportunity to take stock of the Medicaid work requirement landscape since the Trump administration began approving the waivers. Read More

shopping trolley with medicine

Step therapy explained: An increasingly popular tool for cost control

News that the Centers for Medicare and Medicaid Services will allow Medicare Advantage programs to enact “step therapy” programs for drugs under Part B as part of an effort to combat rising drug prices has been making rounds in the health policy world recently.

Step therapy is used by all major private insurers and is aimed at curbing expenditures on expensive drugs. It requires that a patient to try a less expensive alternative treatment. Those who fail treatment with the less expensive drug would then be eligible for coverage of the more expensive treatment. Note that it is very similar to prior authorization, a ubiquitous policy tool in which a drug is approved for coverage only after ensuring certain clinical criteria are met.

What was once a relatively rare tool is now commonly used. I examined UnitedHealthcare’s list of step therapy drugs and there are now over 100 listings. This is an order of magnitude increase from the number of drugs listed just four years ago, when I first got interested in this issue.

Drugs listed for step therapy tend to be either new, extremely expensive therapies (e.g., 3rd-line biologics for rheumatoid arthritis, sofosbuvir for hepatitis C) or more expensive formulations of common drugs (e.g., extended release formulation of quetiapine).

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CMS Abandonment of Outcomes-Based Payment Deal with Novartis is a Missed Opportunity

Earlier this week, Politico broke the news that the Centers for Medicare and Medicaid Services (CMS) had withdrawn its outcomes-based payment deal for Novartis’ CAR-T therapy, Kymriah, without public acknowledgement.

The Food and Drug Administration’s approval of Kymriah in August of last year was accompanied by the announcement of a novel outcomes-based agreement with CMS, in which CMS would pay for Kymriah only if patients had responded to it by the end of the first month. Now, CMS has quietly backed away from that agreement. What does the deal – and its subsequent abandonment – tell us about CMS’ involvement in outcomes-based contracts going forward?

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Setting Hard Limits: A Federal District Court Puts up Major Hurdle to the Reworking of Medicaid in Stewart v. Azar

Since the Republican controlled Congress failed to repeal the Affordable Care Act in 2017, the Trump administration has been trying to implement its more conservative vision of Medicaid through waivers. On June 29, 2018, however, the D.C. federal district court issued a decision in Stewart v. Azar which would make it significantly more difficult for an administration to rework Medicaid without a congressional mandate.

This case, should it survive subsequent appeals, will represent an important turning point in the ability the Department of Health and Human Services has to shrink or undermine Medicaid through the use of administrative waivers.

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Call for Proposals: Symposium – Serving the Needs of Medicaid Populations

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions for presentation at our Twelfth Annual Health Law Symposium: Serving the Needs of Medicaid Populations. The Symposium will take place at Loyola University Chicago School of Law on Friday, November 16, 2018.

The Symposium will explore whether the current Medicaid system is adequately serving the needs of its target population, and how social determinants of health affect access to care in the context of Medicaid. The Symposium is intended to touch upon a wide variety of areas responsive to this overall theme.  Accordingly, we invite submissions addressing any and all aspects of Medicaid and/or its impact upon accessible, quality patient care. Possible approaches to this Call for Proposals include, but are not limited to:

  • Medicaid’s impact on the financial viability of hospital systems and physician practices and the effect this has on access to health care. Topics may explore the financial burdens and/or benefits faced by health systems after Medicaid expansion, economic viability of health systems in states that did not expand Medicaid, and corporate restructuring in the wake of Medicaid reform.
  • The current status of Medicaid in relation to access to health care. Topics may include the health access trends within states that expanded or shrunk Medicaid, state use of Medicaid waivers, Medicaid work requirements, and shifts in DHHS practices and policies.
  • Populations underserved by Medicaid. Topics may explore immigrant access to care in Medicaid, access problems surrounding individuals with medical complexities, and children with disabilities in Medicaid.
  • Proposals to reform Medicaid in order to increase access and reduce social disparities. Topics may include new proposed models that increase access to care, the ACA’s role in expanding access under Medicaid, and bridging the disconnect between health care spending and health outcomes in the United States through Medicaid reform.

Submission Information: Those interested in participating, please send a 1000-word abstract to health-law@luc.edu by June 16, 2018.  Authors will be notified of decisions no later than July 14, 2018. It is our hope presenters will submit papers for publication in the Annals of Health Law. Papers submitted for publication will be due by January 8, 2019.

Massachusetts Wants To Drive Down Medicaid Drug Costs: Why Is The Administration So Nervous?

This new post by Nicholas Bagley and Rachel Sachs appears on the Health Affairs Blog. 

Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration, however expensive they are and however slim their clinical benefits may be.

Massachusetts would like to change all that. In a recent waiver proposal, Massachusetts asked the Centers for Medicare and Medicaid Services (CMS) to allow it to adopt a closed formulary in Medicaid. That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.

Among Medicaid advocates, the proposal is controversial. Some fear that state budgets would be balanced on the backs of Medicaid beneficiaries, who could be denied access to expensive therapies. But Massachusetts thinks there’s room to drive down drug spending without threatening access to needed medications. In any event, the state has to do something. Drug spending in Massachusetts has increased, on average, 13 percent annually since 2010, threatening to “crowd out important spending on health care and other critical programs.”

By all rights, CMS should welcome Massachusetts’s proposal. Closed drug formularies are tried-and-true, market-based approaches to fostering competition over drug prices, and the Trump administration’s Council on Economic Advisers recently released a report saying that “government policy should induce price competition” in Medicaid. If Secretary of Health and Human Services (HHS) Alex Azar means it when he says that “drug prices are too high,” letting Massachusetts try out a formulary makes a ton of sense. […]

 Read the Full post here!

TOMORROW! Health in the Headlines: Reporting on Health Policy in the Trump Era

Health in the Headlines: Reporting on Health Policy in the Trump Era
April 4, 2018 12:00 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join the Center for Health Law and Policy Innovation for a panel discusison with leading health care journalists about the rapidly shifting health policy landscape in Washington DC. The panel will discuss the high drama of a tumultuous year in health policy that has seen repeated congressional attempts to repeal the Affordable Care Act, the resignation of a cabinet secretary amidst scandal, and a steady effort to undermine Obama-era priorities. Further, the panel will explore the role of journalism in modern policy-making, and how social media impacts the dialogue.

Sponsored by the Center for Health Law and Policy Innovation at Harvard Law School; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Shorenstein Center on Media, Politics and Public Policy at the Harvard Kennedy School of Government; the Harvard PhD Program in Health Policy; the Harvard T. H. Chan Student Association (HCSA) at the Harvard T. H. Chan School of Public Health; and the Harvard Health Law Society at Harvard Law School. 

Learn more about the event here!