Midweek Update

U.S. Healthcare

Midweek Update

David Ermer–CDC, Congress, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC —

  • STAT News reports
    • “Republican Sen. Chuck Grassley wants to see his party’s leadership turn up the pressure on pharmacy benefit managers.
    • “They talk in such generalities on this subject that it’s difficult for me to tell where they’re coming from,” he said at a STAT event Wednesday, speaking about top GOP senators’ approach to reforming the drug pricing middlemen who negotiate between pharmaceutical companies and insurers. “We’re hearing… ‘We don’t want to do something splitting the caucus.’ But we’ve got a major problem here with PBMs deciding rebates, deciding the price of drugs, probably being an instrument to drive up the price of drugs, and nobody knows what they’re doing.”
    • “Grassley has reason to push urgency. The Senate leaves this weekend for a July recess, and when they return next month, lawmakers have just over two weeks of working days in the Capitol before a monthlong AugusSt break. Multiple drug pricing priorities hang in limbo.”
  • The Federal Times adds
    • “The House’s fiscal 2024 funding plan for federal civilian agencies would force agencies to roll back telework, keep abortion out of employee health insurance plans and make pay contingent on compliance with Congressional demands.
    • “The Financial Services and General Government Appropriations bill, which will be considered in a hearing Thursday, sets funding for more than two dozen independent agencies, including the Internal Revenue Service and White House offices, for the government fiscal year that starts Oct. 1, according to an executive summary released Wednesday.”
  • STAT News informs us
    • “A panel of experts that advises the Centers for Disease Control and Prevention on vaccinations opted Wednesday not to recommend that all seniors get a vaccine to protect against RSV.
    • “Instead, the Advisory Committee on Immunization Practices said that anyone 60 and older should be able to get one of the new vaccines — being brought to market by GSK and Pfizer — if they and their physicians think it would be worthwhile.”

From the public health front —

  • The National Cancer Institute advises
    • “A new study has found an effective way to help women in rural towns get screened for cancer. But the study didn’t zero in on just one kind of cancer screening. Instead, the researchers tried simultaneously boosting all of the cancer screenings women need—breast, cervical, and colorectal. And a randomized clinical trial of the approach showed that it worked.
    • “In the trial, providing rural women with an interactive video of tailored messages about cancer screening plus a phone call with a patient navigator was the most effective way of getting them up to date on all three cancer screeningsExit Disclaimer. 
    • “Results of the study, which included nearly 1,000 women living in rural parts of Indiana and Ohio, were published April 28 in JAMA Network Open.
    • “The basic message is: Health care providers can, and probably should, address all screenings needed at the same time,” said study co-leader Victoria Champion, Ph.D., R.N., of Indiana University Melvin and Bren Simon Comprehensive Cancer Center.”
  • and
    • “New cases of colorectal cancer in people under the age of 50 have been rising at an alarming rate over the past several decades. But younger adults aren’t routinely screened for colorectal cancer because the disease is still relatively rare in younger adults. 
    • “Now, a study has identified four warning signs that, according to the investigators, could help encourage younger adults to seek medical care so they can potentially catch the disease at an earlier and more treatable stage. 
    • “To conduct the study, the research team analyzed insurance claims data on more than 5,000 people diagnosed before age 50, called early-onset colorectal cancer, and more than 22,000 people without cancer (controls).
    • “The analysis showed that, in the period of 3 months to 2 years before people with colorectal cancer were diagnosed, four signs were more commonly reported in people who developed colorectal cancer than in matched controls:
      • abdominal pain
      • rectal bleeding
      • diarrhea
      • iron deficiency anemia
    • “Having just one of these signs during this period was associated with nearly twice the likelihood of being diagnosed with early-onset colorectal cancer as having none of the signs.
    • “Having three or more of these signs was associated with six times the likelihood of being diagnosed with the disease. The findings were published May 4 in the Journal of the National Cancer Institute.”
  • STAT News reports “Xylazine or ‘tranq’ is making opioid overdoses harder to reverse.”
    • “Six years ago, when you would hit somebody with naloxone, they would be very responsive,” said Sarah Laurel, the executive director of Savage Sisters, a Philadelphia nonprofit that provides resources and care to people who use drugs. But more recently, she said, “I started noticing that my friends, when we would hit them with Narcan, they weren’t responsive. Their color was not returning, and they weren’t beginning to breathe on their own.”
    • “When responding to an overdose in the xylazine era, Laurel said, the new priority is simple: oxygen. Emergency responders and harm-reduction workers are increasingly using whatever tools and techniques they have available to make sure oxygen is reaching overdose victims’ brains, including mouth-to-mouth breathing and oxygen masks.
    • “Amid the fast-changing landscape, doctors, first responders, public health officials, and nonprofits have scrambled to formalize their new overdose-response protocols. At the same time, they have worked to draw up new instructions for bystanders who encounter an overdose in progress. They are, in essence: Administer naloxone, call 911, and then immediately start “rescue breathing” to ensure the overdose victim doesn’t die or experience hypoxic brain injury before emergency responders arrive.
    • “Recent guidance from the Philadelphia Department of Public Health encourages overdose responders to provide supplemental oxygen and employ “airway management” techniques — essentially, manipulating the head, neck, and body to ensure breathing isn’t blocked.”
  • HHS announced
    • The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), issued a new advisory today: Identification and Management of Mental Health Symptoms and Conditions Associated with Long COVID.
    • “Long COVID has a range of burdensome physical symptoms, and can take a toll on a person’s mental health. It can be very challenging for a person, whether they are impacted themselves, or they are a caregiver for someone who is affected,” said HHS Secretary Xavier Becerra. “This advisory helps to raise awareness, especially among primary care practitioners and clinicians who are often the ones treating patients with Long COVID.”
  • and
    • “The Biden-Harris Administration today announced a public-private partnership between the U.S. Department of Health and Human Services (HHS) and Upstream to expand access to contraception, an essential component of reproductive health care, and address the growing disparities in women’s health in the U.S.”

From the plan design front —

  • Health Payer Intelligence points out
    • “Payers should consider program design intensity when implementing value-based purchasing contracts, as higher-intensity programs can lead to better care quality and greater spending reductions, a systematic review published in Health Affairs found.
    • “Value-based purchasing programs can incorporate both financial and non-financial features. Financial aspects include bonuses, penalties, and financial risk-sharing arrangements.
    • “Non-financial aspects aim to help providers respond to the spending and quality incentives in a VBP program. These include analyzed data, reports, or lists; technical assistance through leadership or change management training, infrastructure payments to add more staff; raw claims data; risk-management support; and care management support.
    • “Different combinations of financial and non-financial supports can lead to varying levels of program intensity.”
  • The Wall Street Journal reports
    • Food and insurance companies are exploring ways to link health coverage to diets, increasingly positioning food as a preventive measure to protect human health and treat disease.
    • Insurance companies and startups are developing meals tailored to help treat existing medical conditions, industry executives said, while promoting nutritious diets as a way to help ward off diet-related disease and health problems.
    • “We know that for adults, around 45% of those who die from heart disease, Type 2 diabetes, stroke, that poor nutrition is a major contributing factor,” said Gail Boudreaux, chief executive of insurance provider Elevance Health speaking at The Wall Street Journal Global Food Forum. “Healthy food is a real opportunity.”

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, FDA, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front —

  • Health Affairs launched a new publication called Health Affairs Scholar. Health Affairs also made available its lead article in the new publication titled “Ten Health Policy Challenges for the Next Ten Years.”
  • MedPage Today reports
    • “An increase in pediatric type 2 diabetes cases that began during school closures amid the COVID-19 pandemic has not returned to baseline, according to a retrospective study.
    • “Compared with the year before COVID emerged, the number of new pediatric type 2 diabetes cases ballooned during the first year of the pandemic (March 2020 through February 2021; P=0.005), and then jumped again during the second year (March 2021 through February 2022; P=0.0006), reported Esther Bell-Sambataro, MD, of Nationwide Children’s Hospital and the Ohio State University in Columbus, during ENDO 2023opens in a new tab or window, the annual meeting of the Endocrine Society.”
  • The Food and Drug Administration adds
    • “Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by mouth to treat pediatric type 2 diabetes. Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.
    • “Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, M.D., M.P.H., associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”
  • Also from the FDA
    • “Today, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. 
    • “We believe this guidance and the launch of the pilot program are important steps towards addressing safety risks posed by the use of poorly performing laboratory-developed tests,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments.”
  • The National Institutes of Health informs us
    • “A recent follow-up analysis of data from an international, National Institutes of Health-funded clinical trial suggests daily low-dose aspirin increases the risk of anemia in people age 65 years and older by approximately 20%. Given these findings, older adults on low-dose aspirin and their care providers may want to consider periodic monitoring of red blood cells or hemoglobin. Anemia in older adults is associated with functional decline, increased fatigue, disabilities, depressive symptoms, and cognition problems.
    • “Published in the Annals of Internal Medicine, scientists from the Aspirin in Reducing Events in the Elderly (ASPREE) study examined the effect of long-term low-dose aspirin use on incident anemia and the effect of aspirin on changes in hemoglobin concentration, as well as ferritin levels, as an indicator of iron deficiency. The researchers found that low-dose aspirin led to increased incident anemia in otherwise healthy older adults at enrollment, independent of major bleeding.”
  • The U.S. Preventive Services Task Force released a new recommendation — “Adults 64 years or younger, including pregnant and postpartum persons: Screen for anxiety. Grade: B” — and reissued a 2014 recommendation — “Adults, including pregnant and postpartum persons, and older adults (65 years or older): Screen for major depressive disorder (MDD). Grade: B.”
  • ICD10 Monitor alerts us
    • “The Centers for Disease Control and Prevention (CDC) released the ICD-10-CM codes for the 2024 fiscal year (FY) on Friday, June 16. This release included 395 additions, 25 deletions, and 13 revisions. The deletions are due to the expansion of the diagnosis codes. The total ICD-10-CM codes for FY 2024 is 74,044. These codes will be effective starting with Oct. 1, 2023, visits or discharges.”

From the federal employment front —

  • FedWeek tells us
    • “A hearing set for this week on three high-profile work backlogs likely will add to the pressure from House Republicans for agencies to reduce their levels of telework.
    • “The hearing in the House federal workforce subcommittee will “examine the backlogs of military and civil service personnel records requests, the Social Security Administration’s customer service line and disability claims, and passport backlogs. This hearing will also examine what steps agencies are taking to clear backlogs and provide timely service and support to the American people,” according to the panel.”
  • Govexec reports
    • “An advisory council dedicated to examining issues related to federal employee compensation issued no new recommendations for changes to the map of locality pay areas in a newly released report, instead urging quick implementation of proposals that already received a green light from the president’s pay agent.
    • “In a report dated Feb. 4 but only published by the Office of Personnel Management this month, the Federal Salary Council said none of the regions currently being studied by the Bureau of Labor Statistics regarding the pay disparity between federal workers and private sector employees currently meet the criteria to become locality pay areas.
    • “Instead, the council, which is made up of a mix of presidentially appointed federal human resources experts and representatives of unions and other federal employee organizations, focused its report on reiterating a series of recommendations approved last December by the president’s pay agent, a body made up of OPM Director Kiran Ahuja, Office of Management and Budget Director Shalanda Young and then-Labor Secretary Marty Walsh. But in order for those recommendations to be implemented, OPM must first issue regulations.
    • “In terms of discreet additions to the map of locality pay areas, the salary council urged swift action to implement the new locality pay areas of Fresno, Calif.; Reno, Nev.; and Spokane, Wash. Additionally, Dukes and Nantucket counties, Mass., would join the Boston locality pay area; Huron County, Mich., will join the Detroit locality pay area; and Pacific and San Juan counties, Wash., would be included in the Seattle locality pay area. And Greensville County and the city of Emporia in Virginia would both become part of the Richmond locality pay area.”
  • and
    • “The U.S. Postal Service is preparing layoff notices that could take effect in September, notifying staff earlier this month of the potential for workforce reductions. 
    • “USPS is allowing impacted workers to apply for lateral or downgraded positions, anticipating it can absorb the employees elsewhere. The changes will affect non-union staff in the logistics division serving in management positions. James Lloyd, a USPS director for labor relations policies and programs, said the reductions were developed “based on an evaluation of staffing criteria and manager levels” by headquarters personnel.”

From the U.S. healthcare business front —

  • HHS’s Agency for Healthcare Quality and Research released its annual update to the Compendium of U.S. Health Systems.
    • “The Compendium of U.S. Health Systems includes information on U.S. health systems, defined in this analysis to include at least one hospital and at least one group of physicians providing comprehensive care, and who are connected with each other and with the hospital through common ownership or joint management. The Compendium is updated on a regular basis, with the newest files released in June 2023:
    • “2021 Compendium (New)
    • “2020 Compendium (New)
    • “2018 Compendium“
  • Beckers Hospital Review ranks 35 health systems by revenue.
  • BioPharma Dive reports
    • “Eli Lilly has agreed to buy Dice Therapeutics for about $2.4 billion in a deal that gives the pharmaceutical giant a promising oral autoimmune disease drug in clinical testing.”
    • “Lilly will buy Dice, a young biotechnology company that went public in 2021, for $48 per share in cash, the companies announced Tuesday. The purchase price equates to a roughly 42% premium to Dice shares’ closing price Friday and about 40% above the average trading price over the last month.
    • “The deal is expected to close in the third quarter, pending regulatory clearance and the tender of a majority of Dice’s outstanding stock.”

Happy Juneteenth

David Ermer–Congress, Generative AI, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Photo by Derek Lamar on Unsplash

Mercer Consulting offers us this background

  • “On June 19 this year, 96 year-old Opal Lee will once again invite others to join her on a 2.5 mile Walk for Freedom in Fort Worth, Texas. Known as the “Grandmother of Juneteenth,” Opal began campaigning decades ago for a national holiday to commemorate the anniversary of the day in 1865 when news of the Emancipation Proclamation finally reached the enslaved people in Galveston, Texas. In 2016, at age 89, Opal began a symbolic walk from Fort Worth to Washington D.C. in an effort to get 100,000 people to sign a petition to create the holiday. She was transported from city to city where she would walk 2.5 miles, representing the 2.5 years it took for freedom to reach Texas. By the time she made it to Washington, she had obtained over 1.5M signatures. In June 2021, her efforts succeeded – a bill to make Juneteenth a federal holiday was passed by Congress and signed into law by President Joe Biden.  
  • “Juneteenth has long been celebrated by Black people; Opal Lee has vivid memories of celebrating Juneteenth as a child in East Texas with music, food, and games. Since the creation of the federal holiday, more employers are recognizing its importance and embracing their role in promoting Juneteenth in the workplace. In 2021, just 9% of employers had made Juneteenth a paid company holiday. That jumped to 33% in 2022 and rose again this year, to 39%.”

Mercer Consulting adds

  • “For employers, the JAMA Open Network study [on healthcare disparities] underscores the pressing need to expand provider networks to be inclusive of diverse clinicians. By improving networks, and actively working with partners to dismantle barriers and biases within healthcare, we can begin to empower employees with choice – the ability to connect with providers who better understand their unique needs, experiences, and challenges. Diverse physician networks lead to stronger doctor-patient relationships, which ultimately lead to better health outcomes for marginalized populations.”

From Washington, DC —

  • The U.S. Supreme Court handed down five opinions last week. NPR identifies the remaining cases that it is tracking. (One of them the Indian Child Welfare Act was decided last week in favor of the Indian tribes.)
  • Last week, OMB’s Office of Information and Regulatory Affairs posted its Spring 2023 federal regulatory agenda. Here is a link to the OPM agenda. OPM is planning a second Postal Service Health Benefits Program rule and a rule that would accelerate the effective date of FEHB coverage for new federal employees.

Healthcare Dive reports

  • “The group that advises Congress on Medicare policy released a new report Thursday [June 15] with recommendations on telehealth, overpayments to Medicare Advantage plans and site-neutral payments across some outpatient care settings.
  • “The Medicare Payment Advisory Commission, or MedPAC, included telehealth in the report to satisfy a mandate from Congress after virtual care surged during the COVID-19 pandemic. Telehealth coverage under Medicare was limited before the public health emergency, and it was expanded to preserve access to care.
  • “The report found fee-for-service Medicare spending for telehealth care was $4.8 billion in 2020 and $4.1 billion in 2021, more than 30 times greater than 2019. Early findings show more telehealth use was associated with little change in quality, slightly improved access to care for some beneficiaries and slightly increased costs to Medicare.”

From the MD opinion front —

  • An emergency room doctor writing in MedPage Today gives us his take on the fentanyl crisis.
  • An oncologist writing in STAT News gives us her take on the cancer drug shortage. Her article’s title says it all: “Cancer drug shortages should have patients rioting in the streets.”

From the generative AI front, Healthcare IT News tells us, “An NYU Langone Health [large language model] LLM can predict hospital readmissions. The large language model is still in testing, but the AI tool had a median accuracy score of 77.8% compared to a physician score of 62.8%. The code base is now available to all healthcare organizations [via GitHub].

From the semaglutide drug front —

  • The Wall Street Journal reports that these drugs designed for weight loss also may bring alcohol and tobacco use from an addiction to a controllable level.
  • Politico discusses manufacturer lobbying efforts to convince Congress to cover these drugs for weight loss unconnected to diabetes.
  • Bloomberg informs us
    • “Some dosages of Eli Lilly & Co.’s Mounjaro are again in shortage, the latest in a line of recurring supply issues caused by patients using the diabetes medication as a weight-loss treatment.
    • “The latest shortage will result in “intermittent backorders” for three of six doses through July, according to an update posted by the US Food and Drug Administration on its website on Friday.
    • “Lilly spokesperson Jessica Thompson said the backorders were “due to continued dynamic patient demand” and would affect the three highest doses of Mounjaro. She also said the company is investing in expanding manufacturing capacity.”

From the miscellany front –

  • CNBC reports
    • “Bristol Myers Squibb on Friday sued the Biden administration over Medicare’s new powers to slash drug prices, the third such lawsuit to be filed against the program in a matter of days.
    • “The lawsuit filed in federal district court in New Jersey argues the Medicare negotiations violate the First and Fifth Amendments of the U.S. Constitution.
    • “Bristol Myers Squibb has asked the court to declare the program unconstitutional and prevent the Health and Human Services Department from forcing the company to enter negotiations.
    • “Bristol Myers Squibb’s arguments mirror those lodged last week by Merck, the first company to sue the federal government over the drug negotiations. The U.S. Chamber of Commerce has also sued HHS over the program with similar arguments.”
  • Fierce Healthcare relates
    • “Simple HealthKit has inked a deal with Walmart to bring at-home diagnostic tests, including diabetes, respiratory wellness and sexual wellness labs, to the largest retailer in the world.
    • “Through the retail giant’s website, customers can purchase tests bolstered by Simple HealthKit’s end-to-end healthcare infrastructure, including testing, follow-up and treatment. The digital health company’s HbA1c test identifies key markers for Type 2 diabetes. Respiratory wellness tests include influenza A, influenza B and respiratory syncytial virus. In light of a decrease in sexual health testing during the pandemic, customers can test for three of the most common STDs at home, chlamydia, gonorrhea and trichomoniasis.”
  • Health Payer Intelligence points out
    • Employer-sponsored health plan enrollment among nonelderly Americans will grow after 2025, accompanied by higher private payer premiums, a Health Affairs study found.
    • The study used Congressional Budget Office projections to estimate future coverage trends. However, the researchers noted many uncertainties embedded in these trends, including future economic, policy, and healthcare utilization changes. * * *
    • After 2025, enhanced subsidies will end and employment will increase, driving more people to employer-sponsored coverage. Approximately 157 million individuals may have employer-sponsored coverage in 2027. By 2033 this population will grow to 159 million.
    • Private-payer premiums will also trend upward from 2023 through 2033. In 2023, the private payer premium growth rate will be 6.5 percent. Premiums will grow 5.9 percent from 2024 to 2025 and 5.7 percent from 2026 to 2027. By 2033, the average premium increase will be 4.6 percent.
  • Of course, depending on the outcome of the 2024 federal election, it is possible that the ACA subsidies could be made permanent in 2025. Time will tell.

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • MedPage Today reports
    • “On Friday, President Biden announced his intent to choose former top North Carolina health official Mandy Cohen, MD, MPH, to lead the CDC.
    • “Dr. Cohen is one of the nation’s top physicians and health leaders with experience leading large and complex organization and a proven track record protecting Americans’ health and safety,” Biden said in a statement.” * * *
    • “Cohen earned her bachelor’s degree at Cornell University in Ithaca, New York, her medical degree from the Yale School of Medicine in New Haven, Connecticut, and her master’s in public health from the Harvard Public School of Health in Boston. She completed her residency at Massachusetts General Hospital.”
  • STAT News suggests that Dr. Cohen’s political experience will benefit the CDC. Dr. Cohen’s nomination does not require Senate confirmation. Senate confirmation of CDC Directors will become a prerequisite in 2025.
  • Per Reuters,
    • “The U.S. Supreme Court on Friday preserved the Justice Department’s power to unilaterally dismiss lawsuits filed under a law that lets whistleblowers sue businesses on behalf of the government to recover taxpayer money paid to companies based on false claims in exchange for a portion of any recovery.”
    • In the FEHBlog’s opinion, this is a logical and welcome outcome as the federal government should have control over litigation brought on its behalf.
  • Per the FDA’s website,
    • “Today, the FDA posted information on its website regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. This recommendation incorporates advisory committee input and is based on the totality of the available evidence to select the vaccine composition that the FDA anticipates will best protect public health. The agency anticipates the timely submission of the data and filings to support FDA action on updated COVID-19 vaccines in order to make vaccines available this fall that meet our standards for safety, effectiveness and quality. 
    • “On Thursday, the FDA granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy. The prescribing information includes a Boxed Warning for serious or fatal cytokine release syndrome (CRS). Other warnings and precautions include neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity (ICANS), serious infections, and tumor flare. Glofitamab-gxbm should only be administered by a healthcare professional with appropriate medical support to manage severe reactions, including CRS. View full prescribing information for Columvi.”

From the miscellany department —

  • Healthcare Dive reports
    • A second major health insurer is warning investors about higher-than-anticipated outpatient care utilization that could hike medical costs, potentially cutting into profits. [UnitedHealthCare was the first.]
    • Humana filed an 8-K with the U.S. Securities and Exchange Commission on Friday morning saying elevated outpatient trends are expected to push its medical loss ratio, a marker of how much payers spend on patient care, toward the high end of its outlook for both the second quarter and the full year.
  • NPR tells us
    • Pfizer is facing a shortage of penicillin due to increased demand and more diagnoses of syphilis, the company said in a letter to its customers this week. 
    • The company said there is an “impending stock out situation” for select Bicillin L-A and Bicillin C-R prefilled syringes, Pfizer’s brand name of injectable penicillin. 
    • Prefilled Bicillin L-A pediatric syringes are expected to begin running low by the end of June, while all Bicillin C-R syringes could begin diminishing in the third quarter of this year. 
    • Inventory is predicted to start recovering in the second and third quarters of 2024, Pfizer said. 
    • Penicillin is an antibiotic used to treat various types of infections, including sexually transmitted diseases, such as syphilis and pneumonia.
  • Medscape points out
    • The American Medical Association (AMA) on Wednesday said it will advise doctors to pay less attention to body mass index (BMI) in determining if a patient is at a healthy weight, saying the measure does not predict disease risk equally well across racial and ethnic groups.
    • BMI, a ratio of weight to height, has long been used to define underweight, “normal” weight, overweight, obesity and morbid obesity, despite mounting evidence that it is an inaccurate predictor of health risks on an individual level.
    • At the influential physician group’s annual meeting in Chicago, members voted adopt a new policy that says BMI should be just one factor in determining whether a patient is at a healthy weight. Other measures such as body composition, belly fat, waist circumference, and genetic factors are also important, the AMA said. * * *
    • The AMA’s new policy also says BMI should not be used as a sole criterion for denying insurance reimbursement.
  • MedPage Today interviews the new AMA President-elect, Dr. Bruce Scott.

Thursday Miscellany

David Ermer–Congress, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, D.C.

  • Politico tells us,
  • “The House Energy and Commerce Committee will examine how Medicare pays doctors, Robert King reports.
  • “The panel’s Investigations and Oversight Subcommittee will hold a hearing next week to get an update on the 2015 Medicare Access and CHIP Reauthorization Act, which overhauled the formula used to pay doctors under Medicare, members confirmed.
  • “Doctors have complained that their Medicare payments are effectively being cut under the current system, fueling consolidation among doctors and hospitals.”
  • HR Dive informs us
    • Employers will have to wait at least a few more months for some long-awaited regulatory changes, the U.S. Department of Labor said Tuesday.
    • A proposal to increase the Fair Labor Standards Act’s overtime salary threshold previously expected in May has been pushed to August, DOL’s Wage and Hour Division indicated in its spring regulatory agenda.
    • A final rule expected from WHD, one that would likely tighten rules for classifying workers as independent contractors, was similarly delayed to August. Just days before the agency published its agenda, it also indicated in a court filing that it expects to have the independent contractor rule out soon — by October at the latest.

From the public health front –

  • Health Day points out
    • “Most women diagnosed with early breast cancer will become long-term survivors, according to new research that finds a substantial reduction in the risk of death since the 1990s.
    • “This news should reassure both patients and their doctors, researchers report June 13 in the BMJ.
    • “Our study is good news for the great majority of women diagnosed with early breast cancer today because their prognosis has improved so much,” said the authors, who included Dr. Carolyn Taylor, a professor of oncology at the University of Oxford in England. 
    • “Most of them can expect to become long-term cancer survivors,” they added in a journal news release.”
  • The National Institutes of Health announced
    • “Men were significantly more vulnerable than women to overdose deaths involving opioid and stimulant drugs in 2020-2021, according to a new study(link is external) analyzing death records data from across the United States. The study found that men had a 2–3 times greater rate of overdose mortality from opioids (like fentanyl and heroin) and psychostimulants (like methamphetamine and cocaine). While it has been known that men use drugs at higher rates than women, the researchers found that this alone does not explain the gap in overdose deaths, noting that biological, behavioral, and social factors likely combined to increase the mortality risk for men.
    • “The study, published in Neuropsychopharmacology, was led by investigators at the Icahn School of Medicine at Mount Sinai in New York City and the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
    • “Though men and women are being exposed to the modern, fentanyl-contaminated drug supply, something is leading men to die at significantly higher rates. It may be that men use drugs more frequently or in greater doses, which could increase their risk of death, or there may be protective factors among women that reduce their risk of death compared to men,” said Nora Volkow, M.D., director of NIDA and one of the co-authors on the study. “Understanding the biological, behavioral, and social factors that impact drug use and our bodies’ responses is critical to developing tailored tools to protect people from fatal overdose and other harms of drug use.”
  • NFC relates,
    • “Over the past 12 months, roughly half (45%) of American workers reported spending between $500 and $6,000 on mental health services, with nearly one-third (32%) saying they spent more than $1,501. This comes at a time when 95% of workers report they are concerned about the economic situation in the US, and financial worries are adding to their stress and burnout.
    • “Despite rising employee stress, fewer than 6% of employers say they spend more than $500 on mental health per employee, and 72% do not plan to add additional mental health support in the year ahead.
    • “These are among the findings from leading benefits consultant NFP’s 2023 US Benefits Trend Report.”
  • Bloomberg reports on chemotherapy drug shortages facing our country.

In conference news, AHIP reports on the final day of its conference while Healthcare Dive discusses the actions taken at the AMA House of Delegates meeting. Beckers Hospital Review reports on Kaiser Permanente CEO Greg Adams’ keynote speech at the AHIP conference.

From the U.S. healthcare business front —

  • Beckers Hospital Review tells us
    • “A data visualizer shows the ten most similar hospitals to any one benchmark hospital, challenging traditional, ordinal rank lists in a time of great volatility for hospitals. 
    • “SimilarityIndex | Hospitals comes from Trilliant Health, which created the tool so health economy stakeholders can learn how similar a selected benchmark hospital is to — or different from — highly regarded U.S. hospitals. 
    • “Becker’s took the ten top-ranked hospitals from the latest U.S. News and World Report’s Honor Roll to find their five most similar aggregate peers. Their similarity scores are listed [in the article].” 
  • BioPharma Dive reports
    • “Coherus BioSciences has batted back a legal challenge from AbbVie weeks before it plans to launch a much cheaper version of the latter company’s best-selling rheumatoid arthritis drug Humira.
    • “The latest dispute began after Coherus on June 1 announced plans to sell its biosimilar, dubbed Yusimry, at an 85% discount to Humira and work with Mark Cuban’s online pharmacy to provide it to other patients for even less starting in July. On June 6, Coherus received a notice from AbbVie saying that the plans violated a licensing agreement between the two companies.
    • “After a round of correspondence and dueling court filings, the companies resolved the dispute on Wednesday. AbbVie won’t terminate the license agreement based on its June 6 notice and agreed not to try to terminate the license in the future unless it both notifies Coherus of an alleged breach and also gives the company a chance to fix the problem, Coherus said in a regulatory filing.”
  • KFF reports
    • “A new report has provided the first national count of Americans who rely on health care sharing plans — arrangements through which people agree to pay one another’s medical bills — and the number is higher than previously realized.
    • “The report from the Colorado Division of Insurance found that more than 1.7 million Americans rely on sharing plans and that many of the plans require members to ask for charity care before submitting their bills.
    • “The total membership numbers are likely even higher. The state agency collected data from 16 sharing plans across the U.S. but identified five other plans that did not report their data.
    • “These plans cover more people than we had previously known,” said JoAnn Volk, co-director of the Center on Health Insurance Reforms at Georgetown University.
    • “Under the arrangements, members, who usually share some religious beliefs, agree to send money each month to cover other members’ health care bills. At least 11 of the sharing plans that reported data operated in or advertised plans in all 50 states in 2021.”
  • The Washington Post reports on consumer concerns about employer-sponsored and public health plans.
    • “By the numbers:
    • “About 26 percent said that a doctor covered by their insurance didn’t have any available appointments. One-third of Medicaid enrollees reported having such an issue.
    • “Roughly 18 percent of those surveyed indicated their insurance didn’t pay for care they thought was covered. That complaint was more common among those with employer-sponsored health insurance and Obamacare plans.
    • “Nearly 3 in 4 insured adults who have received mental health treatment in the past year report experiencing a problem with their insurance.” 

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.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The House of Representatives Committee on Education and the Workforce held a hearing today to examine the policies and priorities of the Department of Health and Human Services.
  • STAT News adds
    • “A key House Republican ramped up his criticism of pharmacy benefit managers Tuesday, calling for the government to dismantle companies that have consolidated drug supply chain operations.
    • “We should break these PBMs up,” House Oversight Committee Chair James Comer (R-Ky.) said during an Education and Workforce Committee hearing. Health Secretary Xavier Becerra testified at the hearing on his department’s priorities. * * *
    • “Comer asked Becerra what the administration thinks should be done to reform PBMs.
    • “Transparency,” Becerra responded. “As they say, sunshine is the best disinfectant.”
  • STAT News reports from the Senate
    • “In another bid to lower prescription drug prices, U.S. Sen. Bernie Sanders (I-Vt.) issued a report showing that medicines developed with help from the National Institutes of Health have often cost Americans more than what is paid in other countries. And he called on the agency to reinstate a provision in federal law that would require companies to set reasonable prices when they license NIH inventions. * * *
    • “The report was issued as the Biden administration seeks confirmation of Monica Bertagnolli, who currently heads the National Cancer Institute and was nominated to run the NIH. But the confirmation cannot proceed without support from Sanders because, as chair of the Senate health committee, he controls when nominees are reviewed for positions in the Department of Health and Human Services.
    • “However, Sanders threatened that he will not proceed until the Biden administration provides a “comprehensive” plan to lower prescription drug prices. The White House reportedly responded by acknowledging that prescription drug costs remain high for many Americans and pointed to the Inflation Reduction Act, a recently enacted law that allows Medicare to negotiate prices for certain medicines.”
  • Fierce Healthcare reports
    • “The Biden administration is rolling out new flexibilities that aim to prevent procedural coverage losses as states work through a backlog of Medicaid eligibility determinations.
    • “The Department of Health and Human Services announced that managed care plans can take on a more direct role in assisting members in completing renewal forms. This extends to filling out certain parts of the paperwork on behalf of the member.
    • “In addition, states are able to delay administrative disenrollments by a month for further outreach, which will allow for greater time to fill out necessary forms and paperwork. The agency will also allow pharmacies and community-based organizations to assist in getting coverage reinstated for people who are still eligible but lost coverage for procedural reasons.
    • “Procedural disenrollment is a key concern during the Medicaid redetermination period, as many people who are at risk of losing coverage are not aware that the process is even going on. A recent analysis from KFF looking at early redetermination data found that in a number of states, large numbers of disenrollments are linked to administrative issues.”
  • and
    • “Industry hospital groups are pushing the Centers for Medicare & Medicaid Services (CMS) to consider a higher annual pay bump and to shed some light on why it believes the number of uninsured patients won’t be increasing during fiscal year 2024.
    • “In April, CMS released its proposed fiscal year 2024 Inpatient Prospective Payment Systems (IPPS) rule with a 2.8% increase in payments for the 12-month period beginning in October.
    • “The tentative pay raise for eligible participating hospitals translates to a collective $3.3 billion increase, CMS said at the time, and is based on a 3% projected hospital market basket update minus a 0.2 percentage point productivity adjustment.
    • “Comment letters submitted by the American Hospital Association (AHA) and other major hospital industry groups on Friday homed in on the 2.8% net update as “woefully inadequate” in light of cost pressures, such as inflation and labor spend, that have not subsided since the height of the COVID-19 pandemic.”

From the public health front —

  • The Wall Street Journal tells us
    • “Longevity researchers have spent decades hunting for a magic pill to slow the aging process. But the best solution—at least for now—may be the simplest one: Move more.
    • “No single thing—whether it’s regular cold plunges or off-label drugs and supplements like metformin, rapamycin or taurine—has a track record that can match exercise’s in terms of protecting against age-related diseases and helping people get more from their later years, a vast body of research shows.
    • “The muscle and bone growth stimulated by exercise can help older adults maintain their independence, lessen fatigue and protect against bad injuries from falls, the leading cause of injury-related death among those over 65. 
    • “Regular exercise can reduce the risk of developing certain age-related diseases, including Alzheimer’s, cancer, diabetes and cardiovascular disease. * * *
    • “Any amount of physical activity can help extend a person’s life, research suggests, especially for people who currently are doing very little. Federal guidelines recommend that adults get at least 150 minutes of moderate-intensity exercise a week. 
    • “A team of researchers who analyzed data on more than 650,000 adults over about a decade found that, compared with those who were inactive, those who got about half the government’s recommended physical activity added an average of 1.8 years to their lives. Those who exercised for roughly five to eight hours weekly gained an average of 4.2 years.
    • “When you think about that, in terms of how many years you’re gaining per how many minutes of activity, it’s a very sizable yield,” says Steven C. Moore, the study’s lead author and senior investigator at the National Cancer Institute.”
  • Healthcare Dive informs us
    • “Uber will soon be able to deliver groceries and other over-the-counter items to patients of its payer and provider clients, in the latest benefits expansion of its Uber Health platform.
    • “Uber Health, which already provides non-emergency medical transportation and prescription delivery, has been expanding beyond medical transportation to care coordination across multiple benefits, Catilin Donovan, the head of the division, said in an interview. Soon, provider users will have access to patient benefit data and eligibility files from their health insurers, so they can prescribe services they know are covered.
    • Uber is not yet giving specifics of Uber Health’s financial performance, but Uber Health grew bookings by 75% year over year in the first quarter. Donovan declined to say whether Uber Health was profitable.”
  • The Government Accountability Office released a watchdog report on law enforcement-oriented approaches to reducing deaths from drunk driving.
  • The All of Us campaign issued its June report.

From the medical research front,

  • The National Institutes of Health announced
    • “Repeat treatment with corticosteroid injections improved vision in people with persistent or recurrent uveitis-related macular edema better than two other therapies, according to results from a clinical trial funded by the National Eye Institute (NEI). Compared with methotrexate or ranibizumab intravitreal (in-the-eye) injections, the corticosteroid treatment achieved greater reductions in retinal swelling and was the only therapy in the study that improved vision. The report was published today in the journal Ophthalmology. NEI is part of the National Institutes of Health.”
  • The Cigna Newsroom relates,
    • “A new study by Cigna Healthcare found that site-of-care redirection is associated with favorable clinical outcomes and increased access and affordability for peg­filgrastim, an injection used to prevent infection in cancer patients. The results showed that patients experienced better outcomes when the injection was administered in a home setting rather than a nonhome setting. The study was recently published in the Journal of Clinical Pathways.
    • “This study shows that we can help improve health outcomes by providing cancer patients with treatment such as infusions in a setting where many are most comfortable – home,” said Dr. Scott Josephs, chief medical officer, Cigna Healthcare. “These findings confirm that home infusion of complex and expensive specialty medications presents new opportunities to maximize access, improve effectiveness, increase affordability, and enhance convenience for patients.”

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • Roll Call tells us “A disagreement between Speaker Kevin McCarthy and House conservatives that jammed up legislative business last week eased Monday evening, but members of the rebel bloc made clear it may not be the end of trouble for their leadership.”
  • Govexec informs us
    • “After multiple years of significant spending increases at non-defense agencies, Congress has reverted to austerity by demanding an overall freeze of discretionary funding for domestic agencies. 
    • “The pullback, agreed to as part of a deal struck by President Biden and House Republicans to meet GOP demands for raising the debt ceiling, will force agencies to make difficult decisions as they abandon some efforts to launch new programs and grow existing ones. The 2023 Fiscal Responsibility Act set only a top-level cap for non-defense spending, leaving it to Congress to establish line-by-line funding levels across government. 
    • “The impacts will look different agency to agency,” said Rachel Snyderman, a senior associate director at the Bipartisan Policy Center and former Office of Management and Budget official.”
  • Federal News Network helpfully reviews the 71 public comments submitted to OPM in response to its April 6, 2023, interim final rule implementing the Postal Service Health Benefits Program.
  • Health Payer Intelligence relates, “AHIP offered four recommendations to the Senate Finance Committee on Consolidation and Competition (the Committee) [last week] to support healthy competition and lower healthcare spending in the healthcare industry.”

From the litigation front —

  • Yahoo News reports,
    • “The Biden administration on Monday finalized a deal to preserve the federal mandate requiring U.S. health insurers to cover preventive care like cancer screenings and HIV-preventing medication at no extra cost to patients while a legal challenge continues.
    • “The agreement, first disclosed on Friday and now finalized in a filing in the New Orleans-based 5th U.S. Circuit Court of Appeals, leaves the mandate in place nationwide while the administration appeals a court order striking it down.
    • “It does allow Texas-based Braidwood Management, one of a group of businesses and individuals that sued to challenge the mandate, to stop covering pre-exposure prophylaxis (PrEP) against HIV and other preventive services for its employees for now. The administration agreed not to take any retroactive enforcement action against the company, which operates an alternative health center if the mandate is restored on appeal.”
  • STAT News adds,
    • “The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price negotiation program on Friday, arguing that Congress tried to take too much power away from the courts.
    • “The lawsuit is the second to challenge the new program, enacted by Democrats last August in the Inflation Reduction Act, within a week’s time, but relies on different legal reasoning. Merck, which makes a diabetes drug that could be subject to negotiation, sued on Tuesday.
    • “Medicare is supposed to choose the first ten drugs to be negotiated by the program by Sept. 1. The goal of the lawsuits is to slow down or stop the process from going into effect.”

From the public health front —

  • Politico relates,
    • “The FDA’s independent advisers will discuss and recommend this week which strain of SARS-CoV-2 should be included in the newest Covid booster to be rolled out ahead of fall and winter. The FDA doesn’t have to follow its advisers’ recommendations, but it often does.
    • “Since the beginning of the year, the regulatory agency has made it clear that it will shift gears to prepare for annual Covid-19 shots as the virus becomes endemic. Now that we’re four months out from the intended rollout, the FDA must select a strain that will most likely be prevalent so manufacturers can start developing vaccines.
    • “Novavax, Pfizer-BioNTech and Moderna, the companies that manufacture the three vaccines available in the U.S., need the FDA’s recommendations to begin tweaking their existing platforms. They must also conduct clinical trials to show that the updated formulas generate a similar immune response to their existing products.”
  • MedPage Today reports,
    • “Oseltamivir (Tamiflu) has not panned out for reducing the risk of influenza hospitalization, according to a large meta-analysis.
    • “Among over 6,000 flu patients across 15 studies, the 0.14-percentage point difference in hospitalization rate between those who took oseltamivir and those who did not was not significant (RR 0.77, 95% CI 0.47-1.27), Emily McDonald, MD, MSc, of McGill University Health Centre in Montreal, and colleagues reported in JAMA Internal Medicine.
    • “I wouldn’t prescribe it to an otherwise healthy person,” McDonald told MedPage Today. “There was little evidence that it would prevent you from going to the hospital.”
    • “What’s more, she added, “it’s not completely benign. It does cause uncomfortable side effects.”
  • The Wall Street Journal reports,
    • “During the pandemic, Carl Prudhomme of Alpine, Texas, got his cancer drugs mailed directly to him from his oncologist.
    • “No longer. With the end of the Covid-19 public-health emergency, independent cancer doctors can no longer send prescriptions directly to their Medicare patients—creating hurdles for some people in rural areas who say they have to travel to get their medications. Prudhomme plans to drive the 569 miles each way to his oncologist’s office in Houston every three months to pick up his drugs in person.
    • “The Centers for Medicare and Medicaid Services in September 2021 posted a list of frequently asked questions that said independent oncologists can dispense prescriptions only to a patient who is physically in the doctor’s office at the time. 
    • “Sending oral chemotherapy drugs by mail violates the Stark law, the agency said. The law bans doctors from making referrals of Medicare and Medicaid patients to other organizations or medical businesses where they have a financial stake. The restriction also applies to other independent practices, such as urology, that have an on-site dispensing pharmacy.
    • “Roughly 30% of the more than 5,000 independent oncologists in the U.S. have on-site pharmacies in their practices, according to an analysis led by the University of Pennsylvania’s Perelman School of Medicine. 
    • “The restriction was suspended during the pandemic public-health emergency. Its return has alarmed cancer doctors who are lobbying Congress and CMS to rescind the restriction, even if that means undergoing new rule-making to do so.”

From the U.S. healthcare business front —

  • Fierce Healthcare tells us,
    • “Prior authorization has been a flashpoint for providers, and, while insurers have taken steps to ease these utilization management protocols, they still play a key role as the industry shifts to value-based care.
    • “David Brailer, M.D., executive vice president and chief health officer at the Cigna Group, told Fierce Healthcare in an interview that ultimately the goal is to ensure patients are receiving the best treatment option for them.
    • “And the insurer has seen that in more advanced value-based arrangments, it can relax prior authorization and other utilization management tools, Brailer said. 
    • “That’s going to be a few years before the market shifts,” he said. “We’ve already announced that we’re starting to step down the number of prior auths that we have.”
  • STAT News relates,
    • “Novartis said on Monday it would purchase Chinook Therapeutics for $3.2 billion upfront, picking up two drugs for a chronic kidney disease that are in late-stage clinical trials.
    • “The transaction values Seattle-based Chinook at $40 a share, compared to Friday’s closing price of under $24. The agreement includes another $300 million if certain regulatory milestones are reached.”
  • Healthcare Dive points out
    • CVS Health’s decision to shut down its two-year-old clinical trials unit means less competition for the growing group of retailers in research, but the area is still nascent and potentially challenging for new entrants, experts said.
    • “It may sort of spook some pharma companies who may think that if CVS exited, maybe these other companies will also exit, and it may make them a little bit more hesitant to partner up with the retailers,” said Sari Kaganoff, general manager of consulting at Rock Health. “At the same time, there’s a lot of opportunity, we believe, for pharma companies to use retailers for clinical trials.”
    • CVS will fully exit the clinical trials business by the end of 2024, winding down the business in phases and working with trial sponsors to ensure patients continue to receive care. 

From the Rx coverage front —

  • The Wall Street Journal informs us,
    • Kristen Ireland struggled with bulimia nervosa for years, working with a therapist and taking medications for anxiety and depression.
    • It wasn’t until her psychiatrist prescribed Victoza, a diabetes medication that works much like Ozempic, Wegovy and Mounjaro, that her binges and purges faded away.
    • “I feel free now,” said Ireland, 27 years old, who manages sports-merchandise stores in Jackson Hole, Wyo. 
    • Treating eating disorders is another potential application for a class of drugs that has taken the weight-loss world by storm. The drugs, synthetic versions of the GLP-1 hormone that act on appetite centers in the brain and gut, have helped patients lose 15% of their body weight on average
    • Some studies and the experience of doctors in the field suggest they could also help people stop binge eating.
  • CBS News discusses the side effects of these new weight loss drugs.

Weekend update

David Ermer–Congress, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC —

  • The House of Representatives and the Senate are in session this week for floor voting and Committee business.
  • The Supreme Court has over 20 opinions to issue before it can end its October 2022 term.
  • Fierce Healthcare reports,
    • The Federal Trade Commission is building out its deep dive into the pharmacy benefit management industry yet again.
    • The agency said Thursday that it has sent an order to the group purchasing organization Emisar Pharma Services, requiring it to provide information and records pertaining to its business practices. The order follows similar missives sent to two other GPOs, Zinc Health Services and Ascent Health Services, last month.
    • Emisar negotiates rebates with drugmakers on behalf of Optum Rx, a UnitedHealth Group subsidiary and one of the three largest PBMs.
    • The FTC said its order to Emisar is “substantially similar” to those issued to Zinc and Ascent.

Fortune Well offers us advice on the following topics:

McKinsey and Company explains how to improve children’s developmental trajectories.

Washington Post columnist discusses her recent experience taking Ozempic at length.

  • “I cannot claim to have done this for my health — certainly, appearance was my primary motivation — but the health impact has been impressive. My sleep apnea had been so severe that tests showed I was waking up an alarming 54 times every hour; new testing put it in the mild range, and my sleep apnea machine has been stashed in the closet. In November 2020, my LDL cholesterol — the “bad” kind, which raises your risk of heart disease and stroke — was at 146; it was down to 133 by March 2022 and, a year later, to 120. My A1c levels, measuring blood sugar, have fallen from on the cusp of prediabetes to safely in the normal range. My blood pressure is lower, and my C-reactive protein, an indicator of cardiovascular disease, has plummeted. * * *
  • “There are two things that are important for readers to know: My response to the medication has been extraordinary, and my experience with insurance coverage has also been unusually positive. Most insurers do not currently cover medications for obesity alone. But my doctor was able to point to my risk of developing diabetes, and my insurer, thankfully, did not question the need for coverage. “Ozempic, $24.99,” the Walgreens website informs me when I look back at my prescription records. “Insurance saved you: $1,046.10.”

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.