Weekend update

Congress

Weekend update

David Ermer–Congress, HSA, Medical / Rx research, Medicare, NIH, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

The House of Representatives will be in session for Committee business and floor voting, while the Senate will be on a State work week this week. The Senate press gallery informs us, “In today’s (5/18/23) wrap-up, Schumer reiterated that as discussions concerning the debt ceiling continue over the next week, Senators should be able to return to the Senate within a 24-hour period.”

The Wall Street Journal reports

“President Biden and House Speaker Kevin McCarthy agreed to meet Monday afternoon in a last-ditch effort to reach a deal to avoid a default on U.S. sovereign debt after negotiations to raise the federal borrowing limit reached an impasse.

“Talks between White House and House Republican negotiators largely ground to a halt this weekend, with both sides blaming the other for a failure to bridge their differences over spending levels. But Biden and McCarthy instructed their negotiating teams to resume their discussions, starting with a 6 p.m. meeting on Sunday. * * *

“There’s no agreement. We’re still apart,” McCarthy, a California Republican, told reporters at the Capitol, though he said the call with Biden was productive.” * * *

“Leaders in Washington are rushing to come up with a deal to lift the country’s borrowing limit. If they are unable to do so, the country might be unable to pay all of its bills as soon as June 1, according to an assessment by the U.S. Treasury Department.  

“Appearing Sunday on NBC, Treasury Secretary Janet Yellen said the “odds of reaching June 15th, while being able to pay all of our bills, is quite low.”

“Economists say that failure to lift the debt ceiling, and a subsequent default, would tip the economy into a recession. Moody’s Analytics predicts that a default would cost more than seven million jobs and cause the unemployment rate to move above 8%. The ratings company also predicts that the stock market would lose a fifth of its value.”

Wow.

From the plan design front, the Wall Street Journal reports

“The Internal Revenue Service on Tuesday announced the largest-ever increase to the amount Americans can set aside in health-savings accounts each year.

“For 2024, the maximum HSA contribution will be $8,300 for a family and $4,150 for an individual. That is up from $7,750 for a family and $3,850 for an individual for 2023.

“Participants age 55 and older can contribute an extra $1,000, which means an older married couple could sock away $10,300 a year, up from $9,750 this year. In the last ten years leading up to retirement, a couple could accumulate more than $100,000 in these accounts. * * *

While workers can tap 401(k)s and individual retirement accounts for medical costs, health savings accounts offer more tax savings than both traditional or Roth retirement accounts. There is no tax going in, tax-free growth and tax-free withdrawals if used for eligible healthcare expenses.”

The FEHBlog came to love the high-deductible health plan/health savings account arrangement. The Wall Street Journal endorses the FEHBlog’s viewpoint. The FEHBlog was cut off from the arrangement when he became Medicare primary in late 2019. Because the FEHBlog’s law firm has less than 20 employees, the FEHBlog found it necessary to drop his employer-sponsored coverage in favor of Medicare. Medicare coverage has been fine, but the FEHBlog misses contributing to his HSA. Younger employees should give the HDHP / HSA arrangement a close look.

The Wall Street Journal adds

“Remember one important caveat, however: If you’re sure to spend over the deductible, other plans may be more appropriate for you, such as the PPO plan that will cost you an additional $800. (You forgo the ability to save, but you also face a lower out-of-pocket maximum.) For instance, if you know with reasonable certainty that you need access to a more-expensive provider for a one-time procedure, then you should pick a plan that gives you this access, such as a PPO plan, and switch back to an HMO plan with an HDHP-and-HSA option during next year’s open-enrollment period.

“If you do end up choosing an HDHP, please remember: Do not cut back on care haphazardly, as many people do. Following a doctor’s recommendations is much more important than saving a bit of money.”

While the FEHBlog is not yet retired, he is intrigued by the Fortune Well article on cognitive decline following retirement. The article offers four ways to avoid this otherwise “universal trend.”

  1. Keep or get connected.
  2. Keep active.
  3. Keep stress to a minimum
  4. Keep working, regardless of pay.

Next stop, Walmart greeter??

From the U.S. healthcare business front, Healthcare Dive tells us

“Physician staffing firm Envision Healthcare has filed for Chapter 11 bankruptcy, citing its $7.7 billion in debt obligations, declining patient volumes, “flawed” implementation of the No Surprises Act and exclusionary health insurers as reasons for its financial decline in a restructuring announcement on Monday.

“The bankruptcy wipes out private equity firm KKR’s investment in Envision. In 2018, the PE firm shelled out over $5 billion in 2018 to take Envision private in a deal valued at $9.9 billion, including debt. Last week, The Wall Street Journal reported that an Envision bankruptcy filing would be one of the steepest losses in KKR’s history.”

From the miscellany department, NPR Shots offers articles evaluating experimental cancer treatments and looking into a new NIH study:

There’s plenty of one-size-fits-all nutrition advice. But there’s mounting evidence that people respond differently to food, given differences in biology, lifestyle and gut microbiome.

“The National Institutes of Health wants to learn more about these individual responses through a Nutrition for Precision Health study, and this week researchers began enrolling participants to take part in the study at 14 sites across the U.S.

“It’s part of the All of Us research initiative that aims to use data from a million participants to understand how differences in our biology, lifestyle and environment can affect our health.

“Holly Nicastro of the NIH Office of Nutrition Research says the goal of the precision nutrition study is to help develop tailored approaches for people. “We’ll use machine learning and artificial intelligence to develop algorithms that can predict how individuals will respond to a given food or dietary pattern,” Nicastro says.

“The study will take into account a person’s genetics, gut microbes, and other lifestyle, environmental and social factors “to help each individual develop eating recommendations that improve overall health,” Nicastro says.”

Friday Factoids

David Ermer–Congress, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From Washington, DC. Roll Call informs us,

“Top negotiators for President Joe Biden and Speaker Kevin McCarthy resumed talks Friday evening to lift the nation’s borrowing cap, ending a “pause” put in place hours earlier when Republicans expressed frustration with the White House position.

“After a nearly daylong setback, White House Counselor Steve Ricchetti, White House budget director Shalanda Young, Rep. Garret Graves, R-La., and House Financial Services Chairman Patrick T. McHenry, R-N.C., resumed talks at the Capitol shortly after 6 p.m.”

From the public health front —

  • Reuters reports
    • “The U.S. Centers for Disease Control and Prevention is urging people at high risk of mpox to get two doses of Bavarian Nordic’s (BAVA.CO) Jynneos vaccine, based on new evidence from a U.S. study showing that the regimen is more effective at preventing infection than one shot.
    • “The study, published on Thursday, offered some of the first evidence on the efficacy of the Jynneos vaccine, which was deployed last year during a global outbreak of mpox that affected more than 30,000 people in the United States.”
  • and
    • “A World Health Organization (WHO) advisory group on Thursday recommended that this year’s COVID-19 booster shots be updated to target one of the currently dominant XBB variants.
    • “New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered.
    • “The group suggested no longer including the original COVID-19 strain in future vaccines, based on data that the original virus no longer circulates in human beings and shots targeting the strain produce “undetectable or very low levels of neutralizing antibodies” against currently circulating variants.
    • “COVID-19 vaccine makers like Pfizer/BioNtech (PFE.N), , Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating strains.
    • “The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected.”
  • CNBC reports
    • “NIH is enrolling patients in an early-stage clinical trial to test a universal flu vaccine based on mRNA technology.
    • “The technology is behind Moderna’s and Pfizer’s widely used Covid vaccines.
    • “Scientists hope the vaccine will protect against a wide variety of flu strains and provide long-term immunity so people do not have to receive a shot every year.” 
  • Health Payer Intelligence reminds us that the Affordable Care Act requires health plans to cover four categories of preventive services without cost-sharing when delivered in-network, not just U.S. Preventive Services Task Force Grades A and B recommendations. In addition,
    • “(1) Payers have to cover routine immunizations per the recommendations of the Advisory Committee on Immunization Practices (ACIP), a federal immunization committee. ACIP recommendations are finalized when adopted by the director of the Centers for Disease Control and Prevention (CDC). * * *
    • “(2) The ACA rules around covering preventive care services for women are based on USPSTF and ACIP recommendations. But they also consider Health Resources and Services Administration (HRSA) guidelines, which draw from the Women’s Preventive Services Initiative (WPSI) standards. To comply with the requirements of preventive care services for women, payers must fully cover well-woman visits, breastfeeding support, and screening and counseling related to intimate partner violence and other conditions and circumstances. Contraceptives approved, granted, or cleared by the Food and Drug Administration (FDA) are also covered. * * *
    • “(3) ACA preventive care coverage also encompasses services for children. These requirements are based on HRSA’s Bright Futures Project. They include well-child visits, immunizations, screenings, behavioral and developmental assessments, and more. As of May 2023, the immunization list covered conditions including but not limited to HPV, hepatitis A and B, rubella, influenza, and tetanus.” * * *
  • The Department of Health and Human Services “and the non-profit organization Baby2Baby announced a new pilot program to distribute a one-time only Newborn Supply Kit made up of essential goods and critical maternal health items to new mothers and their infants. * * * HS and Baby2Baby will first distribute 3,000 of the Newborn Supply Kits across Arkansas, Louisiana, and New Mexico – three states experiencing deep levels of family poverty – via hospitals and community-based partner organizations. Any mother giving birth during pilot implementation at one of the partner sites will be eligible to receive a kit. * * * HHS also launched a new website, www.hhs.gov/newbaby, that includes information across all Federal agencies for families on health, feeding, sleeping, child development and programmatic information.”

From the FDA front —

  • Biopharma Dive tells us
    • “A panel of Food and Drug Administration advisers on Thursday backed maternal use of Pfizer’s RSV vaccine for protecting young infants, but recommended its early use be closely monitored to confirm study safety data.
    • “The panel of outside advisers voted 14-0 that Pfizer’s vaccine, called Abrysvo, was effective in protecting infants from infections caused by respiratory syncytial virus, or RSV, when given to their mothers during pregnancy.
    • “Despite some concerns around the shot’s potential risk, they agreed in a 10-4 vote that Pfizer’s data showed it to be generally safe. The FDA, which usually follows the advice of its advisers, is expected to decide whether to approve maternal use of the shot by August. Separately, its use in older adults is due for a decision this month.”
  • MedCity News relates
    • “The inflammatory bowel disorder Crohn’s disease can be treated by several different biologic drugs administered as injections or infusions. The FDA just approved the first daily pill for the chronic condition.
    • “Rinvoq, a blockbuster AbbVie drug already approved for multiple autoimmune and inflammatory disorders, is now approved as a treatment for moderately to severely active Crohn’s disease. The decision announced Thursday specifically covers the treatment of adults whose disease has not been adequately managed by tumor necrosis factors inhibitors, a class of biologic drugs currently used to treat the disorder.”
  • “Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.”

From the Rx coverage front

  • Healio tells us,
    • “Of adolescents with obesity receiving semaglutide in the STEP TEENS trial, 44.9% improved to overweight or normal weight.
    • “The odds of improving body mass index category with semaglutide were 23 times higher than placebo.”
  • STAT News adds.
    • Novo Nordisk is pausing ads for its obesity drug Wegovy as it struggles to keep up with surging demand, the latest hurdle in its rollout of the weight loss drug.
    • “To avoid stimulating further demand for this medicine, we’re pausing some key Wegovy promotional efforts,” the Danish drugmaker said in an emailed statement. “We are pausing all local television advertising and postponing planned national television advertising for Wegovy. We are also assessing our promotional efforts to healthcare professionals and adjusting accordingly.” The news was earlier reported by Endpoints.
  • Medscape informs us,
    • “Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.
    • “The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” said Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”
    • “As of earlier this month, there were 15 oncology drugs on the official US Food and Drug Administration (FDA) drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.” * * *
    • “Drug shortages in the United States have been a chronic problem for more than two decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.”

From the U.S. healthcare business front —

  • MedCity News points out,
    • “If you enter a drugstore in any major American city, there’s a good chance you might see a retail health clinic. In the past decade or so, healthcare stakeholders have gone back and forth as to whether these clinics will have a significant impact on healthcare delivery in the U.S. But a new report reveals that retail clinics are solidifying their position as a major force in the U.S. healthcare system.
    • “Retail clinic claims volumes have shot up by 200% in the past five years, according to the report, which was released Thursday by analytics company Definitive Healthcare. 
    • Claims growth for these clinics, which are usually located in stores like Walmart, CVS and Walgreens, have greatly outpaced growth in claims for urgent care centers, emergency departments and physician practices. Urgent care center claims grew by 70% in the past five years. Meanwhile, emergency room usage dropped by 1%, and primary care office claims declined by 13%.
    • As of this year, there are more than 1,800 active retail clinics across 44 states. Most of these are in major metropolitan areas, with just 2% of clinics located in rural areas. The report argued that this paucity stems from the same factors that have produced care deserts in rural America — mainly low population density and difficulty attracting workers.
    • The report also revealed that about half of all retail clinics are concentrated in the following seven highly populated states: California, Georgia, Illinois, Florida, Ohio, Tennessee and Texas.

Thursday Miscellany

David Ermer–Congress, End of the PHE, NE, FDA, Medical / Rx research, OPM, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC, Roll Call reports

“Lawmakers from both parties suggested negotiators were making progress Thursday toward a bipartisan deal that would raise the $31.4 trillion debt limit, though days of talks still lie ahead.

“Scrambling to avert a debt limit breach that Treasury Secretary Janet L. Yellen said could hit as early as June 1, negotiators are attempting to reach a framework for a deal by Sunday, when President Joe Biden returns from a trip to the G-7 summit in Japan.

“Speaker Kevin McCarthy, who is negotiating with Biden through proxies, said he is hopeful that a deal could come as soon as this weekend. In a sign of progress, the two parties have begun to exchange offers, said House Rules Chairman Tom Cole, R-Okla.

“We’ve made good progress this week, but the work continues,” said Senate Majority Leader Charles E. Schumer. “ No one will get everything they want.”

“If a deal is reached by Monday, the House would vote next week, with 72 hours notice after the text is posted. While the Senate is scheduled to be in recess next week, Schumer said his chamber would be prepared to reconvene with 24 hours’ notice to schedule a vote.”

Per STAT News

“Pharmacy benefit managers would be subject to new transparency rules under a bill that cleared a key House subcommittee, Modern Healthcare says. The Transparent PRICE Act of 2023, which received a unanimous vote in the House Energy and Commerce Committee’s Health Subcommittee, would require pharmacy benefit managers to annually provide employers with detailed data on drug spending, including acquisition costs, out-of-pocket spending, formulary-placement rationale, and aggregate rebate information. The bill also would order the Government Accountability Office to report on group health plan pharmacy networks, including those owned by health insurers.”

Fierce Healthcare discusses other healthcare actions taken by this subcommittee yesterday.

BioPharma Dive tells us

“The U.S. Supreme Court on Thursday ruled against Amgen in its decade-long battle with Sanofi and Regeneron, affirming a lower court’s decision that Amgen’s rivals did not infringe on patents the biotechnology company held on a cholesterol-lowering medicine.

“In a unanimous decision authored by Justice Neil Gorsuch, the court said two Amgen patents on its PCSK9 inhibitor Repatha fell short of a legal standard known as enablement, which requires the claimed invention be described well enough to allow a skilled person in the field to use it. * * *

“The court’s ruling could open the door for challenges to older classes of antibody therapies, [University of Illinois law professor Jacob]Sherkow said. “This decision is probably going to give challengers solace. They’re going to have good options when working with the enablement requirements to challenge competitors’ patents out there.”

From the public health front —

  • The Robert Wood Johnson Foundation released its 2023 U.S. county health rankings while the UnitedHealthFoundation issued its 2023 Seniors Report from its America’s Health Rankings Services.
  • MedPage Today informs us
    • “The CDC encouraged populations at risk of contracting mpox, formerly known as monkeypox, to get fully vaccinated against the disease as part of preparations for summer during a briefing Thursday morning.
    • “Demetre Daskalakis, MD, the White House National Mpox Response Deputy Coordinator, noted that with summer gatherings on the horizon, mpox vaccination should be considered, as should overall sexual health and wellness.
    • “Getting ‘summer ready’ means mpox vaccination, but that’s not all it means — it also means to be up to date on all of your sexual health, and that includes HIV and STIs [sexually transmitted infections] like syphilis, gonorrhea, and chlamydia,” he said.”
  • The Department of Health and Human Services posted a fact sheet with “Resources on Ways Communities Can Stay Protected from Mpox in Advance of Summer Months.”
  • The Wall Street Journal points out the important medical tests that Americans should consider undergoing over the decades of life.
  • The U.S. Preventive Services Task Force notified the public about a draft research plan concerning “Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Interventions” that is open for comment until June 14, 2023.

From the Food and Drug Administration front, the Wall Street Journal reports

“The Food and Drug Administration for the first time cleared a test to gauge a mother’s risk of severe preeclampsia, a leading cause of pregnancy-related illness and death in the U.S.  

“Thermo Fisher Scientific said Thursday that the blood test it already sells in Europe could be available in the U.S. soon. Its introduction could transform prenatal care in the U.S., doctors and maternal-health advocates said.”

Bravo.

From the U.S. healthcare business front —

  • Beckers Hospital Review notes five new details about Kaiser Permanente’s Risant Health deal.
  • Fierce Healthcare discusses provider objections to what appears to the FEHBlog to be a reasonable new prior authorization program that UnitedHealthcare is introducing. No good deed goes unpunished.

From the miscellany department —

  • STAT News relates that
    • “A multibillion-dollar science agency tasked with slashing through research bureaucracy will start its work with a plan to help people regenerate bone.
    • “The Advanced Research Projects Agency for Health, launched a little more than a year ago, announced Thursday that its first official program would target bone and joint damage from osteoarthritis, a condition affecting more than 32 million Americans.”
  • Govexec discusses FEHB coverage of Covid tests and vaccines following the end of the PHE.
  • The Equal Employment Opportunity Commission weighs in on the Title VII compliance implications of employer use of artificial intelligence to make employment decisions.

Midweek update

David Ermer–Congress, End of the PHE, NE, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC, Roll Call informs us,

“Negotiators tapped by President Joe Biden and Speaker Kevin McCarthy to hash out a debt limit compromise were racing against the clock Wednesday to get some principles down on paper that could be written into legislative text in time for votes as early as next week.

“Both the president and his chief GOP counterpart on Capitol Hill said they thought a deal was possible. Biden is scheduled to return Sunday from his trip to Japan for the G-7 summit, telling reporters at the White House on Wednesday he’d be back for “final negotiations” and that he’d hold a press conference upon his return.

“I’m confident that we will get the agreement on the budget, that America will not default,” Biden said. “Every leader in the room understands the consequences if we fail to pay our bills.”

The FEHBlog offers less encouraging news from the public health front —

  • The Wall Street Journal reports
    • “For decades, advances in healthcare and safety steadily drove down death rates among American children. In an alarming reversal, rates have now risen to the highest level in nearly 15 years, particularly driven by homicides, drug overdoses, car accidents and suicides.
    • “The uptick among younger Americans accelerated in 2020. Though Covid-19 itself wasn’t a major cause of death for young people, researchers say social disruption caused by the pandemic exacerbated public-health problems, including worsening anxiety and depression. Greater access to firearms, dangerous driving and more lethal narcotics also helped push up death rates.
    • “Between 2019 and 2020, the overall mortality rate for ages 1 to 19 rose by 10.7%, and increased by an additional 8.3% the following year, according to an analysis of federal death statistics led by Steven Woolf, director emeritus of the Center on Society and Health at Virginia Commonwealth University, published in JAMA in March. That’s the highest increase for two consecutive years in the half-century that the government has publicly tracked such figures, according to Woolf’s analysis. * * *
    • “Many public-health experts say they don’t think the end of the pandemic will reverse the rise in death rates among young people. Rivara predicts these problems will continue due to persistent issues around mental health and the accessibility of guns.
    • “[Dr. Elizabeth] Wolf said demand for child and adolescent psychiatric services still outstrips supply in her Richmond, Va., office. Patients are on months long waiting lists to see a psychiatrist that accepts insurance.”  
  • Digging deeper, the Journal informs us,
    • “Overdose deaths in the U.S. edged higher in 2022, a federal estimate showed, marking only the second time drugs killed more than 100,000 people in a year. 
    • “The Centers for Disease Control and Prevention on Wednesday released a provisional count of overdose deaths last year that indicated the toll of the fentanyl crisis leveling off after two years of surges during the Covid-19 pandemic. The CDC counted 109,680 overdose deaths in 2022 compared with 109,179 deaths from a similar 2021 projection. For overdose deaths to hover at such a high level demonstrates how fentanyl’s ubiquity and potency continue to threaten the lives of illicit drug users. 
    • “I’m glad to see us not get worse, but it’s hard to celebrate,” said Dr. Chad Brummett, an anesthesiologist and co-director of the Opioid Research Institute at the University of Michigan.”
  • STAT News adds
    • “More than a quarter of American adults are depressed, a 10% surge from nearly a decade ago, according to the latest Gallup survey.
    • “The data come as the Biden administration tries to overhaul mental health care costs and boost the number of health care workers licensed to practice behavioral health care. Congress in this year’s budget also allotted hundreds of millions of dollars to mental health care grants and programs, many of them trained on children or substance misuse.”
  • On a related note
    • McKinsey Consulting explores how virtual hospitals could offer respites to overwhelmed health systems.
    • Health Affairs Forefront discusses approaches to integrating behavioral health with primary care.
    • Employee Benefits News identifies three coverage categories that can reduce healthcare disparities and lower costs — 1) Colon cancer screening (Hey OPM, the article suggests giving a free day off to employees who undergo screening colonoscopies); 2) Basic dental care, and 3) fertility coverage.

From the Rx coverage front, the New York Times reports,

“Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels.

“Hospitals are scouring shelves for supplies of a drug that reverses lead poisoning and for a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce following the winter flu season when doctors and patients frantically chased medicines for ailments like strep throat. Even children’s Tylenol was hard to find.

“Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns.

“The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying causes of the faltering generic drug market, which accounts for about 90 percent of domestic prescriptions.”

No bueno.

From the human resources front, HR Dive relates,

  • “Employers cannot automatically revoke reasonable accommodations related to COVID-19, despite the dissolution of the “public health emergency” status for the pandemic, the U.S. Equal Employment Opportunity Commission cautioned employers Monday. “Employers may evaluate accommodations granted during the public health emergency, and, in consultation with the employee, assess whether there continues to be a need for reasonable accommodation based on individualized circumstances,” the agency said. 
  • “The warning came as EEOC announced updates to its technical guidance, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” including additional accommodation examples and tips for preventing COVID-related harassment.
  • “The EEOC highlighted that accommodations include low-cost or free measures, such as uninterrupted work time, a quiet workspace or noise-canceling headphones to facilitate that.”

Tuesday Tidbits

David Ermer–AHRQ, Congress, Medical / Rx research, Patient safety, SDOH–
Photo by Patrick Fore on Unsplash

From Washington, DC,

Roll Call tells us,

“President Joe Biden and Speaker Kevin McCarthy on Tuesday tapped proxies to negotiate directly over how to increase the debt limit with time running short before the government runs too low on funds.”

and

“Lawmakers are beginning to think about changing their plans and staying in Washington in the coming weeks as a standoff over increasing the debt limit bears down. Members of both parties’ leadership said on Tuesday that plans for the Senate to recess next week and the House to leave town the following week could shift.”

BenefitsLink pointed out that the Internal Revenue Service released a revenue procedure identifying inflation-adjusted high deductible health plan and health savings account amounts for use in 2024 just in time for FEHB high deductible health plan benefit proposals due May 31.

STAT News reports

“In an unexpected move, the Federal Trade Commission on Tuesday filed a lawsuit to block Amgen from acquiring Horizon Therapeutics, claiming the $27.8 billion deal would make it possible for Amgen to develop monopolies through a tactic that manipulates health coverage and drives up consumer costs.

“At issue is a practice known as bundling. Simply put, a drug company combines two or more medicines in a package deal for health plans and pharmacy benefit managers, which determine lists of medicines that are covered by insurance. The practice has previously sparked concerns that a drug company will unfairly offer higher rebates for bundles in order to win favorable placement.”

From the medical and drug research fronts —

  • The National Institute of Health informs us,
    • “A study from the National Institutes of Health shows that new cases of chronic pain occur more often among U.S. adults than new cases of several other common conditions, including diabetes, depression, and high blood pressure. Among people who have chronic pain, almost two-thirds still suffer from it a year later. These findings come from a new analysis of National Health Interview Survey (NHIS) data by investigators from the National Center for Complementary and Integrative Health (NCCIH) at the NIH, Seattle Children’s Research Institute, and University of Washington, Seattle, and are published in JAMA Network Open.”
  • The New York Times reports
    • “The man should have gotten Alzheimer’s disease in his early 40s — he had a gene mutation that guaranteed it, or so it seemed. Scans of his brain even revealed severe atrophying and the hallmarks of the disease: rough, hard, amyloid plaques and spaghetti-like tangles of tau proteins. But the fatal brain disease did not appear until the man was 67.
    • “Now an intense research effort has discovered why. The man was protected because another mutation in a different gene blocked the disease from entering his entorhinal cortex. That tiny area of the brain is a hub for neurons involved in memory, recognition of objects, navigation and time perception. And it is there that scientists believe that Alzheimer’s disease begins.
    • “A paper on the finding was published Monday in the journal Nature Medicine.
    • “More than six million people in the United States have Alzheimer’s, a disease that has been notoriously difficult to treat. Yet here was a man with a mutation that causes the most severe and rapidly progressing form of Alzheimer’s. And his disease was delayed for two decades. If a drug could do what the mutation did, resulting in most people getting Alzheimer’s very late in life, the outcome could be transformative.”

From the SDOH front,

  • the National Institutes of Health shared
    • “New research shows that the economic burden of health disparities in the United States remains unacceptably high. The study, funded by the National Institute on Minority Health and Health Disparities (NIMHD), part of the National Institutes of Health,  revealed that in 2018, racial and ethnic health disparities cost the U.S. economy $451 billion, a 41% increase from the previous estimate of $320 billion in 2014. The study also finds that the total burden of education-related health disparities for persons with less than a college degree in 2018 reached $978 billion, about two times greater than the annual growth rate of the U.S. economy in 2018.”

From the AI department,

  • Beckers Payer Issues informs us
    • Payers are putting artificial intelligence to work. 
    • Google recently launched a new AI-powered cloud program for prior authorization and claims processing. Elevance Health is piloting AI-powered concierge care for members. 
    • Becker’s asked 18 payer executives how AI will transform the insurance industry. [The interview squibs are available in the article.]

From the patient front, here is a link to HHS’s Agency for Healthcare Quality and Research March 2023 Chartbook on Patient Safety.

Monday Roundup

David Ermer–AHRQ, Congress, FDA, Federal employment benefits, HSA, Rx coverage, SDOH–
Photo by Sven Read on Unsplash

From Washington DC —

  • The Wall Street Journal reports,
    • “Time isn’t on Washington’s side.
    • “With the U.S. facing a potentially economy-shaking default as soon as next month, logistical hurdles, disagreements on the scope of any talks, a tight legislative calendar and a late start are complicating negotiations over raising the debt ceiling.
    • “President Biden said Monday that the next meeting with congressional leaders will come Tuesday, while responding “no” when asked if there were updates regarding the talks with Republicans. House Speaker Kevin McCarthy (R., Calif.) said that the two sides remain “far apart” and that he would like a deal to be done by this weekend.” * * *
    • “A second meeting with the president and congressional leaders that was originally set to take place on Friday was postponed until early this week. The House and Senate are scheduled to be in session simultaneously for just one more week this month, and Mr. Biden is set to travel overseas for a Group of Seven meeting. Moreover, Republican leaders have so far rejected any short-term debt deal to buy more time.”
  • According to the White House’s briefing room,
    • “President Biden announced his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH), the world’s preeminent biomedical research organization. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader who has the vision and leadership needed to deliver on NIH’s mission to seek fundamental knowledge and promote human health.”  

From the litigation front, the American Hospital Association informs us

“The U.S. Court of Appeals for the 5th Circuit today temporarily restored an Affordable Care Act requirement that most health plans cover certain preventive services without cost sharing. The 5th Circuit ordered that this requirement remain in effect for everyone (except the few health plans challenging the requirement) until it issues a final decision in the case, which is expected later this year. A federal judge in Texas recently vacated the requirement nationwide, prompting the Department of Health and Human Services and plaintiff to appeal the decision and seek this temporary stay.”

From the public health front —

  • HealthDay tells us,
    • “Older Americans are dying of falls at more than double the rate of 20 years ago — with women, men and all racial groups showing increases, according to a new study.
    • “In 2020, the study found, just over 36,500 Americans age 65 and up died of a fall-related injury. That was up from roughly 10,100 deaths in 1999.
    • “Adjusted for age, those numbers translated into a more than twofold increase in the rate of fall-related deaths among older Americans: from 29 per 100,000 in 1999, to 69 per 100,000 in 2020.” * * *
    • The National Council on Aging has a tool for older adults to check their risk of falls.

From the Rx coverage front —

  • MPR relates
    • “The Food and Drug Administration’s (FDA) Pulmonary-Allergy Drug Advisory Committee voted 16:6 in favor for adults, and 17:5 in favor for children (<18 years of age and ≥30kg), that available data support a favorable benefit-risk assessment for neffy® in the treatment of severe allergic reaction (Type 1), including anaphylaxis, for adults and children who weigh more than 30kg. * * *
    • “While not bound to the committee’s recommendations, the FDA does take them into consideration when making final decisions on approval. If approved, neffy would be the first needle-free epinephrine product to treat severe allergic reaction. A decision is expected by mid-2023.”
  • The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension.
  • The Wall Street Journal delves into “How to Get Your Health Insurance to Cover Ozempic and Other Drugs Used for Weight Loss; Tips for checking whether your health plan will pay for a prescription and then getting authorization.”
  • Per Hub International,
    • “CMS recently released its updated Medicare Part D guidelines that can be used by group health plan sponsors to determine whether their plans’ prescription drug coverage is creditable for 2024 and to update the information needed for required Part D disclosures to eligible individuals and to CMS.
    • “To help determine whether prescription drug coverage is creditable, CMS has released the following 2024 parameters for the standard Medicare Part D prescription drug benefit:
      • Deductible: $545 (up from $505 in 2023);
      • Initial coverage limit: $5,030 (up from $4,660);
      • Out-of-pocket threshold: $8,000 (up from $7,400);
      • Total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are not eligible for the coverage gap discount program: $11,477.39 (up from $10,516.25 in 2023); and
      • Estimated total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are eligible for the coverage gap discount program: $12,447.11 (up from $11,206.28).”

From the artificial intelligence front —

  • This week’s episode of the Econtalk podcast features an artificial intelligence discussion between host Russ Roberts and his guest Tyler Cowen. Russ Roberts suggests using ChatGPT to formulate questions for your doctor or your parents’ or your kids’ doctors.
  • Bloomberg examines the use of AI by drug manufacturers.
  • Medcity News looks into the use of AI by pharmacists and PBMs.

From the miscellany department —

  • Fierce Healthcare points out, “Million-dollar claims per million covered employees rose 15% in the past year and 45% from 2019 to 2022, according to a report by Sun Life, a life and disability insurance company.”
  • EHR Intelligence reports,
    • “The Health IT End-Users Alliance has released a consensus statement regarding collecting and using social determinants of health (SDOH) data to support health equity.
    • “The Alliance brings together health information professionals, physicians, hospitals, and other front-line healthcare providers to advance end-user perspectives in health IT policy and standards development.
    • “The statement calls for additional efforts to standardize and increase the uniform collection and reporting of SDOH. The group also calls for more training on collecting this data, better use of appropriate tools and processes to manage and share SDOH, and ongoing research to support these efforts.”
  • Employee Benefit News notes, “Thirteen FSA and HSA-eligible expenses that may surprise you.”

Weekend update

David Ermer–Congress, OPM, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

Happy Mothers’ Day! Here’s a reminder that on June 27, 2023, two new federal employment laws will take effect — the Pregnant Workers Fairness Act and the PUMP Act (fairness for nursing mothers).  

OPM shares excerpts from OPM Director Kiran Ahuja’s commencement address to the graduating class of the University of Georgia’s School of Public and International Affairs.

The House of Representatives and the Senate will be in session this week for Committee business and floor voting.

The Wall Street Journal reports

  • The Biden administration and congressional Republicans are making progress in their negotiations over federal spending and raising the debt limit, Treasury Secretary Janet Yellen said, adding that she believes the talks could result in an agreement.
  • “I’m hopeful. I think the negotiations are very active. I’m told they have found some areas of agreement,” Ms. Yellen said in an interview Saturday at the end of a gathering of finance ministers from the Group of Seven advanced democracies in Japan.
  • Republicans and Democrats are racing to find a compromise for raising the nation’s roughly $31.4 trillion debt limit. Republicans say lifting the debt ceiling should be paired with cuts to federal spending, while Democrats say raising the cap shouldn’t be contingent on broader budget negotiations.

Axios tells us that “The Biden administration is pouring billions of dollars into the development of future coronavirus vaccines, trying to develop a sequel to Operation Warp Speed even as the public health emergency ends.”

Also, from the research front, Biopharma Dive informs us

  • Sanofi and AstraZeneca released new study results on Friday [May 11] that showed their antibody drug for respiratory syncytial virus reduced hospitalizations for infection-related respiratory disease by 83% in infants.
  • The drug, sold as Beyfortus, won approval in Europe in November as a preventive treatment for babies in their first RSV season and is due a decision by U.S. regulators in the third quarter. The results released Friday add to earlier data that showed the drug to be 75% effective in reducing RSV-related hospitalizations over a placebo.
  • RSV is a leading cause of hospitalization in infants, often overlapping with seasonal patterns for influenza and now COVID-19, too. It is estimated that more than 25,000 children under 5 years old die from RSV infections globally each year, with millions hospitalized.

and MedTech Dive points out,

  • Guardant Health on Tuesday presented the results of a pivotal study of Shield, its blood-based test for colorectal cancer, demonstrating an overall sensitivity of 83% and specificity of 90%.
  • Looking at the results by stage, the test only detected 55% of stage I cancers. Its detection of later-stage cancers was 100%.
  • The test should meet the criteria to gain FDA approval and Medicare reimbursement, but its early-stage performance will likely make Shield less competitive against Exact Sciences’ stool-based test, Cologuard, to start, analysts with Craig Hallum wrote in a research note on Wednesday. 

From the SDOH front, Healthcare Finance relates,

  • CVS Health said this week it’s adding mental health screenings to Project Health, the company’s free, community-based health screening program. 
  • It will kick-start its mental health screenings in Greensboro, North Carolina and Petersburg, Virginia. Over the course of the year it will also add nearly 100 organizations to host its mobile units in under-resourced communities.
  • CVS Health plans to host nearly 2,000 Project Health screening events across the U.S. in 2023. The company hosts these events at CVS Pharmacy locations and community organizations, offering free biometric screenings, including blood pressure, cholesterol, glucose level and body mass index, to detect early risks of chronic conditions such as diabetes, hypertension and heart disease.
  • The screenings will now also offer PHQ-2 assessments – screenings to help identify people who require additional evaluation for depression. Following these screenings, participants have the opportunity to meet with a nurse practitioner who can provide referrals for treatment and advice on follow-up care.

Thursday Miscellany

David Ermer–Congress, COVID-19, End of the PHE, NE, FDA, Medical / Rx research, Rx coverage–

From Washington DC —

Photo by Josh Mills on Unsplash
  • The Secretary of Health and Human Services issued a statement on the end of the Covid health emergency which occurred today.
    • Govexec and the Society for Human Resource Management respectively discuss the impact of this event on federal agencies and employers generally.
      • SHRM notes, “President Biden in April ended the pandemic national emergency weeks earlier than expected—but the premature ending won’t shift the deadlines spelled out in the administration’s guidance from March, including the extended deadline for special enrollment in health plans. * * * July 10 will also mark the end of some COBRA-related relief, under which employees were allowed extra time to pay their COBRA premiums or to decide whether they wanted to use the coverage.”
  • The Wall Street Journal reports
    • “A highly anticipated meeting scheduled for Friday between President Biden and congressional leaders to chart a path forward on lifting the debt ceiling was postponed until next week, officials said.
    • “The delay will give White House and congressional staff more time to make progress in their closed-door spending talks, the officials said, adding that one of the lawmakers was unable to attend the meeting Friday because of a scheduling conflict.
  • STAT News informs us
    • “The Senate health committee on Thursday passed a package of bills aimed at speeding generic drug competition and reining in drug middlemen business practices. But they failed to pass an ambitious reform to the pharmacy benefit manager sector, despite strong bipartisan support for it.
    • “Chairman Bernie Sanders (I-Vt.) is pursuing the drug pricing reforms at the behest of Senate Majority Leader Chuck Schumer (D-N.Y.), who wants to hold a floor vote on an even bigger package of health bills later this year. The markup came just a day after the same panel held a major hearing on PBM and drugmakers’ role in high insulin prices.
    • “It’s not clear when the Senate would take up that package, and while the package is bipartisan, it’s not clear whether it has enough support among House Republicans to pass in that chamber. There are a few, tamer PBM bills that the House Energy and Commerce Committee is expected to mark up on May 17, but there is no indication that Senate and House lawmakers are coordinating on PBM legislation.
    • “The committee passed 18 to 3 a bill that would ban PBMs from using so-called spread pricing. It would also require that the middlemen disclose rebates, fees, and other payments they receive and to pass them on to the insurers for whom they negotiate those concessions. * * * The committee included an amendment from Sen. Tina Smith (D-Minn.), that would let patients appeal insurer decisions to make them try cheaper drugs before getting more expensive drugs.”

From the public health front, Healio tells us that “Overweight and obese BMI during adulthood appeared associated with increased risk for colorectal cancer and non colorectal gastrointestinal cancers, according to study results published in JAMA Network Open.” The FEHBlog does not think that the new generation of obesity-reduction drugs needs publicity, but there you go.

From the Rx coverage and more front, the FDA announced

  • “the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.”
    • Medpage Today adds, “Brexpiprazole’s labelopens in a new tab or window will continue to carry a boxed warning about the risk of increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs. The warning further stipulates that the drug is not approved for patients with dementia-related psychosis who are not experiencing agitation associated with Alzheimer’s dementia.”
  • and “finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.”
  • Beckers Hospital Review points out “The Biden administration has been taking action to address the prescription drug supply shortage, which has caused upheaval both for patients and providers, according to a May 10 Bloomberg report.”

From the medical research front —

  • STAT News reports
    • “Home to billions of cells that form trillions of connections, the human brain isn’t just the body’s most important organ; it’s also the hardest to study. But an international team of scientists using cutting-edge stem cell technology has devised a new way to better understand the brain’s cellular cleanup crew — and its connection to neurological disease.
    • “Researchers coaxed stem cells to grow into microglia, immune cells that roam the brain searching for signs of damage and that monitor and maintain neuronal connections. They then added microglia to brain organoids, tiny 3D structures of neurons that mimic some aspects of brain function, and transplanted these microglia-containing “mini-brains” into mice. Doing so caused microglia to look and behave much more like they would in a human brain compared to previous lab experiments conducted in a dish.
    • “The authors also found early hints that they could use these transplanted organoids to study disease, including the role that microglia might play in autism. Microglia in brain organoids derived from people with autism had larger cell bodies than cells from controls and had an overabundance of small cellular extensions associated with an active, inflammatory state researchers believe may contribute to the disorder.”
    • “The findings, published on Thursday in the journal Cell, are the result of a collaboration between scientists from San Diego to Germany to Israel. The study raises the possibility of using transplanted organoids to understand the complex crosstalk between neurons and immune cells across a range of diseases, and to perhaps one day use this system to test potential treatments.”
  • The Washington Post adds
    • “A skin patch being developed by a French pharmaceutical company to treat peanut allergy is showing promise in toddlers, according to a peer-reviewed study published Wednesday.
    • “The “peanut patch” outperformed a placebo in “desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms,” said the study, which was funded by the company DBV Technologies and published in the New England Journal of Medicine.”

Midweek Update

David Ermer–Congress, End of the PHE, NE, NCQA, NIH, OPM, Rx coverage, Telehealth, Uncategorized–
Photo by Michele Orallo on Unsplash

From Capitol Hill —

Roll Call reports

  • “The White House and congressional leaders are discussing the duration of appropriations caps and a debt limit raise as staff talks get underway in advance of the next principals meeting on Friday.
  • “A two-year appropriations deal is under consideration, according to sources familiar with the talks, along the lines of three separate laws since 2015 that were paired with suspensions of the debt limit. 
  • “The White House and top Democrats are pushing for two years of debt limit breathing room, as in the 2019 deal cut with former President Donald Trump. That law contained two years of spending caps, which Speaker Kevin McCarthy pointed out as far back as January.
  • “Such an arrangement would, in theory, remove the threat of fiscal cliffs facing lawmakers and the economy until after the 2024 elections.”

Fierce Healthcare tells us,

  • “The Senate Health, Education, Labor and Pensions (HELP) Committee convened the heads of three big pharmas—Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jørgensen and Sanofi CEO Paul Hudson—as well as the top brass at the three largest PBMs—CVS Health Executive Vice President and President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.
  • “The legislation on the docket for the HELP Committee aims to inject transparency into the pharmaceutical supply chain as well as increase access to generics. PBM reforms on the table include eliminating spread pricing models as well as clawbacks from pharmacies. * * *
  • “The HELP Committee will convene Thursday to mark up four bills that target drug pricing. Sanders said that while these measures are a priority, there’s more work to be done in addressing this issue. He added that issues with affording drugs are a broader part of the ongoing challenges around affordability in healthcare.”

Tomorrow is the last day of the Covid public health emergency, and today the Department of Health and Human Services posted a fact sheet on how the end of the PHE affects telehealth.

From the Rx coverage front, the Wall Street Journal points out

  • “Advisers to the Food and Drug Administration recommended making an oral contraceptive available without a prescription for the first time, potentially widening access to birth control for women across the country. 
  • “The panel of FDA advisers voted 17 to 0 on Wednesday that there was enough evidence for the agency to approve the medication’s sale over-the-counter. The FDA, which is expected to make a final decision this summer, doesn’t have to follow the expert panel’s advice, though it often does.
  • “The FDA approved the pill, called Opill, for prescription use in 1973. HRA Pharma, owned by Perrigo, a Dublin-based generic drugmaker, submitted its application to make Opill available over-the-counter last July. 
  • “The advisory panel said the benefits of making oral contraceptives available over-the-counter outweighed the risks.”

The cost curve is pointing down.

From the medical research front, the National Institutes of Health updates us on multiple mRNA vaccines that show promise for treating HPV-Related cancers.

From the healthcare quality front, NCQA informs us

  • “We launched our Race and Ethnicity Stratification Learning Network.
  • “The network is a free, interactive, online tool that offers data and best practices to help health plans improve how they collect race and ethnicity data on enrollees.
  • Improving data collection of race and ethnicity data is vital to improving health equity.
  • “The data available in this new resource summarize the care of 20 million people enrolled in 14 health plans that reported results on 5 HEDIS measures, stratified by race and ethnicity.
  • “Best practices we identify come from NCQA’s qualitative interviews of key staff at plans in the learning network.
  • “A report groups our findings in three areas.”

Check it out.

From the federal employment front, the Office of Personnel Management announced

  • released proposed regulations that would prohibit the use of previous salary history in setting pay for federal employment offers. Under the new proposed regulations, federal agencies would not be able to consider an applicant’s salary history when setting pay for new federal employees in the General Schedule pay system, Prevailing Rate pay system, Administrative Appeals Judge pay system, and Administrative Law Judge pay system.  
  • “These proposed regulations are a major step forward that will help make the federal government a national leader in pay equity,” said OPM Director Kiran Ahuja. “Relying on a candidate’s previous salary history can exacerbate preexisting inequality and disproportionally impact women and workers of color. With these proposed regulations, the Biden-Harris Administration is setting the standard and demonstrating to the nation that we mean business when it comes to equality, fairness, and attracting the best talent.” 

Weekend update

David Ermer–Congress, FDA, Telehealth, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

The Senate will be on a State work period this week, while the House of Representatives will hold a DC work week. This means that Committee business will occur.

The Wall Street Journal reports

“Top Democrats and Republicans are racing to try to find a politically acceptable way to raise the nation’s borrowing limit in the coming weeks, diving into talks that President Biden has avoided during months of impasse. 

“Mr. Biden will host House Speaker Kevin McCarthy (R., Calif.) and other congressional leaders at the White House on Tuesday, the first direct contact in months as officials grapple with the prospect of the first-ever U.S. default as soon as June 1. 

“While the two parties are publicly standing by their negotiating stances, officials on both sides of the aisle have started to quietly search for a way out of a potential crisis.”

From the Rx coverage front —

  • Fortune Well tells us,
    • “U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.
    • “Advisers to the Food and Drug Administration meet [this] week to review drugmaker Perrigo’s application to sell a decades-old pill over the counter. The two-day public meeting is one of the last steps before an FDA decision.
    • “If the FDA grants the company’s request, Opill would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves or online.
    • “In an initial review posted Friday, the FDA raised several concerns about studies of Opill, citing problems with the reliability of some of the company’s data and raising questions about whether women with certain other medical conditions would correctly opt out of taking it. It also noted signs that study participants had trouble understanding the labeling instructions.
    • “The agency will ask the panel to consider whether younger teenagers will be able to understand and follow the instructions.
    • “At the end of the meeting, the FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks. However, the panel vote is not binding, and the FDA is expected to make its final decision this summer.
  • Healthcare Dive reports,
    • “U.S. supply of Novo Nordisk’s weight loss drug Wegovy will be “reduced temporarily,” the company said Thursday, revealing the latest setback to a launch that’s been slowed by manufacturing issues over the last year and a half. 
    • “Availability of the lower three of Wegovy’s five doses, used as weekly starter shots to gradually increase patients’ tolerance to the drug, will be limited to ensure people who now get maintenance treatment can maintain “continuity of care,” the company said. Novo indicated the problem will be eased once it gets a new contract manufacturer up and running. * * *
    • “Despite the production hurdles, Wegovy sales continued to grow. Sales rose to 4.6 billion Danish kroner, or about $676 million, in the first quarter, up from 2.4 billion kroner the previous quarter and 1.4 billion over the first three months of 2022.”

From the health plan design front, Fierce Healthcare points out

“The first step to living healthier is choosing that lifestyle, and CareFirst BlueCross BlueShield has tapped Noom for Work to help many of its approximately 3.2 million members make that decision.

“The partnership, announced this week, will focus on CareFirst members who struggle with obesity as well as those with prediabetes, according to an announcement.

“In what Noom called a “mind-first approach,” the program will include a curriculum for those struggling with weight control that will focus on the “why” behind the behaviors that have led to problems, and then get to work on changing those behaviors.

“Included are daily lessons tailored to each person’s weight-loss goals, such as continuous education, food intake tracking and advice on how to connect to devices, such as scales and wearables, that offer not only immediate feedback but also encouragement.

From the U.S. healthcare business front, NPR Shots notes

“The Biden administration on Thursday cautioned Americans about the growing risks of medical credit cards and other loans for medical bills, warning in a new report that high-interest rates can deepen patients’ debts and threaten their financial security.

“In its new report, the Consumer Financial Protection Bureau estimated that people in the U.S. paid $1 billion in deferred interest on medical credit cards and other medical financing in just three years, from 2018 to 2020.

“The interest payments can inflate medical bills by almost 25%, the agency found by analyzing financial data that lenders submitted to regulators.”

From the fraud, waste, and abuse front, Fierce Healthcare reports

“Just as the long off-ramp from the COVID-19 public health emergency (PHE) ends and telepsychiatry providers breathe a sigh of relief with a temporary extension of virtual prescribing flexibilities, a report dropped showing an estimated $348 million in telehealth psychotherapy Medicare payments were noncompliant.

“This week, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the findings of an audit (PDF) of Medicare payments from March 2020 through February 2021. During the audit period, Medicare Part B paid $1 billion for more than 13.5 million psychotherapy services, including telehealth services.

“Of the $1 billion in Medicare Part B payments, approximately $591 million was for psychotherapy services that were billed as telehealth services, and approximately $439 million was in payments for in-person psychotherapy services, according to the report.

“The federal watchdog estimates $580 million in improper payments for services that did not comply with Medicare requirements during the audit period, including $348 million for telehealth services, or about 60% of the payments, and $232 million for non-telehealth services.”