Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Federal employment benefits, HSA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
  • Govexec observes “The Office of Personnel Management’s inspector general last month reported that the federal government’s dedicated HR agency faces taller tasks in the form of launching a health insurance program for postal workers and verifying enrollees’ eligibility for the Federal Employees Health Benefits Program.”
  • While Govexec accurately reflects the substance of the OIG’s report, the FEHBlog disagrees with the OIG conclusions for the following reasons —
    • The OIG and GAO focus on family member eligibility issues. FEHB carriers, or their underwriters, hold the FEHB Program’s insurance risk. The biggest eligibility issue is that OPM does not use the HIPAA 820 enrollment roster transaction which would allow carriers to electronically reconcile individual enrollees with the premiums. This remains a yawning internal gap for the FEHBP.
    • OPM intelligently is assigning Postal employees and annuitants to their appropriate PSHB plan this month. OPM is electronically notifying carriers about these enrollments and OPM is mailing notices to these folks about their enrollments which can be changed during Open Season. If OPM’s new enrollment system breaks down (see healthcare.gov in 2013), the FEHBlog is certain that OPM has a Plan B for making PSHB enrollment change. In the FEHBlog’s view, OPM’s plan provides a high likelihood that the PSHB will timely launch on January 1, 2025.
  • Sequoia reminds us,
    • “The Centers for Medicare and Medicaid Services (CMS) issued Final Rules on how and when civil monetary penalties may be imposed when Responsible Reporting Entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting obligations.
    • “Under MSP rules, group health plans are required to submit certain information to CMS on plan participants that are dual enrolled in the group health plan and Medicare. By doing so, CMS can better identify when another party should pay primary, thereby avoiding unnecessary claims payment mistakes.
    • “Generally, a group health plan RRE is the insurer for fully insured plans and the third-party administrator (TPA) for self-funded plans. Employers are not likely to be an RRE, or otherwise have direct reporting obligations, unless as plan administrator they both self-fund and self-administer the plan. However, employers will need to provide any required information requested by the RRE (i.e., insurer or TPA) for them to accurately submit the reporting on the employer’s group health plan to CMS.
    • “Penalties against an RRE are up to $1,000 (as adjusted) per instance of noncompliance for each calendar day that a record is late, with a maximum annual penalty of $365,000 per instance. Penalties may be waived if RREs can show “good faith efforts” to report any records identified by CMS as being noncompliant. Also, CMS will apply a five-year statute of limitations on assessing civil monetary penalties for violations of mandatory reporting requirements.”
    • Important Dates
      • December 11, 2023: Effective date for the Final Rules.
      • October 11, 2024 / TODAY: Earliest date the provisions of the Final Rules will be applied.
      • October 11, 2025: Start date for compliance review and penalty enforcement.
      • April 1, 2026: CMS begins quarterly compliance audit; reviewing a random sample of 250 new records per quarter for a total of 1,000 records per year.
  • Bloomberg lets us know,
    • “Medicare patients changed to outpatient “observation status” after they were initially hospitalized now have a chance to appeal their reclassification under a rule finalized by the Biden administration on Friday. 
    • “The rule (RIN 0938-AV16) would implement a 2020 ruling by the US District Court for the District of Connecticut in a class action involving a dispute over Medicare’s obligation to pay for hospitalizations and long-term care for elderly patients.”
  • The Wall Street Journal reports,
    • “Teva Pharmaceuticals will pay $450 million to resolve allegations that the generic drug manufacturer submitted false claims and violated a federal law that prohibits the payment of kickbacks to generate federal healthcare business or induce patient referrals.
    • “The Justice Department on Thursday said the settlement amount was based on the company’s, whose U.S. headquarters is in Parsippany, N.J., ability to pay. As part of the settlement, there was no admission of wrongdoing on Teva’s part.
    • ‘Teva said it is pleased to put these matters in the past in order to focus on developing and providing access to medicines for patients who need them.”
  • The American Hospital Association News points out,
    • A survey released Oct. 9 and funded by the American Foundation for Suicide Prevention, the Suicide Prevention Resource Center and the National Action Alliance for Suicide Prevention, a public-private partnership whose members include the AHA, shows 63% of U.S. adults are aware of the 988 Suicide and Crisis Lifeline, a 6% increase from 2022. The survey also found that 71% of adults feel comfortable contacting a mental health hotline, while 15% said they have used one previously. Among other findings, 91% of U.S. adults perceive mental health as equal to or more important than physical health, but 49% feel that physical health is treated as more important.

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “COVID-19 activity is declining in most areas. Seasonal influenza is low nationally. Signs of increased RSV activity have been detected in the southeastern United States, including Florida, particularly in young children.
    • “COVID-19
      • “Nationally, COVID-19 activity has continued declining in most areas. Wastewater levels, laboratory percent positivity, emergency department visits, and hospitalizations are continuing to decrease nationally while deaths remain at low levels.
      • “The new XEC variant is estimated to comprise 7-16% among circulating viruses as of October 12, 2024. Because XEC is recombined from two JN.1 lineage viruses, the 2024-2025 COVID-19 vaccines that already include JN.1 strains are still expected to provide protection. Similarly, there are no impacts currently expected on tests, treatments, or symptoms at this time. For additional information, please see CDC COVID Data Tracker: Variant Proportions. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low. However, continuing signs of increased RSV activity have been detected in the southeastern United States, including Florida, particularly in young children.
    • “Vaccination
      • “Vaccinations to prevent fall respiratory viruses have started for the 2024-25 fall and winter virus season. RSV, influenza, and COVID-19 vaccines are available to provide protection.
  • The University of Minnesota’s CIDRAP tells us,
    • “The California Department of Public Health (CDPH) reported today that the US Centers for Disease Control and Prevention (CDC) has confirmed two of its latest probable H5 avian flu cases, as it reported another likely case based on state testing, which if confirmed would raise the state’s total to seven.
    • “California’s flurry of human cases is occurring amid an ongoing surge of outbreaks affecting the state’s dairy farms, which are concentrated in the Central Valley. Also today, the CDC shared the latest findings from genetic sequencing, which so far show no worrying changes.”
  • and
    • “Genetic sequencing has identified a second cluster of tecovirimat-resistant mpox infections in the United States—the first of its kind involving interstate spread. Researchers from the US Centers for Disease Control and Prevention (CDC) and partners from five affected states reported their findings yesterday in Morbidity and Mortality Weekly Report.
    • “The first Tpoxx-resistant cluster was identified in California in late 2022 and early 2023 in people who hadn’t previously been treated with the drug. The new report describes a new unrelated cluster among 18 people with no previous treatment across multiple states. * * *
    • “In vitro testing of seven samples showed resistance to Tpoxx. Whole-genome sequencing showed that the resistance mutations came from a common ancestor but were distinct from the earlier California cluster.
    • “Researchers said because not all viruses from mpox cases are sequenced, the findings likely underestimate the prevalence of the newly identified drug-resistant variant. They added that more surveillance is needed, as well as adherence to CDC Tpoxx use protocols. Also, they wrote that the findings underscore the need for more treatments for mpox, along with smallpox biothreat preparedness.”
  • Reuters reports,
    • “Roughly 15.5 million U.S. adults have attention-deficit hyperactivity disorder, and most of them struggle with gaining access to treatment for the condition, according to data from a U.S. study released on Thursday.
    • “Only about one-third of those reporting a diagnosis of ADHD said they had received a prescription for a stimulant drug used to treat it in the previous year, researchers reported in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
    • “In addition, nearly three quarters of those with a prescription for a stimulant drug reported difficulty getting it filled because the medication was unavailable.
    • “Worldwide, around 2% to 5% of adults experience ADHD symptoms such as inattention, hyperactivity, and impulsivity. This study provides the first prevalence data on ADHD in U.S. adults since 2003.”
  • The Wall Street Journal informs us,
    • “The Food and Drug Administration approved Pfizer’s Hympavzi to prevent or reduce bleeding episodes in patients with certain kinds of hemophilia, the pharmaceutical company said.
    • “The approval is for patients with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX inhibitors, Pfizer said Friday.
    • “Hympavzi, also known as marstacimab, can be given subcutaneously every week for routine prophylaxis in patients aged 12 and up as an alternative to intravenous infusions that are often administered multiple times a week, Pfizer said.
    • “The FDA said the drug is the first non-factor and once-weekly treatment for hemophilia B. The agency said the approval provides “a new treatment option that is the first of its kind to work by targeting a protein in the blood clotting process.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Thursday approved a new Roche drug for breast cancer. Called Itovebi, the drug has been cleared for use with Pfizer’s Ibrance and endocrine therapy in people whose HR-positive, HER2-negative breast tumors have a mutation called PIK3CA.
    • It’ll compete for market share with Novartis’ Piqray, another medicine targeting PIK3CA mutations. Itovebi is one of five drugs Roche aims to add to its portfolio of breast cancer treatments, which already includes the targeted therapies Herceptin, Perjeta and Kadcyla. 
  • Per Health Day,
    • “It’s never too late for a person to quit smoking, even if they’re elderly, a new study finds.
    • “Dropping the smokes even as late as 75 can meaningfully increase a person’s life expectancy, researchers reported recently in the American Journal of Preventive Medicine.
    • “Seniors aged 75 will lose on average more than four years of life if they keep smoking, compared to people who never smoked, researchers found.
    • “On the other hand, a 75-year-old smoker who quits has a 14% chance of gaining at least one extra year of life, and a 65-year-old smoker a 23% chance.
    • “And about 8% of those who quit at age 75 gain at least four years of life compared to those who keep smoking, researchers found.
    • “Quitting smoking is the single best thing anyone at any age can do to increase their life expectancy, researchers concluded.”

From the U.S. healthcare business front,

  • MedTech Dive relates,
    • “Fresenius Medical Care said Thursday it will increase its production of IV fluid and peritoneal dialysis (PD) products as the U.S. manages shortages due to Hurricane Helene’s effect on the supply chain.
    • “The company is maximizing production capacity at its international sites to help add supply amid an industrywide supply shortage of PD products and IV fluids, according to the update. Fresenius Medical Care is also exploring other options to address the shortage at the Department of Health and Human Services’ request.”
  • Beckers Payer Issues offer new payer game plans for improving women’s health.
  • Fierce Healthcare provides details on the latest Medicare Advantage star scores.
  • Modern Healthcare notes,
    • “Mary Beth Jenkins will become the president and CEO of University of Pittsburgh Medical Center Health Plan starting Jan. 1. 
    • “Jenkins was also named president of UPMC Insurance Services Division and an executive vice president of the system. She will succeed Diane Holder, who plans to retire Dec. 31 after 40 years with UPMC.
    • “Jenkins has been executive vice president of UPMC Insurance Services Division and chief operating officer of UPMC Health Plan since 2023. She joined Pittsburgh-based UPMC in 1998.” 
  • Optum offers HSA plans tips on personalized member communications strategies.