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.
Category: 2020 Election
Advancing a Public Health-Promoting National Opioid Policy
Register to attend “Addressing the Overdose Epidemic: Substance Use Policy for the Biden Administration” on March 24th.
By Jennifer D. Oliva & Kelly K. Dineen
“America’s drug regime is a monstrous, incoherent mess.”
– Dr. Carl L. Hart, Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear (2021)
By any measure, American drug policy is an ineffective and costly failure.
The U.S. drug policy regime’s defining quality is its persistent adherence to the same approaches in the face of overwhelming evidence that they are unsuccessful, including supply-side tactics, fear mongering, and misinformation dissemination. These policies are racist by design and their myriad, negative impacts are disproportionately borne by marginalized and stigmatized communities.
The “war on drugs” and its repeated loop of lost battles have earned the nation the highest incarceration rate in the world, fomented a number of serious health issues related to drug use, and fueled a drug overdose and suicide crisis. Our shape-shifting overdose crisis recently claimed the highest number of overdose deaths ever recorded during a twelve-month period in American history.
Bold Steps Needed to Correct Course in US Drug Policies
By Leo Beletsky, Dan Werb, Ayden Scheim, Jeanette Bowles, David Lucas, Nazlee Maghsoudi, and Akwasi Owusu-Bempah
The accelerating trajectory of the overdose crisis is an indictment of the legal and policy interventions deployed to address it. Indeed, at the same time as the U.S. has pursued some of the most draconian drug policies in the world, it has experienced one of the worst drug crises in its history.
The legal and institutional system of U.S. drug control remains defined by its racist, xenophobic, and colonialist roots. It is no surprise, then, that current policy approaches to drug use have amplified inequities across minoritized and economically marginalized Americans. Reliance on the criminal-legal system and supply-side interventions have disproportionately devastated Black and brown communities, while failing to prevent drug-related harms on the population level.
The Biden-Harris Administration has an unprecedented opportunity to chart a different path. The priorities for the Administration’s approach should flow directly from its stated principles: emphasis on scientific evidence and a focus on equity.
The following key areas require immediate, bold, and evidence-grounded action.
It’s Time to Update the ACA’s Anti-Discrimination Protections
By Jenna Becker
Assuming that the Affordable Care Act (ACA) withstands its most recent challenge in California v. Texas, the Biden administration should prioritize as a future reform the codification of clearer nondiscrimination standards.
The ACA’s Section 1557, which provides anti-discrimination protections, has been fraught with challenges. Section 1557 incorporates nondiscrimination protections from four separate civil rights statutes. This vague language allows administrations to offer widely differing interpretations of healthcare anti-discrimination protections.
In a 2016 rule, the Obama administration interpreted Section 1557 broadly, including protections based on gender identity and sexual orientation, as well as specific language access requirements. Many of these protections were eliminated in a 2020 rule promulgated by the Trump administration.
It’s time to end these fluctuating standards. The Biden administration should work with Congress to add clearer nondiscrimination protections to the ACA.
Advantages of Using the Congressional Review Act to Revoke Health Care Waivers
By Matthew B. Lawrence
The Trump Administration has granted health care waivers that the Biden Administration will surely look to end, including work requirement waivers that the Supreme Court is going to consider in Azar v. Gresham. How the Biden Administration approaches this task may set precedents that last far into the future, which is one argument in favor of considering the Congressional Review Act as a potential path forward.
Waivers are a huge part of health policy. They entail a state seeking approval from the federal government to make various changes to ACA or Medicaid programs. Waivers are normally approved for several years at a time, and routinely renewed. They foster experimentation, and are also (or especially) a tool the federal government uses to steer national health policy by pushing states to adopt some reforms and not others, as I explain in a forthcoming article.
Over at the Yale Journal of Regulation blog, I describe how the Congressional Review Act (CRA) could potentially be used to revoke health care waivers (like community engagement, aka work requirement, waivers).
In brief, the CRA is a way Congress can change the law to revoke agency actions without the votes necessary to override a filibuster. The CRA might be a cleaner alternative for revoking health care waivers than administrative revocation by the Biden Administration. One big policy advantage of this route is that it wouldn’t come back to haunt health policy. Revocations through the administrative process would set a precedent that could undermine the stability of all waivers, but revocations through the CRA would not.
Questions for HHS Secretary Nominee Xavier Becerra
By Abe Sutton
With the 2020 election in the rearview mirror, the Senate has turned its attention to vetting President-elect Biden’s cabinet nominees. As Senators on the Finance and HELP committees prepare their questions for California AG Xavier Becerra, the nominee for Health and Human Services (HHS) Secretary, they should consider probing in three areas to understand his health policy priorities.
In this post, I suggest Senators consider asking the nominee about his plans for the future of the Center for Medicare and Medicaid Innovation (CMMI), as well as how he aims to encourage healthcare competition and foster innovation.
His answers may be illuminative about his potential tenure as secretary, and should factor into Senators’ decisions on whether to vote for confirmation amid questions regarding his qualifications. Senators may also wish to weigh the nominee’s moral and human services priorities, topics not discussed in this post.
New Regulation Aims at Accountability for Organ Procurement Organizations
By James W. Lytle and Abe Sutton
Facing a looming deadline for the adoption of pending proposed rules, the Trump Administration finalized a host of healthcare regulations, including highly anticipated regulations addressing drug pricing and Stark Law/anti-kickback rules. Within this flurry of regulatory activity, the Centers for Medicare & Medicaid Services (CMS) also finalized an important, but not as widely discussed, proposal that seeks to hold Organ Procurement Organizations (OPOs) more accountable for their performance.
While some of these last-minute actions by the outgoing administration may ultimately be reversed or revised by the Biden Administration, this rule was associated with a well-regarded Advancing American Kidney Health initiative that has been “widely hailed by health care groups, patient advocacy organizations and Democrats,” making it “the most broadly popular health initiative of Trump’s presidency.” While its fate is not entirely certain, the recently issued final rule may be one of the few last-minute legacies of the Trump Administration likely to be more warmly received by its successor.
Issuing the Most Favored Nation Interim Final Rule Was a Mistake
By Abe Sutton
While the Most Favored Nation (MFN) Interim Final Rule (IFR) advances a well-calibrated policy to standardize pharmaceutical prices across developed nations, procedurally, its issuance was a mistake.
The Trump administration would have been wiser to issue a Notice of Proposed Rulemaking (NPRM) for two reasons: first, an NPRM would have circumvented some of the procedural vulnerabilities of the IFR. And second, had the Trump administration issued an NPRM, President-Elect Biden’s team would have faced significant pressure to finalize the policy.
In this post, I touch on what MFN is, examine why the interim final rule is legally vulnerable, explore why the Biden team likely would have adopted the policy had an NPRM been issued, and explain how industry should think about this situation.
Short-Term, Limited-Duration Insurance May Be Here to Stay
By Abe Sutton
Short-term, limited-duration insurance (STLDI) may be here to stay despite legal attacks, poor branding, and a potential Democratic victory in the upcoming Presidential election.
Though the Obama administration curtailed STLDI, it is now likely to endure due to black letter administrative law and changes in circumstance since 2016.
In light of this, a potential Biden administration should package legislation codifying the current regulations with legislation increasing individual market subsidies. A package along these lines could appeal to both sides of the aisle.
In this post, I provide an overview of what STLDI is, explain why administrative law precedents complicate the reversal of current regulations, and propose a path forward for a potential Biden administration. Read More
How Will Health Policy Change After COVID-19?
By Abe Sutton
The COVID-19 pandemic has highlighted the need for health policy reform in the United States.
In this piece, I walk through three health policy takeaways from COVID-19, which include socializing communicable disease costs, shifting insurance markets from the employer to the individual, and deregulating the supply side of health care.