Insurance Coverage for Psychedelic Therapy

By Vincent Joralemon

As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. For example, experts estimate MDMA-assisted therapy for PTSD will cost upwards of $12,000 per patient.

These high costs highlight the need for comprehensive insurance coverage because many of those experiencing symptoms of conditions like PTSD also frequently lack the resources to pay for such treatments. Looking at how the current system works, including presently available psychedelic therapies, can help to inform coverage policies moving forward.

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Shot of a landline telephone receiver hanging upside down.

Addressing Ghost Networks in Mental Health Care

By Hannah Rahim

Many mental health provider directories for private and public insurance plans contain inaccurate or outdated provider information, which creates a misleading illusion of accessible care. These ghost networks result in many patients being unable to access essential mental health care. To tackle this issue, federal and state governments should strengthen the regulation of insurance networks and insurers should address underlying causes of inadequate networks.

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Mushrooms, capsules, and dropper bottle.

Psychedelics Are Cheap. Psychedelic Treatment Is Not.

By Vincent Joralemon

Psychedelics hold immense potential to address an array of conditions that are otherwise challenging to treat, but accessing these therapies can be costly, which means that potential benefits will be stratified along the lines of socioeconomic status.

This is an acute concern, because many with conditions that psychedelics may help to treat — such as post-traumatic stress disorder, postpartum depression, treatment-resistant depression, and alcohol use disorder — lack the resources to pay for effective health treatments.

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Hundred dollar bills rolled up in a pill bottle

Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment

By Nikhil Chaudhry and Reshma Ramachandran

Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19. This was the first time the Biden Administration had included such a provision as part of its research funding agreements with the private sector, demonstrating that it is indeed possible for the federal government to negotiate deals with pharmaceutical companies that ensure that products developed with public dollars are priced comparably to the global market.

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figurine with a void shape of a child and family of parents with a child. Surrogacy concept.

Forced Gifting: English Surrogacy, Gestational Labor, and the Inequality of Choice

By Lucas Taylor

Surrogacy, the practice in which one party (the surrogate) gestates a fetus on behalf of another pair/person (the intended parent/s or IPs), has sparked academic debates regarding gender equality and bodily integrity in the face of both commercial and altruistic agreements. I re-engage with this topic by challenging how the capacity of the surrogate to choose may be restricted under English and Welsh law. This post does not seek to argue against the practice of altruistic surrogacy. Instead, it seeks to highlight, through the lens of Social Reproduction Theory, that central to the legal framework is a highly gendered devaluation of labor which undermines the potential for surrogates to fully exercise choice in relation to their gestational labor.

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Blood glucose monitor and insulin.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Alexander Egilman, 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 June. The selections feature topics ranging from a review of modifications to blood glucose monitoring systems and related patent protections, an examination of insulin price changes from 2012-2019, and a discussion of why a proposed federal bill that would ban government health care programs from using the quality-adjusted life-year is misguided. A full posting of abstracts/summaries of these articles may be found on our website.

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white pills spilling out of orange plastic pill bottle onto hundred dollar bills.

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

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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Close-up - barista prepares espresso in coffee shop.

The Infertility Shift

By Valarie K. Blake and Elizabeth Y. McCuskey

In vitro fertilization (IVF), like most medical care in the U.S., costs far more than most people can afford out-of-pocket: over $12,500 per cycle, with multiple cycles typically required. But, unlike most other expensive medical care, IVF rarely has insurance coverage to defray the cost.

In 2020, only 27% of employers with 500+ employees and 42% of employers with 20,000+ employees covered IVF in their employer plans. Companies like Starbucks and Amazon know this and use it to draw in employees at low (or essentially neutral) wages.

Recent reports reveal women working second shifts for these corporations solely to qualify for employer health benefits that cover infertility treatments. Starbucks, for example, covers IVF for employees who work 240 hours over three months, or roughly 20 hours per week. Frequently, in these low-wage positions, workers earn just enough to pay for their health insurance premiums and sometimes the associated cost-sharing requirements.

How did we get to a place where women must work an “infertility shift” beyond their full-time jobs to access medical care?

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Bill of Health - silhouette of COVID-19 vaccine vile held in front of company logos, cooperation and antitrust in vaccine production

Unlocking the mRNA Platform Technology: Walking the Talk with Investment Protection

By Aparajita Lath

Two articles published last month in the BMJ analyze the public investment and financing of mRNA COVID-19 vaccines, highlighting the extensive government funding that has supported the development of mRNA technology from 1985 to 2022.

However, rewards from these government investments are going back into the hands of pharma corporations and shareholders, with little thought given to public needs.

Together, these articles underscore the injustice of the present moment and emphasize the need to reform intellectual property protections for government-funded inventions of public health significance.

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