A male pharmacist is examining a drug from a pharmacy inventory.

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 April. The selections feature topics ranging from a discussion of manufacturer’s restricted delivery of 340B drugs to contract pharmacies and ensuing litigation, to an analysis mapping the European patent landscape for medical uses of known products, to an evaluation of the clinical benefit of novel drugs approved in the U.S. from 2018-2019. 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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Baby feet in hands

Regulatory Barriers Present Challenges for At-home Birth

By Bailey Kennedy

Statistics released at the end of last year confirmed what many already knew anecdotally to be true. Many women had turned to home births during the pandemic.

While the absolute number of women who chose to use home birth to deliver their children was quite small — about 9,000 more women chose to give birth at home in 2020 versus 2019 — the percentage increase was notable. In South Dakota, an eye-popping 68% more women gave birth at home during the first year of the pandemic, as opposed to prior years.

The reasons for this shift were as varied as the women who made the decision to give birth in a non-hospital setting. Some women cited concerns that they were especially susceptible to COVID-19; others feared not having access to the support of family and friends if they chose to give birth in a hospital. Others, of course, had been interested in giving birth outside of a hospital prior to COVID, and would have done so even in the absence of the virus.

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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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Social Security Administration Important Information letter next to flag of USA.

Blue Booking Long COVID: Accounting for Long-Term COVID-19 Complications in Social Security Disability Benefits Evaluations

By Jacob Madden

Long COVID has left an estimated 1.6 million Americans unable to work. Those experiencing Long COVID face long-term neurological issues, heart problems, lung damage, and myriad other complications following an initial bout with COVID-19.

Though some who are incapacitated by Long COVID will eventually be able to return to work, others may never work again. Going forward, we must find a way to account and provide for these individuals. Here I suggest a potential solution in amending the Social Security Administration’s Blue Book to include Long COVID in the evaluation of disability benefits.

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Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

A ‘Middle Ground’ in the Legal Abortion Debate Disproportionately Harms Marginalized Communities

By Adrienne R. Ghorashi, Esq.

All eyes are on SCOTUS after the Court heard oral arguments on Mississippi’s 15-week abortion ban in Dobbs v. Jackson Women’s Health Organization and issued narrow rulings in cases related to Texas SB8 early this month. The line of questioning, as well as the Court’s continued decision to allow most abortions in Texas to come to a screeching halt, are a distressing signal that abortion rights are in immediate danger. Under Roe and Casey, bans on abortion prior to fetal viability (around 24 weeks) are a violation of a pregnant person’s constitutional right. While some have characterized Chief Justice Robert’s comments as searching for a supposed compromise to overturning Roe, this proposition ignores the stark reality of the legal landscape of abortion in the United States.

Pre-viability abortion bans, such as the one in Dobbs, already exist in 25 states, ranging from bans at any point in pregnancy, to 6-week “fetal heartbeat” bans, to the more common 20-week ban. Pre-viability abortion bans can also include “reason-based” bans that seek to prohibit abortion based on a person’s reason for seeking one. Many of these states have more than one type of abortion ban in their laws. Although most of the more extreme pre-viability bans are not currently in effect due to court rulings (with Texas SB8 being a frightening harbinger of a post-Roe nation), this legal standard is precisely what’s at stake in Dobbs.

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Chicago, IL, USA - October 18 2021: BinaxNOW Covid-19 Antigen Self Test. Results in 15 minutes at home.

The Devil is in the Details with Biden’s Free COVID Testing Plan

By David A. Simon

Yesterday, President Biden announced a new requirement that private insurers must reimburse purchases of at-home COVID-19 tests.

This represents a significant departure from current policy, which only requires insurance companies to pay for testing at the direction of a healthcare provider. The new policy has yet to take effect — the Department of Health and Human Services (HHS) will release formal guidance for private insurers by January 15th.

Removing the need for clinician approval to access free COVID-19 testing is a noteworthy step; however, the new policy raises a host of questions that remain to be addressed, which are discussed briefly below.

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A male pharmacist is examining a drug from a pharmacy inventory.

HHS’ New Prescription Drug and Health Care Spending Rule

By Cathy Zhang

Today, the Department of Health and Human Services — alongside the Department of Labor, the Department of the Treasury, and the Office of Personnel Management — published an interim final rule requiring health insurance plans and issuers on the marketplace to report data on prescription drug and health care spending to the three Departments.

This rule is part of a series of rules issued by the Biden Administration to implement Title I (No Surprises Act) and Title II (Transparency) of the Consolidated Appropriations Act, 2021.

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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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