Midweek update

CMS

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.”

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.”

Monday Roundup

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–

From Washington DC —

Photo by Sven Read on Unsplash
  • Federal News Network reports,
    • “The House and Senate armed services committees each finished their work on their versions of next year’s defense authorization bill within a day of one another, with both key committees approving overall funding levels that closely match the Biden administration’s 2024 funding request of $842 billion in discretionary DoD spending.
    • “The Senate Armed Service Committee’s bill, approved behind closed doors on Friday, would authorize $844 billion next year, while the House version, debated in a public session a day earlier, would match the administration’s request.
    • “Another area of commonality: both committees endorsed the administration’s proposed pay increase for military service members, making it highly likely that they’ll receive a 2024 increase of 5.2%, the largest military pay raise since 2002.
    • “For now, the measures do not include language that would grant the administration’s request for the same pay raise for federal civilian workers. A provision to achieve that could still be added when the bills reach the House and Senate floors; however, a large faction of House Republicans is pushing an alternative plan that would make all civil servants’ pay increases “merit-based.”
  • The Centers for Medicare and Medicaid Services issued,
    • “a proposed rule that proposes to update payment rates and policies and includes requests for information under the end-stage renal disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2024. This rule also proposes an update to the Acute Kidney Injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2024. In addition, the rule proposes to update requirements for the ESRD Quality Incentive Program (QIP).
    • “For CY 2024, CMS is proposing to increase the ESRD PPS base rate to $269.99, increasing total payments to ESRD facilities by approximately 1.6 percent. The CY 2024 ESRD PPS proposed rule also includes several proposals and requests for information related to ESRD PPS payment policies.
  • The National Institutes of Health announced,
    • “The Biden-Harris Administration awarded $50 million to launch the Persistent Poverty Initiative, an initiative to alleviate the cumulative effects of persistent poverty on cancer outcomes by building research capacity, fostering cancer prevention research, and promoting the implementation of community-based programs. The Persistent Poverty Initiative is the first major program to address the structural and institutional factors of persistent poverty in the context of cancer. It is coordinated by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). These awards create five new Centers for Cancer Control Research in Persistent Poverty Areas that will advance key priorities of the Administration’s Cancer Moonshot — to reduce inequities in the structural drivers of cancer and prevent more cancers before they start by reducing tobacco use and making sure everyone has access to healthy food.”
  • FedScoop informs us,
    • “Most federal government employees will receive between four and eight additional hours of leave time in 2023, the U.S. Office of Personnel Management said.
    • “The 2023 leave year ending Jan. 13, 2024, will have 27 pay periods, OPM said in a memo sent on Monday to human resource directors of U.S. government agencies. That means most federal employees will receive an additional pay period’s worth of leave in 2023, which could be four, six, or eight hours depending on their accrual rate, according to the memo.
    • “The change doesn’t apply to agencies whose first pay period was Jan. 8, 2023, as they will have 26 pay periods, the memo said. 
    • “While most federal workers will get more leave time, the maximum carryover amount for annual leave – 240 hours for most employees and 360 hours for overseas employees – won’t change, OPM said. It encouraged agencies to remind affected workers to use any time over that limit before the end of the leave year so they don’t lose it.”

From the public health front —

  • CBS News tells us,
    • The Centers for Disease Control and Prevention is now separately tracking several new COVID-19 variants, the agency announced Friday, adding more Omicron descendants to an increasingly complex list of new strains that are competing nationwide. 
    • Among the new variants now being tracked by the CDC is EU.1.1, a strain first designated by scientists earlier this year over its rapid ascent in some European countries. 
    • The variant is a more distant descendant of the XBB.1.5 variant that had surged earlier this year, with a handful of more mutations to its spike protein that may be driving its spread. 
    • The CDC estimates that EU.1.1 is now 1.7% of U.S. cases nationwide but may have already reached as much as 8.7% of cases in the region spanning Colorado, Montana, North Dakota, South Dakota, Utah and Wyoming.
    • It is too early to know whether EU.1.1 will lead to new or different symptoms in the U.S.
  • FEHBlog note — Reassuringly, the variants remain descendants of the late, great Omicron.
  • Helio informs us,
    • “Prenatal lifestyle interventions delivered by an allied health professional, with individual delivery formats and a moderate number of sessions, decreased gestational weight gain., according to data published in JAMA Network Open.
    • “In addition, researchers observed associations with reduced gestational weight gain among physical activity and mixed behavioral interventions. 
    • “These findings suggest that future pragmatic research should focus on testing and evaluating components to inform implementation in varied antenatal care settings, including those with limited resources, to optimize population benefits for pregnant individuals and the next generation,” the researchers wrote.”

From the obesity drug front —

  • STAT News reports,
    • “Almost half of Americans would be willing to spend up to $100 a month for new weight loss medicines such as Wegovy, and one-third say they would indefinitely pay whatever they can afford to get the drugs, according to a new survey by STAT and The Harris Poll.
    • “Although 47% say they would only spend the money up to a point — such as losing a certain amount of weight, or up until a special event — demand is so great that nearly one-quarter said they would pay up to $250 each month. And another 17% percent are willing to shell out as much as $500 each month. The survey, which polled 2,046 U.S. adults, was conducted earlier this month.”
  • and
    • An experimental pill from Eli Lilly led to 14.7% weight loss on the highest dose in a 36-week trial, heating up the growing competition among drugmakers to develop an effective oral obesity therapy.
    • The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year. The full results, published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the American Diabetes Association conference.
    • Nonetheless, an overwhelming majority — 84% — believe insurance companies should cover the injectable medicines, which carry list prices ranging from $900 to $1,300 a month.
  • Meanwhile, Healthcare Dive relates,
    • “Pfizer is scrapping of one of two experimental weight-loss pills it’s been developing after spotting signs of potential safety concerns in clinical testing.  
    • “The company on Monday said the decision to stop testing of the pill, lotiglipron, was made after receiving the results from drug-drug interaction studies and observing liver enzyme elevations in early- and mid-stage tests. Patients with liver enzyme spikes, which can be signs of organ damage, didn’t have side effects or require treatment, Pfizer said.  
    • “Pfizer will now focus on its other, similar weight-loss prospect, danuglipron, which so far hasn’t had such concerns. Danuglipron is currently in Phase 2 testing in Type 2 diabetes and obesity, and could move into late-stage development by the end of the year.”  

In other Rx and medical device news

  • Biopharma Dive identifies five Food and Drug Administration (FDA) decisions to watch for in this third quarter of 2023.
  • Beckers Hospital Review points out
    • The FDA has given a fast-track designation to a drug designed to prevent infection from both influenza A and B strains created by San Diego-based Cidara Therapeutics, according to a June 22 news release.
    • The novel drug, CD388, is being developed alongside Janssen Pharmaceuticals primarily for flu prevention in adults who are high risk as well as for individuals for whom flu vaccines “are either ineffective or contraindicated,” the release states. 
    • The FDA’s decision could prove to be timely as early data from the flu season that is currently underway in the Southern Hemisphere is showing that both influenza A and B are both circulating.
  • MedTech Dive notes
    • “Dexcom next year will introduce a continuous glucose monitor aimed at the 25 million non-insulin-using Americans with Type 2 diabetes.
    • “The CGM, which is based on the Dexcom G7, will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.
    • “Dexcom’s analysis shows those patients want help understanding the effect of lifestyle on blood glucose and staying off insulin, leading the company to develop a revised set of features for the new device.” 

From the U.S. healthcare business front

  • The Wall Street Journal reports
    • “UnitedHealth Group will acquire Amedisys for $101 a share, or nearly $3.29 billion, upending a prior deal for the home-health provider to combine with Option Care Health
    • “Amedisys said Monday that it has agreed to a takeover by UnitedHealth’s Optum health-services arm in which each Amedisys share will be converted into the right to $101 in cash. 
    • “Amedisys will become a wholly owned subsidiary of UnitedHealth when the transaction is completed. UnitedHealth’s UnitedHealthcare is the biggest U.S. health insurer. Its Optum business includes a sprawling network of physician groups, surgery centers and other assets.” * * *
    • “The companies didn’t provide an expected closing date on the acquisition, which still needs to be approved by regulators and Amedisys shareholders. 
    • “The combination is likely to draw close antitrust scrutiny from the Federal Trade Commission. Optum will be seeking to take over the No. 2 competitor in the home-health business after recently absorbing the No. 3 company, according to analysts. * * *
    • “When it announced its offer for Amedisys, UnitedHealth said it was confident it could secure approval for the combination, partly because of how fragmented the home-health business is.”
  • Health Payer Intelligence points out
    • “What will happen to the volume and value of mergers and acquisitions in 2023? This is a question at the forefront of payers’ minds as the healthcare industry emerges from the uncertainties of the coronavirus pandemic.
    • “The twelve months ending on May 15, 2023, witnessed strong merger and acquisition volume despite various challenges, according to a report from PwC. At the end of the report’s timeframe, the volume of deals was nearly twice as high as the period of 2018 to 2020.
    • “Still, health services deals dipped slightly, dropping by four percent from 2022. Volume dropped from 1,738 in 2022 to 1,661 as of May 15, 2023.
    • “Deal values declined significantly by 15 percent. In 2022, deal value amounted to $100 billion. In the study’s timeframe, deal value totaled $85 billion. Megadeal values, specifically, have been more than halved in the last two years since 2021, a trend which might continue due to rate hikes.”

Friday Factoids

David Ermer–CDC, CMS, FDA, HSA, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • The American Hospital Association reports,
    • “Medicare will cover new Alzheimer’s drugs that receive traditional approval from the Food and Drug Administration when a beneficiary is diagnosed with mild cognitive impairment or Alzheimer’s disease dementia and has a physician participating in a registry with an appropriate clinical team and follow-up care, the Centers for Medicare & Medicaid Services announced June 22. CMS called the approach consistent with its 2022 national coverage determination for the first monoclonal antibodies targeting amyloid to treat Alzheimer’s. “
  • For those interested, Fierce Healthcare offers a more detailed explanation of this development.
  • The International Foundation of Employee Benefit Plans tells us,
    • “The Internal Revenue Service (IRS) has released Notice 2023-37 on the high deductible health plan (HDHP) preventive care safe harbor specific to 1) COVID-19 testing and 2) recommendations with an “A” or “B” rating by the United States Preventive Services Task Force (USPSTF). 
    • COVID-19 testing and screening
      • “IRS has determined that, with the end of the COVID-19 National Emergency and the Public Health Emergency, the relief described in Notice 2020-15 is no longer needed. Accordingly, Notice 2020-15 applies only with respect to plan years ending on or before December 31, 2024. For subsequent plan years, an HDHP is not permitted to provide health benefits associated with testing for and treatment of COVID-19 without a deductible or with a deductible below the minimum deductible (for self-only or family coverage) for an HDHP, except as otherwise provided in this notice. 
      • “IRS Notice 2023-37 states that the preventive care safe harbor, as described in Notice 2004-23, does not include COVID-19 testing effective June 23, 2023, although HDHPs may continue to provide benefits related to testing for COVID-19 before satisfaction of the applicable minimum deductible for plan years ending on or before December 31, 2024.”
    • Recommendations with an “A” or “B” rating by the USPSTF
      • “Consistent with the position taken in Question and Answer 7 of DOL FAQs Part 59, IRS Notice 2023-37 provides that items and services recommended with an “A” or “B” rating by the USPSTF on or after March 23, 2010, are treated as preventive care for purposes of the HDHP safe harbor, regardless of whether these items and services must be covered, without cost sharing, referencing pending litigation (Braidwood v. Becerra).”
  • MedPage Today informs us,
    • “The CDC’s Advisory Committee on Immunization Practices (ACIP) agreed unanimously on Thursday to include the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar) as an option for U.S. children.”
  • The U.S. Census Bureau announced,
    • “The nation’s median age increased by 0.2 years to 38.9 years between 2021 and 2022, according to Vintage 2022 Population Estimates released today by the U.S. Census Bureau. Median age is the age at which half of the population is older and half of the population is younger.
    • “A third (17) of the states in the country had a median age above 40.0 in 2022, led by Maine with the highest at 44.8, and New Hampshire at 43.3. Utah (31.9), the District of Columbia (34.8), and Texas (35.5) had the lowest median ages in the nation. Hawaii had the largest increase in median age among states, up 0.4 years to 40.7.
    • “No states experienced a decrease in median age. Four states — Alabama (39.4), Maine (44.8), Tennessee (39.1), West Virginia (42.8), and the District of Columbia (34.8) — had no change in their median age from 2021 to 2022.”
  • From the public health front —
  • MedPage Today relates,
    • “While in-hospital delivery-related maternal mortality has decreased, severe maternal morbidity increased, according to a retrospective cross-sectional study.
    • “Among over 11 million hospital discharges from 2008 to 2021, regression-adjusted maternal mortality per 100,000 discharges decreased from 10.6 deaths in 2008 to 4.6 deaths in 2021, reported Dorothy Fink, MD, of the Department of Health and Human Services in Rockville, Maryland, and colleagues.
    • “Each subsequent year after 2008 had an 11% decrease in odds of death compared with the previous year (adjusted OR 0.89, 95% CI 0.87-0.92), they noted in JAMA Open Network.
    • “This large national study found a decreasing trend of in-hospital delivery-related maternal mortality during 2008 to 2021, regardless of racial or ethnic group, age, or mode of delivery, likely demonstrating the impact of national and local strategies focused on improving the maternal quality of care provided by hospitals during delivery-related hospitalizations,” Fink and team wrote.”
  • STAT News reports,
    • Color Health wants to take away any reason you might have for skipping screenings for cancer. 
    • The Silicon Valley company, which pivoted from cancer genomics to Covid-19 testing on a large and hugely profitable scale, has a new program that incorporates both its roots in cancer testing and its logistical experience from the pandemic. Called, simply, the Cancer Prevention and Screening Program, and built in partnership with the American Cancer Society, the program aims to make it easy to get the appropriate screenings, whether at a clinic or at home.” * * *
    • “Research has shown that outreach and navigation can improve participation, screening, follow-up,” said Samir Gupta, a cancer researcher and gastroenterologist at the University of California, San Diego, who does not work with Color. “But we haven’t been able to come up with sustainable models for how that work gets paid for. This is interesting because it’s a market solution for the lack of resources that exist helping people complete screening and follow-up.” * * *
    • “Color does already work with a wide range of customers, including large employers, workers’ unions, and government entities. Many of those existing customers will receive the cancer screening and prevention service from Color, which will officially launch in October.”

From the Rx coverage front

  • STAT News points out.
    • An experimental pill from Eli Lilly led to 14.7% weight loss on the highest dose in a 36-week trial, heating up the growing competition among drugmakers to develop an effective oral obesity therapy.
    • The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year. The full results, published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the American Diabetes Association conference.
    • By the end of the trial, the authors said, participants’ weight loss had not plateaued, suggesting the potential for even greater weight loss over a longer treatment period.
    • Orforglipron, taken daily, is a GLP-1 drug, a type of medication that mimics the effects of the glucagon-like peptide 1 hormone that helps people feel full after eating. This class of drugs has exploded in popularity, with the injectable GLP-1s Wegovy and Mounjaro showing up to 15% and 21% weight loss in trials, respectively. If pills can ultimately prove to work as well, they could be more accessible and more attractive to many patients for their convenience.
  • Fierce Healthcare notes,
    • “Optum Rx will add two more Humira biosimilars to its formulary later this summer.
    • “The pharmacy benefit manager—one of the three largest in the market—will place Boehringer Ingelheim’s Cyltezo and Sandoz’s Hyrimoz on its formulary at parity with Humira starting July 1. Optum added Amgen’s Amjevita to its formulary at parity with Humira earlier this year.
    • “Humira, manufactured by AbbVie, is an injectable treatment for a range of conditions, including rheumatoid arthritis, ankylosing spondylitis and others. It’s a high source of cost, and PBMs have had high hopes that biosimilars coming to market could be critical in addressing those expenses.”

From the U.S. healthcare business front —

  • Healthcare Dive reports,
    • “Deal volumes for health services are holding steady in 2023, even as the sector faces headwinds like high-interest rates, increased regulatory scrutiny and other macroeconomic concerns, according to a report by consulting firm PwC. 
    • “The analysis found deal volumes declined 4% in the 12 months ending May 15, 2023, compared with 2022, and deal value declined 15%. 
    • “However, the firm is “optimistic” about healthcare merger and acquisition activity for the rest of 2023, arguing corporate and private equity players have plenty of cash to spend and health services companies face a climate that demands adaptation and change.”
  • Fierce Healthcare adds.
    • “Ochsner Health and the University of Texas MD Anderson Cancer Center are partnering to build an integrated cancer care program in southeastern Louisiana, the organizations announced Thursday.
    • “Called the Ochsner MD Anderson Cancer Center, their collaboration is the first to bring MD Anderson’s best practices and clinical leadership to the state’s cancer patients. It is the seventh such arrangement MD Anderson has with major health systems.”
  • MedCity News tells us.
    • “There are a lot of administrative hurdles behavioral health providers have to go through to join an insurer’s network. That’s why the industry needs something similar to the “Common App” for applying to be in-network with insurers, said Cara McNulty, president of behavioral health and mental wellbeing at CVS Health. The Common App allows students to apply to multiple colleges through one application.” 

Happy Flag Day!

David Ermer–ACA, CMS, Congress, FDA, No Surprises Act, Rx coverage, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Washington DC —

  • The Senate Finance Committee announced
    • “Senate Finance Chairman Ron Wyden (D-Ore.), Senate Finance Ranking Member Mike Crapo (R-Idaho) alongside U.S. Senators Bob Menendez (D-N.J.), Marsha Blackburn (R-Tenn.), Jon Tester (D-Mont.), Roger Marshall (R-Kan.), today introduced the Patients Before Middlemen (PBM) Act to delink the compensation of pharmacy benefit managers (PBMs) from drug price and utilization in order to better align incentives that will help lower prescription drugs costs for Medicare Part D beneficiaries.”
  • Fierce Healthcare informs us
    • “While national health spending growth slowed in 2022, that trend isn’t likely to stick around.
    • “Experts at the Centers for Medicare & Medicaid Services’ Office of the Actuary predict that health spending growth will outstrip growth in the economy over the next decade, according to a study published in Health Affairs. Between 2022 and 2031, the actuaries predict spending will increase by 5.4% on average each year, faster than the estimated annual gross domestic product growth of 4.6%.”
  • As the French say, Plus ça change, plus c’est la même chose (literally the more it changes, the more it’s the same thing”.
  • CMS made its No Surprises Act website more consumer friendly.

In conference news, MedPage Today fills us in on the American Medical Association conference and Smartbrief does the same for the AHIP conference.

From the Rx coverage front —

  • Beckers Hospital Review tells us,
    • “Mark Cuban Cost Plus Drug Co. considered selling insulin but found the price doubled with shipping costs, CEO and co-founder Alex Oshmyansky, MD, PhD, said June 13 at the AHIP conference. * * *
    • “We were working on bringing in an insulin product to the market for quite some time,” he said at the conference. “We did actually bring one to the market, we did it as sort of a closed beta pilot to see what consumer response would be. But ultimately, direct to consumer mail-order it was $35 for a month’s supply but $65 for the shipping and handling. It didn’t quite make sense within our model. We almost viewed it as a solved problem from the consumer perspective at this point. You know, almost everyone has access to $35 insulin in one form or another now.”
  • Reuters reports,
    • “Pfizer (PFE.N) has warned that a drug used to treat syphilis and other bacterial infections in children could run out by the end of June because it has had to prioritize versions made for adults due to a spike in syphilis infections in that population.
    • “Supply of the pediatric version of the drug, Bicillin L-A, is expected to be exhausted by the end of this quarter, the company said in a letter to the U.S. health regulator dated Monday. Pfizer said in an email on Tuesday that the pediatric formulations of the antibiotic are not widely used.”
  • Medscape informs us
    • The US Food and Drug Administration (FDA) has expanded the indication for linaclotide (Linzess) to children as young as age six years with functional constipation, making it the first approved treatment for pediatric functional constipation.
    • The recommended dosage in pediatric patients is 72 mcg orally once daily.
    • Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
    • There is no known underlying organic cause, and there are typically multiple contributing factors, the FDA notes in a statement announcing the approval.

From the U.S. healthcare business front —

  • Healthcare Dive notes,
    • “Pent-up demand for delayed healthcare during the COVID-19 pandemic is pressuring medical costs for health insurers that had a financial windfall during the pandemic amid low utilization.
    • “UnitedHealth, the parent company of the largest private payer in the U.S., expects its medical loss ratio — the share of premiums spent on member’s healthcare costs — to be higher than previously expected in the second quarter of 2023, due to a surge in outpatient care utilization among seniors,” CFO John Rex said Tuesday during Goldman Sachs’ investor conference.”
  • Fierce Healthcare relates,
    • “Cerner brought in $1.5 billion in revenue in the latest quarter, boosting strong growth for enterprise software giant Oracle. The health IT company also generated $5.9 billion in revenue for Oracle’s 2023 fiscal year, which ended May 31.
    • “Oracle’s revenue reached an all-time high of $50 billion last year, driven by growing demand for its cloud offerings from companies deploying AI.”

In litigation news —

  • Health Payer Intelligence points out,
    • On June 13, “A federal appeals court approved an agreement between parties in Braidwood Management v Becerra, preserving the mandate requiring health plans to cover preventive care services based on recommendations from the US Preventive Services Task Force (USPSTF). * * *
    • “While the federal government works to appeal Judge O’Connor’s ruling, it cannot penalize Braidwood Management for refusing to cover USPSTF-recommended preventive care services. Additionally, if the court upholds the mandate in the appeal, the Biden administration cannot retroactively penalize the plaintiff.”

Friday Factoids

David Ermer–CMS, FDA, Federal employment benefits, Generative AI, Medicare, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the FDA front —

  • MedPage Today tells us
    • “Lecanemab (Leqembi) showed clinical benefit in early Alzheimer’s disease in its confirmatory trial, paving the way for traditional approval of the drug, an FDA advisory committee said Friday.
    • “In a 6-0 vote, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee fully backed the evidence supporting the anti-amyloid monoclonal antibody. * * *
    • “The agency is expected to make its final decision about lecanemab by July 6.
  • KFF provides a cost perspective in anticipation of FDA approval of this drug, which action is expected to trigger CMS approval for Medicare Part B coverage.

From the FEHB front, Tammy Flanagan writing in Govexec delves into FEHB and Medicare Part B coverage.

From the litigation front —

  • The Wall Street Journal reports
    • “Pharmaceutical industry giants completed a deal to pay $19 billion to states that accused them of fueling the opioid crisis, infusing more money into communities still struggling with how to address the scourge of drug use.”
    • “Most states agreed to the deal to settle agreements with manufacturers Teva and Allergan as well as pharmacy chains CVS and Walgreens. The agreement is in addition to a $26 billion so-called global settlement with drug distributors McKesson, Cardinal Health and AmerisourceBergen and manufacturer Johnson & Johnson. The latest settlements close lawsuits against most of the major players and brings the total income from opioid litigation that states will have to spend to about $50 billion. 
    • “The legal fight stretches back nearly a decade, when more than 3,000 lawsuits from states, Native American tribes and counties alleged the drugmakers, pharmacies and distributors played down the risk of painkillers and didn’t stem their flow. Misuse of prescription painkillers sparked a health crisis that was supercharged as fentanyl infiltrated the illicit drug supply and now claims more than 100,000 lives in the U.S. each year. 
    • “Money from the recent settlements will begin to flow to states this year. More than $3 billion from the global settlementhas already been dispersed. The funds are distributed to states based on population adjusted to account for the burden of the opioid epidemic based on deaths and people using drugs. The agreements require most of the money to be spent on abating the opioid crisis, but the parameters are broad and officials are using different strategies to spend it.”
  • KFF has created a tracker to follow the distribution of the opioid litigation settlement funds.

From the CMS front —

  • Healthcare Dive informs us,
    • “CMS is exploring programs that would pay social or community health workers to address patients’ social needs in a bid to invest more heavily in food, housing, transportation and other social determinants of health, according to agency officials.
    • “We are looking at that. For example, in maternal health, thinking about the role of doula and community health workers,” Liz Fowler, director of the Center for Medicare and Medicaid Innovation, said on Thursday during the CMS’ inaugural health equity conference.”
  • and
    • “CMS announced a new model that aims to strengthen and improve primary care, including by ensuring small and rural organizations are able to enter into value-based care arrangements. 
    • “The Making Care Primary Model will run for more than 10 years in eight states — in Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington.
    • “Research shows primary care is key to improving health outcomes and lowering costs. The CMS noted Medicare and Medicaid patients are often diagnosed with multiple chronic conditions, and primary care providers are charged with prevention, screening and management. But, because many patients will see multiple specialists, coordinating care can be challenging.”
  • Fierce Healthcare relates,
    • “The Department of Health and Human Services (HHS) has released a 43-drug list of the Medicare Part B prescription treatments that must repay the program for raising prices above the rate of inflation.
    • “The second quarterly list takes effect in July and is an expansion over the 20 price-capped drugs from April through June. According to HHS, the rebates could save Medicare beneficiaries taking the treatments anywhere from $1 to $449 per average dose in out-of-pocket costs.
    • “The Medicare Prescription Drug Inflation Rebate Program is a critical way to address long-term price increases by drug companies, and [the Centers for Medicare and Medicaid Services (CMS)] is continuing our work to make prescription drugs more affordable for people with Medicare,” CMS Administrator Chiquita Brooks-LaSure said in a release.
    • “The full list of prescription drugs and biological products with adjusted coinsurance amounts for July 1 to Sept. 30 is available here (PDF).
    • “Of note, CMS said the list could be adjusted before or after July 1 based on public feedback notifying the agency of any potential discrepancies, as was the case during the program’s inaugural quarter when a highly publicized list of 27 drugs was later trimmed down to 20.”

From the U.S. healthcare business front —

  • Beckers Hospital Review reports
    • “In the first quarter of 2023, 17 healthcare companies with more than $10 million in liabilities filed for Chapter 11 bankruptcy, a sharp rise compared to seven bankruptcies in the first quarter of 2022, Bloomberg Law reported June 9.
    • “High-profile bankruptcies from Envision, Invacare Corp. and Sorrento Therapeutics contributed to the numbers. The first three months of 2023 saw a slight slump in bankruptcies but remain higher than the same period a year ago.
    • “Despite the year-over-year increase, the first quarter of 2023 still had fewer healthcare bankruptcies than the fourth quarter of 2022.
    • “Once the government money ran out, once all the stimulus dollars around healthcare ran out, there was essentially going to be this backwash,” Timothy Dragelin, a healthcare director at FTI Consulting, told Bloomberg. “The fact that labor costs increased substantially—you also had the issues with supply chain and supply chain caused some disruptions.”
  • Fierce Healthcare tells us
    • “Walgreens Boots Alliance sold its remaining stake in post-acute care and infusion services company Option Care Health for $330 million.
    • “The drugstore chain announced Thursday it sold 10.8 million shares of Option Care Health and plans to use the proceeds primarily for debt paydown, continued support of the company’s strategic priorities and to help fund its healthcare-focused business initiatives, according to a press release.
    • “The transaction is another decisive action WBA is taking to unlock value and further simplify the company’s portfolio,” the company said.
    • “Back in March, Walgreens cut its stake in Option Care Health when it sold 15.5 million shares at $30.75 per share. The transaction reduced Walgreen’s ownership in the company, formerly known as Walgreens Infusion Services, from 14% to 6%, according to a Walgreens news release. “

From the generative AI front —

  • Beckers Hospital CFO Report points out the steps the Google and Microsoft are taking to integrate generative AI in healthcare systems.
  • HR Dive discusses the impact of generative AI on employers and the workplace.

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Medicare, Rx coverage, Telehealth–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Senate Finance Committee held a hearing today about “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs.”
  • Mercer Consulting informs us
    • “Two key House committees voted this week to send a series of health care bills to the House floor, including legislation to make permanent the ability of health savings account-qualifying high-deductible health plans (HSA-qualifying HDHPs) to cover telehealth and other remote care services on a predeductible basis. Originally enacted as part of the 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act, this flexibility was most recently extended as part of the 2023 Consolidated Appropriations Act, and now is set to expire on Dec. 31, 2024, for calendar-year plans (later for noncalendar-year plans).”
  • “The U.S. Department of Health and Human Services (HHS) released the STI Federal Implementation Plan to detail how various agencies and departments across the federal government are taking a comprehensive approach to making meaningful and substantive progress in improving public health. This new plan builds on other key HHS actions to protect the public’s health by addressing the growing threat of sexually transmitted infections (STIs) in America.”
    • Roll Call identifies potential obstacles to implementing this plan.
  • Govexec reports
    • “As smoke from Canadian wildfires moves into the Northeast and Mid-Atlantic regions of the United States, triggering air quality warnings in several cities, the Office of Personnel Management on Thursday reminded agencies to protect the health of federal workers who ordinarily may work or commute to work amid the hazardous haze.”
      • Healthcare Dive discusses health system reactions to this problem.
        • “Hospitals in the northeastern U.S. are keeping an eye on air quality as smoke from Canadian wildfires envelops the region. Most health systems contacted by Healthcare Dive did not report significant spikes in patient volumes yet, but they said they’re continuing to monitor the situation.
        • “Millions of people live in areas currently under air quality alerts, and meteorologists say conditions may not significantly improve for a few more days.
        • “Health systems in the region are urging residents to stay indoors and use masks — particularly snug-fitting N95s — when traveling outside. Though everyone should limit their time outdoors, it’s especially important for older people, children and pregnant women as well as those with conditions like heart or lung disease or asthma, according to Kristin Fless, a pulmonologist at RWJBarnabas Health Medical Group.”
  • The Wall Street Journal relates
    • “Ashish Jha, the White House Covid-19 czar, will be leaving his post next week in the latest sign the Biden administration is confident the country is on stronger footing in its fight against the virus.
    • “Jha plans to leave June 15 and return July 1 to his previous position as dean of Brown University’s School of Public Health. He will be the last of the administration’s rotating Covid-19 czars. Instead, the director of the White House’s nascent Office of Pandemic Preparedness and Response Policy, who hasn’t been named, will advise the president and coordinate federal responses to various biological and pandemic threats.”

From the  public health front —

  • Mercer Consulting tells us
    • Our research over the past few years has tracked the ways employers are working to align employee benefit programs with their organizations’ overarching DEI goals. For Pride month, here’s a round-up of survey results relating to health and well-being benefits of particular importance to the LGBTQ+ community.
    • Here’s a link to the article.
  • The American Hospital Association reports
    • “The first data on the safety of a third mRNA COVID-19 vaccine dose among young children show that a third dose is safe for children ages 6 months to 5 years old, similar to findings for doses one and two, the Centers for Disease Control and Prevention reportedtoday, based on reports to the Vaccine Adverse Event Reporting System and v-safe voluntary smartphone health checker for use after vaccination.
    • “This study’s findings can reassure health care professionals, parents, and caregivers that a third dose of COVID-19 vaccine is safe for children ages 6 months to 5 years and can protect them from severe illness,” CDC said.
    • “While CDC recommends that all children ages 6 months through 5 years old receive at least 1 bivalent mRNA COVID-19 vaccine dose, vaccination rates among this age group have been low.”
  • Health Payer Intelligence informs us
    • “Group health insurance plan members with high healthcare spending often have one or more of the same five chronic diseases, according to a fast facts sheet from the EBRI Center for Research on Health Benefits Innovation (EBRI CRHBI).
    • “The study covered healthcare claims from 8.6 million group insurance health plan members using 2021 data from the Merative MarketScan Commercial Database. Members were 65 years of age or younger and the health plans covered a variety of types.
    • “Five conditions were very common among the group health insurance plan members with the highest healthcare spending: heart disease, respiratory conditions, musculoskeletal conditions, nervous system conditions, and skin disorders. A couple of these are among the most expensive chronic diseases in the US. They are also some of the most common comorbidities.”

From the Rx coverage front —

  • BioPharma Dive notes that tomorrow a Food and Drug Administration advisory committee will consider recommending that the FDA give full marketing approval to the Alzheimer’s drug Leqembi.
    • “A closely watched Alzheimer’s disease medicine appears to be heading toward broader approval, as documents released Wednesday show the Food and Drug Administration appears to have few concerns with it.”
  • BioPharm Dive also tells us that “After years of disappointment, cancer vaccines show new promise. Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.”
    • “Moderna is testing its shot, mRNA-4157, together with Merck’s immunotherapy Keytruda in people with melanoma who have had their primary tumors removed. The goal of such “adjuvant” treatment is to prevent cancer from returning.
    • “In December, the company reported the two drugs reduced the relative risk of death or recurrence by 44% over Keytruda alone. The new data came from an analysis of the risk of cancer spreading to distant organs or tissues, or “distant metastasis free survival.”
    • “One-third of patients who receive Keytruda in this setting experience such spread, driving researchers’ work to come up with better options. “We know that patients with distant metastases experience more morbidity and mortality,” said Adnan Khattak, a clinical professor at Edith Cowan University in Australia, who presented the Moderna data at ASCO.
    • “In the combination trial, mRNA-4157 and Keytruda reduced the risk of distant spread or death by 65% compared to Keytruda alone.”
  • The Associated Press reports
    • “A growing shortage of common cancer treatments is forcing doctors to switch medications and delaying some care, prominent U.S. cancer centers say.
    • “The National Comprehensive Cancer Network said Wednesday that nearly all the centers it surveyed late last month were dealing with shortages of carboplatin and cisplatin, a pair of drugs used to treat a range of cancers. Some are no longer able to treat patients receiving carboplatin at the intended dose or schedule. 
    • “Dr. Kari Wisinski has had to turn to other treatments for some patients or switch the order in which people receive their drug combinations. She said she’s done that “hoping that within three months there will be a better carboplatin supply.” * * *
    • “The U.S. Food and Drug Administration has taken some steps to try to ease the chemotherapy shortage. The agency is allowing the temporary importation of some foreign-approved versions of cisplatin from factories registered with the FDA.”
  • Beckers Hospital Review adds “Seventy percent of the 20 most commonly prescribed medications from GoodRx are in shortage, according to databases from the FDA and the American Society of Health-System Pharmacists.” The article goes on to list the drugs subject to shortages.

From the Medicare front —

  • Beckers Payer Issues informs us
    • “The FDA and CMS are discussing how to handle obesity drugs in Medicare, Bloomberg Law reported June 7. 
    • “The two agencies are in talks over “what to do about obesity drugs,” FDA Commissioner Robert Califf said at the Biotechnology Innovation Organization convention in Boston. Mr. Califf’s comments indicate CMS could expand weight loss benefits, according to Bloomberg Law’s report. 
    • “New GLP-1 drugs to treat obesity and diabetes can be expensive, costing upward of $10,000 a year without insurance coverage. GLP-1 drugs, including Ozempic, Trulicity, Victoza and Mounjaro, are used to treat Type 2 diabetes. Wegovy and Saxenda are approved for weight loss.  
    • “Under current law, Medicare is prohibited from covering weight loss drugs. Drug manufacturers are lobbying Congress to require the program to pay for the drugs. Proposed legislation to pay for the drugs has stalled. 
    • “The drugs could have a big effect on Medicare Part D spending. If 10 percent of people with obesity covered by Medicare were prescribed a brand-name semaglutide, a type of GLP-1, the drug would cost Medicare $26.8 billion annually, according to a study published in the New England Journal of Medicine in March.”
  • and
    • “Medicare spending per person grew by an average of 4.6 percent annually between 2000 and 2022, according to a June 6 analysis from KFF. 
    • “KFF analyzed data from the 2023 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. 
    • “KFF said the “influx of the Baby Boomer Generation added many relatively younger, healthier people to the Medicare beginning in 2011,” while the share of adults aged 80 and older enrolled in the program also continues to grow. Growth in healthcare spending is attributed to this increased volume and use of services, along with the availability of new technologies and rising prices.”
      • 2018: $13,579
      • 2019: $14,189
      • 2020: $14,373
      • 2021: $15,139
      • 2022: $15,727

Thursday Miscellany

David Ermer–CDC, CMS, Congress, COVID vaccine mandate, FDA, Medicare, Rx coverage, U.S. Healthcare–

From Washington, DC –The Wall Street Journal reports

  • “The Senate passed wide-ranging legislation Thursday [night] that suspends the $31.4 trillion debt ceiling [until January 1, 2025] while cutting federal spending, backing a bipartisan deal struck by President Biden and House Speaker Kevin McCarthy to avert an unprecedented U.S. default.
  • “The 63-36 vote reflected support from both Democrats and Republicans, with backers saying the need to raise the nation’s borrowing limit outweighed concern about provisions related to military and domestic spending and energy policy, among other contentious issues.
  • “The measure now goes to the president for his signature with several days to spare before Monday, when the Treasury Department has said that the government will run out of money to pay all of its bills.”
  • The Journal further informs us,
    • “President Biden plans to pick former North Carolina Health Secretary Dr. Mandy Cohen to lead the Centers for Disease Control and Prevention, according to people familiar with the planning. * * *
    • “Cohen, a medical doctor like Walensky, served in the Obama administration as chief of staff at the Centers for Medicare and Medicaid Services. She helped implement the Affordable Care Act and new payment models at the agency.
    • “She also served as North Carolina’s health secretary for nearly five years into 2021, helping lead the state through the Covid-19 pandemic. She is an executive at Aledade, a network of independent primary-care practices. * * *
    • “The White House and the CDC declined to comment. Cohen’s selection for the role was earlier reported by The Washington Post. The role doesn’t require Senate confirmation.”
  • Healthcare Dive tells us,
    • “The CMS on Wednesday issued a final rule lifting the COVID-19 vaccine mandate for workers in healthcare facilities that receive federal funding as soon as early August. The rule, which will go into effect 60 days after being published in the Federal Register, would withdraw regulations requiring the vaccines for healthcare workers that went into effect last year following a number of legal challenges.
    • “The CMS said it will not be enforcing the provisions between now and August.”

From the public health front —

  • The Wall Street Journal reports,
    • “There is a test that could diminish the toll of the nation’s top cancer killer—if people would use it. Doctors are pushing harder to make that happen.
    • “Lung cancer kills upward of 127,000 people in the U.S. each year. The toll has waned in recent years thanks to declining smoking rates and new treatments, but it remains the deadliest cancer for Americans by far. 
    • “A CT scan can catch the disease early to help save lives. The five-year survival rate when lung cancer is caught early is about 60%, compared with around 7% if it is caught after disease has spread, according to the American Lung Association. Medical groups recommend annual, low-dose scans starting at 50 for people who smoke heavily or recently quit. Insurers often cover the test. 
    • “It’s low-hanging fruit for the country,” said Dr. Patrick Hwu, president and chief executive of the Moffitt Cancer Center in Tampa, Fla. “It would save the most lives immediately.”
  • The Journal also lets us know,
    • “About 3.66 million babies were born in the U.S. in 2022, essentially unchanged from 2021 and 15% below the peak hit in 2007, according to new federal figures released Thursday.
    • “The provisional total—3,661,220 births—is about 3,000 below 2021’s final count, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics. Final government data expected later this year could turn that small deficit positive. * * *
    • “Absent increases in immigration, fewer births combined with ongoing baby boomer retirements will likely weigh on the labor force supply within the next 10 years, said Kathy Bostjancic, chief economist at Nationwide, an insurance and financial-services company.
    • “You’re going to have a real shortage of workers unless we have technology somehow to fill the gap,” Bostjancic said.”
  • The U.S. Preventive Services Task Force released a final research plan for its Perinatal Depression: Preventive Interventions project.
  • The Department of Labor points out,
    • [Last week,] “the White House released the first-ever U.S. National Plan to End Gender-Based Violence. The plan lays out a roadmap for a whole-of-government effort to prevent and address gender-based violence in the United States. One of the groundbreaking aspects of this plan is that it reflects principles from the International Labor Organization’s Convention on Violence and Harassment in the World of Work, recognizing gender-based violence and harassment in the “world of work,” which includes not only traditional workplaces but anywhere workers are paid, in places workers take rest breaks, in work-related training, and through work-related communications.” 
  • HR Dive reports,
    • “The percentage of employees in the general U.S. workforce who tested positive for marijuana after a job accident reached a 25-year high in 2022, according to data released May 18 by Quest Diagnostics.
    • “In 2022, 7.3% of the general workforce (private sector employees in non-safety-sensitive jobs) tested positive for marijuana in a post-accident urine test, up from 6.7% in 2021, according to Quest’s latest Drug Testing Index. After rising steadily each year for the past 10 years, the 2022 positivity rate reflected a 204% jump since 2012, Quest said. 
    • “The increase in post-accident marijuana positivity rates corresponds with the legalization of marijuana for recreational use in certain states, starting in 2012 with Colorado and Washington, Quest noted in a news release. The DTI data “provide compelling evidence that increased use of cannabis products can contribute to greater risk for injuries in the workplace,” Katie Mueller, a National Safety Council senior program manager, stated.”

From the U.S. healthcare business front —

  • Beckers Hospital Review shares Newsweek’s list of top-ranked maternity hospitals in the U.S.
  • The American Hospital Association reports
    • “Following discussions between the American Hospital Association (AHA) and United Healthcare (UHC), the insurer late yesterday announced a refocused gastroenterology (GI) policy that relies on additional provider education rather than prior authorizations to address the insurer’s concerns about possible overutilization. The refocused policy avoids potential care denials for patients, particularly vulnerable patients, and will not impact the coverage and payment of claims for these services. The GI policy, which pertains to certain non-screening endoscopy and colonoscopy services, goes into effect today, June 1.
    • “UHC will instead implement a 7-month, or potentially longer, pilot program to collect data that substitutes notification and submission of standard clinical data when services are delivered for prior authorization, removing the risk of potential care delays and claim denials. This data will be applied to UHC’s gold-carding program, beginning sometime in 2024, in order to exempt physicians that are routinely aligned with the insurer’s guidelines. The insurer has yet to determine any additional controls that will be placed on non-gold-carded clinicians at the end of the pilot.”
  • Healthcare Dive tells us
    • “BJC HealthCare and Saint Luke’s Health System announced Wednesday they had signed a non-binding agreement to merge, creating a $10 billion health system serving patients in Missouri, Kansas and Illinois. 
    • “The 28-hospital system would keep their current brands and operate from two headquarters, with the St. Louis base focusing on eastern Missouri and southern Illinois, while the Kansas City, Missouri, headquarters serves western Missouri and parts of Kansas. 
    • “BJC and Saint Luke’s said they’re planning to reach a definitive agreement “in the coming months,” assuming no regulatory hurdles. They expect the deal to close by the end of the year.”
  • and
    • “Oak Street Health plans to enter Arkansas, Iowa, Kansas and Virginia beginning this summer, the value-based primary care chain for seniors announced Tuesday.
    • “The expansion will grow the footprint of Chicago-based Oak Street, which was acquired by CVS for $10.6 billion, to 25 states.
    • “Oak Street also plans to open additional centers in Arizona, Colorado, Georgia, Illinois, Indiana, Louisiana, New York, Ohio and Pennsylvania this year, according to a release.”

From the Rx coverage front —

  • STAT News reports,
    • “In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less.
    • “Specifically, the Coherus medicine will carry a $995 list price for a carton of two autoinjectors, an 85% discount from the $6,922 that AbbVie charges for Humira, which is used to treat rheumatoid arthritis and other conditions. At the same time, Coherus will sell its drug at a discount to the Mark Cuban Cost Plus Drug Company, which will market the treatment for about $579.
    • “The lowball pricing for the drug, which will become available in July, has the potential to alter one of the most closely watched product rollouts by pharmaceutical companies in many years. After enjoying a monopoly that yielded billions of dollars in annual sales, AbbVie is expected to face at least eight biosimilar rivals to Humira by the end of the year.”
  • BioPharma Dive relates,
    • “Medicare on Thursday affirmed plans to limit coverage for certain Alzheimer’s disease drugs, but signaled it’s taking steps to ensure broader access should one of the medicines receive full Food and Drug Administration approval.
    • “In a statement, the Centers for Medicare and Medicaid Services said they would cover drugs like Eisai and Biogen’s Leqembi when patients and their doctors participate in a registry for collecting data on how the treatments work in the real world. The stance is in line with the agency’s current policy, but describes a process that analysts viewed as relatively straightforward to fulfill.
    • “However, the nonprofit Alzheimer’s Association, which has previously attacked Medicare’s policy, criticized the registry requirement and said it “will create unnecessary hurdles to coverage.” The agency’s plan will soon be tested as Leqembi — currently cleared on a conditional basis in the U.S. — is up for full FDA approval, with a decision expected by July.”