Weekend update

Medicare

Weekend update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

The FEHBlog is back in DC for the workweek. So let’s get started with news from the Washington, DC, front,

  • The continuing resolution funding the federal government expires on Friday, November 17.
  • The Wall Street Journal reports,
    • “House Speaker Mike Johnson (R., La.) unveiled a two-step short-term spending proposal that would keep money flowing to federal agencies into early next year, in a bid to stave off a partial government shutdown late [this] week. 
    • “* * * According to a document obtained by The Wall Street Journal, if the two-step plan doesn’t pass, House Republicans will turn to what they call a full-year continuing resolution, keeping spending flat—although it would contain “appropriate adjustments to meet our national security priorities.” * * *
    • “The announcement marks a major test for Johnson, who now needs to sell the plan to House Republicans, a group that has been hard to unify on federal spending. Republicans have a 221-212 majority, with Rep. Gabe Amo of Rhode Island, a Democrat, yet to be sworn in after winning an open seat.”
  • OPM.gov reminds us that the Federal Benefits Open Season begins at midnight November 13. The Open Season ends on December 11, 2023.
  • MedPage Today notes,
    • A proposed federal policy aims to protect older Americans from contracting HIV by offering free preventive medication, the latest effort to catch up to much of Europe and Africa in stemming the spread of the virus.
    • Under the plan from the Biden administration, Medicare would cover patients’ full cost of pre-exposure prophylaxis (PrEP) drugs, which prevent HIV transmission. The drugs would be free in pill form and — for the first time — as long-acting injectables through the government insurance program designed for those 65 and older. Those 50 and over make up half of all people in the U.S. already living with HIV.
  • The FEHBP and other group health plans have been covering PrEP since at least 2020.
  • The Washington Post informs us,
    • “Publishing in the journal Health Affairs, researchers looked at data from the Health Professional Shortage Area (HPSA) program, zeroing in on physician density and mortality. Introduced in 1965, the HPSA program designates areas in need of more physicians and offers bonuses, loan repayment, visa waivers, higher reimbursements and other benefits to doctors who choose to practice and serve Medicare patients in specific communities.
    • “The researchers analyzed outcomes in HPSAs and areas without the designation between 1978 and 2015, matching 844 shortage counties with similar counties with enough providers. Using a variety of statistical methods designed to sift through dense demographic factors, the analysis yielded few clues that HPSA leads to higher physician numbers or reduces deaths. Some small effects were seen, but the changes were statistically insignificant, the researchers write.”

From the public health and medical/drug research front,

  • STAT News tells us,
    • [Novo Nordisk (Novo0] in August had announced that in this trial, called Select, Wegovy reduced the overall rate of major heart problems — heart attacks, stroke, or cardiovascular-related death — by 20%. That finding, which was the primary outcome the trial set out to study, was stronger than many were expecting and led Novo’s stock to surge.
    • Novo’s obesity drug Wegovy notably cut the risk of heart attacks in a landmark cardio-vascular trial that affirms the treatment offers health benefits beyond weight loss. * * *
    • But details of the study, including risk reductions for each specific heart complication, were not released until Saturday when they were presented here — before a standing-room-only crowd — as the first major session of the American Heart Association conference. 
    • The overall 20% risk reduction in heart problems translated to 15 complications prevented for every 1,000 patients treated.
    • Wegovy specifically cut the rate of heart attacks by 28% among patients who were already taking statins and other medications to prevent heart problems, according to the results, simultaneously published in the New England Journal of Medicine. The drug also reduced the rate of cardiovascular-related deaths by 15% and strokes by 7%.
  • Per NPR Shots,
    • “For the first time, researchers have produced evidence that gene-editing can cut high cholesterol, a major risk factor for the nation’s leading killer.
    • “Preliminary results from a study involving ten patients born with a genetic condition that causes very high cholesterol found that editing a gene inside the liver can significantly reduce levels of “bad cholesterol.”
    • “The experimental treatment needs to be tested on more patients who would be followed for much longer to confirm the approach is safe and effective. But the results are being hailed as a potential landmark proof-of-concept that could eventually provide a powerful new way to prevent heart attacks and strokes.
  • The New York Times reports,
    • “A new antibiotic, the first to be developed in decades, can cure gonorrhea infections at least as effectively as the most powerful current treatment, a large clinical trial has found. The drug, zoliflodacin, is taken as a single dose, and it has not yet been approved for use in any country.
    • “But the drug was developed in a way that experts hope will make it widely accessible and will prevent widespread drug resistance. * * *
    • “Pharmaceutical companies have largely abandoned antibiotic development as unprofitable. The development of zoliflodacin represents a new model: G.A.R.D.P., which is funded by many Group of 20 countries and the European Union, developed the drug in collaboration with an American pharmaceutical company called Innoviva Specialty Therapeutics.
    • “The nonprofit sponsored the Phase 3 trial of the drug. In exchange, it holds the license to sell the antibiotic in about 160 countries, while Innoviva retains marketing rights for high-income countries. 
    • “I’ll go out on a limb and say that’s probably the only way in which we develop antibiotics going forward, because the old model is simply not going to work,” said Ramanan Laxminarayan, a senior research scholar at Princeton University who chairs the G.A.R.D.P. board.”
  • Nature adds,
    • “To forestall resistance to zoliflodacin, the drug is being developed only as a treatment for gonorrhea and other sexually transmitted infections (STIs). However, it will be up to regulatory and public health agencies to decide when and how the drug can be used.
    • “New diagnostics will also be important, says Teodora Wi, an STI specialist at the World Health Organization in Geneva. Tests that can rapidly distinguish gonorrhea from other STIs should be more widely available in the near future, but those able to identify drug resistance are further off. National surveillance programs for antibiotic-resistant gonorrhea could also guide the responsible use of zoliflodacin, Wi adds.”

From the U.S. healthcare business front,

  • Forbes reports,
    • “Weight loss prescriptions Wegovy, Rybelsus and Saxenda—along with diabetes drug Ozempic, often used off label for weight loss—are driving health costs for employers up by more than $300 per insured worker this year, new data from benefits consultancy Aon says.
    • “These GLP-1 drug costs are expected to boost healthcare spending through 2025, increasing from $324 per insured member this year up to $500 per insured health plan member in two years, new data from the benefits consultancy Aon says. By comparison, annual spending on such prescriptions in 2021 was $96 per member, Aon data shows.
    • “Employees, too, can expect higher co-payments, deductibles and premiums deducted from their paychecks because employers almost always shift part of their total premium costs onto workers, though this can vary widely depending on employer.
    • “Aon’s analysis comes from its Aon Rx claims data from nearly 500 employers and their 4.4 million health plan members. Aon said weight loss prescriptions Wegovy, Rybelsus and Saxenda have led the growth, with health spending contributions from Ozempic, which is approved to treat diabetes but is often prescribed off label by physicians for weight loss.”
  • Big money.

Midweek Update

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today lauded committee passage of the Better Mental Health Care, Lower Drug Cost, and Extenders Act, which was reported out of committee 26-0.” 
  • “The legislation expands mental health care and substance use disorder services under Medicaid and Medicare, reduces prescription drug costs for seniors at the pharmacy counter, extends essential Medicaid and Medicare provisions that will expire this year, and increases Medicare payments to support physicians and other providers. * * *
  • “Click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • Fierce Healthcare adds,
    • “Under the Senate Finance proposal, the $8 billion in cuts to hospitals through the Medicaid disproportionate share hospital (DSH) payments will be eliminated, saving providers $16 billion over the next two years, according to the mark released earlier this week.
    • “Hopefully in further discussion Senators will decide not to pursue so-called ‘site neutral’ policies,” said Federation of American Hospitals President and CEO Chip Kahn in a statement. “This is no time for hospital cuts – particularly for struggling hospitals serving rural America. This ‘one-size-fits-all’ policy will ultimately threaten service resulting in limits on access to care for seniors and others who are better served receiving necessary treatment in the hospital. “
    • “The draft also includes decreasing physician reimbursements by 1.25%, a reduction from larger cuts that could better appease physician interest groups.”
  • STAT News reports
    • “Eli Lilly’s blockbuster drug tirzepatide, sold as Mounjaro for type 2 diabetes [and nicknamed the Godzilla of GLP-1 drugs], has been cleared to treat obesity, making it the second in a highly effective class of weight loss medications to enter the market.
    • “The Food and Drug Administration’s long-awaited approval of the injectable drug, which will be marketed under the name Zepbound for obesity, is a milestone for Lilly. It also introduces stiff competition for Novo Nordisk, which has had to limit starter doses of its obesity treatment Wegovy due to ongoing shortages. * * *
    • “Lilly will sell Zepbound at a list price of $1,059.87 per month, about the same price as Mounjaro and about 20% lower than the price of Novo’s Wegovy. Lilly is also introducing a savings card program for people with commercial insurance.
    • “Lilly expects the drug to be available in American pharmacies after Thanksgiving. In an effort to prevent future shortages, the company plans to have roughly doubled its manufacturing capacity by the end of the year, CEO David Ricks said on a conference call with reporters. Only about 5 million people in the U.S. receive any form of GLP-1 treatment, Ricks said, but there are roughly 50 million Americans who would be eligible for Zepbound and who have commercial insurance that covers obesity treatments.
    • “We know with such an effective medication there’ll be a lot of demand,” Ricks said. “We’re stepping up to that challenge and hope to fulfill it in the coming years.”
  • Ka-ching!!
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC) today released three reports focusing on different groups of women in the federal government: American Indian and Alaska Native (AIAN) women, African American women, and Hispanic women and Latinas.
    • “The reports examined fiscal year (FY) 2020 data to compare the participation, retention, advancement, and pay of each group of women to three different groups: the total federal workforce, all women, and men of the same ethnicity or race. Results show that employment outcomes for these three groups of women were not equal to the comparison groups. Understanding the challenges these groups of women face in the federal workplace can help agencies better address these inequalities.”

From the public health and research front,

  • The Wall Street Journal reports that children in mental health crises have been surging into hospital emergency rooms.
    • “Broadly, children’s demand for emergency mental-health services has eased from the pandemic’s extreme highs, according to an analysis of records across more than 1,100 hospitals by the research arm of Epic Systems, a medical record software company. Still, the rates remain elevated. 
    • “For adults, the data on trips to emergency departments for psychiatric reasons during the pandemic is limited, but doctors say they are more used to seeing such cases. E.R.s aren’t accustomed to seeing large numbers of children in psychiatric crisis—and many are ill-equipped to handle them.”
  • STAT News reports,
    • “The radiopharmaceutical world is now approaching critical mass. There are currently around 75 such startups in the U.S., several of which have raised sizable financing rounds this year. In September, RayzeBio managed to complete an IPO — rare amid an industry slump — raising $358 million. Bayer has made a few acquisitions in the field. And last month, pharmaceutical giant Eli Lilly jumped in, acquiring Point Biopharma and its Phase 3 radiopharmaceutical treatment for prostate cancer for $1.4 billion.
    • “Investors and executives are optimistic these investments will pay off not just for venture capitalists, but for cancer patients. But just how much they can benefit the field remains to be seen. To achieve anything, radiopharmaceutical companies must hurriedly address supply and production challenges — issues that have handicapped other promising areas of oncology drug development.”
  • and
    • Vaccines work well to prevent cancers caused by the human papillomavirus (HPV). So well, in fact, that it may be time to review HPV screening protocols, according to the somewhat provocative conclusion of a new study examining the occurrence of genital HPV types eight years after immunization, published Wednesday in Cell Host & Microbe.
  • and
    • “In American health care, overtreatment is common. Recently though, there has been a subtle shift in the opposite direction. It’s possible that “less is more” is catching on.
    • “Now, some providers are asking what the line between necessary and unnecessary really is. The results are encouraging, suggesting that, in some cases, it may be possible to achieve the same health outcomes with less treatment — and fewer side effects, too.
    • “This shift is particularly noticeable in cancer care.”
  • Here is a link to the National Cancer Institute’s latest research update.
  • Gallup announced
    • “U.S. workers are optimistic that employer-sponsored wellness initiatives could enhance their wellbeing, according to data from the Bentley-Gallup Business in Society Report. When asked to rate the potential impact of six wellness initiatives on wellbeing, the top three most positively rated (based on combined extremely and somewhat positive ratings) are employers offering a four-day workweek option (77%), providing mental health days (74%) and limiting the amount of work employees are expected to perform outside of work hours (73%).”
  • Becker’s Payer Issues tells us,
    • “Increasing Medicare Advantage enrollment in rural areas did not increase rural hospitals’ financial distress or risk of closing, a study published Nov. 3 in the American Journal of Managed Care found. 
    • “Researchers studied rural hospitals in 14 states from 2008 to 2019. Medicare Advantage enrollment in rural hospital counties increased from 14.3% of Medicare beneficiaries in 2008 to 28.4% in 2019. The percentage of Medicare inpatient stays paid for by MA plans increased from 6.5% in 2008 to 20.6% in 2019. 
    • “The researchers found that when Medicare Advantage penetration increased by 1% in a county, hospitals’ financial stability increased slightly, and they experienced a 5% reduction in risk of closing. 
    • “One in 5 of the hospitals studied treated no Medicare Advantage patients during the study period.” 

From the U.S. healthcare business front,

  • The Segal Company highlights fraud, waste, and abuse trends in this fourth quarter of 2023.
  • Healthcare Dive provides the biggest takeaways from health insurers’ third-quarter earnings.
  • KFF offers
    • “One new analysis shows that the typical beneficiary has a choice of 43 Medicare Advantage plans as an alternative to traditional Medicare for 2024. That is the same number available as in 2023, but more than double the number of plans offered in 2018, which shows how this market is attractive to both enrollees and insurers.
    • “In addition, the typical person covered under traditional Medicare can choose among 21 Medicare stand-alone prescription drug plans (PDPs), the second analysis shows. The number of PDP options for 2024 is lower and the number of Medicare Advantage prescription drug plan (MA-PD) options is higher than in any other year since Part D started, reflecting the broader trend toward Medicare Advantage.”
  • Fierce Healthcare informs us,
    • “A recent federal district court ruling against the office overseeing the 340B Drug Pricing Program has opened the doors for hospitals to more broadly claim discounts, healthcare legal experts say.
    • “The decision in Genesis Healthcare, Inc. v. Becerra, handed down Friday by the U.S. District Court of South Carolina, establishes that “at least some of [the] interpretative policies surrounding the 340B definition of the patient are inconsistent with the 340B statute,” Anil Shankar, a partner at Foley & Lardner, told Fierce Healthcare.
    • “This is a stunning decision that will have the attention of every 340B stakeholder,” he said. “… This creates new opportunities for 340B-covered entities to purchase 340B for their patients and suggests that [the Health Resources and Services Administration’s (HRSA’s)] audit processes will need to change.”
  • and
    • “Building on its One Medical deal, Amazon is now offering a One Medical for Prime membership, including 24/7 virtual care, for $9 per month, or $99 a year. That’s $100 less than the standard One Medical membership fee, according to the company.
    • “Prime members can add up to five additional memberships, each for just $6 a month, or $66 annually.
    • “The One Medical for Prime membership fee covers unlimited access to 24/7 virtual care nationwide, including video chats with licensed providers and access to an in-app “Treat Me Now” feature that lets users get fast care for common concerns like cold and flu, skin issues, allergies, urinary tract infections.”

Monday Roundup

David Ermer–CMS, Congress, Medical / Rx research, Medicare, OPM, Patient safety, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Bloomberg reports,
    • “House lawmakers worked over the weekend on a stopgap measure needed to fund the US government beyond a Nov. 17 deadline, Speaker Mike Johnson said.
    • “While Johnson didn’t mention the proposed length of the extension in a Fox News Sunday interview, he has floated a Jan. 15 timeline since being elected speaker in October.
    • “The extension “would allow us time” to continue the appropriations process, which involves bringing 12 spending bills to the House floor for passage, the Louisiana Republican said.”
  • The FEHBlog watched the House Rules Committee pass a rule on the financial services and general government appropriations bill (HR 4664), which means that the bill will be brought to the House floor this week.
  • From the other side of Capitol Hill,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released the Chairman’s Mark of a legislative package to expand mental health care and substance use disorder services under Medicaid and Medicare, reduce prescription drug costs for seniors at the pharmacy counter, extend essential Medicaid and Medicare provisions that will expire this year, and increase Medicare payments to support physicians and other providers.
    • “The Committee will hold a markup on the legislation on Wednesday, November 8, at 10 a.m.
    • “The Chairman’s Mark can be found here. A section by section can be found here. A CBO analysis can be found here.
    • “Amendments and additional information will be posted here on Tuesday, November 7, after 12 p.m.”
  • The U.S. Office of Personnel Management announced,
    • “The U.S. Office of Personnel Management (OPM) released governmentwide results of the 2023 OPM Federal Employee Viewpoint Survey (FEVS) today. The OPM FEVS is the largest annual survey of government employees in the world that tracks how federal employees view their current work environment, including workforce management, policies, and new initiatives. OPM FEVS is an unmatched government data asset that collects employee feedback from more than 80 executive agencies to assist in driving improvement and supporting the workforce to serve the American people.   
    • “This year’s Federal Employee Viewpoint Survey highlights that federal employees remain remarkably resilient, increasingly engaged, and value diversity, equity, inclusion, and accessibility in the workplace,” said Kiran Ahuja, Director of the Office of Personnel Management. “These encouraging results provide opportunities for agencies to build momentum and support their workforce to leverage workplace flexibilities, continue advancing DEIA, and remain motivated to continue delivering for the American people.”  
  • The Centers for Medicare and Medicaid Services proposed a new Medicare Advantage Program rule that covers multiple topics.
  • Health Payer Intelligence adds,
    • “Medicare Advantage beneficiaries experience higher quality care and better health outcomes than fee-for-service beneficiaries, according to a report from Harvard and Inovalon.
    • “Researchers used Inovalon’s claims data to assess care quality for people enrolled in Medicare Advantage and those with Medicare fee-for-service between 2015 and 2019.”
  • Healthcare Dive reports,
    • “Healthcare employment growth fell across the board during the COVID-19 pandemic. Some sectors have had more difficulty rebounding than others, according to a new study — especially skilled nursing facilities, which face a controversial federal push for more staffing.
    • “Employment in hospitals increased 0.4% per quarter before the pandemic, but that growth rate shrunk to 0.03% during COVID-19, according to the study published in JAMA. By comparison, employment at skilled nursing facilities was already declining before COVID, dropping at a rate of 0.2% per quarter. During the pandemic, the rate of job losses accelerated to 1.1%.
    • “The Biden administration is seeking to impose mandatory nursing staffing minimums at skilled nursing facilities, or SNFs. The nursing home industry largely opposes the rule, arguing there are not enough workers available to meet the staffing mandate.” 

From the public health and research front,

  • The FEHBlog took the RSV vaccine today. The pharmacist who administered the injection told him the RSV vaccine are expected to be a once-every-decade experience for adults like the Tdap vaccine.
  • American Hospital News informs us,
    • “The more than 11,000 patients who received care during the first 16 months of the Acute Hospital Care at Home initiative had a low mortality rate and minimal complications related to escalations back to the brick-and-mortar hospital, according to a study reported Friday in JAMA Health Forum. CMS launched the initiative in November 2021 to address the COVID-19 public health emergency and concerns about hospital bed capacity. The Consolidated Appropriations Act of 2023 extended the CMS initiative through December 2024.
    • “The law also requires hospitals to provide additional data to CMS to monitor the quality of care, and for CMS to undertake a comprehensive study of the AHCAH initiative by September 30, 2024,” the authors note. “This study, data review, and additional monitoring will be important for identifying best practices that support safe and effective inpatient-level care delivered in the home environment.”
  • Per Fierce Healthcare,
    • “U.S. hospitals made gains to reduce healthcare-acquired infections (HAIs) but saw patient experiences further deteriorate in the latest release of an independent watchdog’s twice-yearly safety report.
    • “According to The Leapfrog Group, the sector has significantly reduced the incidences of Methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs) after reaching five-year highs during the COVID-19 pandemic.
    • “Specifically, 66% of the almost 3,000 general hospitals polled by the group improved their performance on at least one of the three HAIs. Nineteen percent improved across all three of the infection measures, while 16% either worsened or made no improvement.
    • “Now that we have pre- and post-pandemic data for patient safety measures, we are encouraged by the improvement in infections and applaud hospitals for reversing the disturbing infection spike we saw during the pandemic,” Leah Binder, president and CEO of The Leapfrog Group, said in a release.”
  • Here is a link to the Leapfrog Group report.
  • Beckers Hospital Review adds, “A comparison of data from CMS and The Leapfrog Group suggests that a hospital’s strong performance in one national quality rating system does not necessarily mean it will be a top performer in another.”
  • The New York Times Magazine gives us a story about the use of bariatric surgery on teenagers.

From the U.S. healthcare business front,

  • Reuters reports,
    • “Cigna is working with an investment bank to evaluate options for its Medicare Advantage business, which could fetch several billions of dollars in a potential divestment, the sources said.
    • “The discussions with interested parties, including other companies and private equity firms, are at an early stage, and Cigna may decide to keep the business, the sources added, requesting anonymity because the matter is confidential.”
  • Per Beckers Hospital Review,
    • “Oakland, Calif.-based Kaiser Permanente reported $156 million in operating income (0.6% margin) for the third quarter, up from a $75 million operating loss (-0.3% margin) in the third quarter of 2022. 
    • “For the three months ended Sept. 30, Kaiser’s health plan, hospitals and their respective subsidiaries posted $24.9 billion in revenue and $24.7 billion in expenses, compared to $24.3 billion and $24.3 billion, respectively, in the same period of the prior year. 
    • “Net income for the third quarter was $239 million, up from a net loss of $1.5 billion in the third quarter of 2022.”
  • and
    • “As operating margins inch upward, hospitals are trending to profitability. But their performance still isn’t at pre-pandemic levels. 
    • “For the first three quarters of 2023, hospital operating margins were up 19% and operating EBIDA was up 11% compared to the same period last year, according to Kaufman Hall’s October National Hospital Flash Report. Net operating revenue per calendar day saw a 6% increase and even inpatient revenue was up 3%. Compared to 2020, year-to-date operating margins in September were down 2% and operating EBIDA margins were down 9%.”

Friday Factoids

David Ermer–CDC, CMS, Congress, Electronic health records, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Department of Health and Human Services discusses its efforts to support rural healthcare.
  • Today, the proposed No Surprises Act regulation that would change current Independent Dispute Resolution processes was published in the Federal Register. OPM’s proposed FEHB rules changes are described on page 75,808 and may be found on page 75,851.
  • The Centers for Medicare and Medicaid Service issued FAQs on its new final rule imposing civil monetary penalties on Section 111 reporting violations. The rule, which impacts FEHB carriers, becomes enforceable on October 11, 2024.
  • Congressman Gerry Connolly (D VA) released a “statement in support of the Office of Personnel Management’s (OPM) expansion of infertility coverage benefits for Federal Employee Health Benefits (FEHB) program enrollees.” The FEHBlog is pleased to read about Congressman Connolly’s support.
  • The Office of the National Coordinator of Health Information Technology created a blog post titled “Coming in Hot! TEFCA Will Soon Be Live and Add Support for FHIR-Based Exchange.” The post indicates that this critically important electronic health record key to data sharing will be going live soon.
    • “Our TEFCA timelines will remain aggressive and ambitious as ONC and the RCE help support the industry to usher in a new era of data exchange for the United States.
    • “For more information on TEFCA in general, please check out the RCE resources and sign up for the RCE newsletter and monthly public calls.”
  • Govexec reports, “The Office of Personnel Management on Friday announced new plans aimed at helping the federal government’s HR agency better weather the annual surge of retirement applications from departing federal employees that occurs each winter.” Good luck.
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission opened its 2022 EEO-1 Component 1 data collection Oct. 31. Reports must be submitted by Dec. 5, the agency said in a news release. 
    • “The EEO-1 Component 1 report is a mandatory demographic data report the EEOC requires from all private-sector employers with 100 or more employees, and from certain federal contractors.
    • “EEOC’s Office of Enterprise Data and Analytics released a booklet to help filers complete the process. It has also provided a Filer Support Team Message Center and other resources, the agency said.”

From the public health front,

  • The Centers for Disease Control posted its inaugural issue of FluSight for the current flu season. Here’s the kickoff forecast.
  • Health Payer Intelligence explains how public and private payers cover healthcare for the LGBTQ+ community.
  • The Institute for Clinical and Economic Research published
    • “its third annual “Barriers to Fair Access” assessment of prescription drug coverage policies (Report |Supplemental Materials) within US commercial insurance and the Veterans Health Administration. The analysis found that major payer coverage policies for 18 drugs often met fair access criteria for cost sharing, clinical eligibility, step therapy, and provider restrictions. However, the report’s findings suggest that major improvements are needed in the transparency of coverage policy information for consumers and in detailing out-of-pocket costs for patients.” 
  • Beckers Hospital Review shares CMS statistics on emergency department wait times across our country.
  • The Wall Street Journal gives advice on how to avoid the gloom associated with turning the clock to standard time this weekend.
    • “Daylight hours affect our brain chemistry. As days grow shorter, light receptors in the eyes receive less light and send a signal to the brain about what chemicals to produce, says Lina Begdache, associate professor of health and wellness studies at Binghamton University. 
    • “Our brains begin producing more melatonin—the sleep-related hormone—and less serotonin, which enhances mood and controls appetite. When the brain starts making more melatonin at 4 p.m. due to the earlier dusk, people can feel prematurely sluggish, which can affect mood, diet, exercise and sleep patterns.  
    • “Focusing on improving one area that is affected by the time change, such as exercise, can help the others and might be more doable than trying to improve everything at once, says Begdache, the associate health and wellness studies professor.  * * *
    • “If you improve your diet, you’re more likely to exercise more. And if you exercise more, you’re more likely to sleep better,” says Begdache, who led a 2021 study on mental well-being and seasonal changes. “
  • The FEHBlog personally likes having more sunlight in the morning.

From the U.S. healthcare business front,

  • Here’s a link to the American Medical Association’s reaction to the 2024 Medicare Part B pay cut announced this week. The pay cut is a wash for FEHB carriers because the cut applicable to Medicare prime annuitants will be offset by price increases for younger members. The big problem is that the cut will drive more doctors out of Medicare Part B. When the FEHBlog, who is on traditional Medicare, lived inside the Beltway, his primary care doctor joined the crowd of local PCPs who had dropped out of Medicare. When the FEHBlog moved to Texas last year, he had no problem finding a PCP who takes Medicare, and what’s more, his PCP participates in an accountable care organization. Access to affordable healthcare and dental care is better in central Texas than inside the Beltway, at least for now. The FEHBlog agrees with the AMA that Congress needs to step up.
  • BioPharma Dive informs us,
    • “Moderna on Thursday shifted its revenue forecast for the year to “at least” $6 billion from a previous range of between $6 billion to $8 billion, a change it said reflected COVID-19 vaccination trends in the U.S.
    • “The biotechnology company also disclosed third-quarter earnings showing a net loss of $3.6 billion, driven mainly by non-cash charges of $3.1 billion related to a “manufacturing resizing” and a tax charge. Shares slumped 6% Thursday on the news but traded up Friday morning.
    • “Moderna said it plans to break even in 2026 through “disciplined investment” and launches for new products like its mRNA flu and respiratory syncytial virus vaccines as well as a combination flu and COVID shot.”
  • MedTech Dive shares medtech executives’ views on the new GLP-1 obesity drugs.
    • “Strong patient interest in GLP-1 drugs to treat obesity has prompted medtech companies to take a hard look at the potential impact on demand for procedures like bariatric surgery and products such as glucose monitors and sleep apnea devices.
    • “The potential threat to medical device sales has spooked investors, who have sold shares in companies across the sector.
    • “Fears that medications such as Ozempic, Mounjaro and Wegovy, which are used for diabetes and weight loss, will eventually reshape treatment for a variety of diseases have driven the most severe correction in the medtech sector since the onset of COVID-19, wiping out about $370 billion in market capitalization, according to Mizuho analyst Anthony Petrone.”

Thursday Miscellany

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

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson said Thursday that Republicans are considering a new approach to stopgap funding that would extend pieces of current appropriations for different time periods, effectively setting up a series of funding cliffs while avoiding a single deadline that could trigger a partial government shutdown for all agencies.
    • “With current funding for the entire government set to expire on Nov. 17, Johnson has proposed a CR to extend funding through Jan. 15, though that date is the federal Martin Luther King Day holiday. But the Louisiana Republican said at a press conference some GOP members raised the idea of a “laddered CR” to extend funding on a piecemeal basis.”
  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released a discussion draft including policies aimed at expanding mental health care under Medicaid and Medicare and reducing prescription drug costs for seniors at the pharmacy counter. The package also includes essential Medicaid and Medicare provisions that will expire this year, as well as changes to Medicare payment to support physicians and other professionals. The Committee intends to advance these legislative proposals, in addition to pharmacy benefit manager (PBM) reforms previously passed out of the Committee in July, and pursue full Senate passage and enactment. As part of that process, the Committee intends to hold a markup on Wednesday, November 8 at 10 a.m. In keeping with Finance Committee rules, the Chairman’s Mark will be released 48 hours in advance of the markup.”
  • It was a very busy day for the Centers for Medicare and Medicaid Services. We learned from the American Hospital Association that
    • The Centers for Medicare & Medicaid Services Nov. 2 issued a final rule that increases Medicare hospital outpatient prospective payment system rates by a net 3.1% in calendar year 2024 compared to 2023. This includes a 3.3% market basket update, offset by a 0.2% cut for productivity.
    • In a statement shared with the media, AHA Executive Vice President Stacey Hughes said “The AHA is concerned that CMS has again finalized an inadequate update to hospital payments. Today’s increase for outpatient hospitals of only 3.1% comes in spite of persistent financial headwinds facing the field. Most hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging day to day. Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, which is why the AHA is urging Congress for additional support by the end of the year.” 
    • The rule also finalizes several changes to the hospital price transparency rule, including requiring a new standard format with an additional data element and a completeness and accuracy affirmation statement. CMS also makes updates to streamline the enforcement process. Compliance dates for the changes range from Jan. 1, 2024, to Jan. 1, 2025. Most formatting changes take effect July 1, 2024.
  • and
    • “Following last year’s unanimous Supreme Court decision in favor of the AHA and others, the Department of Health and Human Services Nov. 2 issued a final rule outlining the agency’s remedy for the unlawful payment cuts to certain hospitals that participate in the 340B Drug Pricing Program. 
    • “HHS’ final rule contains two central components. First, HHS will repay 340B hospitals that were unlawfully underpaid from 2018 to 2022 in a single lump sum payment. The final rule contains the calculations of the amounts owed to the approximately 1,600 affected 340B covered entity hospitals. Second, HHS finalizes a policy to recoup funds from those hospitals that received increased rates for non-drug services from 2018 to 2022. HHS will recoup these funds by adjusting the outpatient prospective payment system conversion factor by minus 0.5% starting in calendar year 2026 (one year later than HHS had originally proposed and as AHA advocated), making this adjustment until the full amount is offset, which the department estimates to be 16 years.
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “Following years of litigation and a unanimous Supreme Court win, the AHA is very pleased that 340B hospitals finally will be reimbursed in full for what HHS unlawfully withheld from them for five years. The one-time, lump-sum repayment hospitals will soon receive will help them to continue providing high-quality care to their patients and communities. However, HHS made a grievous mistake in choosing to claw back billions of dollars from America’s hospitals, especially those that serve rural, low-income and other vulnerable communities. HHS decided to ignore hundreds of comments from hospitals and other providers explaining why this Medicare cut is both illegal and unwise. The AHA will continue to review this rule and consider all available options going forward.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 2 released its calendar year 2024 final rule for the physician fee schedule. The rule will cut the conversion factor by 3.4%, to $32.74 in CY 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a budget-neutrality adjustment. 
    • “As urged by the AHA, CMS addressed the fact that on Jan. 1 practitioners who render telehealth services from home would have been required to report their home address on enrollment and claims forms. The agency delayed this provision until Jan. 1, 2025, and solicits comments on the issue for future rulemaking.
    • “In addition, the agency finalized a revised definition of the substantive portion of a split (or shared) visit. Specifically, for CY 2024, for purposes of Medicare billing, the definition of “substantive portion” means more than half of the total time spent by the physician and non-physician practitioner performing the split (or shared) visit or a substantive part of the medical decision-making.
    • “CMS finalized its proposals to advance access to behavioral health services. First, CMS will implement regulations as directed by the Consolidated Appropriations Act of 2023 to create a new benefit category for marriage and family therapists and mental health counselors under Part B, who will be eligible to provide telehealth services and behavioral health integration services. CMS also established new payment codes for mobile psychotherapy for crisis services as required by the CAA. Separately, the agency will apply an adjustment to psychotherapy services payments billed with a new increased complexity code and will increase the payment rate for the substance use disorder bundle.”
  • What’s more, AHA News reports,
    • “The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, Nov. 2 sued the federal government to bar enforcement of an unlawful, harmful and counterproductive rule that has upended hospitals’ and health systems’ ability to share health care information with the communities they serve, analyze their own websites to enhance accessibility, and improve public health.  * * *  
    • “Today’s lawsuit challenges a “Bulletin” issued by HHS’ Office for Civil Rights. The December 2022 “Bulletin” restricts hospitals from using standard third-party web technologies that capture IP addresses on portions of hospitals’ public-facing webpages that address health conditions or health care providers. For example, under HHS’ new rule, if someone visited a hospital website on behalf of her elderly neighbor to learn more about Alzheimer’s disease, a hospital’s use of any third-party technology that captures an IP address from that visit would expose that hospital to federal enforcement actions and significant civil penalties.”  
  • The U.S. Office of Personnel Management announced “the recipients of the 2023 Presidential Rank Awards (PRA) chosen by President Joe Biden. The PRAs are one of the most prestigious awards in the career civil service, recognizing the important contributions of public servants across the federal government.” Congratulations to the recipients.   

In FEHB news, FedWeek discusses the relationship between FEHBP and FEDVIP plans.

  • “FEDVIP is the “secondary” payer to any benefits provided under an FEHB plan. If you are enrolled in both FEDVIP and FEHB, you must provide your FEHB enrollment information during the FEDVIP enrollment process (which takes place online, on www.benefeds.com). It’s a good idea to provide your FEHB information to the medical office that is providing the dental or vision services under FEDVIP.
  • “Also, if you change your FEHB health plan during the year, you need to notify BENEFEDS immediately. If you fail to provide this information, payment of claims will be delayed.”

From the public health and research front,

  • The U.S. Preventive Services Task Force released its final research plan for “Healthy Diet, Physical Activity, and/or Weight Loss to Prevent Cardiovascular Disease in Adults: Behavioral Counseling Interventions.”
  • The NIH Director’s Blog discusses “How Double-Stranded RNA Protects the Brain Against Infection While Making Damaging Neuroinflammation More Likely.”
    • “The findings show how this tricky balance between susceptibility to infection and inflammation in the brain works in both health and disease. It also leads to the tantalizing suggestion that treatments targeting these various players or others in the same pathways may offer new ways of treating brain infections or neuroinflammatory conditions, by boosting or dampening dsRNA levels and the associated immune responses. As a next step, the researchers report that they’re pursuing studies to explore the role of dsRNA-triggered immune responses in ALS and Alzheimer’s, as well as in neuropsychiatric symptoms sometimes seen in people with lupus.”
  • The Food and Drug Administration released
    • “data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings, which were collected between March and June 2023, show that 10% of U.S. middle and high school students (2.8 million youth) reported current use of any tobacco product.
    • “Among U.S. high school students, current overall tobacco product use declined during 2022-2023 (16.5% to 12.6%). This decline was primarily attributable to reduced e-cigarette use (14.1% to 10%), which translates to 580,000 fewer high school students who reported current use of e-cigarettes in 2023. Among high school students, declines in current use were also observed during 2022-2023 for cigars and overall combustible tobacco smoking, representing all-time lows.”
    • “It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “But we can’t rest on our laurels. There’s more work to be done to build on this progress.”  

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Cigna has hiked its membership expectations for 2023. The health insurer previously expected to lose commercial members in the back half of the year, prepping for an economic downturn that might cause Americans to lose their jobs — and subsequently, their insurance.
    • “But the expected economic downturn has yet to materialize, leading Cigna to say on Thursday it expects to add at least 1.6 million members this year, up 200,000 lives from previous forecasts.
    • “We’ve not seen the disenrollment levels we incorporated into our prior outlook,” said CFO Brian Evanko on a Thursday call with investors. Cigna also raised its revenue and adjusted earnings per share outlook for 2023, after releasing third-quarter earnings.”
  • and
    • “Amwell posted a growing net loss in the third quarter as the telehealth firm notched another hefty goodwill impairment charge.
    • “The Boston-based company’s losses reached $137.1 million — a 94% increase from the same period in 2022 —  including $78.9 million in impairment charges linked to sustained decreases in its share price and market capitalization. Revenue declined 11% year over year to $61.9 million. 
    • “But a recent contract with the Department of Defense’s Health Agency that aims to digitize the military healthcare system “fortifies our path to profitability,” expanding Amwell’s reach within the public sector, CEO Ido Schoenberg said on a call with investors Wednesday.”
  • BioPharma Dive adds
    • “Novo Nordisk and Eli Lilly on Thursday reported strong sales growth for their rival GLP-1 metabolic disease drugs, setting up a 2024 showdown as the latter company’s latest product Mounjaro nears approval as a weight-loss rival to Novo’s Wegovy.
    • “Both companies cautioned about potential supply constraints, however. Wegovy still has limited availability at the starter dose, and Lilly CEO David Ricks said there is a need to increase manufacturing capacity “pretty dramatically from the current levels.
    • “Wegovy sales jumped nearly five-fold to 21.7 billion Danish krone, or about $3.1 billion, through the first nine months of this year, according to Novo. Sales of Ozempic, which is approved as a diabetes drug but used off-label in weight loss, were 65.7 billion krone, a 58% rise. * * *
    • “Lilly on Thursday revealed equally promising sales numbers for Mounjaro, which is so far approved only as a blood sugar-lowering agent for people with Type 2 diabetes. Sales of the dual-acting drug were $3 billion for the first nine months of 2023, which will be its first full year on the market. It is now Lilly’s second-biggest seller after another GLP-1 drug called Trulicity, sales of which have declined as Mounjaro’s have grown.
    • “A Food and Drug Administration decision on approving Mounjaro, known also as tirzepatide, in obesity should come by the end of 2023 * * *.”
  • The Wall Street Journal points out
    • “Both Lilly and Denmarks Novo Nordisk, which makes Ozempic and its sister drug Wegovy, are struggling to meet skyrocketing demand for their medications. There is no quick fix for that given the complexity of building out manufacturing capacity for the injections. Both companies are investing billions of dollars a year to try to catch up. * * *
    • “Keeping up with demand requires investments in factories that take years to build. Morgan Stanley analysts recently forecast the global anti-obesity market would be worth $77 billion by 2030. Mounjaro, Ozempic and Wegovy are injectables, which are complex to manufacture. Some oral medications currently in clinical trials, such as Lilly’s orforglipron, are smaller molecules, which are simpler to make. Supply constraints may only be truly remedied whenorals come to the market, the analysts said.”

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19 testing, Federal employment benefits, Medicare, OPM, Patient safety, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call tells us, “The Senate on Wednesday voted 82-15 to pass the first three of its fiscal 2024 appropriations bills in a “minibus” as the House tees up votes this week on three of its remaining seven fiscal 2024 appropriations bills.”
    • The minibus included “the fiscal 2024 Military Construction-VA, Agriculture, and Transportation-HUD appropriations bills.” 
  • The Centers for Medicare and Medicaid Services issued its “calendar year 2024 Home Health Prospective Payment System (HH PPS) Rate Update final rule.”
  • Per Fierce Healthcare, the rule
    • increases the 2024 home health payments by 0.8%, or $140 million.
    • “The $140 million increase in estimated payments for CY 2024 reflects the effects of the CY 2024 home health payment update percentage of 3% ($525 million increase), an estimated 2.6% decrease that reflects the effects of the permanent behavioral assumption adjustment ($455 million) and an estimated 0.4% increase that reflects the effects of an updated FDL ($70 million increase),” the unpublished rule said.
    • “CMS expects increasing the rate will bring home health payments in line with statutory payment authority.”
  • BioPharma Dive informs us,
    • “An experimental sickle cell disease treatment made with CRISPR technology is one step closer to approval in the U.S., following a meeting Tuesday in which advisers to the Food and Drug Administration seemed generally comfortable with its safety.
    • “Made up of scientists and physicians, the advisory panel spent hours discussing highly technical questions around how best to assess the risk that CRISPR — the gene editing technique often likened to a pair of scissors — might make unwanted, or “off-target,” cuts to DNA.
    • “Ultimately, the panel appeared convinced that Vertex Pharmaceuticals, which developed the sickle cell treatment, had done enough to show the therapy is safe, although they pointed to several avenues for further study.”
  • Reuters adds, “Analysts have been optimistic the therapy, which is a first-of-its-kind product to reach the FDA for review, will win the health regulator’s nod by Dec. 8.”
  • On a related note, an article in Health Affairs Scholar prognosticates,
    • “Despite the potential of gene therapy to transform the lives of patients with rare genetic diseases, serious concern has been raised about the financing of the high up-front costs for such treatments and about the ability of the employer-sponsored insurance system in the United States, particularly in small firms, to pay for discoveries of this type. In this paper, we provide a conceptual framework and empirical evidence to support the proposition that, at present, private group insurance financing of cost-effective gene therapies is not only feasible and competitively necessary in the labor market for employers, regardless of group size, but also that, currently, the number of US workers in small firms who might be stressed by very high-priced claims is a tiny fraction of the group market for genetic treatments. The current system of employer-paid self-insurance supplemented by stop-loss coverage should be able to facilitate the use of new cost-effective gene therapies. Other alternative methods of financing that have been proposed may not be urgently needed. There are, however, some concerns about the long-term resilience of this system if stop-loss premiums continue to have high growth.”
  • The Society for Human Resource Management reminds us,
    • “Employers are required to use the latest version of Form I-9 beginning today.
    • “The new form from U.S. Citizenship and Immigration Services has been available for use since August but becomes mandatory for all employers as of Nov. 1. 
    • “The new I-9 does not make any new changes to employer or employee obligations involved in the verification of work authorization. Cosmetic changes include the reduction of Sections 1 and 2 to a single page, slight revisions to the Lists of Acceptable Documents, and a new box that eligible employers must check if the employee’s documents were examined remotely under the newly authorized alternative procedure for qualified E-Verify employers.”

In FEHB news, as we approach the Open Season,

  • FedSmith offers its perspective on factors to consider when selecting an FEHB plan during Open Season.
  • FedWeek offers retired OPM executive Reg Jones’s views on the upcoming Open Season.
  • The Federal Times highlights the fine points of fertility coverage in 2024 FEHB plans.

From the public health and research front,

  • The Centers for Disease Control reminds us,
    • Every U.S. household can order 4 more free COVID-19 self-tests. 
    • Self-tests (also called at-home tests and over-the-counter tests) are one of several tools that protect you and others by reducing the chances of spreading COVID-19.
    • Self-tests can be taken at home or anywhere, are easy to use, and produce rapid results.
    • You can place an order 
      • Online at COVIDTests.gov
      • By calling 1-800-232-0233 (TTY 1-888-720-7489)
      • By calling or emailing the Disability Information and Access Line (DIAL) at 1-888-677-1199 or DIAL@usaginganddisability.org (for people with disabilities)
  • The Washington Post reports,
    • “Dying from heart failure and ineligible for a human heart transplant, Lawrence Faucette knew that the last chance he had at extending his life was to receive a heart transplanted from a pig. The 58-year-old man said from his Baltimore hospital bed in September that he was “hoping for the absolute best,” but understood that he was the second person in the world to undergo the procedure — and the highly experimental surgery did not guarantee that he would get more time with his wife and two sons.
    • “We’re going to do the best we can,” he said in a video posted by the University of Maryland School of Medicine. “Now at least I have hope. And now I have a chance.”
    • “Faucette died Monday, nearly six weeks after the surgery, becoming the second patient to die after receiving a genetically modified pig heart, medical school officials announced Tuesday.”
  • RIP, Mr. Faucette.
  • The Wall Street Journal reports,
    • “The rate of babies dying in the U.S. increased significantly for the first time in two decades, raising new alarms about maternal-infant health in America.
    • “The nation’s infant mortality rate rose 3% from 2021 to 2022, reversing a decadeslong overall decline, the Centers for Disease Control and Prevention said Wednesday. The rate increased from 5.44 infant deaths for every 1,000 births to 5.6 in 2022, a statistically significant uptick. * * *
    • “The death rate increased significantly for babies born to American Indian and Alaska Native women, babies born to white women, babies born to women ages 25 to 29 years, male babies and preterm babies.
    • “Changes in the rates for other groups weren’t significant, though the agency’s data showed that mortality rates among racial groups in the U.S. remain wide. The rate for babies born to Black mothers was more than double that of white mothers.”
  • STAT New calls attention to the fact that
    • “Most lung cancer screening guidelines hinge on how much people smoked tobacco and when they last smoked, but the American Cancer Society now says it doesn’t matter how long ago they quit. On Wednesday, the ACS released guidance recommending that anyone with a significant smoking history get an annual low-dose CT scan for lung cancer.
    • “The new guidelines also expand the age range for lung cancer screening to 50 through 80, instead of 55 through 74, and lower the smoking history requirement from 30 cigarette pack years to 20 pack years or more. That means the equivalent of a pack a day for 20 years, which includes two packs a day for 10 years or four packs a day for five years. Most private insurance plans are required to cover screening guidelines with an A or B-grade recommendation from the U.S. Preventive Services Task Force, though some organizations do follow ACS guidelines.
    • “These recommendations bring the ACS’ new age range and smoking history requirements in line with that of the task force’s lung cancer guidelines, which were updated in 2021. However, the task force still only extends lung cancer screening eligibility to patients who quit smoking within the last 15 years. 
    • One of the main reasons the ACS wanted to strike the years-since-quit requirement from their guidelines was that many former smokers are still at high risk for lung cancer regardless of when they quit smoking. “The more we dug into the data, the more we saw there was no real evidence for that criterion,” said Robert Smith, the senior vice president of early detection science at the American Cancer Society.”
  • The Lown Institute issued a report on unnecessary heart stent procedures in the U.S.
    • “Every seven minutes, a Medicare patient receives an unnecessary coronary stent at a U.S. hospital, a new report finds. The Lown Institute, an independent think tank, examined the overuse of percutaneous coronary interventions (coronary stent or balloon angioplasty) at 1,733 general hospital inpatient and outpatient facilities and found more than 229,000 procedures met the criteria for overuse.
    • “While coronary stents can be lifesaving for someone having a heart attack, years of research shows that stents for stable heart disease provide no benefit over optimal medication therapy. Across all hospitals, Lown estimates that more than one in five stents were placed unnecessarily in Medicare patients from 2019 to 2021, at a cost of $2.44 billion.
    • “When physicians continue a practice despite the evidence against it, it becomes more dangerous than useful,” said Dr. Vikas Saini, a cardiologist and president of the Lown Institute. “The overuse of stents is incredibly wasteful and puts hundreds of thousands of patients in harm’s way.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • CVS Health beat Wall Street expectations for earnings and revenue in the third quarter, as growth in pharmacy benefits offset higher spending in its health insurance segment.
    • The Rhode Island-based healthcare behemoth continues to wrangle with headwinds including higher-than-expected healthcare utilization, a pharmacist strike and lost bonus payments in Medicare Advantage.
    • As a result, interim CFO Tom Cowhey cautioned investors on a Wednesday morning call to expect 2024 earnings at the low end of the company’s guidance.
  • and
    • “Humana reported growing medical costs in its insurance segment during the third quarter as a result of increased medical utilization among Medicare Advantage members and higher-than-anticipated COVID-19 admissions.
    • “The payer expects higher levels of utilization to continue for the remainder of the year, and is now forecasting its 2023 medical loss ratio (MLR) will outpace prior guidance. Humana is projecting an MLR of 87.5% for 2023, up from the 86.6% to 87.3% range it previously expected.
    • “Humana’s shares slid following the earnings release Wednesday, despite the insurer beating Wall Street expectations on revenue of $26.4 billion and profit of $1.1 billion.
  • Forbes reports that biopharma giant “GSK shares rose on Wednesday after the pharma giant upgraded its profit guidance for the second time this year amid booming demand for its new vaccine for respiratory syncytial virus (RSV).”

Weekend update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • The Medicare open enrollment period began today. It ends on December 7, 2023.

From the public health and research front,

  • Fortune Well informs us
    • The medicine in the diabetes drug Mounjaro [the Godzilla of GLP-1 drugs] helped people with obesity or who are overweight lose at least a quarter of their body weight, or about 60 pounds on average when combined with intensive diet and exercise, a new study shows.
    • By comparison, a group of people who also dieted and exercised but then received dummy shots lost weight initially but then regained some, researchers reported Sunday in the journal Nature Medicine.
    • “This study says that if you lose weight before you start the drug, you can then add a lot more weight loss after,” said Dr. Thomas Wadden, a University of Pennsylvania obesity researcher and psychology professor who led the study.
    • The results, which were also presented Sunday at a medical conference, confirm that the drug made by Eli Lilly & Co. has the potential to be one of the most powerful medical treatments for obesity to date, outside experts said.
  • The FDA has approved Mounjaro as a diabetes treatment but not a weight loss treatment yet.
  • The New York Times tells us,
    • “An Oxford University researcher and her team showed that digital wearable devices can track the progression of Parkinson’s disease in an individual more effectively than human clinical observation can, according to a newly published paper.
    • “By tracking more than 100 metrics picked up by the devices, researchers were able to discern subtle changes in the movements of subjects with Parkinson’s, a neurodegenerative disease that afflicts 10 million people worldwide.
    • “The lead researcher emphasized that the latest findings were not a treatment for Parkinson’s. Rather, they are a means of helping scientists gauge whether novel drugs and other therapies for Parkinson’s are slowing the progression of the disease.”
  • The Washington Post interviews “physician Rosanne Leipzig, vice chair for education at the Brookdale Department of Geriatrics and Palliative Medicine at the Icahn School of Medicine at Mount Sinai in New York.” Dr. Leipzig is the author of “Honest Aging: An Insider’s Guide to the Second Half of Life.” The reporter described the book as “the most comprehensive examination of what to expect in later life I’ve come across in a dozen years covering aging.”
  • The Washington Post also reports,
    • “The United States faces a “bloody transfusion problem” that is fueling preventable deaths and putting national security at risk, three military and civilian physicians write in a JAMA opinion essay.
    • “The JAMA op-ed, published Oct. 12, highlights blood transfusions’ importance in emergency care. Emergency transfusions can decrease deaths, especially when given early, the physicians write. But not enough healthcare facilities and emergency vehicles are equipped for the procedures, they add, which presents a “substantial risk to our nation’s security infrastructure.”
    • “One reason is the national blood supply, which the writers call “tenuous” because of its reliance on volunteers, as well as problems with blood storage and the places where blood is collected and processed.
    • “The physicians cite a 2020 Health and Human Services report that characterized the national blood supply system as “struggling.” That report said blood availability is hindered by issues with donor recruitment, an aging donor population and problems funding collection centers.”

From the U.S. healthcare business front,

  • MedTech Dive points out,
    • “Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales.”Best Buy plans to start selling continuous glucose monitors in the next few weeks, in the tech retailer’s first foray into prescription-based medical device sales.
    • “The company plans to sell the Dexcom G7 CGM at launch and is looking to offer additional CGM systems from other manufacturers, according to the company.
    • “Customers who want to buy a CGM will be routed to the virtual care platform Wheel, where clinicians will determine a patient’s eligibility and write a prescription. Pharmacy tech provider HealthDyne will receive and process prescriptions, and consumers can then purchase the CGMs on Best Buy’s website for home delivery.”
  • BioPharma Dive notes,
    • “Pfizer said on Friday afternoon it plans to cut billions of dollars in spending and lay off staff as it adjusts to lower demand for its COVID-19 drug Paxlovid and vaccine Comirnaty. 
    • “The pharmaceutical company is also significantly revising down its revenue forecast to between $58 billion and $61 billion for the year, a $9 billion cut from its previously issued guidance. 
    • “The bulk of that adjustment is due to the return by the U.S. governmentof nearly 8 million treatment courses of Paxlovid labeled under the drug’s emergency clearance. Distribution of that product will be stopped in November as Pfizer shifts to selling Paxlovid commercially, which it now expects to begin on a wide scale in January. The antiviral treatment won full U.S. approval in May.”

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, Medical / Rx research, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The House Republicans have not settled on a new Speaker yet. Roll Call adds, “The delay in the effort to get 217 Republicans to back anyone for speaker is leading some House members to start reconsidering the idea that Speaker Pro Tempore Patrick T. McHenry is little more than a placeholder.”
  • This morning, the Social Security Administration announced
    • “Social Security and Supplemental Security Income (SSI) benefits for more than 71 million Americans will increase 3.2 percent in 2024. * * *
    • “The maximum amount of earnings subject to the Social Security tax (taxable maximum) will increase to $168,600.”
  • Federal News Network explains how the Social Security announcement impacts federal annuitant cost of living adjustments for 2024.
  • This afternoon, the Centers for Medicare and Medicaid Services announced Medicare Part B premiums for 2024 and more, e.g., income-adjusted premiums for Parts B and D.
    • “The standard monthly premium for Medicare Part B enrollees will be $174.70 for 2024, an increase of $9.80 from $164.90 in 2023. The annual deductible for all Medicare Part B beneficiaries will be $240 in 2024, an increase of $14 from the annual deductible of $226 in 2023. 
    • “The increase in the 2024 Part B standard premium and deductible is mainly due to projected increases in health care spending and, to a lesser degree, the remedy for the 340B-acquired drug payment policy for the 2018-2022 period under the Hospital Outpatient Prospective Payment System.
    • “Beginning in 2023, individuals whose full Medicare coverage ended 36 months after a kidney transplant and who do not have certain other types of insurance coverage can elect to continue Part B coverage of immunosuppressive drugs by paying a premium. For 2024, the standard immunosuppressive drug premium is $103.00.”
  • FedSmith shares Medicare basics for federal employees and annuitants.
  • Fierce Healthcare reports on a discussion of Medicare Advantage at the HLTH conference held in Las Vegas this week.

From the public health and research front,

  • The U.S. Preventive Services Task Force published a draft research plan on prostate cancer screening. The draft plan is open for public comment through November 8, 2023.
  • STAT News informs us,
    • “The brain remains both the body’s most important organ and its least understood. But a draft atlas of the human brain published on Thursday gives scientists important insights into how it works and may pave the way for big advances in disease treatment and diagnosis.
    • This brain map, pieced together by hundreds of researchers from San Diego to Seattle to Stockholm, is essentially a cellular “parts list” of the human brain and a guide to how those pieces are arranged and work together. Scientists say that what they’ve already learned — including a stunning diversity of cell types in the brain — and what they’ll discover in the years to come will improve our understanding of deadly neurological diseases. * * *
    • “The recent findings, reported across 21 studies published in the journals Science, Science Advances, and Science Translational Medicine, offer some early clues. And there’s more to come. These papers are part of an ongoing undertaking researchers openly compare to the Human Genome Project in both its scope and ambition. That project sequenced the DNA of a dozen blood donors from Buffalo, N.Y. The new brain atlas was constructed from the brains of more than 100 people, including deceased donors and surgical patients.”
  • The Wall Street Journal seeks to explain the secret of living to 100 years old.
    • “If you want to live to your 100th birthday, healthy habits can only get you so far.”If you want to live to your 100th birthday, healthy habits can only get you so far.
    • “Research is making clearer the role that genes play in living to very old age. Habits like getting enough sleep, exercising and eating a healthy diet can help you stave off disease and live longer, yet when it comes to living beyond 90, genetics start to play a trump card, say researchers who study aging.
    • “Some people have this idea: ‘If I do everything right, diet and exercise, I can live to be 150.’ And that’s really not correct,” says Robert Young, who directs a team of researchers at the nonprofit scientific organization Gerontology Research Group. 
    • “About 25% of your ability to live to 90 is determined by genetics, says Dr. Thomas Perls, a professor of medicine at Boston University who leads the New England Centenarian Study, which has followed centenarians and their family members since 1995. By age 100, it’s roughly 50% genetic, he estimates, and by around 106, it’s 75%.” 
  • Beckers Clinical Research points out
    • “Researchers at Boston-based Harvard Medical School and University of Oxford in England have created an AI tool to forecast which COVID-19 strains will grow in dominance, according to an Oct. 11 article in Nature. 
    • “The tool, called EVEscape, predicts how the virus can evolve through a model of evolutionary sequences alongside biological and structural data, according to an Oct. 11 Harvard news release. EVEscape works to forecast which future COVID-19 strains are most likely to occur. 
    • “Every two weeks, the researchers will release a ranking of COVID-19 variants. 
    • “The rankings are available here.

From the U.S. healthcare business front,

  • Reuters tells us,
    • Shares of dialysis service providers fell sharply on Wednesday after Novo Nordisk’s Ozempic showed early signs of success in delaying the progression of kidney disease in diabetes patients.
    • Colorado-based DaVita’s shares closed down about 17% and U.S.-listed shares of German rival Fresenius Medical ended 17.6% lower.
    • Novo’s announcement is the latest sign of disruption caused by the success of GLP-1 drugs, which have hit shares of food companies, providers of bariatric surgery and glucose-monitoring device makers.
    • FEHBlog note: That is wiggly whack.
  • Healthcare Dive informs us
    • “Walgreens announced a 2024 earnings outlook below Wall Street expectations on Thursday, two days after announcing a new chief executive officer who the beleaguered retailer says will help with its strategic pivot to healthcare services.
    • “Along with the release of its fourth-quarter earnings, Walgreens said it expects adjusted earnings per share for its 2024 fiscal year to be between $3.20 to $3.50, below the analyst consensus of $3.71, due to lower profit from COVID-19 testing and vaccines among other factors.
    • “On a call with investors Thursday morning, Walgreens leadership said the Deerfield, Illinois-based retailer is focused on accelerating the profitability of its U.S. Healthcare division, which includes value-based medical group VillageMD. As part of that, Walgreens plans to close 60 underperforming VillageMD clinics next year.”
  • Per Beckers Hospital Review,
    • “Nearly two years after Mark Cuban launched a mail-order pharmacy with low-cost medications, the entrepreneur and “Shark Tank” star has secured more than a dozen collaborators. 
    • “In September, Mark Cuban Cost Plus Drug Co. penned a deal with Avanlee Care, which runs an app designed to help caregivers for elderly patients. The app, called Ava, will feature an option for its users to order medications from Cost Plus Drugs. Mr. Cuban’s company also teamed up with two fertility health companies to reduce the burden of the pink tax, or inflated prices on women’s products.
    • “Cost Plus Drugs has also expanded its in-person services by signing deals with pharmacies spanning multiple states and grocery chain pharmacies, such as Kroger. The affiliate network aligns Cost Plus Drugs’ pricing with medications at independent pharmacies. 
    • “In an insurance industry shake-up, Blue Shield of California chose Cost Plus Drugs and a few other vendors to take over services historically filled by CVS Caremark, CVS Health’s pharmacy benefit manager. Mark Cuban’s company is now a preferred pharmacy network for the insurer serving 4.8 million members.”  
  • and
    • “St. Louis-based Ascension is focused on rebounding from a $3 billion operating loss (-5.6 percent operating margin) in fiscal year 2023 amid negative outlooks from two ratings agencies. 
    • “Fitch Ratings recently lowered Ascension’s outlook from stable to negative while S&P Global Ratings affirmed its negative outlook for the health system. 
    • “Despite “real progress” to resume a more typical level of operations through significant and durable cost savings initiatives, Ascension saw a new set of operational challenges in FY 2023, Fitch said in a Sept. 26 report. The system hit its 2022 operational goals largely through improved efficiencies and contract labor and productivity initiatives, but additional challenges continued to hinder operations in FY 2023.
    • “One caveat on the $3 billion operating loss is that it included a one-time, non-cash impairment loss of $1.5 billion as the carrying value of certain assets within Ascension’s markets may not be fully recoverable, according to the health system. When normalized to exclude one-time items, Ascension’s operating loss for FY 2023 was $1.39 billion (-4.9 percent margin) compared to a $1.17 billion loss (-4.2 percent margin) in FY 2022.” 

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medicare, NIH, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC, comes an outcome that the FEHBlog didn’t expect.

  • The Washington Post reports,
    • “Rep. Kevin McCarthy (R-Calif.), after being removed as House speaker Tuesday, told fellow Republican lawmakers that he won’t seek the position again. The vote to remove him was the first such action in congressional history. McCarthy’s ouster was sought by hard-right members of his own party. McCarthy was removed by a 216-210 vote, with eight Republicans joining all Democrats in favor of the removal. The move puts the House in uncharted territory as it searches for a leader.
    • “Following McCarthy’s ouster, Rep. Patrick T. McHenry (R-N.C.) was designated as speaker pro tempore. He presided over the chamber briefly before calling a recess to allow Republicans and Democrats to meet privately.
    • “The House will take no further votes this week. Republicans are expected to hold a speaker candidate forum Tuesday, according to sources familiar with the plans who spoke on the condition of anonymity to discuss private deliberations.
  • The Wall Street Journal informs us
    • “Americans will soon be able to choose a third option in the updated Covid-19 booster-shot campaign.
    • “The Food and Drug Administration on Tuesday authorized the use of Novavax‘s Covid-19 shot in people age 12 and older. The shot has been updated to target a strain of the coronavirus that was circulating earlier this year, which health authorities say could help protect people through the fall and winter.
    • “The Centers for Disease Control and Prevention’s recommendation last month that most people receive updated booster shots applies to all updated boosters cleared by the FDA, now including Novavax’s, a CDC spokesman said. 
    • The recommendation clears the way for the vaccine to become available in pharmacies and other vaccination sites.
    • “Novavax said it priced the updated vaccine at $130 a dose, but most people are expected to be able to get it with no out-of-pocket cost.
    • “The company said it has millions of doses that will start to become available in the coming days. The shots will be offered at more than 13,000 sites around the U.S., including retail pharmacies and physician offices.”

From the public health front,

  • On Saturday, the FEHBlog made an appointment with a local chain pharmacy to get the new Covid booster. Later that day, he received a message from the pharmacy canceling the appointment because the booster was no longer available. Medscape points out that the FEHBlog’s experience was not unusual. The following posts put the FEHBlog’s problem in perspective though. There is good news if you can get to the end of this section.
  • The Washington Post has bad news about American life expectancy.
    • “Sickness and death are scarring entire communities in much of the country. The geographical footprint of early death is vast: In a quarter of the nation’s counties, mostly in the South and Midwest, working-age people are dying at a higher rate than 40 years ago, The Post found. The trail of death is so prevalent that a person could go from Virginia to Louisiana, and then up to Kansas, by traveling entirely within counties where death rates are higher than they were when Jimmy Carter was president.”
    • The FEHBlog thinks you don’t need a moonshot to address this problem. Connect people with primary care physicians early in their adult lives.
  • AHRQ’s Medical Expenditure Panel Survey lets us know,
    • “In 2020, about 1 of every 12 adults aged 18 and older received any heart disease treatment. The percentage of adults who received any heart disease treatment was highest among those aged 65 and older, higher among non-Hispanic Whites than among other racial/ethnic groups, and also higher among those in poor/low-income families than those in middle- or high-income families.
    • “Annual healthcare expenditures for the treatment of heart disease for adults in the civilian noninstitutionalized population totaled $114.9 billion in 2020 (a mean of $5,540 per adult treated for heart disease).
    • “Inpatient hospital care accounted for the largest proportion of annual medical spending for heart disease.
    • “Medicare and private health insurance combined paid about four-fifths of the medical spending for heart disease.”
  • Per Fierce Healthcare,
    • “About 8 in 10 women say they are delaying care until their symptoms worsen or affect their daily lives, and 43% have recently missed a day or more of work due to health issues.”About 8 in 10 women say they are delaying care until their symptoms worsen or affect their daily lives, and 43% have recently missed a day or more of work due to health issues.
    • “These health trends are bad for women and also for their employers.
    • “Primary care provider Parsley Health commissioned a survey of 1,200 full-time employed, insured women ages 18 to 60 to uncover their top health concerns and care challenges. The biggest takeaway? For many women, their healthcare needs have been left behind by a system that has largely ignored the broad, intersecting and complex health needs women experience across their lifetimes, Robin Berzin, M.D., founder and CEO of Parsley Health, said during an exclusive interview to review the survey results.”
  • The National Institutes of Health Directors notes,
    • “Chronic pain is an often-debilitating health condition and serious public health concern, affecting more than 50 million Americans. The opioid and overdose crisis, which stems from inadequate pain treatment, continues to have a devastating impact on families and communities across the country. To combat both challenges, we urgently need new ways to treat acute and chronic pain effectively without the many downsides of opioids.
    • “While there are already multiple classes of non-opioid pain medications and other approaches to manage pain, unfortunately none have proved as effective as opioids when it comes to pain relief. So, I’m encouraged to see that an NIH-funded team now has preclinical evidence of a promising alternative target for pain-relieving medicines in the brain.
    • “Rather than activating opioid receptors, the new approach targets receptors for a nerve messenger known as acetylcholine in a portion of the brain involved in pain control. Based on findings from animal models, it appears that treatments targeting acetylcholine could offer pain relief even in people who have reduced responsiveness to opioids. Their findings suggest that the treatment approach has the potential to remain effective in combatting pain long-term and with limited risk for withdrawal symptoms or addiction. * * *
    • “Finding treatments to modify acetylcholine levels or target acetylcholine receptors may therefore offer a means to treat pain and prevent it from becoming chronic. Encouragingly, drugs acting on these receptors already have been tested for use in people for treating other health conditions. It will now be important to learn whether these existing therapeutics or others like them may act as highly effective, non-addictive painkillers, with important implications for alleviating chronic pain.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Eli Lilly is making a bet on radiopharmaceutical drugs for cancer, announcing Tuesday a deal to buy Point Biopharma and its pipeline of experimental therapies for approximately $1.4 billion.
    • “Per acquisition terms, Lilly will pay $12.50 per Point share, a premium of about 87% to what the biotechnology company’s stock closed at Monday. The companies expect their deal to close “near the end” of this year.
    • “Based in Lilly’s home base of Indianapolis, Point specializes in radiopharmaceuticals, which pair a radioisotope with a targeting compound that delivers radiation directly into tumor cells. Recent improvements in manufacturing and supplying the complex treatments have boosted investment in the field, drawing interest from large pharma companies like Lilly as well as new drug startups.”
  • Healthcare Dive informs us,
    • “Growing expenses outpaced operating revenue at Trinity Health during its 2023 fiscal year ended June 30. The hospital system reported operating revenue of $21.6 billion on total expenses of $21.9 billion.
    • “Acquisitions for the Livonia, Michigan-based healthcare system added both $1.6 billion in revenue and $1.7 billion in operational expenses, according to the results released on Friday. The revenue gains were partially offset by the divestiture of St. Francis Medical Center in December 2022.
    • “Labor expenses continue to plague the hospital operator, which called contract rates “unprecedented” last year. Labor costs rose approximately 7.7% this year to $12 billion compared with $11.1 billion in the year prior. Contract labor accounted for $933 million compared with $626 million in 2022.”

Friday Factoids

David Ermer–Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, OPM–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Efforts to pass a stopgap funding measure before Saturday night’s deadline were sputtering in both chambers Friday, with lawmakers openly predicting a partial government shutdown was inevitable. The only question appeared to be how long the funding lapse would last.”Efforts to pass a stopgap funding measure before Saturday night’s deadline were sputtering in both chambers Friday, with lawmakers openly predicting a partial government shutdown was inevitable. The only question appeared to be how long the funding lapse would last.
    • “Border security talks in the Senate stalled Friday ahead of a key procedural vote Saturday, casting doubt on whether there would be the required 60 votes to end debate on a seven-week stopgap bill.
    • “Meanwhile, House Republicans huddled to discuss remaining options after their last shot at a 31-day continuing resolution chock full of spending cuts and restrictive border policies fell flat on the floor earlier Friday.
    • “None of the options — taking up a Senate bill that hasn’t even passed yet, or a “clean” CR extending current funding levels for a week or two, appeared to be gaining much steam, at least yet.”
  • The Washington Post adds
    • “After a two-hour meeting with the Republican caucus, House Speaker Kevin McCarthy (R-Calif.) said he would support a clean continuing resolution without major funding cuts if it did not include either the $12 billion in Ukraine and disaster relief funding that has bipartisan Senate support or the border security legislation that House Republicans have demanded.”
  • Today, OPM issued a press release about 2024 FEHB premiums and a white paper with 2024 Open Season highlights. The highlights include a list of the plans terminating their participation in the FEHB for 2024. The Compass Rose Benefits Group added a standard option. The FEHBlog noticed that Blue Cross FEP and Kaiser Permanente have unveiled their 2024 FEHB benefits on their websites.
  • FedWeek informs us
    • “OPM has said it will soon administer its Federal Employee Benefits Survey to some 100,000 federal employees who will be notified by email and will have up to six weeks to respond.
    • “The purpose of the FEBS is to measure the importance, adequacy and value of employee benefits to assess if employees believe the available benefits meet their needs. The FEBS will also help us to evaluate whether federal employees understand the flexibilities and benefits available to them,” OPM said in a memo to agencies on chcoc.gov.”
  • Per MedTech Dive,
    • “A proposed rule issued on Friday by the Food and Drug Administration would bring laboratory-developed tests under the agency’s purview, closing a regulatory loophole.
    • “Laboratory-developed tests are designed, manufactured and used within a single clinical laboratory. The FDA has exempted these tests from some regulatory requirements, such as premarket review, but it now seeks to bring all tests under one regulatory framework.
    • “The agency said the changes should better protect public health by ensuring the safety and effectiveness of tests. But it is “unclear if and when the FDA will finalize the rule as it will likely face opposition,” analysts with TD Cowen wrote in a research note on Friday.”
  • Healthcare Dive tells us
    • “The Center for Medicare and Medicaid Innovation, which aims to reduce spending or improve quality of care, increased net federal spending during its first 10 years of operation, and it will likely continue to boost spending over its next decade, according to a report by the Congressional Budget Office. 
    • “The CBO estimated that CMMI’s activities increased direct spending by $5.4 billion, or about 0.1% of the net spending on Medicare, between 2011 and 2020. 
    • “CMMI’s work is projected to increase net federal spending by $1.3 billion, or 0.01% of net spending on Medicare from 2021 to 2030, according to the report.” 
  • The IRS posted draft instructions and forms of 1095-B and 1095-C forms for 2023
  • HHS requests comments on mandating health plan coverage with no-cost sharing and no prescription requirements for low-cost preventive supplies, most of which OPM already mandates for FEHBP. The public comment period will likely expand the list.  The public comment deadline will be in early December. 

From the public health and medical research fronts,

  • The Food and Drug Administration announced,
    • “granting de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers. The test can also help identify potentially cancer-associated hereditary variants in individuals with already-diagnosed cancer. The test, which is the first of its kind to be granted FDA marketing authorization, evaluates DNA extracted from a blood sample to identify variants in 47 genes known to be associated with an elevated risk of developing certain types of cancer.”  
  • Biopharma Dive lets us know
    • “Shares in Structure Therapeutics jumped Friday after the San Francisco-based biotechnology company released results from a small study of an experimental weight loss drug that appear competitive to rival programs from Eli Lilly and Pfizer.
    • “Over the 28-day Phase 1 trial, people taking the highest doses of Structure’s drug lost about 5% of their weight compared to the study’s start, up to around 10 pounds. There were side effects, most commonly mild nausea and vomiting, but no participants stopped treatment as a result, the company said.
    • “Dubbed GSBR-1290, Structure’s drug is a GLP-1 agonist, similar to the much in-demand diabetes and obesity medicines Ozempic and Wegovy. Unlike those, however, GSBR-1290 is taken orally rather than by injection, potentially meaning greater convenience.”
  • and
    • “A cancer drug combination developed by Johnson & Johnson succeeded in an important late-stage trial testing the new regimen against a widely used medicine from AstraZeneca.
    • “According to J&J, treatment with its approved drug Rybrevant and an experimental therapy called lazertinib kept a common type of metastatic lung tumor at bay for longer than AstraZeneca’s Tagrisso alone. The results were from an interim analysis of the study, which is continuing to study patient survival.
    • “J&J’s trial, called Mariposa, has been followed closely by analysts as it could offer J&J a chance to compete with AstraZeneca in a large cancer drug market. J&J didn’t share any specific data in its statement Thursday, but said it plans to submit the study results for presentation at an upcoming medical conference.”
  • Beckers Clinical Leadership points out,
    • “Transport accidents are the leading cause of death for most children while opioids and major cardiovascular disease are the most common leading cause of death for adults, according to a report from USA Facts, a nonprofit organization that conducts data analysis.
    • “The “America in Facts 2023″ report, published in September, used CDC data to calculate the leading causes of death by age for the time periods 2001 to 2002 and 2020 to 2021.”
  • From the Econtalk Podcast
    • “We spend too much of our health care focus on lifespan and not enough on healthspan–the quality of our life as we get older. So argues Dr. Peter Attia, author of Outlive: The Science and Art of Longevity. Attia speaks with EconTalk’s Russ Roberts about what kills us, what slows us down as we age, and the weapons we have to allow us to live better and longer.”
    • Check it out at this link.

In judicial news,

  • Politico reports
    • “A federal judge on Friday denied business groups’ move to halt Medicare’s new drug price negotiation program while multiple lawsuits challenging its constitutionality wind through the courts.
    • “The decision by Judge Michael J. Newman, a Trump appointee, in Ohio’s Southern District preserves the Biden administration’s power to begin haggling with drug companies over the prices of 10 medications. Manufacturers of products that CMS chose for the first tranche of negotiations have until Oct. 1 to agree to the talks.
    • “The Court is not convinced that granting Plaintiffs preliminary injunctive relief will protect them from imminent and irreparable harm,” Newman wrote in his opinion. “Any economic harm — which, on its own, is insufficient to satisfy this prong of a preliminary injunction analysis — will not occur for years in the future.” * * *
    • “Newman denied DOJ’s motion to dismiss to give the chambers the chance to address his concerns, though the government can refile.”