Friday report
Happy first day of Spring!!
From Washington, DC
- Roll Call reports,
- “Senators are sticking around Washington this weekend after a busy week on the Hill highlighted partisan divides, intraparty friction and growing tension between the two chambers. One thing is clear — everyone is ready for spring break.
- “The Senate has largely been wrapped up in an extended debate on the GOP’s marquee voter ID legislation, dubbed the SAVE America Act. Debate on the bill began Tuesday and is anticipated to extend through the weekend, at least.
- “We’re in through this weekend,” Senate Majority Leader John Thune, R-S.D., said on Fox News on Friday morning. “There will be a vote on this bill. We will find out where everybody stands.” * * *
- “After Senate appropriators of both parties held a face-to-face meeting Thursday with White House “border czar” Tom Homan — some of the first signs of progress in weeks — Thune set a deadline of next week for resolving the DHS funding standoff.”
- Bloomberg Law relates,
- “The Trump administration’s Medicare chief said the version of the program run by private insurers doesn’t do enough to control costs, raising questions about how much the US will pay companies in a crucial upcoming rate update.
- “Chris Klomp, a top health official at the US Centers for Medicare and Medicaid Services, said the private Medicare Advantage program “does not sufficiently have control of costs,” in remarks at a STAT conference in New York on Thursday.”
- STAT News adds,
- “President Trump’s Medicare director said Thursday his team is considering a policy that would automatically enroll Medicare beneficiaries into Medicare Advantage plans, a controversial idea that was touted in the conservative Project 2025 policy blueprint.
- “Chris Klomp said the Centers for Medicare and Medicaid Services is mulling the feasibility of models that would either automatically enroll beneficiaries into the private form of Medicare or accountable care organizations, such as those that participate in the Medicare Shared Savings Program. Individuals could still opt into a different insurance arrangement. Right now, people who don’t make a choice are covered by traditional Medicare.
- “Would either of those, in my view, be superior to a default enrollment into a fee-for-service arrangement, where there’s not this long-term, secular relationship between the beneficiary, the patient, and their provider? Yes,” Klomp said.
- “He made the comments in an interview with STAT reporter Mario Aguilar on the sidelines of STAT’s Breakthrough Summit East in New York.”
- Health Affairs Forefront tells us,
- “The only truly clear and formally stated goal of the MFN [most favored nation drug pricing] policies is to lower the prices that Americans pay for drugs. How can we begin to evaluate the extent and impact of this kind of change?
- “It is notoriously difficult to know, precisely, what most Americans “pay” for drugs. We have a complicated system of confidential manufacturer rebates and arrangements with pharmacy benefit managers that often tie out-of-pocket payments to “list” prices that may or may not actually be paid by anyone. People far smarter than I have made careers of shedding light on the cost of drugs in the US, and ultimately, it will be up to them to track whether any person or entity ends up paying less for drugs (and for which drugs) than prior to the policies’ enactment. Until then, Observatory members are watching developments in a few key areas that could influence the reach of MFN policies in the US.
- “First, they are watching the relationship of the MFN policies to the employer-based insurance market, which covers 160 million people, or more than 50 percent of those with health insurance in the US. To date, MFN policies have been announced for Medicare and Medicaid recipients and for individuals who purchase drugs out of pocket on TrumpRx. But even at discounted prices available through TrumpRx, many drugs will remain too costly for consumers unless they can use the insurance for which they already pay premiums.
- “The reach of the new, “lower” prices will be limited if there isn’t a mechanism for those with employer-sponsored insurance to access those prices. Part of such “access” includes having purchases through TrumpRx (or other direct-to-consumer platforms) count toward the deductibles and out of pocket maximums that characterize private coverage. Without explicit mechanisms to enable this kind of accounting—or federal or state mandates to require it—the purchase of drugs at the MFN prices will likely be unappealing to more than half of the US population, significantly diluting the policies’ effectiveness and reach. Further, if employer-sponsored health plans cannot access the MFN prices, then those lower prices cannot be reflected in their overall premiums, which consistently rise far faster than both general inflation and wage growth with escalating pharmaceutical costs being an important contributor.”
- and
- “As reported by the Centers for Medicare and Medicaid Services (CMS) in supplemental tables and public use files, the volume of cases submitted into the [No Surprises Act Independent Dispute Resolution] IDR process continues to exceed all expectations and grew rapidly in the first six months of 2025. During that period, parties submitted 1.2 million new disputes to the IDR portal—more than double the volume of the first two quarters of 2024 when nearly 590,000 disputes were filed. This amounts to a total of 3.4 million disputes from 2022 through June 2025.
- “And the number of disputes is only continuing to increase: Even more recent bi-monthly updates from CMS show that nearly 1.4 million cases were filed from July 2025 through December 2025. This has resulted in a whopping 4.8 million total cases through the end of 2025. As a reminder, federal officials expected approximately 17,000 disputes per year.” * * *
- “Consistent with prior trends, providers continued to initiate (and win) the vast majority of disputes.” * * *
- Four provider groups and provider representatives—mostly backed by private equity—initiated the majority of these disputes: HaloMD, Team Health, Radiology Partners, and SCP Health. HaloMD—a middleman organization that specializes in arbitration—initiated the most disputes, accounting for 17 percent of all disputes in the first quarter of 2025 and 22 percent of all disputes in the second quarter of 2025. For an organization that initiated a mere 1 percent of line-item claims in 2023, this is a rapid rise to prominence. The second most frequent initiator, Team Health, has long been a high-volume IDR participant and initiated 16 percent of all disputes in the first six months of 2025, a level that is consistent with prior years. Combined, the top four initiators accounted for more than half (56 percent) of disputes filed in the first two quarters of 2025.
- Providers also won 88 percent of disputes—the highest provider win rate to date—as compared to 85 percent in 2024 and 81 percent in 2023. Radiology Partners prevailed most often, winning favorable IDR awards in 92 percent and 95 percent of its cases in the first two quarters of 2025, respectively. Team Health saw similar win rates of 94 percent across both quarters. HaloMD won slightly less often but still prevailed in 87 percent and 82 percent of its disputes in the first two quarters of 2025, respectively.
- Per a Centers for Medicare and Medicaid Services news release,
- “The Centers for Medicare & Medicaid Services (CMS) has finalized the Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures Final Rule (CMS-0053-F).
- “This groundbreaking final rule establishes the first-ever Health Insurance Portability and Accountability Act (HIPAA)-adopted standards for health care claims attachments, enabling the secure electronic exchange of health care claims-related supporting clinical documentation such as medical records, x-rays and imaging, clinical notes, telemedicine visit documentation and laboratory results.
- “The rule also establishes requirements for electronic signatures to ensure health care claims attachment transactions are secure, authenticated, and compliant with federal standards.” * * *
- “Health care providers and payers should begin preparing to implement the finalized standards. This final rule is effective on May 26, 2026. The compliance deadlines for all requirements in this rule are set for 24 months from the effective date of the final rule. Stakeholders are encouraged to review the rule and begin implementing the new standards promptly. The final rule can be viewed at: https://www.federalregister.gov/.” * * *
- To view the final rule fact sheet, visit: https://www.cms.gov/newsroom/fact-sheets/administrative-simplification-adoption-standards-health-care-claims-attachments-transactions.
- For more information, visit: https://www.cms.gov/priorities/key-initiatives/burden-reduction/administrative-simplification/hipaa/events-latest-news.
- PCMA points out,
- “The Pharmaceutical Care Management Association (PCMA) is urging the Labor Department to roll back a proposed rule aimed at boosting price transparency in pharmacy benefit management relationships now that Congress has passed industry reforms.”
- “The Pharmaceutical Care Management Association (PCMA) is urging the Labor Department to roll back a proposed rule aimed at boosting price transparency in pharmacy benefit management relationships now that Congress has passed industry reforms.”
- Beckers Payer Issues informs us,
- “Nine percent of people who had ACA Marketplace coverage in 2025 are now uninsured, with healthcare costs as a major reason many enrollees either switched Marketplace plans or dropped coverage, according to a KFF poll.
- “The KFF follow-up survey of Marketplace enrollees was conducted Feb. 12 to March 2 and included 1,117 U.S. adults who had Marketplace insurance in 2025. The sample was drawn entirely from respondents to KFF’s original 2025 Marketplace survey, which included 1,350 participants.”
From the Food and Drug Administration front,
- MedPage Today reports,
- “The FDA issued a safety communication today warning of a potential increased risk of seizures tied to certain medications used to treat Parkinson’s disease.
- “The agency will require manufacturers of carbidopa/levodopa products to update their labels with clearer warnings, to better inform patients and clinicians of this risk. The revised prescribing information will specify that these medications can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures.
- “The warning also instructs healthcare professionals to assess baseline vitamin B6 levels before initiating carbidopa/levodopa therapy and to monitor these levels periodically during treatment, supplementing with vitamin B6 as needed.”
- MedTech Dive adds,
- “Intuitive Surgical has recalled stapler reload cartridges after receiving reports of four serious injuries and one death.
- “The Food and Drug Administration communicated the recall in an early alert Wednesday, one week after Intuitive asked customers to quarantine and return all affected and unused reloads.
- “An Intuitive spokesperson said in an email to MedTech Dive that the company is still investigating the root cause of rare reports of incomplete staple lines when using the recalled 8 mm SureForm gray reload cartridges.”
- Fierce Pharma relates,
- “Rhythm Pharmaceuticals is switching up the tempo for its melanocortin-4 receptor (MC4R) agonist Imcivree. After its initial approval more than five years ago to treat certain patients with genetic-driven obesity, the drug is moving into a different and broader realm with an FDA nod for acquired hypothalamic obesity (HO).
- “Acquired HO, for which Imcivree is the first approved treatment, represents an “expanded thinking” on the weight-regulating MC4R pathway that Rhythm’s product targets, Chief Scientific Officer Alastair Garfield, Ph.D., explained in a recent interview with Fierce.
- “Until now, all of Imcivree’s approved uses have centered around specific genetic causes. HO, on the other hand, is a result of a hypothalamic injury such as a tumor or stroke that impairs the MC4R pathway and causes weight gain and insatiable hunger (hyperphagia).”
- Per an FDA news release,
- “As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissioner’s National Priority Voucher pilot program. The agency also announced a public hearing on June 12, to allow stakeholders to present information and views about the program.
- “The public hearing, consistent with 21 CFR § 15.1 et seq., will seek feedback about the program’s eligibility criteria, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV Review Council, and other aspects of program implementation.” * * *
- “The June 12 public hearing will be held at the FDA’s White Oak Headquarters with both an in-person and virtual option for participation. The FDA panelists will include subject matter experts from the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Oncology Center of Excellence, as well as a presiding officer. Requests to speak are due by May 1. The FDA is also soliciting written comments until June 27. For more information about the hearing: https://www.fda.gov/news-events/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026.”
From the judicial front,
- Fierce Healthcare reports,
- “A federal judge has dealt a blow to the Trump administration’s push to restrict gender-affirming care for minors.
- “Per the New York Times, Oregon [U.S.] District Court Judge Mustafa Kasubhai ruled Thursday that Department of Health and Human Services Secretary Robert F. Kennedy, Jr. overstepped his legal authority in issuing a declaration late last year that would bar hospitals from providing gender-affirming care to minors if they want to participate in Medicare and Medicaid.” * * *
- “Restricting access to gender-affirming care for minors has been a key priority for the Trump administration, and NYT reports that legal experts believe Kasubhai’s decision will likely be appealed.”
From the public health, medical and Rx research front,
- The Centers for Disease Control and Prevention announced today,
- “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. Seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. COVID-19 activity is decreasing in most areas of the country.
- “COVID-19
- “COVID-19 activity is decreasing in most areas of the country.
- “Influenza
- “Overall seasonal influenza activity remains elevated nationally but is decreasing in most areas of the country. Influenza A activity continues to decrease while trends in influenza B activity vary by region.
- “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
- “RSV
- “RSV activity started later than expected in most regions of the United States, though illness is not more severe compared with recent seasons. This unusual timing means that higher levels of RSV activity may continue into April in many regions. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old.
- Vaccination
- “RSV is a leading cause of hospitalization among U.S. babies.
- “To help keep babies safe from severe RSV, babies younger than 8 months of age should get protection in their first RSV season (which usually starts in the fall) in one of these ways:
- “The pregnant mother gets the RSV vaccine during pregnancy, or
- “The baby gets an RSV antibody (nirsevimab or clesrovimab) just before the start of the RSV season or soon after birth, if born during the season.
- “A CDC report showed that these protections are working. During the 2024–25 RSV season, infant RSV hospitalization rates were reduced by up to half compared to rates during seasons before when RSV prevention products were available.
- “Interim estimates for the 2025–26 seasonal influenza vaccine show getting the vaccine reduced the risk of flu-related doctor visits and hospitalizations, supporting CDC’s vaccination recommendations. For children and teenagers, the vaccine was 38%–41% effective at preventing doctor visits and 41% effective at avoiding hospitalizations for the flu. For adults aged 18 and older, it was 22%–34% effective at preventing doctor visits and 30% effective for preventing hospital stays. Read more here: MMWR.
- “Talk to your doctor or trusted healthcare provider about what may be recommended for you and your family.”
- The American Hospital Association News reports,
- “The Centers for Disease Control and Prevention announced today that there are now 1,487 confirmed measles cases nationwide so far this year. The CDC said 5% of cases have been hospitalized, and no deaths have been reported. The vaccination status of 92% of cases is unvaccinated or unknown. The South Carolina measles outbreak, which began in October 2025 and is currently the largest outbreak of any state, is at 997 cases. Utah, which has the second-largest outbreak, is now at 443 cases.”
- Health Day points out,
- “Psychedelic-assisted therapy (PAT) is no more effective than traditional antidepressants (TADs) for treatment of major depression, according to a review published online March 19 in JAMA Psychiatry.”
- “Psychedelic-assisted therapy (PAT) is no more effective than traditional antidepressants (TADs) for treatment of major depression, according to a review published online March 19 in JAMA Psychiatry.”
- Medscape explains how “New Nanoparticles Can Destroy Undruggable Cancer Proteins.”
- Genetic Engineering and Biotechnology News informs us,
- “Current schizophrenia (SZ) medications treat symptoms such as hallucinations and delusions, but do little for cognitive symptoms, such as disorganized thinking or executive dysfunction. As a result, many patients are unable to work, rely on family for lifelong support, become homeless or, in some cases, experience suicidal thoughts and actions.
- “A study in humans and mice, headed by a team at Northwestern University, has discovered a novel biomarker of schizophrenia that could also serve as a new drug candidate to treat cognitive symptoms of the disorder. Their research in a mouse model of schizophrenia showed that treatment with a synthetic protein, SEAD1, corrected overexcited brain circuits. “A lot of people with schizophrenia cannot integrate well into society because of these cognitive deficits,” said Peter Penzes, PhD, professor of neuroscience, pharmacology and psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine. “Our discovery could solve these challenges by establishing the basis of a revolutionary and completely novel treatment strategy through a tandem biomarker-peptide therapeutic approach.”
From the U.S. healthcare business and artificial intelligence front,
- BioPharma Dive reports,
- “Novartis will pay $2 billion up front to acquire a drug that could improve upon existing treatments for patients with a particular form of breast cancer.
- “Through a deal announced Friday, Novartis will purchase Pikavation Therapeutics, a subsidiary of privately held, Delaware-based Synnovation Therapeutics. The buyout hands Novartis an experimental pill called SNV4818, which targets tumors driven to growth by mutations to the PIK3CA gene. Alterations to this gene are implicated in a wide variety of cancers, including an estimated 40% of patients whose breast tumors are hormone-receptor positive, but don’t express the protein HER2, according to Novartis.”
- Healthcare Innovation relates,
- “Mary Bacaj, president of value-based care at Conifer Health Solutions, recently spoke with Healthcare Innovation about misconceptions around preventive care. She argues [in the interview found in the article] that self-insured employers should take a multi-year approach to assessing ROI rather than taking a single-year snapshot.” Check it out.
- Beckers Hospital Review identifies and discusses six healthcare systems which arreinnovating primary care models to expand care.
- Kaufman Hall informs us,
- “Healthcare bankruptcy filings decreased for a second consecutive year, according to a recent report from Gibbons Advisors. The report finds a 21% decline in bankruptcy filings year-over-year, with the bulk of the 45 filings in 2025 occurring in the first quarter. The bankruptcy activity appears to be tempering, adjusting to pre-pandemic trends. By sector, senior care and pharmaceuticals comprise about half of the bankruptcies, with hospitals only accounting for 13.6% of all healthcare bankruptcy filings in 2025.”
- The Withum CPA and consulting firm delves into “Artificial Intelligence and the Rise of Duplicate Claims: What Plan Sponsors Should Understand.”
- “Artificial intelligence is fundamentally changing how healthcare claims are generated, submitted, and processed. As these technologies mature, both claim volume and complexity are likely to increase, placing additional pressure on traditional payment-integrity controls.
- “While duplicate and near-duplicate claims are a visible result of this shift, AI also affects other aspects of the payment-integrity lifecycle, including coding accuracy, claim edits, resubmission behavior, and post-payment recovery.
- “For plan sponsors, the question is no longer whether AI will influence claims administration, but whether current oversight frameworks have evolved to address these broader changes. Understanding duplicate-claim risk, evaluating vendor controls across the payment-integrity continuum, and ensuring transparency are increasingly important for prudent fiduciary governance in an AI-driven claims environment.
- “As AI continues to reshape healthcare billing and claims processing, plan sponsors should periodically reassess whether their oversight frameworks and vendor controls remain aligned with an increasingly automated claims environment.”
