close up of an open book

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from potential Medicare savings on inhaler prescriptions through use of negotiated prices and a defined formulary, to evaluation of the REMS for extended-release/long-acting opioids, to the costs of medication non-adherence in adults with atherosclerotic cardiovascular disease in the US. A full posting of abstracts/summaries of these articles may be found on our website. Read More

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Naughty or Nice 2019? Guests, Zack Buck, John Cogan, and Jennifer Oliva

Ho-ho-ho! It’s the return of “Who’s Been Naughty or Nice?,” TWIHL’s infamous Holiday show. This year’s festive appreciation of those who work in the health care law and policy workshop features the seasonal vocalizations of Zack Buck, John Cogan, and Jennifer Oliva. Nominees for both naughty and nice include a wealth of administration players and policies, plenty of good and bad Medicaid news, drug pricing, and a whole lot more to fill our stockings and remind us that the consumption of prodigious amounts of egg nog is increasingly a quid pro quo for health law and policy work.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.

Ambassador-at-Large Deborah Birx giving a speech from a podium with an American flag and PEPFAR banner in the background

One of the Biggest Public Health Initiatives in History: PEPFAR and HIV

By Daniel Aaron

In October, the Petrie-Flom Center hosted a conference of world-leading experts in HIV/AIDS to discuss one of the biggest public health successes in history: PEPFAR, the President’s Emergency Plan for AIDS Relief. PEPFAR was launched in 2003 in response to a burgeoning global epidemic of HIV. The program offered $2 billion annually, rising to about $7 billion in 2019, to surveil, diagnose, treat, and reduce transmission of HIV around the world.

PEPFAR prevented what could have become an exponentially growing epidemic. It is estimated to have saved more than 17 million lives and avoided millions of new HIV infections. As a result, the speakers at the conference were quick to extol the virtues of the program. Professor Ashish Jha called it an “unmitigated success”; Professor Marc C. Elliott named it a “historic effort”; Dr. Ingrid Katz described PEPFAR as “nothing short of miraculous.”

However, several undercurrents within the conference, as well as more explicit points made by several panelists, suggested the importance of enlarging the discussion beyond PEPFAR itself to include other policies that impact HIV and AIDS, and even other diseases.

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Illustration of a family and large clipboard with items in a list checked off. All are underneath a large blue umbrella

Universal Coverage Does Not Mean Single Payer

This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website.

By Joseph Antos, American Enterprise Institute

Health spending in every major developed country is substantially below that of the U.S., and measured health outcomes appear to be better. Progressives have jumped to the conclusion that adopting single-payer health care would yield a simpler system in which everyone is covered, costs are reduced, and outcomes are improved. The truth is far more complicated.

Most other countries have a mix of public and private coverage. One size does not fit all, even in Europe. The government is the predominant purchaser of medical services in Canada and the U.K. In France and Australia, the government is the primary purchase but many people purchase private supplemental coverage. The government subsidizes individually-purchased insurance in Germany, the Netherlands, and Switzerland. Germany relies on employer coverage, akin to employer-sponsored coverage in the U.S. Read More

Broken, frayed net, representing a broken social safety net

Are Work Requirements Sinking as Arizona and Indiana Abandon Ship?

By Nicolas Terry

There’s an old saying, credited to Will Rogers, “If you find yourself in a hole, stop digging!” When it comes to Medicaid work requirements there has been mounting evidence that excavation cessation would be good advice for states considering this misguided attempt at social engineering. After all, work requirement waivers face unrelenting legal challenges, an obdurate CMS apparently unable to fashion a lawful waiver, mountains of bad data, and increasingly poor optics. Two weeks ago Arizona, which had yet to implement its program, jumped ship notifying CMS that it was postponing implementation. This week Indiana, which began implementation at the beginning of the year, announced a similar postponement.

According to the KFF Medicaid Waiver Tracker, CMS has approved applications from nine states for Section 1115 work requirement (or “community engagement”) waivers. Nine more are pending. Of the nine states with approvals, three (Arkansas, Kentucky, and New Hampshire) have had them overturned by D.C. Circuit Judge Boasberg. Work requirement poster state Kentucky even had a second, revised waiver overturned. Of the six other approved states, five (Arizona, Michigan, Ohio, Utah, and Wisconsin) have yet to implement their work requirements. Until this week, the sixth, Indiana, had been performing a slow and litigation-free roll out. However, with its work requirement sanctions about to get serious, a few weeks ago Indiana also found itself on Judge Boasberg’s docket.

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Matthew Cortland on “The Week in Health Law” Podcast

By Nicolas Terry

This week’s guest is Matthew Cortland, a patient and health care rights advocate from Massachusetts. He received his graduate training in public health from Boston University and earned a J.D. from George Mason University School of Law. He is disabled and chronically ill, a superbly effective lawyer, writer, and speaker as well as a well-known health care and disability rights activist.

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Stack of colorful books in front of a wood paneled wall

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of September. The selections feature topics ranging from the contributions of academia and industry to lung cancer survival gains, to the savings from the EpiPen authorized generic, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.

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Photograph of a gavel and three open books

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron 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 relevant to current or potential future work in the Division.

Read More

A photograph of miniature figures of people standing on top of piles of coins at different heights

Promoting Health, Not Just Health Care

By David Orentlicher

Once again this past Thursday, the Democratic presidential candidate debate began on the topic of health care reform, and moderator George Stephanopoulos quickly steered the discussion to what he termed “the heart” of the debate. Should the United States increase access to care by building on the Affordable Care Act (ACA) or by replacing ACA with a single-payer, Medicare-for-All system?

While this is an important question, there is an even more important question for the candidates to discuss. We need to hear them talk more about health than about health care.

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