FEHBlog

Friday Factoids

David Ermer–No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC

  • The AMA News says,
    • “The Centers for Medicare & Medicaid Services today released a FAQ explaining how it will handle the administrative fee for out-of-network providers and group health plans that initiate payment disputes under the No Surprises Act’s independent dispute resolution process on or after Aug. 3, when a federal judge vacated nationwide a six-fold increase in the fee. According to the FAQ, the fee for disputes initiated on or after Aug. 3 or unpaid before Aug. 3 will return to $50 per party until the Departments of Health and Human Services [HHS}, Labor, and the Treasury set a new fee amount.
    • “The judge also vacated nationwide the department’s restrictions on batching related claims in a single payment dispute. In response to the ruling, CMS has suspended the IDR process, including the ability to initiate new disputes. The agency said the departments intend to reopen the portal for new disputes soon and will notify interested parties at that time.”
  • Bear in mind that the independent dispute resolution entities will continue to charge $400 to $500 per party on top of the government’s fee.

From the Rx coverage front —

  • KFF Health News notes
    • Basics — “Leqembi [the recently approved Alzheimer’s Disease infused drug] is very effective at removing amyloid plaques (a protein that clumps between neurons) from people’s brains. But it doesn’t reverse cognitive decline or prevent future deterioration.”
    • Benefits — Research suggests that patients notice a “clinically meaningful” change in cognitive performance — a noticeable alteration in their ability to think, remember, and perform daily tasks — when scores rise at least 1 point on an 18-point scale used to measure Leqembi’s impact. But the change detected after 18 months for patients taking this medication was only 0.45%.
    • Side Effects — The drugmaker reported 17% of patients taking Leqembi experienced swelling in the brain and 13% had brain bleeds. Most of these side effects occurred during the first three months of treatment and were resolved without serious consequences four months later. In slightly more than 1 in 4 cases, there were also infusion-related side effects — chills, aches, nausea, vomiting, a spike or drop in blood pressure, and more. A little-discussed side effect is a reduction in brain volume associated with Leqembi and other anti-amyloid therapies. “We don’t know what this will mean to patients long term, and that’s concerning,” Alberto Espay, a professor of neurology at the University of Cincinnati College of Medicine said.
    • Not all patients will qualify. “I’m very carefully selecting the patients I think will be appropriate, focusing on people with mild cognitive symptoms who are otherwise healthy,” said Erik Musiek, an associate professor of neurology at the Washington University School of Medicine in St. Louis.
    • Costs could be considerable. Costs for Leqembi are difficult to calculate since Medicare officials haven’t announced what the government [Part B] will pay for services. But the University of Southern California estimates that a year’s worth of care, including the $26,500 cost of the medication, could total about $90,000, according to Schneider. A separate analysis by the Institute for Clinical and Economic Review suggests that all the medical services necessary to administer the drug, monitor patients, and undertake needed testing could total an average of $82,500 yearly on top of Leqembi’s direct cost.
  • Medscape informs us,
    • “A novel triple agonist to receptors for three nutrient-stimulated hormones led to weight loss as high as 24% among people with overweight or obesity but who did not have type 2 diabetes when used at the highest tested dose for 48 weeks. The results are from a phase 2 study of retatrutide that was published in The New England Journal of Medicine on August 9.
    • “This level of weight loss is “unprecedented” for a medication administered for 48 weeks, commented Mary-Elizabeth Patti, MD in an editorial that accompanied the report.
    • “The findings “offer further optimism…that effective pharmacologic management of obesity and related disorders is possible,” writes Patti, a principal investigator at the Joslin Diabetes Center in Boston.”
  • BioPharma Dive reports,
    • The Food and Drug Administration has conditionally approved a new medicine for multiple myeloma, offering patients with hard-to-treat forms of the blood cancer another therapy option.
    • “The medicine, which was developed by Johnson & Johnson and will be sold under the brand name Talvey, is what’s known as a bispecific antibody. A first of its kind, Talvey binds to both “CD3,” a protein found on T cells, and “GPRC5D,” a protein found on malignant blood plasma cells, bringing the two together so the immune system has a better shot at identifying and fighting cancer.
    • “The FDA based its decision on a clinical trial that enrolled multiple myeloma patients whose disease persisted after at least four other therapies. The trial found just under three-quarters of participants responded in some way to J&J’s drug, with roughly a third going into remission. Regulators have requested additional testing to confirm the benefits of Talvey and to keep it on the market.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Healthcare merger and acquisition activity hit a three-year low in the second quarter of this year, according to a report by accounting firm and consultancy KPMG. 
    • “The analysis tallied 245 deals in the second quarter of 2023, a decrease of 7% compared to the same period last year and a 41% decline from the second quarter in 2021. 
    • “Ongoing financial pressures — like potential interest rate hikes, political divisions and uncertainty about valuations of acquisition targets — could keep M&A low in the second half of the year. But some of those headwinds are expected to lighten up as sell-side valuations continue to contract and companies look to divest non-core assets, giving deal-making a boost during the first half of 2024, the report noted.”
  • Fierce Healthcare tells us
    • “While major payers issued warnings to investors ahead of second-quarter earnings about rising utilization rates, patients returning to deferred services did not prevent these companies from turning a profit.
    • “UnitedHealth Group led the way yet again in profitability for the second quarter as well as the first half of 2023, according to company earnings reports. The healthcare giant posted $5.5 billion in profit for the quarter and $11.1 billion through the first six months of the year.
    • “By comparison, the next-highest company for second-quarter profit was CVS Health at $1.9 billion. CVS also reported the second-highest profit for the first half of 2023 with $4 billion, according to the filings.
    • “UnitedHealth also tops the list for revenue in the second quarter and first sixth months of the year. The company reported $92.9 billion in second-quarter revenue and $184.8 billion in midyear revenue.”
  • The AHA News reports on its President Rick Pollack’s views on controlling medical consumer debt. Of course, Mr. Pollack does not mention lowering healthcare prices which is a straight line to debt reduction. Rather, he focuses on adding administrative burdens to health insurers and plans and reducing consumer choice of health plans.

Thursday Miscellany

David Ermer–Uncategorized–
Photo by Josh Mills on Unsplash

From Washington DC,

  • The Wall Street Journal reports
    • “The [U.S.] Supreme Court blocked Purdue Pharma’s $6 billion settlement of opioid lawsuits against its Sackler family owners, agreeing to hear the Justice Department’s claim that the drugmaker’s bankruptcy plan improperly wipes out potential liability to additional parties for allegedly fueling the opioid addiction crisis.”
  • and
    • “Social Security recipients are on track to pocket a significantly smaller raise in 2024 because of a slowdown in inflation.
    • “If inflation climbs in line with its recent trend over the next two months, recipients’ monthly checks will rise by about 3% in 2024, according to estimates from analysts and nonprofits. The estimates follow an 8.7% cost-of-living increase in 2023 as inflation soared.”
  • The Centers for Medicare and Medicaid Services updated its recent No Surprises Act website notice to read,
    • “Effective August 8, 2023, the Departments have directed certified IDR entities to resume processing single and bundled disputes initiated in 2022, as well as single and bundled disputes initiated in 2023 where the administrative fees have been paid (or the deadline for collecting fees expired) before August 3, 2023. Additionally, the Departments have directed certified IDR entities to resume processing batched disputes where the IDR entity determined that the batched dispute was eligible and administrative fees have been paid (or the deadline for collecting fees expired) before August 3, 2023. Processing of other disputes remains temporarily suspended.“
  • The FEHBlog checked the status of the August 3, 2023, decision in the Texas Medical Association versus HHS case, filed in the Eastern District of Texas, and he found that as of today, the Justice Department has not noticed an appeal from that final decision.
  • The Department of Health and Human Services announced,
    • “Today, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, announced awards of more than $100 million to train more nurses and grow the nursing workforce. These investments will address the increasing demand for registered nurses, nurse practitioners, certified nurse midwives, and nurse faculty.
    • “Nurses are an essential part of our nation’s health care system,” said HHS Secretary Xavier Becerra. “Now more than ever, we need to double down on our investments in nurses who care for communities across the country.”

From the public health and Rx coverage fronts,

  • The Wall Street Journal reports
    • “Health officials, vaccine makers and doctors are gearing up for a fall vaccination campaign that will look different from previous ones: Vaccines will be distributed to pharmacies and doctors’ offices through the commercial market, not government purchases. The vaccines are targeting the recently dominant XBB.1.5 strain in line with instructions the Food and Drug Administration set earlier this year. 
    • “Boosters updated to target XBB.1.5 should retain good protection against EG.5, because the Omicron subvariants are similar, Kanter said. It is difficult to predict how long the protection might last, he said.
    • “Pfizer expects its new shots to win approval this month, with vaccinations likely starting in September, Chief Executive Albert Bourla said this month. Pfizer expects the booster to work against EG.5 because it is an offshoot of Omicron—but is conducting laboratory tests to be sure, a spokeswoman said. Pfizer and partner BioNTech presented animal testing to FDA advisers at a June meeting about how to update the vaccine. * * *
    • “Moderna has ample supply of its updated vaccine and is waiting for FDA signoff to distribute doses, a spokesman said. He said that preliminary testing shows the shot works against EG.5 and that more testing is under way.
    • “Novavax, whose Covid-19 vaccine uses a different technology, is submitting data to regulators to authorize its booster and expects to win clearance and ship doses in September, a spokeswoman said.”
  • Cost curve up for health plans.
  • Fierce Healthcare says,
    • “Medicare Part D drug prices have increased by an average of 226% since market entry. These 25 drugs are responsible for $80.9 billion in total Part D spending in 2021.
    • “The new report (PDF) from AARP’s Public Policy Institute shows that high pharmaceutical drug prices are placing an unwelcome burden on customers. Overall, lifetime price increases among 25 name-brand drugs have increased by 20% to 739%, with just one drug exceeding the annual rate of inflation over the same period of time.”
  • The Wall Street Journal adds,
    • “Weight-loss drugs such as Wegovy will continue to be tough to find for the foreseeable future, as demand outpaces drugmakers’ ability to make enough.
    • “Denmark-based Novo Nordisk said Thursday it will continue to reduce the availability of lower doses of Wegovy that are meant for new patients starting out on the drug in the U.S. Capacity limitations at some manufacturing sites will cause continued periodic supply constraints across a number of products and geographies.
    • “Novo Nordisk started this rationing in May as a way to conserve supplies for existing patients who take higher doses of the drug to lose weight and keep it off. The company had said previously the reduction in starting doses would last through September, but Novo Nordisk executives said Thursday that they expect to continue to manage the starting dose supply after September.”

From the healthcare business front,

  • BioPharma Dive informs us
    • “Novo Nordisk agreed to buy metabolic disorder specialist Inversago Pharma in a deal worth as much as about $1.1 billion as the Danish company works to strengthen its leading position in the obesity drug market.
    • “Inversago’s lead experimental drug has shown promise for weight loss in a Phase 1b trial and is being tested in Phase 2 for diabetic kidney disease, Novo said Thursday. The privately held Canadian company is also developing treatments for other metabolic and fibrotic disorders.
    • “Novo didn’t release further financial details of the transaction, which includes potential payments for reaching certain developmental and commercial goals. The companies expect the acquisition to close by the end of the year, after which Novo intends to investigate the potential of Inversago’s lead drug in “obesity and obesity-related complications.”
  • Per Healthcare Dive,
    • “America’s largest for-profit health systems reported higher-than-anticipated revenues this quarter, driven by rebounding admissions and increased demand for elective surgeries.
    • “HCA and Tenet, which both posted revenues that surpassed Wall Street estimates, raised their full revenue forecasts for the year in light of their second quarter performance, and UHS raised its lower-bound revenue guidance. CHS was an outlier, posting a net income loss of $38 million, which analysts said was still an improvement compared to the health system’s net loss of $326 million in the same period last year.
    • “Hospitals said normalizing labor conditions post-pandemic and proactive cost-cutting initiatives helped keep operating margins stable, even as expenses rose year over year.
    • “The reported revenues and cost-cutting initiatives for for-profit hospitals is a contrast to last year, when operators struggled to meet targets during the second quarter amid lower admissions and challenging labor market conditions.”
  • Per Fierce Healthcare
    • “Cigna is teaming up with Virgin Pulse to launch a new, personalized digital health program for its members.
    • “The new platform will be available through the myCigna portal and allows users to set their personal health goals and track daily progress. They can then receive real-time feedback and guidance that’s based on the data they’ve submitted, according to an announcement.
    • “The tool will be offered to nearly 11 million members, Cigna said.
    • “Cigna said it will make the platform available beginning Jan. 1 to people enrolled in its employer plans. It intends to expand further over time.”

Midweek update

David Ermer–COVID-19 vaccine, Medicare, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the public health and Rx coverage front —

  • Think Advisor informs us
    • “Executives from life insurance, health insurance and annuity issuers have spent their second-quarter earnings calls telling securities analysts about an open secret: The U.S. death rate is still noticeably higher than it was before 2020, when the COVID-19 pandemic began.
    • “Some executives emphasized that COVID-19 had little effect on earnings because their companies had prepared for COVID-19 to linger, not because the effects have gone away.
    • “But John Gallina, Elevance CFO, said costs related to COVID-19 and the pandemic’s impact are a headwind.
    • “When you combine COVID and non-COVID cost, the overall cost of the health care system is more expensive than if COVID had never occurred,” Gallina said. “We’ve seen it, we’ve priced for it and we’ve factored it into our expectations. But COVID is not gone. It still exists. It’s just no longer the big significant driving force that it had been for the past several years.”
  • KFF Health News says,
    • “[M]ultiple studies show that firefighters, both military and civilian, have been diagnosed with testicular cancer at higher rates than people in most other occupations, often pointing to the presence of perfluoroalkyl and polyfluoroalkyl substances, or PFAS, in the foam.
    • “But the link between PFAS and testicular cancer among service members was never directly proven — until now.
    • “A new federal study for the first time shows a direct association between PFOS, a PFAS chemical, found in the blood of thousands of military personnel and testicular cancer. * * *
    • “The Department of Veterans Affairs does not recommend blood testing for PFAS, stating on its website that “blood tests cannot be linked to current or future health conditions or guide medical treatment decisions.”
    • “But that could change soon. Rep. Dan Kildee (D-Mich.), co-chair of the congressional PFAS Task Force, in June introduced the Veterans Exposed to Toxic PFAS Act, which would require the VA to treat conditions linked to exposure and provide disability benefits for those affected, including for testicular cancer.
    • “The last thing [veterans] and their families need to go through is to fight with VA to get access to benefits we promised them when they put that uniform on,” Kildee said.”
  • Reuters reports,
    • “U.S. psychiatrists are increasingly prescribing the popular weight-loss drug Wegovy to patients who gain weight from medicines used to treat mental disorders, such as schizophrenia or bipolar disorder, according to Reuters interviews with ten prescribers across the country.
    • “Many antipsychotic drugs and mood stabilizers can cause patients to gain significant weight and contribute to diabetes and heart disease, the leading cause of death among adults with schizophrenia.”
  • The New York Times provides us with information about who should get the flu, Covid and R.S.V. vaccines, and when this fall.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “The average U.S. physician earns $350,000 a year. Top doctors pull in 10 times that.
    • “When those simple data points were first presented in 2020, a small subset of physicians came unglued on the microblogging site formerly known as Twitter, slinging personal insults and at least one deeply unflattering photo illustration of an economist.
    • “We couldn’t understand why. The figures are nigh-on unimpeachable. They come from a working paper, newly updated, that analyzes more than 10 million tax records from 965,000 physicians over 13 years. The talented economist-authors also went to extreme lengths to protect filers’ privacy, as is standard for this type of research.
    • “By accounting for all streams of income, they revealed that doctors make more than anyone thought — and more than any other occupation we’ve measured. In the prime earning years of 40 to 55, the average physician made $405,000in 2017 — almost all of it (94 percent) from wages. Doctors in the top 10 percent averaged $1.3 million. And those in the top 1 percent averaged an astounding $4 million, though most of that (85 percent) came from business income or capital gains.”
  • Fierce Healthcare relates,
    • “Hospitals nationwide charge payers more than double for healthcare services covered under commercial plans than they do for the same insurer’s Medicare Advantage (MA) plans, according to a recent Johns Hopkins analysis of hospitals’ published pricing data.
    • “The work, published this week in Health Affairs, reviewed more than 200,000 unique combinations of hospitals, insurers, settings and services for which a commercial and an MA price were available for direct comparison. In total, it included pricing data from 2,434 hospitals and 118 insurers collected in September 2022.
    • “Commercial prices were, on average, between $600 and $707 more expensive than MA prices, or 2.1 to 2.2 times more expensive.
    • “The dollar gap for prices was widest within the surgery and medicine service category where median commercial prices were nearly $800 more expensive than the charges for MA plans ($1,702 versus $928), 1.8 times higher. The median price increases were consistent across the other three reviewed service categories: imaging ($490 versus $191, 2.6 times higher), lab tests ($32 versus $12, 2.7 times higher) and ED visits ($519 versus $262, 2.0 times higher).”
  • Beckers Hospital Review points out the payer mix of largest for profit health systems based on their second-quarter earnings reports.
  • BioPharma Dive reports on the latest biotech M&A deals as the market begins to pick up.

From the miscellany department,

  • AHA News reminds us that “Health care providers must comply with the HIPAA rules with respect to telehealth effective Aug. 9 at 11:59 p.m., when the 90-day enforcement discretion period announced in April expires.” 
  • MedPage Today notes
    • “A new blood test from Quest Diagnostics has Alzheimer’s experts concerned.
    • “The Quest AD-Detect test, which consumers can now purchase from home without visiting a doctor, measures amyloid-beta 42 and amyloid-beta 40 in blood to provide an amyloid-beta 42/40 ratio. In theory, the ratio may help identify the risk of developing Alzheimer’s disease. In practice, the value of the Quest test is unknown.
    • “The test has not been cleared or approved by FDA.”

Tuesday Tidbits

David Ermer–FDA, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington DC —

  • FedScoop reports
    • “Amid scrutiny of the retirement services division within the Office of Personnel Management, congressional inquiries to the agency have grown drastically, according to a February letter sent by Retirement Services Associate Director Margaret Pearson.
    • “According to the missive, which was sent in response to questions from House lawmakers, OPM’s Congressional, Legislative, and Intergovernmental Affairs branch received more than 9,000 congressional inquiries in 2022, compared with more than 3,000 in 2020. In other words, the number of inquiries from Congress to the agency has approximately tripled in three years.”
  • Fedsmith adds
    • “The latest data from the Office of Personnel Management (OPM) show that the backlog of outstanding retirement claims now stands at 17,047, 4.1% higher than at the end of June. The number of incoming claims was much higher in July than in June, 7,261 versus 4,854, respectively, a difference of 50%. Although OPM still processed nearly the same number of claims in July (6,584) as in June (6,609), this served to drive the backlog higher.
    • “Another contributing factor was that the monthly average processing time was higher in July than in June. It took OPM 85 days on average in July to process retirement applications versus 74 days in June. July was the second-highest monthly average processing time so far in 2023, second only to January (93 days).”
  • The Labor Department’s Assistant Secretary for Employee Benefits Security, Lisa Gomez, blogs about the ACA regulator’s proposed amendments to the federal mental health and substance use disorder rule. Why must all of the pressure to improve mental health care be placed on health plans?
  • Federal News Network says,
    • “The Postal Service is falling short of its goal to turn around its financial losses this year, but is pointing to an ongoing shakeup of its nationwide delivery network as a critical part of its plan to break even by the end of the decade.
    • “Postmaster General Louis DeJoy said Tuesday that “more aggressive cost reductions to operations” are needed to keep USPS’ long-term financial goals within reach — and that USPS reshaping its nationwide delivery network is key to those savings.
    • “This undertaking is massive and long overdue, and time is of the essence if we wish to enjoy the benefits of this cherished institution for years to come,” DeJoy told the USPS Board of Governors.
    • “USPS reported a $1.7 billion net loss for the third quarter of fiscal 2023, and is expected to see a net loss for the entire fiscal year.”

From the public health and Rx coverage fronts–

  • STAT News informs us
    • “The momentum around weight loss drugs is about to get even bigger in the wake of Novo Nordisk’s announcement that its semaglutide drug Wegovy cut the risk of cardiovascular disease by 20% in its large SELECT trial.
    • “The full results of the study, funded by Novo, will be presented at the American Heart Association meeting in November. Doctors and researchers say they expect the findings to have a big impact on how clinicians approach the treatment of both obesity and cardiovascular disease, as well as increase the likelihood that prescriptions for obesity drugs will be covered by insurance.
    • “But experts who spoke with STAT also cautioned that the long-term safety and efficacy of Wegovy and other weight loss drugs remain unknown. The SELECT study has yet to be peer-reviewed, and not enough information is yet available to make independent assessments of the results.”
  • The Wall Street Journal adds,
    • “The surging demand for GLP-1s has prompted analysts to raise their forecasts for the global obesity market, with Morgan Stanley recently revising its estimate to $77 billion in annual sales by 2030, up from $54 billion.
    • “For now, doctors are prescribing more of Mounjaro and Wegovy than the companies can make, with a lack of manufacturing capacity frequently leading to shortages. Eli Lilly on Tuesday reported $980 million in Mounjaro sales in the second quarter, trouncing analyst estimates of $740 million on FactSet. The Mounjaro beat allowed the company to raise its annual guidance as well. Mounjaro is approved for diabetes and is expected to receive Food and Drug Administration approval for obesity treatment this year, though doctors are already prescribing it off-label.”
  • The Wall Street Journal also lets us know,
    • “Women are closing a gender gap, but it isn’t a good one: They’re catching up to men when it comes to problem drinking.
    • “Women’s drinking, on the rise for the past two decades, jumped during the pandemic as women reported more stress. Although men still drink more alcohol than women and have higher alcohol-related mortality rates, doctors and public health experts say women are narrowing that divide.
    • “Alcohol-related emergency department visits, hospitalizations and deaths are increasing faster for women than for men. And studies suggest that women are more susceptible to alcohol-related liver inflammation, heart disease and certain cancers.”
  • Independence Blue Cross announced,
    • ” Independence Blue Cross (Independence) and the Colorectal Cancer Alliance (the Alliance) announced the launch of 45+ Reasons, a campaign to get more than 5,000 Black Philadelphians ages 45-75 screened for colorectal cancer to reduce the significantly higher incidence and mortality rates of Black Americans. The campaign supports the Cycles of Impact initiative launched by Independence and the Alliance in 2022.
    • T”he campaign is a flagship program of Philadelphia’s Accelerate Health Equity, a city-wide initiative to produce tangible improvement in health inequities, and ultimately achieve measurable, positive changes in health outcomes in Philadelphia. Colorectal cancer screening and treatment is a priority area for Accelerate Health Equity.”
  • The All of Us Program released its August 2023 newsletter.
  • Fierce Healthcare tells us,
    • “There has been a 2% rise in maternity care deserts since 2020—meaning 1,119 additional counties, a new analysis suggests.
    • “The latest 2022 report on maternity care deserts, put together by nonprofit March of Dimes (PDF), relied mostly on 2019-20 data for its analysis.
    • “It classified more than a third of all U.S. counties as maternity care deserts in the report. These were defined as counties with no hospitals or birth centers offering obstetric care and no obstetric providers. 
    • “Nationwide, 5% of counties have less maternity access than two years ago while 3% shifted to higher access. Florida had the most women impacted by improvements to maternity care access, while Ohio had the most women impacted by overall reductions in access to care.” 

From the U.S. healthcare business front —

  • BioPharma Dive relates
    • “Eli Lilly became the most valuable healthcare company in the U.S. after a stock price surge Tuesday morning propelled the Indianapolis drugmaker’s market value above $500 billion for the first time in its 147-year history.
    • “Shares jumped 15% on second-quarter earnings that showed the company’s revenue rose by 28%, driven by fast sales of its diabetes medicine Mounjaro. The drug has attracted intense interest for its potential as an obesity treatment, a use for which it’s expected to earn Food and Drug Administration approval later this year.”
  • STAT News reports that Sage Therapeutics finds itself under financial pressure due to the FDA’s decision to approve its new drug for postpartum depression but not other types of depression.
    • “Sage’s chief business officer, Chris Benecchi, declined to name a price or a price range for Zurzuvae, saying that the company is working together with its partner Biogen to “determine adjustments for thinking on price given the PPD label.” Sage expects the drug to be available in the fourth quarter following its scheduling by the Drug Enforcement Administration because of the drug’s low potential for misuse.
    • “Sage hosted the pre-market call without Biogen, raising analysts’ eyebrows as the two companies signed a commercialization deal in 2020 valued at over $1.5 billion, predicated on the hope that zuranolone would become a blockbuster drug for major depression. Despite many questions about what exactly would be needed for the drug to get FDA approval for major depression and whether Biogen would continue its partnership with Sage, Greene declined to give any insight into how committed Sage and Biogen are to pursuing the MDD indication, or whether Biogen was going to vacate the partnership.”
  • Healthcare Dive offers five takeaways from the health insurers’ second-quarter earnings.
    • “Major health insurers saw their shares dip coming into the second quarter, as investors prepared themselves for skyrocketing medical costs due to seniors returning for outpatient care.
    • “But health insurers generally outperformed market expectations in the quarter, helped by cost control measures.”
  • Meanwhile, the American Hospital Association’s President takes these health insurers to task in U.S. News and World Report for imposing cost control measures.

Monday Roundup

David Ermer–CDC, CMS, COVID-19, Federal employment benefits, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • Fedscoop reports
    • “The Office of Personnel Management is expecting to conduct a four-month trial of a new online retirement application platform for federal employees later this year, FedScoop has learned.
    • “In a letter to lawmakers, which was obtained by this publication through a Freedom of Information Act request, agency director Kiran Ahuja said OPM will conduct an approximately 120-day pilot in coordination with the National Finance Center, which is a federal agency division under the United States Department of Agriculture.
    • “Responding to questions from lawmakers, including Sen. Dick Durbin, D-Il., Ahuja wrote: “Between the electronic employee data received from the payroll center and the online retirement application, RS will receive all the information necessary to process a retirement application electronically.”
    • “She added: “The pilot will likely last 120 days, at which point RS will evaluate the results and determine the appropriate next steps to expand the program.” 
  • The Federal Times says that “Unions representing more than 900,000 federal workers are pushing back against President Joe Biden’s plan to bring back more in-person work for federal employees, citing contract terms and the benefits of a hybrid workforce.”
  • The FEHBlog had time today to redline the proposed amendments to the mental health parity rule in the existing rule, 45 C.F.R. Sec. 146.136. The FEHBlog thought that the proposed amendment would downplay the complicated non-quantitative treatment limitation (NQTL) provisions in favor of more direct requirements to improve access to, and lower costs for, mental health and substance use disorder care. Au contraire, the regulators seek to achieve these goals via the NQTL rules, which will become hyper-complicated. It’s disappointing, considering that parity could be achieved much more efficiently by covering medical/surgical and mental health/substance use disorder care under a unified set of rules.

From the public health front —

  • U.S. News and World Report informs us
    • A new coronavirus strain has taken over as the top variant circulating in the U.S.
    • EG.5 was responsible for more than 17% of new coronavirus cases over the past two weeks, according to data from the Centers for Disease Control and Prevention. That’s the highest prevalence of any strain circulating, rising above the so-called “arcturus” variant, which caused nearly 16% of infections. * * *
    • XBB.1.5, which will be the target of the updated COVID-19 vaccines coming in the fall, is decreasing in the U.S. Still, health experts say that the shot should work on other omicron subvariants as well.
    • Health officials hope that the upcoming fall booster campaign will increase protection against the coronavirus ahead of a potential fall and winter wave.
  • Reuters points out
    • “Five major U.S. health systems said they would offer Eisai and Biogen’s promising new Alzheimer’s drug Leqembi after working out payment and administrative policies, and how to assess and monitor patients, most likely in the next month or two.
    • “Leqembi, which won full U.S. regulatory approval last month, is the first treatment proven to slow progression of the mind-robbing disease for people in the earliest stages of Alzheimer’s.
    • “The disease affects an estimated 6.5 million people, most of whom are part of the U.S. government’s Medicare plan for people 65 and older.
    • “The patients are lining up. They want to be treated, but it’s difficult to rush right into it,” said Dr. James Galvin, who heads the Alzheimer’s research program at the University of Miami Miller School of Medicine.
    • “Neurologists at the Mayo Clinic in Rochester, Minnesota, Chicago’s Northwestern Memorial and Los Angeles’ Cedars-Sinai all said they plan to roll out the drug in the next few months. Cleveland Clinic and Utah’s Intermountain health system said they have not started offering it.”
  • Per Health Day,
    • “By age 75 years, approximately half the global population can expect to develop a mental disorder, according to a study published online July 30 in The Lancet Psychiatry.
    • “John J. McGrath, Ph.D., from Queensland Centre for Mental Health Research in Brisbane, Australia, and colleagues used data from 156,331 adult participants in the World Mental Health surveys (2001 to 2022; 29 countries) to estimate age-of-onset distributions, lifetime prevalence, and morbid risk for mental disorders.
    • “The researchers found that the lifetime prevalence of any mental disorder was 28.6 percent for male respondents and 29.8 percent for female respondents. By age 75 years, the morbid risk for any mental disorder was 46.4 percent for male respondents and 53.1 percent for female respondents. At 15 years, the conditional probabilities of first onset peaked, with a median age of onset of 19 years for male respondents and 20 years for female respondents. Alcohol use disorder and major depressive disorder were the two most prevalent disorders for male respondents, while major depressive disorder and specific phobia were most prevalent for female respondents.”

From the No Surprises Act front

  • According to Healthcare Dive,
    • “A Texas judge has vacated portions of the No Surprises Act dispute resolution process after the state’s medical group argued it was illegal and overly favorable to health insurers, leading the HHS to once again suspend arbitrations until further notice.
    • “Judge Jeremy Kernodle for the Eastern District of Texas on Thursday vacated regulators’ increase of the dispute resolution administrative fee to $350 and the “batching rule,” which allowed arbitration processes only on claims with the same service code.
    • “The judgment removes barriers for providers to file dispute resolution claims and will likely increase the volume of claims, especially from physician groups and hospital outpatient departments, according to a health lawyer.”
  • CMS adds
    • Effective August 7, 2023, the Departments have directed certified IDR entities to resume processing single and bundled disputes where the administrative fees have been collected (or the deadline for collecting fees expired) before August 3, 2023. Additionally, the Departments have directed certified IDR entities to resume processing batched disputes where the IDR entity determined that the batched dispute was eligible and collected administrative fees (or the deadline for collecting fees expired) before August 3, 2023. Processing of other disputes remains temporarily suspended.
  • The federal government appealed one of Judge Kernodle’s decisions in favor of the Texas Medical Association and may appeal this one too. The FEHBlog has no problem with Judge Kernodle’s batching rule. He thinks that the regulators should ladder the administrative fee based on the sum of the QPAs in dispute. The higher the sum; the higher the fee. By the way, the government’s administrative fee is on top of the independent dispute entity’s fee, which runs from $400 to $500 fee per party.

In other U.S. healthcare business news —

  • Fierce Healthcare relates
    • “Large health systems are scooping up independent hospitals, and that consolidation negatively affects employers, insurers and patients, according to a new analysis backed by Blues giant Elevance Health.
    • However, the American Hospital Association was quick to dispute the findings, with CEO Rick Pollack telling Fierce Healthcare in an email that the analysis “draws absurd conclusions about the impact of healthcare systems on access to care, cost and quality.”
  • Beckers Payer Issues ranks health insurers by commercial membership here.
  • Beckers Hospital Review names three U.S. hospitals that announced shutdown plans last week.

Weekend update

David Ermer–Congress, FDA, Rx coverage, U.S. Healthcare, Uncategorized–

From Washington, DC —

  • While on August recess, Congress is holding four out-of-town hearings.
  • The recently proposed mental health parity rule was published in the Federal Register last Thursday. The deadline for public comments is October 2, 2023.
  • WTOP reports,
    • “President Joe Biden has asked Cabinet officials to “aggressively execute” plans to bring federal employees back to their offices, ending a precedent of remote work that started during the COVID-19 pandemic three years ago, according to multiple sources.
    • “Axios first reported that White House Chief of Staff Jeff Zients sent an email on Friday to every member of the Cabinet saying federal agencies must return to in-person work “because it is critical to the well-being of our teams and will enable us to deliver better results for the American people.”
    • “Zients said remote work won’t be completely eliminated, but that in-person time will be prioritized to “build a strong culture, trust, and interpersonal connections” within agencies, according to The Washington Post.”

From the public health front —

  • Fortune Well provides more background on the new Sage Therapeutics drug that the Food and Drug Administration approved to treat post-partum depression last Friday.
    • “In trials, zuranolone [trade name Zurzuvae] showed a “rapid reduction of depressive symptoms starting as early as day three—after two doses of medicine—and showed continued improvement through day 15,” Deligiannidis said, adding that the drug continues to work even after patients stop taking it, for 45 days in all.
    • “The fast-acting, temporary nature of the drug stands in contrast to standard-of-care antidepressants that might otherwise be prescribed. Such medications—typically SSRIs, or selective serotonin reuptake inhibitors, which increase serotonin levels in the brain—usually take four to six weeks to begin to work, and two to three months to fully kick in, according to Deligiannidis. * * *
    • “Because zuranolone is a controlled substance, the U.S. Drug Enforcement Administration now has 90 days to assign a schedule to it. Earlier this week, Chepke predicted it would be designated a Schedule IV drug or one with a low potential for abuse and dependence like Xanax, Valium, Ativan, and Ambien.
    • “From there, he anticipated it would soon be in the hands of prescribers and patients, where it’s sorely needed. * * *
    • “Sage Therapeutics and co-developer Biogen had also applied for approval to use the drug in cases of major depressive disorder. The federal agency on Friday did not issue a ruling on such use.”
  • NPR Shot tells us “Testing your genes for cancer risk is way cheaper now — and it could save your life.”

From the Rx coverage front —

  • The FEHBlog wants to point out the Center for Biosimilars website, which is chock-a-block full of useful articles on this important topic.
  • BioPharma Dive reports
    • “The Food and Drug Administration on Friday approved a second medicine for a common type of vision loss, clearing a drug developed by biotechnology company Iveric Bio for geographic atrophy.
    • “The monthly eye injection, which will be sold as Izervay, is meant to slow the progression of the condition, which Iveric and its new owner, Japanese drugmaker Astellas Pharma, estimate affects 1.5 million people in the U.S.
    • “The FDA’s decision on Izervay follows about six months after the agency greenlighted the first geographic atrophy treatment, Apellis Pharmaceuticals’ Syfovre. Both drugs work by blocking a part of the immune system, slowing the growth of eye lesions and, in theory, preserving vision. Such a benefit on visual function hasn’t been proven yet, however.
    • “The medicines are expected to become blockbuster sellers.”

From the U.S. healthcare business front —

  • KFF News offers “An Early Look at What is Driving Health Costs in 2024 ACA Markets.”
    • “This updated analysis of marketplace insurers’ early rate filings are requesting a median premium increase of 6% for 2024, which they say is largely due to price increases for medical care and prescription drugs. Insurers’ rate requests are preliminary and may change during the review process before being finalized in late summer.
    • “In addition to inflation’s impact on medical costs, insurers say the higher premiums are a result of growth in the utilization of health care, which fell in 2020 but has since returned to more normal levels.
    • “The analysis is available on the Peterson-KFF Health System Tracker, an online information hub dedicated to monitoring and assessing the performance of the U.S. health system.”
  • Although the FEHB is affected by the same cost drivers, OPM’s wise decision to approve the use of Part D EGWPs in the FEHB for 2024 will offset these cost drivers to a substantial extent.

Cybersecurity Saturday

David Ermer–Cybersecurity, Generative AI–

From the cybersecurity policy front —

  • Cybersecurity Scoop reports,
    • “The Cybersecurity and Infrastructure Security Agency [CISA] released its strategic plan for fiscal year 2024 through 2026 on Friday, following a plethora of strategies and implementation plans released over the past several months by the White House aimed at improving the nation’s overall cybersecurity preparedness. 
    • “Within CISA, this Plan will serve as a keystone for implementation, resource, and operational planning, as further executed through our Annual Operating Plans. Externally, it will help stakeholders understand and participate in our long-term cybersecurity planning and prioritization,” the document reads.
    • “CISA’s strategic plan will focus on three goals: address immediate threats, harden the terrain and drive security at scale. Additionally, the strategy has nine objectives, three for each goal, outlining the agency’s scope for the next three years.
    • “The release comes shortly after the Office of the National Cyber Director released a National Cyber Workforce and Education Strategy, as well as the National Cybersecurity Strategy in March and subsequent Implementation Plan in July.”
  • and
    • “The Biden administration’s strategy for building the U.S. cybersecurity workforce calls for government, industry and civil society groups to collaborate in increasing the number of cybersecurity workers and also urges an overhaul of the U.S. immigration system. 
    • “To address a dire shortage of cybersecurity workers, Monday’s strategy document takes a broad approach in overhauling the cybersecurity workforce. “The national cyber director’s office can only really task federal departments and agencies because, realistically, we need all of society. We need them to be feel supported and heard and seen as we approach these ecosystem models,” Acting National Cyber Director Kemba Walden told CyberScoop.”

From the cybersecurity breaches and vulnerabilities front —

  • Health IT Security brings us up to date on MOVEit breaches affecting healthcare organizations.
  • Health IT Security adds, “The healthcare sector continued to face a high volume of cyberattacks in the past few months as infostealing malware rose in popularity, BlackBerry stated in its latest Global Threat Intelligence Report.”
  • Cybersecurity Dive reports
    • “Half of the 12 most-commonly exploited vulnerabilities in 2022 were discovered the previous year, cyber authorities from the Five Eyes said in a joint advisory released Thursday. One of the top 12 vulnerabilities was discovered in 2018.
    • “Flaws in Microsoft products accounted for 1 in 3 of the most-routinely exploited vulnerabilities, including three Exchange Server CVEs from 2021. Two-thirds of the most-exploited vulnerabilities were found in products from three vendors: Atlassian, Microsoft and VMware.
    • “Other vendors that made the list include Apache’s Log4j, F5 Networks, Fortinet and Zoho.
    • * * * “Delayed or inconsistent vulnerability patching remains an underlying problem. This, combined with the unmet need for vendors, designers and developers to adhere to secure-by-design and secure-by-default principles, is aggravating the risk of compromise by malicious cyber actors.
    • “The Five Eyes intelligence alliance, which includes authorities from the U.S., Australia, Canada, New Zealand and the U.K., reiterated the need for vendors to follow secure design practices throughout the software development lifecycle.”
  • Security Week tells us
    • The US government’s cybersecurity agency CISA is calling attention to under-researched attack surfaces in UEFI [Unified Extensible Firmware Interface], warning that the dominant firmware standard presents a juicy target for malicious hackers.
    • “UEFI is a critical attack surface. Attackers have a clear value proposition for targeting UEFI software,” the agency said in a call-to-action penned by CISA technical advisor Jonathan Spring and vulnerability management director Sandra Radesky. 
  • CISA’s Director Jen Easterly blogs about the importance of securing the Border Gateway Protocol, which she describes as being the most important part of the internet you have never heard of.
  • On July 31, CISA added another known exploited vulnerability to its catalog.

From the ransomware front —

  • HHS’s Health Sector Cybersecurity Coordination Center released a sector alert on August 4, 2023.
    • “Rhysida is a new ransomware-as-a-service (RaaS) group that has emerged since May 2023. The group drops an eponymous ransomware via phishing attacks and Cobalt Strike to breach targets’ networks and deploy their payloads. The group threatens to publicly distribute the exfiltrated data if the ransom is not paid. Rhysida is still in early stages of development, as indicated by the lack of advanced features and the program name Rhysida-0.1. The ransomware also leaves PDF notes on the affected folders, instructing the victims to contact the group via their portal and pay in Bitcoin. Its victims are distributed throughout several countries across Western Europe, North and South America, and Australia. They primarily attack education, government, manufacturing, and technology and managed service provider sectors; however, there have been recent attacks against the Healthcare and Public Health (HPH) sector.”
  • Bleeping Computer informs us that “Clop ransomware now uses torrents to leak data and evade takedowns” and it offers its Week in Ransomware.
    • “Ransomware gangs continue to prioritize targeting VMware ESXi servers, with almost every active ransomware gang creating custom Linux encryptors for this purpose.
    • “This week, BleepingComputer analyzed the Linux encryptor for Abyss Locker and illustrated how it was specifically designed to encrypt ESXi virtual machines.”

From the cybersecurity defenses front —

  • Per Forbes
    • “Traditional passwords have proven to be an increasingly problematic authentication strategy in the evolving face of cybersecurity. Biometrics, such as fingerprints, facial recognition and iris scanning, are ushering in a new era of safe authentication.
    • “Biometrics provide distinct advantages over passwords in terms of security, convenience and user experience. But why exactly are biometrics more secure, and how can businesses successfully implement this technology into their existing strategies?
    • Forbes article explains how.
  • HelpNet offers advice on building cybersecurity defenses.
  • Security Intelligence explains how artificial intelligence can reduce data breach life cycles and costs.

Friday Factoids

David Ermer–COVID-19, FDA, HSA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The Food and Drug Administration announced today
    • “approv[ing Sage Therapeutic’s] Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a healthcare provider in certain healthcare facilities.
  • STAT News informs us
    • “A new White House task force on drug shortages held a rare in-person meeting last Friday with representatives from hospitals, drugmakers, pharmacies, and others in the drug supply chain to brainstorm policies for stemming shortages of cancer drugs.
    • “The meeting at the Eisenhower Executive Office Building focused on immediate steps that could help alleviate shortages, such as allowing temporary importation of drugs from other countries, according to an attendee and three others with knowledge of the discussion. It also touched on purchasing issues.”
  • HR Dive relates
    • “The National Labor Relations Board on Wednesday reversed its Trump-era stance that allowed employers to maintain certain handbook policies, such as those mandating a respectful workplace (Stericycle, Inc. and Teamsters Local 628).
    • “The shift means all policies that restrict employee speech and actions must be reviewed — “and very likely rewritten,” according to Peter Spanos, a partner at law firm Taylor English.”

From the public health front —

  • The Leapfrog Group now offers ratings on maternity care services.
  • Health Day relates,
    • “A micronutrient in human breast milk may provide significant benefit to developing newborn brains, according to new research that sheds light on the link between nutrition and brain health.
    • “Scientists looked at this sugar molecule in rodents and in human neurons. They said the micronutrient, called myo-inositol, may lead to improved infant formulas.
    • “The current research does indicate that for circumstances where breastfeeding is not possible, it may be beneficial to increase the levels of myo-inositol in infant formula,” said study co-author Thomas Biederer.
    • “Myo-inositol may also play a part in the aging brain, according to the research conducted at the Jean Mayer USDA Human Nutrition Research Center on Aging (HNRCA) at Tufts University in Boston.”
  • STAT News lets us know,
    • “Early-stage cancer diagnoses decreased by nearly 20% in the first year of the Covid-19 pandemic. A new study published in Lancet Oncology emphasizes how, because of disruptions in care, patients were more likely to get diagnosed with deadly metastatic disease — across nearly all cancer types.
    • “This study is the most comprehensive analysis of cancer diagnoses during the pandemic, using a nationwide registry that captures over 70% of all cancers in the United States. The starkest decline was observed after the initial shutdowns, with the regular 70,000 monthly cancer diagnoses (captured by the study’s inclusion criteria) being cut in half in April 2020.”
  • KFF News offers polling data on consumer interest in the new injectable weight loss drugs and their attitudes toward pharmaceutical companies and “A Look at the Latest Suicide Data and Change Over the Last Decade” in our country.

From the U.S. healthcare business front —

  • The Kaiser Foundation announced
    • “For the quarter ending June 30, 2023, Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals, and their respective subsidiaries (KFHP/H) reported operating revenues of $25.2 billion and operating expenses of $24.4 billion compared to operating revenues of $23.5 billion and operating expenses of $23.4 billion in the same period of the prior year. Operating income was $741 million for the second quarter of the year compared to operating income of $89 million in the second quarter of 2022.
    • “Like all health systems, Kaiser Permanente is experiencing ongoing cost headwinds and volatility driven by inflation, labor shortages, and the lingering effects of the pandemic on access to care and service.
    • “Due to favorable financial market conditions, Kaiser Permanente benefited from strong investment income with other income (net of other expenses) of $1.3 billion for the second quarter, compared to a $1.4 billion loss in the second quarter of 2022. For the second quarter, net income was $2.1 billion compared to a net loss of $1.3 billion in the same period of 2022.”
  • Healthcare Dive points out
    • “Patrick Conway is stepping up as CEO of UnitedHealth pharmacy benefit manager OptumRx effective immediately, according to a Thursday post on the executive’s LinkedIn, as part of a leadership shakeup at the healthcare giant.
    • “Conway is replacing Heather Cianfrocco, who is pivoting to president of Optum. Cianfrocco will lead the division’s pharmacy and care delivery capabilities, per UnitedHealth’s website.
    • “Cianfrocco replaces John Prince as Optum president. Prince has departed the company to serve as a senior advisor to private equity firm TPG, according to his LinkedIn.”
  • EBRI announced
    • “A new research report published today by the Employee Benefit Research Institute (EBRI) found that cost-sharing shifted from deductibles to copayments and coinsurance among enrollees in HSA-eligible health plans for a number of services impacted by IRS Notice 2019-45. The report, “The Impact of Expanding Pre-Deductible Coverage in HSA-Eligible Health Plans on Employee Choice of Health Plan and Cost Sharing,” analyzed claims data to quantify the effect of expanding pre-deductible coverage on enrollee choice of health plan and cost-sharing.
    • “In response to IRS Notice 2019-45, three-quarters of large employers and health plans offering HSA-eligible health plans expanded pre-deductible coverage for medications and services that prevent the exacerbation of chronic conditions. As a result, it is not surprising that when examining medical claims, cost-sharing shifted from deductibles to copayments and coinsurance for enrollees in HSA-eligible health plans,” explained Paul Fronstin, Ph.D., director, Health Benefits Research, EBRI. “The percentage of cost sharing paid through deductibles fell for antidepressants, insulin and other glucose-lowering agents, statins, beta blockers and inhaled corticosteroids.”
  • Health Payer Intelligence updates us on the status of provider challenges to the No Surprises Act’s arbitration rules.
    • “The legal challenges highlight the difficulties of prioritizing affordable healthcare for consumers. With payers and providers holding opposing views, federal policymakers must reach a conclusion that benefits both sides and improves costs for consumers.
    • “If federal agencies cannot establish reasonable guidelines for the IDR process, Americans may face an inflationary federal IDR process that results in higher premiums and healthcare costs, according to Georgetown University’s O’Neill Institute.
    • “There is a strong urgency to determine concrete guidelines, given the high amount of disputes that payers and providers have submitted through September 2022, a CMS report indicated.”
  • Behavioral Health Business reports
    • “The Cigna Group (NYSE: CI) has seen a historic but expected rise in behavioral health benefits utilization in recent years. 
    • “These insights, presented by the health care insurance and service conglomerate’s executives, echo others made by UnitedHealth Group (NYSE: UNH) executives on their second-quarter earnings call. 
    • “As it relates to what we’re seeing in terms of trends in terms of utilization, behavioral health has certainly been growing at a strong clip, not just this year, but for the past few years,” Brian Evanko, The Cigna Group’s CFO said Thursday on the company’s second-quarter earnings call. “Part of that is by design as we engage with our customers. And over time, that’s a good thing because the more utilization we see in behavioral health services, [the more] it helps to defray core medical costs.”

Thursday Miscellany

David Ermer–ACA, AHRQ, CDC, COVID-19, FDA, Telehealth, U.S. Healthcare–

From Washington, DC —

  • Medscape tells us
    • “The US Food and Drug Administration (FDA) [on July 31] cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.
    • “The device helps identify lesions in real time, and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.”
  • MedPage Today lets us know,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously — 10 to 0 — in favor of nirsevimab (Beyfortus) for protecting a wide swath of at-risk infants from respiratory syncytial virus (RSV).
    • “At a meeting on Thursday, ACIP recommended that all infants younger than 8 months who are born during or approaching their first RSV season receive one dose of nirsevimab.
    • “The advisory committee also voted 10-0 to recommend that children 8 to 19 months who are at increased risk of severe RSV and approaching their second RSV season receive one dose of the monoclonal antibody against RSV.
    • As a result of this action, FEHB plans and health plans generally must cover the preventive service with no cost sharing when delivered in-network.
  • The Labor Departments Office of Federal Contract Compliance Programs announced
    • “a final rule titled “Pre-enforcement Notice and Conciliation Procedures.”
    • “The final rule modifies the agency’s earlier rule, “Nondiscrimination Obligations of Federal Contractors and Subcontractors: Procedures to Resolve Potential Employment Discrimination” which took effect on December 10, 2020. * * *
    • “To learn more, read Acting Director Michele Hodge’s blog about the final rule here. You can also read the Final Rule here.  
    • “The final rule will take effect on September 5, 2023.”

From the public health front —

  • UPI reports, “In examining real-world data on the long-term health of elderly patients who received the COVID-19 vaccine, researchers at Brown University and Boston-based Hebrew SeniorLife determined that the Moderna variety was the safest and most effective for older adults.”
  • The Washington University School of Medicine announced,
    • “Scientists at Washington University in St. Louis have developed a breath test that quickly identifies those who are infected with the virus that causes COVID-19. The device requires only one or two breaths and provides results in less than a minute.
    • “The study is available online in the journal ACS Sensors. The same group of researchers recently published a paper in the journal Nature Communications about an air monitor they had built to detect airborne SARS-CoV-2 — the virus that causes COVID-19 — within about five minutes in hospitals, schools and other public places.”
  • MedPage Today informs us
    • “Thymectomy carried a substantially increased risk of all-cause mortality and cancer for adults, a “landmark” study showed.
    • “Adults who had undergone thymectomy had at least double the risk of all-cause mortality and cancer at 5 years post-surgery compared with matched patients who had undergone cardiothoracic surgery without thymectomy * * *.
    • “Incidental thymectomy is common during cardiothoracic surgery due to the pyramid-shaped organ’s location in the chest in front of the heart where surgeons need to access the surgical field.
    • “While the thymus plays a critical role in normal immune system development, it was thought to be safe to remove in adulthood, “particularly since the thymus naturally involutes with age,” the researchers noted.
    • “Their conclusion from the study was that the thymus continues to be functionally important for human health in adulthood.”
  • HHS’s Agency for Healthcare Research and Quality has made available a
    • “Toolkit for Improving Perinatal Safety, a second bundle of AHRQ tools is available to improve the safety culture of labor and delivery (L&D) units. The second bundle provides resources that align the toolkit’s adaptive care processes with the clinical care processes recommended in the Alliance for Innovation on Maternal Health (AIM) program.
    • “The new tools are designed to help L&D units reduce obstetric hemorrhage and severe hypertension in pregnancy, two leading known causes of preventable maternal mortality and severe maternal morbidity in the United States.”
  • On a related note, Fierce Healthcare reports
    • “To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.”To improve maternal and infant healthcare, Health Care Service Corporation announced the launch of a program that will rely in part on the cooperation of local groups to ensure its success.
    • “HCSC said it wants to increase access to providers and reduce gaps in healthcare as well as engage and educate residents about maternal and infant well-being. The customer-owned health insurer plans to install the program in the states in which it operates: Illinois, Montana, New Mexico, Oklahoma and Texas.
    • “The initiative will first launch in the Lone Star State, HCSC said.
    • “We’re collaborating with trusted community organizations and partners, leveraging their knowledge, experience and talents on a local level,” HCSC Chief Clinical Officer Monica Berner, M.D., said in a press release. “We seek to build healthier communities by using our resources to respond to societal needs.”
  • KFF News points out that “Doctors Sound Alarm About Child Nicotine Poisoning as Vapes Flood the US Market.”

From the U.S. healthcare business front —

  • Beckers Payers Issues notes
    • “The Cigna Group raised its year-end revenue projections to $190 billion and reported a 6 percent decrease in shareholders’ net income, according to the company’s second quarter earnings published Aug. 3.
    • “Total revenues in the second quarter were $48.6 billion, up 7 percent year over year.
    • “In the second quarter, net income was nearly $1.5 billion, down 6 percent from $1.6 billion year over year. The company cited an absence of income from recently divested businesses, including the sale of businesses to Chubb in six countries and divestiture from a joint venture in Turkey.
    • “Evernorth pharmacy revenues rose 7 percent year over year to $35.2 billion. The insurance side of the business, Cigna Healthcare, reported second-quarter revenues of $12.7 billion, up 11 percent from the previous year.
    • “The company’s medical loss ratio was 81.2 percent in the second quarter, compared to 80.7 percent during the same period last year.”
  • Healthcare Dive adds
    • “Investors were concerned about medical cost trends coming into the second quarter, but health insurers have largely bucked the worst of rising expenses. Cigna, one of the last major payers to report earnings, was no different.
    • “We planned and priced for more normalized levels of utilization this year. Our year-to-date claims experience has been broadly in line with this expectation,” Cigna CFO Brian Evanko said in a Thursday morning call with investors.”
    • Cigna’s medical loss ratio, or how much of the premium dollar is spent on patient care, was 81.2% in the second quarter, according to new financial results — better than analysts expected.
  • Healthcare Dive also reports
    • “Telehealth company Amwell lowered its 2023 revenue outlook after missing analyst expectations and racking up another non-cash goodwill impairment charge in the second quarter.
    • “The company now expects to bring in revenue between $257 million and $263 million for the year, compared with earlier guidance of $275 million to $285 million, Amwell said in second-quarter results released Wednesday. 
    • “Amwell’s revenue declined 3% year over year to $62.4 million in the quarter. The telehealth vendor posted a net loss of $93.5 million, which included a $27.3 million goodwill impairment charge to make up for the “sustained decrease” in Amwell’s stock and market capitalization, according to an SEC filing.”
  • Fierce Healthcare lets us know
    • “UnitedHealthcare tapped 66 not-for-profit organizations spread over 12 states to receive grant funding to help expand access to care.
    • “The $11.1 million in grant funding, which falls under UnitedHealthcare’s Empowering Health program, aims to help improve the healthcare options of individuals living in underserved communities by addressing the social determinants of health, the insurance giant said. Specifically, it’ll target food insecurity, social isolation, behavioral health issues and health literacy efforts.
    • “Some of the organizations to receive funds include the Upstate Foundation in Syracuse, New York, CHRIS 180 in Atlanta and Trellis in Minneapolis and Saint Paul.”

Midweek Update

David Ermer–ACA, Federal employment benefits, Generative AI, Medical / Rx research, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC —

  • MedPage Today informs us
    • “In a letter to the American public, the heads of the Drug Enforcement Administration (DEA) and FDA acknowledged ongoing stimulant drug shortages [to treat ADHD] and recounted their initiatives to improve access — while calling for efforts to diminish potential overuse and misuse of these powerful medications.”
  • and
    • “Jeanne Marrazzo, MD, will be the next director of the National Institute of Allergy and Infectious Diseases (NIAID), NIH Acting Director Lawrence Tabak, DDS, PhD, announced on Wednesday.
    • “Dr. Marrazzo brings a wealth of leadership experience from leading international clinical trials and translational research, managing a complex organizational budget that includes research funding and mentoring trainees in all stages of professional development,” Tabak said in a press release. “I look forward to welcoming Dr. Marrazzo to the NIH leadership team.”
  • FedWeek explains why the federal long-term care insurance program is the “Zeppo Marx” of federal employee benefits programs and offers information about deferred annuities available to federal employees.
    • Conundrum “If you are eligible for a deferred annuity, you may elect a survivor annuity. However, you won’t be eligible either to participate in the Federal Employees Health Benefits program or acquire Federal Employees’ Life Insurance coverage.”

From the public health front —

  • From Healthcare Dive, we have an opinion piece titled, “Strengthening primary care the key to fixing healthcare system woes. Primary care advocates Ann Greiner and Shawn Martin argue the U.S. needs to turn around decades of underinvestment in its primary care chassis.” Check it out.
  • The Wall Street Journal reports that some large employer-sponsored health plans, such as the University of Texas, are canceling coverage of GLP-1 agonistes, like Wegovy, for weight loss treatment due to the high cost of the drugs. The UT plan will continue to cover these drugs, like Ozempic, for diabetes treatment.
    • “The prescription-drug benefit plan for state government employees in Connecticut now requires members to obtain anti-obesity drugs through Intellihealth, a Connecticut-based, anti-obesity medical practice that offers telehealth and app-based care.  
    • “The state’s costs for the GLP-1 anti-obesity drugs for plan members have risen 50% since 2020, and are on track for $30 million annually by the end of this year, said Connecticut State Comptroller Sean Scanlon.
    • “To me, saying we’re not going to cover these anymore was a nonstarter, because these drugs do work. People want to take them,” he said.”
  • The University of Michigan’s employee health benefits program raised the deductible on Wegovy from $20 to $45.
    • “Denmark-based Novo Nordisk charges a list price of $1,349 for roughly a month’s supply of each Wegovy and Saxenda. A related drug, Ozempic, is approved to treat Type 2 diabetes and costs about $930 a month, but isn’t typically covered by insurance plans for weight loss in people without diabetes.” That price differential doesn’t make sense to the FEHBlog.
  • MedPage Today tells us
    • “An investigational vaccine that contains the nucleoprotein of the influenza A virus appeared promising as a universal flu shot that could protect against multiple strains, regardless of annual mutations, a phase IIa dose-finding study showed.”
  • CNN informs us
    • “Artificial intelligence found more breast cancers than doctors with years of training and experience and cut doctors’ mammogram reading workload almost in half, a new early-stage study found.
    • “This doesn’t mean your hospital will let a computer determine whether you have cancer any time soon. There’s still a lot more research to do, but the study, published Tuesday in the journal The Lancet Oncology, shows that AI is safe to use in breast cancer detection and could make doctors even more effective at finding cancer than they are now.”

From the U.S. healthcare front

  • Healthcare Dive reports
    • “CVS Health announced a company-wide restructuring initiative on Wednesday after the healthcare giant’s profit fell 37% year over year to $1.9 billion in the second quarter.
    • “As part of the restructuring, the Woonsocket, Rhode Island-based company plans to terminate certain initiatives. That should allow it to reallocate resources to growth areas like healthcare services and technology, CEO Karen Lynch said on a Wednesday call with investors.
    • “CVS lowered its 2024 adjusted earnings per share target from $9 to between $8.50 and $8.70 as a result of cost pressures — flat from its 2023 guidance range. CFO Shawn Guertin also told investors to “no longer rely” on the company’s target of $10 for 2025.”
  • and
    • “Humana beat Wall Street expectations on earnings and revenue in the second quarter, reporting a topline of $26.7 billion, up 13% year over year, and profit of $959 million, up 38% year over year.
    • “Rising medical utilization earlier in the quarter appears to have stabilized based on recent claims activity, management said. The payer on Wednesday reiterated the 2023 medical loss ratio guidance of between 86.3% and 87.3%.
    • “Humana also raised its Medicare Advantage membership growth expectations following the quarter. The Louisville, Kentucky-based health insurer now expects to add 825,000 MA members in 2023.”
  • Fierce Healthcare relates
    • “Amazon Clinic is expanding to all 50 states, including nationwide telehealth services to offer access to clinicians through its website and mobile app.
    • “The online retail giant unveiled Amazon Clinic back in November as a virtual medical clinic to provide care for 35 common health concerns like urinary tract infection, pink eye, and acid reflux. Launched as a message-based virtual consultation service, Amazon Clinic connects consumers with licensed clinicians who can diagnose, treat and prescribe medication for a range of common health and lifestyle conditions.
    • “The service was available in 34 states and has now been expanded nationwide and to Washington, D.C., along with the addition of video visits with providers on Amazon.com and the mobile app, the company announced in a blog post on Tuesday.
    • “Amazon Clinic is currently cash pay and does not yet accept insurance, the company said.” 
  • Beckers Payer Issues points out
    • “The first wave of UnitedHealthcare’s previously announced 20 percent reduction in prior authorization requirements takes effect Sept 1. 
    • “The remainder of the reductions will occur Nov. 1, according to an Aug. 1 post on UnitedHealthcare’s website. 
    • “The prior authorization code eliminations will take place on Sept. 1 and Nov. 1 for Medicare Advantage, commercial, Oxford, and individual exchange plans. Eliminations for community plans will take place Nov. 1. “
  • and
    • “UnitedHealthcare controls almost one-quarter of the Medicare Part D plan market, according to an analysis from KFF.
    • “The analysis, published July 26, compared market share in 2023 for major payers offering both Medicare Advantage plans and stand-alone Part D plans.
    • “Most payers analyzed, aside from Kaiser Permanente, offer both standalone plans and Medicare Advantage policies, according to KFF. CVS Health, Centene and Cigna have greater enrollment in standalone Part D plans than Medicare Advantage options, while UnitedHealthcare and Humana have more Medicare Advantage members.”
  • Benefits Pro reassures us
    • “When the Affordable Care Act was passed in 2010, it was assumed that many employers would drop workplace health insurance in response. However, a new study by the Employee Benefit Research Institute found that starting in 2015, both the percentage of employers offering health insurance and the percentage of workers eligible for such coverage began to increase.
    • “It should then come as no surprise that the percentage of workers and their families being covered by employment-based health insurance has been relatively steady over the long term,” the report said.”