Happy Labor Day!

OPM

Happy Labor Day!

David Ermer–Congress, COVID-19 testing, Federal employment benefits, Mental health care, OPM, U.S. Healthcare–

Way back in the day, OPM routinely would announce the next year’s FEHB premiums around Labor Day. The announcement was known as OPM’s Labor Day press release. Currently, the announcement is made in the last week of September.

Tammy Flanagan writes in Govexec about federal employee benefit issues confronting couples who both work for Uncle Sam, specifically

  • “Should we carry two self only plans under the Federal Employees Health Benefits program or one self plus one plan if we don’t need to cover children?
  • “Do we need to provide survivor annuities for each other?”

Check it out.

The Senate returns from its August State work break tomorrow for a shortened week of Committee business and floor voting. The House of Representatives returns to the Nation’s Capital next Tuesday.

From the public health front,

  • The Washington Post reports
    • “The Centers for Disease Control and Prevention on Friday [September 1] issued a national alert warning health-care professionals to watch out for infections of Vibrio vulnificus, a rare flesh-eating bacteria that has killed at least 13 people on the Eastern Seaboard this year.
    • “Although infections from the bacteria have been mostly reported in the Gulf Coast, infections in the eastern United States rose eightfold from 1988 to 2018, the CDC said. In the same period, the northern geographic range of infections has increased by 30 miles every year. This year’s infections came during a period of above-average coastal sea surface temperatures, the agency said.
    • “Up to 200 people in the United States every year report Vibrio vulnificus infections to the CDC. A fifth of the cases are fatal, sometimes within one or two days of the onset of illness, according to the agency.”
  • The Wall Street Journal tells us
    • “A two-decade decline in [prostate cancer] death rates has stalled. Some doctors worry deaths could rise in coming years.
    • “We’re finding them with disease not contained in the prostate but also in the bones, in the lymph nodes,” said Dr. James Porter, a urological surgeon in Seattle. “That’s a recent phenomenon.” 
    • “The pendulum swing hits at a fundamental problem in screening for all cancers: Testing too many people leads to more invasive procedures some patients don’t need. Testing too few misses opportunities to catch cases while there is a better chance treatment will work.
    • “Groups including the American Cancer Society are reviewing their own guidance for prostate-cancer screening. Many doctors want to better target the test, limiting screening for some men while encouraging high-risk groups including Black men or those with a strong family history to get testing earlier. 
    • “PSA recommendations have been ping-ponging back and forth, and what’s been lost in that is the high-risk people,” said Dr. Heather Cheng, director of the Prostate Cancer Genetics Clinic at Fred Hutchinson Cancer Center in Seattle. She is helping to review the American Cancer Society’s prostate-cancer screening guidelines. 
    • “Cheng and other doctors working to better calibrate screening said the risks of overdiagnosis have declined. More doctors now monitor low-risk tumors for growth before rushing a man into surgery or radiation. Better imaging tools have reduced biopsies.”
  • In other words, the problem is not necessarily the screening test; rather the problem may be the reaction of the medical community to screening results.  
  • NPR Shots informs us,
    • “The idea of food as medicine dates back to the ancient Greek doctor Hippocrates, and a new study adds to the evidence that a diet full of fruits and vegetables can help improve heart health. The research comes amid an epidemic of  diet-related disease, which competes with smoking as a leading cause of death.
    • “Researchers evaluated the impact of “produce prescriptions,” which provide free fruits and vegetables to people with diet related diseases including diabetes, obesity and hypertension. The study included nearly 4,000 people in 12 states who struggle to afford healthy food. They received vouchers, averaging $63 a month, for up to 10 months, which could be redeemed for produce at retail stores or farmers markets, depending on the location. 
    • “Health care providers tracked changes in weight, blood pressure and blood sugar among the participants. “We were excited to see improvements,” says study author Kurt Hager, an instructor at UMass Chan Medical School.
    • “Among adults with hypertension, we saw that systolic blood pressure decreased by 8 mm Hg and diastolic blood pressure decreased by about 5 mm Hg, which could have a meaningful impact on health outcomes,” Hager says.
    • “Among people with uncontrolled diabetes, their A1C levels, which is a 2-3 month average of their blood sugar, also declined significantly, by about .6 percent. “The reductions we saw in blood sugar were roughly half of that of commonly prescribed medications, which is really encouraging for just a simple change in diet,” Hager says.” 
  • Fortune Well explains how to deal with the uncertainty that serves as the root of anxiety.
    • “Uncertainty is life’s promise to us all. For more than twenty years, I have watched people rise from unspeakable pain to venture again into a future that withholds all certainty. I work with people who have endured shocking traumas and, predictably, our early conversations are filled with interrogative pleas for a certain safety: “How can I be absolutely sure nothing like this will ever happen again?” they ask me.
    • “The answer is: they cannot.
    • “After many years, the thing that still takes my breath away is the grace and courage of people who accept this truth and say: I rise again not because I know for sure, but because I hope anyway.”
  • The New York Times offers a reminder about how to use at home COVID tests effectively. Bear in mind that Paxlovid should be taken within five day after showing Covid symptoms.

Thursday Miscellany

David Ermer–CMS, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC,

  • The Washington Post reports
    • “The White House on Thursday urged Congress to adopt a short-term measure to fund the federal government, a move meant to buy time for lawmakers to craft a broader spending deal and avert a shutdown at the end of September.
    • “The Biden administration coupled its call to action with a new request that Congress address funding for a series of cash-starved programs — including, for example, an additional $1.4 billion to prevent a potential disruption in nutritional aid for low-income families.”
  • HHS Secretary Xavier Berrara reflected on the Administration’s efforts to end the opioid public health emergency on this International Overdose Awareness Day.
  • In related news, the New York Times informs us
    • “Narcan, the first opioid overdose reversal medication approved for over-the-counter purchase, is being shipped to drugstore and grocery chains nationwide, its manufacturer said Wednesday. Big-box outlets like Walgreens, CVS, Walmart and Rite Aid said they expected Narcan to be available online and on many store shelves early next week.
    • “Public health experts have long called for greater accessibility to the drug, which they describe as a critical weapon against rising overdose rates. There were more than 100,000 opioid overdose fatalities in each of the last two years in the United States.
    • “Narcan is already a staple for emergency personnel and street outreach teams. Now scientists and health officials are hoping Narcan will eventually become commonplace in public libraries, subways, dorms, corner delis and street vending machines.
    • “They also predict it may become a fixture in medicine cabinets, as more people realize that illicit party drugs like cocaine and counterfeit Xanax pills may be tainted with deadly fentanyl, an opioid.”
  • Govexec relates
    • “President Biden on Thursday formalized his plan to provide civilian federal employees with an average 5.2% pay increase, their largest in four decades, in a letter to congressional leaders.
    • “In March, Biden first announced his pay raise plan as part of his fiscal 2024 budget proposal, recommending the largest pay increase for civilian federal workers since the Carter administration. Thursday’s announcement confirms that, if implemented, federal employees will see an across-the-board increase in basic pay of 4.7% and an average 0.5% boost to locality pay.
    • “In his letter, Biden said the pay raise is critical to his administration’s goal of ensuring that the federal government is a model employer and able to attract qualified candidates to join the workforce.”
  • The U.S. Office of Personnel Management announced issuing
    • the final regulations to implement the Fair Chance to Compete for Jobs Act of 2019 (Fair Chance Act), which prohibits federal agencies and federal contractors from requesting an applicant’s criminal history information before the agency makes a conditional offer of employment to the applicant. The final regulations also provide applicants with a complaint process and hold accountable federal employees who are in violation of the Fair Chance Act. 
    • “If you have the qualifications, skills, and willingness to serve the American public, you deserve a fair chance to compete for employment within the federal government,” said Kiran Ahuja, OPM Director. “America is a nation of second chances, and every person deserves to be treated with dignity and respect.” 

From the Medicare front,

  • MedPage Today reports on CMS efforts to recruit specialty practices in Medicare value-based purchasing programs.
  • Milliman issued a white paper titled “Part D redesign under the Inflation Reduction Act / Potential financial ramifications for Part D plans and pharmaceutical manufacturers.” Check it out.
  • CMS recently announced
    • “a new voluntary nationwide model – the Guiding an Improved Dementia Experience (GUIDE) Model – a model test that aims to support people living with dementia and their unpaid caregivers. CMS is accepting letters of interest for the GUIDE Model through September 15, 2023, and will release a GUIDE Request for Applications (RFA) for the model in Fall 2023. The model will launch on July 1, 2024, and run for eight years. * * *
    • “Participants in the GUIDE Model will establish dementia care programs (DCPs) that provide ongoing, longitudinal care and support to people living with dementia through an interdisciplinary team. GUIDE participants will be Medicare Part B enrolled providers/suppliers, excluding durable medical equipment (DME) and laboratory suppliers, who are eligible to bill for Medicare Physician Fee Schedule services and agree to meet the care delivery requirements of the model.”

From the public health and medical research fronts

  • We have four articles from STAT News
    • Miscarriage treatment news. “A [Woodbury,] Minnesota clinic tries to rewrite medicine’s approach to miscarriage.” Bravo.
    • CAR-T Therapy News — “Saar Gill and Carl June, cell therapy researchers at the University of Pennsylvania, wanted to make a single treatment that could tackle virtually all blood cancers. It was an audacious goal. * * *
    • “On Thursday, though, Gill, June and a graduate student, Nils Wellhausen, published a solution in Science Translational Medicine. It’s a complicated dance involving a new form of genome editing and multiple cellular infusions, and still years away from clinical trials. But outside experts say that if academics or companies can figure out manufacturing and logistics, it could open new avenues to tackling cancers that have so far remained out of reach.
    • “It’s very clever and really a tour de force,” said Marcela Maus, director of the cellular immunotherapy program at Mass General Hospital.”
    • Depression treatment news — “A single dose of psilocybin may have enduring benefits for people with major depressive disorder, according to a randomized clinical trial published Thursday in the Journal of the American Medical Association.”
    • AD Treatment News — Drug firms are studying whether drugs like Leqembi can halt Alzheimer’s Disease before symptoms appears.
  • From the U.S. healthcare business front,
    • Per Fierce Healthcare,
      • “GoodRx has launched a new feature to allow healthcare professionals to see the cost of a patient’s prescription with their insurance.
      • “The real-time benefit check (RTBC) feature was developed in collaboration with AssistRx, a specialty therapy initiation and patient solutions provider. The RTBC surfaces a patient’s coverage and benefits at the point of care with the goal of increasing price transparency and access to drugs. It also includes whether a prior authorization is required.
      • “AssistRx built its advanced access and patient support solutions to be interoperable, Edward Hensley, the company’s co-founder and chief commercial officer, said in a press release.”

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, FDA, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • Roll Call reports,
    • “House Republicans are planning to take up a short-term stopgap funding measure next month to avoid a partial government shutdown, Speaker Kevin McCarthy, R-Calif., told members of his conference during a Monday night call, sources familiar with the conversation said. 
    • “The continuing resolution is expected to extend current funding until early December, giving lawmakers a few extra months past the Sept. 30 deadline to complete fiscal 2024 appropriations. McCarthy said Monday that he did not want to have a continuing resolution run up to the Christmas recess, sources said. 
    • “The speaker’s announcement, which came as little surprise, served as an acknowledgment that the clock had run out for completing appropriations on time for the fiscal year that begins Oct. 1.”
  • Govexec says,
    • “Although President Biden and congressional appropriators appear to be in accord on the White House’s plan to grant federal employees their largest annual raise in more than two decades in 2024, there is still work to be done to make it a reality.
    • “Biden first proposed an average 5.2% pay increase for civilian federal workers and members of the military next year when he unveiled his fiscal 2024 budget plan. That figure marks the highest annual pay increase federal employees have seen since President Carter authorized a 9.1% raise in 1980.
    • “And although the administration and Senate Democrats have been butting heads with GOP appropriators in the House on a variety of funding issues in recent months, neither the House nor the Senate have included language in their respective spending packages to overrule the pay raise plan.”
  • The article explains the legal steps that the President must take this year to implement his pay raise plan.
  • Federal News Network informs us,
    • “In another effort to try to usher young talent into the federal workforce, the Office of Personnel Management is proposing changes to decade-old parameters for the Pathways Program.
    • “The new proposed regulations from OPM, in part, look to expand eligibility for the recent graduates’ Pathways Program, to include individuals who may not have a college degree, but who have completed different “technical education programs.” By counting experience in the Peace Corps, AmeriCorps, Job Corps and the Registered Apprenticeship Program, OPM said it hopes to make the program overall more inclusive, and help agencies attract a broader, more diverse pool of early-career applicants.”
  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) recently published new changes to further advance health equity and increase participation under the ACO REACH model.
    • “National Association of ACOs President and CEO Clif Gaus said the changes will “satisfy many concerns and stabilize future participation.” * * *
    • “Currently, there are 132 participants under ACO REACH, a value-based care model that began in January and replaced the Direct Contracting Model. The new model pushes providers to form accountable care organizations, or ACOs, for fee-for-service Medicare enrollees, and allows for providers to take on more financial risk. Participants are required to implement a health equity plan identifying disparities in care.”
  • A STAT News explains,
    • “The Inflation Reduction Act passed and signed into law a year ago attempts to deal with high drug prices paid by the U.S. government, allowing Medicare to negotiate the prices of some medicines after they have been on the market for years. (Industry would say it’s not negotiation but price-fixing.) But while the IRA is desperately needed — branded medicines cost 2.4 times more in the U.S. than in other developed countries, according to the RAND Corporation — there are ways in which it makes the situation worse.
    • “Here is the problem. The process of testing new experimental medicines takes a long time, sometimes a decade or more, and it is much longer for some objectives, such as preventing heart attacks, than others, like slightly extending the lives of terminal cancer patients.
    • “If one got to design a drug-pricing system from a blank slate, allowing drug prices to spike and then be cut after a few years would look less than ideal. It would be far better to set a lower price at the outset and not raise it but to allow a company to sell a drug for longer so the manufacturer has an incentive to fully study the benefits and risks of its medicines. * * *
    • “There are alternative models of how the drug pricing system can work. Take vaccines, for instance. They are not made nearly as expensive as, say, cancer drugs. But, in most cases, drug companies can trust that the market for them will be long and stable.
    • “This brings us back to the cancer drug shortage. All of the medicines in shortage are treatments that are generic, made into commodities by Hatch-Waxman. This problem could be changed if, say, hospitals were in a position to pay more to manufacturers who were seen as having a more stable supply.
    • “All of it is a reminder that the health care system in the U.S. is a Rube Goldberg machine created by past decisions that were made as much out of expediency as sober planning. The IRA, in particular, is another one of these decisions, pushed through a partisan Congress after the pharmaceutical lobby spent decades avoiding real change. It’s not surprising that a bill that has to be ushered in along partisan lines is not fully thought out or that many of the details are left to bureaucrats.
    • “At some point, we might want to actually design something sensible. Until then, we’d be better served by being more conscious of the mess we’re in.”

From the public health front —

  • Medscape points out,
    • “The newest version of the COVID-19 vaccine will be available by the end of September, according to the CDC. 
    • “The updated vaccine still needs final sign-offs from the FDA and the CDC.
    • “We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast last week hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
    • “For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6 to 8 months since their last dose. For all other people, it’s OK to wait for the new version.”
  • AHA News adds,
    • “Receiving a COVID-19 mRNA vaccine or booster during pregnancy can benefit pregnant people and their newborn infants, according to findings from a federally funded study published in Vaccine. The study looked at 167 pregnant people who received a primary or booster vaccine, which generated antibodies that crossed to the cord blood and likely conferred some protection in their newborns. Participants who received a booster dose had substantially more antibodies in their own blood and in their cord blood, suggesting that boosting increased their newborns’ immune defenses against COVID-19.
  • STAT News reports
    • “Every year, doctors get better tools to fight cancer. Engineered cancer-killing cells, immunotherapies, targeted drugs, and more are helping clinicians cure more patients. Increasingly, though, oncologists are trying to use less radiation, long one of the main pillars of cancer therapy. In some cases, they are even keeping certain patients with low-risk tumors off radiation entirely.
    • “We are in an era of radiation omission or de-escalation,” said Corey Speers, vice chair of radiation oncology at the University Hospitals Seidman Cancer Center and Case Western Reserve University. “Radiation is perhaps one of the most precise and most effective cancer therapies we have, so it will always play an important role in cancer management, but there are situations now on an individual patient basis where radiation may not be needed.”
  • MedPage Today notes that “Incident dementia was tied to exposure to fine particulate matter, especially air pollution from wildfires and agriculture, an observational study of 28,000 adults over age 50 suggested.”

From the judicial front,

  • A unanimous panel of the U.S. Court of Appeals for the 10th Circuit ruled today that ERISA and Medicare Part D preempt certain provisions of an Oklahoma PBM reform law that purport to apply to contracts between PBMs and ERISA and Part D plans. The opinion is helpful to the FEHB Program because the “relates to” clause in the ERISA state law preemption clause, 29 U.S.C. Sec. 1144, is read. analogously or “in pari materia” with the “relates to” clause in the FEHB Act’s state law preemption clause, 5 U.S.C. Sec. 8902(m)(1). Hopefully, this new precedent will pick up steam for ERISA and FEHB preemption of state laws, which do help control premiums.

From the Rx coverage front,

  • Healthcare Dive relates
    • “Amazon on Tuesday added more than 15 new manufacturer-sponsored coupons for insulin brands and diabetes care products to its online pharmacy.
    • “The additions bring Amazon’s manufacturer coupons that are automatically applied during check-out for eligible customers to 36.
    • “The new coupons include some of the most commonly prescribed products from drugmakers including Novo Nordisk, Eli Lilly and Sanofi, including insulin vials, pens and continuous glucose monitors, according to a blog post on Amazon’s website.
  • BioPharma Dive calls attention to
    • “Radiopharmaceuticals for cancer: Making radiation precise
    • “More than a dozen startups are developing drugs that deliver a dose of radiation directly to tumors. Here’s where they stand, and why their progress is worth watching.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans informs us,
    • “U.S. corporate employers project a median healthcare cost increase of 7% for 2024, according to International Foundation of Employee Benefit Plans survey results. The 7% increase is on pace with cost trends projected last year in a similar survey conducted by the International Foundation.
    • “Plan sponsors shared their thoughts on the primary reasons contributing to a rise in medical plan costs for 2024. The top four responses are:
      • 22%—Utilization due to chronic health conditions (up from last year)
      • 19%—Catastrophic claims (same percentage as last year)
      • 16%—Specialty/costly prescription drugs/cell and gene therapy (new in the top four this year)
      • 14%—Medical provider costs (up from last year).
      • The effects of the pandemic appear to be waning as only 4% of responding employers indicated that the primary reason for cost increases is utilization due to delayed preventive/elective care during the pandemic (down from 12% last year).”
    • These factors will be largely offset by Medicare savings for those FEHB plans that are offering Medicare Part D plans for 2024, in the FEHBlog’s view.
  • Health Payer Intelligence explains,
    • “How Payers Are Reducing Prior Authorizations, Limiting Care Disruptions
    • “To limit patient care disruptions, payers have reduced prior authorization requirements for genetic testing, cataract surgeries, and physical therapy.”
  • and reports
    • “Payers prefer to utilize claims and administration platforms from vendors that are efficient, manage multiple business lines, and can meet their complex needs, according to a KLAS report.
    • “The Payer Claims & Administration Platforms 2023 report includes KLAS Decision Insights data and KLAS performance data, which reflects information about vendors and feedback from healthcare organizations.
    • “Among 28 payer organizations, 14 considered using HealthEdge’s claims and administration solutions. The vendor received an overall performance score of 76.5 on a 100-point scale. Twelve organizations considered using Cognizant, which received a score of 74.7.”
  • Healthcare Dive relates
    • “More than three years after the onset of the COVID-19 pandemic, only 1% of primary care clinicians surveyed by the Larry A. Green Center and the Primary Care Collaborative believe their practice has fully recovered from its impacts, and 61% characterize U.S. primary care as “crumbling.”
    • “Nearly 80% of respondents felt the current workforce is undersized to meet patient needs, and just 19% of clinicians report their practices are fully staffed.
    • “The results are emblematic of a “larger national crisis,” and policymakers must act to reinforce primary care, said Rebecca Etz, co-director of the Larry A. Green Center, in a statement. “ … It is not a matter of if, but when there will be another pandemic … If we don’t act soon, primary care won’t be there when it happens.”

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.

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.”

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Generative AI, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Mount Rushmore

From Washington, DC —

  • STAT News reports
    • “Senators on the Finance Committee on Wednesday nearly unanimously passed a bill to clamp down on drug middlemen but kicked the can down the road on some of the more challenging policies.
    • “The bill would offer some more transparency into the business practices of pharmacy benefit managers, ensure PBMs aren’t skimming off of the money they send to insurers, prohibit them from overcharging insurers, and ensure certain fees in the Medicare program aren’t tied to a drug’s price.”
  • From the Senate Finance Committee, “click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • The House Ways and Means Committee relates,
    • “Congresswoman Nicole Malliotakis, a member of the House Committee on Ways and Means, today announced her legislation, the Protecting Patients from Middlemen Act, passed out of the full committee and will be included in the committee’s Health Care Price Transparency Act of 2023.
    • “Specifically, Malliotakis’ legislation, which was introduced in partnership with Rep. Brad Wenstrup (OH-02), would prohibit prescription drug plans and Pharmacy Benefit Managers (PBMs) in Medicare Part D or Medicare Advantage from charging patients more in drug cost-sharing that the net price of the drug.”
  • AHA News tells us,
    • “The House Ways and Means Committee July 26 voted 25-16 to pass the Health Care Price Transparency Act (H.R. 4822), legislation that would impose additional site-neutral payment cuts and regulatory burdens on off-campus hospital outpatient departments, impose additional Medicare sequester cuts on hospitals, and codify and make changes to hospital price transparency regulations. * * *
    • “In other action today, the committee voted 23-17 to pass the Providers and Payers COMPETE Act (H.R. 3284), AHA-opposed legislation that would impose new regulatory responsibilities on the Department of Health and Human Services regarding consolidation.”
  • Federal News Network informs us,
    • “Federal retirees, and employees looking to retire, have some new resources to help them through the often long and thorny retirement process.
    • “A new series of video tutorials from the Office of Personnel Management lays out, step by step, a couple of key items on the federal retirement to-do list.
    • “With the three new videos, OPM said it hopes to reduce the number of errors from federal retirees when trying to log in to manage their online retirement accounts. And in theory, the videos should also help reduce wait times at retirement services call centers, OPM said, now that more detailed information is readily available to feds who get caught up in some of the early steps of the process.”
  • Forbes reports
    • “The FDA has approved Octapharma’s drug Balfaxar, which is used by patients who require surgery but have seen a reduction in blood clotting factors due to being treated with the blood thinner warfarin.” 

From the public health front —

  • Employee Benefits News offers expert views on the current state of Covid.
  • The National Institutes of Health announced
    • “Researchers have found that people with obstructive sleep apnea have an increased cardiovascular risk due to reduced blood oxygen levels, largely explained by interrupted breathing. Obstructive sleep apnea has long been associated with an increased risk of cardiovascular issues, including heart attack, stroke, and death, but the findings from this study, partially supported by the National Institutes of Health and published in the American Journal of Respiratory and Critical Care Medicine, show the mechanism mostly responsible for the link.
    • “These findings will help better characterize high-risk versions of obstructive sleep apnea,” said Ali Azarbarzin, Ph.D., a study author and director of the Sleep Apnea Health Outcomes Research Group at Brigham and Women’s Hospital and Harvard Medical School, Boston. “We think that including a higher-risk version of obstructive sleep apnea in a randomized clinical trial would hopefully show that treating sleep apnea could help prevent future cardiovascular outcomes.”
  • Medscape considers where exercise boosts cognition.
  • Fierce Healthcare lets us know,
    • “One in three counties in the U.S. is considered a maternal healthcare desert.
    • “Since that statistic was dropped back in October 2022 by March of Dimes, care in corners of the country has only continued to dry up. In response to the crisis, providers are using every seed in their seed bag and looking to “multimodal” technology strategies to predict health emergencies before they happen.
    • “Those multimodal approaches combine telehealth, remote patient monitoring (RPM) and text messages to identify high-risk patients. High blood pressure monitoring and hypertension screening are currently recommended for pregnant patients by the U.S. Preventive Services Task Force, as heart disease and stroke are two of the leading causes of maternal mortality.
    • “Lucienne Ide, M.D., is the CEO of the digital health company Rimidi. She sees the country teetering on an inflection point.
      • “We’re at this fork in the road of looking at what we could do with technology, identifying high-risk women and getting them into the programs where we’re proactively and earlier identifying something dangerous and doing something about it,” Ide told Fierce Healthcare.
      • “But the alternate narrative is really, really bad, and it’s going to get worse. It’s not like, ‘Here we are today, and we could do better.’ No, here we are today, and it’s going to get worse, but we can actually do better,” she said.

From the U.S. healthcare business front —

  • Per Fierce Healthcare,
    • “As hospitals acquire ambulatory care centers, consumers are more likely to be forced to pay outpatient facility fees for routine care traditionally covered by physician offices at lower costs.
    • “These new costs, appearing seemingly out of nowhere to the average consumer through out-of-pocket spending and premium increases, can add up to hundreds or thousands of dollars in additional expenses for a patient, according to a report from Georgetown University’s Center on Health Insurance Reforms.
    • “Outpatient facility fees cover a hospital’s operational expenses. But when hospitals acquire physician practices, that usually generates another outpatient facility bill, eventually passing on the cost to the patient. Consumers are often unaware that they are now responsible for an extra cost.”
  • Healio reports that the growth of telehealth in cancer care continued after the initial surge during the COVID-19 pandemic.
  • Per Healthcare Dive, the path toward reducing physician burnout is widening.
    • “Amazon has become the latest tech giant to announce a clinical documentation service that allows providers to automatically create medical notes using generative AI.
    • “The Amazon Web Services tool announced Wednesday, called HealthScribe, allows providers to build clinical applications that use speech recognition and generative AI to create transcripts of patient visits, identify key details and create summaries that can be entered into an electronic health record.
    • “HealthScribe is being previewed for two specialties: general medicine and orthopedics. An Amazon spokesperson said AWS could expand to additional specialties based on client feedback. HealthScribe costs users a set amount per second of audio processed each month.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, COVID-19, Electronic health records, FDA, Federal employment benefits, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Department of Labor announced
  • STAT News adds,
    • “The new rule would force insurers to evaluate their own networks to measure not just whether they’re offering adequate mental health and addiction coverage but also whether patients are truly accessing it.
    • “This rule will ensure that we have true parity,” Neera Tanden, President Biden’s domestic policy advisor, said during a press call. “It will help ensure we finally fulfill the promise of mental health parity required under the law, to ensure that mental health is covered just like physical health.”
  • The public comment deadline will occur in late September.
  • The FEHBlog notes that health plans cannot coerce providers into their networks. The FEHBlog thought that hub and spoke tele-mental health networks would fill the gap, but that apparently hasn’t happened.
  • AHIP announced
    • “AHIP, the American Medical Association (AMA), and the National Association of ACOs (NAACOS) today announced the release of data-sharing best practices that organizations may voluntarily adopt to support a sustainable future for value-based care. The playbook, The Future of Sustainable Value-Based Care and Payment: Voluntary Best Practices to Advance Data Sharing, is intended to advance the adoption of value-based care arrangements in the private sector that could have a greater impact on the quality and equity of care and ease participation by fostering voluntary alignment of data sharing practices.”
    • Check it out.
  • The National Coordinator for Health Information Technology released on July 20, 2023,
    • “ONC Standards Bulletin 2023-2 (SB23-2) [which] describes the background of United States Core Data for Interoperability (USCDI) and the development of the USCDI Version 4 (USCDI v4) * * *. USCDI is a standard developed and adopted by ONC on behalf of the U.S. Department of Health and Human Services (HHS) that sets the technical and policy foundation for the access, exchange, and use of electronic health information to support nationwide, interoperable health information exchange. USCDI benefits a wide range of entities, individuals, and other interested parties, including federal agencies supporting health and healthcare, hospitals, research organizations, clinicians, and health IT developers. ONC publishes new versions of USCDI annually, with a draft version in January and a final version in July. This publishing cadence keeps pace with medical, technological, and policy changes. USCDI v4 includes new data elements that advance the Biden-Harris Administration’s priorities of advancing equity, diversity, and access across all healthcare settings.
    • “SB23-2 describes the ONC approach for the continued expansion of USCDI, as well as the specific priorities for adding new data elements to USCDI v4. This bulletin also includes discussion of the feedback received on the Draft USCDI v4, including recommendations received from the ONC Health IT Advisory Committee (HITAC).”
  • The U.S. Preventive Services Task Force gave a draft inconclusive grade for “screening for speech and language delay and disorders in children age 5 years or younger.” The USPSTF previously gave the same grade to the screening service in 2015. The public comment deadline is August 21, 2023.
  • FedSmith notes that the OPM final rule expanding FEDVIP eligibility will add “over 70,000 federal employees and 118,000 Postal employees” to the pool of employees eligible for FEDVIP.

From the public health front —

  • U.S. News reports
    • “Both coronavirus emergency department visits and test positivity increased, according to CDC data. The agency no longer tracks COVID-19 cases. Instead, it focuses on hospitalizations and deaths, which don’t yet show an increase.
    • “The CDC reported last week that it was the first time since January that COVID-19 metrics showed an increase. The uptick is small, but it’s a notable reversal after months of declining coronavirus numbers.
    • “Certain COVID-19 indicators continued their recent rise last week, according to data from the Centers for Disease Control and Prevention.”
  • HHS’s Agency for Healthcare Research and Quality issued a roundtable report about “Optimizing Health and Function as We Age.”
  • Yahoo News tells us,
    • “Drugmaker Pfizer Inc said over 30 drugs, including injections of painkiller fentanyl and anesthetic lidocaine, may see supply disruption after a tornado destroyed a warehouse at its Rocky Mount, North Carolina, plant last week.
    • “The company sent a letter late last week to its hospital customers saying it had identified around 64 different formulations or dosages of those more than 30 drugs produced at the plant that may experience continued or new supply disruptions.
    • “The company has placed limits on how much supply of those drugs its customers can buy.”
  • Medscape shares CDC guidance about the two new RSV vaccines for adult that the FDA and CDC recently approved.
    • “Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinician, say authors of a Centers for Disease Control and Prevention report published Friday.
    • “Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.“

From the U.S. healthcare business front,

  • BioPharma Dive informs us,
    • “Biogen on Tuesday said it will eliminate 1,000 jobs as part of a cost-cutting drive that it expects will save $1 billion in annual operating expenses by 2025.
    • “The company plans to invest $300 million of those savings into product launches as well as research and development, which it has spent the first half of this year reorganizing under new CEO Chris Viehbacher.
    • “There’s been a complete redesign of Biogen,” Viehbacher said on a conference call with analysts. “This is an opportunity to make sure that in this year, before we get into [new] product launches, that we are truly fit for growth.”
  • STAT News lets us know that “As Alzheimer’s drugs hit the market, the race for early detection blood tests heats up” and offers an interview with the American Medical Association’s new president Dr. Jesse Ehrenfeld.
  • Fierce Health relates,
    • “Teladoc’s second-quarter revenue jumped 10% to $652 million, boosted by strong growth in its BetterHelp direct-to-consumer mental health segment.
    • “The telehealth giant also narrowed its losses this past quarter to a net loss of $65 million, or a loss of 40 cents per share, compared to a loss of $3 billion for the second quarter of 2022. Both results beat Wall Street estimates.
    • “The Zacks Consensus Estimate for Teladoc’s second-quarter earnings per share was pegged at a loss of 44 cents and revenue of $649 million.”

In low-value care news, the National Institutes of Health tells us, “A device known as a pessary, thought promising for reducing preterm birth risk due to a short cervix, appears no more effective than usual medical care, according to a study funded by the National Institutes of Health. A pessary is a rounded silicone device that fits around a cervix that has shortened, to keep it from opening and leading to miscarriage or preterm birth. The device is typically removed before the 37th week of pregnancy.”

Monday Roundup

David Ermer–FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • OPM has finalized a rule
    • “to expand eligibility for enrollment in the Federal Employees Dental and Vision Insurance Program (FEDVIP) to additional categories of Federal employees and certain Postal employees. This rule also updates the provisions on enrollment for active duty service members who become eligible for FEDVIP as uniformed service retirees pursuant to the National Defense Authorization Act of 2017 (fiscal year 2017 (FY17) NDAA). In addition, this rule adds exceptions to decrease an enrollment type and to cancel an enrollment for certain enrollees who may become eligible for dental and/or vision services from the Department of Veterans Affairs (VA).” 
  • Per Medscape, the Food and Drug Administration
    • “today approved quizartinib (Vanflyta) for adults with acute myeloid leukemia (AML) that carries the FLT3-ITD genetic mutation.
    • “The FDA also approved the LeukoStrat CDx FLT3 Mutation Assay to determine whether patients have this mutation.
    • “The agency granted quizartinib a first-line indication for use in combination with standard chemotherapy — cytarabine and anthracycline induction followed by cytarabine consolidation — and as maintenance monotherapy afterward, in adults whose tumors express FLT3-ITD.” * * *
    • “In a company press release, the drug’s manufacturer Daiichi Sankyo said quizartinib will be available in the US soon.”
  • Per Fierce Healthcare, the Federal Trade Commission expanded its war on prescription benefit managers by withdrawing earlier guidance that protected PBMs.

Speaking of war, STAT News reports

  • “A new lawsuit accuses Cigna of using an algorithm to automatically deny claims in bulk instead of individually reviewing each case, putting patients on the hook for bills the health insurer otherwise would have paid.
  • “The complaint filed Monday in the Eastern District of California says Cigna uses a system called PXDX to identify discrepancies between diagnoses and the tests and services it covers for those ailments. The company then allegedly denies claims in bulk without looking into each coverage request. California law requires insurers to give each claim a “thorough, fair, and objective investigation.”

For the past twenty years, health claims have been submitted and processed electronically. This is nothing new. The article adds that Cigna plans to mount a defense. The FEHBlog trusts that the court will see the light.

From the public health front,

  • MedPage Today tells us
    • “The prevalence of hepatitis C virus (HCV) infections in pregnant women increased 16-fold over a 21-year period, with associated higher risks of adverse perinatal outcomes, according to a cross-sectional study.
    • “Among more than 70 million hospital admissions for childbirth or spontaneous abortion in the U.S. from 1998 through 2018, the prevalence of HCV-positive pregnancies increased from 0.34 (95% CI 0.26-0.41) cases per 1,000 pregnancies to 5.3 (95% CI 4.9-5.7) cases per 1,000 pregnancies, reported Po-Hung (Victor) Chen, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, and colleagues in JAMA Network Open. * * *
    • “Overall, our data support the recommendations for universal HCV screening with each pregnancy proposed by the Centers for Disease Control and Prevention and American College of Obstetricians and Gynecologists,” Chen and team wrote. “Perinatal care and delivery may be the initial healthcare exposure for many women. These touchpoints represent an opportunity for health care professionals to identify HCV infection and link women and their children to appropriate specialist care.”

In medical and drug research news

  • The National Institutes of Health announced,
    • “Statins, a class of cholesterol-lowering medications, may offset the high risk of cardiovascular disease in people living with HIV by more than a third, potentially preventing one in five major cardiovascular events or premature deaths in this population. People living with HIV can have a 50-100% increased risk for cardiovascular disease. The findings are published in the New England Journal of Medicine.
    • “This research suggests that statins may provide an accessible, cost-effective measure to improve the cardiovascular health and quality of life for people living with HIV,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), a study funder. “Additional research can further expand on this effect while providing a roadmap to rapidly translate research findings into clinical practice.”
  • BioPharma Dive reports
    • “Roche will partner with Alnylam Pharmaceuticals to study a promising new treatment for high blood pressure, becoming the latest large drugmaker to commit in a big way to the often lengthy and expensive process of developing new medicines for the heart. 
    • “Through a deal announced Monday, Roche will pay Alnylam more than $300 million upfront to share rights to the experimental treatment, called zilebesiran. The Swiss pharmaceutical company will also fund the majority of the costs for a large clinical trial to test whether zilebesiran can lower the risk of dangerous cardiovascular events like heart attacks and strokes. 
    • “With this collaboration, we now can develop zilebesiran in a more robust way, allowing us to have cardiovascular outcomes data in hand at launch to ensure results relevant not only for health authorities but also for access and clinical practice in order to ultimately reach as many patients as possible,” Alnylam CEO Yvonne Greenstreet said in a statement.” 
  • BioPharma Dive adds
    • “Gilead Sciences has stopped a closely watched trial involving an experimental cancer drug the company acquired three years ago in a roughly $5 billion deal, marking the latest setback in the company’s plans to grow its oncology business.
    • “According to Gilead, a Phase 3 study testing its drug magrolimab in patients with the bone marrow cancer myelodysplastic syndrome, or MDS, was discontinued because treatment proved ineffective at an interim analysis. Safety findings were “consistent” with the drug’s profile and what’s typically observed with MDS patients, the company said late Friday. It didn’t provide details.
    • “Gilead acquired magrolimab through a buyout of biotechnology company Forty Seven. The drug is still being evaluated in two other pivotal trials in acute myeloid leukemia, with results expected next year. However, after Friday’s announcement, Wall Street analysts appear to be viewing those trials with more skepticism.”

From the U.S. healthcare business front —

  • MedCity News points out that “When asked what the key issues influencing benefits strategy are, 80% of employers said competition for talent, 67% said rising costs, 41% said a focus on inclusion and diversity and 39% said increasing mental health problems, according to a recent Willis Towers Watson survey.”
  • Fierce Healthcare relates
    • “While payers are facing headwinds going into the latter part of this year, the ongoing financial impacts of healthcare’s labor shortage will be felt in the hospital sector far longer, according to a new report from analysts at Moody’s Investors Service.
    • “The “acute” impacts of labor issues have tapered off, according to the report, but “the budgetary aftershocks will reverberate for years to come.” The analysts expect that the labor issues will pull down hospitals’ operating results through 2024, if not longer.
    • “For example, though conditions have improved, the industry’s nursing shortage is expected to extend through 2030, according to projections from the Bureau of Labor Statistics. This will force hospitals and other providers to develop and roll out new strategies that blunt the impacts, the Moody’s analysts said.
    • “Hospitals are benefiting from some expense relief as staffing has become easier and the need to use pricey contract labor has decreased,” the analysts wrote in the report. “But it will take time for improved margins to follow, and labor issues will remain an underlying sector challenge.”

Friday Factoids

David Ermer–Generative AI, HIPAA Privacy and Security Rules, HSA, OPM, Patient safety, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us, “The Office of Personnel Management on Friday proposed new regulations aimed at granting federal agencies greater flexibility in selecting new federal employees during the hiring process.” The public comment deadline is September 19, 2023.
  • Federal News Network offers a table of federal government return-to-office policies.
  • The Society for Human Resource Management informs us,
    • “The U.S. Citizenship and Immigration Services (USCIS) announced Friday a new Form I-9—which has been streamlined and shortened—that employers should use beginning Aug. 1, 2023.
    • “Employers may continue to use the older Form I-9 (Rev. 10/21/19)  through Oct. 31., 2023. After that date, they will be subject to penalties if they use the older form. The new version will not be available for downloading until Aug. 1.  
    • “Additionally, the U.S. Department of Homeland Security (DHS) issued a final rule that allows the agency to create a framework under which employers could implement alternative document examination procedures, such as remote document examination. The new form subsequently has a checkbox to indicate when an employee’s Form I-9 documentation was examined using a DHS-authorized alternative procedure.
    • “At this time, the final rule only allows employers using E-Verify to use alternative verification methods.”
  • Healthcare Dive notes
    • “The Federal Trade Commission and the HHS’ Office for Civil Rights are warning hospitals and telehealth companies about embedding online tracking technologies on their websites or apps, saying the trackers risk exposing consumers’ personal health data to third parties. 
    • “The trackers, like the Meta Pixel or Google Analytics, collect identifiable information about users and could reveal information about health conditions, diagnoses, treatments, frequency of visits and more, the agencies wrote in a letter to about 130 health systems and telehealth providers.
    • “The warning marks the latest move from regulators regarding the healthcare industry’s use of tracking technologies, which monitor user behavior on websites. Sharing consumers’ health data with third parties, like advertisers, has been a recent target of FTC oversight.”

Following up on the tornado that struck a Pfizer factory in Rocky Mount, NC, STAT News reports

  • “Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does not appear to have caused “any major damage” to areas that produce medicines.
  • “The company reported most damage from the storm occurred at a warehouse that stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance personnel. As a result, it remains unclear about the extent to which destruction at the facility — which produces nearly 8% of all sterile injectables used in U.S. hospitals — will exacerbate a growing shortage of prescription drugs across the country.”

The Food and Drug Administration also issued a report on the incident.

From the medical malpractice front, STAT News points out

  • “A new study published this week in BMJ, * * * estimates that “371,000 people die every year following a misdiagnosis, and 424,000 are permanently disabled — a total of 800,000 people suffering “serious harm,” said David Newman-Toker, the lead author of the paper and a professor of neurology at Johns Hopkins School of Medicine and director of its Center for Diagnostic Excellence. Settling on an exact number is hard because many cases of misdiagnosis go undetected, he said. It could be fewer than his study identified or more — between half a million and a million — though in any event, it would be the most common cause of death or disability due to medical malpractice. 
  • “He likens the issue of misdiagnosis to an iceberg, saying cases leading to death and disability are but a small fraction of the problem. “We focused here on the serious harms, but the number of diagnostic errors that happen out there in the U.S. each year is probably somewhere on the order of magnitude of 50 to 100 million,” he said. “If you actually look, you see it’s happening all the time.” 
  • “But misdiagnoses typically don’t lead to severe consequences because, most times, people aren’t visiting the doctor with a serious condition. “The risk level just walking through the door in the doctor’s office that something horrible is going to happen to you because of a diagnostic error is actually quite low,” said Newman-Toker.”

In related news “[The American Hospital Association] AHA today released its quarterly Health Care Plan Accountability Update, featuring the latest news on AHA efforts to hold commercial health insurers accountable for policies that can delay care for patients, burden health care providers and add unnecessary costs to the health care system. READ MORE.”

From the factoid front —

  • HealthEquity suggests three ways to drive health savings account plan adoption.
  • Beckers Payer Issues points out how seven payers are using artificial intelligence.
  • MedTech Dive reports, “Intuitive Surgical posted strong robotic volume growth in the second quarter and raised its full-year procedure outlook but said patient interest in new weight-loss drugs is curbing demand for bariatric surgeries.”