About Health Policy
Impact of Trump tariffs on US medical device market “President Trump’s plan to impose tariffs on imported goods will affect the prices of the approximately 75% of available US-marketed medical devices that are manufactured out of the country, and more specifically the 69% of available US-marketed devices that are manufactured solely outside of the US, according to GlobalData’s Medsource Database, which collates data on the medical device supply chain…
As a result of these policy changes, companies will be forced to increase prices to make up for losses incurred by the proposed tariffs. Additionally, this may cause supply chain disruptions, reducing accessibility to medical devices and inflating the cost of these products due to the higher demand in comparison to the supply.”
Trump's tariffs could raise the cost of generic drugs in the U.S. “Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said that about half of all generic drugs are manufactured overseas and that about 80% of all active pharmaceutical ingredients, or APIs, are produced abroad, in China, India and other places.
Generic drugs are the backbone of medicines prescribed in the U.S.: They account for about 90% of all prescriptions filled…”
Comment: Not only will prices go up, but the tariff will disrupt the supply chain and exacerbate shortages.
About health insurance/insurers/costs
Double-digit medical cost increases expected globally in 2025 “Insurers expect global medical costs to increase by 10.4% in 2025, which mirrors this year’s rate. The projected growth in medical costs varies by region:
In North America, costs are projected to rise from 8.1% in 2024 to 8.7% in 2025.
In the United States, insurers project a 10.2% increase in 2025, up from 9.3% this year.
Costs also are projected to accelerate in Asia Pacific, the Middle East and Africa, while Europe and Latin America will see slower increases”
About pharma
Thousands turn to Wegovy copies each month as FDA considers shortage status “Summary:
—More than 200,000 prescriptions for Wegovy alternatives are filled in the U.S. each month
—FDA is weighing whether to remove Wegovy from its shortage list
—Pharmacy compounding group has asked FDA to consider its data when making a decision”
Obesity Drugs Would Be Covered by Medicare and Medicaid Under Biden Proposal “The Biden administration, in one of its last major policy directives, proposed on Tuesday that Medicare and Medicaid cover obesity medications, a costly and probably popular move that the Trump administration would need to endorse to become official.
The proposal would extend access of the drugs to millions of Americans who aren’t covered now.
C.M.S. estimates that around 3.4 million more patients in Medicare would become eligible for obesity drugs, and around four million patients in Medicaid would gain coverage…
C.M.S. estimates that coverage will cost the federal government about $25 billion for Medicare and $11 billion for Medicaid over a decade; states would pay around $4 billion for their share of the Medicaid bill…”
Roche inks $1.5B Poseida buyout, betting off-the-shelf CAR-Ts will democratize access to cell therapies “Roche has struck a $1.5 billion deal to buy Poseida Therapeutics. The takeover will establish off-the-shelf cell therapies, which Roche has said can democratize CAR-Ts, as a new core capability at the drugmaker.”
About the public’s health
Ten Americas: a systematic analysis of life expectancy disparities in the USA “Our analysis confirms the continued existence of different Americas within the USA. One's life expectancy varies dramatically depending on where one lives, the economic conditions in that location, and one's racial and ethnic identity. This gulf was large at the beginning of the century, only grew larger over the first two decades, and was dramatically exacerbated by the COVID-19 pandemic. These results underscore the vital need to reduce the massive inequity in longevity in the USA, as well as the benefits of detailed analyses of the interacting drivers of health disparities to fully understand the nature of the problem. Such analyses make targeted action possible—local planning and national prioritisation and resource allocation—to address the root causes of poor health for those most disadvantaged so that all Americans can live long, healthy lives, regardless of where they live and their race, ethnicity, or income.”
Look at Table 1 for an explanation of the “10 different Americas.”
Global rates of HIV infections and deaths fall sharply “Global rates of HIV infections and deaths related to the virus have dropped sharply but must fall faster to meet a UN target to end Aids as a public health threat by 2030, research has found. New HIV infection rates in sub-Saharan African countries have plunged more than half since their 1995 peak, but risen steeply in central Europe, eastern Europe and central Asia, the international survey said.
Supreme Court rejects tobacco industry challenge to graphic anti-smoking images on cigarette packs “The Supreme Court declined Monday to hear a challenge from major tobacco companies to the Food and Drug Administration’s requirement that they place graphic health warnings on cigarette packages and in advertisements.
The FDA issued a rule in 2020 that requires health warnings on cigarette packages and in advertisements, occupying the top 50% of the area on the front and back panels of packages and at least 20% of the area at the top of cigarette ads, according to the FDA.”
About healthcare IT
Yale study shows how AI bias worsens healthcare disparities “A new research report from Yale School of Medicine offers an up-close look at how biased artificial intelligence can affect clinical outcomes. The study focuses specifically on the different stages of AI model development, and shows how data integrity issues can impact health equity and care quality.”
Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices “The FDA is providing this list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area. The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.”
Teladoc Health launches AI motion detection solution to improve patient safety in hospital beds “Teladoc Health launched an artificial-intelligence-enabled technology that allows hospital staff to virtually detect when a patient is at risk of falling from a hospital bed. The solution, unveiled Monday and called Virtual Sitter, is now commercially available.”
The Office for Civil Rights Should Enhance Its HIPAA Audit Program to Enforce HIPAA Requirements and Improve the Protection of Electronic Protected Health Information From the OIG: “OCR fulfilled its requirement under the HITECH Act to perform periodic HIPAA audits. However:
OCR’s HIPAA audit implementation was too narrowly scoped to effectively assess ePHI protections and demonstrate a reduction of risks within the health care sector. Specifically:
OCR’s audits consisted of assessing only 8 of 180 HIPAA Rules requirements; and
only 2 of those 8 requirements were related to Security Rule administrative safeguards and none were related to physical and technical security safeguards.
OCR oversight of its HIPAA audit program was not effective at improving cybersecurity protections at covered entities and business associates.
We made a series of recommendations to OCR to enhance its HIPAA audit program, including that it expand the scope of its HIPAA audits to assess compliance with physical and technical safeguards from the HIPAA Security Rule, document and implement standards and guidance for ensuring that deficiencies identified during the HIPAA audits are corrected in a timely manner, and define metrics for monitoring the effectiveness of OCR’s HIPAA audits at improving audited covered entities and business associates’ protections over ePHI and periodically review whether these metrics should be refined.”
Comment: According to StatNews analysis: “OCR has not conducted any HIPAA audits since 2017, leaving the nation’s health care organizations to either police themselves or wait until a cyberattack exposes their systems’ inadequacy.”