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.”