Friday Factoids

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us, “The Office of Personnel Management on Friday proposed new regulations aimed at granting federal agencies greater flexibility in selecting new federal employees during the hiring process.” The public comment deadline is September 19, 2023.
  • Federal News Network offers a table of federal government return-to-office policies.
  • The Society for Human Resource Management informs us,
    • “The U.S. Citizenship and Immigration Services (USCIS) announced Friday a new Form I-9—which has been streamlined and shortened—that employers should use beginning Aug. 1, 2023.
    • “Employers may continue to use the older Form I-9 (Rev. 10/21/19)  through Oct. 31., 2023. After that date, they will be subject to penalties if they use the older form. The new version will not be available for downloading until Aug. 1.  
    • “Additionally, the U.S. Department of Homeland Security (DHS) issued a final rule that allows the agency to create a framework under which employers could implement alternative document examination procedures, such as remote document examination. The new form subsequently has a checkbox to indicate when an employee’s Form I-9 documentation was examined using a DHS-authorized alternative procedure.
    • “At this time, the final rule only allows employers using E-Verify to use alternative verification methods.”
  • Healthcare Dive notes
    • “The Federal Trade Commission and the HHS’ Office for Civil Rights are warning hospitals and telehealth companies about embedding online tracking technologies on their websites or apps, saying the trackers risk exposing consumers’ personal health data to third parties. 
    • “The trackers, like the Meta Pixel or Google Analytics, collect identifiable information about users and could reveal information about health conditions, diagnoses, treatments, frequency of visits and more, the agencies wrote in a letter to about 130 health systems and telehealth providers.
    • “The warning marks the latest move from regulators regarding the healthcare industry’s use of tracking technologies, which monitor user behavior on websites. Sharing consumers’ health data with third parties, like advertisers, has been a recent target of FTC oversight.”

Following up on the tornado that struck a Pfizer factory in Rocky Mount, NC, STAT News reports

  • “Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does not appear to have caused “any major damage” to areas that produce medicines.
  • “The company reported most damage from the storm occurred at a warehouse that stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance personnel. As a result, it remains unclear about the extent to which destruction at the facility — which produces nearly 8% of all sterile injectables used in U.S. hospitals — will exacerbate a growing shortage of prescription drugs across the country.”

The Food and Drug Administration also issued a report on the incident.

From the medical malpractice front, STAT News points out

  • “A new study published this week in BMJ, * * * estimates that “371,000 people die every year following a misdiagnosis, and 424,000 are permanently disabled — a total of 800,000 people suffering “serious harm,” said David Newman-Toker, the lead author of the paper and a professor of neurology at Johns Hopkins School of Medicine and director of its Center for Diagnostic Excellence. Settling on an exact number is hard because many cases of misdiagnosis go undetected, he said. It could be fewer than his study identified or more — between half a million and a million — though in any event, it would be the most common cause of death or disability due to medical malpractice. 
  • “He likens the issue of misdiagnosis to an iceberg, saying cases leading to death and disability are but a small fraction of the problem. “We focused here on the serious harms, but the number of diagnostic errors that happen out there in the U.S. each year is probably somewhere on the order of magnitude of 50 to 100 million,” he said. “If you actually look, you see it’s happening all the time.” 
  • “But misdiagnoses typically don’t lead to severe consequences because, most times, people aren’t visiting the doctor with a serious condition. “The risk level just walking through the door in the doctor’s office that something horrible is going to happen to you because of a diagnostic error is actually quite low,” said Newman-Toker.”

In related news “[The American Hospital Association] AHA today released its quarterly Health Care Plan Accountability Update, featuring the latest news on AHA efforts to hold commercial health insurers accountable for policies that can delay care for patients, burden health care providers and add unnecessary costs to the health care system. READ MORE.”

From the factoid front —

  • HealthEquity suggests three ways to drive health savings account plan adoption.
  • Beckers Payer Issues points out how seven payers are using artificial intelligence.
  • MedTech Dive reports, “Intuitive Surgical posted strong robotic volume growth in the second quarter and raised its full-year procedure outlook but said patient interest in new weight-loss drugs is curbing demand for bariatric surgeries.”

Midweek update

Photo by Manasvita S on Unsplash

From Washington DC —

  • STAT News tells us,
    • “Ahead of a major Food and Drug Administration meeting on a new Alzheimer’s treatment this week, several Democratic lawmakers are ratcheting up their criticism of how the Biden administration is planning to handle a potential approval this summer.
    • “Sen. Bernie Sanders (I-Vt.), who leads the Senate’s health committee, wrote to health secretary Xavier Becerra on Wednesday asking him to ”use the full extent” of his authority to ensure Medicare doesn’t pay the list price of $26,500 for Eisai and Biogen’s Leqembi.”

From the U.S. healthcare business front —

  • Healthcare Dive informs us,
    • “The financial performance of the seven largest publicly traded U.S.-based insurers remains stable so far this year, despite “continued challenges” in the healthcare sector, according to a report out Tuesday from credit ratings agency Fitch Ratings.
    • “Though persistent staffing shortages and high inflation has been pressuring healthcare providers, the largest payers, which Fitch estimates to account for about 70% of the privately ensured U.S. population, reported a 7.7% operating EBITDA margin in the first quarter compared with 7.6% during the same period in 2022.
    • “However, the report noted that cost pressures at the provider level could impact payer and provider contract negotiations and cause premium rates to increase over the next few years, contributing to “heightened public discourse around healthcare costs for consumers.”
  • Per the Lown Institute
    • A recent New York Times investigation found that Allina Health System, a nonprofit health system in the Midwest, has been rejecting patients for appointments if they have unpaid medical bills. If patients amass at least $1,500 in medical debt three separate times, they may not be allowed to come back to a clinic or hospital until they pay up. In many cases, Allina’s electronic health record system precludes doctors from making new appointments with patients that have unpaid debt.
    • The policy, which was started in 2006, applies to patients struggling with chronic conditions like diabetes and depression, and is even applied to children. The Times heard from doctors and patients who described being unable to complete medical forms that children needed to enroll in day care or show proof of vaccination for school. Allina’s dominance in the region also means that patients who are rejected for care–especially patients in rural areas–may have trouble finding other providers. 
    • How is a nonprofit system allowed to deny needed care for patients with debt? While nonprofit hospitals are required by federal law to accept any patient for emergency care regardless of ability to pay, the same requirement doesn’t apply to non-emergency care. 
    • Because there aren’t regulations against this practice, Allina is not alone in rejecting patients with debt. According to a 2022 KFF Health News investigation of 528 hospitals sampled nationwide, 55 indicated in their written policy that they do allow deniels of non-emergency care for patients with medical debt, 22 said this is allowed but not current practice, and 85 others had no information in their policy on whether or not they do this. (Allina Health Faribault Medical Center was included in this last group, but no other Allina hospitals were included in the study). Among the hospitals that allow for care denials are within some of the largest nonprofit systems in the country, including Ascension, Indiana University Health, Cedars-Sinai Medical Center, Mayo Clinic, Trinity Health, and more.

From the healthcare research front, BioPharma Dive offers its wrap-up report on the ASCO conference held in Chicago this week.

From the SDOH front —

  • Healthcare Dive points out,
  • “Patients of color, or those on public insurance, are still at increased risk for certain adverse events compared to White patients, regardless of high hospital safety ratings, according to a report out Wednesday from the Leapfrog Group.
  • “Although higher hospital safety ratings generally correspond with fewer adverse safety events, the report found that pattern doesn’t hold true for patients of color or those on Medicare or Medicaid, who were more likely to experience adverse events after surgery, including sepsis, blood clots and respiratory failure.
  • “Rather than suggesting problems with individual hospitals, the data points to a “systemic issue impacting the quality of care for Black and Hispanic patients and those with public insurance plans,” according to the report.”

From the mental healthcare front, Health Payer Intelligence discusses six strategies that payers can use to promote behavioral health prevention, along with a strong provider network.

From the litigation front —

  • Fierce Healthcare reports
    • “A federal appeals court held a brief hearing Tuesday afternoon to hear from attorneys on both sides as it decides whether to lift a nationwide freeze on a lower court’s ruling that struck down preventive care protections in the Affordable Care Act (ACA).
    • “A panel of judges at the Fifth Circuit Court of Appeals, based in New Orleans, issued a stay on the District Court ruling while the appeals process plays out, though it could choose to lift the stay following Tuesday’s hearing. Legal experts expect a decision on the pause in short order.”
  • The FEHBlog is willing to bet the ranch that the panel will uphold the existing stay.

From the generative AI front —

  • Healthcare Dive relates
    • “Google is linking up with longtime collaborator Mayo Clinic to explore generative artificial intelligence’s applications in the hospital, the tech giant announced Wednesday morning.
    • “Mayo will use a Google Cloud tool that lets organizations create chatbots and search applications using generative AI to answer complex questions and produce summaries faster than traditional search functionalities.
    • “Mayo could improve the efficiency of clinical workflows and make it easier for clinicians and researchers to find information, Google said.”

In federal employee benefits news, Federal News Network tells us

  • “The Office of Personnel Management’s backlog of retirement claims dropped by 2,259 in May. OPM received 6,096 claims, just over 2,200 fewer than in April, which saw 8,298. OPM processed 8,355 claims, bringing down the inventory backlog to 18,125, the lowest it has been since June 2020, when it reached 17,432.
  • “OPM still has improvements to make, as the inventory backlog is more than 5,000 claims above the steady state goal of 13,000.”

Midweek update

From Washington, DC —

  • The Wall Street Journal reports,
    • “The House passed a sweeping bill that suspends the federal government’s $31.4 trillion debt ceiling in exchange for spending cuts, as Republican Speaker Kevin McCarthy muscled through a deal struck with President Biden to avert a looming government default.
    • “The 314-117 vote relied on support from both Republicans and Democrats. Passage of the deal sends the measure to the Senate, where leaders have promised quick action, and Biden has said he is eager to sign the measure into law. Treasury Secretary Janet Yellen has said the government could run out of the cash it needs on June 5 to pay its bills on time and warned of severe economic damage and market disruptions unless Congress acts.
    • “The House vote marks the culmination of a hard-fought debate in the chamber, where Republicans were intent on using the debt ceiling as leverage to deeply cut deficit spending and roll back many of Biden’s signature initiatives—but ended up settling for more modest changes.
    • “The outcome showed, for now, that McCarthy has the power to deliver high-stakes deals with Democrats while still keeping his job, and bolstered Biden’s reputation as a deal maker who was willing to find a middle ground with Republicans.”
  • Healthcare Dive provides details on the healthcare provisions in the bill (HR 3746).
  • STAT News tells us
    • “As Congress considers wide-ranging reforms to pharmacy benefit managers, a top executive at CVS Health, which owns one of the largest PBMs in the country, said the company would find ways to maintain its level of profit if those reforms to things like drug rebates went into effect.
    • “There’s other ways in the economic model that we can adjust to if one of those things changes,” Shawn Guertin, CVS’ chief financial officer, said at an industry conference Wednesday. “The other important part of this, if some of these things change, it could lead to higher costs for employers and health plans.”
  • If the FEHBP’s experience with transparent prescription drug pricing is any guide, the reforms under consideration will not lower costs for employers and health plans. For example, OPM mandated full transparency of manufacturer rebates and 100% distribution of those rebates to the health plans, causing higher administrative expenses for FEHB plans. Presumably, the larger rebates and higher administrative expenses wash. OPM also mandates triennial RFP processes for PBM contracts which do produce savings.

Speaking of FEHBP, Govexec brings us up to date on Postal Service Health Benefits Program implementation. The article illustrates the support that carriers and the Postal Services, among other agencies, are providing OPM with this project. All of the major Postal unions are FEHB carriers.

Today is the deadline for FEHB carriers to submit their 2024 benefit and rate proposals to OPM. Fierce Healthcare discusses a Mercer survey of employer expectations for 2024 premiums.

From the public health front —

  • Kaiser Family Foundation News points out that medical debt is materially higher in the Diabetes Belt found in the southeastern U.S. “The CDC says the Diabetes Belt consists of 644 mostly Southern counties where rates of the disease are high. NPR found that more than half of the counties have high levels of medical debt in collections — meaning at least 1 in 5 people are affected.”
  • Healio relates
    • Compared with reoffering colonoscopy and fecal immunochemical test alone, offering a blood test as a secondary option resulted in a nearly twofold increase in colorectal cancer screening in veterans who had declined first-line screening. 
    • “We know screening prevents colorectal cancer, but participation in screening is suboptimal,” Peter S. Liang, MD, MPH, assistant professor of medicine and population health at NYU Langone Health, told Healio. “Compared to widely used screening modalities such as colonoscopy and stool-based testing, a blood test has certain advantages: It is noninvasive, can be done at point of care and does not require self-collection.”
  • Leapfrog Group calls attention to its newly released 2023 maternity care report.
  • STAT News explains why new cancer patients need navigation support
    • [P]eople * * * in this suspected peri-diagnostic period (the time between a positive finding on a screening test and leading up to a formal diagnosis and treatment) are not looking for specific answers so much as they are seeking general support.
    • Patients want a trusted person to help provide a general overview of the journey ahead. They want someone to help them through the structural and logistical challenges of our cumbersome and sometimes unresponsive health systems. They would like triage on whether their case is common enough that they can access high-quality, convenient, and accessible community care, or whether their diagnosis warrants the specialized care available at large academic medical centers. They want guidance on what sorts of questions to ask their care team. They want to know if they should pursue second opinions, and if so, how to go about getting insurance approval or the mechanics of how to actually secure an appointment.
  • Medscape reports
    • “About 10% of people infected with Omicron reported having long COVID, a lower percentage than estimated for people infected with earlier strains of the coronavirus, says a study published in The Journal of the American Medical Association.”

From the Rx coverage front —

  • The Hill reports
    • “The Food and Drug Administration (FDA) on Wednesday approved Pfizer’s vaccine to prevent the respiratory disease RSV in older adults, the company announced.
    • The approval of Pfizer’s Abrysvo marks the second authorized RSV shot for older adults in the U.S. this month, after GlaxoSmithKline won approval for its rival shot, Arexvy. “
  • Medscape informs us
    • Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter (SGLT) 1 as well as SGLT2, received marketing approval from the US Food and Drug Administration (FDA) on May 26 for reducing the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and also for preventing these same events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.
    • This puts sotagliflozin in direct competition with two SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), that already have indications for preventing heart failure hospitalizations in patients with heart failure as well as approvals for type 2 diabetes and preservation of renal function.
    • Officials at Lexicon Pharmaceuticals, the company that developed and will market sotagliflozin under the trade name Inpefa, said in a press release that they expect US sales of the agent to begin before the end of June 2023. The release also highlighted that the approval broadly covered use in patients with heart failure across the full range of both reduced and preserved left ventricular ejection fractions.
    • Lexicon officials also said that the company will focus on marketing sotagliflozin for preventing near-term rehospitalizations of patients discharged after an episode of acute heart failure decompensation.

From the U.S. healthcare business front —

  • Beckers Hospital Review reports
    • “The median year-to-date operating margin index for hospitals slightly improved in April to 0 percent, according to Kaufman Hall. 
    • “The neutral margin marks a slight improvement from the -0.3 percent recorded in March, according to Kaufman Hall’s latest “National Flash Hospital Report” — based on data from more than 900 hospitals.
    • “Hospitals saw increased bad debt and charity care and decreased inpatient and outpatient volumes in April, which Kaufman Hall experts correlate to the winding down of the COVID-19 Public Health Emergency, which ended May 11.” 
  • Healthcare Dive tells us
    • “Nonprofit hospital and health plan operator Kaiser Permanente announced Tuesday that it was committing $10 million to safety-net hospital and regional operator Denver Health, as the facility struggles with “unprecedented financial challenges” including increased expenses and a rise in uninsured patients.
    • “Denver Health provides care for around 30% of the city’s population — including the largest percentage of uninsured patients. The system has struggled with a rise in costs and a surge in sicker patients, with expenses totaling $1.3 billion for Denver Health in fiscal year 2022.
    • “The announcement comes as both nonprofit and for-profit hospitals across the country struggle with negative margins and pent-up financial challenges stemming from the COVID-19 pandemic, including persistent heightened contract labor costs, inflationary pressures and unfavorable payer mixes.”

From the miscellany department —

  • Bloomberg updates us on the promising hunt for a breast cancer vaccine.
  • MedCity News relates
    • About 65% of Americans believe that employer-sponsored insurance provides them with “financial peace of mind,” a new survey shows.
    • The AHIP report, published Wednesday, was conducted by Locust Street Group from April 17 to April 25 as part of AHIP’s Coverage@Work campaign, which aims to gather insights on Americans’ thoughts on employer-sponsored coverage. It included responses from 1,000 U.S. consumers with employer-sponsored coverage.
  • Beckers Payer Issues ranks the States by Medicare Advantage enrollment.
  • The Society for Human Resource Management reports
    • “In a memo released May 30, National Labor Relations Board (NLRB) General Counsel Jennifer Abruzzo announced that noncompete agreements violate the National Labor Relations Act (NLRA). The announcement, which applies to nonunionized and unionized employers, may result in unfair labor practice charges for any employer that uses noncompetes, said Thomas Payne, an attorney with Barnes & Thornburg in Indianapolis.
    • “However, a manager’s or supervisor’s noncompete would seemingly be unaffected by the memo because the NLRA applies only to nonmanagerial, nonsupervisory staff, said James Redeker, an attorney with Duane Morris in Philadelphia.  Managers and supervisors are the most likely to have noncompetes, he noted.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

Roll Call tells us,

“President Joe Biden and Speaker Kevin McCarthy on Tuesday tapped proxies to negotiate directly over how to increase the debt limit with time running short before the government runs too low on funds.”


“Lawmakers are beginning to think about changing their plans and staying in Washington in the coming weeks as a standoff over increasing the debt limit bears down. Members of both parties’ leadership said on Tuesday that plans for the Senate to recess next week and the House to leave town the following week could shift.”

BenefitsLink pointed out that the Internal Revenue Service released a revenue procedure identifying inflation-adjusted high deductible health plan and health savings account amounts for use in 2024 just in time for FEHB high deductible health plan benefit proposals due May 31.

STAT News reports

“In an unexpected move, the Federal Trade Commission on Tuesday filed a lawsuit to block Amgen from acquiring Horizon Therapeutics, claiming the $27.8 billion deal would make it possible for Amgen to develop monopolies through a tactic that manipulates health coverage and drives up consumer costs.

“At issue is a practice known as bundling. Simply put, a drug company combines two or more medicines in a package deal for health plans and pharmacy benefit managers, which determine lists of medicines that are covered by insurance. The practice has previously sparked concerns that a drug company will unfairly offer higher rebates for bundles in order to win favorable placement.”

From the medical and drug research fronts —

  • The National Institute of Health informs us,
    • “A study from the National Institutes of Health shows that new cases of chronic pain occur more often among U.S. adults than new cases of several other common conditions, including diabetes, depression, and high blood pressure. Among people who have chronic pain, almost two-thirds still suffer from it a year later. These findings come from a new analysis of National Health Interview Survey (NHIS) data by investigators from the National Center for Complementary and Integrative Health (NCCIH) at the NIH, Seattle Children’s Research Institute, and University of Washington, Seattle, and are published in JAMA Network Open.”
  • The New York Times reports
    • “The man should have gotten Alzheimer’s disease in his early 40s — he had a gene mutation that guaranteed it, or so it seemed. Scans of his brain even revealed severe atrophying and the hallmarks of the disease: rough, hard, amyloid plaques and spaghetti-like tangles of tau proteins. But the fatal brain disease did not appear until the man was 67.
    • “Now an intense research effort has discovered why. The man was protected because another mutation in a different gene blocked the disease from entering his entorhinal cortex. That tiny area of the brain is a hub for neurons involved in memory, recognition of objects, navigation and time perception. And it is there that scientists believe that Alzheimer’s disease begins.
    • “A paper on the finding was published Monday in the journal Nature Medicine.
    • More than six million people in the United States have Alzheimer’s, a disease that has been notoriously difficult to treat. Yet here was a man with a mutation that causes the most severe and rapidly progressing form of Alzheimer’s. And his disease was delayed for two decades. If a drug could do what the mutation did, resulting in most people getting Alzheimer’s very late in life, the outcome could be transformative.”

From the SDOH front,

  • the National Institutes of Health shared
    • “New research shows that the economic burden of health disparities in the United States remains unacceptably high. The study, funded by the National Institute on Minority Health and Health Disparities (NIMHD), part of the National Institutes of Health,  revealed that in 2018, racial and ethnic health disparities cost the U.S. economy $451 billion, a 41% increase from the previous estimate of $320 billion in 2014. The study also finds that the total burden of education-related health disparities for persons with less than a college degree in 2018 reached $978 billion, about two times greater than the annual growth rate of the U.S. economy in 2018.”

From the AI department,

  • Beckers Payer Issues informs us
    • Payers are putting artificial intelligence to work. 
    • Google recently launched a new AI-powered cloud program for prior authorization and claims processing. Elevance Health is piloting AI-powered concierge care for members. 
    • Becker’s asked 18 payer executives how AI will transform the insurance industry. [The interview squibs are available in the article.]

From the patient front, here is a link to HHS’s Agency for Healthcare Quality and Research March 2023 Chartbook on Patient Safety.

Midweek Update

From Washington, DC, the Wall Street Journal reports

  • “The Biden administration and Capitol Hill leaders are scrambling to avoid a first-ever government default that could arrive as soon as June 1, taking potential alternative strategies more seriously after months of deadlock over raising the country’s borrowing limit.  
  • “Publicly, both Republicans and Democrats are still sticking to their demands as the clock ticks. GOP lawmakers are seeking to force cuts to federal spending in exchange for supporting raising the debt limit, while Democrats continue to call for a debt-limit increase without any other policy conditions.
  • “Privately, though, Biden administration officials and lawmakers have started to weigh potential alternatives to their negotiating position, including a short-term increase in the borrowing limit that would buy them time to find a compromise, according to people familiar with the matter. Biden administration officials are also taking a fresh look at experimental ways the U.S. could potentially keep paying the government’s bills even if Congress doesn’t raise the debt limit, the people said.” 

From the Rx coverage front —

MedPage Today informs us,

  • “The FDA has approved the first-ever vaccine for respiratory syncytial virus (RSV), the agency announced on Wednesday.
  • “Marketed under the trade name of Arexvy, the adjuvanted RSV prefusion F protein-based vaccine is specifically indicated for preventing lower respiratory tract infections in adults 60 and over.
  • “Until now, no vaccine has existed to protect against RSV infection, a common scourge both for young children and older adults.  * * *
  • GSK said the vaccine would be available ahead of the 2023/2024 RSV season, and that the CDC’s Advisory Committee on Immunization Practices will weigh in on the RSV vaccine’s appropriate use in June.”

Beckers Pay Issues points out,

  • “Payers are anticipating the cost of expensive new gene therapy drugs to be a significant issue in the coming years, according to a survey from the Pharmaceutical Strategy Group. 
  • “The survey, published May 1, asked 182 benefits leaders at employers and health plans about their organization’s specialty drug benefit design. 
  • “Read the full report here. 

From the drug research front, the Wall Street Journal reports

  • “An experimental Eli Lilly drug slowed cognitive and functional decline for people with early-stage Alzheimer’s disease in a new study that signals drugmakers are turning a corner in long-running efforts to find meaningful treatments for the memory-robbing disease.
  • “Based on the new data, Lilly said Wednesday it plans to apply this quarter to the U.S. Food and Drug Administration for approval to market the drug, setting up a potential agency decision later in 2023 or in 2024. * * *
  • “Researchers designed Lilly’s drug donanemab and Leqembi, from Eisai and Biogen, to work by targeting and reducing amyloid, a substance that forms plaque in the brain and is a prime suspect in fueling the worsening of Alzheimer’s. * * *
  • “In the study of more than 1,730 patients, the [intravenously administered] drug slowed patients’ decline by 35% compared with people who received a placebo over 18 months of treatment, Lilly said. Researchers gave the drug to elderly people who testing indicated were in the early stages of Alzheimer’s. * * *
  • “The findings could bolster donanemab’s appeal to some doctors and patients when compared with Eisai and Biogen’s Leqembi, according to analysts.
  • “Leqembi slowed Alzheimer’s patients’ decline by 27% versus a placebo over 18 months in a separate study, though there were differences in the studies that make direct comparisons difficult.
  • “Yet Leqembi’s safety profile might give it an advantage over donanemab with other doctors and patients, analysts said.”

From the U.S. healthcare business front, Healthcare Dive informs us that “CVS [Health] lowers 2023 earnings outlook on Oak Street, Signify deal costs.”

  • “Despite lowering 2023 earnings guidance by 20 cents to a range of $8.50 to $8.70 per share, “we remain committed to achieving the $9 and $10 targets for 2024 and 2025,” CFO Shawn Guertin said on a Wednesday earnings call.”

From the patient safety front, the Leapfrog Group released

  • “the spring 2023 Leapfrog Hospital Safety Grade. An analysis found the average risk of three healthcare-associated infections (HAIs)— including Methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI)—spiked to a 5-year high in hospitals during the COVID-19 pandemic.” 
  • “Additional highlights from the spring 2023 Safety Grades include:
  • “Twenty-nine percent of hospitals received an “A,” 26% received a “B,” 39% received a “C,” 6% received a “D,” and less than 1% received an “F.”
  • “The top ten states with the highest percentages of “A” hospitals are: New Jersey, Idaho, Utah, Pennsylvania, Connecticut, North Carolina, South Carolina, Colorado, Virginia and Massachusetts.
  • “There were no “A” hospitals in Delaware, the District of Columbia or North Dakota.

Weekend Update / Cybersecurity Saturday

Blue Bonnets — The Texas State Flower

The FEHBlog’s Friday Insights did not publish as scheduled on Saturday morning. To get the email distribution back on schedule the FEHBlog is combining the Weekend Update and the Cybersecurity Saturday posts below.

Weekend Update

The House of Representatives and the Senate will be in session for Committee business and floor voting on Wednesday, Thursday and Friday this week.

Recently, the Centers for Medicare and Medicaid Services confirmed that the No Surprises Act air ambulance reporting will not occur in 2023.

Under section 106 of the No Surprises Act, air ambulance providers, insurance companies, and employer-based health plans must submit to federal regulators information about air ambulance services provided to consumers. The Centers for Medicare & Medicaid Services (CMS) in the Department of Health & Human Services (HHS) is conducting this Air Ambulance data collection (AADC), which will be used to develop a public report on air ambulance services.
The proposed rules describing the proposed form and manner of the data collection can be found at this link. The final rules will specify the final reporting requirements, including the data elements and the deadlines for the data collection. The data collection will not begin until after the final rules are published. This page will be updated when the rules are finalized and more information on data collection is available.

From the value added care front, Behavioral Health Business discusses how Aetna and Optum are collaborating with a large mental health provider, Universal Health Services, to develop reliable outcome measurements for mental health services.

From the healthcare developments front —

NPR tells us

When the FDA approved bempedoic acid, marketed under the brand name Nexletol, back in 2020, it was clear that the drug helped lower LDL — “bad” cholesterol. The drug was intended for people who can’t tolerate statin medications due to muscle pain, which is a side effect reported by up to 29% of people who take statins.

What was unknown until now, is whether bempedoic acid also reduced the risk of cardiovascular events. Now, the results of a randomized, controlled trial published in The New England Journal of Medicine point to significant benefit. The study included about 14,000 people, all of whom were statin intolerant.

“The big effect was on heart attacks,” says study author Dr. Steven Nissen of Cleveland Clinic. 

People who took daily doses of bempedoic acid for more than three years had about a 23% lower risk of having a heart attack, in that period, compared to those taking a placebo. There was also a 19% reduction in coronary revascularizations, which are procedures that restore blood flow to the heart, such as a bypass operation or stenting to open arteries.

Medscape highlights a “revolutionary” treatment for suicidal depression, the Stanford neuromodulation therapy (SNT) protocol.

From the medical research front, Medscape reports

A common chemical that is used in correction fluid, paint removers, gun cleaners, aerosol cleaning products, and dry cleaning may be the key culprit behind the dramatic increase in Parkinson’s disease (PD), researchers say.

An international team of researchers reviewed previous research and cited data that suggest the chemical trichloroethylene (TCE) is associated with as much as a 500% increased risk for Parkinson’s disease (PD).

Lead investigator Ray Dorsey, MD, professor of neurology, University of Rochester, New York, called PD “the world’s fastest-growing brain disease,” and told Medscape Medical News that it “may be largely preventable.”

“Countless people have died over generations from cancer and other disease linked to TCE [and] Parkinson’s may be the latest,” he said. “Banning these chemicals, containing contaminated sites, and protecting homes, schools, and buildings at risk may all create a world where Parkinson’s is increasingly rare, not common.”

The paper was published online March 14 in the Journal of Parkinson’s Disease.

The FEHBlog has several friends with Parkinson’s Disease.

From the Medicare front, Health Payer Intelligence relates

Beneficiaries with end-stage renal disease (ESRD) are increasingly shifting from Medicare fee-for-service (FFS) to Medicare Advantage, leading more Medicare Advantage plans to form value-based arrangements with kidney care management companies, according to Avalere.

Beneficiaries with ESRD have typically received coverage through Medicare FFS because only those already enrolled in a Medicare Advantage plan before initiating dialysis were eligible for the private program through 2020.

A provision under the 21st Century Cures Act that went into effect on January 1, 2021, made all Medicare beneficiaries with ESRD eligible to enroll in Medicare Advantage plans.

Although patient safety awareness week is over, the Wall Street Journal makes us aware that

Black boxes on airplanes record detailed information about flights. Now, a technology that goes by the same name and captures just about everything that goes on in an operating room during a surgery is making its way into hospitals.

The OR Black Box, a system of sensors and software, is being used in operating rooms in 24 hospitals in the U.S., Canada and Western Europe. Video, audio, patient vital signs and data from surgical devices are among the information being captured.

The technology is being used primarily to analyze operating-room practices in hopes of reducing medical errors, improving patient safety and making operating rooms more efficient. It can also help hospitals figure out what happened if an operation goes wrong. * * *

Duke University Hospital, where two operating rooms are equipped with black boxes, is using the technology to study and improve on patient positioning for surgery to reduce the possibility of skin-tissue and nerve injuries. It is also studying and using the technology to improve communication among nursing personnel throughout a surgical procedure to ensure that key tasks—such as confirming that surgical instruments and medical devices are available for a procedure—are being completed promptly, effectively and efficiently.

Cybersecurity Saturday

From the cybersecurity policy front, the American Hospital Association informs us that

The Senate Homeland Security and Governmental Affairs Committee held a full Committee hearing examining cybersecurity risks to the healthcare sector on March 16. Witnesses included Scott Dresen, chief information security officer for Corewell Health, a large integrated health system in Michigan. 
“The increasing frequency of attack from nation state actors and organized crime has created a sense of urgency within the healthcare sector and we need help from the United States government to respond to these threats more effectively,” Dresen said.
Specifically, he called for enhancing existing partnerships with and between federal agencies, expanding the sharing of actionable threat intelligence, incentivizing access to affordable technology to defend against advanced threats, ensuring there is an adequate cyber workforce, and reforming legislation to encourage the adoption of best practices while not penalizing the victims of cyberattacks.

STAT News reveals why an HHS rule amending the HIPAA Privacy Rule will wreak financial havoc on health systems. The proposed rule was issued in January 2021, so the final rule has been pending for a long time.

Federal News Network reports

The Cybersecurity and Infrastructure Security Agency (CISA) is looking to position a new “Cyber Analytics and Data System” at the center of national cyber defenses, as the agency’s post-EINSTEIN plans come into focus in its fiscal 2024 budget request.

CISA is seeking $424.9 million in the 2024 budget for “CADS.” The program is envisioned as a “system of systems,” budget documents explain, that provides “a robust and scalable analytic environment capable of integrating mission visibility data sets and providing visualization tools and advanced analytic capabilities to CISA cyber operators.”

The new program is part of the “restructuring” of the National Cybersecurity Protection System, according to the documents. More commonly known as “EINSTEIN,” the NCPS has been in place to defend federal agency networks since the Department of Homeland Security’s inception in 2003.

From the cyber breaches front, Tech Target brings us up to date on the DC Health Link breach.

An additional wrinkle to the breach came Monday [March 13] when another user on the same dark web forum using the alias Denfur, who had previously published sample data from the breach, created a thread supposedly aiming to clear up misinformation surrounding the breach.

Claiming to be a friend of IntelBroker, Denfur said the attack vector for the breach was an exposed, insecure database belonging to DC Health Link. Moreover, the poster said the database was likely exposed “for over a year and a half” before the breach occurred. TechTarget Editorial contacted DC Health Link in order to verify Denfur’s claims, but a spokesperson declined to comment.

Nextgov reports

At least two hacking groups were able to gain access to at least one federal agency’s servers through an old vulnerability in a software development and design product, according to a cybersecurity advisory issued Wednesday.

According to an alert issued by the Cybersecurity and Infrastructure Security Agency, or CISA, hackers were able to gain access to and run unauthorized code on a federal agency’s server, though they were not able to gain privileged access or move deeper into the network. The malicious activity was observed between November 2022 and early January, though the initial compromise goes as far back as August 2021.

Hackers used a vulnerability in old versions of Telerik UI, a software developer kit for designing apps, which, when exploited, allows hackers with access to execute code. The vulnerability was discovered in 2019 and builds on previous vulnerabilities discovered in 2017 that allow bad actors to gain privileged access and “successfully execute remote code on the vulnerable web server.”

The National Vulnerability Database—managed by the National Institute of Standards and Technology—rates this a critical vulnerability, with a score of 9.8 out of 10.

From the cyber vulnerabilities front, HHS’s Healthcare Cybersecurity Coordination Center (HC3) released its February 2023 list of vulnerabilities of interest to the health sector.

In February 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for this month are from Microsoft, Google/Android, Apple, Mozilla, SAP, Citrix, Intel, Cisco, VMWare, Fortinet, and Adobe. A vulnerability is given the classification as a zero-day if it is actively exploited with no fix available or is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.

Cybersecurity Dive informs us.

  • Researchers are warning that state-linked and financially motivated threat actors may try to exploit a critical zero-day vulnerability in Microsoft Outlook to launch new attacks against unpatched systems. 
  • Microsoft urged customers to patch their systems against CVE-2023-23397 to address the critical escalation of privilege vulnerability in Microsoft Outlook for Windows, the company said Tuesday. Microsoft Threat Intelligence warned that a Russia-based threat actor launched attacks against targeted victims in several European countries.
  • Mandiant researchers warned that other criminal and cyber-espionage actors will race to find new victims vulnerable to the zero day before organizations can apply patches. 

CISA added three and then one more known exploited vulnerability to its catalog this week.

Security Week highlights that “Deepfakes are becoming increasingly popular with cybercriminals, and as these technologies become even easier to use, organizations must become even more vigilant.”

Deepfakes are part of the ongoing trend of weaponized AI. They’re extremely effective in the context of social engineering because they use AI to mimic human communications so well. With tools like these, malicious actors can easily hoodwink people into giving them credentials or other sensitive information, or even transfer money for instant financial gain. Deepfakes represent the next generation of fraud, by enabling bad actors to impersonate people more accurately and thus trick employees, friends, customers, etc., into doing things like turning over sensitive credentials or wiring money.

Here’s one real-world example: Bad actors used deepfake voice technology to defraud a company by using AI to mimic the voice of a CEO to persuade an employee to transfer nearly $250,000 to a Hungarian supplier. Earlier this year, the FBI also warned of an uptick in the use of deepfakes and stolen PII to apply for remote work jobs – especially for positions with access to a lot of sensitive customer data.

The Security Week article also discusses defenses to deepfake tactics.

From the ransomware date infiltration front –

  • The Federal Bureau of Investigation (FBI), CISA, and the Multi-State Information Sharing and Analysis Center (MS-ISAC) has released a joint cybersecurity advisory (CSA), #StopRansomware: LockBit 3.0. This joint advisory details known indicators of compromise (IOCs) and tactics, techniques, and procedures (TTPs) that FBI investigations correlated with LockBit 3.0 ransomware as recently as March 2023. LockBit 3.0 functions as an affiliate-based ransomware variant and is a continuation of LockBit 2.0 and LockBit. CISA encourages network defenders to review and apply the recommendations in the Mitigations section of this CSA.
  • HC3 posted a threat profile on Black Basta.
    • “Black Basta was initially spotted in early 2022, known for its double extortion attack, the Russian-speaking group not only executes ransomware but also exfiltrates sensitive data, operating a cybercrime marketplace to publicly release it, should a victim fail to pay a ransom. The threat group’s prolific targeting of at least 20 victims in its first two weeks of operation indicates that it is experienced in ransomware and has a steady source of initial access. The level of sophistication by its proficient ransomware operators, and reluctance to recruit or advertise on Dark Web forums, supports why many suspect the nascent Black Basta may even be a rebrand of the Russian-speaking RaaS threat group Conti, or also linked to other Russian-speaking cyber threat groups. Previous HC3 Analyst Notes on Conti and BlackMatter even reinforce the similar tactics, techniques, and procedures (TTPs) shared with Black Basta. Nevertheless, as ransomware attacks continue to increase, this Threat Profile highlights the emerging group and its seasoned cybercriminals and provides best practices to lower risks of being victimized.”

Here is a link to the always interesting Bleeping Computer Week in Ransomware.

From the cyber defenses front —

CISA announced

the creation of the Ransomware Vulnerability Warning Pilot (RVWP). Through the RVWP, CISA:     

  1. Proactively identifies information systems—belonging to critical infrastructure entities—that contain vulnerabilities commonly associated with ransomware intrusions.
  2. Notifies the owners of the affected information systems, which enables the owners to mitigate the vulnerabilities before damaging intrusions occur. 

Review the RVWP webpage for details, including information on the authorities and services CISA leverages to enable RVWP notifications.

HelpNetSecurity tells us how to use ChatGPT to improve cyber defenses.

Thursday Miscellany

Photo by Josh Mills on Unsplash

The Wall Street Journal reported this morning that maternal mortality cases in the U.S. spiked in 2021, rising from around 850 to 1200 nationwide. From examining Journal reader comments, the FEHBlog ran across a helpful breakdown of maternal deaths per U.S. state.  The lowest maternal death rate is in California, and the highest maternal death rate is in Louisiana.  The breakdown points out what the States with the lowest rates are doing right and what the States with the highest rates are doing to remedy the problem. Healthcare is local.

The FEHBlog also was directed to this article from the T.H. Chan public health school at Harvard:

October 21, 2022 – Women in the U.S. who are pregnant or who have recently given birth are more likely to be murdered than to die from obstetric causes—and these homicides are linked to a deadly mix of intimate partner violence and firearms, according to researchers from Harvard T.H. Chan School of Public Health.

Homicide deaths among pregnant women are more prevalent than deaths from hypertensive disorders, hemorrhage, or sepsis, wrote Rebecca Lawn, postdoctoral research fellow, and Karestan Koenen, professor of psychiatric epidemiology, in an October 19 editorial in the journal BMJ.

The U.S. has a higher prevalence of intimate partner violence than comparable countries, such violence is often fatal, and it frequently involves guns, Lawn and Koenen noted. They cited one study that found that, from 2009–2019, 68% of pregnancy-related homicides involved firearms. That study also found that Black women face substantially higher risk of being killed than white or Hispanic women.

I also located the CDC’s website on keeping new mothers alive.

This evening the Journal discussed why our country’s maternal mortality rate is so high.

Finally, STAT News reports that this afternoon the Centers for Disease Control announced preliminary 2022 maternal mortality figures.

Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests.

More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.

Officials say the 2022 maternal death rate is on track to get close to pre-pandemic levels. But that’s not great: The rate before Covid-19 was the highest it had been in decades.

The CDC counts women who die while pregnant, during childbirth, and up to 42 days after birth. Excessive bleeding, blood vessel blockages, and infections are leading causes.

Covid-19 can be particularly dangerous to pregnant women, and experts believe it was the main reason for the 2021 spike. Burned out physicians may have added to the risk by ignoring pregnant women’s worries, some advocates said.

In 2021, there were about 33 maternal deaths for every 100,000 live births. The last time the government recorded a rate that high was 1964.

What happened “isn’t that hard to explain,” said Eugene Declercq, a long-time maternal mortality researcher at Boston University. “The surge was Covid-related.”

The FEHBlog’s goal is to provide perspective on this vital issue.

From the Omicron and siblings front, MedPage Today informs us

An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19.

By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to reduce the risk of hospitalization or death in outpatients at risk for severe outcomes.

“Besides oxygen, Paxlovid has probably been the single most important treatment tool in this epidemic, and it continues to be,” said Richard Murphy, MD, MPH, of the White River Junction VA Medical Center in Hartford, Vermont.

The Mercer consulting firm considers employer approaches to coverage of Covid tests following the end of the public health emergency.

Employers have some important decisions to make over the next two months before the COVID Public Health Emergency (PHE) comes to an end on May 11. One is how to handle cost-sharing for PCR and other COVID tests and related services provided by a licensed healthcare or otherwise authorized provider. Under the PHE, group health plans had to cover testing received either in- or out-of-network at no cost to participants. 

We recently polled recipients of our New Shape of Work newsletter to ask whether they planned to impose cost-sharing requirements once allowed. Of the more than 1,000 readers who responded, about half indicated that their organization will  not make any change when the PHE ends:  22% will continue to cover PCR testing at 100% both in- and out-of-network, and 29% say that they require COVID testing at their worksites and provide it at no cost.  Only about a fourth (26%) will now require cost-sharing from participants even when they use an in-network facility for testing; about another fourth (23%) will add a cost-sharing requirement only for out-of-network services.   

Personally, the FEHBlog would opt for restoring a cost-sharing requirement only for out-of-network services.

From the Rx coverage front

  • STAT News tells us, “Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024.”
  • The Mercer consulting firm offers its perspective on coverage of the new era of weight loss drugs, e.g., Ozempic.

For plans covering weight-loss medications, adding prior authorization criteria can help manage cost growth. These include requirements such as a certain body mass index (BMI), co-morbid conditions, enrollment in a behavior modification program, and/or reduced calorie diet. Upon initiation of therapy, patients and clinicians should partner to create a comprehensive plan to achieve goals and use the medication purposefully alongside a targeted and managed lifestyle program. The plan should include a discussion regarding medication discontinuation when/if goals are met to prevent relapse and weight regain/ weight cycling. Medical nutrition therapy (MNT) with a registered dietitian should be covered; ideally 14 in-person or telenutrition sessions.

Cognitive-behavioral therapy, self-monitoring, motivational interviewing, structured meal plans, portion control and goal setting are recommended interventions. Ideally, patients would progress from dietary intervention (covered MNT or weight management solution), to weight loss medications, and then, potentially, to bariatric surgery.  

In recognition of Patient Safety Awareness Week, the Partnership to Fight Infectious Disease announced, making March 18 a day of action to raise awareness of the need to #squashsuperbugs so that we can all do our part to prepare and perhaps even prevent a future pandemic due to antibiotic resistance.

From the No Surprises Act front, Fierce Healthcare reports

An “astronomical” number of surprise billing arbitration dispute cases is impacting the Centers for Medicare & Medicaid Services (CMS), a top agency official said.

Education and communication are integral to an “orderly transition” in the handling of independent dispute resolutions for out-of-pocket charges, the official said. The agency has grappled with legal issues and implementation hiccups surrounding a controversial process for settling feuds between payers and providers on out-of-network charges.

“We are seeing more than expected number of disputes getting to that last stopgap part, which is the independent dispute resolution part,” said Ellen Montz, director of CMS’ Center for Consumer Information and Insurance Oversight. Montz spoke during a session Wednesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. 

The agency is also seeing a lot of ineligible cases that don’t qualify for the dispute resolution process, which requires a third party to choose between out-of-network charges submitted by the payer and provider. 

These ineligible cases require “a lot of casework, phone calls and back and forth to determine eligibility,” Montz said. 

From the Medicare front, Healthcare Dive tells us

The group that advises Congress on Medicare policy is recommending updating base physician payment rates by 1.45% for 2024, according to its annual March report out Wednesday.

The Medicare Advisory Payment Commission, or MedPAC, did not make recommendations for ambulatory surgery center payment updates or for Medicare Advantage plans.

The commission did note concern with MA plan coding intensity, and said Medicare now spends more on MA enrollees than it would have spent had those enrollees remained in fee-for-service plans.

The FEHBlog doubts that this MedPAC report made anyone happy.

From the federal employee benefits front, FedWeek reminds folks that while the dependent care flexible spending accounts available to federal employees typically are used for child care, they also can be used for senior care in certain circumstances.

Monday Roundup

Photo by Sven Read on Unsplash

From our Nation’s capital, OPM released its Fiscal Year 2024 Congressional Budget Justification document, which is part of the federal budget process. Of interest to the FEHBlog is this OPM goal:

Improve customer experience by making it easier for Federal employees, annuitants, and other eligible persons to make a more informed health insurance plan selection. 

By September 30, 2023, complete user-centered design and develop a minimum viable product for a new, state-of-the-art Decision Support Tool that will give eligible individuals the necessary information to compare plan benefits, provider networks, prescription costs, and other health information important to them and their families.

Federal News Network tells us about a related Office of Management and Budget analytical perspective on federal workforce issues.

The Office of Management and Budget, in one of its analytical perspectives supplementing the Biden administration’s 2024 budget request, said federal workers’ pay is “increasingly hamstrung” by statutory requirements “that curb the ability of agencies to reward talent, including for specialized occupations, in a national competitive job environment.”

From the Rx coverage front —

The Wall Street Street Journal reports

Eisai Co.’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year. 

Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.

An estimated 167,954 veterans receiving care through the VA have Alzheimer’s dementia, according to government estimates. To qualify for Leqembi, patients must be over 65, have early-stage symptoms and elevated brain amyloid, sticky protein fragments, which the drug is designed to remove.

STAT News describes the VA’s step as “unexpected,” which is an understatement because CMS does not plan to issue a Medicare national coverage decision until mid-year. STAT News adds

The [VA] published a guide on its formulary saying coverage will extend to any veteran who meets specified criteria, including an MRI scan within the previous year, amyloid PET imaging consistent with Alzheimer’s and a staging test indicating mild Alzheimer’s dementia. There is also a long list of criteria that would exclude veterans.

The agency can negotiate prices for drugs, but the price it will pay for Leqembi was not listed and the Eisai spokesperson did not offer a cost. Leqembi has an annual wholesale price of $26,500, although the Institute for Clinical and Economic Review recently said the treatment should cost between $8,900 and $21,500 per year to be considered cost effective.

Under federal law, the VA can bill other health plans (including FEHB but not Medicare) for non-service related care such as this drug. For this reason, this VA action opens the back door to FEHB coverage of Leqembi.

From the end of the public health emergency front —

The Society for Human Resource Management offers its take on how employers should prepare for the end of the PHE, now less than two months away.

The American Hospital Association points out

The Food and Drug Administration will end 22 COVID-19-related policies when the public health emergency ends May 11 and allow 22 to continue for 180 days, including temporary policies for outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective equipment practices for sterile compounders not registered as outsourcing facilities, the agency announced. FDA plans to retain 24 COVID-19-related policies with “appropriate changes” and four whose duration is not tied to the PHE, including its recently revised policy for COVID-19 tests

From the Rx business front —

BioPharma Dive informs us

Pfizer has agreed to buy Seattle-based Seagen for $43 billion in a blockbuster deal that would unite the pharmaceutical giant with a biotechnology company that pioneered a new type of tumor-killing medicine.

The acquisition is the largest Pfizer has attempted since its 2009 purchase of Wyeth, and is the most sizable in the drug industry by value since AbbVie’s $63 billion buyout of Allergan in 2019.

Acquiring Seagen gives Pfizer control of the top-selling lymphoma medicine Adcetris as well as a pipeline of cancer treatments that’s yielded three new drug approvals in the past three years. Seagen specializes in a type of cancer therapy known as an antibody-drug conjugate, and has steadily improved on the technology since its founding in 1997.

STAT News relates

Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion.

The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.

The French pharma giant will now own TZield outright, paying $25 per share to acquire Provention — a 273% premium over Friday’s closing stock price.

In recognition of Patient Safety Awareness Week

  • The HHS Agency for Healthcare Quality and Research’s Director Robert O. Valdez, Ph.D., M.H.S.A. explains how AHRQ is sharpening its focus on diagnostic safety.
  • Beckers Hospital Review reports
    • The pediatric mental health crisis is the most pressing patient safety concern in 2023, the Emergency Care Research Institute said on March 13. 
    • The ECRI, which conducts independent medical device evaluations, annually compiles scientific literature and patient safety events, concerns reported to or investigated by the organization, and other data sources to create its top 10 list.
    • Here are the 10 patient safety concerns for 2023, according to the report: 
      • 1. The pediatric mental health crisis
      • 2. Physical and verbal violence against healthcare staff
      • 3. Clinician needs in times of uncertainty surrounding maternal-fetal medicine
      • 4. Impact on clinicians expected to work outside their scope of practice and competencies
      • 5. Delayed identification and treatment of sepsis
      • 6. Consequences of poor care coordination for patients with complex medical conditions
      • 7. Risks of not looking beyond the “five rights” to achieve medication safety
      • 8. Medication errors resulting from inaccurate patient medication lists
      • 9. Accidental administration of neuromuscular blocking agents
      • 10. Preventable harm due to omitted care or treatment
  • The U.S. Department of Labor announced on March 10
    • the launch of a series of online dialogues to gather ideas and other public input on how health policies can support workers’ mental health most effectively.
    • The crowdsourcing will focus on four areas of concern for people with mental health conditions, including benefits policies that meet their needs, access to workplace care and supports, the reduction of related social stigmas, disparities faced by people in underserved communities, shortages of behavioral health professionals, and the establishment of state resource systems.
    • Part of the department’s ePolicyWorks initiative, the dialogues will remain open until April 3. Input received will inform the next meeting of the Mental Health Matters: National Task Force on Workforce Mental Health Policy
  • Healthexec calls attention to FDA recalls of certain eyedrops.

From the value-based care front, Health Payer Intelligence notes

CareFirst BlueCross BlueShield (CareFirst) has formed a strategic alliance with Aledade, Inc. (Aledade), offering independent primary care physicians tools and resources to improve healthcare affordability and effectiveness, supporting CareFirst member physicians in achieving value-based care goals.

Through this value-based relationship, CareFirst member physicians can leverage specialists, including onsite business support for physician practices, a technology platform that works with more than 100 different EHRs, and healthcare regulatory and policy expertise.

From the medical debt front, Healthcare Dive reports

  • Hospitals are a prime source of medical debt in America that hits underserved populations hardest, despite charity care programs and financial assistance policies, according to a new analysis from the Robert Wood Johnson Foundation.
  • Of the 15% of U.S. adults with past-due medical debt, almost two-thirds owe some or all of that debt to hospitals, according to research from the Urban Institute. That medical debt disproportionately affects underserved populations, such as low-income individuals and people with disabilities, researchers found.
  • While medical debt remains a persistent financial burden in the U.S., a new analysis from the Urban Institute highlights how targeting hospital billing could ameliorate the problem.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports

The Biden administration will send its budget for the next fiscal year up to Capitol Hill on March 9, according to a memo from top White House aides.

That’s about a month later than the statutory deadline, which is the first Monday in February, though that target is often missed and there’s no penalty for doing so.

National Econonic Council Director Brian Deese and Office of Management and Budget Director Shalanda Young laid out the timing in a memo to “interested parties” that also discussed agenda topics for Wednesday’s scheduled meeting between President Joe Biden and Speaker Kevin McCarthy, R-Calif.

The memo, first reported by ABC News, said Biden will ask McCarthy to “commit to the bedrock principle that the United States will never default on its financial obligations,” a reference to the upcoming fight over the statutory debt ceiling. Treasury Secretary Janet L. Yellen has warned that the U.S. could be in danger of missed payments by early June if Congress doesn’t act to raise or suspend the $31.4 trillion debt limit.

The memo also says Biden will urge McCarthy and House Republicans to release their own fiscal 2024 budget blueprint that spells out the spending cuts they want to attach to any debt limit deal and how their budget will balance if they plan to extend expiring tax cuts.

Senator Tina Smith (D MN) and a bipartisan group of colleagues sent several large health insurers a letter requesting answers to questions about ghost networks. It turns out the ghost networks are online provider directories with errors. The FEHBlog thinks that the Senators should be pressuring the No Surprises Act regulators to implement the provider directory accuracy provision in that law.

From the Omicron and siblings front, the New York Times explores why Paxlovid, a reliable treatment, is underprescribed by doctors.

Doctors prescribed it in about 45 percent of recorded Covid cases nationwide during the first two weeks of January, according to White House data. In some states, Paxlovid is given in less than 25 or even 20 percent of recorded cases. (Those are likely overestimates because cases are underreported.)

Why is Paxlovid still relatively untapped? Part of the answer lies in a lack of public awareness. Some Covid patients also may decide that they don’t need Paxlovid because they are already vaccinated, have had Covid before or are younger. (My colleagues explained why even mild cases often still warrant a dose of Paxlovid.) * * *

Experts have increasingly pointed to another explanation for Paxlovid’s underuse: Doctors still resist prescribing it. Today’s newsletter will focus on that cause.

Some doctors have concerns that are rooted in real issues with Paxlovid and inform their reluctance to prescribe it. But experts are unconvinced that those fears are enough to avoid prescribing Paxlovid altogether, especially to older and higher-risk patients.

“What I’m doing for a living is weighing the benefits and the risks for everything,” said Dr. Robert Wachter, the chair of the medicine department at the University of California, San Francisco. In deciding whether to prescribe Paxlovid, he said, the benefits significantly outweigh the risks.

This isn’t very encouraging.

From the U.S. healthcare business front —

Beckers Hospital Review reports

Six years after regulators approved Amjevita, a biosimilar to the nation’s most lucrative drug, Humira, Amgen’s drug jumped on the U.S. market Jan. 31 with two list prices.

The biosimilar to AbbVie’s most profitable drug will either cost 5 percent or 55 percent less than Humira’s price, according to Amgen. Humira costs $6,922 for a month’s supply, meaning Amjevita’s price — depending on the buyer — will be $6,576 or $3,115. The higher price is designed to entice pharmacy benefit managers, and the lower one is for payers, according to Bloomberg

As Humira’s 20-year, $114 billion, 247-patent-strong monopoly ends with the first biosimilar, more copycat versions are set to premiere in the next few months.

STAT News dives deeper into the implications of Amgen’s pricing approach.

AHIP responded yesterday to CMS’s final Medicare Advantage plan audit rule.

“Our view remains unchanged: This rule is unlawful and fatally flawed, and it should have been withdrawn instead of finalized. The rule will hurt seniors, reduce health equity, and discriminate against those who need care the most. Further, the rule would raise prices for seniors and taxpayers, reduce benefits for those who choose MA, and yield fewer plan options in the future. 

“We encourage CMS to work with us, continuing our shared public-private partnership for the health and financial stability of the American people. Together, we can identify solutions that are fair, are legally sound, and ensure uninterrupted access to care and benefits for MA enrollees.” 

Is the next step the courthouse?

Money Magazine offers a list of hospitals that provide bariatric surgery with Leapfrog safety grades.

From the mental healthcare front, Fierce Healthcare tells us

Parents can now be added alongside providers, health insurers and employers to the list of stakeholders with growing concerns about mental health, according to a study by the Pew Research Center.

The study found that 40% of parents call the fact that their children might be struggling with anxiety and depression their No. 1 concern—something they’re extremely or very worried about—followed by 35% of parents who put the fear that their children are being bullied into that category.

From the tidbits department —

  • The NY Times lists ten nutrition myths that experts wish would be forgotten.
  • The NIH Directors blog explains why a “New 3D Atlas of Colorectal Cancer Promises Improved Diagnosis, Treatment.”
  • The National Association of Plan Advisors points out that “Despite a rebound in out-of-pocket health care spending in 2021, health savings account (HSA) balances increased on average over the course of the year, the Employee Benefit Research Institute (EBRI) recently found. Its analysis of HSA balances, contributions, and distributions also found, “patients sought health care services more frequently in 2021—and spent more out of pocket, as well—than they did in 2020, yet the average end-of-year balance was higher than the average beginning-of-year balance.”

Monday Roundup

    Photo by Sven Read on Unsplash

    Today was another busy day.

    The biggest surprise is that OPM begun refreshing its website and has revealed its logo.

    U.S. Office of Personnel Management logo
    New OPM Logo

      From the public health front —

      • The Hill reports that the President plans to end the national and public health emergencies for the Covid pandemic on May 11, 2023. Congress took steps to arrange for a soft landing in the Consolidated Appropriations Act 2023, which likely is a factor in reaching this executive decision.
      • Health IT Analytics tells us, “Researchers from New York University (NYU) Grossman School of Medicine and the Robert Wood Johnson Foundation (RWJF) unveiled the Congressional District Health Dashboard (CDHD), an online data tool that provides health data for all 435 US congressional districts and the District of Columbia.” Interesting.
      • The New York Times informs us, “A new report [on maternal health in the U.S.] highlighted the dangers faced by Native American women, who face the greatest risks during and after pregnancy. Native American women were 3.5 times as likely to die during this critical period, compared with white women, the study found.” This rang a bell with the FEHBlog because the FEHB Program included Native American employers who have contracted with OPM for FEHB coverage for their employees. “During and after pregnancy, Black women also faced heightened odds of death that were almost double those of white women, along with a risk of dying specifically from pregnancy complications that was 2.8 times that of white women.” No child should be deprived of a mother due to inadequate healthcare.
      • Yale New Haven Hospital offers insights on heart disease for lay people/patients.
      • Medpage Today discusses recently extended and updated Body Mass Indices (BMIs0 for children and adolescents.
      • LifeSciences Intelligence reports that “In a recent news release, the Emergency Care Research Institute (ECRI) highlighted gaps in communication regarding medical device recalls, noting that these gaps could be a significant threat to patient safety. This commentary was a part of the organization’s Top 10 Health Technology Hazards report.”

      From the Affordable Care Act front, the ACA regulators today promulgated a proposed rule that would create

      a new independent pathway through which individuals enrolled in plans or coverage sponsored or arranged by objecting entities that have not opted for the existing accommodation (including those enrolled in individual health insurance coverage issued by such an objecting entity) could access contraceptive services at no cost. Specifically, these proposed rules would create a mechanism, independent from the employer, group health plan, plan sponsor, institution of higher education, or issuer, through which individuals could obtain contraceptive services at no cost from a willing provider of contraceptive services. This individual contraceptive arrangement would be available to the participant, beneficiary, or enrollee without the objecting entity having to take any action facilitating the coverage to which it objects. Simply put, the action is undertaken by the individual, on behalf of the individual. * * *

      These proposed rules, if finalized, would rescind the moral exemption to covering contraceptive services without cost sharing, while keeping intact the religious exemption and without narrowing its scope or the types of entities or individuals that may claim the religious exemption. These proposed rules would also maintain the optional accommodation for sponsors of group health plans and institutions of higher education arranging student health insurance coverage that qualify for the religious exemption. 

      Here’s a link to the regulator’s fact sheet. This strikes the FEHBlog has a wise solution to this knotty problem.

      From the healthcare business front —

      The American Hospital Association relates

      Last year was the worst financial year for U.S. hospitals and health systems since the start of the COVID-19 pandemic, as growth in expenses outpaced growth in revenues and volumes, according to the latest report on hospital finances from Kaufman Hall. 

      “The increases were driven in part by a competitive labor market, as well as hospitals needing to rely on more expensive contract labor to meet staffing demands,” the report notes. “Increased lengths of stay due to a decline in discharges also negatively affected hospital margins.” 

      Hospitals experienced negative operating margins for most of the year, with approximately half of the nation’s hospitals ending the year in the red. According to the report, hospitals’ expense pressures “are unlikely to recede in 2023.”

      STAT News discusses business focused on improving human longevity.

      Health Payer Intelligence reports

      The US Department of Health and Human Services (HHS) has released a final rule that aims to introduce more oversight into the Medicare Advantage risk adjustment data validation and payment process. * * * Under the finalized rule, CMS will not extrapolate audit findings for payment years 2011 through 2017, the CMS fact sheet stated. CMS will collect non-extrapolated overpayments for plan years 2011 through 2017. Extrapolation will begin with the plan year 2018 risk adjustment data validation audit using any extrapolation technique that is statistically valid. The audits will center on high-risk plans.

      The Wall Street Journal adds “A Centers for Medicare and Medicaid Services official, Deputy Administrator and Center for Program Integrity Director Dara Corrigan, said the estimated recoveries for 2018 would be around $479 million, and the agency projected a total of about $4.7 billion over a decade. The large recoveries wouldn’t actually occur until 2025 and after, however.”

      Will this regulation drive companies out of Medicare Advantage? Time will tell. In the meantime here is a link to HHS’s fact sheet.