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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U.S. Supreme Court building

Health Law Cases in the Upcoming Supreme Court Term

By Alexa Richardson

The next Supreme Court term is shaping up to include a number of critical cases that will impact health law. From insurance, the Affordable Care Act, abortion access, and mental health, the decisions made this term could have significant impacts on public health moving forward. Here are some of the key health law cases upcoming this term to keep an eye on:

June Medical Services, LLC v. Gee

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Photograph of a stack of magazines on a chair

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 July. The selections feature topics ranging from the price increases of protected-class drugs in Medicare Part D, to the impact of price regulation on the availability of new drugs in Germany, 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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Medical devices in a doctor's office

What the Trade War with China Means to the Medical Industry

If you rely on a pacemaker, an implanted defibrillator, a prosthetic hip, wear contacts or need an MRI, then you should be concerned about the constant threat and imposition of tariffs on Chinese imports by the Trump Administration. Using Section 301 of the Trade Act of 1974, President Donald Trump imposed new tariffs on an array of Chinese imports based on the assertion that they were stealing United States intellectual properties. The first volley occurred in July 2018 when the administration applied tariffs of 25% to over $34 billion in Chinese imports, and then again in August 2018 when it added another $16 billion in products to the list.

In an ongoing tit-for-tat, on May 10, 2019, the United States raised tariffs from 10% to 25% on an additional $200 billion worth of Chinese goods, including many health care products, from surgical gloves to chemical reagents. While medical supplies are only a small, biopsy-sized sample of the goods that will face these tariffs, they are sure to have some impact on an already financially burdened health care delivery system here in the United States. This will result in higher prices for health care products, devices, and components that are all passed off to the consumer.

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Protesters hold up signs that read "everyone deserves healthcare"

The Future of Health Care? How States are Trailblazing Medicaid Buy-In Programs

States can be laboratories of health reform.

Massachusetts and Oregon expanded insurance coverage during previous periods of federal inaction, and with solutions unlikely to come from a politically divided Washington D.C., how will states tackle the problem of health insurance becoming increasingly unaffordable and unattainable for many families?

Is there a role for the government to play a greater role in making health insurance affordable and accessible? As public support for action on health care grows, what options are available to states now?

I spoke to former Petrie-Flom Student Fellow and Medicaid policy scholar Emma Sandoe about states that have begun to explore Medicaid Buy-In policies, which allow people to purchase government backed health insurance or Medicaid-like plans. Read More

hand reaching for blue pills

The Rotten U.S. Antiparasitic Drug Market

Recently, there has been a lot of media attention on galling price hikes of generic drugs.

Historically, the social contract in pharmaceutical pricing has been tolerating expensive brand-name drugs while they have been on patent (a government-granted monopoly), followed by allowing low cost generics to rush to market after patent expiration. Yet these norms are now being challenged in the setting of increased generic manufacturer consolidation and single-source generic drugs.

Probably the most well known example is the case of Martin Shkreli (the so-called “Pharma Bro”) and Turing Pharmaceuticals, which bought out the rights of pyrimethamine (Daraprim), a key treatment for Toxoplasmosis and other infectious diseases, raising the price from $13.50 per pill to $750 per pill.

Note that even the pre-price hike price is significantly more than people other countries pay. In the UK it costs only $0.66 per pill and in Australia it is $0.18 per pill.

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image of a doctor neck-down holding a piggy-bank

Short-Term Limited Duration Insurance Can Now Be Less Short-Term

Short-term, limited-duration insurance was designed as a temporary gap-filler while a person transitions from one kind of health insurance to a different plan or coverage. In 2016, recognizing its serious limitations, an Obama Administration rule mandated that coverage of short-term, limited-duration insurance be limited to three months, including any period of renewal.

But due to a final rule in August 2018 from the Trump Administration, short-term, limited-duration insurance coverage contracts can now last as long as one day short of a year, and can last as long as three years with renewals or extensions. The Trump Administration explained in its final rule that it selected this standard to promote access to choices of health coverage and to individual health insurance coverage. The rule also acknowledged this kind of insurance may not be the most appropriate or affordable for everyone. As of Tuesday, October 2, insurers can sell these “skimpy” plans for the extended duration.

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The Semantics of Health Care

By Gali Katznelson

shopping trolley with medicine
The push toward commodification of health care is a luxury not everyone has. (toons17/Thinkstock)

Recently there has been a shift in popular parlance toward referring to PCPs as primary health care providers. Not primary health care physicians or practitioners, but providers.

This change seems to have increased in popularity after the original passage of the ACA, specifically with the opening of the health insurance marketplaces.

But it was particularly jarring, as a Canadian, to become accustomed to terminology that reframes physicians as providers, and patients as consumers.

Ostensibly, this language comes from a movement to empower patients to be more engaged in their health care rather than to accept passively that the “doctor knows best.” It is an effort to shift away from health care delivery by paternalistic doctors of the past, and toward the contemporary active patients who take ownership of their health and participate in making decisions. As a result, doctors are framed as service providers who cater to the needs of their consumers.

But we must challenge this narrative.

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World Trade Month: Trade’s impact on domestic drug prices

By Oliver Kim

Happy World Trade Month! While health policy is often seen as something particularly domestic, trade can have an impact on health policy here at home.

Just a day before President Trump’s speech outlining the administration’s approach to rising drug costs, the Pharmaceutical Research and Manufacturers of America (PhRMA) declared May as a time to “celebrate the many American companies exporting products around the world.” However, PhRMA also warned that “Americans should not subsidize the medicine costs in other wealthy countries.”

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