• A federal judge in Texas blocked a key Affordable Care Act provision that requires insurance plans to cover certain preventive services at no cost for patients, eliminating the mandate nationwide and limiting coverage for nearly 168 million people. District Court Judge Reed O’Connor, who has ruled against the ACA multiple times, decided that the U.S. Preventive Services Task Force that recommends services like cancer and HIV screenings to be covered has been acting unconstitutionally since 2010, and therefore, its recommendations should not be mandated. (Politico)
• While O’Connor’s decision has significant implications for patients across the United States, insurance plans are not likely to drop no-cost coverage immediately as the legal fight plays out, experts said. The Biden administration is expected to appeal the ruling and ask for a stay on the judge’s order, and AHIP, one of the nation’s top insurer lobby groups, said in a statement that there “will be no immediate disruption in care or coverage.” (Axios)
• Sen. Sherrod Brown (D-Ohio) and Rep. Jan Schakowsky (D-Ill.) said they would reintroduce legislation that sets minimum nurse-to-patient ratios for all hospital units after staffing shortages have plagued the industry throughout the COVID-19 pandemic. (Healthcare Dive) Meanwhile, House Republican leaders have asked Food and Drug Administration Commissioner Robert Califf to answer 10 questions on the agency’s response to ongoing U.S. drug shortages, including questions on drug tracking, prevention strategies and inspection priorities. (Fierce Pharma)
• The United States could see an mpox outbreak this year that was worse than last year’s, which led to a public health emergency declaration, as just an estimated 23% of the at-risk population has been fully vaccinated, according to new modeling from the Centers for Disease Control and Prevention. Dr. Demetre Daskalakis, deputy coordinator of the White House’s mpox response, said that “we know there’s a linear relationship between how many people are vaccinated and the chance of not having an outbreak,” and as a result, health agencies are increasing vaccination outreach to prepare for a potential summer surge. (CBS News)

Teen overdose deaths have doubled in three years. Blame fentanyl.

The Hill

Trans health care, already under attack, faces new obstacle with end of Covid public health emergency

Theresa Gaffney, Stat News

As states across the U.S. introduce anti-trans legislation, transgender and nonbinary people face increasing restrictions in their ability to access gender-affirming care. Now experts say the government’s plans to end the Covid public health emergency on May 11 could further jeopardize the health and safety of trans people across the country.

 

Employer Health Plans Encouraged to Continue Free Covid Tests

Sara Hansard, Bloomberg Law

Employer health plan sponsors and health insurers were encouraged by the Biden administration to continue covering Covid-19 tests without requiring beneficiaries to pay out-of-pocket costs after the public health emergency ends May 11. The departments of Labor, Health and Human Services, and the Treasury issued Frequently Asked Questions guidance March 29 urging the coverage while noting that it will no longer be required.

 

COVID led to sharp rise in vaccine compensation schemes, but gaps remain -Oxford

Maggie Fick, Reuters

The COVID-19 pandemic led to a nearly six-fold increase in the number of non-fault compensation schemes for vaccine injuries globally, said Oxford University researchers who on Friday made public an online database tracking the schemes.

ACA court ruling gives Democrats new political ammo

Caitlin Owens, Axios

Democrats may hate the substance of yesterday’s court ruling striking down elements of the Affordable Care Act — this time, its requirement that employers cover certain preventative care services. But politically, it feeds right into the party’s 2024 campaign narrative.

 

Obamacare Court Decision Hits Hardest for Low-Income Americans

Ian Lopez and Sara Hansard, Bloomberg Law

Certain cancer screenings and HIV prevention drugs are among the preventive services attorneys say will be harder for lower income Americans to access after a federal judge’s decision to strike down requirements in the Affordable Care Act.

 

Healthcare industry reacts to preventive care ruling

Victoria Turner, Modern Healthcare

A court ruling to end the Affordable Care Act’s guarantee of no-cost access to preventive medical care triggered opposition from major healthcare trade associations, advocacy groups and Democratic officials.

 

Drug middlemen switch tactics, but the outcome is the same: high prices

John Wilkerson, Stat News

The changes came to light at a Senate Finance Committee hearing Thursday on the impact of PBMs on drug costs — a meeting that made it clear both parties are considering reining in common industry practices.

 

Pharmacy benefit managers caught in crosshairs of battle to reduce drug costs

Nick Robertson, The Hill

Many patient advocates and industry experts see them as middlemen, only adding to the complication of the pharmaceutical industry and increasing costs.

 

NY Times reporter shoots back at Biden’s health chief over missing migrant children

Lauren Sforza, The Hill

Becerra faced several congressional hearings this week, and Republicans took the chance to grill him over reports of unaccompanied minor refugees being placed with sponsors who send them to work in poor conditions. A New York Times report written by Dreier found that HHS could not reach more than 85,000 children after being placed with sponsors and lost “immediate contact” with one-third of the children, citing HHS data.

 

Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

Ed Silverman, Stat News

Skinny labeling refers to a process in which a generic company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.

 

Possible culprit identified in outbreak of severe liver damage cases in children

Erika Edwards, NBC News

An onslaught of common childhood viruses may have been behind the mysterious outbreak of cases of severe liver damage in children that began popping up in late 2021, as lockdowns were relaxed and schools reopened.

 

Prescriptions for ADHD drugs spiked during the pandemic, CDC report finds

Kaitlin Sullivan, NBC News

The jump in prescriptions came after several years of increases, going back to 2016, the report found. The trend coincides with rising rates of ADHD diagnoses in adolescents, adults and women.

 

Emergency room visits from firearms dropped in 2022, but remained higher than pre-pandemic rate

Kyla Russell, CNN

According to a new study published Thursday by the US Centers for Disease Control and Prevention in the Morbidity and Mortality Weekly Report, the weekly number of emergency department visits related to firearm injuries began to rise in March 2020 before sharply increasing in May 2020 and remaining high.

 

Pharmacists are burning out. Patients are feeling the effects.

Marc Kaufman, The Washington Post

Growing workloads and resulting stresses on pharmacists have led to well-documented burnout and subsequent staffing shortages. Reflecting new demands on pharmacies, the Centers for Disease Control and Prevention reports that 301 million coronavirus vaccinations had been administered in pharmacies as of March 9, roughly half of all such shots given nationally.

 

Genetic differences in breast tumors may contribute to racial disparities

Angus Chen, Stat News

Research published on Thursday in the Journal of American Medical Association found that Black patients tended to have worse responses to pre-surgical chemotherapy in nearly every subtype of breast cancer, but the disparity was most dramatic in HR negative and HER2 positive tumors.

 

Blue states push to protect trans health care

Torey Van Oot and Melissa Santos, Axios

While Republican politicians in some states work to limit gender-affirming care for transgender young people, a number of Democratic-controlled legislatures are doing the opposite. Democratic lawmakers in more than a dozen states, including Colorado, Washington, Oregon, Minnesota and Vermont, want to shield patients and providers.

 

When homelessness and mental illness overlap, is compulsory treatment compassionate?

April Dembosky et al., Kaiser Health News

Democratic leaders in California and Oregon are becoming more open to using involuntary psychiatric commitment to combat homelessness, drug abuse and untreated mental illness.

 

Health research focus could give NIH competition for funding

Ariel Cohen, Roll Call

Lawmakers are more interested in biomedical research than ever, but with limited funds for nondefense spending, experts worry the National Institutes of Health could end up in competition with the new agency the Biden administration wants to build to confront the toughest problems.

 

Maryland voters to decide abortion constitutional amendment

Brian Witte, The Associated Press

Maryland voters will decide next year whether to enshrine the right to abortion in the Maryland Constitution, after the House of Delegates voted Thursday to put a constitutional amendment on the ballot.

 

Venture capital fund formed to focus on dementia treatment startups

Dan Primack, Axios

This is the first dementia-focused fund ever raised entirely by a European VC firm, although there was an earlier one in 2013 that was partially formed and funded by various governments.

Don’t expect big changes to insurance, yet

Tina Reed, Axios

Thursday’s federal court ruling against the Affordable Care Act’s preventive services requirement won’t bring a seismic shift to employer-sponsored health care. But experts say it could well add new costs for the approximately 100 million privately insured people who use such services.

 

Making Money in Government Health Care Is About to Get Harder

John Tozzi, Bloomberg

Imminent changes to Medicare and Medicaid may mean lower profits and slower growth, threatening to temper the robust trajectory of the big companies that operate taxpayer-funded health plans for older and low-income Americans.

 

In Texas, Medicaid Coverage Ends Soon After Childbirth. Will Lawmakers Allow More Time?

Elena Rivera, KERA

Pregnancy-related Medicaid coverage ends just two months after childbirth in Texas — some advocates and researchers say that cutoff contributes to maternal deaths and illnesses in the state.

 

How to renew Medicaid as coverage cliff approaches

Erin Doherty, Axios

U.S. states will undergo a phased “unwinding” of coverage after years of Medicaid agencies being required under the COVID public health emergency to provide continuous Medicaid coverage to all enrollees, even if their eligibility changed.

How Community Health Centers and PhRMA Went From Foes to Friends

Nisha Shetty, Bloomberg Law

An unusual alliance between the pharmaceutical industry and community health centers is seeking to reform the drug discount program, hopeful that Congress will be impressed by the groups’ willingness to compromise and implement their policies.

 

There’s No Such Thing as a Casual Interaction With Your Doctor Anymore

Zoya Qureshi, The Atlantic

Many calls and messages now count as a “visit” that you could be charged for.

 

CVS-Oak Street deal clears federal regulatory hurdle

Lauren Berryman, Modern Healthcare

The Justice Department and Federal Trade Commission allowed the antitrust waiting period to lapse on Monday without taking action to prevent the two companies from combining, Chicago-based primary care provider Oak Street reported in a filing to the Securities and Exchange Commission Thursday.

Eisai, Biogen’s Leqembi set to generate $12.9B in sales through 2028: report

Kevin Dunleavy, Fierce Pharma

According to analysts with GlobalData Healthcare, the companies are poised to realize $12.9 billion in revenue from Leqembi through 2028. The data analytics company estimates sales in the United States will grow at an annual rate of 106%, totaling $7.7 billion during the period. 

 

FDA Can Apply Faster Drug Withdrawal Powers Without New Guidance

Jeannie Baumann, Bloomberg Law

A 2022 law gives the FDA the power to take ineffective drugs off the market more quickly, even those that went through the accelerated approval process before the law went into effect, the agency said.

 

‘Stunning’ 4% yearly rise in R&D share has emerging biopharma dominating pipeline

Gabrielle Masson, Fierce Biotech

So-called emerging biopharmas — a term for companies with less than $200 million in R&D spending and annual sales lower than $500 million — were responsible for 67% of 2022’s R&D pipeline, according to IQVIA’s report. This is a jump from about 63% pipeline ownership the year prior, 51% five years ago and 33% back in 2002 ago, according to the report. 

 

As deadly pathogen spreads, GSK throws a lifeline to Scynexis with $90M deal to market antifungal

Angus Liu, Fierce Pharma

Just as the CDC warns about the alarming spread of an emerging drug-resistant fungus, GSK has moved to snatch an FDA-approved drug that could tackle the pathogen—and salvage a floundering company along the way.

 

Predator and prey: Harnessing phages to fight antibiotic resistance

Karissa Waddick, PharmaVoice

Phages, bacteria’s natural predator, could help combat the growing threat of superbugs. But can these therapies rise above antibiotic market woes?

FDA drafts guidance to ease path to updates for AI-enabled devices

Elise Reuter, MedTech Dive

Typically, medical algorithms are “locked” and do not change after they are cleared by the FDA. The guidance would allow for some modifications, within a predetermined scope reviewed by regulators.

 

Fair Health finds 76% drop in telehealth use from 2020 to 2021

Brian T. Horowitz, Healthcare Dive

Telehealth use fell 76% from 2020 to 2021, according to nonprofit Fair Health’s sixth annual healthcare indicators and medical price index. This year’s report also revealed that retail clinic utilization increased 51% nationally during the same period.