The White House, Washington, DC.

What Can the Federal Government Do When States Make Dangerous Decisions?

By Jennifer S. Bard

The threat posed to the welfare, economy, and security of the United States by the rapidly spreading COVID-19 virus is as serious as any we have ever confronted.

But, at the same time that the federal government is spending billions of dollars on distributing vaccines, and exerting their authority by prohibiting evictions and requiring masks on public transportation, many individual states are not just refusing to take effective measures to stop the spread, but also are pouring gasoline on the fire by doing all they can to undermine even the remaining, weak guidelines published by the CDC. Some have gone so far as to restrict the flow of information by prohibiting public health officials from disseminating news about the vaccines provided by the federal government.

The effects of these actions not only promote the spread of COVID-19, but also fuel its mutation into new forms, and cannot be confined by any existing geographic or cartographic boundary. So how is the federal government allowing this to happen? It’s not for lack of authority.

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image of the US Supreme Court

The Patent Trial and Appeal Board Again Survives Supreme Court Review

By Gregory Curfman

For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.

In his opinion, Chief Justice John Roberts allowed the Patent Trial and Appeal Board (PTAB) to survive and to continue to provide an alternative route for generic drugs and biosimilars to gain early market entry.

Patients, who may rely heavily on these less costly alternatives for their prescription drugs, will also benefit significantly from the Court’s decision in this case.

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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

The Many Harms of State Bills Blocking Youth Access to Gender-Affirming Care

By Chloe Reichel

State legislation blocking trans youth from accessing gender-affirming care puts kids at risk, thwarts physician autonomy, and potentially violates a number of federal laws, write Jack L. Turban, Katherine L. Kraschel, and I. Glenn Cohen in a viewpoint published today in JAMA.

So far this year, 15 states have proposed bills that would limit access to gender-affirming care. One of these bills, Arkansas’ HB1570/SB347, already has become law.

This legislative trend should be troubling to all, explained Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. In an email interview, he highlighted “how exceptionally restrictive these proposed laws are,” adding that they are “out of step with usual medical, ethical, and legal rules regarding discretion of the medical profession and space for parental decision-making.”

Turban, child and adolescent psychiatry fellow at Stanford University School of Medicine also offered further insight as to the medical and legal concerns these bills raise over email.

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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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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

Now Is the Time for a Sex-Based Civil Rights Movement in Health Care

By Valarie K. Blake

The Biden administration and all three branches of government are poised to finally deliver a sex-based civil rights movement in health care that generations have waited for.

Sex discrimination is prevalent in health care, but especially so for LGBTQ people. Combine this with other forms of discrimination that LGBTQ people experience, and the result is a population that suffers from serious health disparities, including heightened risks of mental health conditions, substance use disorders, and suicide.

A much needed ban on sex discrimination in health care finally passed in 2010, as part of the Affordable Care Act (ACA). Section 1557 of the ACA prohibits health care entities that receive federal money from discriminating on the basis of sex, along with race, age, and disability. Specifically, Section 1557 bans sex discrimination in health care by way of extending Title IX, which previously applied to educational entities only. Section 1557 reaches most hospitals, providers, and insurers. Sex equality in health was a long time coming. Similar bans on discrimination by recipients of federal money had passed decades earlier: race discrimination in 1964, disability discrimination in 1973, and age discrimination in 1975.

Despite its historic nature, Section 1557 has yet to deliver on its promise, owing to delays and volatility in rulemaking and near-constant litigation. The statute was barebones, requiring interpretation, but the Obama administration only promulgated a rule and began full enforcement six years after the passage of the ACA. The Obama rule broadly banned gender identity and sexual orientation discrimination, but the part of the rule banning gender identity discrimination was judicially stayed only months later in Franciscan Alliance v. Burwell.

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U.S. Capitol Building at Night

A Legislative Override Could Save the ACA (and Fix Other Misapplications of Health Laws)

By John Aloysius Cogan, Jr.

The Congressional Democrats and the Biden administration need not wait for the Supreme Court to determine the fate of the Affordable Care Act (ACA) in California v. Texas; they can take charge of the case today by enacting and signing into law overriding legislation. 

Since the threat to the ACA is based on the interpretation of a federal statute — the ACA’s “inseverability clause” — Congress is within its rights to take charge of the case. Why? Because courts are not the final word on the meaning of a statute, Congress is.

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Medical bill and health insurance claim form with calculator.

Price Transparency: Progress, But Not Yet Celebration

By Wendy Netter Epstein

Price transparency has long eluded the health care industry, but change — fueled by rare bipartisan support — is afoot. 

The Trump Administration promulgated new rules relating to health care price transparency, and the Biden Administration seems poised to keep them. Though patients have grown accustomed to going to the doctor and agreeing to pay the bill — whatever it ends up being — they aren’t happy about it. The majority of the public (a remarkable 91%) supports price transparency. And lack of access to pricing has long been a significant glitch in a system that relies on markets to bring down prices. 

Though recent rulemaking looks like progress, it is still too soon to celebrate. Questions remain about consumer adoption, the role that providers will be willing to play, and the impact that transparency will have on pricing. The possibility that transparency will worsen existing inequities also requires careful observation.

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Fairview Heights, IL—Jan 5, 2020; Sign on medical clinic announces Planned Parenthood branch is now open, the southern Illinois clinic was built to serve St Louis after Missouri restricted abortions.

Financing Reproductive Justice Through Title X

By Elizabeth Sepper

The Trump administration left Title X in tatters. In the last year, its capacity to finance family planning and reproductive health services for the poor was cut in half. Many family planning providers, including Planned Parenthood, whose clinics alone served 40% of patients, were forced out of the program. Six states were left with no active Title X providers at all. 1.5 million people lost access to care.

The Biden administration has said it will undo the harm. The Department of Health and Human Services (HHS) has promulgated new rules to restore the family planning network. But more than restoration is in order. The administration must actively pursue reproductive justice. Doing so will require Congress. But failure to do so will leave Title X’s poor and uninsured patients to serve as a political football once again.

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President Joe Biden and Vice President Kamala Harris.

Symposium Introduction: Recommendations for a Biden/Harris Health Policy Agenda

By Erin C. Fuse Brown

This digital symposium explores recommendations for the Biden/Harris administration’s health policy agenda. We asked leading health law scholars to describe one health policy action the administration should pursue, beyond the pandemic response. Their recommendations make up this symposium. The responses range from concrete policy changes to broad reform ideas and can be grouped into three categories, those that (1) Reverse and Restore; (2) Reinforce; (3) Reform.

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Rows of gold post office boxes with one open mail box.

FDA Expands Medication Abortion Access During Pandemic, but State Barriers Remain

By Adrienne R. Ghorashi, Esq.

Last week, the Food and Drug Administration (FDA) suspended an in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic, allowing patients to access medication abortion by mail.

Previously, the FDA REMS requirement mandated that mifepristone must be dispensed in person, forcing patients to travel to a clinic in order to pick up the medication. In light of the pandemic, the requirement would lead to unnecessary risks of COVID exposure for patients and providers, in addition to imposing logistical and financial burdens.

This FDA decision is the latest development in a battle that made its way to the U.S. Supreme Court earlier this year. In its first abortion decision since Justice Amy Coney Barrett joined the bench, the Supreme Court reinstated the in-person dispensing requirement after it had previously been blocked by a federal district court in Maryland due to the risks of COVID-19.

Advocates for abortion access are celebrating the FDA decision as a win for science and evidence-based policy rooted in a growing body of research on the benefits of medication abortion and telemedicine for abortion.

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