By Vincent Joralemon
In my last post, I discussed the rise of psychedelic lobbying — how companies with vested economic interests in psychedelics have applied pressure to shape regulations that favor their business models.
One such initiative — the ketamine therapy industry’s push to extend the COVID-era telemedicine flexibilities for prescriptions of controlled substances — highlights how sophisticated these campaigns can be, and how their impact stretches beyond the psychedelic industry.
By James Love
On March 21, 2023, the NIH, acting on behalf of HHS Secretary Xavier Becerra, rejected a petition from four cancer patients asking HHS to use the government’s rights in the prostate cancer drug enzalutamide, in order to remedy pricing abuses by the patent holder. The abuse is charging U.S. cancer patients two to six times as much as other high income countries for Astellas’ and Pfizer’s Xtandi, a drug invented on federal grants.
The cancer patients could seek a remedy to the abusive and discriminatory pricing because the U.S. government had funded the R&D for each of the three patented inventions that are currently blocking generic competition.
By Elizabeth Weeks
The most promising path forward in public health is to continue recognizing federal authority and responsibility in this space. I carefully choose “recognizing,” rather than “expanding” or “moving” because it is critical to the argument that federal authority for public health already exists within the federalist structure and that employing federal authority to address public health problems does not represent a dimunition of state authority. Rather than a pie, of which pieces consumed at the federal level necessarily reduce pieces consumable at the state level, we should envision the relationship as a Venn diagram, where increasing overlap strengthens authority for promoting and protecting public health broadly.
By Nicole Huberfeld
Once again, health law has become a vehicle for constitutional change, with courts hollowing federal and state public health authority while also generating new challenges. In part, this pattern is occurring because the New Roberts Court — the post-Ruth Bader Ginsburg composition of U.S. Supreme Court justices — is led by jurists who rely on “clear statement rules.” This statutory interpretation canon demands Congress draft textually unambiguous laws and contains a presumption against broadly-worded statutes that are meant to be adaptable over time. In effect, Congress should leave nothing to the imagination of those responsible for implementing federal laws, i.e., executive agencies and state officials, so everything a statute covers must be specified, with no room for legislative history or other non-textual sources.
By Doron Dorfman and Scott Landes
One of the most important lessons from the ongoing COVID-19 pandemic needs to be about health surveillance of marginalized health populations — indeed, “who counts depends on who is counted.”
As disability scholars who use data and empirical tools in our work, we want to remind decision makers that advancing just law and policy depends on the systematic collection of accurate data. Without such data, our laws and policies will be fundamentally incomplete.
By Cathy Zhang
Last week, on the heels of attacks on trans youth and their families in Texas, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) issued a notice and guidance expressing support for transgender and gender nonconforming youth and highlighting the civil rights and privacy laws surrounding gender affirming care.
OCR all but names the Texas attacks as unlawful under Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex, age, and disability by federally funded health programs or activities. It notes that for federally funded entities, restricting medically necessary care on the basis of gender — such as doctors reporting parents of patients to state authorities — “likely violates Section 1557.”
The guidance directs those who have been discriminated against on the basis of gender identity or disability in seeking access to gender-affirming health care to file a complaint through OCR. HHS can go further, however, by formally acknowledging that individuals have a legal right to enforce Section 1557 when they have experienced prohibited health care discrimination.
By James R. Jolin
Weatherization serves as an important yet strikingly neglected tool not only to meet vulnerable communities’ energy needs, but also to combat the negative health effects associated with the climate crisis.
In the United States, households with lower gross income experience higher “energy burdens” — that is, the proportion of a household’s income that is expended to meet energy costs. Indeed, households earning 200% of the federal poverty line spend an estimated 8% of their income on meeting energy costs, as compared to the national median of 3%. Weatherization, the catch-all term for home improvements intended to improve the efficiency of home energy use, is a way to decrease disparate energy costs across socioeconomic classes.
Standard weatherization measures, which include (but are not limited to) repairing and modernizing temperature control systems and installing insulation, reduce the amount of money households need to spend on heating and cooling. In all, weatherization measures save over $280 on average per year, according to the U.S. Department of Energy — a modest but nonetheless important savings.
Crucially, however, weatherization also confers significant health benefits, which are not only ideal in their own right, but also result in further significant financial savings.
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.
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.
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.