Pill pack.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron 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 March. The selections feature topics ranging from a discussion of patient assistance programs and the Anti-Kickback Statute, to an analysis of the effects of state opioid prescribing laws on the use of opioids and other pain treatments, to an evaluation of the association between regulatory drug safety advisories and changes in drug use. A full posting of abstracts/summaries of these articles may be found on our website.

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Waiting area in a doctor's office

Churntables: A Look at the Record on Medicaid Redetermination Plans

By Cathy Zhang

The COVID-19 Public Health Emergency (PHE) expires at the end of this week, with Department of Health and Human Services (HHS) Secretary Xavier Becerra expected to renew the PHE once more to extend through mid-July.

When the PHE ultimately expires, this will also trigger the end of the Medicaid continuous enrollment requirement, under which states must provide continuous Medicaid coverage for enrollees through the end of the last month of the PHE in order to receive enhanced federal funding. This policy improves coverage and helps reduce churn, which is associated with poor health outcomes.

After the PHE, states can facilitate smooth transitions for those no longer eligible for Medicaid by taking advantage of the full 12- to 14- month period that the Centers for Medicare & Medicaid Services (CMS) has established for redetermining eligibility.

In August 2021, CMS released guidance giving states up to 12 months following the end of the PHE to redetermine whether Medicaid enrollees were still eligible and renew coverage. Last month, CMS released new guidance specifying that states must initiate redeterminations and renewals within 12 months of the PHE ending, but have up to 14 months to complete them. The agency is encouraging states to spread its renewals over the course of the full 12-month unwinding period, processing no more than 1/9th of their caseloads in a month, in order to reduce the risk of inappropriate terminations.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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

By Ameet SarpatwariBeatrice Brown, Aviva Wang, 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 February. The selections feature topics ranging from an analysis of how the Bayh-Dole Act can be updated to promote innovation and affordable access to drugs developed using federal funds, to an examination of the upcoming reauthorization of the Prescription Drug User Fee Act and its implications for FDA regulation and policies, to a systematic review and meta-analysis of preapproval clinical testing of biosimilars used in the treatment of cancer. A full posting of abstracts/summaries of these articles may be found on our website.

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Person in nursing home.

Struggles Over Care Will Shape the Future of Work

By Andrew Milne

The future of work will largely be the future of care work. Health care is rapidly becoming the largest employer in the U.S., expanding to serve the fastest growing demographic, aging seniors. As a lawyer for seniors in need of free legal services, I see my clients struggle to access care made scarce by the for-profit care industry’s understaffing and underpaying of workers attempting to meet the growing need. The future of work and of aging will be shaped by struggles over care from both giving and receiving ends, perhaps against those profiting in between.

Recall that the first COVID-19 outbreak in the U.S. spread between nursing homes. These facilities, like most nursing homes, are for-profit businesses that pad their margins by cutting labor costs. The resulting understaffing has deadly effects in normal times. The pandemic intensified those effects, as underpaid care workers, forced to work at multiple facilities to survive, unintentionally spread the virus between facilities.

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Lady Justice blindfolded with scales.

Achieving Economic Security for Disabled People During COVID-19 and Beyond

By Robyn Powell

The COVID-19 pandemic has highlighted the pervasive inequities experienced by historically marginalized communities, including people with disabilities.

Activists, legal professionals, scholars, and policymakers must critically examine the limitations of our current disability laws and policies, including the Americans with Disabilities Act (ADA), to elucidate why disabled people continue to endure these inequities, including those related to economic insecurity.

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Large pile of amber prescription pill bottles

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

By Ameet Sarpatwari, Alexander Egilman, 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 January. The selections feature topics ranging from a discussion of why state laws restricting mifepristone access may be subject to federal preemption, to an analysis of patents impacting the availability of biosimilars, to an evaluation of the hypothetical out-of-pocket costs of guideline-recommended medications for the treatment of older adults with multiple chronic diseases. A full posting of abstracts/summaries of these articles may be found on our website.

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Up close shot of an orange prison jumpsuit

Prison Health Care is Broken Under the Medicaid Inmate Exclusion Policy

By Sarah Wang

Incarcerated individuals need health care, but punitive policies make securing access to care particularly difficult among this population, which numbers about 2.1 million as of 2021.

As a first step to protecting incarcerated individuals’ right to health, Congress should repeal the Medicaid Inmate Exclusion Policy (MIEP).

The MIEP, established in 1965, prohibits Medicaid from covering incarcerated individuals, despite any prior eligibility. Through the MIEP, two populations are affected: first, jail inmates, defined as those convicted or accused of a crime, and second, prison inmates, defined as those convicted or awaiting trial. In other words, both convicted individuals and those still presumed innocent are stripped of their access to the federal health insurance program for low-income individuals.

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Busy Nurse's Station In Modern Hospital

Call Your Senator and Help Give Doctors a Break

By Jacob Madden

Want to help make a big change for our nation’s overworked doctors? Call your senator and tell them to hire more.

In March of this year, Senators Robert Menendez (D-N.J.), John Boozman (R-Ark.), and Chuck Schumer (D-N.Y.) introduced S.834, the Resident Physician Shortage Reduction Act to confront the country’s growing shortage of doctors.

The proposed legislation will increase the number of resident physician positions supported by Medicare by 2,000 each year from 2023 to 2029, for a total of 14,000 newly supported positions.

This legislation could make a small but significant dent in the nation’s physician shortage. By 2034, the Association of American Medical Colleges expects a shortage ranging from 17,800 to 48,000 primary care physicians, and 21,000 to 77,100 non-primary care physicians. Take both worst-case scenarios, and we are short 125,100 doctors.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

What Democrats’ Drug Pricing Plan Means for Consumers

By Cathy Zhang

At the start of the month, Democrats announced a new drug pricing plan, detailed in the House’s Build Back Better Act (H.R. 5376). In the immediate short term, the drug pricing plan has enabled the $1.75 trillion bill to go forward through the House. If ultimately enacted, it will generate savings for consumers, some more directly than others, and at a more modest pace and magnitude than many had hoped.

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Senior citizen woman in wheelchair in a nursing home.

The Barriers to Aging in Place

By Renu Thomas and John Roth

The COVID-19 pandemic has highlighted the risks associated with institutionalized care for the elderly, and has further shifted sentiments toward a preference for aging in place. But most seniors and their loved ones don’t realize the barriers that make aging in place a difficult proposition until a crisis occurs and they’re faced with finding services.

Take our family, for example. My father was diagnosed with Parkinson’s disease and it was after his first fall and discharge from the hospital that our family realized my parents’ independence was severely limited. We knew their house was not wheelchair or walker accessible, but we also needed to address other issues as well; neither of them could drive anymore, so how would we get them to appointments, how would their prescriptions and groceries get picked up, and how could we prevent them from being socially isolated? Like many families, we do not live nearby, let alone in the same state, which made coordinating these services even more challenging.

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