From Washington, DC,

• Politico reports,
  • “The Senate approved a stopgap funding bill Thursday night for President Joe Biden’s signature, thwarting a partial government shutdown on Saturday and buying more time to finalize half a dozen spending bills that congressional leaders aim to pass next week.
  • “Congress now officially has until March 8 to clear that initial six-bill bundle, which leaders struck a deal on earlier this week. But they’re still working on an agreement to fund the rest of the government, including the military and some of the biggest domestic programs, before a second deadline on March 22. The upper chamber cleared the measure in a 77-13 vote, following votes on four Republican amendments that were defeated on the floor.”

• Per an HHS press release,
  • “Continuing the ongoing implementation of President Biden’s prescription drug pricing law, the Inflation Reduction Act of 2022, the Centers for Medicare & Medicaid Services (CMS) released the final part one guidance – PDF for the new Medicare Prescription Payment Plan. Today’s guidance helps ensure that Medicare Part D plan sponsors can successfully implement the Medicare Prescription Payment Plan and effectively build the necessary infrastructure to provide a seamless experience for people enrolled in a Medicare Part D prescription drug plan who elect to participate in this program. * * *
  • “The guidance released today is an important step in helping certain people with Medicare prescription drug coverage who have high upfront drug costs to spread out their cost sharing over the year,” said CMS Administrator Chiquita Brooks-LaSure. “CMS remains committed to implementing the historic Inflation Reduction Act in order to help people with Medicare lower costs and access the prescriptions they need.”
  • FEHBLOG note: This CMS implementation timeline for the program is helps the reader to gain familiarity with it.
  • “For the fact sheet on the final part one guidance for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/fact-sheet-medicare-prescription-payment-plan-final-part-one-guidance.pdf – PDF
  • “For the draft part two guidance fact sheet, please visit: https://www.cms.gov/files/document/fact-sheet-medicare-prescription-payment-plan-draft-two-guidance.pdf – PDF.”

• The U.S. Preventive Services Task Force posted for public comment a draft research plan concerning Primary Care Interventions for Tobacco and Nicotine Use Prevention and Cessation in Children and Adolescents. The comment period ends on March 27, 2024.

• The Labor Department’s Office of Federal Contract Compliance Programs created an updated website for the “The Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA) [which] is a law that prohibits federal contractors and subcontractors from discriminating in employment against protected veterans and requires employers take affirmative action to recruit, hire, promote, and retain these individuals.”

• Yesterday, the Politico Pulse posted a story on a December 2022 Government Accountability Office report, released January 9, 2023, criticizing OPM’s internal controls over FEHB family member eligibility. Here is a link to the GAO’s website for the report which offers August 2023 updates on OPM’s efforts to implement GAO’s recommendations. Here’s are FEHBlog recommendations for GAO and OPM:
  • Family member eligibility hinges on the enrollee’s eligibility. OPM needs to have the payroll offices implement the HIPAA 820 enrollment roster electronic transaction which allows carriers to reconcile premiums to actual headcount. Use of the HIPAA 820 will be a huge step toward confirming the accuracy of family member eligibility and the 50% of FEHB enrollees who have self only coverage.
  • The Politico article suggests that the high cost of a family member eligibility audit discourages OPM from implementing one for the FEHBP. Auditors do their work based on samples. Arrange for a family member eligibility audit using statistically appropriate samples which will disclose, at the very least, the scope of the problem.

From the U.S. public health and medical research front,

• The New York Times reports,
  • “Long Covid may lead to measurable cognitive decline, especially in the ability to remember, reason and plan, a large new studysuggests.
  • “Cognitive testing of nearly 113,000 people in England found that those with persistent post-Covid symptoms scored the equivalent of 6 I.Q. points lower than people who had never been infected with the coronavirus, according to the study, published Wednesday in The New England Journal of Medicine.
  • “People who had been infected and no longer had symptoms also scored slightly lower than people who had never been infected, by the equivalent of 3 I.Q. points, even if they were ill for only a short time.
  • “The differences in cognitive scores were relatively small, and neurological experts cautioned that the results did not imply that being infected with the coronavirus or developing long Covid caused profound deficits in thinking and function. But the experts said the findings are important because they provide numerical evidence for the brain fog, focus and memory problems that afflict many people with long Covid.”
• and
  • “Alcohol-related deaths surged in the United States by nearly 30 percent in recent years, with roughly 500 Americans dying each day in 2021, according to a new study published by the Centers for Disease Control and Prevention.
  • “The study chronicled a sustained spike in drinking during the Covid pandemic that continued to rise after the shock of the lockdowns of 2020. The incidence of alcohol-related deaths was higher in men, but among women the death rate shot up at a quicker pace.
  • “I think the results of this research are really alarming,” said Dr. Michael Siegel, who is a professor of public health at Tufts University School of Medicine and was not involved in the study. “It shows that there’s been a truly substantial increase in alcohol-related deaths over the last six years.”
• and
  • “The 2022 outbreak of mpox, previously known as monkeypox, was curbed in large part by drastic changes in behavior among gay and bisexual men, and not by vaccination, according to a new analysis published on Thursday in the journal Cell.
  • “Public health response to outbreaks often relies heavily on vaccines and treatments, but that underestimates the importance of other measures, said Miguel Paredes, lead author of the new study and an epidemiologist at the Fred Hutchinson Cancer Center in Seattle.
  • “Although the Food and Drug Administration approved a vaccinefor mpox in 2019, getting enough doses produced and into arms proved challenging for many months after the outbreak began. Vaccines for new pathogens are likely to take even longer.
  • “The new analysis suggests an alternative. Alerting high-risk communities allowed individuals to alter their behavior, such as reducing the number of partners, and led to a sharp decrease in transmission, Mr. Paredes said. In North America, the outbreak began petering out in August 2022, when less than 8 percent of high-risk individuals had been vaccinated.
  • “Public health messaging can “be really powerful to control epidemics, even as we’re waiting for things like vaccines to come,” he said.”

• Roll Call adds,
  • “Cases of measles are rising across the country and seem to be striking counties at random, but experts say there is one thing the public health system can do to turn the tide, and that’s to stem the post-pandemic vaccine lag and get parents to vaccinate their kids.
  • “General vaccination rates, including measles vaccination, declined during the COVID-19 pandemic, as people had less access to health care and kids were unable to access in-school vaccine clinics.
  • “That, combined with a new wave of vaccine skepticism and anti-vaccine sentiment has contributed to a wave of unvaccinated kids falling sick with the once-eradicated virus.”

• MedPage Today tells us,
  • “The benefits of vaccination against respiratory syncytial virus (RSV) for adults ages 60 and older probably outweigh the small risk of vaccine-related Guillain-Barré syndrome (GBS), the CDC’s Advisory Committee on Immunization Practices (ACIP) reaffirmed.
  • “In a presentation on the second day of the ACIP’s 2-day meeting, Amadea Britton, MD, of the CDC’s RSV adult vaccination work group in Atlanta, noted that a small number of cases of Guillain-Barre syndrome had been observed in the clinical trials for both FDA-approved RSV prefusion F protein vaccines, but that it remained unclear whether those cases were actually caused by RSV vaccination or just chance occurrences.”
• and
  • The CDC has issued new guidance —  its first since 1988 — on identifying and responding to clusters of suicide, as tens of thousands of lives are lost to suicide each year in the U.S.
  • Though suicide clusters are rare, they “can have unique characteristics and challenges,” and “are often highly publicized and can have considerable negative effects on the community, including prolonged grief and elevated fear and anxiety about further deaths,” Michael Ballesteros, PhD, of CDC’s National Center for Injury Prevention and Control (NCIPC), and colleagues wrote in Morbidity and Mortality Weekly Report (MMWR).

• Beckers Hospital Review informs us,
  • “The CDC is anticipating a shortage of Td vaccines — which protect against tetanus and diphtheria — as the maker of one shot has discontinued production. 
  • “As a result, the CDC has updated guidance for providers and is recommending that they switch to administering Tdap vaccines, which protect against pertussis in addition to tetanus and diphtheria, whenever possible.  
  • “MassBiologics discontinued production of its TdVax shot, and while Sanofi also manufactures a Td vaccine and is working to boost supplies, the CDC anticipates the U.S. could see a shortage of the vaccines later this year. 
  • “Because not everyone can receive the Tdap vaccine, “the limited supply of Td vaccine needs to be preserved for those with a contraindication to receiving pertussis-containing vaccines,” the CDC said in its guidance.” 

• Medscape notes,
  • “Injectable weight loss drugs like Wegovy, Saxenda, and Zepbound have been getting all the glory lately, but they’re not for everyone. If the inconvenience or cost of weight loss drugs isn’t for you, another approach may be boosting your gut microbiome.
  • “So how does one do that, and how does it work?
  • “In theory, all you have to do is boost your gut microbiome.
  • “There are a lot of different factors naturally in weight gain and weight loss, so the gut microbiome is certainly not the only thing,” said Chris Damman, MD, a gastroenterologist at the University of Washington. He studies how food and the microbiome affect your health. “With that caveat, it probably is playing an important role.”

• STAT News adds,
  • “New obesity drugs like Wegovy and Zepbound are currently taken once a week, indefinitely. But what if they could be taken once a year instead, like a vaccine?
  • “That’s a question that Novo Nordisk, the pharma company behind Wegovy, is exploring as it faces increased competition from other drugmakers aiming to develop similar GLP-1-based treatments for obesity.
  • “We have a very early think tank on: what would it take us, from a technology point of view and from an ecosystem point of view, to make long-lasting GLP-1 molecules?” Marcus Schindler, Novo’s chief scientific officer, said in an interview with STAT Wednesday. “Could we think about vaccine-like properties, where imagine you had, once a year, an injection with an equivalent of a GLP-1 that really helps you to maintain weight loss and have cardiovascular benefits?”

From the U.S. healthcare business and cybersecurity issues front,

• Beckers Hospital Review informs us,
  • “Optum’s Change Healthcare confirmed Feb. 29 that it was hacked by a ransomware gang after the group claimed to have stolen massive amounts of data.
  • “Change Healthcare can confirm we are experiencing a cybersecurity issue perpetrated by a cybercrime threat actor who has represented itself to us as ALPHV/Blackcat,” an Optum spokesperson emailed Becker’s on Feb. 29. “We are actively working to understand the impact to members, patients and customers.” * * *
  • “ALPHV/Blackcat, aka BlackCat, claimed responsibility for the hack, posting on its dark web leak site that it stole 6 terabytes worth of Change Healthcare data involving “thousands of healthcare providers, insurance providers, pharmacies, etc,” Bleeping Computer reported Feb. 28. The allegedly stolen data includes medical records, patient Social Security numbers, and information on active military personnel (Change serves some military healthcare facilities).
  • “But as Politico noted Feb. 28: “Ransomware groups, which demand extortion payments in exchange for restoring or not publishing stolen data, often exaggerate their exploits as a negotiating tactic.”
  • “ALPHV/Blackcat, which has been linked to Russia, has been targeting the U.S. healthcare industry since December after the FBI disrupted its operations.”

• STAT News adds,
  • “The outage caused by the Change Healthcare cyberattack could last weeks, a top UnitedHealth executive suggested in a Tuesday conference call with hospital cybersecurity officers, according to a recording obtained by STAT.
  • “UnitedHealth Group Chief Operating Officer Dirk McMahon said the company is setting up a loan program to help providers who can’t submit insurance claims while Change is offline. He said that program will last “for the next couple of weeks as this continues to go on.”
  • “McMahon’s remarks about the loan program highlight the scope of UnitedHealth’s damage control. UnitedHealth maintained it has “not determined the [cyberattack] incident is reasonably likely to materially impact our financial condition or results of operations,” according to its annual report to investors this week. But doctors and pharmacists are scrambling to find ways to get patients what they need, and to get paid. As of 2022, Change facilitated $1.5 trillion in health care transactions.”

• HR Brew lets us know,
  • “The cost of healthcare went up last year, according to a new report from Marsh McLennan Agency (MMA), a US-based subsidiary of global brokerage Marsh. The amount that employers spent on health benefits per employee grew by 5.2%, while the estimated cost of employer contributions to premiums increased by more than $1,400, to $11,762.
  • “Healthcare inflation can affect employees, as well, the report noted, with 38% of Americans reporting they put off medical treatment in the last year due to cost concerns. MMA noted that “delayed care is associated with worse health outcomes and higher costs for patients and benefit providers.”
  • “Younger workers appear to be feeling the pinch of high health costs the most, with 74% of millennial and 56% of Gen Z patients canceling doctors’ visits because of high costs, compared to 13% of Baby Boomer patients. Putting off behavioral healthcare, in particular, can be costly for younger age groups, said Monte Masten, chief medical officer with MMA. Given these trends, employer investment in incentives may be warranted, he told HR Brew.”

• Drug Store News alerts us,
  • “Walgreens’ VillageMD is closing six Chicago clinic locations—five standalone and one co-located with a Walgreens store, per a Telehealth & Telecare Aware report.
  • “The closures in Walgreens’ home state are set to take place April 19. These closures follow on the heels of news last week that VillageMD exited the Florida market.” 

• Per Fierce Healthcare,
  • “Telemedicine clinic Virta Health believes its members can achieve significant and sustained improvement in weight loss, even if a patient has stopped taking a GLP-1 drug, a newly released paper in Diabetes Therapy shows.
  • “According to the company, it is a first-of-its-kind study offering an opposing viewpoint against clinical trials showing GLP-1 deprescription leading to weight regain. The results have potentially major implications for employers and plans looking to help its members improve health outcomes and fight obesity but that are concerned about rising costs amid increasing demand.
  • “This is unheard of,” said Sami Inkinen, Virta Health CEO and co-founder. “To my knowledge, nobody has published or shown this kind of data to date.”

• Beckers Health Payer Issues points out five health insurers that “are making commitments to advance a White House initiative to end hunger and reduce diet-related disease by 2030.” 

• Per BioPharma Dive,
  • “Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous system disorders.
  • “Cure Ventures, a new venture capital firm founded by three longtime biotech investors, co-led the Series A round announced Thursday, alongside Alaska Permanent Fund Corporation and The Column Group. The investment is the first announced by Cure since it debuted last year with a $350 million fund. Euclidean Capital and Saisei Ventures also participated in the round.
  • “Previously known as Ryne Bio, Kenai’s research aim is to create so-called off-the-shelf cell therapies that replace neurons. The company’s most advanced medicine is made from genetically reprogrammed stem cells and designed to treat Parkinson’s disease by restoring dopamine production.
  • “The medicine has “displayed robust survival, innervation, and behavioral rescue in preclinical models of Parkinson’s disease,” according to Kenai, which claims it could work in inherited forms of the disease as well as in cases where the exact cause isn’t understood.
  • “The company said the funding proceeds will be enough to push the medicine, named RNDP-001, into human testing and through early-stage clinical trials, which should start within the year.”