Medicaid Expansion Goes to the Polls

By Rahul Nayak

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.

Continue reading

A status update on the Medicaid work requirement landscape

People standing in a line

By Alexandra Slessarev

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. Continue reading

Step therapy explained: An increasingly popular tool for cost control

By Rahul Nayak

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).

Continue reading

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

The Centers for Medicare and Medicaid Services have cancelled an outcomes-based price plan with drug maker Novartis. (Wikimedia Commons)

By Rachel Sachs

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?

Continue reading

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

Health and Human Services Secretary Alex Azar testifying in front of Congress in June. HHS has come under scrutiny for its use of 1115 waivers.

By Carmel Shachar

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.

Continue reading

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 at 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!

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.

Continue reading

FDA Commissioner Rolls Back 40 Years of Orthodoxy on Cost-Exposure

FDA Commissioner Scott Gottlieb

Speaking yesterday at America’s Health Insurance Plans’ (AHIP) National Health Policy Conference, FDA Commissioner Scott Gottlieb railed against patient cost-exposure (e.g., copays).   His prepared speech said:

Patients shouldn’t be penalized by their biology if they need a drug that isn’t on formulary. Patients shouldn’t face exorbitant out of pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries, or is used to buy down the premium costs for everyone else. After all, what’s the point of a big co-pay on a costly cancer drug? Is a patient really in a position to make an economically-based decision? Is the co-pay going to discourage overutilization? Is someone in this situation voluntary seeking chemo?  Of course not.  Yet the big co-pay or rebate on the costly drug can help offset insurers’ payments to the pharmacy, and reduce average insurance premiums. But sick people aren’t supposed to be subsidizing the healthy.

Wow.  This may seem like common sense to some readers, but it is revolutionary to hear from a senior American government official, and indeed a Republican one no less.

In a new paper, Victor Laurion and I have chronicled the ways in which American politicians at the highest levels have blindly embraced the opposite point of view for half-a-century.  This sort of ideological adherence to simplistic economic reasoning (which James Kwak calls ‘economism‘) is  why U.S. health insurance exposes patients to all sorts of deductibles, copays, and coinsurance.  As a result, even insured Americans find themselves “underinsured” — denied access to care or falling into bankruptcy if they stretch to pay nonetheless. Continue reading

REGISTER NOW! Will Value-based Care Save the Health Care System?

Will Value-based Care Save the Health Care System?
March 2, 2018 9:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.

To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

REGISTER NOW! Will Value-based Care Save the Health Care System?

Will Value-based Care Save the Health Care System?
March 2, 2018 9:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.

To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

REGISTER NOW! Will Value-based Care Save the Health Care System?

Will Value-based Care Save the Health Care System?
March 2, 2018 9:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.

To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

How to “Lower Drug Prices” Without Lowering Drug Prices

Yesterday, Alex Azar was sworn in as the Secretary for the Department of Health and Human Services. A key question is whether Azar will take action against high drug prices, and if so, what he will do. At his confirmation hearing, Azar stated clearly that “drug prices are too high.” And during Azar’s swearing-in ceremony, the President stated that Azar was “going to get those prescription drug prices way down.” But I’m skeptical that Secretary Azar will do much to address the problem in the near term.

To be clear, I’m skeptical for a host of reasons, none of which are necessarily reflective of Secretary Azar. Much like health care, drug pricing is complicated. HHS should (and will) worry about potential unintended consequences of drug pricing proposals, proceeding cautiously and taking concerns seriously. HHS’ ability to act may be limited without Congressional involvement, and Congress has thus far been unable to act on this issue. Other proposals may take years to develop or implement, leaving patients without relief in the interim.

As a former President of Eli Lilly, Secretary Azar understands the drug pricing system deeply. He’s absolutely right that “there’s not one action that all of a sudden fixes this.” But if Azar is under pressure to deliver drug pricing changes in the short term, I’d expect to see focus in three main areas. Here’s the problem, though: at least two of these would not necessarily lower drug prices individually or drug spending overall. They might well increase overall spending. Importantly, that may not be a bad thing (as I’ll explain). But they won’t hurt the bottom line of the drug companies the President believes are “getting away with murder,” and they may well bolster it. The third area may lower prices – but it wouldn’t be Azar’s accomplishment.

Continue reading

Medicaid Program Under Siege

This new post by Robert Greenwald and Judith Solomon appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

For more than 50 years, Medicaid has been our nation’s health care safety net. Medicaid allows our lowest-income, sickest, and often most vulnerable populations to get care and treatment, and supports the health of more than 68 million Americans today. As an entitlement program, Medicaid grows to meet demand: There is no such thing as a waiting list. This vital health program found itself under fire in 2017, and while there were no major reductions in funding or enrollment, it is far from safe in 2018. Whether by new legislation or actions the Trump administration may take, the threats to Medicaid are not going away anytime soon.

Congressional Threats To Medicaid’s Expansion, Structure, And Funding

Throughout 2017, Republicans tried unsuccessfully to roll back the Affordable Care Act (ACA), including the law’s expansion of Medicaid. Underpinning each effort was the oft-stated belief, held by Republican leadership, that the expansion was a disastrous move that extended coverage to more than 12 million able-bodied people who should not be getting health insurance from the government. While these unsuccessful efforts were commonly referred to as attempts to “repeal and replace the ACA,” every bill that gained any traction in 2017 went far beyond repealing only the ACA’s Medicaid expansion. The proposals also included plans to fundamentally alter the way in which the traditional Medicaid program is structured and paid for. […]

Read the full post here!

Searching For Stability: The Political Future Of The Affordable Care Act

This new post by Benjamin Sommers and John McDonough appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

Efforts to repeal and replace the coverage expansions in the Affordable Care Act (ACA) as well as the tax increases that financed them were persistent throughout 2017. Even after the congressional Republicans’ highly visible failures earlier this year, they kept coming back—finally succeeding in zeroing out the penalties in the ACA’s individual mandate as part of federal tax cut legislation signed into law in late December.

Of keen interest and importance now is the question: What’s next for the ACA?

Originally, many ACA supporters assumed during the years of the Obama administration that once the law’s major coverage provisions took effect in January 2014, the reality on the ground of a successful coverage expansion and broader insurance benefits would transform the ACA into a popular program—growing in acceptance and inevitability as Social Security, Medicare, and Medicaid all did before it. […]

Read the full article here!

REGISTER NOW! Will Value-based Care Save the Health Care System?

Will Value-based Care Save the Health Care System?
March 2, 2018 9:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.

To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President’s Commission on Combating Drug Addiction Misinterpreted Scientific Studies

By Mason Marks

The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Continue reading

Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading