Medicaid - Bill of Health

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Merck Price Negotiation Lawsuit May Face Same Obstacles as 340B Takings Claims

June 15, 2023June 15, 2023 Laura Dolbow Leave a comment

By Laura Dolbow

Merck recently filed a lawsuit that challenges the constitutionality of the Medicare price negotiation program created by the Inflation Reduction Act. Under this program, HHS will select a small number of single source drugs for price negotiation. Merck alleges that the price negotiation program operates as a price control because it effectively requires manufacturers to accept the maximum fair price as a condition of participation in Medicare and Medicaid. Merck argues that this form of price regulation charts a “radical new course” for Medicare that violates the Takings Clause of the Fifth Amendment.

But the price negotiation program is not the first time that Congress has placed a restriction on the prices that Medicare program participants can charge. And Merck’s lawsuit is not the first suit that has alleged that such price regulations are unconstitutional takings. Drug manufacturers recently made similar claims in litigation involving the 340B Drug Pricing Program. Two district courts rejected those claims, highlighting several obstacles that Merck’s takings claim may face as well.

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Going Public – The Future of ART Access Post-Dobbs

May 23, 2023May 23, 2023 kkraschel Leave a comment

By Katherine Kraschel

The loss in Dobbs and the bleak outlook for abortion rights within the federal courts may afford advocates a unique opportunity to fully adopt a reproductive justice framework and apply it to access to fertility care, as other contributors to this symposium have argued.

This article outlines specific strategies for blue states eager to stake a claim in the reproductive justice movement to consider.

President Joe Biden at desk in Oval Office.

Federalizing Public Health

February 28, 2023February 27, 2023 The Petrie-Flom Center Staff Leave a comment

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.

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The End of Public Health? It’s Not Dead Yet

February 27, 2023February 24, 2023 The Petrie-Flom Center Staff Leave a comment

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.

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COVID-19 as Disability Interest Convergence?

September 29, 2022September 29, 2022 The Petrie-Flom Center Staff Leave a comment

By Jasmine E. Harris

Some have suggested that the COVID-19 pandemic could be a moment of what critical race theorist Derrick Bell called “interest convergence,” where majority interests align with those of a minority group to create a critical moment for social change.

It would be easy to think that interests indeed have converged between disabled and nondisabled people in the United States. From education to employment, modifications deemed “unreasonable” became not only plausible but streamlined with broad support.

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A Different Future Was Possible: Reflections on the US Pandemic Response

September 28, 2022September 28, 2022 Justin Feldman Leave a comment

By Justin Feldman

The inadequacies of the early U.S. pandemic response are well-rehearsed at this point — the failure to develop tests, distribute personal protective equipment, recommend masks for the general public, protect essential workers, and take swift action to stop the spread.

But to focus on these failures risks forgetting the collective framing and collective policy response that dominated the first few months of the COVID-19 pandemic. And forgetting that makes it seem as though our current, enormous death toll was inevitable. This dangerously obscures what went wrong and limits our political imagination for the future of the COVID-19 pandemic and other emerging crises.

Bill of Health - A worker gives directions as motorists wait in lines to get the coronavirus (COVID-19) vaccine in a parking lot at Dodger Stadium, Friday, Jan. 15, 2021, in Los Angeles, covid vaccine distribution

Countercyclical Aid Is Not Enough to Fix the Broken US Approach to Public Health Financing

September 8, 2022September 7, 2022 The Petrie-Flom Center Staff Leave a comment

By Philip Rocco

In the last month, the U.S. Centers for Disease Control and Prevention’s failed responses to COVID-19, ranging from “testing to data to communications,” have prompted a call to reorganize the agency.

Yet restructuring the CDC will have little effect on pandemic preparedness if the decentralized American approach to health finance remains in place. This structure was already stripped bare by decades of state and local austerity even before the first cases of COVID-19 were identified, and has been further worn down since 2020.

If the pandemic has taught us anything about public policy, it is that the model of countercyclical federal aid — which expands at the onset of an economic crisis but abates as that crisis is resolved — is fundamentally inadequate when applied to the realm of public health.

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Harms and Biases Associated with the Social Determinants of Health Technology Movement

September 2, 2022September 2, 2022 The Petrie-Flom Center Staff Leave a comment

By Artair Rogers

Many health systems have begun using new screening technologies to ask patients questions about the factors outside of the clinic and hospital that contribute to an individual or family’s health status, also known as the social determinants of health (SDOH). These technologies are framed as a tool to connect patients to needed community resources. However, they also have the potential to harm patients, depending on how patient data is used. This article addresses key harms and biases associated with the SDOH technology movement, and provides suggestions to address these issues going forward.

Prior Authorization Insurance Requirements: A Barrier to Accessing Lifesaving Treatment for Opioid Use Disorder?

August 22, 2022August 19, 2022 Temple University Center for Public Health Law Research Leave a comment

By Juan M. Hincapie-Castillo and Amie J. Goodin

Policies to mitigate the drug overdose crisis continue to fall short, as evidenced by increasing rates of opioid-involved overdoses and deaths in the United States. The COVID-19 pandemic has exacerbated this overdose crisis, and efforts are urgently needed to mitigate harm.

Individuals who have problematic opioid use are most frequently involved in opioid-involved overdoses, meaning that the use of a prescription opioid, or much more commonly a non-prescription opioid (such as non-medically sourced fentanyl or heroin), is used in a way that adversely affects the person’s life. Problematic opioid use may lead to a diagnosis of opioid use disorder (OUD). The medication buprenorphine has been proven to reduce opioid-involved overdose and harms and is one of few OUD treatments available as a prescription that can be dispensed by community pharmacies rather than from specialized facilities or specialty providers.

The federal government and several states have implemented strategies to improve and promote OUD treatment access, especially for the relatively inexpensive and effective medication buprenorphine. However, there are significant barriers that remain that preclude adequate and timely access to buprenorphine.

Churntables: A Look at the Record on Medicaid Redetermination Plans

April 13, 2022April 13, 2022 czhang Leave a comment

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.

Tag: Medicaid