- KFF Health News Original Stories 5
- A Bitter Battle Over the ‘Orphan Drug’ Program Leaves Patients’ Pocketbooks at Risk
- Proposed Medicare Advantage Changes Cannot Accurately Be Called 'Cuts,' Experts Say
- California Says It Can No Longer Afford Aid for Covid Testing, Vaccinations for Migrants
- In Tennessee, a Medicaid Mix-Up Might Land You on a 'Most Wanted' List
- Listen to the Latest 'KFF Health News Minute'
From KFF Health News - Latest Stories:
KFF Health News Original Stories
A Bitter Battle Over the ‘Orphan Drug’ Program Leaves Patients’ Pocketbooks at Risk
Patients who depend upon special drugs to treat rare diseases are caught in the crossfire as drugmakers and the FDA battle over regulations that reward companies for developing treatments for relatively small pools of patients. (Sarah Jane Tribble, 2/22)
Proposed Medicare Advantage Changes Cannot Accurately Be Called 'Cuts,' Experts Say
CMS advanced two proposed changes that could affect Medicare Advantage plans. One would allow the government to recover past overpayments. As a result, it could reduce those insurers’ profits, leading them to increase enrollees' out-of-pocket costs or reduce benefits. But it's inaccurate to characterize the changes as "cuts." (Madison Czopek, PolitiFact and Yacob Reyes, PolitiFact, 2/22)
California Says It Can No Longer Afford Aid for Covid Testing, Vaccinations for Migrants
Gov. Gavin Newsom is winding down state assistance for health care services to migrants seeking asylum. He’s lobbying the Biden administration to increase aid along the state’s southern border. (Don Thompson, 2/22)
In Tennessee, a Medicaid Mix-Up Might Land You on a 'Most Wanted' List
Tennessee posts the names and photos of people arrested for alleged Medicaid fraud on a government website and social media. Some people even wind up on a "most wanted" list. (Blake Farmer, Nashville Public Radio, 2/22)
Listen to the Latest 'KFF Health News Minute'
“Health Minute” brings original health care and health policy reporting from the KFF Health News newsroom to the airwaves each week. (1/2)
Summaries Of The News:
Merck's Covid Drug Not Effective At Preventing Household Transmission
Merck and Co's late-stage trials failed to show that its oral antiviral Lagevrio, also known as molnupiravir, cut the risk of preventing covid from spreading to others living in the same house. Merck had hoped to build a case for use of the medication as prophylactic treatment.
Reuters:
Merck's COVID Pill Fails To Prevent Infection Among Household Members
Merck & Co Inc said on Tuesday its COVID-19 pill was not effective at cutting the risk of coronavirus infections in people living with someone infected with the virus. The results were similar to data from rival Pfizer Inc, whose COVID pill Paxlovid also failed to prevent infections among household contacts. (2/21)
FiercePharma:
Slump Of Merck's COVID-19 Pill Continues With Trial Failure
Initially hyped as a game-changing COVID-19 treatment, the shine was off Merck and Ridgeback’s oral antiviral Lagevrio (molnupiravir) even before it was authorized for use in the United States. Nevertheless, the pill generated more than $6.6 billion in sales over its first five quarters on the market, despite mounting evidence of its limited effectiveness. (Dunleavy, 2/21)
From the states —
Des Moines Register:
Tyson Foods’ Petition In COVID Death Cases Dismissed By Supreme Court
The U.S. Supreme Court has declined to hear Tyson Foods’ arguments about why federal judges should oversee lawsuits tied to the COVID-19 deaths of workers at its plants, including its nearly 2,800-worker pork processing plant in Waterloo. The court on Tuesday denied Tyson’s petition to review the decision of lower court judges, who ruled in multiple cases that Tyson employees can sue the company in state-level courts. (Jett, 2/21)
USA Today:
Idaho Bill Could Criminalize Anyone Administering MRNA COVID Vaccines
Two Republican Idaho lawmakers last week introduced a new bill that would criminalize the administration of mRNA vaccines across the state. ... Under the bill, all mRNA technology would be banned in the state.If passed, the Idaho state code would be amended so that those administering mRNA vaccines to any person or mammal within the state would face misdemeanor charges. (Nguyen, 2/21)
KHN:
California Says It Can No Longer Afford Aid For Covid Testing, Vaccinations For Migrants
All day and sometimes into the night, buses and vans pull up to three state-funded medical screening centers near California’s southern border with Mexico. Federal immigration officers unload migrants predominantly from Brazil, Cuba, Colombia, and Peru, most of whom await asylum hearings in the United States. (Thompson, 2/22)
In other covid-related research —
Scientific American:
COVID Poses Severe Risks During Pregnancy, Especially In Unvaccinated People
Millions of people have been pregnant and given birth during the pandemic. When the COVID-causing virus SARS-CoV-2 first emerged, it wasn’t clear what additional risks—if any—it posed to pregnant people and their babies. But accumulating evidence now shows that having COVID during pregnancy increases the likelihood of severe outcomes and death in the parent, as well as the possibility of fetal complications. (Lewis, 2/22)
Ars Technica:
Unvaccinated More Likely To Have Heart Attack, Stroke After COVID, Study Finds
A bout of COVID-19 is known to increase a person's long-term risks of having a major cardiovascular event, such as a heart attack or stroke. But being fully vaccinated or even partially vaccinated appears to bring that risk down, according to a study published this week in the Journal of the American College of Cardiology. (Mole, 2/21)
Los Angeles Times:
Kids Under 5 Being Left Behind With COVID-19 Vaccines
Black and Latino children in Los Angeles County younger than 5 have COVID-19 vaccination rates in the single digits, reflecting a broad trend nationwide that has public health experts concerned and seeking ways to boost those figures. Only 12% of children between 6 months and 4 years old have received at least one dose of a COVID-19 vaccine, and only 7% are fully vaccinated, according to L.A. County data. (Evans, 2/21)
CIDRAP:
CIDRAP Unveils Roadmap For Advancing Better Coronavirus Vaccines
Before the COVID-19 pandemic, the warning signs for newly emerging and deadly coronaviruses were already flashing bright red. Researchers were still working on SARS-CoV studies in 2012 when the even deadlier MERS-CoV arrived on the scene in the Middle East, repeatedly jumping from camels over the years and sparking large healthcare-related outbreaks. (Schnirring, 2/21)
Meanwhile, the pandemic is having unexpected side-effects —
Fox News:
Post-COVID, Many Parents Are Giving Kids Fever-Reducing Medicine When It's Not Necessary: Study
Parents might want to think twice before reaching for aspirin or ibuprofen to bring down a child’s fever. One in three parents give their kids fever-reducing medicine when it’s not really needed, a new study from Michigan Medicine at the University of Michigan found. (Rudy, 2/21)
Medicare Advantage Enrollment Reaches 31 Million Though Is Slowing
In an analysis by the Chartis Group, enrollment in Medicare Advantage 2023 plans is up 5.5%. Last year's signups grew 9% over the previous year. Other news relates to inpatient claim denials, Medicare drug pricing negotiations, and more.
Modern Healthcare:
Medicare Advantage Enrollment Growth Slowed For 2023
Medicare Advantage growth slowed for the 2023 plan year, according to a report the Chartis Group published Tuesday. Enrollment increased 5.5% for this year, down from a record 9% the prior year, driven by California and a handful of other states where the number of people signed up for private Medicare plans actually fell, said Nick Herro, a principal at the Chartis Group and co-author of the study. (Tepper, 2/21)
Healthcare Finance News:
Medicare Advantage Plans Denying More Inpatient Claims
Healthcare systems have found themselves in precarious financial standing due to a dramatic increase in the number of inpatient claims being denied by health insurers based on the lack of medical necessity, according to data collected by accounting and technology firm Crowe. These level-of-care reimbursement disputes are especially rising in frequency among Medicare Advantage plans. (Lagasse, 2/21)
North Carolina Health News:
Medicare Advantage Faces New Challenges To Costs, Practices
The popular Medicare Advantage program, known for attractive perks — yet questioned for some policies — is facing a recent series of critiques over its practices and cost to the U.S. budget. It’s part of what might be called a battle for Medicare’s heart and soul being fought by powerful interests in North Carolina, where hundreds of thousands have enrolled for the plan, and beyond. (Goldsmith, 2/22)
On Medicare drug costs —
Bloomberg Law:
Drug Price Negotiation Deadlines Expose Medicare To Litigation
The Medicare agency risks legal challenges from the pharmaceutical industry as it scrambles to meet rapidly approaching deadlines in President Joe Biden’s landmark drug pricing law, attorneys say. The timeline Congress set in the Inflation Reduction Act (Public Law 117-169) to begin negotiating certain drug prices are “tremendously tight” for the Centers for Medicare & Medicaid Services, said Jonathan Blum, the agency’s principal deputy administrator and chief operating officer. (Castronuovo, 2/22)
Fierce Healthcare:
Senators Urge CMS To Rethink Coverage For Alzheimer's Drugs
A group of senators is urging the Biden administration to rethink its restrictive coverage determination for emerging Alzheimer's disease treatments. The letter to Department of Health and Human Services Secretary Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure is signed by 20 senators comprising 18 Republicans and two Democrats. (Minemyer, 2/21)
Meanwhile, Sen. Bernie Sanders is skeptical about the future of Medicare for All —
The Hill:
Sanders: Medicare-For-All ‘Ain’t Going To Happen’ In Divided Congress
Sen. Bernie Sanders (I-Vt.) said “Medicare for All,” a system that would establish government-run health care for all U.S. citizens, “ain’t going to happen” during the next two years amid a divided Congress. (Gans, 2/21)
On Medicaid news from Missouri and Tennessee —
St. Louis Public Radio:
Missouri Senate Gives Initial Approval To Maternal Health Bill
The Missouri Senate has given initial approval to expanding how long someone would have access to Medicaid coverage after giving birth. However, the expansion will only occur after around 5,000 people are removed from the state’s Medicaid program. Senators gave first-round approval to legislation on Tuesday that expands coverage for one full year after giving birth. It must go through one more vote before moving on to the House. (Kellogg, 2/21)
KHN:
In Tennessee, A Medicaid Mix-Up Might Land You On A ‘Most Wanted’ List
Life was upended for LaShonia Ingram over the past year, and a shadow still follows her around. Search her name online, and the first result includes the words “fraud” and “most wanted.” “It was horrible. I couldn’t get a job,” said the 42-year-old mother from Memphis, Tennessee. “All doors were being closed in my face.” (Farmer, 2/22)
CMS Warns 500 Hospitals Missing Price Transparency Requirements
As an early step in increased efforts to enforce transparency rules, the Centers for Medicare and Medicaid Services says that 300 of the 500 facilities have addressed the cited issues and are now compliant. In other news: hospitals feel greater lawmaker scrutiny of outpatient billing, and CMS overhauls hospice inspections.
Fierce Healthcare:
CMS: Tighter Price Transparency Enforcement On The Horizon
Centers for Medicare and Medicaid Services leaders say the agency has handed out nearly 500 warnings to hospitals falling short on price transparency, as of January, and plans to streamline enforcement and standardize hospital reporting requirements. (Muoio, 2/21)
Axios:
Hospital Outpatient Billing Draws Bipartisan Heat
Hospitals could be playing defense this year as bipartisan scrutiny builds in Congress over the way facilities charge more for outpatient services that can be done in less-expensive settings, like a private doctor's office. (Dreher and Sullivan, 2/22)
ProPublica:
Regulators Overhaul Inspections Of Hospice Providers
In late January, amid intensifying scrutiny of the quality of care provided by the American end-of-life care industry, the Centers for Medicare and Medicaid Services has reformed how it inspects hospice providers. The changes, detailed in a 196-page document, went into effect immediately. Under the new protocol, inspectors must sample data from multiple locations where the hospice operates and evaluate a broader range of metrics. These include records on the hospice’s inpatient care, bereavement practices and reasons patients are leaving the service alive. “An unusually high rate of live discharges could indicate that a hospice provider is not meeting the needs of patients and families or is admitting patients who do not meet the eligibility criteria,” the revised rules note. (Kofman, 2/22)
More from the Biden administration —
The Wall Street Journal:
FTC Alleges Supplement Company ‘Hijacked’ Amazon Reviews To Boost Sales
Nutritional supplement company Bountiful Co. will pay $600,000 following Federal Trade Commission allegations that it made products on Amazon look like they had more reviews and higher average ratings than they really did. The FTC said the case marks its first enforcement action against a practice called “review hijacking,” in which a marketer makes reviews for one product appear to apply to another. (Graham, 2/21)
Politico:
FTC Won't Challenge Amazon's One Medical Deal
“The FTC’s investigation of Amazon’s acquisition of One Medical continues,” said FTC spokesperson Douglas Farrar. “The commission will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.” (Sisco, 2/21)
CBS News:
FDA Hasn't Reviewed Some Food Additives In Decades
Cristina Ochoa often worries if the food she's feeding her two young kids is safe, even after carefully reading ingredient labels. "Some ingredients I have no idea what they are, how to pronounce them," she said. "I want the best for my children. I would think that as a society we want the best for our children." (Tracy, 2/21)
On mental competency tests for politicians —
The Hill:
Nikki Haley: Bernie Sanders Is ‘Exactly The Reason’ Mental Competency Tests Are Needed
Presidential candidate Nikki Haley defended her proposal for mental competency tests here on Tuesday — in startlingly personal terms. Haley said that one critic of the proposal, Sen. Bernie Sanders (I-Vt.), was “exactly the reason we need it.” Sanders, 81, had told Stephen Colbert of CBS’s “Late Show” Monday that Haley’s plan for mandatory tests of the mental acuity of politicians over the age of 75 was “nothing more than old-fashioned ageism” and “not acceptable.” (Stanage, 2/21)
Politico:
Older Voters Balk At Nikki Haley’s Competency Test
Older Republicans say they aren’t opposed to Nikki Haley’s call for a new generation of politicians leading their party. But when she calls for mental competency tests for politicians over the age of 75, some of them start to feel insulted. (Kashinsky and Allison, 2/21)
In other political, legal health care news —
Politico:
Suit Seeks To Force EPA Action On Incinerator Compliance
The stakes could be high: There are more than 330 incinerators covered by the standards that collectively release thousands of tons of carbon monoxide, lead, mercury and other pollutants each year, according to EPA figures cited in the suit. The agency's alleged foot-dragging thus "prolongs and increases the hazardous air pollutant exposure of local communities, wildlife, plant, water, land, and ecosystems," the filing adds. (Reilly, 2/21)
Reuters:
J&J Loses Challenge To $302 Million Judgment Over Pelvic Mesh Marketing
The U.S. Supreme Court on Tuesday let stand a $302 million judgment against Johnson & Johnson (JNJ.N) in a lawsuit brought by the state of California accusing the company of concealing the risks of its pelvic mesh products. The court, following its usual practice, did not give any reason for refusing to hear J&J's appeal. (Pierson, 2/21)
The Washington Post:
Department Of Defense Advises Military To Avoid Poppy Seeds
The Defense Department is advising U.S. military personnel to be mindful of a substance that could derail their careers: poppy seeds. In a memo published Tuesday, Gilbert R. Cisneros Jr., the undersecretary of defense for personnel and readiness, warned service members that eating poppy seeds could result in a failed drug test. (Melnick, 2/22)
20 Democratic Governors Move To Protect Abortion Rights
The coalition's goal is to expand abortion access in their respective states even as bans continue to be enacted elsewhere. In Ohio, an abortion rights campaign released its proposal to amend the state constitution.
Axios:
20 Dem Governors Form Coalition To Protect Abortion Access
A group of 20 Democratic members on Tuesday announced they are forming a coalition to protect and expand abortion access in their states as bans continue to be enacted following the fall of Roe v. Wade. (Gonzalez, 2/21)
AP:
Democratic Governors Form Alliance On Abortion Rights
Organizers, led by California Gov. Gavin Newsom, described the Reproductive Freedom Alliance as a way for governors and their staffs to share best practices and affirm abortion rights for the approximately 170 million Americans who live in the consortium’s footprint — and even ensuring services for the remainder of U.S. residents who live in states with more restrictive laws. (Barrow and Mulvihill, 2/21)
The Boston Globe:
With Abortion Under Attack Nationwide, Healey Joins 19 Other Governors In Effort To Shore Up State Protections
Amid attacks on abortion access and other forms of reproductive care across the country, Governor Maura Healey will join 19 other governors to share ideas on how to reinforce reproductive freedoms in their own states. The multistate group, the Reproductive Freedom Alliance, is being formed eight months after the Supreme Court eliminated the constitutional right to an abortion, resulting in millions of Americans losing access to the procedure. (Gross, 2/21)
In news on abortion rights in Ohio, New Mexico —
The (Cleveland) Plain Dealer:
Ohio Abortion-Rights Campaign Unveils Ballot Proposal In First Official Step For Possible Statewide November Vote
A proposed amendment to the state constitution would give Ohioans an individual right to abortion modeled after a successful ballot initiative that last year enshrined abortion rights into Michigan’s state constitution. Backers call the amendment the “Right to Reproductive Freedom with Protections for Health and Safety,” according to a written summary they filed Tuesday afternoon with the Ohio Attorney General’s Office. (Tobias, 2/21)
The Wall Street Journal:
Ohio Abortion-Rights Coalition Begins Push For Constitutional Amendment
An effort to place a constitutional amendment protecting abortion rights on the ballot is brewing in Ohio. Ohioans for Reproductive Freedom and Ohio Physicians for Reproductive Rights filed paperwork with the state’s attorney general Tuesday in one of its first steps to try to enshrine abortion rights in the state constitution. (Calfas, 2/21)
Albuquerque Journal:
House Endorses Proposal Intended To Strengthen Abortion Rights In New Mexico
Legislation adopted by the state House late Tuesday would prohibit cities and public schools in New Mexico from interfering with a person’s access to abortion or gender-affirming care. The proposal, House Bill 7, now advances to the Senate, following an intense, three-hour debate that touched on the rights of teachers, parents and children. (McKay, 2/21)
Meanwhile, on other abortion-related news across the country —
Reuters:
U.S. Groups Suing To Ban Abortion Pill Lose Bid For Early Trial
A Texas federal judge on Tuesday refused to set an accelerated trial schedule for a lawsuit by anti-abortion groups seeking to end U.S. sales of the abortion pill mifepristone, in a case that could severely disrupt access to medication abortion nationwide. (Pierson, 2/22)
AP:
NC GOP Lawmakers Seek To Defend Abortion Pill Restrictions
North Carolina Republican legislative leaders asked on Tuesday to participate in litigation to defend state restrictions on dispensing abortion pills because Democratic Attorney General Josh Stein has made clear he won’t. Lawyers for Senate leader Phil Berger and House Speaker Tim Moore filed papers in federal court asking to enter the case as new defendants, saying someone must be in place to rigorously defend state abortion laws. (Robertson, 2/21)
WUSF Public Media:
Out-Of-State Patients Fuel An Increase In Abortions In Florida
More people got abortions in Florida last year despite the state's decision to ban the procedure after 15 weeks of pregnancy, with people traveling from out of state largely fueling the increase. Agency for Health Care Administration data shows 82,192 people got abortions in Florida in 2022, up from 79,817 in 2021. Of those, 6,708 people came from out-of-state, a 38% increase from the year before. (Colombini, 2/21)
Though Covid Hit Screenings, New Cancer Cases Didn't Surge: Report
An analysis of health records showed that though cancer screenings dropped off during the pandemic, there was no significant uptick in certain types of cancer cases. Meanwhile, a different study links low wages to higher mortality risk for middle age workers.
Axios:
COVID-Driven Drop In Cancer Screenings Didn't Result In More New Cases
The dropoff in cancer screenings during the pandemic didn't result in significantly more breast, cervical and colon cancer cases, or how advanced those cases were, according to a review of nearly 375,000 diagnoses in electronic health records. (Bettelheim, 2/21)
On health and the workforce —
CNN:
Low Wages Linked With Elevated Mortality Risk For Middle-Age Workers In The US, Study Finds
Middle-age workers who tend to earn a low wage have an elevated mortality risk, especially when they experience unstable employment, according to a study published Tuesday in the medical journal JAMA. (McPhillips and Wallace, 2/21)
The Wall Street Journal:
After Testing Four-Day Week, Companies Say They Don’t Want To Stop
Want to try a four-day workweek? Put this on the boss’s desk. A large majority of U.K. companies participating in a test of a four-day workweek said they would stick with it after logging sharp drops in worker turnover and absenteeism while largely maintaining productivity during the six-month study. (Fuhrmans, 2/21)
In other public health developments —
Axios:
The Next Phase Of The Global HIV/AIDs Fight
The President's Emergency Plan for AIDS Relief — the biggest effort by one nation to address a particular disease — is hitting a milestone anniversary. But advocates worry the U.S. may take its foot off the gas. (Reed, 2/21)
The Hill:
Wildlife Species Worldwide Exposed To ‘Forever Chemicals,’ Survey Shows
Wildlife from around the world — from polar bears, to monkeys, to dolphins — may be exposed to cancer-linked “forever chemicals,” a new survey has found. A comprehensive map curated by the Environmental Working Group (EWG) provides a window into just how many kinds of animals, including some that are endangered or threatened, may be contaminated by per- and polyfluoroalkyl substances (PFAS). (Udasin, 2/22)
The Hill:
These Cities Are Home To The Happiest Americans
To uncover the happiest places in America, SmartAsset analyzed the 200 largest cities, 164 of which had available data. This analysis looked at 13 different metrics across three categories: personal finance, well-being and quality of life. For details on our data sources and how SmartAsset put all the information together to create final rankings, read the Data and Methodology section below. (Solum, 2/21)
Study Highlights High Fatality Of Mpox For People With Advanced HIV
News outlets cover the results of the first major study of mpox among people with advanced cases of HIV, showing it often causes severe illness and has a high death rate. Among other news, a study finds Hispanic and Black veterans are having to wait longer to see health specialists.
NBC News:
Mpox Is Highly Fatal Among People With Advanced HIV, Study Finds
Mpox can have a devastating impact on people with advanced cases of HIV, leading to severe skin and genital lesions and causing death in as many as 1 in 4 of those with a highly compromised immune system. This is according to the first major study of mpox in this population, which a global team of authors published in The Lancet on Tuesday. The analysis included 382 people from 28 nations, all of whom were HIV-positive and had a count below 350 of key immune cells called CD4 cells, which help ward off infections. Twenty-seven of these individuals died. (Ryan, 2/21)
The New York Times:
Mpox Often Leads To Severe Illness, Even Death, In People With Advanced H.I.V.
In people with advanced H.I.V. disease, the mpox virus — formerly known as monkeypox — often causes severe illness, with a death rate of about 15 percent, researchers reported on Tuesday. The seriousness of the infection warrants the inclusion of mpox among the opportunistic conditions that are particularly dangerous to people with advanced H.I.V., the researchers said at the Conference on Retroviruses and Opportunistic Infections in Seattle. (Mandavilli, 2/21)
Meanwhile, in other research news —
Noticias Telemundo for Axios:
Study Finds Hispanic Veterans Wait Longer For Specialists
Black and Hispanic veterans' access to specialty health care declined during the pandemic, according to a recently published study that also found non-Hispanic white veterans were largely unaffected. About 12% of vets are Black and 8% are Latino. Those numbers are projected to grow to 15% and 12% respectively by 2045, according to the Department of Veterans Affairs. (Franco, 2/21)
St. Louis Public Radio:
Wash U Study Links Depression In Black College Grads To Racism
Researchers from the Brown School at Washington University in St. Louis found that college-educated Black Americans are suffering racial discrimination that leads to depression. For “Understanding the Impact of Contemporary Racism on the Mental Health of Middle Class Black Americans”, researchers conducted a nationwide online survey of 528 college graduates over 24 years old to determine if there is a health cost to being a college-educated Black American. (Henderson, 2/17)
CIDRAP:
Trial Finds Prophylactic Doxycycline Doesn’t Reduce STIs In Cisgender Women
A clinical trial in Kenya found that taking the antibiotic doxycycline after sex did not prevent sexually transmitted infections (STIs) in cisgender women, researchers reported at this week's Conference on Retroviruses and Opportunistic Infections (CROI). (Dall, 2/21)
On research relating to covid —
CIDRAP:
Brain Changes May Be Linked To Anxiety, Depression In Long COVID
People who have long COVID and experience anxiety and depression following a mild infection may have brain changes that affect its structure and function, Brazilian researchers reported yesterday at the American Academy of Neurology (AAN) annual meeting in Boston. (Schnirring, 2/21)
FDA May Approve RSV Vaccine From Pfizer On Expedited Basis
Pfizer said Tuesday that the Food and Drug Administration is expected to make a decision on its respiratory syncytial virus vaccine in August. Separately, Teva has secured FDA approval for a modified formulation of its nervous system disorders drug Asustedo.
CNBC:
Pfizer RSV Vaccine For Infants Could Receive FDA Approval This Summer
Pfizer’s vaccine that protects infants from respiratory could receive Food and Drug Administration approval by the end of this summer. Pfizer on Tuesday said the FDA is reviewing the vaccine on an expedited basis. The agency is expected to make a decision on whether to clear the shot in August, just before respiratory virus season. (Kimball, 2/21)
FiercePharma:
Teva's Flagship Drug Austedo Scores New Approval At The FDA
Attuned to the burdens of people living with Huntington’s disease (HD) chorea and tardive dyskinesia (TD), Teva has been eager to cut the amount of pills patients need to take in half. Now, it's scored an FDA approval to do just that. (Kansteiner, 2/21)
Reuters:
Eli Lilly's Diabetes Drug Back To Shelf After Two-Month Shortage
Eli Lilly & Co (LLY.N) said on Tuesday all doses of its new diabetes drug Mounjaro were now available with wholesalers having inventory on hand after a two-month-long shortage. "Because Mounjaro is still a launch product with dynamic demand, some pharmacies may continue to experience intermittent delays from time to time," Eli Lilly told Reuters in an emailed statement. (2/22)
In other industry news —
Stat:
AbbVie Sued By Dutch Group Over Humira Pricing, Human Rights
A Dutch public interest group has filed a lawsuit claiming AbbVie breached a duty to human rights by using unfair and excessive pricing to bolster sales of its Humira drug and dominate the market at the expense of the health care system in the Netherlands. (Silverman, 2/21)
Fierce Healthcare:
UnitedHealth's $5.4B LHC Group Buy Set To Close This Week
Another controversial UnitedHealth Group acquisition is set to close this week. According to a notice filed with the Nasdaq, home health provider LHC Group will halt trading on the exchange after markets close Wednesday, and its merger with UHG is "tentatively scheduled" to close the following morning before trading begins. Should the deal close as planned, LHC's shares will be suspended on Friday, Feb. 24. (Minemyer, 2/21)
CNN:
Only 5.7% Of US Doctors Are Black, And Experts Warn The Shortage Harms Public Health
Only about 5.7% of physicians in the United States identify as Black or African American, according to the the latest data from the Association of American Medical Colleges. This statistic does not reflect the communities they serve, as an estimated 12% of the US population is Black or African American. And while the proportion of Black physicians in the US has risen over the past 120 years, some research shows, it’s still extremely low. (Howard, 2/21)
Fierce Healthcare:
Program Promises To Take A Team Approach To Tackling Severe Kidney Disease
Kidney disease often advances quietly and then falls on patients, providers and payers like an avalanche of complex medical conditions that cost a lot of money to control. To address this, Providence Health Plan is teaming up with Interwell Health, a company that focuses on care for patients with severe kidney complications, to mitigate these challenges before they become costly, life-disrupting emergencies. (Diamond, 2/21)
On the impact of a fight over the orphan drug program —
KHN:
A Bitter Battle Over The ‘Orphan Drug’ Program Leaves Patients’ Pocketbooks At Risk
A prescription drug that helps Lore Wilkinson walk and talk despite a rare muscle disease cost her so little for more than a decade that she didn’t even use her insurance to pay for it. But now, her Medicare insurance is shelling out about $40,000 for a one-month supply of the drug, and she fears she’ll be slammed with a $9,000 copayment. (Tribble, 2/22)
Also —
KHN:
Listen To The Latest ‘KHN Health Minute’
“Health Minute” brings original health care and health policy reporting from the KHN newsroom to the airwaves each week. (2/21)
CDC To Probe Ohio Derailment Site; Operator Must Pay For Cleanup
CDC epidemiologists and environmental health scientists are in Ohio, Politico says. Meanwhile, the EPA has ordered the train operator, Norfolk Southern, to pay all cleanup costs. Other health news is from Utah, Florida, New York, Georgia, Connecticut, North Carolina, and elsewhere.
Politico:
CDC Expects To Launch Probe Into Derailment Aftermath
CDC epidemiologists and environmental health scientists are in Ohio this week, Krista has learned. They’re helping assess and investigate the health risk after a 150-car train derailed in the small town of East Palestine earlier this month carrying dangerous chemicals. (Mahr and Payne, 2/21)
The New York Times:
E.P.A. Orders Norfolk Southern To Pay All Cleanup Costs In East Palestine, Ohio
The operator, Norfolk Southern, will not only be compelled to identify and clean contaminated soil and water, but also must reimburse the E.P.A. for the costs of cleaning private homes and businesses, according to the agency. If the E.P.A. deems that Norfolk Southern has failed to complete any of the tasks it has been ordered to do, the agency will conduct the cleanup itself and charge the company triple the cost, it said. (Robertson, 2/21)
In other health news across the states —
ProPublica & The Salt Lake Tribune:
94 Women Allege A Utah Doctor Sexually Assaulted Them. Here’s Why A Judge Threw Out Their Case.
Under Utah’s rules of medical malpractice, claims made by victims who allege a health care worker sexually assaulted them are literally worth less than lawsuits brought by someone who was assaulted in other settings — even if a jury rules in their favor, a judge is required to limit how much money they receive. And they must meet a shorter filing deadline. (Miller, 2/22)
The Washington Post:
Pregnant Woman's Fetus Should Be Released From Jail, Writ Argues
A few months after becoming pregnant, Natalia Harrell sat in a corrections van without air conditioning, according to a recent petition in Florida’s appellate courts. It was more than 100 degrees inside the van, the petition says, and a Miami-Dade County jail employee opened a door only after hearing Harrell banging against the walls. (Melnick, 2/22)
The Hill:
Florida ‘Reverse Woke Act’ Would Make Employers Liable For Detransition Care
Companies offering coverage for gender-affirming health care in Florida may soon find themselves responsible for the total costs of an employee’s detransition care under a new state Senate bill filed this week. Florida’s proposed “Reverse Woke Act,” introduced Monday by Republican state Sen. Blaise Ingoglia, would require businesses that cover gender-affirming medical care to be financially responsible for any subsequent detransitions — even for individuals that it no longer employs. (Migdon, 2/21)
Politico:
Exclusive: Patients Are Languishing In New York Hospitals At A Cost Of Millions
Long delays in discharging patients cost dozens of New York hospitals an estimated $169 million over a three-month period last year, according to a new report from the Healthcare Association of New York State, which was shared first with POLITICO. Each emergency department delay cost hospitals $18,000 on average, while inpatient discharge delays cost about $168,000 per case — but the report concluded those estimates were likely conservative. (Kaufman, 2/21)
Atlanta Journal-Constitution:
Bipartisan Bill Aims To Build On 2022 Effort To Boost Georgia’s Mental Health Care
A year after passing legislation that aimed to improve Georgia’s mental health system, the same bipartisan group of lawmakers has filed a new bill that they say will address the shortage of mental health providers and streamline the way agencies share information about patients. Last year’s effort was a priority of then-House Speaker David Ralston, who aimed to ensure that mental health care was covered by insurance companies in the same way that physical health care is covered. Lawmakers also greatly increased funding for mental health services. Ralston died in November. (Prabhu, 2/21)
The CT Mirror:
Lamont Administration Seeks Change In CT Hospital And Drug Costs
Gov. Ned Lamont addressed rising health costs and hospital consolidation Tuesday with two bills that put a free-market governor at odds with Big Pharma and a hospital industry that is a major employer throughout Connecticut. (Pazniokas, 2/21)
AP:
Medical Marijuana Advances Again At North Carolina Senate
Marijuana legalization in North Carolina for medical purposes is advancing again within the state Senate, less than a year after a very similar measure setting a structure for its sale and consumption passed the chamber by a wide margin. (Robertson, 2/21)
AP:
Mississippi Governor Vows To Sign Limit On Transgender Care
Mississippi Gov. Tate Reeves confirmed Tuesday that he plans to sign a bill to ban gender-affirming care in the state for anyone younger than 18 — part of a broad effort in conservative states to restrict transgender athletes, gender-affirming care and drag shows. House Bill 1125 won final approval Tuesday in the Republican-controlled Mississippi Senate, and it will be sent in the coming days to Reeves, a Republican who is running for reelection. (Wagster Pettus and Goldberg, 2/21)
CBS News:
Wisconsin Supreme Court Race Could Have Big Implications For Abortion, Election Laws
Wisconsin voters winnowed a field of four state Supreme Court candidates to two on Tuesday in a critical race to determine which party will hold the majority on the state's highest court. Liberal Milwaukee County Circuit Judge Janet Protasiewicz and the conservative former state Supreme Court Justice Dan Kelly have advanced to the general election, The Associated Press reported. (Navarro, 2/21)
Lexington Herald Leader:
Drugs In Vape Pens May Have Have Sickened Kentucky Students
A school district in southeastern Kentucky has asked businesses to guard against selling vape pens to minors after students in a nearby county got sick from using vape pens that may have contained an illegal drug. Officials from the Harlan County school district distributed letters Monday to businesses across the county urging them to move vaping products behind the counter and to try to make sure employees don’t sell to minors. (Estep and Spears, 2/21)
Read about the biggest pharmaceutical developments and pricing stories from the past week in KHN's Prescription Drug Watch roundup.
ScienceDaily:
Pill For Skin Disease May Also Curb Excessive Drinking
Researchers have identified a pill used to treat a common skin disease as an 'incredibly promising' treatment for alcohol use disorder. On average, people in a proof-of-concept study who received the medication, called apremilast, reduced their alcohol intake by more than half -- from five drinks per day to two. (Oregon Health and Science University, 2/21)
CIDRAP:
Higher Ivermectin Dose, Longer Duration Still Futile For COVID, Trial Finds
A randomized, controlled trial (RCT) shows that even at a higher dose and longer treatment duration, the antimalarial drug ivermectin didn't shorten the time to a sustained recovery from COVID-19. (Van Beusekom, 2/21)
The Boston Globe:
Moderna Expands CRISPR Gene Editing Research With ElevateBio Partnership
Moderna is aiming to build a gene editing franchise powered by some of the same technologies used in its COVID-19 vaccines. The Cambridge biotech company announced Wednesday that it will partner with Life Edit Therapeutics to develop potentially permanent treatments for rare genetic diseases and other conditions. (Cross, 2/22)
CIDRAP:
Shorter Drug Regimen Shows Promise In TB Trial
The results of a randomized clinical trial conducted in five countries suggests that an intensified drug regimen at the beginning of treatment could shorten treatment duration for tuberculosis (TB). (Dall, 2/21)
CIDRAP:
Bacterial Vaccines Network Gets Funding Boost
The Bacterial Vaccines Network (BactiVac) announced today that it has received £1 million ($1.2 million US) from UK-based charitable organization Wellcome to accelerate the development of bacterial vaccines. (Dall, 2/21)
Read recent commentaries about drug-cost issues.
Bloomberg:
Crispr Breakthroughs: Gene Therapy’s Success Hinges On Delivery
For years, we’ve known that genetic diseases could one day be cured by technologies like Crispr. But there has always been a catch: These technologies can only fix the genome in the parts of the body that they can reach, and right now, their reach is very limited. (Lisa Jarvis, 2/22)
USA Today:
Fear Of Opioids Is Causing Patients To Needlessly Suffer Severe Pain
A decade ago, most people thought of Tylenol (acetaminophen) as a medicine for fever, malaise and minor aches and pains. Nobody imagined that it would become the go-to drug for treating moderate, let alone severe, postoperative pain. (Jeffrey A. Singer and Josh Bloom, 2/16)
USA Today:
$130,000 A Year For Medicine Is Outrageous. But I Blame The Government, Not Drugmakers
One of my family members, who has multiple sclerosis, takes two prescriptions to treat the illness. Together, the medications cost $130,000 a year. Thankfully, her family's insurance and the MS LifeLines charity cover the majority of the cost. If not for the charity and her insurance, the medication would simply cost too much. (Chris Schlak, 2/21)
Chicago Tribune:
Abortion Pill Extremists Are Disingenuous Absolutists
When the U.S. Supreme Court overturned Roe vs. Wade last year, freeing states to limit or ban abortion, we knew abortion pills would become a target.What’s the point of a law, after all, that can be circumvented by using a few pills shipped to private homes anywhere in the country after a simple telehealth or online appointment? (2/20)
The Washington Post:
Comstock Laws Could Threaten Access To Abortion Pills
The latter-day vice suppressors are trying to use the Comstock Act to make abortion medications, and maybe even all abortions, unavailable — not just in states that prohibit the procedure, but nationwide. (Ruth Marcus, 2/15)
Chicago Tribune:
Nation Should Follow Illinois’ Lead And Protect Patients By Banning Health Copay Accumulators
The availability of manufacturer coupons and charitable organizations have traditionally been a way for patients to get access to the care they need at a much lower cost. But that’s changed over the past few years. Increasingly, insurers and pharmacy benefit managers, or PBMs, the insurers’ middlemen, are implementing “copay accumulators,” which enable them to avoid counting patient assistance toward their customers’ annual out-of-pocket maximums, rendering coupon cards useless. (Greg Harris, 2/21)
The Washington Post:
The FDA Can Save Lives By Making Injectable Naloxone More Accessible
Two panels advising the Food and Drug Administration voted unanimously on Wednesday to recommend making naloxone, an opioid overdose-reversing drug, available over the counter in nasal-spray form. This would be a crucial step toward making this lifesaving drug more accessible. (Leana S. Wen, 2/15)
Stat:
Another Pharma Flip-Flop: Claims About The IRA And Small-Molecule Drugs
The Inflation Reduction Act of 2022, which includes provisions requiring Medicare to negotiate lower drug prices for some of the United States’ most costly drugs, marks the first time in decades that the pharmaceutical industry has lost a major policy battle. (David Mitchell, 2/17)
Different Takes: Americans Are Struggling With Mental Health. Here Are Ways To Help.
Opinion writers discuss mental health care in America.
The Washington Post:
Fetterman’s Depression Disclosure Is A Paradigm Shift For Mental Health
It might surprise people to learn how common depression is. The Centers for Disease Control and Prevention reports that during the pandemic, more than 41 percent of Americans experienced recent symptoms of a depressive or anxiety disorder. (Leana S. Wen, 2/21)
Dallas Morning News:
Our Teens Are In Crisis. They Need Our Help Now
Health care professionals will tell you there are certain patients you will always remember. Years ago in a different state, I had that life-changing experience with a teen I was seeing for therapy as a child and adolescent psychiatrist. To be honest, I adored her. She was kind, authentic, resilient and funny as hell. (Kristen Pyrc, 2/22)
Philadelphia Inquirer:
Your Primary Care Doctor Can Help You With Mental Health Challenges, Too
As we were finishing up his quarterly office visit for management of diabetes, I turned toward my patient, sat quietly for a moment, and then asked, “Is there any other concern that you were hoping we could talk about?” I try to ask this as a matter of routine, but on this occasion, his mood seemed a little flat. Most of the time, there’s nothing further patients want to discuss, but occasionally, like on that day, there’s something important they want to talk about and need the extra encouragement to share. (Jeffrey Millstein, 2/21)
Viewpoints: How Worried Should We Be About Avian Influenza?; New Ways To Manage Chronic Pain
Editorial writers examine these public health topics.
The Boston Globe:
Is Bird Flu The Next Pandemic?
Just as the world is emerging from three years of the COVID-19 pandemic, a strain of avian influenza, or bird flu, known as highly pathogenic avian influenza, went from simmering to a rumbling boil. Will bird flu, another fast-mutating virus that originates in animals, be the start of the next pandemic or is the capacity of the virus to gain human-to-human transmission still out of reach? (Nichola Hill, 2/21)
The New York Times:
This Book Changed My Relationship To Pain
Physical pain is a universal human experience. And for many of us, it’s a constant one. Roughly 20 percent of American adults — some 50 million people — suffer from a form of chronic pain. (Ezra Klein, 2/21)
The New York Times:
America Has Lost The War On Drugs. What Now?
Drug use and addiction are as old as humanity itself, and historians and policymakers likely will debate whether the war on drugs was ever winnable, or what its true aims even were. In the meantime, it’s clear that to exit the current morass, Americans will have to restore public health to the center of its approach. (2/22)
The Boston Globe:
Three- And Four-Bed Nursing Home Rooms Should Be Phased Out
Studies have shown that single-occupancy rooms are best for nursing home residents, though some may prefer to live with a spouse or friend. Residents living in single-occupancy rooms tend to have lower rates of infectious diseases, better sleep patterns, fewer medication errors, and a greater sense of privacy and control, according to a 2021 report by national health care consulting firm Health Management Associates. (2/21)
Stat:
Use 'Racial Privilege' To Measure And Understand Health
When I go to a health care provider and check “Black” for my race or ethnicity, it means that my provider — before even seeing me — knows I have dark skin and “different” hair. But the biases or stereotypes emanating from my answer could include assumptions that I have no husband, limited education, or earn a low income or none. (Elizabeth A. Brown, 2/22)
Stat:
The U.S. Needs To Build A Solid Biodata Infrastructure
An executive order from the Biden administration aims to build a robust bioeconomy “in a manner that benefits all Americans and the global community and maintains United States technological leadership and economic competitiveness.” The executive order acknowledged the importance of biodata to growing the U.S. bioeconomy and calls for “a biological data initiative.” (Tara O'Toole, 2/22)
The New York Times:
The Mask Mandates Did Nothing. Will Any Lessons Be Learned?
The most rigorous and comprehensive analysis of scientific studies conducted on the efficacy of masks for reducing the spread of respiratory illnesses — including Covid-19 — was published late last month. Its conclusions, said Tom Jefferson, the Oxford epidemiologist who is its lead author, were unambiguous. (Bret Stephens, 2/21)