Midweek Update

Rx coverage

Midweek Update

David Ermer–Congress, Electronic health records, HSA, No Surprises Act, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From Washington, DC —

Roll Call brings us up to date on the debt ceiling issue. “House Republicans unveiled legislation Wednesday to pair their favored spending cuts and energy and regulatory policies with a debt limit increase lasting through early next year.” “Measure viewed as a ‘conversation starter’ with government cash crunch seen as early as June.”

The Wall Street Journal informs us that the U.S. Supreme Court extended its stay of an injunction restricting sales of an abortion pill from midnight tonight to midnight Friday.

  • “The justices have three primary options. They could grant the emergency requests and leave mifepristone on the market indefinitely during litigation, which could preserve the status quo for many months. They could leave the pill in place temporarily and agree to review the case in full, even though lower courts aren’t done reviewing it. Or they could deny the emergency appeals outright.” 

As anticipated, Health Affairs Forefront has posted here and here helpful articles explaining the final 2024 Notice of Benefit and Payment Parameters released earlier this week.

From the U.S. healthcare business front —

  • Beckers Payer Issues tells us,
    • Elevance Health posted double-digit revenue growth and beat investor expectations in the first quarter of 2023, according to the company’s earnings report published April 19.
    • “Elevance Health is off to a strong start in 2023, driven by our continued focus on whole health and advancing health beyond healthcare,” President and CEO Gail Boudreaux said.
  • Beckers Hospital Review adds,
    • Mark Cuban is creating an independent pharmacy network to “serve patients more widely” after pitching the idea to local pharmacy owners in February. 
    • Mark Cuban Cost Plus Drug Co. has operated as a mail-order, online pharmacy since January 2022, but with its latest endeavor, the business is looking to expand access to its portfolio of more than 1,000 prescription drugs.
    • The collaboration between independent pharmacies and Cost Plus Drugs includes a “Team Cuban Card,” which acts like an insurance card at pharmacy checkouts. 
    • Independent pharmacists interested in partnering with Cost Plus Drugs were asked to complete an interest form with the company detailing the type of pharmacy they run and how patients access the services offered. So far, Cost Plus Drugs has 36 affiliate locations, with five in Florida, seven in Indiana, six in New Jersey and 18 in Texas. The company said it will add new sites every month.
    • This is part of a larger movement to prevent more local pharmacy closures, Mr. Cuban told Becker’s. 
  • STAT News reports
    • Because Johnson & Johnson is the largest healthcare company in the world, its financial fortunes tend to be a bellwether for the industry at large. And parsing J&J’s positive results from the last quarter, released yesterday, analysts see hope that the pharmaceutical business is in good shape despite a difficult macroeconomic environment.

From the HIMSS conference —

  • Med City News shares a conference presentation by “Glen Tullman — CEO of care navigation company Transcarent, as well as former CEO of Allscripts and Livongo. Mr. Tullman discussed what he thinks the future of healthcare will look like during the HIMSS conference in Chicago. He laid out five predictions, including an increased focus on consumer expectations and more investment in AI.”
  • Fierce Healthcare points out
    • Companies like Best Buy and VillageMD are disrupting the traditional healthcare industry by bringing a more consumer-centric approach to providing medical services.
    • During a keynote address Wednesday morning at HIMSS23, executives at these so-called “disrupters” shared their vision for the future of care delivery.
  • You will find HIMSS links to its sessions here and here.

From the Rx and medical test coverage front —

  • The Institute for Clinical and Economic Research issued a white paper
    • Evaluating Best Practices and Potential Reforms for White Bagging, Brown Bagging, and Site of Service Policies that Seek to Address High Markup in Drug Prices
      • — White bagging, brown bagging, and site of service policies developed by payers can reduce significant markup costs for clinician-administered drugs but have sparked concerns and legislative action related to their impact on patients and providers —
      • — White paper evaluating best practices and potential policy reforms was informed by input from a diverse set of hospitals, provider groups, and payers.
  • Medscape delves into the debate over the optimal time period for using weight loss drugs.
  • The Wall Street Journal examines new blood tests that offer early detection of cancers and Alzheimer’s Disease.
    • “Questions include who should be getting them, and what patients should do about positive results.”

From the miscellany front —

  • Fierce Healthcare informs us, as the FEHBlog expected,
    • The federal No Surprises Act “appears” to be effectively protecting patients from the most frequent sources of unexpected medical bills, though several coverage gaps such as those relating to ground ambulance services are still leaving some patients with hefty bills, according to a new qualitative report.
    • To get a read on the consumer protection legislation after a full year of implementation, researchers from the Urban Institute and Georgetown University’s Center on Health Insurance Reforms, with backing from the Robert Wood Johnson Foundation, interviewed 32 regulators and stakeholders representing consumers, payers, hospitals, billing companies and other relevant industry subsectors.
    • These informants “largely agreed that consumers are being well protected from surprise balance bills covered under the law,” researchers wrote in the report.
  • Health Payer Intelligence notes
    • Many consumers would be interested in a type of account that was like a health savings account (HSA) in its construction but able to be attached to plans other than high deductible health plans (HDHPs), a survey from Employee Benefit Research Institute (EBRI) stated.
    • “We decided to test enrollee interest in a new type of health account similar to an HSA. Like an HSA, the new health account could be funded by both workers and employers, could be invested in the stock market, and would be portable from job to job. Earnings would grow tax free, and contributions would be capped,” the EBRI researchers explained.
    • “Unlike an HSA, this new health account would not have to be paired with a high-deductible health plan; it could be paired with any health plan.”
  • “AHIP released the latest version of its comprehensive, biennial report, Health Coverage: State-to-State 2023, which analyzes health coverage and health insurance provider industry employment for all 50 states and the District of Columbia.”

Tuesday’s Tidbits

David Ermer–COVID-19, COVID-19 vaccine, Electronic health records, FDA, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front

The Wall Street Journal reports

  • Americans seeking messenger RNA vaccines for Covid-19 for the first time will get one, updated shot targeting both the Omicron variant and the original strain of the virus under new moves rolled out Tuesday by federal health officials. 
  • The Food and Drug Administration also authorized a second booster of the updated shots for people at high risk of Covid-19, specifically people 65 years and older or people who have weak immune systems.
  • The agency’s actions mark the latest tweaks to Covid-19 vaccines, and could be followed up by further efforts to simplify the complicated vaccination regimen, perhaps by enshrining plans for a once-a-year shot for most people.
  • “The agency believes that this approach will help encourage future vaccination,” said Dr. Peter Marks, head of the FDA’s division that oversees vaccines. “Covid-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination.”

The U.S. Preventive Services Task Force maintained its I or incomplete grade for “visual skin examination by a clinician to screen for skin cancer in adolescents and adults.” In other words, USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of this screening examination.

The Department of Health and Human Services made available a readout from the Secretary’s roundtable on Black maternal health.

  • One critical action the Administration has taken to move the needle was implementing the state option to extend Medicaid’s postpartum coverage from two months to twelve months, a lifesaving opportunity made possible by President Biden’s American Rescue Plan (ARP) and made permanent by the Consolidated Appropriations Act, 2023 (CAA, 2023), which President Biden signed into law earlier this year. So far, 31 states and DC have signed on. Congresswoman Robin Kelly – who also sponsors the MOMMA’s Act, which aims to prevent maternal mortality – helped champion this extension. 
  • Participants who lead community organizations helped shine a light on what effective, scalable solutions can look like, and the outcomes speak for themselves.
  • Jennie Joseph shared that by removing barriers to care for women at higher risk for maternal mortality and morbidity, her organization has never had a mother or baby die in 25 years, and of the 1,200 patients served since 2020, only five babies were born premature.
  • Aza Nedhari remarked that her organization’s Home Visitation Program, which provides expectant and new parents with culturally congruent comprehensive home visiting services during pregnancy and postpartum, has supported over 2,000 families and has facilitated a zero percent mortality rate since 2015.

From the obesity treatment front

Healthcare Dive tells us.

  • Telehealth giant Teladoc Health is expanding its physician-based care product for employers to weight management and prediabetes, as interest explodes in drugs meant for diabetes control that are being more frequently prescribed for weight loss, resulting in nationwide shortages.
  • The medications, called GLP-1 drugs, include Novo Nordisk’s Ozempic, which has been at the center of a national conversation about health, weight loss and medication access as more people, especially celebrities, use the drug to lose weight.
  • The provider-based program, which includes access to a Teladoc-employed doctor for a personalized care plan, along with daily coaching with digital tools, will become available for diabetes prevention and weight management in the third quarter, the company told Healthcare Dive.

Beckers Payer Issues adds.

  • UnitedHealth Group CEO Andrew Witty told investors [last week] it is “good news” that there are innovations being made in weight management. 
  • “We need to get focused on the facts and reality of this marketplace. We need to really be clear about which patients really do benefit from these medicines and make sure we properly understand how they’re going to use those medicines,” Mr. Witty said. “So there’s a lot still to learn, I think, as these things progress through their final phases.”

From the interoperability front

  • HIMSS reports on its sessions held today.
  • The American Hospital Association relates.
    • About 84% of hospitals had posted a machine-readable file containing rate information by the end of first-quarter 2023, up from 65% the previous quarter, according to a report released today by Turquoise Health. The report also found that 183 commercial health insurers representing over 95% of U.S. commercially insured lives were publishing machine-readable files of their in-network negotiated rates and out-of-network allowed amounts, up from 68 in July 2022.

From the U.S. healthcare business front

  • The Wall Street Journal reports
    • Hospitals are joining the gig economy. 
    • Some of the nation’s largest hospital systems including Providence and Advocate Health are using apps similar to ride-hailing technology to attract scarce nurses. An app from ShiftKey lets workers bid for shifts. Another, CareRev, helps hospitals adjust pay to match supply, lowering rates for popular shifts and raising them to entice nurses to work overnight or holidays.
    • The embrace of gig work puts hospitals in more direct competition with the temporary-staffing agencies that siphoned away nurses during the pandemic. The apps help extend hospitals’ labor pool beyond their employees to other local nurses who value the highly flexible schedules of gig work. 
    • The shift is among many ways hospitals are revamping hiring, schedules and pay to give nurses more control and to fill staffing gaps created by persistent labor shortages. Vacancies are straining many hospitals’ operations despite recent hiring gains at hospitals and reports of softer demand from some temporary-staffing companies.
  • Healthcare Dive informs us
    • Pharmacists are arguing they should play a more active role in care teams by being allowed to practice the full scope of their license, according to comments at the HIMSS conference in Chicago.
    • Nearly half of U.S. counties have shortages of primary care providers, with just one of those doctors for every 1,500 people, while 61% of those counties have a high volume of retail pharmacy locations that could help make up the deficit, according to new data from health IT network Surescripts.
    • But pharmacists at HIMSS say they need access to a greater range of medical data to get there.
  • OPM held a session on this topic on the first day of its FEHB carrier conference on March 29.
  • Beckers Payer Issues reports
    • CVS Health has named Brian Kane as executive vice president and president of Aetna, effective September 1.
    • Mr. Kane will report directly to CVS President and CEO Karen Lynch. He is replacing Daniel Finke, who is stepping down for health reasons, according to an April 17 news release.

From the tidbits/miscellany department

  • The National Association of Letter Carriers calls attention to the fact that the Postal Service has issued Postal Service Health Benefits Program fact sheets for Postal employees and annuitants.
  • The Drug Channels blog makes ten predictions about how the Inflation Reduction Act will impact market access and drug channels.
  • Govexec predicts expanded childcare options and higher pay for childcare workers based on an executive order that the President signed today.

Monday Roundup

David Ermer–ACA, CDC, CMS, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

The HIMSS conference is being held this week in Chicago. The HIMSS organization is providing the publich with morning and afternoon session updates.

From the regulatory front, the Department of Health and Human Services released the final 2024 Notice of Benefit and Payment Parameters which is applicable to qualified health plans in the marketplaces.

From the US healthcare business front

  • Healthcare Dive reports
    • Hospital and health system merger and acquisition activity remained consistent in the first quarter of 2023 with 15 healthcare industry transactions, a slight drop from 17 in the fourth quarter of 2022, according to a new report from hospital consultancy Kaufman Hall. The 15 transactions comprised $12.4 billion in total transacted revenue, down from the high of $12.7 billion in 2018.
    • Mergers and acquisitions are trending toward cross-regional partnerships, and the size of the smaller party in mergers is increasing to between $250 million and $750 million in annual revenue, according to the report.
    • Realignment of for-profit health system portfolios continued in the first quarter of 2023, particularly for high financial and operational performing health systems.
  • AHIP issued a report finding that hospital markups on specialty drugs cost patients thousands of dollars.
  • Beckers Hospital CFO Reports identifies 22 US hospitals that are cutting care.
  • Beckers Payer Issues informs us that
    • UnitedHealthcare’s plans to implement a gold-card program in 2024 might cut another 10 percent of its prior authorization volumes on top of a 20 percent reduction that will roll out this summer, UnitedHealthcare CEO Brian Thompson said during UnitedHealth Group’s April 14 earnings call, which was transcribed by Seeking Alpha.
    • The payer plans to implement the national gold-card program in early 2024 for care provider groups that meet eligibility requirements, according to a March 29 company news release. The gold-card status applies for most UnitedHealthcare members across commercial, Medicare Advantage and Medicaid. 
    • Qualifying care provider groups “will follow a simple notification process for most procedure codes rather than the prior authorization process,” according to the release. 

From the public health front, Medpage Today reports

  • Chronic pain continued to affect more than one in five U.S. adults, new CDC survey data showed.
  • During 2021, an estimated 51.6 million adults (20.9%) had chronic pain lasting 3 months or longer, and 17.1 million (6.9%) had high-impact chronic pain — pain severe enough to restrict daily activities — reported S. Michaela Rikard, PhD, of the CDC’s National Center for Injury Prevention and Control, and co-authors.
  • Pain prevalence was higher in adults who were American Indian or Alaska Native, who identified as bisexual, or who were divorced or separated, the researchers said in Morbidity and Mortality Weekly Report.

From the Rx coverage front, the Institute for Clincical and Economic Research released a Final Evidence Report on Lecanemab for Alzheimer’s Disease.

  • — Independent appraisal committee voted that currently available evidence is not adequate to demonstrate a net health benefit for lecanemab when compared to supportive care —
  • — Using best estimates from current data, ICER analyses suggest lecanemab would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —
  • — Manufacturers should release all patient-level data to help patients, clinicians, researchers, and regulators understand more about the link between amyloid reduction and cognitive outcomes

Lecanemab is an FDA approved drug that the CDC is considering for Medicare coverage beyond clinical testing. The VA has agreed to cover FDA marketing label uses for the drug in its patient population which overlaps with FEHBP.

From the medical research front, a National Institutes of Health study outlines “opportunities to achieve President Biden’s Cancer Moonshot goal of reducing cancer death rates in the United States. Accelerated progress is needed to achieve Cancer Moonshot goal of cutting the age-adjusted cancer death rate by at least 50% over 25 years, NIH study says.”

  • The study was conducted by researchers in NCI’s Division of Cancer Epidemiology and Genetics, the Center for Cancer Research, and their collaborators, using data from NCI’s Surveillance, Epidemiology, and End Results (SEER) Program and the Centers for Disease Control and Prevention’s National Center for Health Statistics. The researchers examined trends in age-standardized cancer incidence, survival, and mortality rates from 2000 to 2019 for all cancers combined, as well as for the six cancers that together account for 57% of cancer deaths: lung, colorectal, pancreatic, breast, prostate, and liver. They then projected the overall cancer death rate in 2047 based on the assumption that current trends would continue.
  • According to their analysis, because of decreasing cancer incidence and improvements in survival, age-adjusted death rates from all cancers combined declined by 1.4% per year from 2000 to 2015 and by 2.3% per year from 2016 to 2019. These declines reflect substantial reductions in deaths from lung cancer (-4.7% per year during 2014–2019), as well as colorectal cancer (-2.0% per year during 2010–2019) and breast cancer (-1.2% per year during 2013–2019).
  • Trends in prostate, pancreatic, and liver cancer death rates have been less promising. Death rates from prostate cancer had declined strongly (-3.4% per year during 2000–2013), but the decline has slowed (to -0.6% per year during 2013–2019). Death rates from pancreatic cancer have been increasing (0.2% per year during 2006–2019). Death rates from liver cancer, which had been increasing for decades, recently began to decline (-0.5% per year during 2016–2019). Death rates from all other cancer types combined have declined (-1.7% per year during 2016–2019).

Late Week Miscellany

David Ermer–ACA, CDC, COVID-19, FDA, No Surprises Act, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Dear FEHBlog readers — The FEHBlog wrote a quick blog post for Thursday but overlooked hitting the publish button, so here are the two items from Thursday and the remainder from Friday.

Wednesday afternoon, the Affordable Care Act regulators issued ACA FAQ 59 about the Braidwood Management decision. The FAQs expressly endorsed OPM’s informal administration action last Friday using FEHB Act Section 8902(d) to endorse the U.S. Preventive Services Task Force recommendations that the decision rejected because they had no federal government endorsement. The FEHBlog wonders why HHS hasn’t pulled this page out of OPM’s playbook.

Wednesday night, the U.S. Court of Appeals for the Fifth Circuit (2-1 decision) stayed a portion of the abortion pill injunction on statute of limitations grounds in a 42-page opinion. The Fifth Circuit opinion allows the abortion pill to stay on the market with reinstated in-person medical visit prerequisites and without delivery by mail. The Attorney General has stated that he will ask the Supreme Court to weigh in. Axios reports that the Supreme Court would decide quickly.

Axios was correct because the Wall Street Journal reported that today

  • The Supreme Court temporarily blocked lower court orders that would have limited access to the abortion drug mifepristone beginning Saturday, preserving the pill’s availability while the justices weigh the Biden administration’s emergency request to leave current Food and Drug Administration approvals in place during a continuing legal battle with antiabortion groups.
  • In a pair of orders Friday, Justice Samuel Alito, who oversees emergency matters for the lower courts that limited or suspended approval of the widely used abortion pill, gave the antiabortion groups until noon Tuesday to file briefs in response to appeals by the FDA and Danco Laboratories LLC, which makes the branded version Mifeprex.
  • The temporary orders expire at 11:59 p.m. Wednesday, suggesting a high court decision on whether and to what extent mifepristone will remain available during litigation may come by then.

In other judicial news, the American Hospital Association informs us

  • The U.S. Supreme Court today unanimously reversed a 9th Circuit decision that impliedly stripped federal district courts of jurisdiction over constitutional challenges to the Federal Trade Commission structure, procedures and existence. Ruling in the FTC case and another case involving the Securities and Exchange Commission, the Supreme Court said, “The statutory review schemes set out in the Securities Exchange Act and Federal Trade Commission Act do not displace a district court’s federal-question jurisdiction over claims challenging as unconstitutional the structure or existence of the SEC or FTC.”
  • As a result of this decision, parties may bring claims in federal court alleging that “the structure, or even existence, of an agency violates the Constitution” without having to first go through costly and time-consuming administrative proceedings before the SEC or FTC.

Turning now to the federal employment front –

  • Govexec tells us
    • Office of Management and Budget guidance released Thursday tasks agencies with developing a new system to monitor their “organizational health and organizational performance” on an ongoing basis. With the new system comes an expectation that federal agencies will rely less on telework and remote work, although that must be balanced with the need to compete for talent with private sector employers who continue to offer similar workplace flexibilities, wrote OMB Deputy Director for Management Jason Miller in a blog post accompanying the memo.
  • Federal News Network reports OPM’s implementation of the Postal Service Health Benefits Program.

From the public health front

  • The Centers for Disease Control begins to bring down the curtain on its now bi-weekly review of its Covid statistics and updates us on the bird flu situation.
  • The Food and Drug Administration announced granting emergency use authorization to an improved Covid test.
  • The Robert Wood Johnson Foundation offers various perspectives on achieving joyful, healthy births for all, a worthy goal.
  • Medscape identifies troubling trends in colorectal cancer data recently released by the American Cancer Society.

From the regulatory front —

  • Mercer Consulting offers advice on the recent instructions concerning RxDC reporting for the 2022 reference year due June 1.
  • Healthcare Finance tells us
    • The Office of Civil Rights is providing a 90-day transition period for healthcare providers to come into compliance with the HIPAA Rules regarding telehealth, according to the Department of Health and Human Services OCR. 
    • The transition period will be in effect beginning on May 12 and will expire at 11:59 p.m. on August 9.
    • OCR said it would continue to exercise its enforcement discretion and not impose penalties on covered providers for noncompliance during the 90- day transition period. 
    • During the public health emergency, providers did not have to be licensed in the state where the patient was located. They were allowed to treat patients in other states. 
    • Also, under the PHE, non-HIPAA-compliant platforms were allowed as long as they were not public facing.
    • Both of these flexibilities are coming to an end with the PHE on May 11, with providers now getting a 90-day grace period.
    • Other telehealth provisions expire at the end of 2023 and 2024

From the Rx coverage front —

  • Fierce Healthcare informs us that Cigna’s Express Scripts unveiled two new programs on Thursday, Copay Assurance and ClearCare Rx, which reminds the FEHBlog of OPM’s transparent pharmacy pricing program.
  • The Institute for Clinical and Economic Research (ICER) published an
    • Evidence Report on Treatments for Non-Alcoholic Steatohepatitis [liver inflammation]
      • — Evidence suggests that both resmetirom and obeticholic acid improve liver histology without evidence yet demonstrating improved long-term outcomes; obeticholic acid has more concerning side effects —
      • — Current evidence suggests that resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year, while obeticholic acid would achieve these thresholds if priced between $32,800-$40,700 per year —
      • — At the April 28 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatments’ comparative clinical effectiveness, other potential benefits, and long-term value for money —

From the U.S. healthcare business front

  • Beckers Payer Issues reports, “UnitedHealth Group posted revenues of $91.9 billion in the first quarter of 2023, up 15 percent from $80.1 billion over the same period last year, according to the company’s earnings report released April 14.”
  • Beckers Hospital Review ranks 29 physician specialties by annual compensation.

Midweek update

David Ermer–Congress, HIPAA Privacy and Security Rules, Medical / Rx research, Mental health care, Rx coverage–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From our Nation’s capital —

  • STAT News reports
    • “Senators are slightly delaying their latest legislative push on health care, but as they do, a clearer picture is emerging about what’s in — and out — of the mix.
    • “The Senate health committee was expected to mark up legislation related to generic drugs, pharmacy benefit managers, and some leftovers from the Food and Drug Administration’s user fee agreements next week, but leaders are planning to reschedule the meeting, several sources told STAT.
    • “But 17 health care industry lobbyists and Senate staffers said Democratic leadership is targeting relatively low-hanging fruit that is bipartisan, and already has established history in legislation [i.e., a $35 copay on insulin in the commercial market]”.
  • Beckers Payer Issues tells us that “the Justice Department has decided to seek a stay pending appeal of a Texas federal judge’s ruling that struck down an ACA provision requiring insurance companies to provide coverage for preventive services, CNN reported April 11.”
  • The Department of Health and Human Services proposed a HIPAA privacy rule change “to strengthen its protections by prohibiting the use or disclosure of protected health information (PHI) to investigate, or prosecute patients, providers, and others involved in the provision of legal reproductive health care, including abortion care.” The public comment period will end sixty days after April 17, 2023, the day on which the proposed rule will be published in the Federal Register.

From the public health front —

  • MedPage Today informs us
    • Fentanyl adulterated with xylazine is an “emerging drug threat” in the U.S. and requires immediate action, the Biden administration warned.
    • “This is the first time in a nation’s history that a substance is being designated as an emerging threat by any administration,” said Rahul Gupta, MD, director of the White House Office of National Drug Control Policy (ONDCP), during a phone call with reporters late Tuesday afternoon. “And it couldn’t come at a more critical time.”
  • ABC News reports
    • The number of sexually transmitted infections (STIs) in the United States shows “no signs of slowing,” new federal data shows.
    • A total of 2.53 million cases of chlamydia, gonorrhea and syphilis were recorded in 2021, according to a new report published Tuesday from the Centers for Disease Control and Prevention.
    • That’s a 5.8% increase from the 2.39 million cases reported in 2020 and a 7% increase from five years ago when 2.37 million STIs were recorded in 2017.
    • “I’d like people to understand that this data actually impacts them whether they think it does or not and it’s because STIs happen to everyone, regardless of socioeconomic, religious, political lifestyle,” Dr. Kameelah Phillips, an OBGYN in New York City, told ABC News. “I’d like them to really understand that routine testing at their health care office is super important … gonorrhea doesn’t care who you are.”
    • While certain STIs did not reach pre-pandemic levels, others — such as syphilis — are recording the highest numbers seen in more than 70 years.

From the mental healthcare front —

  • Benefits Pro highlights a survey finding that
    • 21% of workers at ‘high mental health risk’ and unaware of available [employer sponsored] counseling.
    • Employees often do not know the range of resources available to them in their benefits packages and are often unaware of counseling included in the company’s employee assistance program, according to a TELUS survey.

Federal agencies and the Postal Service sponsor EAPs, but the FEHBlog is unaware of OPM creating a connection between those programs and the FEHBP.

From the Rx coverage front —

  • Drug Channels offers a report on specialty pharmacies which informs us that “Drug Channels Institute (DCI) estimates that in 2022, retail, mail, long-term care, and specialty pharmacies dispensed about $216 billion in specialty pharmaceuticals prescriptions. That’s an increase of 12% from the 2021 figure.”  
  • The Institute for Clinical and Economic Research released
    • a Protocol outlining how we will conduct our third annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies, and
    • a Draft Evidence Report assessing the comparative clinical effectiveness and value of exagamglogene autotemcel (“exa-cel”, Vertex Pharmaceuticals and CRISPR Therapeutics) and lovotibeglogene autotemcel (“lovo-cel”, bluebird bio) for sickle cell disease.  The draft report represents the midpoint in ICER’s eight month long review process.

From the medical research developments front

  • STAT News reports, “A Parkinson’s ‘game changer,’ backed by Michael J. Fox, could lead to new diagnostics and, someday, treatments.” It’s a heartening medical research story about Mr. Fox’s productive efforts.
  • Medscape reports
    • Phototherapy is a safe, effective, noninvasive, and inexpensive way of boosting cognition for patients with dementia, new research suggests. It may be “one of the most promising interventions for improving core symptoms” of the disease.
    • A new meta-analysis shows that patients with dementia who received phototherapy experienced significant cognitive improvement compared to those who received usual treatment. However, there were no differences between study groups in terms of improved depression, agitation, or sleep problems.

Weekend update

David Ermer–Congress, FDA, Mental health care, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Eric Heininger on Unsplash

Congress remains on a District / State work break which concludes next Monday following the Easter and Passover holidays.

OPM has rescheduled the second day of the 2023 OPM AHIIP carrier conference for April 20, 2023 from 11 am to 4:15 pm ET.

From the public health front —

  • NPR Shots discusses the simple intervention that may keep Black moms healthier — daily home-administered blood pressure readings.
    • Blood pressure is just one way to measure a person’s health, but during pregnancy and soon after, it’s a critical metric. Unchecked, high blood pressure can contribute to serious complications for the pregnant woman and baby, and increase the risk of death.
  • Politico tells about new efforts underway to solve the crisis in mental health problems among children and adolescents that accompanied the Covid pandemic.
    • Sen. Bob Casey (D-Pa.) plans to introduce three bills aimed at improving mental health care for kids, one of his aides told POLITICO. One bill, set to be reintroduced soon, would create grants for children’s mental health services and make them more accessible. Another would help gather more accurate national data on mental health and children, and the third would focus on the mental health of kids in foster care.
    • And children’s health providers tell government leaders it’s now critical that the federal government step up support for an overburdened system, arguing for increased funding for graduate medical education programs and boosted government reimbursement rates for mental health services.

From the Rx coverage front —

  • USA Today discusses challenges related to using the new generation of weight loss drugs. “Drugmakers are working hard to convince Americans they need their next-generation weight loss medications. But many come with side effects – and the fact we don’t really know what happens long-term.”
  • The Wall Street Journal offers an essay about potential uses for inhalable therapies beyond asthma.
    • “We’re pushing the boundaries of delivery,” said Philip Santangelo, a professor of biomedical engineering at Emory University. 
    • Respiratory diseases that spread through the air are a key target. Dr. Santangelo and colleagues are developing inhalable drugs that use an RNA-editing tool known as CRISPR-Cas13 and messenger RNA to kill viruses such as Covid-19, influenza and respiratory syncytial virus or RSV. Using nebulizers that dispense medicine as mist via a mask, they have tested the delivery of some of the medicines on rhesus monkeys, cows, horses and pigs. The tests in pigs showed that getting the drugs to the lungs reduces the severity and spread of infections, Dr. Santangelo said. 

From the medical research front —

  • Forbes reports, “Researchers have uncovered an unusual way some cancer cells make nutrients they need to grow, a discovery that could hold the key to starving one of America’s deadliest cancers [pancreatic] with a drug we already possess and raising hopes for a powerful new treatment against a disease that is often caught late and has one of the lowest survival rates of any cancer.”
  • Fortune Well discusses new developments in cancer testing via blood studies.

Thursday Miscellany

David Ermer–CMS, COVID-19, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

Today is National Employee Benefits Day, a celebration created by the International Foundation of Employee Benefit Plans.

From inside the Capital Beltway —

  • OPM issued a press release on its interim final rule concerning Postal Service Health Benefits Program implementation. That IFR was published in the Federal Register today.
  • Federal News Network reports that members of Congress are pressuring OPM to fix the consistent delays in processing federal employee retirement applications. The straightest path to solving the delay problem is reconfiguring or replacing the current Federal Employee Retirement System that replaced an even more complex Civil Service Retirement System prospectively in the mid-1980s. That is Congress’s responsibility.
  • Govexec tells us that “The Internal Revenue Service will bring on about 30,000 employees over the next two years as it begins spending the $80 billion in new funds Congress provided last year, the Biden administration said in an operational plan it unveiled on Thursday.”
  • Govexec further informs us that
    • On Thursday, President Biden signed an executive order to improve the effectiveness of the regulatory review process and regulatory analysis, which implements his Day One memo.
    • “Parts of the federal regulatory review process haven’t been updated since the 1990s, and since then, we’ve seen substantial advances in scientific and economic knowledge,” wrote Richard Revesz, administrator of the Office of Information and Regulatory Affairs, in a blog post. “These new steps will produce a more efficient, effective regulatory review process that will help improve people’s lives—from protecting children from harmful toxins and lowering everyday costs for families to improving rail safety and growing our economy from the middle out and bottom up.”

From the Rx and medical devices coverage front

  • Fierce Healthcare reports
    • Health and Human Services’ highly publicized list of the first Medicare Part B prescription drugs hit with rebates under the Inflation Reduction Act discreetly dropped from 27 to 20, prompting critiques from the pharma lobby over the Biden administration’s swift implementation of the legislation’s drug controls.
    • As spotted by Endpoints, the press release and accompanying guidelines released by HHS were updated on March 30 with the removal of several previously listed drugs: Gilead’s Yescarta and Tecartus, Bausch + Lomb’s Xipere, Acrotech Biopharma’s Folotyn, Shionogi’s Fetroja, Kamada’s WinRho and Stemline Therapeutics’ Elzonris.
  • MedTech Dive reports
    • Abbott has initiated a recall for [4.2 million] reader [devices] for its FreeStyle Libre glucose monitoring systems, which are at risk of catching fire if improperly stored or charged, according to the Food and Drug Administration. 
    • The agency categorized the recall as Class I, the most serious category of problems with medical devices, which can cause serious injury or death. Abbott noted that users do not need to send the devices back to the company but can continue to use them as long as they use chargers and cables supplied by Abbott with the device. * * *
    • The company has set up a special website with more information for people who use the FreeStyle glucose readers.
    • Abbott said that users can replace the reader with a smartphone app. 
  • Beckers Hospital Review relates
    • The FDA withdrew its approval of Makena, the only preterm birth drug greenlit by the agency, on April 6 after research showed the treatment did not work better than a placebo. 
    • The repealed approval follows an FDA advisory panel voting in favor of removing Makena and the drugmaker announcing it would halt sales. 
  • Beckers Pharmacy News tells us
    • Mark Cuban Cost Plus Drug Co. now sells more brand-name drugs. 
    • After breaking into the brand-name market in March — over a year since launching its online wholesaler company — Cost Plus Drugs offers three brand-name products made by Janssen, a Johnson & Johnson business. Cost Plus Drugs sells about 1,000 generics and four brand-name drugs. 
    • The three products are Invokana (canagliflozin), Invokamet (canagliflozin-metformin HCl) and Invokamet XR (canagliflozin-metformin HCl), according to a Cost Plus Drugs tweet.
    • One of them, Invokana, is a Type 2 diabetes drug that typically costs more than $675, according to Cost Plus Drugs’ website. Mr. Cuban’s company’s price is $243.90. 

From the public health front —

  • JAMA announced the following study results
    • In the first year of the COVID-19 pandemic, 2 US studies suggested that people hospitalized for COVID-19 had nearly 5 times the risk of 30-day mortality compared with those hospitalized for seasonal influenza.1,2 Since then, much has changed, including SARS-CoV-2 itself, clinical care, and population-level immunity; mortality from influenza may have also changed. This study assessed whether COVID-19 remains associated with higher risk of death compared with seasonal influenza in fall-winter 2022-2023.
    • [Based on an examination of Veterans Administration electronic health records] there were 8996 hospitalizations (538 deaths [5.98%] within 30 days) for COVID-19 and 2403 hospitalizations (76 deaths [3.16%]) for seasonal influenza (Table). After propensity score weighting, the 2 groups were well balanced (mean age, 73 years; 95% male).
    • The death rate at 30 days was 5.97% for COVID-19 and 3.75% for influenza, with an excess death rate of 2.23% (95% CI, 1.32%-3.13%) (Figure). Compared with hospitalization for influenza, hospitalization for COVID-19 was associated with a higher risk of death (hazard ratio, 1.61 [95% CI, 1.29-2.02]).
    • The risk of death decreased with the number of COVID-19 vaccinations (P = .009 for interaction between unvaccinated and vaccinated; P < .001 for interaction between unvaccinated and boosted). No statistically significant interactions were observed across other subgroups 
  • The U.S. Preventive Services Task Force released its final research plan for “Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Falls and Fractures in Community-Dwelling Adults: Preventive Medication.”
    • Community-Dwelling means “Community and primary care–relevant settings, including assisted and independent living facilities,” but not inpatient, SNF, or rehabilitation settings.

From the healthcare spending front —

  • Health Payer Intelligence reports
    • The average out-of-pocket spending per non-birth-related pediatric hospitalization was $1,313 for privately insured children, but spending varied depending on the time of the year, chronic condition prevalence, and plan generosity, a study published in JAMA Pediatrics found.
    • Non-birth-related pediatric hospitalizations occur 2.5 million times per year and can lead to high medical costs for privately insured families.
    • Researchers used claims data from 2017 to 2019 from the IBM MarketScan Commercial Database to assess out-of-pocket spending for these hospitalizations and which factors influence this spending.
  • Aon released on April 5
    • findings showing more U.S. employers are looking to steer employees to affordable, quality care options as a way to combat rising medical costs and improve health outcomes.
    • Aon’s 2022 Health Care Survey outlines employer priorities in health and benefits strategies and shows how they are responding to looming health care inflation, which Aon forecasts to rise 6.5% this year to more than $13,800 per employee on average.
    • Data show employers are eager to steer participants toward high-quality, cost-effective hospitals and physicians using a combination of narrow network strategies, plan design, provider guidance services and financial incentives. Thirty-seven percent of employers said they were interested in using plan design to steer members to optimal providers, while 35% already have these plan design features in place.
  • Fierce Healthcare interviews a WTW expert about ways employers can control rising healthcare costs.
    • Last June, the major tracker of inflation—the Consumer Price Index—hit 9.1% but has been receding ever since. Employers should be aware that the healthcare industry will not see a similar reduction in prices and, in fact, should expect costs to rise substantially, according to an expert at Willis Towers Watson.
    • Tim Stawicki, a WTW senior health and benefits consultant, said in a recent blog post that a different dynamic will function in the healthcare industry because contracts lock in negotiated prices, usually for one to three years.
    • When those contracts end, providers will want to make up for profits they may feel that they missed out on, and that’s especially the case in the wake of the COVID-19 pandemic. * * *
    • Stawicki advised employers that they can avoid the worst of this fallout through better management of utilization and reviewing physician networks to make sure that they coincide with an employer’s coverage area that may have changed because of COVID-19. In addition, employers should try to improve the employee experience and implement more cost-effective points of care by steering individuals to urgent care centers or making it easier to use virtual care and choose provider networks based on their geographic footprint.

Midweek Update

David Ermer–CMS, COVID-19, Federal employment benefits, Medicare, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

Govexec and the Federal Times report about yesterday’s release of OPM’s Postal Service Health Benefits Program interim final rule.

Fedweek offers interesting observations on the federal workforce demographics:

“For years, [federal agencies] focused on the “retirement wave”—or still more sweeping, the “retirement tsunami”—when the Baby Boom population hit retirement eligibility. That view continues today, with the constant repetition of statistics such as that 15 percent of the federal workforce is already eligible to retire, and that in five years 30 percent of current employees will be eligible.

“That wave never happened and there is no reason to believe it will.

“What has actually happened is that federal retirements have been a fairly steady flow at around 60,000 to 70,000 each year from agencies apart from the Postal Service (which accounts for about 40,000 more on average). That’s around 3 percent per year, so when it’s five years later, 15 percent or so already have retired and there’s still only 15 percent who are eligible.

“Since those first soundings about a retirement wave, the workforce actually has been increasing in age. The average is now 47—five years older than the overall U.S. workforce—with about 28.7 percent age 55 or above, up by a half-point just in the last six years. The percentage aged 60 and older—which more or less equates to retirement eligibility—rose from 9.4 to 14.5 percent over the last 15 years.”

This is the demographic challenge facing the FEHB Program which is ameliorated by the coordination of benefits with Medicare beginning at age 65. OPM improved the opportunities for coordination of benefits with Medicare by allowing carriers to integrate Medicare Part D prescription drug plans for 2024.

From the public health front —

  • Dana Farber Cancer Institute offers insights into which States have the highest cancer rates.
  • The Department of Human Services announced making progress in the “whole of government” response to long Covid.

“[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, but not for CMV. And testing for the infection in newborns isn’t widespread.”[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, but not for CMV. And testing for the infection in newborns isn’t widespread.

“Through my entire career, it’s been so clear that this field is really lacking in progress,” said Laura Gibson, an infectious diseases physician at UMass Memorial Health. “It’s just been frustrating to all of us in the field over decades.”

“That is starting to change, as state public health committees and legislatures begin to debate whether to mandate doing more robust screening for CMV. In 2019, Ontario became the first region in the world to test every baby for CMV. This year, Minnesota followed suit.”

“Obesity and diabetes in mothers have traditionally been considered risk factors for the child to also develop obesity. But a new study suggests that more narrow measures of health during pregnancy could help better assess that risk.

“Researchers grouped pregnant women based on specific metabolic traits and found that insulin resistance was associated with the highest risk, compared with other traits such as high cholesterol and triglycerides, according to a study published in JAMA Network Open on Tuesday.

“The risk linked to insulin resistance was even higher than that associated with prepregnancy obesity, defined as a body mass index over 30, and with diabetes diagnosed in gestation, the study said.”

From the Rx coverage front —

  • AHIP offers a new resource that “highlights how biosimilars offer an effective, lower-cost alternative to a brand name biologic product. In the last 10 years, for example, $36 billion of biosimilar medication spending was associated with $56 billion in savings. And savings from biosimilars are expected to exceed $180 billion over the next 5 years — a more than 4-fold increase from the last 5 years.”
  • STAT News reports on cancer drug shortages that have plagued our country for years.

From the telehealth front, mhealth intelligence informs us that “According to the FAIR Health Monthly Telehealth Regional tracker, telehealth use increased [7.3%] across the country in January, with rates rising at the national level and in all US Census regions.” My word, telehealth use increased in the winter?!?

Finally, in Medicare Advantage and Part D News, CMS lowered the boom on Medicare Advantage and Part D plans with a new final rule to “strengthen Medicare Advantage and hold health insurance companies to higher standards for America’s seniors and people with disabilities by cracking down on misleading marketing schemes by Medicare Advantage plans, Part D plans and their downstream entities; removing barriers to care created by complex coverage criteria and utilization management; and expanding access to behavioral health care.” This action follows a payment policy and risk adjustment rule compromise last week.

Monday Roundup

David Ermer–CDC, COVID-19, FDA, Rx coverage–
    Photo by Sven Read on Unsplash

    From the Omicron and siblings front, Kaiser Family News reports

    More than three years into the COVID-19 pandemic, about half (53%) the public says they would likely get an annual COVID-19 vaccine if offered similar to an annual flu shot, the latest KFF COVID-19 Vaccine Monitor finds. This includes about a third (32%) who would be “very likely” to do so.
    The findings provide a window into the potential uptake of an annual COVID-19 vaccine, which the Food and Drug Administration has raised as a potential option to provide future protection from the virus. 

    * * *

    • Nearly a quarter (23%) of adults say they’ve gotten the latest bivalent COVID-19 booster, which has been available since September. Similar shares say they have received an earlier booster shot (25%) or have gotten their initial course of vaccinations but no booster (25%). That leaves slightly more than a quarter (27%) who say that they are either partially vaccinated or not vaccinated at all.
    • Half (49%) of adults say they’ve heard at least something about the Biden administration’s plan to end the COVID-19 public health emergency on May 11.

    * * *

    Nearly a third (32%) of all adults nationally say they have never tested positive for COVID-19 or never thought they’ve had the virus, and the new survey examines their experiences. This never-had-it group includes nearly half (46%) of adults ages 65 and older, who generally had earlier access to the vaccines due to their high risks.

    In other public health news

    • “The U.S. Department of Health and Human Services (HHS) released a National Cancer Plan, developed by the National Institutes of Health’s (NIH) National Cancer Institute (NCI). The plan provides a framework for everyone—across the federal government and all of society—to collaborate in ending cancer as we know it, and to realize the vision laid out by President Joe Biden and First Lady Jill Biden’s Cancer Moonshot.”
    • Reuters informs us
      • “The U.S. National Institute on Aging (NIA) is funding a 6-year, up to $300 million project to build a massive Alzheimer’s research database that can track the health of Americans for decades and enable researchers to gain new insights on the brain-wasting disease.
      • “The NIA, part of the government’s National Institutes of Health (NIH), aims to build a data platform capable of housing long-term health information on 70% to 90% of the U.S. population, officials told Reuters of the grant, which had not been previously reported.”
    • Bloomberg Prognosis looks back at the perfect storm of serious ailments that afflicted children worldwide last year. The culprit was socially distancing the kids.

    In FDA and drug development news

    • BioPharma Dive points out five FDA drug decisions to watch for in this quarter. “By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy, two vaccines for RSV and a closely watched ALS drug.”
    • “The U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”
    • The Wall Street Journal offers a fascinating look at how Lilly reengineered its drug development business. The article explained that in the last decade, Lilly focused on non-interference with the patent status of existing blockbuster drugs, e.g., squeezing the last egg out of the golden goose. Late last decade, Lilly redirected its focus to bringing new drugs to market regardless of patent concerns. As a result, Lilly is close to receiving FDA market approval for the “King Kong” of obesity drugs Mounjaro.

    People who are overweight are flocking to the drug Ozempic to slim down. Looming is an even more powerful weight-loss treatment.

    The drug Mounjaro helped a typical person with obesity who weighed 230 pounds lose up to 50 pounds during a test period of nearly 17 months. 

    No anti-obesity drug has ever safely made such a difference. In the coming months, it is widely expected to get the go-ahead from U.S. health regulators to be prescribed for losing weight and keeping it off, and some patients are already using it unapproved for that purpose.

    The advance of Mounjaro, which is already on the market to treat Type 2 diabetes, has excited doctors and patients who have been waiting decades for effective treatments, while helping turn its maker, Eli Lilly & Co., into the most valuable standalone pharmaceutical company in the U.S. with a market value of more than $300 billion.

    Friday Factoids

    David Ermer–ACA, CDC, CMS, Congress, COVID-19, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–
    Photo by Sincerely Media on Unsplash

    The various Covid-19 pandemic-related mandates are tied to the end of the public health emergency and the end of the national emergency. The Administration has told us to expect the end of both emergencies on May 11.

    The CDC’s Covid data tracker and weekly review support ending the emergencies.

    Congress has passed a bill (House Joint Resolution 7) which the President has agreed to sign ending the national emergency upon signing. Mercer Consulting explains:

    During the NE, group health plans have been required to extend certain participant deadlines that would have expired during the “Outbreak Period,” which began March 1, 2020, and will end 60 days after the end of the NE. These deadlines related to:

    • Special enrollment rights under HIPAA
    • COBRA elections, payments and notifications
    • Benefit claims, appeals and external reviews

    Employers will have less time to prepare for the end of the Outbreak Period relief if, as the pending legislation would require, the NE ends before May 11, 2023. Other COVID-19 relief measures, described in this post, are tied to the PHE and are not impacted by the pending legislation.

    This week, regulators provided FAQs and a blog to assist employers preparing for the NE and PHE to end. The FAQs provide many helpful examples illustrating how the extended deadlines available during the Outbreak Period will wind down. However, the FAQs assume that the NE will end on May 11 and the Outbreak Period 60 days later, on July 10. Assuming President Biden signs the legislation ending the NE earlier than May 11, the dates in the FAQs will need to be adjusted.

    Any deadline adjustments for these three mandates impact employers directly and group health plans indirectly. The three mandates had have had limited FEHBP impact.

    Following up on Thursday’s post, MedPage Today offers a broader perspective on Thursday’s Senate Finance Committee PBM hearing. The hearing’s theme was “transparency.” For over ten years, OPM has required FEHB carriers covering most enrollees to use a strict drug pricing transparency system. This has allowed the FEHB to avoid certain practices criticized at the hearing, such a spread pricing, and it facilitates OPM Inspector General audits of the PBMs. However, it takes Congress to address the key economic concern about rebates inflating drug prices discussed at the hearing:

    Karen Van Nuys, PhD, of the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California in Los Angeles, highlighted her 2021 JAMA Internal Medicine research letter that found that Medicare would have saved $2.6 billion in 2018 on 184 drugs if patients had purchased them without insurance at Costco.

    CMS finalized its Medicare Advantage and Medicare Part D payment policies for 2024 today. Of note, Fierce Healthcare reports,

    The Biden administration finalized a proposal to raise Medicare Advantage payments by 3.32% in 2024, slightly above the 1% raise that it proposed. 

    The final payment rule released Friday comes after an intense lobbying campaign from insurers who claimed that the original advance notice released in February would amount to a cut to plans. The agency also finalized changes to the MA risk adjustment model, but will instead phase the changes in over three years as opposed to implementation next year.

    CMS also offered a fact sheet on the final actions.

    From the SDOH front, Health Payer Intelligence informs us

    OMB’s 1997 Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (Directive No. 15). The directive regulates consistency in federal data-sharing and the 1997 iteration emphasized that data gathering practices should seek to mirror the nation’s diversity.

    OMB’s directive requires that data collection include two category options for ethnicity (Hispanic or Latino and Not Hispanic or Latino) and five for race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, and white). In contrast, the Centers for Disease Control and Prevention (CDC) includes over 900 categories for these two designations.

    The directive does not include any requirement to indicate sexual orientation and gender identity (SOGI) data. Very few regulations or standardizing entities do.

    OMB will release changes to Directive No. 15 in 2024.

    Several associations, including AHIP and BCBSA, have commented on the importance of OMB including changes to Directive No. 15 that facilitate health insurer efforts to reduce social determinants of health-related health disparities.

    From the miscellany department —

    • EBRI posted Fast Facts on “High-Cost Health Care Claimants: Health Care Spending and Chronic Condition Prevalence Among Top Spenders.”