Thursday Miscellany

Electronic health records

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, Electronic health records, FDA, Medical / Rx research, NIH, Rx coverage–
Photo by Josh Mills on Unsplash

From Washington, DC, —

  • The New York Times reports
    • “Top White House officials and Republican lawmakers were closing in on Thursday on a deal that would raise the debt limit for two years while capping federal spending on everything but the military and veterans for the same period. Officials were racing to cement an agreement in time to avert a federal default that is projected in just one week.
    • “The deal taking shape would allow Republicans to say that they were reducing some federal spending — even as spending on the military and veterans’ programs would continue to grow — and allow Democrats to say they had spared most domestic programs from significant cuts.
    • “Negotiators from both sides were talking into the evening and beginning to draft legislative text, though some details remained in flux.”
  • The Wall Street Journal adds
    • “The Treasury Department is preparing to change how the U.S. processes federal agencies’ payments if the debt ceiling is breached, dusting off a contingency plan crafted after the 2011 borrowing-limit standoff, people familiar with the matter said.
    • “Just days away from becoming unable to pay all of the government’s bills on time unless Congress raises the debt limit, Treasury officials have been quietly laying the groundwork for potentially delaying some payments after June 1.
    • “Under the backup plan created for a debt-limit breach, federal agencies would submit payments to the Treasury Department no sooner than the day before they are due, the people familiar with the talks said. That would represent a change from the current system, in which agencies may submit payment files well before their due dates. The Treasury Department processes them on a rolling basis, often ahead of the deadlines. Some payments are already sent to the department one day early, one person said. 
    • “The plan would enable the Treasury to make daily decisions about whether it can pay all of the government’s bills the next day.”
  • Back to the New York Times,
    • “The [U.S.] House of Representatives passed legislation on Thursday that would make permanent harsh criminal penalties and strict controls on fentanyl-related drugs, with scores of Democrats joining nearly all Republicans in a vote that reflected the political challenges of tackling what both parties consider America’s most pressing drug crisis.
    • “The bill, approved by a vote of 289 to 133, would permanently list fentanyl-related drugs as Schedule I controlled substances, a designation that mandates severe prison sentences for highly addictive, nonmedicinal chemicals, and which is now set to expire at the end of 2024.
    • “The bipartisan vote reflected agreement among Republicans and a solid bloc of Democrats that stiffening penalties for fentanyl-related drugs is a necessary component of the federal response to the crisis. According to the Centers for Disease Control and Prevention, there were roughly 75,000 synthetic opioid overdose deaths in 2022, with fentanyl being a main culprit.”
  • Federal News Network informs us
    • “With many agencies’ return-to-office plans still uncertain, Republicans on the House Oversight and Accountability Committee want to take matters into their own hands.
    • “GOP committee leaders changed their strategy for trying to get more federal telework data, now reaching out directly to agency heads. In a series of 25 letters, the lawmakers asked for up-to-date  numbers of teleworking federal employees, after saying the Biden administration was “not adequately tracking the specific levels of telework.”
    • “The Biden administration “has not provided current data about the specific amount of telework occurring within federal agencies or across the entire federal workforce. Furthermore, it has provided no objective evidence concerning the impact of elevated telework on agency performance — including any deleterious impacts,” lawmakers said in the letters, published May 18.”

From the Rx coverage front —

  • Today the Food and Drug Administration granted full marketing approval to Paxlovid, the Covid treatment pill, which in the FEHBlog’s opinion, brought us to the end of the pandemic. Here’s a link to a MedPage Today report on this FDA action
  • The Institute for Clinical and Economic Research released “a Final Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH).”
    • “Independent appraisal committee narrowly voted that currently available evidence for resmetirom is adequate to demonstrate a net health benefit over lifestyle management, whereas current evidence for obeticholic acid was deemed inadequate to demonstrate a net health benefit —
    • “ICER analyses suggest resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year assuming that short-term effects on liver fibrosis translate into longer-term reductions in cirrhosis; under the same assumptions, obeticholic acid would achieve common thresholds for cost-effectiveness if priced between $32,600 – $40,400 per year.
    • “Payers should develop coverage criteria based on non-invasive testing to foster equitable access to early detection and treatment across diverse communities.
  • BioPharma Dive tells us
    • “Apellis Pharmaceuticals on Thursday became the latest drugmaker to give up on a potential treatment for amyotrophic lateral sclerosis, a neurodegenerative disorder that has frustrated researchers for decades.
    • “The decision came after a Phase 2 trial showed no benefit for the drug, known as systemic pegcetacoplan, compared with a placebo. It failed to meet the primary endpoint, measured by a statistical tool called the Combined Assessment of Function and Survival, as well as secondary goals assessing overall function, survival, lung function and muscle strength.
    • “The final results weren’t a total surprise; an independent board monitoring the study had already advised the company not to start a second, “open-label” part of the trial that would have offered the medicine to all participants after the initial 52-week research period. Apellis executives had also signaled to analysts that the trial had a low chance of success.”

From the miscellany department —

  • The National Institutes of Health announced
    • “Initial findings from a study of nearly 10,000 Americans, many of whom had COVID-19, have uncovered new details about long COVID, the post-infection set of conditions that can affect nearly every tissue and organ in the body. Clinical symptoms can vary and include fatigue, brain fog, and dizziness, and last for months or years after a person has COVID-19. The research team, funded by the National Institutes of Health, also found that long COVID was more common and severe in study participants infected before the 2021 Omicron variant.
    • The study, published in JAMA, is coordinated through the NIH’s Researching COVID to Enhance Recovery initiative, a nationwide effort dedicated to understanding why some people develop long-term symptoms following COVID-19, and most importantly, how to detect, treat, and prevent long COVID. The researchers hope this study is the next step toward potential treatments for long COVID, which affects the health and well-being of millions of Americans.
  • The New York Times discusses the miraculous case of a paralyzed man who has begun to walk again thanks to brain and spine “implants that provided a “digital bridge” between his brain and his spinal cord, bypassing injured sections” of his body.
  • HealthDay relates
    • “Older Americans are increasingly likely to log into “patient portals” to access their health care information — but confidence levels vary. 
    • “About 78% of people aged 50 to 80 now use at least one patient portal, according to the new University of Michigan (U-M) National Poll on Healthy Aging. 
    • “Five years ago, just 51% in this age range used patient portals, the researchers said. 
    • “The poll also found that 55% of those who used patient portals had done so in the past month. About 49% had accounts on more than one portal. 
    • “This surge is partly due to the increase in use of telehealth visits, said Denise Anthony, the U-M School of Public Health professor who worked on the poll.
    • “This change makes access to secure portals even more important for older adults who want to see their doctors and other health care providers virtually. It also makes the disparities we found in our poll even more troubling,” Anthony said in a Michigan Medicine news release. 
    • “Older adults with annual household incomes below $60,000, and those who were Black or Hispanic, had lower rates of portal use. These groups were also less likely to say they’re comfortable using a portal.”
  • The Washington Post reports
    • “U.S. authorities have seized increasing quantities of illegal ketamine, according to new research, a trend that coincides with the psychedelic drug’s rising popularity as a treatment for mental health ailments.
    • “The number of ketamine seizures by federal, state and local law enforcement in the United States increased from 55 in 2017 to 247 in 2022, while the total weight increased by more than 1,000 percent over that time, according to a letter published Wednesday in JAMA Psychiatry. Most of the ketamine was in powder form, which could raise the risk of being adulterated with deadly drugs such as fentanyl.”

Midweek update

David Ermer–Congress, Electronic health records, End of the PHE, NE, Generative AI, Medical / Rx research–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Wall Street Journal reports
    • “Negotiators worked Wednesday to reach an agreement on reining in government spending, which has emerged as the central hurdle to a deal to raise the debt ceiling, with a possible government default just a week away.
    • “U.S. stocks extended declines Wednesday, reflecting rising anxieties about the debt ceiling, with the Dow Jones Industrial Average posting a fourth-straight session of losses.
    • “The White House has offered a spending freeze for next year, while GOP negotiators have insisted that any deal must result in lower discretionary spending, calling it a critical step in starting to address the country’s growing debt, which now stands at $31.4 trillion.”

Healthcare Dive, MedPage Today, and Fierce Healthcare discuss a House Oversight and Accountability Committee hearing on prescription benefit managers held yesterday.

The House Energy and Commerce Committee cleared a bunch of healthcare-related bills for floor consideration today.

STAT News tells us, “Matt Eyles, CEO of America’s Health Insurance Plans, is leaving by this October, the lobbying group said Wednesday.” Good luck, Mr. Eyles.

From the public health front —

  • Helen Branswell, writing in STAT News, points out
    • :An impressive number of vaccines and monoclonal antibody products are racing toward the end of the development pipeline, with two products aimed at protecting children expected to receive approval from the Food and Drug Administration by autumn. One, a maternal vaccine developed by Pfizer, received a recommendation last week from FDA’s vaccine advisory committee.
    • “But there are sizable hurdles standing in the way of the implementation of these products, hurdles that could see the promise they offer squandered because of bureaucracy, health systems that don’t interact with one another, and steep price tags.”
  • Ms. Branswell discusses the hurdles with experts on the matter.
  • Forbes reports
    • This week, Achieve Life Sciences announced that its drug, cytisinicline, saw strong results in its latest phase III trial. While the drug has been used for decades in eastern Europe, it’s not yet been approved by the FDA. The drug works by targeting the nicotine receptors in the brain, CEO John Bencich tells Forbes. “It works to reduce the satisfaction you get while smoking, but also helps with the cravings and withdrawal symptoms.” 
    • The study, which followed 792 patients, had patients take the drug for either 6 weeks or 12 weeks. Both patients who received the drug and those who got a placebo also went through a behavioral program about quitting smoking. The company says that over 30% of those who took the drug for 12 weeks stopped smoking completely in the last four weeks of the study, compared to less than 10% in the placebo group. For six weeks of treatment, the drug had a nearly 15% success rate compared to 6% in the placebo group. The company saw similar success in a smaller study it reported in the spring on the success of the drug in helping patients quit vaping. Patients will be monitored for 24 weeks after completing the cessation program, and the company expects to file a new drug application with the FDA in the first half of 2024. 
  • This week’s Econtalk podcast offers an interview between host Russ Roberts and University of Chicago economist Casey Mulligan about the macroeconomic angles of public health issues, like the Covid pandemic. Check it out.

From the interoperability front,

  • Fierce Healthcare relates
    • The total number of Epic customers pledging to join the electronic medical record provider in its participation in the Trusted Exchange Framework and the Common Agreement (TEFCA) has jumped to 27. 
    • After announcing the participation of 20 health systems plus health tech company KeyCare and health information exchange OCHIN on Monday, five more organizations have joined the pledge including Kaiser Permanente.
    • According to Matt Doyle, interoperability software development lead at Epic, the EMR company is optimistic that nearly all of the 2,000 hospitals and 600,000 clinicians that use Epic across the country will participate. 
  • Let’s go.

From the generative AI front,

  • Patient Engagement HIT tells us
    • Can ChatGPT really replace doctors? Probably not, at least for right now, as surveying shows that patient trust in chatbots and generative AI in healthcare is relatively low.
    • The report from The University of Arizona Health Sciences showed that around half of patients don’t fully trust AI-powered medical advice, like the information issued from chatbots like ChatGPT. Instead, patients still trust and prefer their traditional healthcare providers.
    • However, patients may be more receptive to chatbot medical advice if the AI is guided by a doctor’s or human’s touch.

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.

Weekend update

David Ermer–Congress, COVID-19, Electronic health records, FDA, SDOH–
Photo by JOSHUA COLEMAN on Unsplash

The Senate and the House of Representatives will be in session this week for Committee business and floor voting.

As we close out Black History Month, let’s join the Trust for American Health in celebrating notable African American in public health.

From the Covid front, the Wall Street Journal reports

The U.S. Energy Department has concluded that the Covid pandemic most likely arose from a laboratory leak, according to a classified intelligence report recently provided to the White House and key members of Congress.

The shift by the Energy Department, which previously was undecided on how the virus emerged, is noted in an update to a 2021 document by Director of National Intelligence Avril Haines’s office.

The new report highlights how different parts of the intelligence community have arrived at disparate judgments about the pandemic’s origin. The Energy Department now joins the Federal Bureau of Investigation in saying the virus likely spread via a mishap at a Chinese laboratory. Four other agencies, along with a national intelligence panel, still judge that it was likely the result of a natural transmission, and two are undecided.

From the miscellany department —

  • Fortune Well provides us with insights on how to manage a life-threatening diagnosis.
  • Health Payer Intelligence tells us what payers can expect to find in the proposed CMS electronic prior authorization rule. The public comment deadline on the rule is March 13, 2023

Friday Factoids

David Ermer–CDC, COVID-19, Electronic health records, FDA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Errata — In Thursday’s post, the FEHBlog’s item on the CDC action concerning Alzheimer’s Drug coverage in Medicare should say that the CDC was NOT changing its position that such coverage is limited to clinical trials.

From the No Surprises Act front, U.S. District Judge Jeremy Kernodle modified the NSA’s independent dispute resolution (IDR) arbitration rule on February 6 so it does not skew in favor of the statutory qualifying payment amount. The FEHBlog personally marked up the relevant portion of the IDR rule to show the edits. The FEHBlog, who represents health plans, does not find the edits earthshaking.

The NSA regulators sensibly told the NSA arbitration community to stop issuing arbitration awards while considering the next steps. This afternoon, the American Hospital Association tells us that an interim step was announced.

Effective Feb. 27, certified independent dispute resolution entities will resume issuing payment determinations for payment disputes involving out-of-network services and items furnished before Oct. 25, 2022, the Centers for Medicare & Medicaid Services announced. CMS has posted guidance for certified IDRs issuing payment determinations for items and services furnished before Oct. 25, 2022.
 
“The standards governing a certified IDR entity’s consideration of information when making payment determinations in these disputes are provided in the October 2021 interim final rules, as revised by the [February 2022] opinions and orders of the U.S. District Court for the Eastern District of Texas ” CMS said. [This refers to the FEHBlog’s edited portion of the IDR rule without the Judge’s Feburary 6, 2023 edits.]
 
The agency said IDRs will hold issuance of payment determinations for items or services furnished on or after Oct. 25, 2022 until the departments of Health and Human Services, Labor,The and the Treasury issue further guidance.
 

There you go.

From the public health front, the CDC’s Covid Data Tracker new cases, hospitalizations, and deaths continue their downward trend, while the CDC’s weekly interpretative review of its Covid data notes that “As of February 23, 2023, there are 67 (2.1%) counties, districts, or territories with a high COVID-19 Community Level, 655 (20.3%) with a medium Community Level, and 2,498 (77.6%) with a low Community Level [of the disease].

Sign of the times — the CDC Weekly Review is moving to a bi-weekly schedule.

The CDC’s FluView, which will shut down at the traditional end of the flu season, reports, “Seasonal flu activity is low nationally.”

Meanwhile, the Food and Drug Administration announced issuing

an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes. 

In other public health news

  • Healio informs us
    • People with many low-risk sleep factors had reduced all-cause, CV and cancer mortality risk vs. those with one or no low-risk sleep factors, according to data slated for presentation at the American College of Cardiology Scientific Session.
    • “We saw a clear dose-response relationship, so the more beneficial factors someone has in terms of having higher quality of sleep, they also have a stepwise lowering of all cause and cardiovascular mortality,” Frank Qian, MD, an internal medicine resident physician at Beth Israel Deaconess Medical Center and a clinical fellow in medicine at Harvard Medical School, said in a press release. “These findings emphasize that just getting enough hours of sleep isn’t sufficient. You really have to have restful sleep and not have much trouble falling and staying asleep.”
  • The Washington Post reports
    • One in five Americans will experience major depressive disorder in their lifetime, and many will not find relief from current therapies. But now researchers have identified an unexpected source of the problem: inflammation.
    • Inflammation in the body may be triggering or exacerbating depression in the brains of some patients. And clinical trial data suggests that targeting and treating the inflammation may be a way to provide more-precise care.
    • The findings have the potential to revolutionize medical care for depression, an often intractable illness that doesn’t always respond to conventional drug treatments. While current drug treatments target certain neurotransmitters, the new research suggests that in some patients, depressive behaviors may be fueled by the inflammatory process.
  • The Powerline Blog shares eye-catching charts on the U.S. population’s gray wave.

From the wearables front —

  • mHealth Intelligence relates
    • In 2023, about 40 percent of U.S. adults are using healthcare-related applications, and 35 percent are using wearable healthcare devices, a new survey shows.
    • Released by Morning Consult, the survey polled 2,201 adults between Jan. 23 and Jan. 25. The results were compared to a previous Morning Consult poll conducted in December 2018 among 2,201 adults.
    • The 2023 survey shows gains in health app and wearables use. While health app use jumped 6 percentage points from 2018, wearables use increased by 8 percentage points.
    • Health app and wearables use varied across age groups, according to the survey. Forty-seven percent and 40 percent of respondents aged 18 to 34 used health apps and wearables, respectively, compared to 30 percent and 25 percent of adults over 65.
    • Of those who said they used health apps and wearables, most use them daily.
  • Bloomberg adds that “Apple Makes Major Progress on No-Prick Blood Glucose Tracking for Its Watch.” Completion of the moonshot project remains “years away.”

From the miscellany department

  • Beckers Hospital Review relies on the Harvard Business Review to identify “four measures needed to create shoppable healthcare beyond price transparency.”

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19, Electronic health records, FDA, Mental health care, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From our Nation’s capital

  • Govexec informs us that the President “doubled down Thursday on his administration’s commitment to using the federal government’s power to support underserved communities and advance racial equity.  A new executive order issued by the president builds on one he signed his first day in office as well as other executive and legislative actions.”
  • “The U.S. Office of Personnel Management (OPM), Department of Labor, and Office of Management and Budget (OMB) have developed and launched a new portal on USAJOBS for prospective Federal interns. Located at intern.usajobs.gov, the Federal Internship Portal is a one-stop shop for prospective interns to find opportunities and apply for internships in the Federal government.”
  • The Senate Commerce, Science and Transportation Committee held a hearing on PBM transparency and accountability, which Fierce Healthcare describes as the hearing as “heated.”
  • The Senate Health, Education, Labor and Pensions Committee held a hearing on healthcare workforce shortages, which Fierce Healthcare describes as the beginning of “a major effort to shore up the healthcare workforce after lingering shortages have roiled the industry.”
  • The U.S. Commissioner of Food and Drugs updated the public on his agency’s efforts prevent drug overdoses and reduce deaths.
    • In related news from MedPage Today, “Advisors to the FDA unanimously recommended the agency approve the first over-the-counter (OTC) naloxone (Narcan) product, though many committee members expressed continued concern about user instructions for the opioid overdose reversal drug. * * *While the FDA is not required to follow the recommendations of its advisory committees, it typically does.”

From the medical research front

  • STAT News tells us, “A team of researchers from Stanford and University of California San Francisco have built a predictive model that uses electronic health records to calculate the risk of sepsis, cerebral palsy, and other serious conditions in newborns. The team trained a deep learning model on health records from more than 30,000 mother-newborn pairs treated in the Stanford health system, building a neural network that could predict 24 different health outcomes. The researchres, who also published an interactive website for readers to explore the network’s data. said the predictions outperformed currently-used risk scores.” 
  • Nature explains “How a pioneering diabetes drug teplizumab offers hope for preventing autoimmune disorders. Approving an antibody therapy that pauses the progression of type 1 diabetes is a first in the field, and some say, a model for other drug developers.
  • The National Institutes of Health disclosed that “Black and Hispanic Americans appear to experience more symptoms and health problems related to long COVID, a lay term that captures an array of symptoms and health problems, than white people, but are not as likely to be diagnosed with the condition, according to new research funded by the National Institutes of Health. The findings – from two different studies by NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative – add to a growing body of research aimed to better understand the complex symptoms and other issues associated with long COVID that millions have experienced.”
  • The All of Us program shared its research roundup, focusing on heart disease this month.
  • The Robert Wood Johnson Foundation offers an award-winning scholar’s “Lessons From the Intersection of Race, Inequality, and Health.”
  • The Institute for Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH). This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“

From the U.S. healthcare business front —

  • Beckers Payer Issues identified over thirty payers who made Forbes rankings of top U.S. employers.
  • Beckers also reports, “A federal judge granted Cigna a temporary restraining order in its lawsuit alleging former executive Amy Bricker’s departure for rival CVS Health violated a noncompete agreement, Bloomberg Law reported Feb. 15.”  A TRO is a short duration order that allows the court time to consider awarding a preliminary injunction.
  • According to Healthcare Dive
    • CommonSpirit Health announced Wednesday that it will acquire regional health system Steward Health Care in Utah for $685 million.
    • The deal marks CommonSpirit’s entry into Utah, expanding the hospital operator’s footprint to a total of 22 states.
    • CommonSpirit will acquire five hospitals from Steward, along with more than 40 clinics and other ambulatory services, the system said. The deal is expected to close later this year. CommonSpirit’s Centura Health will manage the Utah sites.
  • Also from Healthcare Dive
    • Wednesday is the last day that LHC Group will trade on the Nasdaq, suggesting UnitedHealth will complete its acquisition of the home health business prior to market open on Thursday.
    • LHC’s stock will be halted aftermarket on Wednesday, according to a Nasdaq notice. As a result, the merger is tentatively scheduled to close the next morning, subject to pending regulatory approvals.
    • Speculation that the Federal Trade Commission will move to block the $5.4 billion deal has been rampant, but reports late last month suggest that regulators are unlikely to challenge the transaction. 
    • Louisiana-based LHC is a major player in the home health space, with more than 960 locations in 37 states and $2.2 billion in revenue last year
  • The Baton Rouge Business Report discusses a foundation that would be created in the wake of the Blue Cross and Blue Shield of Louisiana sale would have more than $3 billion in assets. The Accelerate Louisiana Initiative, as the foundation would be called, would be one of the largest private foundations in the nation, says Cindy Wakefield with BCBSLA. 
  • Fierce Healthcare reports, “EHR provider Elation Health announced its acquisition of medical billing company Lightning MD. The growth adds a piece to the Elation puzzle as it seeks to become the sector’s first all-in-one technology solution for primary care practices, the company said.”

From the miscellany department —

  • Health Payer Intelligence reports, “AHIP Asks CMS to Reconsider Proposed Medicare Advantage Policy Changes. The extensive policy changes included in the proposed rule will negatively impact Medicare Advantage beneficiaries and plans, AHIP said.” It’s easier to write up orders than to implement them.
  • CMS announced that “a new chart titled Top 10 Section 111 Group Health Plan Reporting Errors, covering the July 1 – December 31, 2022, is now available in the Download section below.  Descriptions of these and all reporting errors are available for review in the GHP User Guide.”
  • WTW explains “What the end of the COVID-19 emergencies will mean for group health plans.”

Tuesday Tidbits

David Ermer–CDC, CMS, COVID treatment, Electronic health records, FDA, Medicare, Mental health care, NCQA, Rx coverage, Telehealth–
Photo by Laura Ockel on Unsplash

From the Omicron and siblings front, HealthDay tells us

Paxlovid remains a powerful weapon against the Omicron variants BA.4 and BA.5, new research shows

The antiviral continued to protect against hospitalization and death in patients [including the immunocompromised] who took it

Research is ongoing to see if Paxlovid also guards against newer Omicron variants such as XBB.1.5 and BQ.1

From the public health front —

  • Medscape reports that the five-year survival rate in pancreatic cancer is increasing.
  • MedPage Today explains that while there’s no ‘Recipe’ to reduce dementia risk, here’s how to discuss it with patients until more evidence emerges.
  • The U.S. Preventive Services Task Force reaffirmed a Grade D recommendation against routine serologic screening for genital herpes simplex virus infection in asymptomatic adolescents and adults, including pregnant persons.

From the healthcare quality front

  • Beckers Hospital Review shares Healthgrades’ 2023 list of top hospitals for joint replacement by state.
  • The National Committee for Quality Assurance opened its 2023 HEDIS public comment period yesterday. The comment period closes on March 13.

From the Medicare front —

  • The Department of Health and Human Services unveiled three models for reducing prescription drug costs charged to Medicare beneficiaries, including two-dollar generic drug prescriptions for Medicare Part D.
    • “Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans participating in the Model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug”.
  • Beckers Payer Issues reports, “Medicare beneficiaries who enroll in a Medicare Advantage plan may need less retirement savings to cover their healthcare costs, an analysis published Feb. 9 by the Employee Benefits Research Institute found.”
  • Fierce Healthcare informs us
    • “Health insurers and the Biden administration are at loggerheads over whether Medicare Advantage (MA) plans will see a pay cut next year, the ramifications of which come amid increased regulatory scrutiny for the popular program.
    • “Insurer groups and some politicians charge that the latest 2024 payment rule will wind up being a 2.27% cut to MA plans after considering risk adjustment changes and other factors. The Centers for Medicare & Medicaid Services (CMS) has pushed back, arguing that isn’t true.”
  • STAT News relates, “Medicare advisers on Tuesday recommended that the program alter its requirements for drugs, diagnostics, and medical devices that face coverage restrictions [such as the Biogen Eisai Alzheimers Disease drugs] to make the process more transparent and better incorporate diversity data.”
    • Speaking of which, USA Today reports
      • One in 10 new drugs was cleared by federal drug regulators in recent years based on studies that didn’t achieve their main goals, a new study shows.
      • The study by Harvard and Yale researchers found that of 210 new therapies approved by the Food and Drug Administration from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or endpoints, that wasn’t achieved. Those 21 drugs were approved to treat cancer, Alzheimer’s and other diseases.
      • Researchers said the findings raise questions about whether the federal agency’s drug approvals lack transparency about some products’ safety and effectiveness. 

In hospital pricing transparency news —

  • Healthcare Dive discusses a JAMA-published study of available hospital pricing data, which produced head-scratching results.
  • Beckers Hospital Review explains four ways CMS is trying to improve hospital price transparency in 2023. Good luck with that.

From the HR department

  • The Society for Human Resource Management tells us
    • “Employers need to understand that the timeline for submitting their demographic data to the U.S. Equal Employment Opportunity Commission (EEOC) is somewhat different this year. The agency recently confirmed that EEO-1 reporting for 2022 data is scheduled to begin in mid-July. In recent years, the starting points and deadlines for data collection have varied.”
    • “All private employers with 100 or more employees and federal contractors with 50 or more employees must file EEO-1 reports each year that summarize employee headcount by sex, race/ethnicity, and job category. This component of data collection, called Component 1, does not include pay data.
  • HR Dive explores how the Pregnant Workers Fairness Act protects pregnant workers beginning this June and how do those accommodations stack up to the federal Family and Medical Leave Act? 
  • HR Dive also notes, “Short breaks of fewer than 20 minutes taken by hourly, non-exempt employees who telework or must be counted as compensable time under the Fair Labor Standards Act — as is the case for employers working from an employer’s own location — Jessica Looman, principal deputy administrator of the U.S. Department of Labor’s Wage and Hour Administration, wrote in a Field Assistance Bulletin published Thursday.”

From the tidbits department

  • Healio advises “Adolescents and young adults with type 1 diabetes who primarily attend diabetes clinic visits via telehealth have better overall attendance and less diabetes distress compared with those who attend in person, according to study data.”
  • MedCity News states, “Since the start of the Covid-19 pandemic, there has been a 23% increase in alcohol abuse and a 16% increase in drug abuse, and people in self-isolation reported a 26% higher consumption than usual, according to the National Library of Medicine. Some apps are trying to meet this need, including Sober Sidekick and SoberBuddy.”

Tuesday’s Tidbits

David Ermer–COVID-19, Electronic health records, FDA, No Surprises Act, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC, the Society for Human Resource Management tells us that Labor Secretary Marty Walsh will be leaving his position to become head of the National Hockey League (NHL) Players’ Association, according to news reports. 

In other regulatory news, Health Payer Intelligence reports

The Alliance of Community Health Plans (ACHP) was among around 50 organizations—including AHIP and Blue Cross Blue Shield Association—to sign a letter to HHS that supported fully aligning the substance use disorder patient data requirements in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) with the Health Insurance Portability and Accountability Act (HIPAA).

The group noted that the proposed rule falls short of this goal.

Also, the Office of National Coordinator of Health IT announced that “On Monday, February 13, HHS will recognize the first set of applicant organizations that are approved for onboarding as Qualified Health Information Networks (QHINs) under TEFCA.” The ongoing launch of TEFCA, which will serve as a backbone for the country’s electronic health record systems, is exciting.  

From the Omicron and siblings front —

  • The Kaiser Family Foundation’s Covid Vaccine Monitor informs us “nearly four in ten households (38%) were affected by this winter’s” tripledemic. The flu affected the largest share of households (27%), followed by Covid (15%) and RSV (10%). “At the same time, almost three years into the COVID-19 pandemic, most of the public says they are “not too” or “not at all” worried about getting seriously ill from the virus (69%), though 31% still say they are worried.”
  • The Food and Drug Administration offers step-by-step guidance on reporting Covid test results to public health authorities.

From the public health front,

  • Health Affairs discusses an interesting study finding: “A high prevalence of mental health diagnoses in adults alongside ongoing shortages of mental health specialists and expansion of the patient-centered medical home has increased the involvement of primary care clinicians in treating mental health concerns.” 
  • McKinsey and Company offer the following interview: “McKinsey Global Publishing’s Eleni Kostopoulos chats with Alex Jadad and Tamen Jadad-Garcia about their new book, Healthy No Matter What: How Humans Are Hardwired to Adapt (Penguin Random House, January 2023). Dr. Jadad created the widely popular Jadad scale for assessing clinical trials. Now, he’s combining his medical expertise with his daughter’s health entrepreneurship to explore what it truly means to be ‘healthy’.”

From the No Surprises Act front, Becker’s Payer Issues reports on a February 6, 2023, opinion from the Eastern District of Texas striking down certain provisions of the latest independent dispute resolution rule. Judge Kernodle considers those stricken provisions to conflict with the statute by placing too much emphasis on one of six factors that the law allows the arbitrator to consider: the health plan’s qualified payment amount. The FEHBlog doubts that this decision will immediately impact the IDR process, which continues to be quite bogged down. Providers should emphasize resolving billing disputes during the initial open negotiation period. Regardless, the plaintiff Texas Medical Association has two more NSA issues pending before the good Judge.

From the fraud, waste, and abuse front, the Justice Department announced that False Claims Act settlements and judgments exceeded $2 billion in fiscal year 2022. “[H]ealth care fraud remained a leading source of False Claims Act settlements and judgments.”

From the U.S. healthcare business front

  • Fierce Healthcare tells us that Health insurer Centene announced its fourth-quarter 2022 financial results today.
  • Medcity Today relates, “The U.S. healthcare system spent $60 billion on administrative tasks last year, which is about $18 billion more than it spent in 2021, according to a new report from the Council for Affordable Quality Healthcare (CAQH).” The report attributed the increase to a labor shortage and greater utilization of healthcare services in 2022.
  • The Drug Channels blog assesses biosimilar challenges to Humira.

Monday Roundup

David Ermer–ACA, CMS, COVID-19, Electronic health records, Medicare, OPM, Patient safety, U.S. Healthcare–
    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.