Monday Roundup

Rx coverage

Monday Roundup

David Ermer–Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network tells us,
    • “The Biden administration has now ended many of the policies that previously dictated agencies’ health and safety responses to the COVID-19 pandemic. But for federal employees, the administration is still offering some on-the-job flexibility for the foreseeable future.
    • “One of the few remaining policies from a series of 2021 executive orders lets federal employees still take up to four hours of paid administrative leave to get COVID-19 vaccine booster shots, the Office of Personnel Management said in an April 12 memo.
    • “The administration strongly encourages federal employees to get recommended doses of updated COVID-19 vaccines even when receiving those vaccines is not a job requirement,” OPM Director Kiran Ahuja said in the memo addressed to agency heads. “Vaccines remain the best tool we have in our toolbox to combat COVID-19. They are safe, effective and free.”
    • “For federal employees, the offered administrative leave will cover the time it takes to get the COVID-19 booster shot, as well as feds’ travel time to and from the vaccination site. As is standard, employees should get approval from their supervisors before taking leave for this purpose, OPM said. Four hours is the maximum OPM is allotting, but federal employees should only take off as much time as they actually need to get the shot.”
  • OPM should take the same approach with cancer screening services, such as colonoscopies and mammographies.
  • The American Hospital Association News reports,
    • “The Change Healthcare cyberattack was a significant event that caught many off guard, said the Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure, reiterating the agency’s commitment to supporting impacted hospitals. Brooks-LaSure stated the Administration is listening to stakeholders and when possible, facilitating solutions, noting the importance of meeting the needs of providers.
    • “In addition, Brooks-LaSure celebrated important improvements CMS made to promote greater transparency for prior authorization criteria. CMS took steps earlier this year finalizing new regulations to streamline and reduce burden associated with the prior authorization process in Medicare Advantage and fee-for-service and managed care programs for Medicaid and the Children’s Health Insurance Program.  
    • “CMS continues to hear from patients and providers over some commercial insurer prior authorization denials and delays, Brooks-LaSure said, noting that the volume of frustration has “just exploded.” The private sector, she said, has an opportunity to step up with solutions of their own to address concerns.
    • “I’ve told the health plans this: it doesn’t have to all be regulated [by the federal government], there may be things that they can do,” Brooks-LaSure said.”
  • Beckers Payer Issues adds,
    • “AHIP’s chief executive criticized the hospital lobby’s response to the Change Healthcare cyberattack as “opportunistic” and “maintaining the status quo.”
    • “AHIP President and CEO Mike Tuffin pointed to comments that hospital lobbyists made to the media about the hack being “another talking point” to prevent health systems from implementing site-neutral payments, as well as an industry association’s opposition to cybersecurity mandates.
    • “Insisting on maintaining the status quo simply makes the healthcare system a more inviting target for the ever-more sophisticated hacking operations targeting the sector,” Mr. Tuffin wrote in the April 12 article. “Instead of taking a constructive leadership role in what can be done to protect consumers and the system moving forward, the hospital lobby chooses to use the moment to point fingers and shirk responsibility.”
    • “Rather than “playing politics,” all industry stakeholders should be focusing on preventing and preparing for future healthcare cyberattacks, he said.”
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission announced on Monday its final rule implementing the Pregnant Workers Fairness Act, clarifying that abortion is included under “pregnancy, childbirth or related medical conditions” that are protected under the PWFA.
    • “EEOC said this interpretation of the law’s text is “consistent with the Commission’s and courts’ longstanding interpretation of the same phrase in Title VII.” It also noted that employees are entitled to the law’s provisions even if they have not worked for an employer for a specific length of time.
    • “EEOC had originally slated the rule for publication at the end of 2023, but the commission’s deadline passed without a rule in place. The rule is scheduled to be published in the Federal Register Friday, and will take effect 60 days after publication, approximately mid-June.”
  • The Government Accountability Office released a report on selected States regulation of pharmacy benefit managers.

From the public health and medical research front,

  • The Washington Post considers why
    • “Rural Americans ages 25 to 54 — considered the prime working-age population — are dying of natural causes such as chronic diseases and cancer at wildly higher rates than their age-group peers in urban areas, according to the report. * * *
    • “The USDA researchers analyzed mortality data from the Centers for Disease Control and Prevention from two three-year periods — 1999 through 2001, and 2017 through 2019. In 1999, the natural-cause mortality rate for rural working-age adults was only 6 percent higher than that of their city-dwelling peers. By 2019, the gap had widened to 43 percent.” * * *
    • “The USDA’s findings were shocking but not surprising, said Alan Morgan, CEO of the National Rural Health Association. He and other health experts have maintained for years that rural America needs more attention and investment in its health care systems by national leaders and lawmakers.”
  • “MedPage Today editor-in-chief Jeremy Faust, MD, talks with Monica Bertagnolli, MD, the 17th director of the National Institutes of Health (NIH), about the day-to-day work at the NIH on pandemic preparedness, the importance of looking for new approaches to testing, and the status of long COVID research.”
  • Healio points out,
    • “Physical activity patterns that included vigorous exercise, housework or walking were associated with lower stroke risk.
    • “Watching TV and commuting were linked to higher risk for stroke.”
  • Per Medscape,
    • “Low- to moderate-intensity physical exercise in patients with severe mental illness is linked to improved medication adherence, regardless of medication type or duration of illness, new research shows.
    • “The positive association between adherence and moderate physical activity emphasizes that physical activity improves overall health and functional status. Promoting physical activity can be a valuable and integrated strategy that can be easily implemented into our routine clinical practice,” said study investigator Rebecca Silvestro, MD, Department of Psychiatry, Università degli studi della Campania Luigi Vanvitelli in Naples, Italy.
    • “The findings were presented at the European Psychiatric Association 2024 Congress.” 

From the U.S. healthcare business front,

  • STAT News reports,
    • “The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., surged to 36% from just 5% during the first week of April, thanks to the expanding reach that CVS Health has over the prescription drug market.
    • “The big jump was attributed to one particular biosimilar called Hyrimoz, which is manufactured by Sandoz, a former unit of Novartis that is a leading supplier of generic and biosimilar medicines. However, Hyrimoz is jointly marketed with Cordavis, a new subsidiary that CVS created last August specifically to sell any number of biosimilar medicines in the U.S.
    • “This connection is crucial to the sudden jump in Hyrimoz prescriptions. How so? On April 1, CVS Caremark, which is one of the largest pharmacy benefit managers in the U.S., removed Humira from its major national formularies for health plans that cover about 30 million lives. Formularies are the lists of medicines that are covered by health insurance.
    • “The move quickly shifted market share to Hyrimoz. During the week ending March 29, the number of new prescriptions written for the biosimilar was about 640, but rose to nearly 8,300 in the week ending April 5, according to a report to investors by Evercore ISI analyst Elizabeth Anderson. That pushed the share for all Humira biosimilars to 36%, with Hyrimoz contributing 93% of the growth.”
  • Health Leaders Media discusses three ways that independent physician practices can maintain their independence.
  • According to BioPharma Dive,
    • “Roche’s new dual-acting blood cancer drug Columvi combined with chemotherapy helped people with a type of lymphoma live longer than people given Rituxan and chemo, the company said Monday. The data could help Roche persuade the Food and Drug Administration to convert Columvi’s conditional OK into a full approval.
    • “Roche didn’t disclose full data from the Phase 3 “Starglo” trial in people with diffuse large B-cell lymphoma whose disease advanced after initial treatment and who weren’t eligible for stem cell transplants. The results will be presented at an upcoming medical meeting, the company said.
    • “Columvi is a new type of drug called a “bispecific” antibody that triggers an immune response to cancer cells. A competitor developed by Genmab and AbbVie has also gained accelerated approval and could have confirmatory data later this year, while the FDA rejected a bispecific from Regeneron because its confirmatory trial isn’t far enough advanced.”
  • MedTech Dive reports,
    • “Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday.
    • “Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type.
    • “Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company.”

Tuesday Tidbits

David Ermer–CDC, COVID-19, Cybersecurity, FDA, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital News reports,
    • “Health care leaders and other officials April 9 discussed challenges to rural health care access and potential solutions during an event in Washington, D.C. sponsored by the Coalition to Strengthen America’s Health Care: Protecting 24/7 Care. The AHA is a founding member of the Coalition, which recently rebranded to reflect its renewed focus to protect and strengthen patients’ access to 24/7 care. 
    • “Today’s event hosted by Punchbowl News involved discussions on a range of topics including access, the importance of telehealth, health care innovations and Medicare underpayment, among others. 
    • “You can watch a video of today’s event here. “
  • The Wall Street Journal lets us know,
    • “The U.S. Postal Service said Tuesday it is seeking to raise the price of a stamp by 5 cents, in what would be the fourth increase since the start of 2023. 
    • “The proposed price of 73 cents, up 7.4% from the current price of 68 cents, would still need to be approved by the Postal Regulatory Commission. 
    • “The last increase happened in January 2024, when the cost of a stamp rose from 66 cents to 68 cents. Before that, the agency hiked prices in July 2023 by 3 cents. * * *
    • “The new 5-cent increase would go into effect July 14, the Postal Service said. 
    • “The Postal Service said it also wants to raise prices for other services, including sending a letter outside the U.S., which would cost $1.65, up from $1.55. Mailing a postcard within the U.S. would cost 3 cents more at 56 cents. And sending metered letters, a service used by small businesses, would cost 5 cents more at 69 cents.”
  • MedTech Dive relates,
    • “The Department of Justice filed a consent decree of permanent injunction against Philips on Tuesday in response to the company’s ongoing recall of sleep apnea and respiratory devices.
    • “The settlement would restrict Philips from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and other devices in the U.S. until the company meets certain requirements. Philips also faces restrictions on exporting devices that are being provided to patients impacted by the recall “to help ensure remediation of U.S. patients is prioritized over export for commercial distribution.” 
    • “Philips is required to implement a recall remediation plan that the Food and Drug Administration must agree on, including providing patients with new or reworked devices, or a partial refund. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Tuesday statement that the finalization of the decree is a “significant milestone.” 

From the public health and medical research front,

  • KFF notes,
    • “Rates of long COVID have begun to flatten. About 1 in 10 adults with COVID have reported having long COVID since rates fell in 2023, according to a KFF analysis of the latest data from the Centers for Disease Control and Prevention. If the rate continues to hold steady, new forms of prevention or treatment may be important to achieve future reductions in long COVID.
    • “As of March 2024, 7% of all adults (17 million people) reported that they have long COVID. Among the 60% of adults who reported ever having had COVID, roughly 3 in 10 reported having long COVID at some point and about 1 in 10 reported currently having it. The ongoing gap between the two long COVID rates indicates that people are continuing to recover, even as rates stabilize.”
  • US News and World Report informs us,
    • “Measles infections have continued to spread in pockets of the U.S., as the latest nationwide count shows the number of cases have now reached more than 100.
    • “A total of 113 cases have been reported across 17 states as of April 5, according to the most recent figures from the Centers for Disease Control and Prevention, nearly double the total of 58 that for all of 2023.
    • “So far, seven outbreaks have occurred – defined by the CDC as three or more related cases – up from four in 2023. More than 70% of all cases this year have been associated with an outbreak, and approximately half of patients are children under the age of five.
    • “More than 80% of measles infections are among those who are either unvaccinated or with an unknown vaccination status, according to the CDC, while 12% of cases are those who have received only one dose of the measles, mumps and rubella vaccine.
    • “Chicago has had the majority of U.S. cases, with 58 infections as of April 8, according to the most recent figures from the Chicago Department of Public Health.
    • “The majority of measles infections in Chicago have been tied to an outbreak at one of the city’s largest migrant shelters.
    • “In an update released on April 5, CDPH stated measles cases were decreasing in the city, with a total of five new cases reported during the week of March 31 through April 5, compared to 23 infections reported from March 24 through March 30.”
  • The Wall Street Journal reminds us,
    • The fight against dementia actually starts in your 40s.
    • Midlife, not your 70s or 80s, is when brain changes start to occur that can pave the way toward dementia, Alzheimer’s disease and cognitive decline later, according to a growing body of research. 
    • Intervening earlier to improve brain health—and studying the midlife brain more closely—might help people stay sharper in their later years, researchers say. Regular exercise, getting enough sleep and doing activities that keep your brain stimulated are all steps that can help you combat dementia later in life.
    • “Middle age is an opportune time to make lifestyle choices and obtain treatment that will bring an enormous return on investment in old age,” says Terrie Moffitt, a professor of psychology and neuroscience at Duke University.
    • More scientists are looking for clues in the midlife brain because efforts to target dementia in older people have largely failed, says Ahmad Hariri, a professor of psychology and neuroscience also at Duke.
  • Beckers Hospital Review points out,
    • “Surprise pregnancies may be an unexpected side effect experienced by women who use Ozempic or other GLP-1 medications, The Washington Post reported April 5.”Surprise pregnancies may be an unexpected side effect experienced by women who use Ozempic or other GLP-1 medications, The Washington Post reported April 5.
    • “Numerous social media platforms include posts and discussions about unplanned pregnancies while on Ozempic or similar drugs. Although the reports of a possible Ozempic “baby boom” are anecdotal, it is a phenomenon researchers and experts are watching closely. 
    • “Experts speculate that weight loss drugs may impact the absorption of contraceptives, causing birth control failures or that they can affect ovulation and fertility. Others say losing weight can improve chances of pregnancy.”
  • According to Fierce Healthcare,
    • “Supplemental benefits administrator Avesis and Elevance Health subsidiary Amerigroup Georgia have teamed up with Uber Health in a pilot project to tackle the state’s maternal health crisis.
    • “Utilizing community health partners like the Georgia Primary Care Association and federally qualified health centers (FQHCs), hundreds of Amerigroup’s Medicaid members in December 2022 started receiving two individualized nutritional counseling sessions, a scale and $300 of Uber Eats vouchers.
    • “Though the program’s results have not been shared yet, Avesis Senior Manager of Care Transformation Don Trainor said the program has had promising results so far.”
  • The AHA News tells us,
    • “Women with health-related social needs such as food insecurity, housing instability and lack of transportation were less likely to report receiving a mammogram in the past two years when surveyed in 2022, according to a report  released April 9 by the Centers for Disease Control and Prevention. About 66% of women aged 50-74 with at least three health-related social needs were up to date with their mammograms, compared with 83% of women with no health-related social needs. Mammography use also was lower among women without health insurance and a usual source of care.”  

From the U.S. healthcare business front,

  • United Health Group has refreshed its response to the cyberattack against Change Healthcare website.
  • Per Fierce Healthcare,
    • “Artificial intelligence categorization can help stem the flood of patient messages that would otherwise demand physicians’ expensive time, Kaiser Permanente researchers report.
    • “In a recently published JAMA Network Open research letter, members of the system’s research division and medical group outlined a strategy that used real-time natural language processing (NLP) algorithms to attach category labels to messages and then direct them to an appropriate respondent.
    • “The approach, they wrote, allowed 31.9% of the more than 4.7 million patient messages reviewed by program staff to be resolved before reaching the inbox of a specific physician. Instead, these messages were handed by a “regional team” made up of medical assistants or teleservice representatives, pharmacists and other doctors.”
  • and
    • “Consumers expect a simple and easy digital experience, and health plans have plenty of room to improve on that front, according to a new report.
    • “J.D. Power released its inaugural U.S. Health Insurance Experience Study on Tuesday, where it found that 42% of adults with insurance ran into issues using their plan’s website and/or mobile app in the past year.
    • “The study is based on responses from more than 5,500 people enrolled in the 14 largest Medicare Advantage (MA) plans and 15 largest commercial plans. It was conducted alongside Corporate Insight.”
  • Beckers Hospital Review names the “25 drugs at Mark Cuban’s online pharmacy with biggest cost reductions.”

Friday Factoids

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Healthcare Dive informs us
    • “The Senate continued to probe the impact of private equity on healthcare delivery this week, launching both an inquiry into PE’s emergency department management practices and holding a subcommittee field hearing on “corporate greed” and PE’s impact on patient care.
    • “The field hearing and request for information come as private equity has increased its investment in healthcare. As of January, more than a quarter of the nation’s rural hospitals and 460 total hospitals in the U.S. were owned by private equity firms, according to a tracker produced by nonprofit watchdog, the Private Equity Stakeholder Project. 
    • “PE-backed physician staffing groups operate nearly one-third of emergency departments across the country, according to letters sent Monday to some of the nation’s largest private equity companies by Sen. Gary Peters, D-Mich., and chair of the Senate’s Homeland Security Committee. * * *
    • “PE firms acquire assets and then seek to sell them for profit, typically within a three- to five-year time frame. The investors may also have limited direct knowledge of healthcare, and the funds are subject to fewer regulations than public companies, according to a 2023 report from the CommonWealth Fund. As a result, the firms tend to have fewer patient-centric guardrails in place compared to traditional healthcare owners and investors.”
  • Fierce Healthcare tells us,
    • “Centers for Medicare & Medicaid Services finalized a host of actions ranging from broker compensation, health equity, mental health, supplemental benefits and biosimiliars, in the Contract Year 2025 Medicare Advantage and Part D final rule Thursday night.
    • “Technical experts and industry execs warned the changes will be consequential for MA plans.
    • “Yesterday’s 2025 Final Rule was one of the more impactful that I can recall in my two-plus decades in the industry,” said Sean Libby, president at BeneLynk. “It is clear that MA plans need a roadmap for health related social needs and health equity.”
    • “It is difficult to put words to the extent and impact of changes codified today,” saidMelissa Newton Smith, senior advisor for Oliver Wyman. “Every MA leadership team needs to be thoughtfully redesigning your stars and quality approach in order to earn quality bonus payments in 2025.”
    • “The primary winners are behavioral health providers, namely Arcadia Healthcare and Universal Health Systems,” said global strategy firm Capstone in a new analysis.
  • Per BioPharma Dive,
    • “The Food and Drug Administration has cleared Bristol Myers Squibb and 2seventy Bio’s multiple myeloma cell therapy for earlier use treating the blood cancer, approving the CAR-T medicine for patients who have previously received at least two previous drug regimens.
    • “The OK comes three weeks after a panel of FDA advisers agreed the benefit of earlier treatment outweighed the risks, including a concern raised by agency reviewers over data indicating an elevated risk of death among treated study participants in the first year of the companies’ main trial.
    • “Overall, trial results showed the CAR-T therapy, Abecma, reduced the risk of disease progression or death by about half, compared to standard regimens. Bristol Myers cited patient crossover from the control arm to treatment as confounding survival data, while the advisory panel noted complications with the “bridging” therapy used prior to CAR-T treatment.”
  • Fierce BioTech lets us know,
    • “As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-related unknowns.
    • “We are ready to review—we’re open for business,” Marks, director of the FDA’s Center for Biologics Evaluation and Research, said of cancer vaccines at the 2024 World Vaccine Congress (WVC).
    • “We have therapeutic cancer vaccines coming in; I think we would review them very much like we could review potentially a CAR-T cell or other therapeutic products,” Marks said.”
  • Per an FDA press release,
    • “Today, the FDA issued an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for people aged 14 years or older with a self-collected nasal swab specimens and aged 2 years or older when an adult collects the nasal swab specimens.”
  • The Washington Post reports,
    • “A group of public health experts and scientists is calling on the Food and Drug Administration to rescind its controversial approval of a DNA test that promises to predict genetic risk of opioid addiction.
    • “In a letter sent to the agency on Thursday, 31 experts in genetics, addiction, psychiatry and medical-device regulation called the approval of AvertD a mistake that relied on faulty science and puts patients at risk. The group sent a separate letter to the Centers for Medicare and Medicaid Services urging the agency, which oversees government health insurance programs, to deny coverage for the prescription-only test.
    • “The Washington Post last month highlighted concerns about the test’sreliability and the unintended consequences of false results. The letters said a negative test could give patients a false sense of security, or lead doctors to “refrain from prescribing opioids to patients who test positive, even in situations where opioids are beneficial.”
  • MedTech Dive lets us know,
    • “Smiths Medical is recalling more than 2,900 emergency ventilators in the U.S. after receiving reports of a fault linked to eight serious injuries, the Food and Drug Administration said Thursday.
    • “The fault can cause patients to receive the wrong amount of ventilation or too little oxygen, as well as a complete or partial airway obstruction. The FDA categorized the event as a Class I recall because of the risk of serious injury or death.
    • “Smiths Medical, which has faced a series of regulatory actions in recent years, told customers to continue using the Pneupac Parapac Plus 300 and 310 Ventilator Kits but to take precautions.”

From the public health and medical research front,

  • The Centers for Disease Control announced today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 6 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.   
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.
  • STAT News reports,
    • “The Centers for Disease Control and Prevention urged medical practitioners on Friday to be on the lookout for people who might have contracted H5N1 bird flu from cows. The agency also urged state health departments to rapidly assess any suspected human cases, and recommended that dairy farms with confirmed or suspected outbreaks require workers to use personal protective equipment.
    • “The recommendations were outlined in a health alert network advisory, or HAN in CDC parlance. The advisory is in response to the outbreak of H5N1 avian influenza in at least 16 dairy herds in six states across the country, which has led to at least one human infection so far.
    • “Health care providers should ask themselves “Could this be an H5N1 infection?” if they are faced with a patient with what CDC called a relevant exposure history — for instance, someone who works with dairy cows or lives with someone who works with dairy cows.”
  • Medscape notes,
    • “Cognitive assessments administered via a smartphone app are a reliable and valid way to detect frontotemporal dementia (FTD) in high-risk individuals, new research showed.
    • “Cognitive tests administered remotely on the phone “showed similar findings as our gold standard in-clinic cognitive tests and brain imaging,” study investigator Adam M. Staffaroni, PhD, with the Memory and Aging Center, University of California San Francisco, told Medscape Medical News.
    • “We also provided evidence that these assessments may be useful for detecting early symptoms of the disease at a level that is on par, or perhaps slightly better, than our gold standard in-person tests,” Staffaroni said.
    • “The study was published online on April 1 in JAMA Network Open.

From the U.S. healthcare business front,

  • CNBC reports,
    • “CVS Health on Thursday said its drug plans will cover the first over-the-counter birth control pill in the U.S. at no cost for many health plan sponsors, a decision that could open the door for more people to prevent unintended pregnancies without a prescription. 
    • “The company’s pharmacy benefit manager, CVS Caremark, said the pill will be added to its preventive services oral contraceptives list and will be covered at zero cost for many sponsors. The drug, known as Opill from Perrigo, was available at pharmacies starting April 1, according to a pharmacy update from CVS Caremark dated last week and viewed by CNBC.
    • “Pharmacy benefit managers, or PBMs, maintain lists of drugs covered by health insurance plans and negotiate drug discounts with manufacturers. At most stores, Opill has a retail price of $19.99 for a one-month supply and $49.99 for a three-month supply.” 
    • FEHBlog note — Smart move, CVS Health.
  • The President of the Institute for Clinical and Economic Review comments,
    • “Yesterday Amylyx announced it would remove Relyvrio, a treatment for amyotrophic lateral sclerosis (ALS), from the market. The drug was originally approved in 2022 based on a small phase II trial, well ahead of the conclusion of its phase III trial. The results of that phase III trial were reported last month and unfortunately, the therapy failed to provide any benefit to patients. Historically, a failed trial following FDA approval has not resulted in an automatic revocation of FDA approval or withdrawal of the drug from the market, and post-marketing trial requirements are not consistently used to assess the regulatory status of all approved products. Despite this hole in regulation, Amylyx made the responsible decision to discontinue this drug, and is being rightly lauded for the choice. 
    • “Of course, everyone hopes that treatments approved early with limited evidence will prove effective. But when they don’t, this is how it is supposed to play out: patients get early access to a potentially promising treatment, and then when all the data come in and the benefits fall short, the manufacturer removes the drug from the market. What’s missing from this story though is price: since 2022, the health system paid a steep price for a drug with no proven benefit to patients. When ICER reviewed Relyvrio (prior to FDA approval), we recommended that the manufacturer consider setting the launch price, “close to the cost of production until the benefits of treatment can be adequately evaluated.” Amylyx priced the drug at $158,000 per year, far beyond ICER’s recommended price of $9,100 to $30,700 per year, a price range based on the benefits shown in the small phase II trial. The fact is, that when our health care system allows pricing of treatments far above any reasonable alignment with the benefits they have demonstrated for patients, we do real harm to unseen people in the health care system. Costs increase for everyone without making anyone healthier. And as costs increase, more people forgo care or drop their health insurance all together. 
    • “Even though the story played out as planned this time, the system can be improved to protect all patients and ensure affordability for everyone.”
  • BioPharma Dive relates,
    • “Johnson & Johnson has agreed to acquire Shockwave Medical for approximately $13.1 billion, the companies announced Friday morning. The deal values Shockwave at $335 per share.
    • “J&J said in a statement that Shockwave will expand its “cardiovascular portfolio into two of the highest-growth, innovation-oriented segments of cardiovascular intervention – coronary artery disease and peripheral artery disease.”
    • “Both companies’ boards have approved the transaction, and J&J expects the deal to close in mid-2024.”
  • and
    • “Boehringer Ingelheim is laying off staff in response to sluggish adoption of its Humira biosimilar Cyltezo, a company spokesperson confirmed to BioPharma Dive. Stat first reported the news Thursday.
    • “The German company said it will trim its customer-facing teams in favor of a hybrid in-person and virtual sales model by June 30, but didn’t specify how many jobs are affected. Pharmacy benefit managers, or PBMs, have kept Humira on their coverage lists, resulting in cheaper copycats like Cyltezo falling below their “anticipated potential,” the spokesperson said.
      • “Humira, a blockbuster immune disease drug sold by AbbVie, began facing biosimilar competition in the U.S. last year. Launched in July,Cyltezo is one of more than half a dozen Humira biosimilars now available, but holds an advantage due to its “interchangeable” designation, which allows pharmacists to substitute it for Humira.”
  • Per Healthcare Dive,
    • “Teladoc Health’s long-time chief executive officer Jason Gorevic is leaving the virtual care giant effective immediately, the company said Friday.
    • “Gorevic has been CEO since 2009 and oversaw a period of exponential growth for Teladoc during the COVID-19 telehealth boom. However, he’s departing after the telehealth company struggled to sustain that momentum as the pandemic waned. Teladoc’s stock has sunk significantly since early 2021, and recently hit an eight-year low.
    • “The leadership change is probably coming at the right time, as the company focuses on a longer-term profit growth strategy, Leerink Partners analysts Michael Cherny, Daniel Clark and Ahmed Muhammad wrote in a Friday note.”
  • and
    • “Telehealth company Amwell is in trouble with the New York Stock Exchange for its stock price trading below the minimum standard for listing.
    • “Amwell was a high-flying stock during COVID-19, as the value of telehealth companies soared due to demand for virtually provided medical care. The price of Amwell’s shares peaked at $42.80 in January 2021. However, for the past 30 days, Amwell’s shares have closed at less than $1, sparking a warning notice from the NYSE.
    • “NYSE rules give Amwell six months to regain compliance. In a Thursday release, Amwell said it plans to effect a reverse stock split — when existing shares are consolidated into fewer but more valuable shares, boosting a company’s stock price. Amwell’s board and shareholders will vote on the proposal at an annual meeting later this year.” 
  • In this regard, the FEHBlog heard a health system executive comment at the ABA’s Health Law Section’s Emerging Healthcare Law Issues conference —
    • While the amount of telehealth services has returned a little higher than pre-pandemic 2019 levels, telehealth vendors that hang on will be a lifesaver in the looming physician shortage crisis.

Friday Factoids

David Ermer–CDC, Government Contracting, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The New York Times reports,
    • A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart.
    • The tiny Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions. * * *
    • “When reporting on outsize bleeding rates related to the Impella devices, Dr. Desai, of Yale, has also noted that its payments are far higher than the balloon pump, creating an urgent need for rigorous studies of how to best treat patients.
    • “You hate to think this is part of that story, but I think we would be naïve to think that that couldn’t be part of the story,” he said.”
  • The Labor Department’s Office of Federal Contractor Compliance Programs announced,
    • “Contractors that meet certain jurisdictional thresholds have an obligation to develop and maintain written Affirmative Action Programs (AAPs).
    • “The Contractor Portal is OFCCP’s platform where covered federal contractors and subcontractors must certify, on an annual basis, whether they are meeting their requirement to develop and maintain annual AAPs. The portal allows multiple users from individual organizations to register, manage records, and certify each establishment and/or functional/business unit, as applicable.
    • “Beginning April 1, 2024, federal contractors will be able to certify the status of their AAPs for each establishment and/or functional/business unit, as applicable. The deadline for certifying compliance is July 1, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 9 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high or very high activity the previous week. This week no jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.   
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.  
    • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, remains low.
    • “Reported on Friday, March 29th, 2024.“
  • The Hill informs us,
    • “Tuberculosis rates in the U.S. rose by 16 percent in 2023, marking the third year that cases went up following nearly 30 years of decline.
    • In the most recent Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC), the number of TB cases in 2023 totaled at 9,615, a jump of 1,295 over 2022.
    • “The last time annual TB cases in the U.S. were higher than 9,500 was in 2012, when 9,906 were detected. As the report noted, TB cases had declined for 27 years, reaching a record low of 7,171 in 2020 before creeping back up.
    • “While there is a vaccine for tuberculosis, the CDC notes that it’s mostly used in countries with a high prevalence of TB and isn’t recommended for use in the U.S. due to low risk of infection.
    • “In a January report to Congress, the United States Agency for International Development attributed the rise in TB cases globally to the disruptions brought on by the COVID-19 pandemic.
    • “After two years of COVID-19-related disruptions to TB prevention, diagnosis, and treatment efforts, 2023 had the highest number of people diagnosed and started on treatment since the beginning of the disease’s global monitoring in 1995 that affected access to and provision of health services – due in part to concerted efforts to recover from the pandemic’s devastating global impact,” the agency said.”
  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention issued a health advisory Thursday [March 27] about a rise in rare but severe forms of meningococcal infections. These bacterial infections can cause potentially life-threatening inflammation of the membranes surrounding the brain and spinal cord.
    • “The CDC says 422 cases were reported in 2023, the highest annual number seen since 2014. Of the 94 cases with known outcomes, 17 died. Since March 25, 143 cases have been reported to the CDC — 62 more cases than what was seen over the same time period in 2023.
    • “The spike is notable in part because infections are disproportionately affecting people ages 30 to 60, as well as African American individuals and those with HIV. Typically, infants younger than 1, teenagers and young adults ages 16 to 23 as well as individuals older than 85 have a higher risk of contracting meningococcal disease.
    • “The agency says health-care experts should increase monitoring for meningitis symptoms, and the public should take steps to prevent its spread.
    • “We’re not recommending any unusual precautions,” said Lucy McNamara, an epidemiologist in the meningitis and vaccine-preventable diseases branch at the CDC.
    • “We would like for the general public to be aware of the symptoms of meningococcal disease and to contact their health-care provider if they or members of their family have those symptoms,” she said, adding that officials also “want to make sure that they’re up to date for meningococcal vaccinations.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb’s cancer pill Krazati helped people with a certain kind of non-small cell lung cancer live longer without their disease progressing and shrank tumors at a higher rate than those given chemotherapy, the company said Thursday.
    • “The data could help Bristol Myers persuade the Food and Drug Administration to convert Krazati’s conditional approval into a full clearance, potentially giving it an advantage over Amgen’s rival drug Lumakras. Amgen’s bid to gain confirmatory approval was unsuccessful, and the company has four years to complete another trial testing its pill.
    • “Both Krazati and Lumakras target tumors harboring a mutation in a gene called KRAS — a long-sought goal of drugmakers. While their uptake is currently modest, both Bristol Myers and Amgen are working to expand their use into earlier lines of treatment and other types of cancer.”

From the U.S. healthcare business front,

  • CNN calls our attention to the fact
    • “For the first time, women in the US can walk into a store and buy a supply of birth control pills right off the shelf, without the need for a prescription or health insurance.
    • “Opill, the first oral contraceptive approved by the US Food and Drug Administration for over-the-counter use, has arrived at most stores in certain retail pharmacy chainssuch as CVS, Walgreens and Walmart.
    • “The product is “is now available at CVS.com and through the CVS Pharmacy app and is arriving at more than 7,500 CVS Pharmacy stores in the coming weeks,”spokesperson Matt Blanchette said in an email. “For added privacy and convenience, customers will be able to choose same-day delivery or buy online and pick-up in store.”
    • “Walgreens began offering Opill in late March, spokesperson Samantha Stansberry said.
    • “The product “will be available at Walgreens nationwide in the family planning aisle and behind the pharmacy,” Stansberry said in an email. “Customers can also purchase the product online for 30-minute Pickup, 1-hour Delivery, or ship to home.”
    • “At Walmart, “it is currently available on walmart.com and will be in stores in early April,” spokesperson Tricia Moriarty said in an email.”
  • Kaufmann Hall issued its March National Hospital Flash Report on March 27.
    • “Key Takeaways
      • “Margins this month were at 3.96%, continuing a strong start to 2024. However, data
        this month do not reflect the full impact of the Change Healthcare outage, which
        began February 21st.
      • “Gross revenue continues to rise at a faster rate than net revenue, highlighting payer
        mix changes. Bad debt and charity care have also risen over the last few years.
      • “Revenue growth is primarily being driven from the outpatient setting. There
        continues to be a decline in inpatient revenue and increase in outpatient revenue.”
  • STAT News lets us know,
    • “Diabetes drugs are too expensive in the U.S., and insulin is infamously six to 13 timesmore expensive here than in comparable high-income countries. And blockbuster GLP-1 drugs, too, could be a lot less expensive, according to an investigationpublished this week in JAMA Network Open, with a simple change: robust generic competition.
    • “The study, led by Melissa Barber, a Yale postdoctoral fellow, and conducted in collaboration with Doctors Without Borders, a nonprofit medical organization working in low-resource and emergency settings, found that making a generic vial of insulin could cost $61 to $111 per year — 97% less than than the current market price in the U.S., based on an estimate that factors in a 10% to 50% profit margin. * * *
    • “Findings for the cost of making GLP-1 biosimilars were along the same lines. Researchers calculated that the cost of producing a patient’s monthly supply of a GLP-1 drug would range from $0.75 to $72.50; currently, Ozempic costs about $1,000 a month in the U.S, $155 in Canada, and less than $60 in Germany, according to a statement by Sen. Bernie Sanders, who cited the study as evidence of pharmaceutical overpricing and called on Novo Nordisk to lower the price of Ozempic.”
  • and
    • “The staff of the Institute for Clinical and Economic Review, or ICER, are known as the nerds of the drug industry: bespectacled killjoys who emerge a few times a year to scold drugmakers for pricing their latest cancer or MS advance far beyond reason.
    • “But last year, they sat down and concluded a forthcoming treatment was worth up to $3.9 million — more than any medicine in history, more than a 45-year supply of Humira, the autoimmune drug often held up as an emblem of America’s runaway drug spending. 
    • “It was a testament to the power of a new class of gene therapies to deliver something pharma so rarely does: Genuine cures. The treatment, approved last week as Lenmeldy, may allow some babies born with an ultra-rare neurodegenerative disease called metachromatic leukodystrophy, or MLD, to grow up and live essentially normal lives.
    • “David Rind, ICER’s chief medical officer, compared Lenmeldy to Zolgensma, a gene therapy approved in 2019 for spinal muscular atrophy that the nonprofit estimated could be worth up to $2.1 million. * * *
    • “Lenmeldy, Rind said, is still overpriced. Orchard Therapeutics, Lenmeldy’s developer, is tacking on an additional $325,000, for a $4.25 million total. But its price falls closer to those estimates, as a percentage, than the vast majority of medicines it reviews.”
  • Healthcare Dive brings us “inside CVS Health’s push to transform customer experience. The transformation, led by Deloitte Digital, focused on increasing customer feedback to identify pervasive issues and closing the loop on customer inquiries.”
  • Beckers Payer Issues relates,
    • “UnitedHealth Group has named CFO John Rex as president of the company. 
    • “Mr. Rex is taking over the president role from COO Dirk McMahon, who plans to retire. UnitedHealth Group has not announced a successor in the COO role. Mr. McMahon spent 20 years in various leadership positions at UnitedHealth Group, and was named president and COO in 2021.  
    • “According to a March 28 regulatory filing, Mr. Rex will assume the president role April 1, in addition to his current position as CFO.” 

Tuesday Tidbits

David Ermer–AHRQ, FDA, Generative AI, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “The Supreme Court appeared likely to preserve access to the abortion pill mifepristone, following arguments Tuesday in which justices suggested that protecting doctors who oppose abortion wasn’t enough justification to roll back access to the drug.
    • “Several justices, including some who voted to overrule Roe v. Wade two years ago, focused their questioning on whether the doctors and medical associations that brought the case in fact have the right to sue. Those doctors and groups don’t prescribe mifepristone, don’t perform abortions and have no legal obligation to help women end unwanted pregnancies. 
    • “Just to confirm,” said Justice Brett Kavanaugh, “under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?”
    • “Yes,” answered U.S. Solicitor General Elizabeth Prelogar, who argued on behalf of the Biden administration. “We think that federal conscience protections provide broad coverage here.” 
  • American Hospital Association News tells us,
    • “This April through June under the Inflation Reduction Act, Medicare will reduce the coinsurance amount for 41 Part B prescription drugs from 20% to somewhere between 3.8% and 19.9%, depending on the drug, the Centers for Medicare & Medicaid Services announced March 26. Medicare will pay health care providers the difference between the Medicare allowed amount and the adjusted beneficiary coinsurance, after applying the Part B deductible and prior to sequestration, if applicable.
    • “The IRA requires drug companies to pay rebates to Medicare when prices for certain single-source and biosimilar prescription drugs covered under Part B increase faster than the rate of inflation. Part B drugs impacted by a coinsurance adjustment may change quarterly. For more information, see the CMS fact sheet.” 
  • HHS’s Agency for Healthcare Research and Quality released its latest medical expenditure panel survey results,
    • “Dental utilization and expenditures in the United States declined in the first year of the COVID-19 pandemic. Total dental expenditures declined by 16.1% from 2019 to 2020; the number of people using dental services declined by 12.5%, and the total number of dental visits decreased by 19.0%.
    • “In 2020, around 131 million persons utilized dental care (40.8% of the total U.S. civilian noninstitutionalized population aged 2 and over), 18 million fewer people than the year before (149 million; 46.7%).
    • “In 2020, the monthly dental visit volume dipped substantially for three consecutive months compared to the same months in 2019.
    • “Between 2019 and 2021, the average—inflation-adjusted—annual expenditures for dental care among persons with any dental care did not differ significantly.”
  • Per an FDA press release,
    • “The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of federal law.
    • “Some of these products are labeled to contain ingredients, such as lidocaine, at concentrations that are higher than what is permitted for over-the-counter, topical pain relief products. When these products that contain high concentrations of lidocaine intended to be used before or during certain cosmetic procedures are applied in ways that could lead to increased absorption of the drug product through the skin, it may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties. These products may also interact with medications or dietary supplements a consumer is taking.
    • “These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”

From the public health and medical research front,

  • Nature lets us know,
    • “A team led by Google scientists has developed a machine-learning tool that can help to detect and monitor health conditions by evaluating noises such as coughing and breathing. The artificial intelligence (AI) system1, trained on millions of audio clips of human sounds, might one day be used by physicians to diagnose diseases including COVID-19 and tuberculosis and to assess how well a person’s lungs are functioning.
    • “This is not the first time a research group has explored using sound as a biomarker for disease. The concept gained traction during the COVID-19 pandemic, when scientists discovered that it was possible to detect the respiratory disease through a person’s cough2.
    • “What’s new about the Google system — called Health Acoustic Representations (HeAR) — is the massive data set that it was trained on, and the fact that it can be fine-tuned to perform multiple tasks.
    • “The researchers, who reported the tool earlier this month in a preprint1 that has not yet been peer reviewed, say it’s too early to tell whether HeAR will become a commercial product. For now, the plan is to give interested researchers access to the model so that they can use it in their own investigations. “Our goal as part of Google Research is to spur innovation in this nascent field,” says Sujay Kakarmath, a product manager at Google in New York City who worked on the project.”
  • The Institute for Clinical and Economic Review announced,
    • “releasing a Draft Evidence Report assessing the comparative clinical effectiveness and value of 3,4-Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP; Lykos Therapeutics) for the treatment of post-traumatic stress disorder (PTSD).
    • This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.
    • “PTSD can be a severe condition affecting nearly all aspects of an individual’s life,” said ICER’s Chief Medical Officer David Rind, MD. “Current therapeutic options are insufficient for many people with PTSD. While MDMA-AP may be a promising therapy for PTSD, functional unblinding in the clinical trials and additional concerns around trial design and conduct leave many uncertainties about the balance of benefits and harms. It will be incumbent on regulators with complete access to primary data to carefully assess whether MDMA-AP has been proven safe and effective.”
    • The Draft Evidence Report and Draft Voting Questions are now open to public comment. All stakeholders are invited to submit formal comments by email to publiccomments@icer.org, which must be received by 5 PM ET on April 22, 2024. 
  • Healio informs us,
    • “Around one in eight hospitalized adults treated for community-acquired pneumonia in a Michigan study were inappropriately diagnosed, and most of those patients received unneeded antibiotics, according to a study.
    • “For patients at high risk of poor outcomes from delayed treatment of community-acquired pneumonia (CAP), it may be pertinent to empirically prescribe antibiotics while finishing diagnostic evaluation,” Ashwin B. Gupta, MD, a clinical associate professor at University of Michigan Health, and colleagues wrote.
    • “However, according to Gupta and colleagues, “For patients at high risk of poor outcomes from delayed treatment of CAP, it may be pertinent to empirically prescribe antibiotics while finishing diagnostic evaluation. In these populations, guidelines recommend reconsideration, de-escalation, and cessation of antibiotics within 48 to 72 hours once infection has been ruled out. In the present study, we found little evidence of antibiotic cessation.”
  • American Hospital Association News notes,
    • “A new report from the National Academies of Sciences, Engineering, and Medicine calls for developing better diagnostics, vaccines and treatments to enhance U.S. readiness for an outbreak or attack involving smallpox or related diseases, and systems and policies that would allow public health and health care systems to respond quickly and effectively.
    • “It is now possible to engineer variola virus, the virus that causes smallpox, raising the possibility of accidental or intentional release,” the press release notes. “Furthermore, illnesses related to smallpox such as mpox, Alaskapox, and cowpox are increasingly found in humans, presenting the need for medical countermeasures that can detect, treat, and prevent these diseases.”

From the U.S. healthcare business front,

  • Beckers Payer Issues calls attention to the biggest investments that payer and healthcare system executives are making this year.
  • Beckers Hospital Review lists the 21 most innovative health systems according to Fortune.
  • The Wall Street Journal reports,
    • “Merck is making a big bet that its new drug, approved Tuesday in the U.S. for a potentially fatal lung disease, will take the company a long way toward heading off a massive revenue decline later this decade.
    • “The drug, which will sell under the name Winrevair, treats a condition called pulmonary arterial hypertension that affects nearly 40,000 people in the U.S. In 2021, Merck paid $11.5 billion for the company developing the medicine. Some analysts estimate sales as high as $7.5 billion a year.
    • “Merck is counting on the blockbuster performance. More than 40% of the drug company’s revenue, some $25 billion last year, comes from cancer treatment Keytruda. The immunotherapy is the world’s top-selling drug. Merck’s main U.S. patent for it expires in 2028, opening the door for lower-cost versions to eat into sales.
    • “Winrevair will list for a price of $14,000 a vial, which for about two-thirds of patients will be the amount given every three weeks. That translates into about $242,000 for a full year, though Merck said the cost would vary by patient because dosage is weight-based.”
  • BioPharm Dive relates,
    • “A dual-acting weight loss pill from Viking Therapeutics helped people with obesity lose up to 5% of their body weight over four weeks in a small trial designed to identify a dose for more advanced studies, the company said Tuesday.
    • “The news helped Viking rebound from a stock slump that followed Novo Nordisk’s announcement a similar weight loss pill it’s developing drove double-digit weight loss over three months in a larger, more advanced trial.
    • “One Wall Street analyst noted the Viking drug’s “exceptional tolerability” may separate it from medicines being developed by Novo, Eli Lilly and Amgen. Only a small number of Viking trial participants reported gastrointestinal side effects, a principal problem people have with weight loss drugs like Novo’s Wegovy and Lilly’s Zepbound.”
  • Bloomberg adds,
    • “Patients, doctors and pharmacists across the US are struggling to get their hands on Eli Lilly & Co.’s powerful new obesity drug Zepbound, as demand for the weight-loss shot soars. * * *
    • “The [FDA] doesn’t consider Zepbound to be in shortage, a spokesperson said. However, nine pharmacists and technicians in six states at CVS, Walgreens and Walmart told Bloomberg News that some or all of the doses of Zepbound were on backorder. Two CVS pharmacies in Ohio have been unable to fill prescriptions for Zepbound’s smallest dose for at least 10 days, two pharmacy technicians said. Amazon Pharmacy, which has a partnership with Lilly, is also listing multiple doses of Zepbound as currently unavailable. None of the pharmacy chains or Amazon responded to requests for comment.” 
  • Fierce Healthcare looks at both sides of the dispute over the value of digital diabetes tools.
  • The AMA News headlined this RevCycle Intelligence article this morning because it trashes health plan claims processing. Health plans are paid to monitor spending and it shouldn’t be surprising that they deny claims.

Monday Roundup

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

From Washington, DC,

  • STAT News reminds us,
    • “The public will soon find out whether the federal government is willing to meet the health insurance industry’s demands and deposit more money into the bank accounts of next year’s Medicare Advantage plans.
    • “Budget officials within the Biden administration started reviewing final payment regulations for 2025 Medicare Advantage plans last week after more than 42,000 public comments rolled into the federal government’s inbox. Those rules will come out no later than April 1.
  • Becker’s Hospital CFO Report adds,
    • “Onerous” authorization requirements and high denial rates have health systems considering whether to drop Medicare Advantage plans, according to a report from the Healthcare Financial Management Association and Eliciting Insights. 
    • “HFMA Health System CFO Pain Points Study 2024” is based on a survey of 135 health system CFOs conducted in January. 
    • According to the report, 16% of health systems are planning to stop accepting one or more Medicare Advantage plans in the next two years. Another 45% said they are considering the same but have not made a final decision.
    • Health systems have been increasingly pushing back on Medicare Advantage. Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s last year that “it’s becoming a game of delay, deny and not pay.” Scripps terminated Medicare Advantage contracts effective Jan. 1 for its integrated medical groups. The medical groups, Scripps Clinic and Scripps Coastal, employ more than 1,000 physicians, including advanced practitioners. Mr. Van Gorder said the health system was facing an annual loss of $75 million on MA contracts.  
    • “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed,” he said.
    • Despite tensions with some health systems, the Medicare Advantage program had a 95% quality satisfaction rating among enrolled members in 2023.
  • The FEHBlog notes that MA plans are subject to the Affordable Care Act’s medical loss ratio. The medical loss ration encourages health plans to make payments to providers.
  • FedSmith lets us know,
    • The Federal Salary Council (FSC) recently proposed adding about 15,000 federal employees to existing locality pay areas for 2025 from the “Rest of the U.S.” Being added to a locality pay area usually results in higher pay for impacted employees.
    • FSC is recommending the Pay Agent add Wyandot County, OH, to the Columbus, OH, locality pay area and Yuma County, AZ, to the Phoenix, AZ, locality pay area. These recommendations do not create new locality pay areas. In this case, they are adding employees to existing pay areas using various techniques to reduce employees in the “Rest of the U.S.” and add more to higher-paying locality pay areas.
    • A proposal from the Federal Salary Council does not mean a decision to make these additions is finalized. The recommendations have to be approved by the President’s Pay Agent. That approval usually follows, although not necessarily in the recommended time frame. Once the Pay Agent decides to move ahead, the Office of Personnel Management has to issue a proposed change in the Federal Register and a final decision in the Federal Register a few months later.
  • Reg Jones, writing in Fedweek, discusses “Survivor Annuity Benefits for Children of Deceased Federal Employees and Retirees.”
  • KFF discusses Medicare spending on GLP-1 drugs, like Ozempic, to treat diabetes.
    • “Gross spending on Ozempic alone increased from $2.6 billion in 2021 to $4.6 billion in 2022, pushing it to 6th place among the top-selling drugs in Medicare Part D that year, up from 10th place the year before.  
    • “The fact that covering GLP-1s under Medicare Part D for authorized uses is already making a mark on total Part D program spending could be a sign of even higher spending to come as Part D plans are now able to cover Wegovy for its heart health benefits, and if new uses for GLP-1s are approved.”
  • CNBC adds,
    • “Americans can’t seem to get enough of weight loss drugs despite their limited insurance coverage and roughly $1,000 monthly price tags before discounts. 
    • “But some patients are willing to pay more out of pocket for those treatments than others — and it’s strongly correlated to their annual income.
    • “That’s according to a recent survey from Evercore ISI that focused on GLP-1s, which include Novo Nordisk’s weight loss injection Wegovy and diabetes counterpart Ozempic.

From the public health and medical research front,

  • The American Medical Association advises its members about measles, now at 64 cases, and tells patient what doctors wish they knew about vasectomies.
  • Medscape shares five things to know about Adult Respiratory Syncytial Virus (RSV) Infection.
  • The Washington Post features a Consumer Reports article on maintaining kidney health. “Hydration and exercise are just two of the keys to reducing the risk of kidney disease.”
  • The Society for Human Resource Management offers nine mental health questions for employee engagement surveys.
  • CNN reports,
    • “Drugmaker Eli Lilly warned this week that two of its formulations of insulin would be temporarily out of stock through the beginning of April, citing a “brief delay in manufacturing.”
    • “The 10-milliliter vials of Humalog and insulin lispro injection will be in short supply at wholesalers and some pharmacies, Lilly said in a statement posted online Wednesday [March 20]. The company said that prefilled pen versions of those medicines are still available in the US and that it continues to manufacture the 10-milliliter vials “and will ship them as soon as we can.”

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “Hospitals are adding billions of dollars in facility fees to medical bills for routine care in outpatient centers they own. Once an annoyance, the fees are now pervasive, and in some places they are becoming nearly impossible to avoid, data compiled for The Wall Street Journal show. The fees are spreading as hospitals press on with acquisitions, snapping up medical groups and tacking on the additional charges. 
    • “The fees raise prices by hundreds of dollars for widely used and standard medical care, including colonoscopies, mammograms and heart screening. 
    •  “Hospitals say facility fees help offset the extra costs that they incur to meet federal regulations. “It’s not as simple as same services, across-the-board,” said Jason Kleinman, director of federal relations for the American Hospital Association.” * * *
    • “Lawmakers and Congress have proposed limiting fees covered by Medicare, which advisers to the federal insurer have unanimously recommended. Under a bill passed by the House in December, Medicare would no longer pay hospital facility fees for chemotherapy and other drugs infused by doctors in clinics off a hospital campus, saving about $3.7 billion over 10 years. 
    • “The American Hospital Association opposes limiting the fees, saying restrictions would cut revenue to hospitals already squeezed financially by high labor costs and inflation.”   
  • Beckers Hospital CFO Report adds,
    • “Kaufman Hall’s latest “National Hospital Flash Report,” which is based on data from more than 1,300 hospitals, outlined three key areas that separate high-performing hospitals’ and low-performing hospitals when it comes to their operating performances: 
      • “Outpatient revenue. In general, hospitals with higher and accelerating outpatient revenue are more profitable.
      • “Contract labor. Hospitals that quickly reduced their percentage of contract labor demonstrate improved operating profitability. In addition, hospitals that aggressively marched down contract labor costs were correlated to rising wage rates for full-time staff. Rising wage rates appeared to attract and retain full-time staff, which has allowed those hospitals to decrease contract labor more quickly, all of which has led to increased profitability, according to the report. 
      • “Average length of stay. A lower average length of stay corresponded with improved profitability. Hospitals that hyper-focused on patient throughput — which has led to appropriate and prompt patient discharge — have also proven this to be a solid financial strategy, according to the report.”
    • “Hospitals on the other end of the scale continue to struggle, with the poorest financially performing hospitals reporting negative margins from -4% to -19%, according to Kaufman Hall. Continuation of this level of performance is unsustainable and makes it impossible to reinvestment in community care.” 
  • Per BioPharma Dive,
    • “Novo Nordisk will pay as much as $1 billion to acquire RNA drug developer Cardior and its experimental treatment for heart failure, the companies announced Monday. 
    • “Cardior’s treatment, dubbed CDR132L, is currently being tested in a mid-stage study involving 280 people with heart failure who previously experienced a heart attack. Results are expected by September, according to a U.S. clinical trial database.
    • “In addition to that study, Novo said it plans to start another Phase 2 trial in heart failure patients whose heart muscle has become thick and stiff, also known as cardiac hypertrophy. Novo, which will pay an undisclosed upfront payment to Cardior per deal terms, expects the acquisition to close in the second quarter.”
  • and
    • “Abbvie is expanding its pipeline of inflammatory disease drugs, announcing Monday a small deal to acquire biotechnology company Landos Biopharma.
    • “Per the deal, Abbvie will buy Landos for $20.42 per share, or about $138 million. Abbvie has also agreed to pay a so-called contingent value right worth $11.14 per share, or another $75 million, if certain milestones are met. The upfront price represents a premium of about 155% to the closing price Friday of Landos stock.
    • “Landos is currently running a mid-stage trial of its lead drug, dubbed NX-13, in ulcerative colitis. Abbvie is also interested in NX-13’s potential in Crohn’s disease.”
  • Per Healthcare Dive,
    • “Change Healthcare said its largest claims clearinghouses would come back online over the weekend, more than a month after a cyberattack at the technology firm disrupted the healthcare sector. 
    • “More than $14 billion in charges have been prepared for processing, according to an update from parent company UnitedHealth Group on Friday. Change’s electronic payments platform has also been restored, and the company is working on payer implementations.”

Midweek Update

David Ermer–CMS, Congress, COVID-19, Cybersecurity, Employee Wellness Programs, FDA, Generative AI, Medical / Rx research, Mental health care, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Speaker Mike Johnson, R-La., and his top lieutenants on Wednesday morning moved to quell reservations among their conference about the emerging $1.2 trillion-plus final spending package headed for a vote likely on Friday, while their Democratic counterparts did likewise in a separate meeting.
    • “Appropriators were scrambling under a tight timeline to finish drafting the measure, which is taking longer than expected due to a last-minute decision to write a full-year Homeland Security bill. But Johnson told reporters after a GOP conference meeting that text is expected as soon as Wednesday afternoon.
    • “Other sources expected the bill drop to slip to Thursday, with the standard “reading out” of the DHS title, to catch any errors before posting, not even expected to begin until later Wednesday. But no matter: Lawmakers said they expect the chamber to vote as soon as Friday, regardless of a 72-hour review rule. * * *
    • “Final passage wouldn’t come until this weekend at the earliest, and senators are working to accommodate Sen. Susan Collins, R-Maine, who has never missed a vote but will be attending her mother’s funeral on Saturday. That could push votes off until Sunday or Monday, though few are worried at this point about the effects of such a brief funding lapse. 
    • “I don’t think we’ll do a [continuing resolution],” Johnson said.”
  • The American Hospital Association (AHA) News informs us,
    • “The House Energy and Commerce Committee March 20 unanimously passed AHA-supported legislation to reauthorize through 2029 the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 7153), which provides grants to help health care organizations offer behavioral health services for front-line health care workers. The bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. Without congressional action, the law will expire at the end of this year.”
  • and
    • “Congress should address any statutory constraints that prevent the Centers for Medicare & Medicaid Services and Department of Health and Human Services from adequately helping hospitals and other health care providers impacted by the Change Healthcare cyberattack, AHA said a letter submitted to the House Ways and Means Committee for a hearing March 20 with HHS Secretary Xavier Becerra on fiscal year 2025 funding for HHS.”
  • Govexec tells us,
    • “The top senator with direct oversight of the U.S. Postal Service is calling on its leadership to pause its overhaul of the agency’s mailing network due to potential impacts they are having on delivery, rejecting USPS assertions that is has provided transparency. 
    • “USPS should not continue its nationwide operational reforms until it can prove the changes will not negatively impact mail service, Sen. Gary Peters, D-Mich., who chairs the Senate Homeland Security and Governmental Affairs Committee, said in a letter to Postmaster General Louis DeJoy. Agency leadership said in response to the letter it has offered volumes of documents and many staff-level briefings to Congress, though Peters said USPS ignored many of his requests for additional information on its efforts and left Congress uncertain about the fallout that could befall postal customers.”
  • On March 18, 2024, the Office of Management and Budget’s Office of Information and Regulatory Affairs received for final regulatory review an OPM proposed rule with additional requirements and clarifications for the Postal Service Health Benefits Program (RIN 3206-AO59).
  • The AHA News tells us,
    • “U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced March 19, citing potential quality and performance issues. The recommendations do not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, FDA said. The agency advises health care providers to confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.”
  • The Assistant Secretary of Labor for Employee Benefit Security, Lisa M. Gomez, posted on her blog about “Health and Money Smarts for Women.”
  • Fierce Healthcare lets us know,
    • “The Employee Retirement Income Security Act, or ERISA, is turning 50 this year and lawmakers are curious to hear about how the law could be updated to increase coverage affordability and care access.
    • “Payers and providers, it turns out, have very different ideas on where Congress should focus its efforts.
    • “In response to the House Committee on Education and the Workforce’s January request for information, lobbying groups representing both sides of the industry weighed in on the act that outlines federal guidelines for employee benefit plans, including employer-sponsored group health plans.”
    • The article delves into these comments.
  • Newfront offers insights about 2024 RxDC reporting considerations. The reports are due June 1, 2025.
  • The Congressional Budget Office released a presentation about “The Federal Perspective on Coverage of medications to treat obesity. Assuming Congress allows Medicare to cover anti-obesity medications (AOM),
  • “The future price trajectory of AOMs is highly uncertain.
    • “CBO expects semaglutide to be selected for price negotiation by the Secretary of Health and Human Services within the next few years, which would lower its price (and potentially the prices of other drugs in the AOM class).
    • “CBO expects generic competition for semaglutide and tirzepatide to start in earnest in the second decade of a policy allowing Medicare Part D to cover AOMs.
    • “New AOMs are expected to become available. The new drugs might be more effective, have fewer side effects, or be taken less frequently or more easily than current medications. Those improvements could translate to higher prices, on average, even if prices decline for drugs that exist today.”
  • See also the Beckers Hospital Review article below on the next generation of AMOs.
  • Healthcare Dive tells us,
    • “The Medicare Advisory Payment Commission, which advises Congress on Medicare policy, is recommending boosting hospital payment rates by 1.5% in 2025 and base physician payment rates by 1.3% above current law, according to its annual report released Friday. 
    • “MedPAC suggested tying the rate of physician payment increasesmoving forward to the Medicare Economic Index, an annual measure of practice cost inflation. MedPAC suggested payments increase “by the amount specified in current law plus 50% of the projected increase in the MEI.”
    • “Provider groups, including the Medical Group Management Association and American Medical Association, have said the proposed payment increases are inadequate.”

From the public health and medical research front,

  • The Washington Post reports,
    • “More than two-thirds of young children in Chicago could be exposed to lead-contaminated water, according to an estimate by the Johns Hopkins Bloomberg School of Public Health and the Stanford University School of Medicine.
    • “The research, published Monday in the journal JAMA Pediatrics, estimated that 68 percent of children under the age of 6 in Chicago are exposed to lead-contaminated drinking water. Of that group, 19 percent primarily use unfiltered tap water, which was associated with a greater increase in blood lead levels.
    • “The extent of lead contamination of tap water in Chicago is disheartening — it’s not something we should be seeing in 2024,” lead author Benjamin Huynh, assistant professor of environmental health and engineering at the Johns Hopkins Bloomberg School of Public Health, said in a news release.”
  • The Wall Street Journal relates,
    • “Debi Lucas had a tremor in her arm. Her feet froze when she tried to walk and she fell into her coffee table, busting her lip. 
    • “She went to a neurologist who thought she had Parkinson’s disease. Doctors normally diagnose the neurodegenerative condition by symptoms. Lucas, 59, had them. 
    • “But the neurologist, Dr. Jason Crowell, couldn’t be sure. The symptoms might be related to a traumatic brain injury Lucas suffered in a car accident decades earlier, he thought. Or they might be from her medications. 
    • “To find an answer, Crowell turned to a new test: a skin biopsy that can detect an abnormal protein people with Parkinson’s have inside their nerves. He took samples of skin near her ankle, knee and shoulder and sent them to a lab. 
    • “The results confirmed that Lucas has Parkinson’s. The diagnosis was scary, but Lucas finally knew what was causing her symptoms. “I was glad to have a name on it,” she said. 
    • “The test sped her diagnosis, said Crowell, a movement-disorders neurologist at the Norton Neuroscience Institute in Louisville, Ky. “It just gives me more confidence,” he said. 
    • “The skin test is an important part of progress researchers are making against Parkinson’s, the second-most common age-related neurodegenerative condition, which is on the rise and a major driver of disability, dementia and death. The test Lucas received, made by CND Life Sciences, a medical technology company in Scottsdale, Ariz., is one of a few in use or development to allow doctors to diagnose Parkinson’s based on biology rather than symptoms that can take years to appear“.
  • Medscape explains “why a new lung cancer treatment is so promising.”
  • MedPage Today notes,
    • “The FDA has approved aprocitentan (Tryvio), making it the first endothelin receptor antagonist for the treatment of high blood pressure (BP), Idorsia Pharmaceuticals announced on Wednesday.
    • “The once-daily oral medication is indicated in combination with other antihypertensive drugs to lower BP in adult patients who do not have their BP controlled with other therapies.
    • “It is believed that some people may respond better to the drug’s novel mechanism, as aprocitentan is a dual endothelin receptor antagonist that works differently than conventional diuretics, renin-angiotensin-aldosterone system antagonists, calcium channel blockers, and beta-blockers used to lower BP.”
  • Beckers Hospital Review considers the three generations of weight loss drugs.
    • “Anita Courcoulas, MD, defines GLP-1s as “generation one;” dual GLP-1 and GIPs as the second; and a triple threat of GLP-1, GIP and GCGRs as the third generation of weight loss drugs. 
    • “Dr. Courcoulas is chief of Pittsburgh-based UPMC’s minimally invasive bariatric and general surgery program. She told Becker’s the next class of anti-obesity medications are finally reaching weight loss outcomes seen from gastric sleeve and bypass procedures, the two most common surgeries for trimming pounds. * * *
    • “Dr. Courcoulas said the biggest unknown is long-term durability of these medications, a concern other bariatric experts have raised. 
    • “She expects GLP-GIP-GCGR medications to gain approval and enter the U.S. market next year. 
    • “I think it’s very exciting to realize there are medications that are under investigation now that could come to market that could have even better weight loss results than the two drug [classes] we’re seeing now,” Dr. Courcoulas said.”
  • The National Institutes of Health announced,
    • “SARS-CoV-2, the virus that causes COVID-19, can damage the heart even without directly infecting the heart tissue, a National Institutes of Health-supported study has found. The research, published in the journal Circulation, specifically looked at damage to the hearts of people with SARS-CoV2-associated acute respiratory distress syndrome (ARDS), a serious lung condition that can be fatal. But researchers said the findings could have relevance to organs beyond the heart and also to viruses other than SARS-CoV-2.
    • “Scientists have long known that COVID-19 increases the risk of heart attack, stroke, and Long COVID, and prior imaging research has shown that over 50% of people who get COVID-19 experience some inflammation or damage to the heart. What scientists did not know is whether the damage occurs because the virus infects the heart tissue itself, or because of systemic inflammation triggered by the body’s well-known immune response to the virus.
    • “This was a critical question and finding the answer opens up a whole new understanding of the link between this serious lung injury and the kind of inflammation that can lead to cardiovascular complications,” said Michelle Olive, Ph.D., associate director of the Basic and Early Translational Research Program at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH. “The research also suggests that suppressing the inflammation through treatments might help minimize these complications.”
  • and
    • “An investigational gene therapy for a rare neurodegenerative disease that begins in early childhood, known as giant axonal neuropathy (GAN), was well tolerated and showed signs of therapeutic benefit in a clinical trial led by the National Institutes of Health (NIH). Currently, there is no treatment for GAN and the disease is usually fatal by 30 years of age. Fourteen children with GAN, ages 6 to 14 years, were treated with gene transfer therapy at the NIH Clinical Center and then followed for about six years to assess safety. Results of the early-stage clinical trial appear in the New England Journal of Medicine. 
    • “The gene therapy uses a modified virus to deliver functional copies of the defective GAN gene to nerve cells in the body. It is the first time a gene therapy has been administered directly into the spinal fluid, allowing it to target the motor and sensory neurons affected in GAN. At some dose levels, the treatment appeared to slow the rate of motor function decline. The findings also suggest regeneration of sensory nerves may be possible in some patients. The trial results are an early indication that the therapy may have favorable safety and tolerability and could help people with the rapidly progressive disease.
    • “One striking finding in the study was that the sensory nerves, which are affected earliest in GAN, started ‘waking up’ again in some of the patients,” said Carsten G. Bonnemann, M.D., senior author and chief of the Neuromuscular and Neurogenetic Disorders of Childhood Section at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH. “I think it marks the first time it has been shown that a sensory nerve affected in a genetic degenerative disease can actually be rescued with a gene therapy such as this.”
  • Lifesciences Intelligence reports,
    • “Recently, JAMA Network Open published a study analyzing the association between a healthy diet, sleep duration, and type 2 diabetes (T2D) risk. The study data revealed that habitual short sleep duration was linked to an increased probability of T2D by as much as 41%.
    • “Using data on 247,867 individuals from the UK biobank, researchers divided patients into groups based on their sleeping habits. The stratified groups included normal (7–8 hours per night), mildly short (6 hours per night), moderately short (5 hours per night), and extremely short (3–4 hours per night).
    • “Across all study participants, only 3.2% were diagnosed with T2D; however, the adjusted hazard ratios revealed that the prevalence of T2D was higher among shorter sleep groups. More specifically, the increased probability of T2D was identified in those who slept 5 hours or less per night. Those in the moderate short sleep group were 16% more likely to have a T2D diagnosis. Additionally, those in the extremely short sleep group had a 41% greater likelihood of being diagnosed with T2D.”

From the U.S. healthcare business front,

  • BioPharma Dive relates,
    • “Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease at a record-setting wholesale price of $4.25 million. 
    • “The therapy, Lenmeldy, won Food and Drug Administration approval on Monday to treat patients with early-onset metachromatic leukodystrophy, or MLD. The disease, which most often attacks infants between six months and two years of age, robs patients of the ability to walk, talk and function in the world, killing most of its earliest victims within five years of onset.
    • “Lenmeldy’s price tag will leapfrog those of the two most expensive gene therapies available in the U.S. Sarepta Therapeutics sells its Elevidys treatment for Duchenne muscular dystrophy for $3.2 million, while CSL and UniQure’s hemophilia treatment Hemgenix costs $3.5 million.”
  • MedPage Today lets us know,
    • “Despite being a growing percentage of the physician workforce, women physicians continued to be paid less than their male colleagues, a strong body of evidence shows.
    • “While the gender pay gap decreased by 2% from 2021 to 2022 — from 28% to 26% — the gap was still significant, according to online networking service Doximity’s 2023 physician compensation reportopens in a new tab or window.
    • “Women doctors in 2022 earned nearly $110,000 less per year than men physicians, on average, after adjusting for specialty, location, and years of experience. Data from individual states have backed up this figure, too. For instance, in 2022, the Maryland State Medical Society conducted a survey and found that women doctors in Maryland are paid about $100,000 less annually than men.”
  • Beckers Hospital Review lists ten common issues in pharmacies.
  • United Healthcare updated its Change Healthcare cyberattack response website today.
  • HR Daily Advisor explains how companies are exploring the limitations of employee assistance plans amid the country’s mental health crisis.
  • Forbes reports,
    • “Medical diagnosis and procedure codes are so numerous and varied that Debbie Beall, manager of coding at Houston Methodist in Texas, needs a 49-person team to translate the medical notes written by the system’s 1,600 clinicians into the codes needed to bill insurers.
    • “There is a medical code for every imaginable scenario – from “burn due to water-skis on fire” to “spacecraft collision injuring occupant” — and their specificity determines how much the insurance companies pay. Each team member processes anywhere from 70 to 250 claims per day, depending on the complexity, she said. That’s why Beall is so excited about the possibility of using artificial intelligence to speed up the job.
    • “There’s no way I’m ever going to replace coders completely with an AI system,” Beall told Forbes. But for run-of-the-mill procedures performed multiple times a day in a hospital, like X-rays and EKGs? “Yes, an AI engine can do that.”
    • “Beall was one of the first dozen or so people to test a prototype of an AI-powered medical coding tool from electronic health records giant Epic Systems, which had $4.6 billion in revenue in 2022. Based on GPT-4, the large language model that powers the viral chatbot ChatGPT, Epic’s coding assistant prototype ingests and summarizes clinician notes and then tees up the “most likely” diagnosis codes and procedures codes, along with suggestions of “other potential codes,” according to mock ups viewed by Forbes that did not include real patient information. * * *
    • “While Epic has so far focused on using generative AI in back office functions, it has also been working on a patient-facing application that wouldn’t require human review. Krause told Forbes a tool that would help explain the patient’s bill, including their deductible and outstanding balance, could be rolled out by November. “We feel like that’s a fairly benign place to start. It’s not about healthcare at that point, but it’s really about their billing,” he said. “That’s not going to harm a patient in any way.”

   

Monday Roundup

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

From Washington, DC

  • Roll Call reports,
    • “Lawmakers are back to writing a full-year fiscal 2024 Homeland Security appropriations bill in a dramatic, last-minute shift following White House intervention over the weekend, sources familiar with the decision said Sunday night. 
    • “Appropriators had been working on a yearlong stopgap measure, negotiating necessary changes to the fiscal 2023 status quo to be included as “anomalies,” after talks on a full-year bill initially fell apart late last week. * * *
    • “While the situation remains fluid, the move back toward a full-fledged bill is ultimately a sign of forward momentum. However, release of text for the complete six-bill package is now expected Monday at the earliest, putting Congress on a compressed timeline to clear the legislation before Friday at midnight, when current stopgap funding lapses.
    • “House rules allot members 72 hours to read legislation before voting on it, and it usually takes the Senate a couple days to process any legislation. The package will also include the Defense, Labor-HHS-Education, Financial Services, Legislative Branch and State-Foreign Operations measures.” 
  • The White House issued an Executive Order on Advancing Women’s Health Research and Innovation. Here is a link to the White House fact sheet.
    • “Today, President Biden is signing a new Executive Order that will direct the most comprehensive set of executive actions ever taken to expand and improve research on women’s health. These directives will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, and will galvanize new research on a wide range of topics, including women’s midlife health.”
  • The White House also announced,
    • “President Biden’s Cancer Moonshot is accelerating progress to prevent, detect, and treat cancer while boosting support for families facing cancer, including by undertaking an aggressive effort to protect families and workers from hazardous chemicals like known carcinogens. After more than three decades of inadequate protections, today the Environmental Protection Agency (EPA) is announcing a historic ban on ongoing uses of asbestos. This marks the first rule finalized under the nation’s updated chemical safety law, a milestone in the Biden-Harris Administration’s efforts to protect public health, advance environmental justice, and end cancer as we know it.”

From the Food and Drug Administration front,

  • The FDA informed us,
    • “Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). 
    • “Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management.”
  • MPR reports,
    • “The Food and Drug Administration (FDA) has approved Xhance® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. Previously, the treatment was only approved for adults with nasal polyps.
    • “Xhance is a drug-device combination therapy that delivers fluticasone, a corticosteroid, deep into difficult-to-access sinuses and sinonasal drainage tracts. The medication is delivered into the nose by actuating the pump spray into 1 nostril while simultaneously blowing (exhaling) into the mouthpiece of the device.”

From the public health and medical research front,

  • MedPage tells us,
    • “Preventing SARS-CoV-2 infection in immunocompromised people hasn’t gotten any easier as the pandemic trundles on into its fifth year. * * *
    • “Vaccination against SARS-CoV-2 is now the key prevention strategy for this vulnerable population, and people who are immunocompromised should still get COVID boosters — but, given that they are less likely to generate an adequate immune response to the vaccines, the question is: how often? * * *
    • “Of three clinicians who treat moderately to severely immunocompromised patients and spoke with MedPage Today, all of them offered a similar recommendation: people who are immunocompromised should get a COVID vaccine about every 6 months, with the caveat that intervals between vaccine doses should be tailored to individual patient needs.”
  • and
    • “Electronic nudges sent to patients failed to increase influenza vaccine uptake in one randomized clinical trial, while another trial found that slight increases in vaccination rates from letters emailed to patients failed to impact clinical outcomes.
    • “Neither portal nor text messages to remind patients to get an influenza vaccination were effective at a population level at improving vaccination uptake, Peter Szilagyi, MD, MPH, of the UCLA Mattel Children’s Hospital at the University of California in Los Angeles, and colleagues reported in JAMA Internal Medicine. Among patients who received care from 79 primary care practices in a large healthcare system, flu shot rates remained at approximately 47% whether patients received portal messages, text messages, or no reminders at all.
    • “And in an analysis of the Danish NUDGE-FLU trial, an about 1% boost in influenza vaccination associated with email letters encouraging patients to get vaccinated did not translate into improvements in cardiovascular, respiratory, or other clinical endpoints, Niklas Johansen, MD, of the Copenhagen University Hospital-Harlev and Gentofte in Denmark, and colleagues wrote in the Annals of Internal Medicine“
  • Healio lets us know,
    • “A CDC program to distribute free HIV self-test kits has mailed nearly double the number of tests in its first year than expected.
    • “More than one-quarter of people receiving tests had never tested for HIV before.”
  • The National Institutes of Health announced,
    • “Using advanced imaging techniques and in-depth clinical assessments, a research team at the National Institutes of Health (NIH) found no significant evidence of MRI-detectable brain injury, nor differences in most clinical measures compared to controls, among a group of federal employees who experienced anomalous health incidents (AHIs). These incidents, including hearing noise and experiencing head pressure followed by headache, dizziness, cognitive dysfunction and other symptoms, have been described in the news media as “Havana Syndrome” since U.S. government personnel stationed in Havana first reported the incidents. Scientists at the NIH Clinical Center conducted the research over the course of nearly five years and published their findings in two papers in JAMA today.
    • “Our goal was to conduct thorough, objective and reproducible evaluations to see if we could identify structural brain or biological differences in people who reported AHIs,” said Leighton Chan, M.D., chief, rehabilitation medicine and acting chief scientific officer, NIH Clinical Center, and lead author on one of the papers. “While we did not identify significant differences in participants with AHIs, it’s important to acknowledge that these symptoms are very real, cause significant disruption in the lives of those affected and can be quite prolonged, disabling and difficult to treat.”
  • and
    • “Fenoprofen, a nonsteroidal anti-inflammatory drug (NSAID), successfully alleviated pain and inflammation in a rodent model of endometriosis, according to researchers funded by the National Institutes of Health (NIH). They chose the drug after using a computer algorithm to evaluate nearly 1,300 existing compounds for their ability to reverse gene expression related to endometriosis disease. The study was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
    • “Analysis by researchers at the University of California, San Francisco, using publicly available data from people with endometriosis, returned 299 candidate compounds with seven considered top candidates. These drugs included commonly used treatments for the disease, such as aspirin, as well as those not yet studied for this purpose. The researchers chose fenoprofen for further evaluation because it returned the highest gene expression reversal score and belongs to a drug class—NSAIDS—that is one of the first-line treatments for endometriosis.
    • “Fenoprofen is a prescription drug approved for the relief of mild to moderate pain and is often prescribed for arthritis. The researchers analyzed electronic medical records from five University of California healthcare institutions and found that the drug had been prescribed for less than 1% of patients with endometriosis or related conditions. They then tested fenoprofen in a rodent model of the disease, observing that it successfully alleviated vaginal hyperalgesia, a surrogate marker for endometriosis-related pain.
    • “If future studies in people confirm these findings, the researchers suggest that fenoprofen could be prescribed more frequently to treat endometriosis pain. Their work also supports continued use of their computer-based approach to repurpose other existing drugs as potential therapeutic candidates for endometriosis.”

From the U.S. healthcare business front,

  • Beckers Hospital Review updates us on the Change Healthcare situation. UHC updated its Change Healthcare cyberattack response website today.
  • The Washington Post considers whether the millions of dollars that Medicare pays for remote vital signs monitoring is worthwhile.
    • “While some small studies show remote monitoring can improve patient outcomes, researchers say it is unclear which patients are helped most and how long they need to be monitored.
    • “The research evidence is not as robust as we would like to show that it is beneficial,” said Ateev Mehrotra, a Harvard Medical School researcher.
    • “A January report by the Bipartisan Policy Center, a D.C. think tank, warned about “a lack of robust evidence on the optimal use of remote monitoring” and said some policy and medical experts “question whether we are effectively ‘rightsizing’ the use of these services, ensuring access for patients who need it most, and spending health care dollars in effective ways.”
  • Beckers Hospital Review lets us know the fifteen best and worst states for doctors.
    • “Montana, South Dakota and Nebraska are the top three states for physicians to practice in the U.S., according to WalletHub’s 2024 ranking published March 18. Hawaii, Rhode Island and New Jersey were deemed the worst.
    • “The annual ranking is based on two key dimensions: opportunity and competition, and medical environment.”
  • Per Fierce Healthcare,
    • “Highmark Health recorded $27.1 billion in revenue and a net income of $533 million for 2023, the company announced during its fourth-quarter results Monday.
    • “The company reported an operating margin of $338 million, though there was an operating loss of of $117 million during 2023 for the Allegheny Health Network as the system recovers from the pandemic. That was offset by gains seen in health insurance and other investments.
    • “According to a press release, Highmark holds $11 billion in cash and investments, and Highmark Health Plans reported an operating gain of approximately $400 million in 2023. It remains the largest insurer in Pennsylvania, Delaware, Virginia and western New York, said CEO David Holmberg. It was also selected to provide Medicaid to eligible members in West Virginia.
    • “He said Highmark’s annual revenue has grown 72% and Highmark Health Plan’s membership has grown 32% since 2013.
    • “We have transformed from a successful regional insurer into an innovative, diversified health organization, comprehensive solutions and national influence,” he said.”
  • The Washington Post relates,
    • “AstraZeneca is capping out-of-pocket costs for inhalers and related medication at no more than $35 per month, the drugmaker announced Monday.
    • “The Britain based pharma giant said the expanded savings are intended to help vulnerable patients with asthma or chronic obstructive pulmonary disease, especially those without health insurance. The price cap takes effect June 1.”
  • Beckers Hospital Review adds,
    • “First-time prescriptions for Eli Lilly’s Zepbound surpassed those for Novo Nordisk’s Wegovy in early March, according to data cited by Reuters. 
    • “For the week ending March 8, 77,590 new prescriptions were filled for Zepbound and about 71,000 were filled for Wegovy. It’s the first time Zepbound, a chronic weight management therapy approved in early November and released in December, eclipsed Novo Nordisk’s blockbuster weight loss drug.” 

Happy Pi Day!

David Ermer–CDC, Congress, FDA, HSA, Medical / Rx research, Medicare, Rx coverage–
Photo by Taso Katsionis on Unsplash

From Washington, DC

  • The bipartisan leadership of the Senate Finance Committee are pressing Congress for prescription benefit manager reform.
    • Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo R-Idaho, today renewed their call for the passage of their bipartisan legislation to crack down on pharmacy benefit managers (PBMs) and their shadowy tactics that are driving up the cost of prescription drugs and forcing pharmacies across the country to close their doors.
    • Ahead of a press conference this morning where Senators Wyden and Crapo were joined by pharmacy and patient advocates to press for PBM reform, the Senators sent a letter to their Finance Committee colleagues reaffirming their commitment to getting their legislation across the finish line as soon as possible this Congress.
  • FEHBlog observation — Read this Brookings Institution article to understand why the Senator’s position may be overwrought.
  • STAT News reports,
    • “Novo Nordisk’s newly won permission to market the heart benefits of its obesity drug Wegovy could provide a backdoor way to expand access to the drug for people on Medicare, experts told STAT.
    • “Currently, Medicare is prohibited by law from covering medications for obesity treatment alone. While companies that manufacture wildly popular anti-obesity medications and their allies haven’t been successful in lobbying Congress to change the law, the Food and Drug Administration’s move could give doctors an avenue to prescribe the medications to some Medicare patients.
    • “Wegovy’s new label indicates that the drug can be used to reduce the risk of major heart complications for people who are overweight or obese and have existing heart disease, Novo said in a statement Friday.
    • “This is definitely… an opportunity for patients with both cardiovascular disease and obesity to potentially get this drug when they couldn’t get it just for obesity alone,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at KFF.”
  • MedPage Today tells us,
    • “The FDA granted accelerated approval to resmetirom (Rezdiffra) as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH), also now referred to as metabolic dysfunction-associated steatohepatitis (MASH).
    • “A once-daily oral agent, resmetirom is a liver-directed thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH; the drug is specifically indicated for NASH patients with moderate to advanced liver fibrosis, consistent with stages F2 to F3 fibrosis, and should be used along with diet and exercise, according to the agency.
    • “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, MD, of FDA’s Center for Drug Evaluation and Research, in a statement. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
    • “A result of non-alcoholic fatty liver disease (NAFLD) progression, NASH can lead to liver fibrosis and dysfunction, raising the risk of transplant and hepatocellular carcinoma. The condition is often associated with hypertension and diabetes.
    • “According to some estimates, 6 million or more Americans have NASH with stages F2 to F3 fibrosis, a number only expected to increase in the coming years.”
  • Healthcare IT News fills us in on an interesting conversation between the Deputy Coordinator of Health Information Technology and the CDC Director at the HIMSS conference in Orlando.

From the public health and medical research front,

  • The New York Times reports,
    • “Teen pregnancy increases the chances that a young woman will drop out of school and struggle with poverty, research has shown. Teenagers are also more likely to develop serious medical complications during pregnancy.
    • “Now a large study in Canada reports another disturbing finding: Women who were pregnant as teenagers are more likely to diebefore their 31st birthday. The trend was observed among women who had carried teen pregnancies to term, as well as among those who had miscarried.
    • “The younger the person was when they became pregnant, the greater their risk was of premature death,” said Dr. Joel G. Ray, an obstetric medicine specialist and epidemiologist at St. Michael’s Hospital in Toronto and the first author of the study. It was published in JAMA Network Open on Thursday.
    • “Some people will argue that we shouldn’t be judgmental about this, but I think we’ve always known intuitively that there’s an age that is too young for pregnancy,” he added.
  • The Washington Posts informs us,
    • “A new study calls into question the extent of the maternal mortality crisis in the United States, which has long posted a disproportionately high rate of maternal deaths compared with peer nations.
    • “Data classification errors have inflated U.S. maternal death rates for two decades, according to the study published Wednesday in the American Journal of Obstetrics & Gynecology. Instead of the maternal death rate more than doubling since 2002, it has remained flat, researchers found.
    • “There has been a lot of alarm and apprehension surrounding the fact that some of these reports show a threefold increase in maternal mortality, and that is not what we found. We found low and stable rates,” said K.S. Joseph, the study’s lead author and professor in the departments of obstetrics and gynecology and the School of Population and Public Health at the University of British Columbia in Vancouver. * * *
    • “Some experts say the study’s biggest takeaway is the persistent racial disparities, with many pregnant Black people experiencing more medical complications involving Caesarean sections, postpartum hemorrhaging and preterm births. However the data is calculated, the pattern remains the same, said Colleen Denny, an associate professor in the department of obstetrics and gynecology and director of family planning at NYU Langone Hospital as well as a fellow of the American College of Obstetricians and Gynecologists.
    • “We should be targeting a lot of our public outreach to focus on conditions that are affecting patients of color while they’re pregnant,” said Denny, who was not involved with the study.”

From the cybersecurity front,

  • UHC updated its Change Healthcare cyberattack response website today.
    • “Palo Alto Networks Unit 42 experts are on the ground, collaborating diligently with UnitedHealth and their partners to restore operations and ensure a swift and secure resolution following the recent disruption. To date we have reviewed and protected a large majority of infrastructure, including the server and application space, and assisted in bringing critical services back online that allowed for more than 9 million prescriptions to be filled.” 
  • The American Hospital Association News lets us know,
    • “The Centers for Medicare & Medicaid Services March 13 released additional information on the Medicare accelerated and advance payments that hospitals, physicians and others impacted by the Change Healthcare cyberattack may apply for through their Medicare Administrative Contractors. According to CMS, the MACs aim to review requests and notify most providers/suppliers of the outcome of their request within five business days of receipt.
  • Aetna provides a good example of the information that other carriers are sharing with their network providers and members about the Change Healthcare situation.

From the U.S. healthcare business front,

  • EBRI offers new research about health savings accounts.
    • “HSA balances continued to increase over the course of the year, despite higher spending on health care. Continuing a trend observed post-COVID-19 pandemic, patient spending on health care increased in 2022. Still, average end-of-year HSA balances were higher than average beginning-of-year balances. Average balances increased at an even faster rate in 2022, conditional on those accounts receiving either an employee or employer contribution over the course of the year. 
    • “Accounts that received an employer contribution saw higher total contributions and were more likely to invest. Employers seeking to help their workers engage with their HSAs may find employer contributions to be a useful tool, as accountholders who received an employer contribution on their behalf had higher average total contributions and were more likely to invest. Our analysis indicates, however, that these accountholders were also more likely to take more frequent and larger distributions. 
    • “Most accountholders took a distribution in 2022. More than half of the HSAs in EBRI’s database saw a distribution in 2022, and the average distribution was $1,868. 
    • “Relatively few HSAs are invested. One of the largest advantages HSAs offer is the ability to invest assets within the account. However, our analysis reveals that only 13% of accountholders invested their HSAs in assets other than cash. 
    • “Age and tenure play a major role in HSA utilization. Consistent with previous findings, accountholder age — as well as accountholder tenure — is closely related to average balances, contributions, and distributions, as well as the propensity to invest. On average, older accountholders contributed more to their HSAs, had higher balances, more frequently took distributions, and had a higher likelihood of investing at least some portion of their HSA in assets other than cash.”
  • McKinsey and Co. shares its report on the future of Medicare Advantage.
    • “The Medicare Advantage program is undergoing its biggest shifts in more than two decades. Payers can take steps now to mount a strategic, agile response as the changes unfold.”

 

Monday Roundup

David Ermer–AHRQ, COVID-19, Electronic health records, Medical / Rx research, Medicare, Obesity, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “President Biden proposed Monday a $7.3 trillion budget for the next fiscal year that would raise taxes on wealthy people and large corporations, trim the deficit and lower the costs of prescription drugs, child care and housing.
    • “The proposal isn’t expected to gain momentum in Congress, but will be a cornerstone of Biden’s re-election campaign as he looks to contrast his economic policies with those of presumed Republican presidential nominee Donald Trump. The administration has yet to reach an agreement with Congress on the budget for the current fiscal year, which began Oct. 1, and House Republicans have blasted Biden’s new proposal as reckless.
    • “The fiscal 2025 budget would cut the deficit by $3 trillion over the next decade, and it would raise taxes by a net total of $4.9 trillion, or more than 7% above what the U.S. would collect without any policy changes.” 
  • Here’s a link to the OMB page for the FY 2025 budget.
  • The Department of Health and Human Services offers a fact sheet on the budget measures impacting health insurance.
  • Govexec delves into the significant program reforms found in the budget details.
  • Federal News Network adds,
    • “For 2025, the White House is pushing for a more modest 2% federal pay raise for the roughly 1.5 million federal employees on the General Schedule.
    • “If enacted, most civilian federal employees would see the boost to their paychecks starting in the first full pay period of January 2025. Military members would receive a 4.5% raise next year, according to the budget request.
    • “The percentage adjustment would be the smallest pay raise since President Joe Biden took office. Federal employees received raises of 5.2%, 4.6% and 2.7%, in 2024, 2023 and 2022, respectively. In all three years, Biden’s federal pay raise proposals were finalized without intervention from Congress.
    • “The Biden administration said it opted for the smaller raise proposal for 2025 due to financial constraints agencies are expected to face over the next fiscal year.”
  • The U.S. Office of Personnel Management posted its FY 2025 Congressional Budget Justification and Annual Performance Plan. Here are OPM’s legislative proposals for FEDVIP and FEHBP/PSHBP:
    • “Expand Family Member Eligibility Under FEDVIP;
    • “Expand FEDVIP to Certain Tribal Employers;
    • “Expand FEHB to Tribal Colleges and Universities;
    • “Preempt State/Local Taxation of FEDVIP Carriers to Align with FEHB Carriers;
    • “Shorten FEDVIP Contract Terms to Allow Flexibility for New Carriers;
    • “Require Coverage of Three Primary Care Visits and Three Behavioral Health Visits Without Cost-Sharing;
    • “Limit Cost-Sharing for Insulin at $35 per Month.”
  • These proposals generally are retreads from earlier performance plans. If at first you don’t succeed, etc.

From the patient safety front,

  • HHS’s Agency for Healthcare Research and Quality reminds us that this is Patient Safety Awareness Week.
  • Fierce Healthcare tells us,
    • “Through no fault of their own, clinicians who started practicing medicine in the last several years didn’t have the same early experience as those who came before them–before the pandemic laid bare critical weaknesses in our healthcare system,” Marcus Schabacker, M.D., president and CEO of ECRI, said in a release. “ECRI’s top patient safety concern is a call to action to set new clinicians up for success through a ‘total systems safety’ approach and assess and redesign the environments in which clinicians are trained, onboarded, mentored and supported.”
    • “Among the recommendations proposed by ECRI and its affiliate, the Institute for Same Medication Practices (ISMP), in the patient safety report are new collaborative partnerships between healthcare and academic to support hands-on and simulation-based learning, as were wellness programs and adopting “a culture of safety that empowers newly trained clinicians to report safety events.”
    • “Just behind new hire challenges in ECRI’s 2024 ranking was concern that healthcare staff’s workarounds for barcode medication administration systems could lead to an increase in medication safety events.
    • “These workarounds occur when drug’s barcode can’t be scanned due to damage on a label, or when a medication hasn’t yet been added to an organization’s system, ECRI explained. This can lead to back-charting, proxy scanning, unlogged medication administration and ignored system alerts, and has historically been to blame for a majority of technology-related medication safety issues, according to the report.”
  • USAA Today reports,
    • “Beginning this year, the Centers for Medicare & Medicaid Services announced it would cover navigation services for older Americans on Medicare. The agency also established billing codes for hospitals and doctors to bill health insurance companies for navigator services.
    • “The Biden administration announced that seven large private health insurance companies have agreed to cover navigator services: Aetna, Blue Cross Blue Shield of Minnesota, Elevance Health, Health Alliance Plan, Humana, Priority Health and Select Health.
    • “In addition, 40 cancer care centers and clinics will extend navigator services to patients. The list includes high-profile cancer care centers such as Dana-Farber Cancer Institute in Boston, the Duke Cancer Institute, Northwell Health and the Mayo Clinic.
    • “This is about making sure that a growing number of Americans can get access as they need it,” Arati Prabhakar, director of the White House Office of Science and Technology Policy, told USA TODAY. “The companies that have signed up to provide insurance coverage for these services … reach 150 million Americans.”

From the Food and Drug Administration front,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results that proved the medicine can protect heart health. 
    • “The agency on Friday approved use of Wegovy to reduce the risk of heart attacks, strokes or death in people with cardiovascular disease and who are either obese or overweight. The drug should be used alongside exercise and a reduced-calorie diet, the agency said. 
    • “Wegovy, part of a popular class of medicines that control blood sugar and appetite, is already approved for use in treating obesity. The drug generated about $4.5 billion in sales in 2023 despite manufacturing issues that made it difficult for the company to meet surging demand.” * * *
    • “The FDA clearance issued Friday is one step in that direction. It was based on the results of a large study, the results of which were published in The New England Journal of Medicine last year, showing that treatment with Wegovy reduced the risk of heart attack, stroke or cardiovascular death by 20% compared to a placebo.” 
  • MedTech Dive lets us know,
    • “A Food and Drug Administration advisory committee has voted that the benefits of a new agent used in Lumicell’s breast cancer imaging tool outweigh the risks.
    • “The committee, which convened last week, assessed evidence that the tool can detect residual cancer in real-time during breast conserving surgery. Detecting residual cancer during surgery could reduce the need for additional procedures.
    • “While the committee supported the risk-benefit profile of the agent, pegulicianine, by a 16-2 vote, many of the experts noted its limitations, with one panelist who voted yes saying that the “incremental benefits outweigh the small risks of anaphylaxis.”

From the public health and medical research front,

  • David Leonhardt writing in the New York Times reflects on the fourth anniversary of the beginning go of the Covid shutdown in the U.S.
  • The American Medical Association tells us what doctors wish their patient knew about sickle cell disease.
  • The Institute for Clinical and Economic Review posted a “Final Evidence Report on Treatment for Schizophrenia — An independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for KarXT compared to generically available aripiprazole; if long-term data confirm KarXT’s benefits and lack of weight gain, it would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year.
  • Beckers Hospital Review relates,
    • “Pfizer’s shortage of penicillin G benzathine injection, an antibiotic for syphilis and other bacterial infections, is now predicted to last until the end of 2024. 
    • “Pfizer previously said the medication’s supply would rebound by the end of June, but in a March 8 update on the FDA’s drug shortage website, the drugmaker said the estimated recovery date is the fourth quarter of 2024. 
    • “Two solutions are in limited availability and another, the 600,000 [iU]/1 mL solution, is unavailable until its next shipment in April. 
    • “The FDA first reported the supply issue in April 2023, and Pfizer then said it would end within five months. A year later, clinicians are rationing penicillin, and the U.S. is importing solutions from a France-based drugmaker as syphilis rates dramatically increase.”

From the HIMSS global conference front,

  • This week, HIMSS is holding its popular global conference in Orlando, Florida.

From the U.S. healthcare business front,

  • Fierce Healthcare discusses lobbying efforts to obtain a Congressional extension of Medicare’s hospital at home program.
  • Healthcare Dive notes,
    • “Elevance Health said on Monday it closed its deal to acquire infusion and drug therapy company Paragon Health.
    • “Under the deal, the insurer will expand Plano, Texas-based Paragon’s real estate footprint and scale up operations, according to the announcement. Paragon will operate under CarelonRx, Elevance’s pharmacy services segment.
    • “An Elevance spokesperson declined to share financial terms of the deal. However, Axios, citing sources familiar, reported the purchase would run Elevance over $1 billion.”
  • Beckers Hospital Review ranks 34 health systems by operating margin.
  • Medscape informs us,
    • “A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were.
    • “The civil suit alleges that Aledade, Inc.’s, billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records.
    • “Aledade did whatever it took to make patients appear sicker than they were,” according to the suit.”
  • HR Dive reminds us,
    • “The U.S. Department of Labor’s independent contractor final rule went into effect Monday, after businesses scrambled last week to have it enjoined or halted through a preliminary injunction. 
    • “DOL announced the final rule in January, more than a year after it proposed changes to its evaluation of workers’ independent contractor status in October 2022. 
    • “The new “totality-of-the-circumstances” framework uses six nonexhaustive factors to determine workers’ independent contractor status, including the nature and degree of control over the work, extent to which the work performed is an integral part of the employer’s business and permanence of the arrangement.