First Edition: Sept. 29, 2023

KFF Health News: These Appalachia Hospitals Made Big Promises To Gain A Monopoly. They’re Failing To Deliver
Five years ago, rival hospital companies in this blue-collar corner of Appalachia made a deal. If state lawmakers let them merge, leaving no competitors, the hospitals promised not to gouge prices or cut corners. They agreed to dozens of quality-of-care conditions, spelled out with benchmarks, and to provide hundreds of millions of dollars in charity care to patients in need. (Kelman and Liss, 9/29)

KFF Health News: Social Security Overpayments Draw Scrutiny And Outrage From Members Of Congress
Several members of Congress are calling on the Social Security Administration to answer for issuing billions of dollars of payments it says beneficiaries weren’t entitled to receive — and then demanding the money back. Many of the recipients are elderly, poor, or disabled and have already spent the money. They have little or no way of repaying it. (Hilzenrath and Fleischer, 9/29)

KFF Health News: She Received Chemo In Two States. Why Did It Cost So Much More In Alaska?
Emily Gebel was trying to figure out why she was having trouble breastfeeding. That’s when she felt a lump. Gebel, a mother of two, went to her primary care doctor in Juneau, Alaska, who referred her for testing, she said. Her 9-month-old was asleep in her arms when she got the results. (Zionts, 9/29)

KFF Health News: GOP Presidential Primary Debate No. 2: An Angry Rematch And The Same Notable No-Show
From the start of the second Republican presidential primary debate of the 2024 campaign, the seven candidates on stage were boisterous and unruly. Florida Gov. Ron DeSantis, former South Carolina Gov. Nikki Haley, South Carolina Sen. Tim Scott, entrepreneur Vivek Ramaswamy, former Vice President Mike Pence, former New Jersey Gov. Chris Christie, and North Dakota Gov. Doug Burgum spent most of the evening talking loudly over — and sometimes quite angrily at — one another. (9/28)

Politico: House Republicans Introduce National Ban On Abortion Pills
Rep. Andy Ogles (R-Tenn.), flanked by leaders of anti-abortion groups, introduced a bill Thursday that would ban abortion pills nationwide. “Banning these dangerous drugs for the purpose of chemical abortion is an important step in protecting life,” he told reporters. “We have a duty to uphold the sanctity of life.” The new bill, which has 13 Republican co-sponsors as of Thursday, comes on the 23rd anniversary of the FDA approving the abortion drug mifepristone for terminating a pregnancy in the first 10 weeks. In recent years, the pills have become the most common method of abortion nationwide. (Miranda Ollstein, 9/28)

Politico: Appeals Court Lifts Partial Block On Idaho Abortion Ban 
A federal appeals court has lifted a lower court ruling that prevented the State of Idaho from enforcing aspects of its near-total ban on abortion. The 9th Circuit Court of Appeals issued an order Thursday granting Idaho officials’ request to put the injunction against the law on hold while the state appeals the lower judge’s decision. (Gerstein, 9/28)

AP: Republican Offers New Twist On Abortion Exceptions As Issue Stays At Forefront Of Kentucky Campaign
The complexities of abortion-related politics in the post-Roe v. Wade era continue to put the squeeze on Republican Daniel Cameron, who appeared to redefine his position on Kentucky’s strict anti-abortion law for the second time in two weeks while campaigning for governor. After revealing last week that he would sign legislation adding rape and incest exceptions to the state’s abortion ban, Cameron seemed to take a more hardline stance Wednesday. He did so while trying to reassure someone who claimed to be concerned that he was weakening his anti-abortion position. Cameron indicated that he would support such exceptions “if the courts made us change that law.” (Schreiner, 9/29)

The Hill: How A Shutdown Would Impact Key Health Care Programs
The current spending laws expire at 11:59 p.m. Sept. 30. Without a deal by that night, funding will lapse and many government functions, including some health care programs, will temporarily stop. Here’s how a shutdown will, and won’t, impact health agencies and services. (Weixel, 9/28)

The Wall Street Journal: Kevin McCarthy Wins Three, Loses One In Late-Night Spending Votes
House Republicans largely succeeded in passing a series of annual spending bills late Thursday night, trying to show that the often fractured conference can stay united on legislation headed into any last-gasp negotiations with Democrats to avert a government shutdown this weekend. (Stech Ferek, Hughes, Wise and Peterson, 9/29)

Politico: Manchin Snarls Top VA Nominee Over Abortion
Manchin (D-W.Va.) has joined Republicans on the Veterans’ Affairs Committee in blocking Anjali Chaturvedi, a top Department of Justice lawyer, over the agency’s policy allowing it to provide abortion counseling and some abortions. The VA last fall finalized the policy, which enables it to provide the procedure when the life or health of a veteran or beneficiary is in peril, or in cases of rape or incest. The policy also covers dependents. (Leonard, 9/28)

The Hill: Bipartisan Battle Over Prescription Intermediaries Heats Up
The intermediaries in the prescription drug supply chain are stuck between a rock and a hard place, facing congressional scrutiny and pharmaceutical-industry-backed efforts to reform the multibillion-dollar industry. Pharmacy benefit managers (PBMs) have emerged as a bipartisan target in a divided Congress. (Choi and Giorno, 9/28)

Politico: Merck Agrees To Medicare Drug Price Negotiations
Merck confirmed on Thursday it will enter talks with CMS for Medicare price negotiations on its diabetes drug Januvia, saying that it has no choice but to agree. The drugmaker in June sued the Biden administration challenging the constitutionality of the negotiations policy. It is the fourth company to say it will opt into talks with the government ahead of an Oct. 1 deadline joining AstraZeneca, Bristol-Myers Squibb and Boehringer Ingelheim. (King, 9/28)

Politico: CBO: Center Tasked With Saving Medicare Money Falls Short
The agency tasked with lowering Medicare costs by changing how physicians and hospitals are paid is on pace to increase spending by more than $1 billion through 2030. The Congressional Budget Office released an updated estimate Thursday that shows the Center for Medicare and Medicaid Innovation, created under Obamacare to test new ways to pay for health care, will increase federal spending by $1.3 billion from 2021 to 2030. From 2011 through 2020, the center increased spending by $5.4 billion. (King, 9/28)

Politico: The Trump Health Insurance Policy That Biden Hasn’t Scrapped
When President Joe Biden took office, his administration gutted many of the health policies former President Donald Trump had implemented. But there’s one Trump-era health insurance regulation that Biden has yet to touch: the 2019 rule that allowed employers to provide tax-exempt subsidies to help workers purchase Obamacare plans. The lack of action is puzzling left-leaning health care advocates who say the Trump rule allows employers to dump sicker, more expensive employees onto the Affordable Care Act exchanges, raising premiums for everyone else. (Hooper, 9/28)

Politico: Cardin Vows To Re-Up Global AIDS Program But There’s No Deal In Sight
Sen. Ben Cardin (D-Md.) said Thursday he will keep pushing for a five-year renewal of the country’s $7 billion annual global HIV-AIDS initiative, even as his colleagues call for a shorter extension to satisfy anti-abortion groups. “It’s important to give the signal to the international community that we’re in the game,” said Cardin, who took over as chair of the Senate Foreign Relations Committee this week after Sen. Bob Menendez was indicted. (Miranda Ollstein and Paun, 9/28)

The Boston Globe: Sec. Tutwiler: More Mental Health Support In Schools A "Priority"
Similar to the updated health, physical, and sex education framework the Board of Elementary and Secondary Education unanimously approved last week, the mental and behavioral health framework would be a set of guidelines and recommendations for how schools and teachers could teach about mental health in all grades, Tutwiler said. “What we want to do is establish a strategy around mental health and that, quite frankly, does not exist,” Tutwiler said in an interview with the Globe on Thursday. (Griswold, 9/28)

Politico: House Judiciary Committee Approves Bill To Combat Illicit Opioids
The House Judiciary Committee advanced legislation Thursday to reauthorize the Support for Patients and Communities Reauthorization Act, a major 2018 opioid law providing treatment and support to people with opioid use disorder. The measure includes an amendment by New York Rep. Jerry Nadler, the top Democrat on the panel, that would make the horse sedative xylazine — which drug traffickers are adding to illicit fentanyl with deadly effect — a Schedule III controlled substance, for three years, subject to additional Drug Enforcement Administration regulation. (Paun, 9/28)

Politico: FDA Fines 22 Retailers In 13 States For Selling Illegal Vapes
The FDA on Thursday said that for the first time, it was fining 22 retailers for more than $19,000 each after it found they continued to sell unauthorized flavored e-cigarettes despite warnings to stop. (Ellen Foley, 9/28)

The Hill: CDC Director Urges Flu, COVID Vaccination Amid Low Uptake
Vaccination rates for COVID-19 and the flu have declined, and a significant portion of the U.S. population indicated they are not interested in getting either this year, according to a new survey. The survey from the National Foundation for Infectious Diseases found that only about 20 percent of Americans are worried about themselves or someone in their family getting infected with the flu, COVID-19 or respiratory syncytial virus (RSV). (Weixel, 9/28)

AP: What To Know As Fall Vaccinations Against COVID, Flu And RSV Get Underway
Updated COVID-19 vaccines may be getting a little easier for adults to find but they’re still frustratingly scarce for young children. Health officials said Thursday the kid shots have started shipping — and reminded most everyone to get a fall flu shot too. About 2 million Americans have gotten the new COVID-19 shot in the two weeks since its approval despite early barriers from insurance companies and other glitches, according to the Department of Health and Human Services. (Neergaard, 9/28)

CBS News: Thousands Of Cantaloupes Sold In 19 States Recalled Due To Potential Salmonella Contamination
Thousands of whole cantaloupes sold in 19 states and Washington, D.C., have been recalled due to potential salmonella contamination, the Food and Drug Administration announced. Eagle Produce, based in Scottsdale, Arizona, is doing a voluntary recall of 6,456 cases of whole cantaloupe after the fruits were tested in a distribution center by the FDA, the agency said in a news release. (Martinez, 9/28)

CBS News: Parasite Found In Drinking Water Could Make Vulnerable People In Baltimore Area Sick, DPW Says
Low levels of a microscopic parasite were found during routine testing of Druid Lake Reservoir, the Baltimore Department of Public Works said, meaning the drinking water could sicken some vulnerable populations in parts of Baltimore, Baltimore County and Howard County. Today, Thursday, Sept. 28, DPW announced that during a routine test of the Druid Lake Reservoir low levels of the microscopic parasite Cryptosporidium were discovered. pic.twitter.com/VUBF6KJnBH (Mattu, 9/28)

The Boston Globe: Combatting Loneliness Is One Step Toward Solving The Mental Health Crisis, Surgeon General Says In N.H. Visit
As the surgeon general, part of Vivek H. Murthy’s job is to figure out what ails the country and how we can heal. His diagnosis: As we have receded from the places and activities where we used to find community, our mental health is worse than ever. “Our connection to one another as a foundation on which we build a healthy society, as that foundation has crumbled and weakened, we’ve seen that we’re suffering across the board,” he told Dartmouth students and faculty during a panel at the college on Thursday. (Gokee, 9/28)

Fortune: TikTok Influencers Promoting Steroids, Warns Nonprofit
TikTok has become a key marketing channel for vendors promoting steroids and other bodybuilding drugs to millions of the app’s users, according to a report released Thursday that the social media company disputes. In the study, the nonprofit Center for Countering Digital Hate says popular videos encouraging use of the products for aesthetic or athletic gain are being posted by influencers who often downplay the risks associated with them. It follows a warning issued by the U.S. Food and Drug Administration in April about performance-enhancing drugs being marketed to teenagers and young adults on social media platforms. (Hadero, 9/28)

CIDRAP: Evolving Peak SARS-CoV-2 Loads Relative To Symptom Onset May Influence Home-Test Timing
In a group of adults in the state of Georgia tested for both COVID-19 and influenza A, most of whom were vaccinated and/or previously infected, median SARS-CoV-2 viral loads peaked on the fourth day of symptoms, while flu loads peaked soon after symptom onset. The authors of the study, published today in Clinical Infectious Diseases, say the findings have implications for the use of rapid antigen tests for COVID-19 and flu. (Van Beusekom, 9/28)

CBS News: COVID Vaccine During Pregnancy Still Helps Protect Newborns, CDC Finds
Maternal vaccination was 54% effective against COVID-19 hospitalization in infants younger than 3 months old over the past season. The findings from the CDC-backed Overcoming COVID-19 Network were published Thursday in the agency's Morbidity and Mortality Weekly Report. They drew from data on hospitalizations from 26 pediatric hospitals around the country through May 2023. (Tin, 9/28)

CIDRAP: Antibiotic Shows Efficacy Against Complicated Staph Bacteremia
The results of a phase 3 clinical trial show an antibiotic used for treating pneumonia could be an option for treating bloodstream infections caused by antibiotic-resistant bacteria, researchers reported today in the New England Journal of Medicine. The trial, which was led by investigators from Duke University and received funding from the US Department of Health and Human Services, found that the cephalosporin antibiotic ceftobiprole was noninferior to daptomycin for treatment of patients with complicated Staphylococcus aureus bacteremia, including methicillin-resistant S aureus (MRSA). (Dall, 9/28)

CIDRAP: Study: 75% Of Infants Hospitalized With COVID-19 Born To Unvaccinated Women
This week, studies in Morbidity and Mortality Weekly Report describe the landscape of COVID-19 vaccination among women of reproductive age and those who are pregnant, showing better outcomes for infants whose mothers were vaccinated during pregnancy. Maternal mRNA vaccines against COVID-19 have been widely recommended by providers for more than 2 years, and now evidence from the Omicron surge shows they were effective in preventing hospitalizations for infants ages 6 months or less. (Soucheray, 9/28)

Modern Healthcare: Hospitals, Health Systems Facing Credit Rating Downgrades
Dozens of hospitals and health systems have faced credit rating downgrades this year as the industry continues to wrestle with a challenging operating environment. As of the end of August, more than 60 hospitals and health systems have been downgraded by at least one of the three largest credit rating agencies. ... Reports from the agencies often cited operating losses stemming from labor shortages and high costs plus dwindling liquidity, high debt-to-cash ratios and/or possible default on debt agreements as reasons for the downgrades. (Hudson, 9/28)

Stat: Data Show Record Exodus Of Life Scientists From Academia 
New data released Thursday by the National Science Foundation show the exodus of young life scientists from the Ivory Tower to industry has reached the highest level in nearly three decades, deepening concerns about the future of academic science in the U.S. (Wosen, 9/28)

Crain's Cleveland Business: Duly Health And Care Lays Off Workers, Reducing Services
After overhauling its C-suite, Chicago’s largest physicians group is shedding staff, cutting compensation and reducing services as it battles industrywide headwinds and lugs a heavy debt burden from a 2017 private-equity deal. Downers Grove-based Duly Health & Care laid off a number of workers in September across the organization, the second round of job cuts in recent months, current and former employees say. (Davis, 9/28)

The Boston Globe: Broad Institute Co-Founder Scales Back His Role
Stuart L. Schreiber, one of the four founding members of the Broad Institute of MIT and Harvard, is scaling back his work at the renowned biomedical research center in Cambridge. Schreiber, a Harvard professor known for his role in the development of the field of chemical biology, is “transitioning his status to founding core institute member emeritus as he enters the next phase of his career,” David Cameron, a Broad spokesman, confirmed Thursday. He had no further details. (Saltzman, 9/28)

The Wall Street Journal: FemHealth Ventures Closes $32 Million Fund For Women’s Health Investments
FemHealth Ventures, which invests in companies focused on women’s health, has closed a $32 million debut fund despite a difficult fundraising environment for new venture firms. (Gormley, 9/28)

The Boston Globe: Harbinger Health Raises $140 Million For Blood Test To Screen For Cancers
A Cambridge biotech run by the former head of the Food and Drug Administration has raised $140 million to complete the study of a blood test it developed to screen for cancers in people without symptoms. Harbinger Health, founded in 2020 by Flagship Pioneering, the venture capital giant that created the vaccine-maker Moderna, is testing the cancer screening technology in a clinical trial of 10,000 volunteers. Some trial results are expected next year. Saltzman, 9/28)

Reuters: Eli Lilly Settles Whistleblower Lawsuit Over Manufacturing Problems 
Eli Lilly and Co and a former employee agreed to settle a lawsuit in which the worker claimed she was terminated after pointing out poor manufacturing practices and data falsification involving one of its blockbuster diabetes drugs, according to court filings. The former human resources officer, Amrit Mula, contended in the lawsuit that she repeatedly urged leaders at a New Jersey plant to remedy problems involving several biologic drugs, including Type 2 diabetes medicine Trulicity. (Levine and Taylor, 9/28)

The Hill: FDA Approves Exxua For Depression Treatment After Multiple Rejections Over More Than Two Decades
The U.S. Food and Drug Administration (FDA) on Thursday approved the medication Exxua to treat major depressive disorder – a significant step after a decades-long battle for approval. Exxua is unique for its ability to target the serotonin 1A receptor, which is a regulator of mood and emotion. In doing so, it avoids undesirable side effects that often come with drugs that treat anxiety and depression disorders, including sexual dysfunction and weight gain, according to the press release from drug manufacturer Fabre-Kramer Pharmaceuticals. (Fortinsky, 9/28)

Reuters: Merck's Blood Vessel Disorder Therapy Receives US FDA's Priority Review
Merck said on Thursday the U.S. health regulator will review its experimental therapy to treat a type of progressive blood vessel disorder on a priority basis. The drugmaker had gained rights to the therapy, sotatercept, through its $11.5 billion acquisition of Acceleron Pharma in 2021. The U.S. Food and Drug Administration has set March 26, 2024 as a target action date for the review, Merck said. (9/28)

Reuters: Amicus' Muscle Disorder Therapy Gets US FDA Nod But Restricted Label Drags Shares
Amicus Therapeutics' treatment for a rare muscle disorder called Pompe disease was approved by the U.S. health regulator, the drugmaker said on Thursday, ending its years-long efforts to launch the therapy. (Roy, 9/29)

Reuters: J&J's Lung Cancer Therapy Succeeds In Head-To-Head Study With AstraZeneca's Drug
Johnson & Johnson said its cancer drug combination increased the time patients with a type of non small-cell lung cancer live without the disease worsening compared to AstraZeneca's Tagrisso in a late-stage study. J&J said on Thursday it expects the combination to become a first-line treatment for non small-cell lung cancer (NSCLC) patients with a type of mutation in EGFR protein that causes rapid tumor cell growth. (Satija, 9/28)

AP: Thousands Of Women March In Latin American Cities Calling For Abortion Rights
The streets of cities across Latin America were bathed in green Thursday as tens of thousands of women marched to commemorate International Safe Abortion Day. Latin American feminists have spent decades fighting to roll back strict prohibitions, although there are still few countries with a total ban, like El Salvador and Dominican Republic. (Janetsky and Rey, 9/29)

The New York Times: Vulnerable New Yorkers Suffer As Some Services Decline Under Mayor Adams
The city’s eight sexual health clinics saw nearly 95,000 annual visits before the pandemic; that number has dropped to nearly 62,000 over the last year, according to data from the Health Department. Only five of the clinics offered sexual health services, and a sixth reopened in July. As for tuberculosis — a highly infectious disease that has higher rates in some other countries from which people emigrate to New York — one of the city’s four clinics, in Washington Heights, closed as part of the pandemic response and has not reopened. (Rubinstein and Fitzsimmons, 9/29)

The Washington Post: Sixth Circuit Ban Trans Youth Health Care In Kentucky And Tennessee
After a very active legislative session in which more than a dozen states passed restrictions on gender-affirming care, many of the laws are now being challenged in court as unconstitutional. Federal courts have started to weigh in, offering conflicting decisions. The ruling by the U.S. Court of Appeals for the 6th Circuit is the latest of these. The U.S. Court of Appeals for the 6th Circuit issued a ruling Thursday evening that allowed Tennessee and Kentucky to enforce laws banning gender-affirming medical care for minors, such as puberty blockers and hormones. (Javaid, 9/28)