Tuesday Tidbits

Rx coverage

Tuesday Tidbits

David Ermer–ACA, Generative AI, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front,

  • Health Affairs reports
    • “National health expenditures are projected to grow 5.4 percent, on average, over the course of 2022–31 and to account for roughly 20 percent of the economy by the end of that period. The insured share of the population is anticipated to exceed 92 percent through 2023, in part as a result of record-high Medicaid enrollment, and then decline toward 90 percent as coverage requirements related to the COVID-19 public health emergency expire. The prescription drug provisions of the Inflation Reduction Act of 2022 are anticipated to lower out-of-pocket spending for Medicare Part D enrollees beginning in 2024 and to result in savings to Medicare beginning in 2031.”
  • The U.S. Preventive Health Services Task Force gave an inconclusive grade to screening for lipid disorders in children and adolescents 20 years or younger.
  • The Wall Street Journal offers ways to protect yourself and your family against the ill effects of forever chemicals that may be in your tap water or else in your homes.

From the regulatory front,

  • The Food and Drug Administration “published a safety communication to warn consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, and Well-Being Reality. The devices have not been reviewed by the FDA. The safety and effectiveness of these devices have not been established to diagnose, treat, or cure medical conditions.”
  • HMFA informs us
    • “Hospital price transparency regulations are undergoing changes heading into their fourth year as CMS seeks to step up enforcement while making compliance more straightforward.
    • “As part of the 2024 proposed rule for hospital outpatient payments, CMS is adding to the requirement for hospitals to maintain a machine-readable file of their charges for services. In addition, enforcement actions against hospitals would be publicized even before assessment of civil monetary penalties.
    • “CMS said the impetus for the proposed technical requirements is feedback from “interested parties” that the files would be more beneficial if they were more standardized.
    • “In particular, IT specialists have indicated that the current flexibilities and lack of encoding specifications hinder the machine-readability of the data in the files, presenting a barrier to the intended use of the data,” CMS wrote. “Additionally, hospitals have asked us for more specificity on how they should publicly display their standard charge information, with an emphasis on how they should explain and display their payer-specific negotiated charges.”
    • “The agency also said enforcement would be easier if the files were more consistent.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “In the past 10 years, there has been a dramatic shift in physician practice ownership as less than half of doctors now work in private practices, according to a new analysis.
    • “Between 2012 and 2022, the share of physicians working in private practices fell by 13 percentage points from 60.1% to 46.7%.
    • “In contrast, the share of physicians working in hospitals as direct employees or contractors increased from 5.6% to 9.6% in the same 10-year time period, and the share of physicians working in practices at least partially owned by a hospital or health system increased from 23.4% to 31.3%, according to a benchmark analysis the American Medical Association. * * *
    • “In 2022, 4.5% of physicians worked in a practice owned by a private equity group, similar to the percentage in 2020 when the AMA first added private equity to the analysis.
    • “According to the analysis, there also has been a redistribution of physicians from small to large practices. The share of physicians in small practices (10 or fewer physicians) shrank from 61.4 % to 51.8% between 2012 and 2022. Conversely, the share of physicians in large practices (50 physicians or more) grew from 12.2% to 18.3% in the same 10-year time period.
    • “The shares of physicians in mid-sized practices (those with 11 to 24 and 25 to 49 physicians) remained relatively stable over the last decade.”
  • BioPharma Dive informs us,
    • “Biotechnology startup creator Flagship Pioneering is teaming up with Pfizer to develop 10 new drug candidates, with each company pledging to invest $50 million in the new effort.
    • “Together, Flagship and Pfizer will take stock of the technologies available to the former firm and its affiliated startups, hunting for opportunities to develop medicines aligned with Pfizer’s research priorities. Per deal terms announced Tuesday, Pfizer will fund the development of selected medicines, each of which it can choose to acquire later.
    • “The collaboration involves Flagship’s “Pioneering Medicines” initiative, which has struck similarly structured deals in the recent past with Novo Nordisk and the Cystic Fibrosis Foundation.”
  • Healthcare Dive relates,
    • “Teladoc Health is expanding its partnership with Microsoft, announcing plans to add artificial intelligence tools for clinical documentation to its telehealth platform for hospitals and health systems.
    • “The companies will work to integrate Microsoft Azure’s OpenAI Service and Cognitive Services and Microsoft-owned Nuance’s Dragon Ambient eXperience into its Solo platform, allowing physicians to automatically transcribe clinical notes during virtual patient exams.
    • “Teladoc’s medical group also plans to use DAX Express, a version of the medical scribe that uses the large language model GPT-4 and doesn’t require human authentication, the New York-based telehealth vendor said. Financial terms of the deal were not disclosed.”

From the Rx coverage front, the Drug Channel blog delves into the biosimilars’ challenge to Humira. The article illustrates the relatively new distinction between low-list drug prices and high-list drug prices. Low list prices do not include a manufacturer rebate. The FEHBlog understands that the distinction is driven by the Inflation Reduction Act.

Monday Roundup

David Ermer–ACA, COVID-19, FDA, Generative AI, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front —

  • The Wall Street Journal reports
    • “Parents have a new tool to protect their newborns from a common but potentially deadly respiratory virus that sends tens of thousands of babies to the hospital each year.
    • “The Food and Drug Administration on Monday approved the first drug to protect all infants against respiratory syncytial virus. RSV is the leading cause of hospitalization of infants in the U.S., killing as many as 300 children under the age of 5 each year.  
    • “The FDA said it approved the drug Beyfortus from Sanofi and AstraZeneca based on studies that found it safely prevented the lower respiratory tract infections caused by the virus. * * *
    • “While Beyfortus isn’t a vaccine, it has a similar objective. The injection gives infants antibodies to neutralize the virus before their immune systems are mature enough to generate them on their own.  * * *
    • “Sanofi plans to make Beyfortus available in time for this year’s RSV season. Before the drug can become widely available, CDC advisers will need to recommend the drug’s use.”  
  • The FEHBlog’s favorite columnist on Covid, the New York Times David Leonhardt, let us know, “The United States has reached a milestone in the long struggle against Covid: The total number of Americans dying each day — from any cause — is no longer historically abnormal.” Consequently, the pandemic era is over.
  • In other Covid news, Medscape tells us,
    • “An air monitor made by researchers at Washington University in St. Louis can detect COVID-19 virus in a room with an infected person within 5 minutes. 
    • “The project was a collaboration among researchers from the university’s engineering and medical schools. Nature Communications published the results of their work in the journal’s Monday edition. * * *
    • “The team tested their device both in laboratory experiments where they released aerosolized SARS-CoV-2 into a room-sized chamber, as well as in the apartments of two people who were COVID-positive.
    • “There is nothing at the moment that tells us how safe a room is,” Washington University neurology professor John Cirrito, Ph.D., in a statement. “If you are in a room with 100 people, you don’t want to find out 5 days later whether you could be sick or not. The idea with this device is that you can know essentially in real-time, or every 5 minutes if there is a live virus in the air.”
    • “Their goal is to develop a commercially available air quality monitor, the researchers said.” 
  • Cigna discusses how to help women to stay on track with screenings for common cancers.
  • KFF explains why different BMI standards apply to older folks. For example,
    • “Epidemiologic research suggests that the ideal body mass index (BMI) might be higher for older adults than younger adults. (BMI is a measure of a person’s weight, in kilograms or pounds, divided by the square of their height, in meters or feet.)
    • “One large, well-regarded study found that older adults at either end of the BMI spectrum — those with low BMIs (under 22) and those with high BMIs (over 33) — were at greater risk of dying earlier than those with BMIs in the middle range (22 to 32.9).
    • “Older adults with the lowest risk of earlier deaths had BMIs of 27 to 27.9. According to World Health Organization standards, this falls in the “overweight” range (25 to 29.9) and above the “healthy weight” BMI range (18.5 to 24.9). Also, many older adults whom the study found to be at the highest mortality risk — those with BMIs under 22 — would be classified as having “healthy weight” by the WHO.
    • “The study’s conclusion: “The WHO healthy weight range may not be suitable for older adults.” Instead, being overweight may be beneficial for older adults, while being notably thin can be problematic, contributing to the potential for frailty.”
  • According to STAT News,
    • “At the turn of the century, nearly 18 million women in the United States were battling hot flashes, night sweats, and other symptoms of menopause with hormones. But in 2002, the therapy went into a free-fall when a landmark trial suggested treating menopause with estrogen and progesterone increased the risk of breast cancer and cardiovascular disease. The study was shut down early — and a year later, prescriptions had plummeted to nearly half what they had been in 2001.
    • “More than two decades later, menopause experts have come to think about the results of the trial very differently. Newer research points to more benefits than risks for many healthy women under 60 treating menopause symptoms with hormone therapy. But many women who are good fits still aren’t getting treatment. “The pendulum has been slowly — too slowly — swinging back,” said OB-GYN Mike Green, chief medical officer of menopause telehealth company Winona. 
    • “Winona is part of a new generation of virtual-first health care companies aiming to give that pendulum a push. In the last five years, more than a dozen telehealth companies have started up to serve women in and approaching menopause, including with hormone therapy. 
    • “Women fall through the cracks,” said internist Lisa Larkin, president-elect of The Menopause Society and founder of concierge women’s health network Ms. Medicine. “That’s why the telemedicine business is booming.” 

From the Alzheimer’s Disease front,

  • Medscape tells us,
    • “Eastern and southeastern areas of the US have the highest rates of Alzheimer’s disease (AD), new research shows.
    • “Investigators at Rush University in Chicago, Illinois, found AD prevalence was highest in Maryland, New York, Mississippi, and Florida. At the county level, Miami-Dade in Florida, Baltimore in Maryland, and the Bronx in New York were among the US counties with the highest prevalence of the disease.
    • “Such geographical variations may be due to the unique make-up of regional populations, study investigator Kumar Rajan, PhD, professor of Medicine and director of Rush Institute for Healthy Aging, Rush University Medical Center, in Chicago, told Medscape Medical News.”
  • STAT News relates,
    • Medicare on Monday proposed ending restrictions on how many PET scans patients can receive to detect amyloid plaques in their brains, which will offer physicians more options as they treat patients with a new drug to slow the progression of dementia.
    • The agency that oversees Medicare had previously restricted coverage to a single scan for patients who participated in clinical studies. Advocates had warned that it could cause issues related to a new class of Alzheimer’s drugs designed to clear those plaques.
  • BioPharma Dive calls our attention to
    • “A closely watched experimental drug for Alzheimer’s disease slowed the decline patients typically experience by about half a year in a key clinical trial, according to new results released Monday.
    • “The drug, called donanemab, is being developed by Eli Lilly and works in a similar way as two other medicines recently approved in the U.S. to treat Alzheimer’s. These therapies are designed to break up clusters of “amyloid beta,” a mutated protein that forms toxic brain plaques and has long been viewed as a root cause of the disease. * * *
    • “Along with its presentation, Lilly disclosed it had completed its approval application to the FDA and expects a verdict by the end of the year. The results were also published in the medical journal JAMA.”
  • Reuters adds,
    • “Alzheimer’s disease experts are revamping the way doctors diagnose patients with the progressive brain disorder – the most common type of dementia – by devising a seven-point rating scale based on cognitive and biological changes in the patient.
    • “The proposed guidelines, unveiled by experts on Sunday in a report issued at an Alzheimer’s Association conference in Amsterdam, embrace a numerical staging system assessing disease progression similar to the one used in cancer diagnoses. They also eliminate the use of terms like mild, moderate and severe.”

From the generative AI front, Fierce Healthcare explains how Blue Cross licensee HCSC is using AI to speed up prior authorization.

From the U.S. healthcare business front,

  • The American Hospital Association informs us,
    • “The Federal Trade Commission July 14 voted 3-0 to withdraw two antitrust policy statements related to enforcement in health care markets, calling the 1996 and 2021 statements outdated. The Department of Justice withdrew the same statements in February.  
    • “AHA is deeply disappointed that the FTC made the same mistake as the DOJ in withdrawing antitrust guidelines for hospitals and other health care providers,” said AHA General Counsel & Secretary Melinda Hatton. “Over the years, AHA has urged both federal antitrust agencies to modernize the guidelines to accommodate the need for more flexibility in enforcement actions to support hospitals’ ability to navigate a changing healthcare landscape. And AHA was instrumental in securing appropriate ACO guidance that allowed hospitals to fully participate in that important program. Withdrawing all the guidance without consultation with the field is both unnecessary and reckless.”
  • According to STAT News,
    • “Sanofi will license a new CRISPR enzyme from the startup Scribe Therapeutics in a bid to be the first to develop a safer, simpler, and more scalable cure for sickle cell disease.
    • “The French drugmaker will pay Scribe $40 million upfront and promise another $1.2 billion in potential milestones to license a DNA-cutting enzyme called CasX for use in a potential single-infusion treatment for the serious blood disorder — what’s known as in vivo therapy. CasX was discovered in CRISPR pioneer Jennifer Doudna’s lab, which subsequently spun out Scribe. * * *
    • “The company will have competition on tackling sickle cell in new ways. In 2021, Novartis started collaborating with the Gates Foundation to develop an in vivo therapy. The base editing company Beam Therapeutics has presented data on an approach that still requires cells to be edited outside the body but is much less toxic. And Sana Biotechnology has a program that hopes to target stem cells with virus-like particles. None of the companies, however, have yet begun clinical trials. 

In employment news,

  • HR Dive reports,
    • “The Occupational Safety and Health Administration published Friday its final electronic recordkeeping rule requiring employers with 100 or more employees in certain industries to submit information from the agency’s Forms 300 and 301 once per year.
    • “OSHA’s rule also updates its system for determining which industries are subject to the information submission requirement. In a departure from the proposed rule, OSHA has retained the requirement for employers with 250 or more employees to electronically submit information from Form 300A once per year. Additionally, employers with 20 to 249 employees in certain designated industries will continue to be required to electronically submit information from Form 300A once per year.
    • “Per the rule, the agency will post data gathered via these submissions on a public website, with identifying information — such as employees’ names and contact information — removed. The final rule is effective Jan. 1, 2024.”

Midweek update

David Ermer–CMS, Congress, COVID-19, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC —

  • Politico reports,
    • “The Senate Finance Committee is releasing the next in its parade of legislation targeted at pharmacy benefit managers — an industry that Democrats and Republicans on Capitol Hill argue drives up the cost of drugs.
    • “Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) — along with Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) — plan to unveil legislation that would require PBMs, which manage prescription drugs for health insurers, to report a broader range of data about their business practices. The lawmakers seek comment on their proposal.
    • “The bill would require PBMs to submit annual reports to the Medicare drug plans that detail information about the treatments the plan covers, the discounts PBMs negotiate with drugmakers on medicines and the fees they collect.
    • “It’s the latest in a plan from Wyden and Crapo, who released a roadmap in April of PBM-focused legislation they want the committee to pursue.”
  • The Senate Finance Committee adds,
    • “Senate Finance Committee Chair Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) today announced that the committee will mark up legislative proposals to modernize and enhance federal prescription drug programs on Wednesday, July 26th at 2 p.m. The committee package will focus on addressing pharmacy benefit manager practices that have grown increasingly complex and opaque in recent years at the expense of patients and taxpayers.”
  • The American Hospital Association further informs us,
    • “The House Education & Workforce Committee July 12 voted 39-0 to pass legislation (H.R. 4509) that would require off-campus hospital outpatient departments to obtain a separate unique health identifier and include it on all claims for services billed to commercial group health plans or their enrollees. The legislation would prohibit the health plan from paying the claim and the hospital from collecting payment from the plan enrollee if the claim excludes the identifier, and impose civil monetary penalties on hospitals that violate the requirement. * * *
    • “In other action, the committee also passed bills that would strengthen price transparency requirements for commercial group health plans (H.R. 4507); require that the plans’ contracts with service providers allow the employer/plan fiduciary to access all de-identified claims and encounter data (H.R. 4527); and require the plans to further report to the employer/fiduciary their financial arrangements with pharmacy benefit managers (H.R. 4508).”

From the public health front —

  • Beckers Clinical Leadership and Infection Control tells us,
    • “After identifying a new COVID-19 omicron subvariant — EU.1.1, a descendant of XBB.1.5 — in late June, its growth has slowed, according to the CDC. 
    • “Right now, the subvariant accounts for only 1.1 percent of cases in the U.S., data shows. Nationwide, hospitalizations and deaths both continue to decline. The CDC’s most recent data shows that hospitalizations decreased by 0.8 percent as of July 1, and deaths decreased by 9.1 percent in the same one-week period.
  • CNN reports
    • Childhood cancer diagnoses in the US have been trending up for more than a decade, according to a study published Tuesday in the Journal of the National Cancer Institute.
    • There were 14,381 new childhood cancer diagnoses in the US in 2019: about 177 new cases for every 1 million children and teens up to age 19. Incidence rates have dropped since reaching a peak in 2016 but are still about 8% higher than they were in 2003, when there were about 165 new cases for every 1 million children and teens.
    • “Overall, cancer is very rare in children and adolescents, and the increases were small,” said Dr. David Siegel, a pediatric oncologist and an epidemiologist with the US Centers for Disease Control and Prevention’s cancer division who was the lead author of the study. “Past studies have also reported increased survival rates. So the combination of increases in incidence and decreases in deaths means that there are more and more cancer survivors that need long-term care and resources.”
  • The U.S. Census Bureau issued a report examining “Racial/Ethnic Disparities in Disability by Health Condition.”
    • “The data show patterns in health-related disability among adults age 40 and older and key differences by sex, race and Hispanic origin.
      • “Among findings:
      • “Women were more likely than men to have health conditions that limited their daily activities.
      • “Asian (non-Hispanic) adults reported the lowest rates (17.2%) of disability-related health conditions.
      • “Black (non-Hispanic) adults (31.8%) and those reporting Other or multiple-race non-Hispanic identity (42.9%) were among those with higher rates.
  • The All of Us Program released its July 2023 Medical Minutes.

From the Rx coverage front

  • Per Healthcare Dive,
    • Major pharmacy benefits manager CVS Caremark is partnering with drug discounter GoodRx on a joint program to bring down out-of-pocket drug costs, the companies announced Wednesday.
    • Commercially insured customers will be able to pay GoodRx’s discounted pricing when filling commonly prescribed generic prescriptions at in-network pharmacies. The payments will be automatically applied to their deductibles and out-of-pocket limits.
    • The program, called Caremark Cost Saver, will be available for tens of millions of CVS Caremark clients’ members at in-network pharmacies starting January 2024.
  • Per Beckers Payer Issues,
    • ‘About two-thirds of patients who take popular weight loss drugs end their regimen within a year, according to a Prime Therapeutics study released July 11.
    • ‘Prime, a pharmacy benefit manager owned by 19 Blue Cross Blue Shield companies, analyzed pharmacy and medical claims of 4,255 patients who took GLP-1 receptor agonists — such as Ozempic and Wegovy — for weight loss in 2021. The study found only 32 percent of patients continued their weight loss treatment after one year. 
    • “The majority of patients aren’t getting the value of the product and there’s waste, especially with an expensive therapy,” Patrick Gleason, PharmD, Prime’s assistant vice president for health outcomes and a co-author of the analysis, told Reuters. “I was a little bit surprised by the persistency rate.”
  • STAT News delves into how Medicare Advantage plans are approaching the FDA’s approval of the infused Alzheimer’s drug Leqembi. The most illuminating part of the article concerns the Mayo Clinic.
    • As a condition of coverage, Medicare rolled out a new patient registry to collect more information from physicians prescribing Leqembi. Information is supposed to be submitted every six months. Physicians who had previewed the registry said it appeared to function, though many clinics are still finalizing protocols for prescribing Leqembi.
    • “I’m not sure it’s sufficiently detailed to answer the [coverage with evidence development] questions that the [national coverage decision] put forth. We and others would need to collect more detailed information to understand the true benefits and risks of the medicine,” said Ronald Petersen, the director of the Mayo Clinic Alzheimer’s Disease Research Center.
    • Mayo Clinic isn’t prescribing Leqembi yet, as it’s planning to launch an Alzheimer’s treatment clinic in October, Petersen said. He said there has been interest from patients, but it “hasn’t been a landslide.”
    • Petersen is hoping to start a new research study at Mayo Clinic to do more detailed monitoring on patients. To start, Mayo physicians will likely only agree to treat patients in the geographic area close to the facility so they can oversee the follow-up appointments.
    • “We’d be more than happy to share our data with broader communities or merge it with data from CMS. It is incumbent upon all of us to share data to learn from each other what works,” Petersen said.

From the U.S. healthcare business front —

  • MedPage Today points out
    • “Private equity acquisitions of U.S. physician practices have risen dramatically over the last decade, driving up consumer prices in the process, according to a new report.
    • “In 2012, there were 75 private equity deals for physician practices across a range of specialties; in 2021, there were 484, marking a more than six-fold increase, Richard Scheffler, PhD, of the University of California Berkeley, and colleagues found.
    • “Over the entire period, the largest number of deals occurred in dermatology (376), ophthalmology (276), gastroenterology (120), and primary care (118), collectively accounting for 81% of the activity, Scheffler and colleagues wrote in the report, a joint effort by the American Antitrust Institute, the Nicholas C. Petris Center on Health Care Markets and Consumer Welfare at the University of California Berkeley, and the Washington Center for Equitable Growth.”

In telehealth news,

  • Fierce Healthcare tells us,
    • “While payers should cover telehealth, where these services are the most valuable still requires investigation, according to a study in Information Systems Research.
    • “The Centers for Medicare & Medicaid Services made the rules about telehealth usage more flexible during the COVID-19 pandemic, and some lawmakers want to make those changes permanent. But that should not mean giving providers carte blanche approval in using the new technology, nor should payers cover all uses of telehealth, suggests a study by researchers with the University of Texas.
    • “Telehealth should not be regarded as a one-size-fits-all solution to virtualize healthcare,” the study said.
    • “Despite that, however, the study also states that “insurance plans should expand their telehealth coverage to include more providers and close the healthcare access divide in rural locations, which can reduce subsequent hospitalizations and unnecessary costs.”
    • “The authors argue that telehealth’s benefits can be seen in treating conditions and diseases with “high virtualization potential” such as mental health, skin problems, metabolic conditions and musculoskeletal diseases. However, telehealth did not significantly reduce visits to specialists or emergency departments for circulatory, respiratory or infectious diseases.
    • “Indranil Bardhan, Ph.D., one of the authors of the study, said in a press release that “people believed that telehealth would be the next big thing, the future of healthcare. But our research shows that its impact is not as straightforward as people might think. It’s more nuanced.”

Tuesday Tidbits

David Ermer–Congress, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The Senate Health Education Labor and Pensions Committee held its Superbugs hearing today.
  • STAT News informs us
    • “The witnesses largely seemed to organize behind the Pasteur Act in terms of how Congress should respond. This bipartisan legislation, which has been introduced in both the House and Senate, would encourage drug development by creating a subscription-style business model. In other words, the U.S. government would offer upfront payments to drugmakers in exchange for responsible stewardship policies and unlimited access to their antibiotics. A similar model has been successfully piloted in England over the past year, with the National Health Service planning a wider rollout to more pharmaceutical companies and to Northern Ireland, Scotland and Wales.
    • “The goal, as STAT has previously reported, is to enable pharmaceutical companies to recover their costs and make a profit — without predicating this on large volumes of antibiotics being prescribed. Helen Boucher, Dean of Tufts University School of Medicine, testified that this law would recognize these drugs “for their value, not for their use. It de-links incentives for overusing antibiotics.”
  • The Government Accountability Office released “a new report on the agency’s key findings and recommendations with an eye toward helping federal agencies be better prepared for future emergencies. GAO has regularly reported on the accountability and effectiveness of the federal government’s $4.7 trillion pandemic response since 2020.”
  • Per the White House,
    • “Today, in the continued efforts to fight the dangerous and deadly combination of xylazine mixed with fentanyl, the White House Office of National Drug Control Policy (ONDCP) released a National Response Plan to coordinate a whole-of-government response against this threat. Earlier this spring, ONDCP Director Dr. Gupta used an executive designation authority to designate fentanyl combined with xylazine as an emerging threat to the United States and proactively address this dangerous threat head-on.”
    • “Read the full National Response Plan to Fentanyl Combined with Xylazine HERE.
    • “Read about the Biden-⁠Harris Administration’s efforts to crack down on illicit fentanyl supply chains HERE.
    • “Read the Biden-Harris Administration’s National Drug Control Strategy HERE.”

From the public health front —

  • Federal News Network reports that twelve House of Representatives members are asking the Postal Service about steps being taken to protect letter carriers against the effects of high outdoor heat following the death of a letter carrier who passed away while delivering the mail in Texas.
    • “Eugene Gates Jr., a 66-year-old letter carrier in Texas, died June 20 while delivering mail during a heat wave with temperatures as high as 115 degrees. * * *
    • “The National Association of Letter Carriers, which represented Gates, said he collapsed and died in a customer’s yard while delivering mail. Gates, an Army veteran, served as a letter carrier for 36 years.
    • “Eugene was a dedicated letter carrier with a long and successful Postal Service career,” NALC National President Brian Renfroe said in a statement. “He will be greatly missed.”
  • STAT News tells us,
    • Weight loss medications from Novo Nordisk are being investigated by the European Medicines Agency after several reports of suicidal risks were referred to the watchdog, Bloomberg News reports. The regulator is looking at adverse events noted by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic. One additional case relating to thoughts of self-injury has been raised in connection with Saxenda. The agency is investigating the possible side effects in relation to patients who have used medicines containing the active ingredients semaglutide or liraglutide for weight loss. Novo’s hit weight loss drug Wegovy also contains semaglutide.
  • The Bloomberg article adds,
    • “Wegovy is currently available in the US with a warning and precaution for suicidal behavior and ideation on the label. While clinical trials of Wegovy did not support an increased risk of suicidal behavior, suicidal ideation, or other psychiatric adverse events, clinical trials of other weight management drugs have reported suicidal behavior and ideation, a spokesperson for the Food and Drug Administration said Monday.
    • “If newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence,” the spokesperson said.”

From the medical research front,

  • According to the National Science Foundation —
    • “While it’s known that sleep plays a crucial role in strengthening memory, scientists are still decoding how the process plays out in the brain overnight.
    • “U.S. National Science Foundation-supported research led by scientists at UCLA and Tel Aviv University offers new evidence from inside the human brain supporting the dominant theory of how the brain consolidates memory during sleep.
    • “The researchers found that targeted deep brain stimulation during a critical time in the sleep cycle improved memory consolidation. The result came from a novel “closed loop” system that delivered electrical pulses in one brain region that activated the cerebral cortex, synchronized with brain activity recorded in another area, the hippocampus.
    • “The research, published in Nature Neuroscience, could offer new clues to how deep brain stimulation during sleep could help patients with memory disorders, said study co-author and physician-scientist Itzhak Fried of UCLA.”

From the Medicare front, NerdWallet identifies four Medicare policies that “should come with warning labels.” Number 1 is the Part B late enrollment penalty. The article encourages picking up Part B at the first opportunity, even if health expenses at the time are modest. Granted, this article is aimed at people, like the FEHBlog, who have Medicare without supplemental employer coverage. Nevertheless, federal employees should consider the advice too.

From the Rx coverage front

  • Beckers Hospital Review notes
    • “The FDA is allowing 10 more lots of cisplatin from a China-based pharmaceutical company to be imported to the U.S. to ease the ongoing cancer drug shortage, Bloomberg reported July 10. The additional lots are set to arrive next week. 
    • “In June, federal regulators cleared four lots of cisplatin from Qilu Pharmaceutical. While the version of the drug is unapproved in the U.S., it is similar to the approved version distributed across the country. 
    • “We will continue the importation until manufacturers can meet all needs,” Chanapa Tantibanchachai, an FDA spokesperson, told Bloomberg.
    • “Shortages of the essential cancer drug began in February and have caused some cancer centers to ration cisplatin and carboplatin, another cancer drug in shortage, treatments for patients. More recently, there have been signs of supplies stabilizing.” 
  • Fierce Healthcare discusses a recent HHS report on approaches to avoiding drug shortages.
  • Following up on its recent report about the lead-covered cabling problem in our country, the Wall Street Journal points out
    • “Supplies are running out for a key antidote for life-threatening lead poisoning.
    • “The drug, named dimercaprol, has been a go-to treatment for years for the worst cases of lead poisoning. But doctors have had to scrounge for dwindling doses since the medicine’s sole manufacturer for the U.S. declared bankruptcy in February.
    • “Now that some parts of the country don’t have any supplies left, doctors have been forced to turn to other, less preferred treatments.
    • “We’re using whatever we can get, knowing it will help, but not knowing if it’s doing as good of a job,” said Dr. Diane Calello, who directs the New Jersey Poison Control Center at Rutgers New Jersey Medical School.”

In U.S. healthcare business news

  • Beckers Payer Issues tells us
    • “The Cigna Group’s network of behavioral health providers grew by more than 30 percent in 2022, according to the company’s 2022 Environmental, Social, and Governance Report.
    • “The July report said the behavioral health network has grown to include more than 300,000 mental health and substance use providers, doubling its size over the past four years. The company also nearly doubled its virtual care network, which has grown to include more than 163,000 virtual behavioral health providers. In-network providers who support cultural and race-related counseling were increased.
    • “For behavioral health providers that specifically work with children, Cigna added 27,000 providers to its network in 2022, or an increase of 19 percent. It also increased the numbers of facilities treating children by 8 percent to 2,700 total.”
  • The Wall Street Journal delves into high-priced “clinics cater[ing] to a growing number of people obsessed with fighting aging.”
    • “Practitioners at Healthy Longevity Clinic, which has locations in Boca Raton, Fla., and Prague, build patients a personalized “longevity road map.” Those maps can include recommendations for diet, exercise, sleep and supplements. Patients are encouraged to stick with the program for at least a year, over which time their bill can run between $25,000 to more than $100,000, says Petr Sramek, the clinic’s chief executive.
    • “Longevity-clinic treatments aren’t often covered by health insurance. Some providers say they work with insurers to get coverage for medications or laboratory tests. 
    • “Many clinics use membership-based models in an effort to keep client loads low enough that providers can spend time with each patient. Others are fee-for-service or use a combination of the two.”

Monday Roundup

David Ermer–Medicare, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front

  • The New York Times reports,
    • “Drowning is the leading cause of death for children ages 1 to 4, according to the Centers for Disease Control and Prevention. Deaths are likely to surge this month, as they do every July, with children drowning just feet from their parents without a scream, struggle or splash. A 4-year-old at a Texas hotel pool, a 5-year-old in a California river, a 6-year-old at a Missouri lake and a 10-year-old at an Indiana public pool all drowned just this past week. * * *
    • “The National Institutes of Health recently published a call for research proposals to examine drowning prevention, writing that “little is known” about what intervention strategies work. The C.D.C. said it planned to do an in-depth analysis of childhood drownings in several states to better understand the contributing factors.
    • “But epidemiologists point to an array of factors that could make it increasingly difficult to close the gap, including shrinking recreation department budgets, a national lifeguard shortage and an era of distraction on pool decks as parents juggle child supervision with laptops and cellphones when they work from home.”
  • and
    • “When Dr. Benjamin Han, a geriatrician and addiction medicine specialist, meets new patients at the School of Medicine at the University of California, San Diego, he talks with them about the usual health issues that older adults face: chronic conditions, functional ability, medications and how they’re working.
    • “He asks, too, about their use of tobacco, alcohol, cannabis and other nonprescription drugs. “Patients tend to not want to disclose this, but I put it in a health context,” Dr. Han said.
    • “He tells them, “As you get older, there are physiological changes and your brain becomes much more sensitive. Your tolerance goes down as your body changes. It can put you at risk.”
    • “That’s how he learns that someone complaining about insomnia might be using stimulants, possibly methamphetamines, to get going in the morning. Or that a patient who has long taken an opioid for chronic pain has run into trouble with an added prescription for, say, gabapentin. * * *
    • “Aging boomers “still use drugs far more than their parents did, and the field wasn’t ready for that.”
    • “Evidence of a growing problem has been stacking up. A study of opioid use disorder in people over 65 enrolled in traditional Medicare, for instance, showed a threefold increase in just five years — to 15.7 cases per 1,000 in 2018 from 4.6 cases per 1,000 in 2013.”
  • Fierce Healthcare informs us,
    • “Americans are likely to skip important health screenings, and women have a less positive outlook than men regarding their current and future health prospects, according to a survey released by Aflac.
    • “The survey, based on about 2,000 employed adults, examined attitudes, habits and opinions about health and preventive care and found that half of adults have avoided at least one common health screening. These screenings include tests for certain diseases.
    • “But for the 51% of respondents who said they have had cancer, that diagnosis came following a routine checkup or screening. For Hispanic survey respondents, 72% of individuals said a diagnosis was discovered at a routine checkup.
    • “Skipping regular checkups is common among individuals who feel healthy. One in 4 respondents said they miss routine checkups. Reasons cited include a conflict with work hours, the individuals are “not thinking about it,” a general dislike for going to the doctor’s office, insurance issues, fear of hearing bad news and the time commitment required.”
  • In the FEHBlog’s view, the best action for a health plan to take in response to these concerns is to connect members with in-network primary care providers.

From the Medicare front, Beckers Payer Issues points out that “Caps on Medicare prescription drug costs will save Part D enrollees a collective $7.4 billion in 2025, according to a report from HHS’ Office of the Assistant Secretary for Planning and Evaluation.  The report, published July 7, broke down expected savings from price caps by state. An estimated 18.7 million people, around 1 in 3 Medicare Part D enrollees, will save on drug costs in 2025. The average annual saving per person is estimated at $396.08.” That’s good news for FEHB and PSHBP plans with Part D EGWPs.

From the Rx coverage front, Fierce Healthcare notes

  • “On the heels of a similar announcement from Optum Rx, pharmacy benefit management giant Express Scripts said Monday that it will add three biosimilars to its formulary to compete with Humira.
  • “The PBM announced that it will include Boehringer Ingelheim’s Cyltezo and two biosimilars produced by Novartis’ Sandoz in its National Preferred Formulary. Humira, a drug for people with inflammatory conditions, is the top-selling pharmaceutical product in the world and has been viewed as a key target for savings thanks to biosimilar products.
  • “Express Scripts said its trend data show that anti-inflammatory drugs accounted for nearly 25% of total drug spending for its commercial business last year. An analysis from its parent company, Evernorth, found that increased biosimilar competition could save $225 billion to $375 billion over the next decade.”

Those savings will benefit FEHB and PSHBP plans.

From the employment front, the Society for Human Resource Management discusses steps that employers can take to support employees who have children with developmental disabilities.

STAT News and its readers offer 27 healthcare reads and podcasts for the beaches and mountains.

 

Friday Factoids

David Ermer–ACA, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The White House kicked off its Friday with a bunch of new healthcare measures, none of which impact the FEHB. Roll Call offers a useful overview of the measures.
  • Here is a link to the related Affordable Care Act FAQ 60, which discusses the No Surprises Act measures, which are explained in the separate White House press release. To maintain one’s sanity, read the No Surprise Billing section of that press release before reading the FAQ. That will help you decide the relevance of the FAQ to your work.
  • In combing through the various press releases, the FEHBlog did run across this link to an HHS report to Congress on the No Surprises Act, which may be worth a gander.
    • “This first report focuses largely on establishing a baseline and a framework for further evaluation. The report details key trends in factors that will be important to evaluate NSA effects, including the implementation and impacts of state surprise billing laws already in effect; trends in market consolidation and concentration; the impact of market consolidation and concentration on prices, quality, and spending; and trends in OON billing. This report also describes a conceptual framework for considering the healthcare market effects of NSA, as well as describing potential methodologic approaches (and their limitations) for estimating these effects. Subsequent reports will implement these approaches.”
  • STAT News reports
    • “Medicare is planning to send $9 billion in lump-sum payments to more than 1,600 hospitals that participate in a drug discount program [known as 340B] after the Supreme Court found the program underpaid them for prescription drugs, the agency announced on Friday.
    • “To pay for the restitution, Medicare would slash all hospitals’ payments for other items and services by 0.5% for the next 16 years.”
    • The FEHBlog paraphrases the Bible, “First it giveth, then it taketh away.”
  • The Society for Human Resource Management tells us
    • “The U.S. Equal Employment Opportunity Commission (EEOC) has postponed the deadline for employers to file their 2022 EEO-1 reports, which list workforce demographic data, including race and sex.
    • “An announcement on the EEOC’s website explained: “The EEOC is currently completing a mandatory, three-year renewal of the EEO-1 Component 1 data collection by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). Accordingly, the EEOC has updated the tentative opening of the 2022 EEO-1 Component 1 data collection to the Fall of 2023.”
    • “A more precise date was not available. Previously, the tentative deadline for filing was in mid-July.”

Let’s wrap us this Friday with potpourri:

  • Politico interviews the income president of the American Medical Association Jesse Ehrenfeld, MD.
  • Benefits Pro discusses Rx optimization programs.
  • Health IT Analytics explains “How Elevance Health and MVP Health Care are leveraging data analytics. The two payers share how they leverage data analytics, predictive modeling, and data quality frameworks to improve outcomes for members.”
  • MedPage Today points out
    • “As research interest in the therapeutic potential of psychedelics has grown — with academic centers popping up across the country, and compounds already in developmen — the FDA recently caught up, issuing a draft guidance on managing clinical trials of these drugs.
    • “The draft guidance was released on June 23, as one of the largest U.S. psychedelic conferences was underway. It outlined the agency’s views on best practices in clinical trial design for psychedelic drugs — including psilocybin, lysergic acid diethylamide (LSD), and methylenedioxymethamphetamine (MDMA) — in the treatment of medical conditions, including psychiatric or substance use disorders.
    • “In an email to MedPage Today, an FDA spokesperson called psychedelics “a very active and challenging area of drug development.”
    • “As an emerging area of drug development, there is limited experience as to the configuration of programs that may support approval of a psychedelic drug,” the spokesperson wrote. “The guidance presents foundational constructs that all sponsors, including academic sponsor-investigators, studying the therapeutic potential of psychedelic drugs should consider.”
  • The Wall Street Journal questions whether people should be judgmental about other people who lose weight with the new generation of weight loss drugs.
    • “Elizabeth Owen didn’t let her husband’s comments dissuade her from taking Ozempic. (John Owen, 60, who had recommended his wife continue to exercise and eat healthy to lose the weight, says he was just telling her to do what he would have done in her situation.) At 5’2” and 142 pounds, she was the heaviest she had ever been, despite regular workouts with a personal trainer.
    • “Owen, who lives in Orlando, Fla., says she has been embarrassed to tell her personal trainer about taking Ozempic. She did tell a good friend, who told her the drug would make her sick.
    • “She has lost 34 pounds so far and takes a small maintenance dose. Recently, John’s doctor advised him to lose weight and prescribed Wegovy, which he’s taking. 
    • “Friends and family also are starting to ask about her treatment in a more positive way, she says. 
    • “They’re curious because I’m maintaining the weight loss,” she says. “A year later, they all want to know why.”

Thursday Miscellany

David Ermer–CDC, COVID-19, FDA, Federal employment benefits, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Wall Street Journal reports
  • STAT News adds
    • “Previous treatments for Alzheimer’s targeted the disease’s symptoms and not the underlying cause of worsening dementia. The debate among physicians is whether that 27% slowing seen with Leqembi is clinically meaningful enough to make the drug, which carries a list price of $26,500 per year, suitable for every patient who might want it.
    • “My general argument is that ‘clinically meaningful’ is personal and specific to a patient and their families, and it’s not something I or any provider can paternalistically determine,” said James Galvin, a neurologist who leads the Comprehensive Center for Brain Health at the University of Miami. “I can’t tell you what’s clinically meaningful to you.”
    • “Eisai’s trial enrolled patients with mild cognitive impairment or early-stage Alzheimer’s who also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. The drug’s label reflects the same narrowed patient population, estimated to encompass approximately 1 million people in the U.S., or just under 20% of those currently living with Alzheimer’s.
    • “In the drug’s prescribing label, the FDA recommends doctors test for a genetic mutation, affecting about 15% of people with Alzheimer’s, that increases the risks of ARIA and reduces the efficacy of Leqembi. The agency also warns doctors to take “additional caution” when considering prescribing to people who are taking blood thinners, which could increase the risk of serious brain bleeds.”
  • Here is a link to the FDA’s press release.
  • In closing, the Wall Street Journal points out
    • Drugmakers and researchers are working on dozens of potential [Alzheimer’s Disease] drugs. Next up for approval is another amyloid-reducing antibody drug, called donanemab, from Eli Lilly. In a small, mid-stage trial, donanemab also modestly slowed the cognitive decline of study subjects compared with placebo.
    • “As of early 2022, there were 143 drugs in clinical trials for Alzheimer’s disease, including 31 drugs in Phase 3, typically the last stage of testing before a drug can be approved, according to a report in Alzheimer’s & Dementia: Translational Research and Clinical Interventions.”
  • Federal News Network reports on OPM’s diminishing yet still excessive backlog of federal retirement claims.
  • Govexec tells us
    • “The Office of Personnel Management last week reminded agencies of the array of workplace flexibilities at their disposal such as leave and telework to help federal workers who have been impacted by natural disasters.
    • “The memo, distributed by OPM Director Kiran Ahuja to heads of federal agencies, corresponds with the start of the annual hurricane season and comes shortly after Typhoon Mawar caused disruptions in Guam and the Northern Mariana Islands, both of which are under U.S. jurisdiction.”

From the public health front —

  • The Associated Press reports
    • “Drinking water from nearly half of U.S. faucets likely contains “forever chemicals” that may cause cancer and other health problems, according to a government study released Wednesday.
    • “The synthetic compounds known collectively as PFAS are contaminating drinking water to varying extents in large cities and small towns — and in private wells and public systems, the U.S. Geological Survey said.
    • “Researchers described the study as the first nationwide effort to test for PFAS in tap water from private sources in addition to regulated ones. It builds on previous scientific findings that the chemicals are widespread, showing up in consumer products as diverse as nonstick pans, food packaging and water-resistant clothing and making their way into water supplies. * * *
    • “The heaviest exposures were in cities and near potential sources of the compounds, particularly in the Eastern Seaboard; Great Lakes and Great Plains urban centers; and Central and Southern California. Many of the tests, mostly in rural areas, found no PFAS.
    • “Based on the data, researchers estimated that at least one form of PFAS could be found in about 45% of tap water samples nationwide.
    • “The study underscores that private well users should have their water tested for PFAS and consider installing filters, said Faber of the Environmental Working Group. Filters containing activated carbon or reverse osmosis membranes can remove the compounds.”
  • The Wall Street Journal informs us
    • A new longitudinal study has examined the medical records of all citizens of Denmark over the age of 16, some 6.5 million people in all, for patterns of diagnosis, hospitalization and treatment for substance use between 1995 and 2021. In the paper, published in the journal JAMA Psychiatry in May, Dr. Oskar Hougaard Jefsen of Aarhus University and colleagues showed that people who had previously been diagnosed with cannabis use disorder were almost twice as likely to be diagnosed later with clinical depression. According to the Centers for Disease Control and Prevention, cannabis use disorder is characterized by craving marijuana, using it more often than intended, spending a lot of time using it, and having it interfere with friends, family and work.
    • Even more dramatically, the paper also found that people with cannabis use disorder were up to four times as likely to be diagnosed later with bipolar disorder with psychotic symptoms. As is true of many psychological disorders, the increased risk was higher in men than in women, and the more a person consumed, the greater the risk. The study did not distinguish between different forms and concentrations of cannabis.
    • Though the association was strong, the authors note that they can’t say for certain whether chronic and heavy cannabis use induces psychosis, or whether people prone to mental illness are more likely to be heavy users. It makes sense that people who feel the symptoms of incapacitating depression or mania, or who sense apparitions or voices only they can hear, might try to self-medicate with cannabis. Without a randomized controlled trial, which would be unethical in the extreme, it’s hard to untangle these strands definitively.
    • But the study is still eye-opening due to its sheer magnitude. With so many people over so many years, there is very little statistical “noise.” And because the information was gathered from the national Danish Health Registry, there were few dropouts—often a big problem in longitudinal studies. As much as possible, the researchers confirmed that the symptoms of a person’s psychiatric disorder emerged after their chronic cannabis use and diagnosis, not before, and that they compared people who were alike in all ways except the frequency of their use.
  • Beckers Hospital Review notes that “In an effort to prevent a repeat of last winter’s “tripledemic” of respiratory illnesses, public health officials are encouraging Americans to get not only a flu shot but also a COVID-19 vaccine and a new vaccine against the respiratory syncytial virus, The New York Times reported July 5.” The FEHBlog thinks that immunity created by the tripledemic will tamp down the viruses this year. Nevertheless, the FEHB plans to get all three vaccines.

From the telehealth and artificial intelligence fronts, we learn from

  • Healthcare Dive that
    • “Nearly one-third of American adults and 40% of adults under 34 report that they would be comfortable with an artificial intelligence-led primary care appointment, according to a new survey released by Outbreaks Near Me and SurveyMonkey.
    • “But the option isn’t their preference. Although survey respondents reported believing that AI in healthcare could reduce medical bias and improve diagnostic accuracy, over 80% of respondents would prefer seeing a human medical professional for prescribing pain medications, deciding when to go to the emergency room and other services.
    • “The latest survey suggests that, while AI hype may be on the upswing, entrenched patient attitudes and preferences for care could be slow to shift.”
  • and
    • “Mental healthcare led telehealth utilization for the sixth straight month in April, representing 68.4% of telehealth claim lines among privately insured patients, according to Fair Health’s April telehealth report.
    • “Although nationwide demand for telehealth services dipped by 5.4% from March to April this year, the percentage of telehealth claims related to mental health services grew for the fourth consecutive month.
  • and
    • “Telehealth patients across most medical specialties are less likely to attend follow-up appointments 90 days after a visit compared to in-person appointments, according to new research from Epic.
    • “The analysis of follow-up visits comes after a December report from Epic found most telehealth patients did not require a follow-up appointment in the three months after an initial visit. Mental health, physical medicine, and rehabilitation and pain medicine had the highest in-person follow-up rates compared to telehealth visits, according to the latest research.
    • “The[se] new telehealth stud[ies] come as federal lawmakers debate whether to make pandemic-era virtual care flexibilities permanent before they expire in 2024.”

From the U.S. healthcare business front

  • Beckers Payer Issues relates
    • “Eli Lilly is now the largest healthcare company in the world by market value, surpassing UnitedHealth Group, Bloomberg reported July 5. 
    • “The pharmaceutical company’s market capitalization surpassed UnitedHealth Group’s July 5 — the first time Eli Lilly has closed above UnitedHealth Group since 2013, according to Bloomberg. 
    • “Eli Lilly’s success is driven by Monjauro, its drug approved for diabetes treatment and expected to receive FDA approval for weight loss, analysts told Bloomberg. The drug is expected to net between $25 and $48 billion in sales once approved.”
  • STAT News tips its cap to Lilly’s leadership David Ricks, 55, Lilly’s CEO, and Daniel Skovronsky, 50, its chief scientific officer.
  • The American Hospital Association offers its two cents on the recent Wall Street Journal article about the state of hospital finances.
  • Fierce Healthcare tells us
    • “Baylor Scott & White Health (BSW) is adding dozens of Texas urgent care clinics to its network thanks to a newly announced deal with NextCare Urgent Care.
    • “Forty-one facilities in “fast-growing areas” such as Houston, San Antonio and Abilene will give the state’s largest nonprofit health system a foothold in new markets. The deal also catapults BSW to a new role as one of Texas’ major providers of urgent care services.
    • “We are dedicated to providing customers with as much choice as possible when seeking care,” Pete McCanna, CEO of BSW, said in a Thursday release from the system. “Through this venture, the NextCare sites across the state will be integrated into our ecosystem of offerings, which already includes 24/7 virtual care available to all Texans via MyBSWHealth.com.”
  • and
    • “Hospital outpatient departments are marking up the prices for biologic medicines more than physician offices, particularly for “innovator biologics” that have clinically equivalent and lower cost alternatives on the market, according to a new analysis from the Employee Benefit Research Institute (EBRI).
    • “These higher charges for these products among hospital outpatient departments (HOPDs) are “roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition,” the independent research group found in its review of a proprietary commercial claims database of 25 million people with private health insurance.
    • “While HOPDs tend to charge higher prices for all medicines relative to the [physician office], higher HOPD markups on biologic medicines are roughly doubling costs for employers and minimizing savings that could be achieved through biosimilar competition,” Paul Fronstin, director of health benefits research at EBRI, and M. Christopher Roebuck, CEO of health policy research firm RxEconomics, wrote in the brief.”

 

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19, Employee Wellness Programs, FDA, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–

The FEHBlog hopes his readers enjoyed their Fourth of July weekend. The FEHBlog certainly did.

From Washington, DC —

  • FedWeek informs us
    • “The House version of the annual defense authorization bill would require DoD and OPM to conduct a “comprehensive review of the civilian workforce on FEHB to ensure that all family members and dependents who are currently receiving benefits are in fact eligible.”
    • “The language, inserted as an amendment to a bill that could come to floor voting in the upcoming weeks, would be the most concrete response to date regarding an issue that has been the subject of repeated warnings from OPM’s inspector general’s office and most recently from the GAO: ineligible persons being covered in the program as family members.”
  • FEHBlog note — The largest internal control problem with FEHB eligibility stems from the fact that OPM does not take advantage of the HIPAA 820 electronic enrollment roster, which allows health plan carriers to reconcile premium to headcount. For example, if the carrier finds via the HIPAA 820 that it is not receiving premiums on a self and family enrollee, then the outcome may be disenrolling the individual and their covered family members in a fair way. In the FEHBlog’s view, it does not make sense to move forward with a family member eligibility audit until the HIPAA 820 transaction is operational in FEHB. That is the most logical first step.
  • Federal News Network provides us with background on OPM’s new employee assistance program guidance. In the FEHBlog’s opinion, OPM should team up EAPs with FEHB plans in order to better coordinate their respective coverages.
  • Fedweek also explains for the benefit of federal and postal employees how to continue FEGLI coverage into retirement.
  • Healthcare Dive relates
    • “The CMS is proposing to cut Medicare reimbursements to home health agencies by 2.2% next year, or $375 million less than providers received in 2023, according to draft regulation released Friday. 
    • “The agency said the proposed rule includes a 2.7% payment bump that’s offset by a 5.1% cut related to the Patient-Driven Groupings Model, which aimed to better sort patients into different payment categories by clinical need and other factors.
    • “The reimbursement changes also reflect an estimated 0.2% increase due to an updated fixed-dollar loss ratio, according to regulators.”

From the public health front —

  • CBS News reports
    • “Nearly 1 in 4 U.S. adults and older teens had still not caught COVID-19 by the end of last year, according to new estimates from the Centers for Disease Control and Prevention, while 77.5% had antibodies from at least one prior infection. The figures are based on the final batch of results from the agency’s nationwide studies of antibodies in Americans ages 16 and up. * * *
    • “Virtually every American ages 16 and older — 96.7% — had antibodies either from getting vaccinated, surviving the virus or some combination of the two by December, the CDC now estimates. The study found 77.5% had at least some of their immunity from a prior infection. * * *
    • Rates were similar among men and women. Black and White people also have similar prior infection rates, between 75% and 80%. 
    • Among other racial and ethnic groups, Asian Americans had the smallest proportion of people with antibodies from a prior infection, at 66.1%, while Hispanic people had the highest, at 80.6%.

From the Rx and medical devices coverage front —

  • BioPharma Dive points out
    • “Moderna on Wednesday said it’s submitted applications to regulatory agencies around the world in a bid to win approval of a new vaccine to fight respiratory syncytial virus, or RSV, in older adults.
    • “The company filed with regulatory agencies in Europe, Switzerland and Australia and began a rolling submission to the U.S. Food and Drug Administration for the vaccine, which is currently known as mRNA-1345. Future applications are planned for other nations as well.
    • “Moderna’s submissions come two months after the FDA approved the first RSV vaccine, developed by GSK. The agency cleared a second RSV shot from Pfizer weeks later. Both products are approved for use in patients who are at least 60 years old, the same group Moderna aims to treat.”
  • Forbes reports
    • “On Wednesday, medtech giant Abbott announced that its new leadless pacemaker system, Aveir DR, has been approved by the FDA. This is the first time the FDA has given a thumbs up to a device of this type for two different chambers of the heart, which opens up this technology to nearly any patient who needs a pacemaker.
    • “From a clinical perspective, we know that leadless pacing offers a number of important advantages to patients in terms of getting away from the complications related to traditional pacemakers,” says Leonard Ganz, a cardiologist and Abbot’s chief medical officer for cardiac rhythm management. “This will expand the number of patients who can benefit from leadless pacing many, manyfold,” he tells Forbes.” * * *
    • “Although pacemakers have been life-changing for millions of people, they do carry downsides, explains Ganz, in particular, risk of infection both from the surgical procedure needed to implant them as well as the leads themselves should their insulation become compromised. Leadless pacemakers, by contrast, are much smaller, don’t require surgical implantation and have no wires connected to the heart. Instead, they are injected using a catheter in a vein and placed directly in the heart in a way that allows for removal if need be. All of these factors significantly reduce the risk of complications.
    • “The first leadless pacemaker, manufactured by Medtronic, was cleared by the FDA in 2016. Abbott’s first leadless pacemaker, the Aveir VR, was approved by the FDA in March 2022. [In contrast to the new Abbott device, b]oth of these products only work in a single chamber of the heart. About 80% of the patients that require a pacemaker need shocks in two cardiac chambers in order to keep the desired heart rhythm.”
  • The New York Times discusses “food noise,” which the new weight loss drugs dissipate.
    • “The active ingredient in Ozempic and Wegovy is semaglutide, a compound that affects the areas in the brain that regulate appetite, Dr. Gabbay said; it also prompts the stomach to empty more slowly, making people taking the medication feel fuller faster and for longer. That satiation itself could blunt food noise, he said.
    • “There’s another theoretical framework for why Ozempic might quash food noise: Semaglutide activates receptors for a hormone called GLP-1. Studies in animals have shown those receptors are found in cells in regions of the brain that are particularly important for motivation and reward, pointing to one potential way semaglutide could influence cravings and desires. It’s possible, although not proven, that the same happens in humans, Dr. Hwang said, which could explain why people taking the medication sometimes report that the food (and, in some cases, alcohol) they used to crave no longer gives them joy.”

From the U.S. healthcare business front

  • Segal Consulting delves into health plan prior authorization practices.
  • The Wall Street Journal reports that “Some hospitals that spent big on nurses during the pandemic are now short on cash; Distressed institutions are closing unprofitable services, selling assets to avoid default on debts.” Ruh-roh!
  • Forbes reports
    • “Rite Aid reported a quarterly loss of more than $306 million as the drugstore chain grapples with the loss of customers from its Elixir pharmacy benefits business as executives work to turn around the struggling drugstore chain.
    • “Rite Aid, which has closed more than 140 unprofitable stores in the last two years, reported a fiscal first-quarter loss of $306.7 million, or $5.56 per share, for the period ended June 3, 2023. That compares with a loss of $110.2 million, or $2.03 per share, in last year’s first quarter.”

From the fraud, waste, and abuse front, HealthTech explains how the Justice Department is using advanced analytics to combat healthcare fraud.

From the medical research front, the National Institutes of Health announced that “The first clinical trial of a three-month TB treatment regimen is closing enrollment because of a high rate of unfavorable outcomes with the investigational course of treatment.” The FEHBlog appreciates NIH’s transparency.

Monday Roundup

David Ermer–CMS, Congress, FDA, Federal employment benefits, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • The House of Representatives and the Senate remain on a District / State work break until next week. Of course, tomorrow is a federal holiday even for Congress as our Nation celebrates its 247th birthday.
  • Roll Call reports that the House Republican leadership is already
    • “discussing the possibility of putting a stopgap spending bill on the floor as soon as this month as a fail-safe option while they try to build support for passing fiscal 2024 appropriations bills that appear on shaky ground.
    • “The idea, according to one person familiar with the conversations, is to have a stopgap in place to continue government funding past Sept. 30 in the event all the regular appropriations bills are not passed by the end of the fiscal year. That move would avoid a partial government shutdown in October if the Senate also passed the stopgap and President Joe Biden signed it into law.”
  • The Food and Drug Administration (FDA) is expected to decide this week whether or not to accept its advisory committee’s recent unanimous decision to give full marketing approval to Eisai / Biogen’s Leqembi. If that approval is given, the Centers for Medicare and Medicaid Services plans to provide Medicare Part B coverage for the drug based on the following prerequisites identified by Pharmacy Practice News
    • “To receive benefits for lecanemab-irmb [marketed as Leqembi], a Medicare patient must be:
    • “1. enrolled in Medicare Part B;
    • “2. diagnosed with mild cognitive impairment or early dementia caused by Alzheimber’s Disease;
    • “3. have an appropriate clinical team and follow-up care;
    • “4. meet any label requirements the FDA specifies; and
    • “5. be attended by a qualified physician participating in a registry that collects evidence about the drug’s performance.
  • “CMS will offer a nationally available online portal where clinicians can submit data via an “easy-to-use” format, the agency said. This kind of registry, which has been used after regular approval of other drugs, is critical for researchers to better understand the benefits and risks of this new class of drugs.”
  • The intravenously delivered drugs is retail priced at $26,500 annually.
  • The Washington Post and NPR offer lengthy articles on this development that are worth reading.
    • From NPR:
    • “The first drug shown to slow down Alzheimer’s disease is likely to receive full approval from the Food and Drug Administration by July 6.
    • “In theory, the move would make lecanemab (Leqembi) available to more than a million Medicare patients in the early stages of Alzheimer’s. In practice, though, the number is likely to be much smaller.
    • “I’d be surprised if right away we saw demand from that many people,” saysDr. David Rind, chief medical officer of the Institute for Clinical and Economic Review. The number could be in the hundreds of thousands, though, he says.
    • “Lecanemab’s rollout could be slowed by factors ranging from the extra paperwork required of doctors to a shortage of medical personnel trained to diagnose and treat patients, experts say.”
  • MedPage Today emphasizes the importance of cognitive assessments in the rollout of this new drug.
    • “Clinical trials show that lecanemab can be highly effective in clearing the brain of amyloids, the plaque-like substance closely associated with Alzheimer’s. Physicians must confirm the presence of amyloid beta pathology before starting treatment.
    • “Reducing amyloids in individuals who have advanced symptoms, however, is pointless. The amyloids need to be cleared before they can ravage the brain, which puts greater emphasis on cognitive screening to find individuals most at risk.”
  • In related news, Medscape tells us
    • “Roche has received US Food and Drug Administration (FDA) 510(k) clearance for additional cerebrospinal fluid (CSF) assays for Alzheimer’s disease (AD), supporting timely diagnosis and treatment decision-making.
    • “The Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys total-tau CSF assays (tTau) (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for AD.
    • “They join the Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022, as reported previously by Medscape Medical News.
    • “An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.
    • “Appropriate use recommendations for new and emerging AD drugs call for confirmation of amyloid pathology. Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.”

In other FDA news,

  • Medscape informs us
    • “The US Food and Drug Administration (FDA) has approved Suflave, a new low-volume, lemon-lime flavored liquid osmotic laxative for colonoscopy preparation in adults, the manufacturer, Sebela Pharmaceuticals, has announced.
    • “Suflave comes in a carton containing two bottles and two flavor packets. Each bottle contains 178.7 g polyethylene glycol 3350, 7.3 g sodium sulfate, 1.12 g potassium chloride, 0.9 g magnesium sulfate, and 0.5 g sodium chloride. One bottle and one flavor packet are equivalent to one dose.
    • “Administration of both doses is required for complete preparation for colonoscopy. After each dose, an additional 16 ounces of water must be consumed. 
    • “In a clinical trial, 94% of patients achieved successful bowel cleansing with Suflave, the company said in a news release. 

In Rx coverage news —

  • Reuters brings us up to date on the Humira biosimilars that charged out of the starting gate on July 1.

In public health news —

  • HHS’s Health Resources and Services Administration published in the Federal Register
    • “the first of two notices planned for the coming months informing the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs). This notice includes the lists of HPSAs in a designated status as of April 28, 2023. The lists are available on the shortage area topic page on HRSA’s data.hrsa.gov website * * *.”
  • The Journal of the American Medical Association published an original investigative report on “Trends in State-Level Maternal Mortality by Racial and Ethnic Group in the United States.”

From the mental health front, NPR offers a step-by-step guide to finding a therapist “taking both your mental health needs and your budget into account.”

From the federal employee benefits front,

  • FedWeek shares last-minute checks for federal and postal annuitants.
    • “Are you enrolled in the Federal Employee Health Benefits (FEHB)program? Most employees are. If you are one of them and are planning to retire, you need to be aware of the 5-year rule. To carry your FEHB coverage into retirement, you must have been enrolled in the program for 5 consecutive years before you retire or from your first opportunity to enroll (note: there is an exception for those retiring with an early retirement offer). If you meet the requirement, your coverage will continue, and your premiums will be the same as they were when you were an employee.
    • “If you retire but haven’t met that retirement, you’ll be given 31 days of coverage at no cost to you. After that, you’ll have the option of continuing in that plan (or another plan of your choice) under the Temporary Continuation of Coverage (TCC) provision for up to 18 months. If you choose to do that, you’ll pay 100 percent of the premiums plus 2 percent to cover the administration cost incurred by your agency. When that coverage ends, you’ll need to make other arrangements for your health insurance.”

Friday Factoids

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Rx coverage–

On the day I return to Texas, the DC air quality improved from unhealthy to unhealthy for sensitive groups, all due to wildfire smoke. The air quality in Dripping Springs, TX, where the FEHBlog lives, is good.

Also from Washington, DC, the Supreme Court closed its October 2022 term today.

Politico tells us

  • “It’s CDC Director Rochelle Walensky’s last day at the agency, but she’s still thinking a lot about the agency’s work ahead.
  • “She’s been working to smooth potential bumps in a transition, in contact with her successor, Mandy Cohen — an Obama administration alum and formerly North Carolina’s top public health official.
  • “And she looks to stay in the game, telling Pulse she’s “eagerly wanting to champion health and public health from a new perch,” though she’s been vague about what that might be.”

The Department of Health and Human Services announced

  • “actions to lower health care costs and implement President Biden’s lower cost prescription drug law – the Inflation Reduction Act (IRA) – which is already saving covered seniors and people with disabilities hundreds of dollars annually.
  • “HHS released revised drug price negotiation guidance from the Centers for Medicare & Medicaid Services (CMS). The guidance is a critical step in implementing the IRA, which finally took on Big Pharma and will allow Medicare to negotiate lower drug prices on behalf of people with Medicare. * * * “
  • “HHS today also announced that President Biden’s cap on insulin costs at $35 per month will go into effect for people who get their insulin through Medicare Part B and Medicare Advantage with use of a traditional pump starting tomorrow, July 1, 2023. Millions of people with Medicare Part D are already benefiting from the Inflation Reduction Act’s $35 monthly cap on insulin costs, and if these rules for Part B and Part D had been in effect in 2020, 1.5 million beneficiaries would have saved an average of $500 per year.
  • “More information on the Medicare Drug Price Negotiation Program is available at https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation
  • “To read more on how the $35 insulin cap is already benefiting seniors and other Medicare enrollees across the country, visit: https://aspe.hhs.gov/reports/insulin-affordability-ira-data-point.”

From the public health front, MedPage Today informs us

  • “Drug overdose deaths with xylazine involvement have multiplied, with age-adjusted death rates 35 times higher in 2021 than in 2018, the CDC reported.
  • “The age-adjusted rate of drug overdose deaths involving the animal sedative, also known as “tranq,” rose from 0.03 per 100,000 people to 1.06 per 100,000, Merianne Rose Spencer, PhD, MPH, a researcher at the CDC’s National Center for Health Statistics in Hyattsville, Maryland, and co-authors reported in Vital Statistics Rapid Release. * * *
  • “While never approved for human use, xylazine has increasingly been found adulterating other drugs, particularly fentanyl. It slows breathing and heart rate, lowers blood pressure to unsafe levels, complicates efforts to reverse opioid overdoses with naloxone (Narcan), and can lead to serious flesh wounds.”

From the medical research front, the National Institutes of Health announced

  • “Insights into healing and aging were discovered by National Institutes of Health researchers and their collaborators, who studied how a tiny sea creature regenerates an entire new body from only its mouth. The researchers sequenced RNA from Hydractinia symbiolongicarpus, a small, tube-shaped animal that lives on the shells of hermit crabs. Just as the Hydractinia were beginning to regenerate new bodies, the researchers detected a molecular signature associated with the biological process of aging, also known as senescence. According to the study published in Cell Reports, Hydractinia demonstrates that the fundamental biological processes of healing and aging are intertwined, providing new perspective on how aging evolved.
  • “Studies like this that explore the biology of unusual organisms reveal both how universal many biological processes are and how much we have yet to understand about their functions, relationships and evolution,” said Charles Rotimi, Ph.D., director of the Intramural Research Program at the National Human Genome Research Institute (NHGRI), part of NIH. “Such findings have great potential for providing novel insights into human biology.”

From the healthcare spending front, Mercer Consulting explains what’s happening with the boatload of claims data that health plans began posting to their websites last year.

  • “It’s been almost a year since group health plan sponsors and issuers, in order to comply with the Transparency in Coverage final rule, posted machine-readable files (MRFs) that contain in-network negotiated charges for every medical service with every provider in their networks. This data had previously been considered by insurers as proprietary and confidential, but the government saw the need to put more data about the cost of healthcare into the hands of consumers. There have been eye-opening reports in the past revealing wide discrepancies in the price of medical services from one healthcare facility to the next; the hope was that making price data freely available would make these kinds of studies much easier to do. Given that the data has been available to the public since July 2022, why haven’t we seen more stories on the cost of healthcare in the United States? What happened to all that medical price data?
  • “Well, it’s certainly out there. By some estimates, over 700 terabytes of MRF data have been published since last summer. * * *
  • “While we’re excited about the possibilities for this price data, we’ll need to be patient as the market moves to put more of it to use. Importantly, this data also underpins the final leg of the transparency regulations, which requires real-time benefit cost estimators be made available to the public for 500 shoppable services this year and for everything else by 2024. So if you haven’t already, make sure your data partners are ready for this next step of compliance.
  • “While we are still a long way from achieving price transparency in health care, this data is a crucial starting point.”

From the Rx coverage front, BioPharma Dive discusses Biomarin Phamaceutical’s plans to market its FDA-approved hemophilia gene therapy in the U.S.

  • “BioMarin’s chief commercial officer, Jeff Ajer, told investors during a conference call Thursday afternoon that the first priority of the launch will be getting the country’s largest hemophilia treatment centers to use Roctavian. The FDA approved the therapy for certain people living with severe hemophilia A, a group that totals around 2,500 in the U.S. by BioMarin’s estimates.
  • “Like other approved gene therapies, Roctavian is expensive. BioMarin set its list price at $2.9 million, which Ajer said translates to net revenue of approximately $1.9 million. The company expects to record between $50 million and $150 million in Roctavian revenue this year. BioMarin is also tying the drug’s price to patient outcomes, promising a warranty that will reimburse insurers up to 100% if patients don’t respond, and a pro-rated rebate for the first four years if the response wanes.  
  • “But unlike most available gene therapies, Roctavian treats a disease with a variety of available options. BioMarin argues that its therapy would likely save the healthcare system money over time. Many hemophilia A patients are currently treated multiple times a week with “replacement Factor,” medicines that supply them with the key blood-clotting protein they’re missing. These treatments are costly too, at about $800,000 per year for the typical patient, according to BioMarin.”