a pill in place of a model globe

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Beatrice Brown, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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Hundred dollar bills rolled up in a pill bottle

Aducanumab: A Bitter Pill to Swallow

By Emily Largent

On June 7, the U.S. Food and Drug Administration (FDA) used the Accelerated Approval pathway to approve aducanumab, which will go by the brand name Aduhelm, to treat patients with Alzheimer’s disease (AD). Aducanumab, developed by Biogen, is the first novel therapy approved for AD since 2003. This news has left many experts stunned.

I have at least one colleague, Dr. Jason Karlawish, who has publicly stated that he will not prescribe aducanumab. Other clinicians have said they will only prescribe it reluctantly. These are individuals who have dedicated decades of their lives to treating patients with AD, to conducting path-breaking research and serving as investigators in clinical trials, and to advocating for public policies that will better serve AD patients and their families. Many have also seen their own families affected by AD. My colleagues are hardly indifferent to the suffering wrought by AD and would like to have a meaningful treatment to offer to patients and their families. But, they have concluded, aducanumab is not it.

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Senior citizen woman in wheelchair in a nursing home.

COVID-19 and Dementia Care: Lessons for the Future

By Marie Clouqueur, Brent P. Forester, and Ipsit V. Vahia

Alongside the COVID-19 epidemic in the U.S., the country faces another public health epidemic: dementia, and particularly Alzheimer’s disease.

Currently one in nine older adults in the U.S. — 6.2 million — have Alzheimer’s disease. The number of adults with Alzheimer’s in the U.S. will increase rapidly as the Baby Boomers age — it is expected to double by 2050.

The COVID-19 pandemic has exacerbated the situation. Acute, surging demand for dementia care services will turn into a persistent problem if we do not increase our capacity for services and better support our frontline workers. We have a chance now to reflect and take action to prepare for what is coming.

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Map of the United States.

Health Reform via State Waiver

By Erin Fuse Brown and Chelsea Campbell

The path to systemic health reform in the U.S. may run through the states. To get there, the Biden/Harris administration should use its existing waiver authority under federal health care statutes to facilitate progressive state health reform efforts, including a state-based public option or single-payer plan.

One of the benefits of the United States’ federalist system, in which the power to enact policy and govern is divided between the national government and the states, is that we can test policies at the state level, and if we can establish a proof of concept there, it smooths the way for federal reform.

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U.S. Capitol Building.

Possibilities and Pitfalls of Health Reform Through Budget Reconciliation

By Nicole Huberfeld

The Biden administration entered office promising health reform. But the evenly-split Senate means ten Republican votes are necessary to move major legislation — cooperation that seems unlikely after years of Republican attempts to repeal and obstruct the Affordable Care Act (ACA).

Still, expanding health insurance coverage may be on the menu through budget reconciliation. A budget reconciliation bill progresses with a simple majority vote: special rules limit debate and make filibuster impossible.

The Biden administration has already navigated budget reconciliation to enact speedy health policy measures in response to the pandemic. Signed March 11, the American Rescue Plan Act of 2021 (ARPA) is a reconciliation bill which, among other things, offers federal money to support states’ and localities’ public health needs; facilitates economic recovery; increases tax subsidies provided through health insurance exchanges to expand affordability; and builds on the ACA and 2020 COVID relief bills by offering Medicaid non-expansion states an enhanced federal match of 5% for each enrollee to encourage expansion and counterbalance costs. The ARPA also addresses determinants of health and health equity, for example by extending the option of maternal Medicaid coverage for a year after the 60-day post-partum period and creating a new child tax credit. Most provisions last no more than two years.

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Grafton, Illinois, USA, June 1, 2019 -Car submerged under flood water in small river town, Grafton, Illinois, as Mississippi River floods roads, businesses and houses. vehicle under water, men in boat

Bail Out Humans

By Christina S. Ho

This past year has sensitized us politically to government’s affirmative obligations, especially the duty to backstop health catastrophes in order to dampen the risks that ordinary people must bear. 

Our government bails out large risks in so many other arenas. Yet we too often fail to backstop the most human risk of all — our vulnerability to suffering and death. 

Throngs of scholars have described our deep tradition of government-sponsored risk mitigation to nurture favored private activities and expectations, and relieve those favored actors from catastrophes beyond what they could be expected to plan for. I have characterized this distinctive political role figuratively as one of “government as reinsurer.”

The federal government provides standard reinsurance for private crop insurers, virtually full risk-assumption for private flood insurance, guarantees for employer pension benefits, robust backstops for bank liquidity risks, FHA mortgage insurance and a federal secondary market to absorb the risks of housing finance.

In these arenas and more, statistically correlated or high-magnitude catastrophic losses are shed onto the state in order to smooth out and shore up the underlying private risk market. We have yet to commit similarly in the health care domain. 

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People protesting with signs that say "healthcare is a human right" and "medicare for all."

A Long View on Health Insurance Reform: The Case for an Employer Public Option

By Allison K. Hoffman

Historically, job-based health insurance coverage was the gold standard. It was broadly available to workers and was comprehensive. It covered the lion’s share of most services someone might need. 

Yet, job-based private health coverage has been in decline. Employers are struggling to maintain plans in the face of escalating health care prices, and indicating the need for government involvement to solve this problem.  

Even before the pandemic, a decreasing share of workers, especially lower wage workers, had health benefits through their jobs. The majority of the currently uninsured are workers, either those whose jobs do not offer them coverage, such as gig workers and part-time workers, or those who are offered coverage but cannot afford their share of the cost. Ironically, some of these workers become ineligible for Affordable Care Act (ACA) marketplace subsidies because they are offered job-based coverage. 

Even for those who have job-based coverage, health benefits have become less generous over time, leaving households vulnerable to unmanageable health care expenses. The average deductible for a worker-only plan has increased 25% over the last five years and 79% over the last ten years. 

To help address these shortcomings and challenges of job-based coverage, the Biden administration should offer employers a Medicare-based public health insurance option for their employee coverage. It would simultaneously offer an out for employers who want it, and start to build the foundation for a simpler, more equitable financing system down the road.

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doctor holding clipboard.

Transformation of Behavioral Health Care Through Section 1115 Waivers

By John Jacobi

As the Biden administration works to improve health access and transform health delivery, behavioral health reform should be at the front of the queue.

People with severe mental illness and opioid use disorder are dying young for lack of routine health care. Much of the work that needs to be done in behavioral health is developed or developing at the state level. But the Biden administration has a powerful tool for encouraging state-level innovation in the § 1115 Medicaid waiver process.

Reform through state waivers

Section 1115 waiver authority permits the Department of Health and Human Services to approve pilots and demonstrations if they are found likely to promote the objectives of the Medicaid program. Waivers, which do not require Congressional or formal regulatory enactments, permit relatively rapid cycling of innovation, in contrast to the lumbering pace of legislative or regulatory change.

While applications for waivers originate with the states, presidents have set the agenda by signaling what categories of waivers will be looked upon favorably, offering the administration the ability to put its stamp on the development of care for low-income and disabled people.

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Hand holding pencil drawing a path.

Roll Back Harmful Section 1115 Waivers: Charting the Path Forward

By Sidney D. Watson

On March 18, 2021, the U.S. Department of Health and Human Services (HHS) sent formal notices to Arkansas and New Hampshire that it was withdrawing their Section 1115 waivers that allowed the states to require poor adults to work as a condition of Medicaid coverage.  

This appears to be the first time that HHS has invoked its authority to rescind an approved 1115 waiver. It won’t be the last. 

Waiver withdrawals provide a path forward for the Biden administration to end a grab bag of Trump-era Section 1115 waivers that create a risk of loss in coverage and harm to Medicaid beneficiaries.  

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Illustration of fetus, DNA, lab supplies

Assisted Reproductive Technologies: A Bioethical Argument for Medicaid Coverage

By Sravya Chary

Assisted reproductive technologies (ARTs) such as artificial insemination, egg retrieval, and in-vitro fertilization (IVF) have revolutionized the landscape for people facing reproductive obstacles. Disappointingly, none of these technologies are covered under Medicaid — an insurance program for low-income adults and children, and people with qualifying disabilities.

Given the high prices of ARTs, those on Medicaid, which includes a disproportionate number of BIPOC individuals, are left behind in sharing the benefits of advancements in reproductive technologies. It is vital for ARTs to be covered under Medicaid to uphold reproductive justice and autonomy for this patient population.

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