Berries, tomatoes, and green beans in small green containers at farmer's market.

Food is Medicine Approaches to Address Diet-Related Health Conditions

By Hannah Rahim

Food is Medicine interventions aim to prevent and treat diet-related chronic health conditions and reduce food insecurity by providing food to individuals and communities, in connection with the health care system. While Food is Medicine has been gaining prominence in recent years, it has also received some criticism. This article will explore the development of Food is Medicine and its limitations, and briefly offer recommendations for successful Food is Medicine initiatives.

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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Many mental health provider directories for private and public insurance plans contain inaccurate or outdated provider information, which creates a misleading illusion of accessible care.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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Medical personnel stand at a doctor's meeting, give advice, nurses and assistants, hospital personnel, professionalism.

Equity in Health Care Education: Ethical Distribution of CMS Funding

By Stephen Wood

The number of physicians in the U.S. is shrinking, especially among those who choose primary care. Advanced practice providers, such as Advanced Practice Nurses (APRNs) and Physician Assistants (PAs), are helping to fill that void.

In order to maintain a health care system that can serve our aging population, and one that is aligned with the health care needs and goals of our nation, there is a need for legislative support to fund APRN and PA clinical education in a way commensurate with residency training programs.

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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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Health insurance application form with money, calculator, and stethoscope.

Going Public – The Future of ART Access Post-Dobbs

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.

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

By Ameet Sarpatwari, Aviva Wang, 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 April. The selections feature topics ranging from an analysis of government and industry investments for recently approved drugs, to a discussion of court decisions on mifepristone, and an examination of the added therapeutic benefit associated with the top-selling brand-name drugs in Medicare.

A full posting of abstracts/summaries of these articles may be found on our website.

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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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Hundred dollar bills rolled up in a pill bottle

How Soon Could President Biden Enable Generic Competition to Xtandi? Very Quickly, If There Is the Will.

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.

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Magazines on wooden table on bright background.

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

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 February. The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with a skinny label and their associated Medicare savings, to a discussion of the Philips Respironics recall and the need for reforms to U.S. medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.

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