FEHBlog

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19 vaccine, FDA, Medicare, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The Senate Finance Committee held a hearing today on “Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers.” Fierce Healthcare reports

Sen. Ron Johnson, R-Wisconsin, said during the hearing that “this whole area is ripe for gamesmanship.” He then asked Matthew Gibbs, PharmD and Capital Rx President, what Capital Rx’s model would bring to the table that sets it apart from other players like Amazon or Mark Cuban Cost Plus Drug that are aiming to shake up the traditional PBM space.

Gibbs emphasized Capital Rx’s focus on transparency, something that sets it apart in the broader market.

“Using a price index like NADAC, which is published by CMS, they actually do the survey of the pharmacies, and getting it more robust so that it’s not voluntary—today it’s a voluntary survey—and getting responses to that will lead us to the actual drug costs,” Gibbs said. “And then you can have your nuances of Costco, Mark Cuban. And the person can actually go in and look and actually be informed about the real prices once and for all. The only way is to level set.”

“We have the tools already,” he said. “We just need to employ them.”

Meanwhile, the National Council of State Legislatures discusses the wide variety of state laws being imposed on PBMs, which only complicates matters.

In Affordable Care Act New, MedPage Today reports, “A federal judge on Thursday struck down the Affordable Care Act (ACA) provision requiring all insurers to cover certain preventive services free of charge, angering the law’s supporters.” The FEHBlog won’t delve into this case now because he expects the U.S. Court of Appeals for the Fifth Circuit to promptly stay this decision.

From the Omicron and siblings front, WebMD tells us

The CDC has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website now explains.

16.4% of people in the U.S. have gotten the latest booster that was released in September, CDC data shows.

MedPage Today opines on a World Health Organization “Booster Update: Here’s What They Got Right and Wrong.”

In FDA / drug development news —

  • Beckers Hospital Review reports
    • On May 9 and May 10, an FDA advisory panel will discuss whether to recommend the agency approve what could be the first over-the-counter birth control pill. 
    • The pill, a 0.075-milligram norgestrel tablet [manufactured by French drugmaker Laboratoire HRA Pharma], “is proposed for nonprescription use as a once-daily oral contraceptive to prevent pregnancy,” according to a document published March 29 on the Federal Register.
  • BioPharma Dive informs us
    • “Johnson & Johnson will stop developing its experimental vaccine for respiratory syncytial virus in an unexpected retreat from a high-profile research effort that had put the pharmaceutical giant among the leading companies seeking to win the first approval of a preventive shot.
    • “The company said Wednesday it will discontinue a 23,000-person Phase 3 trial, called Evergreen, of its RSV vaccine in adults following a review of its drug pipeline. The company does not plan to develop the shot for pregnant women or infants, a spokesperson confirmed.
    • “J&J’s pullback comes amid a restructuring of its infectious disease division, which was reported by Fierce Pharma in February. Its decision also thins the RSV vaccine competition, leaving GSK and Pfizer in the lead with shots that are currently under review by the Food and Drug Administration. Moderna is also developing an RSV vaccine and could file for approval this year.”

From the U.S. healthcare business front —

Healthcare Dive relates

  • Walgreens’ growing U.S. healthcare segment is continuing to bolster the retail health chain’s financial performance. The business, which includes value-based provider VillageMD, recorded $1.6 billion in sales in the second quarter, an increase of $1.1 billion from last year.
  • VillageMD sales were up 30%, including a boost from its recent acquisition of medical group Summit Health. Specialty pharmacy Shields Health Solutions grew sales 41%, while at-home care provider CareCentrix’s sales were up 25%.
  • Thanks in part to a jump in revenue in its healthcare segment, Walgreens’ results beat Wall Street expectations even as profit declined more than 20% amid lower COVID-19 vaccine volumes and test sales, higher salary costs, opioid litigation charges and costs associated with its $3.5 billion investment in its Summit acquisition.

and

  • Oak Street Health disclosed on Thursday that the antitrust waiting period for its planned sale to CVS Health has expired.
  • CVS and Oak Street filed the required notification forms under the Hart-Scott-Rodino Act with the Department of Justice and Federal Trade Commission on Feb. 24. The waiting period under the HSR Act ended Monday, according to a new proxy filing from Oak Street.
  • The disclosure means the $10.6 billion deal has cleared one regulatory hurdle — companies can’t consummate mergers until the HSR waiting period expires — but regulators could still challenge the acquisition on antitrust grounds in the future.

From the healthcare studies front —

  • Bloomberg tells us the story behind a breast cancer scare. Last week, I noticed a breast cancer study report that struck the FEHBlog as overblown, and it turns out that this report is the breast cancer scare that Bloomberg discusses.
  • NBC News reports
    • “Losing weight — even if some pounds are gained back — may help your heart over the long term, according to a study published Tuesday in the journal Circulation: Cardiovascular Quality and Outcomes.
    • “The findings may be welcome news to those who have found it difficult to keep weight off and feared the risks thought to be associated with gaining weight back.
    • “In the new study, researchers analyzed data from 124 clinical trials with a total of more than 50,000 participants. They found that risk factors for heart disease and Type 2 diabetes decreased for people who lost weight through intensive behavioral programs. The diminished risk persisted for years after they were done with the programs, even if some, but not all, of the weight came back.”
    • “The whole time your weight is less than it would otherwise have been, your risk factors for heart disease are lower than they would have been,” co-author Susan Jebb, a professor of diet and population health at the University of Oxford in the United Kingdom, said in an email.
  • The Centers for Disease Control announced 
    • The expanded availability of opioid use disorder-related telehealth services and medications during the COVID-19 pandemic was associated with a lowered likelihood of fatal drug overdose among Medicare beneficiaries, according to a new study.
    • “The results of this study add to the growing research documenting the benefits of expanding the use of telehealth services for people with opioid use disorder, as well as the need to improve retention and access to medication treatment for opioid use disorder,” said lead author Christopher M. Jones, PharmD, DrPH, Director of the National Center for Injury Prevention and Control, CDC. “The findings from this collaborative study also highlight the importance of working across agencies to identify successful strategies to address and get ahead of the constantly evolving overdose crisis.”

From the healthcare quality front, Beckers Hospital Review relates

CVS and Optum have struggled to integrate behavioral health into their payer-provider models, Behavioral Health Business reported.

For Optum, the challenges lie in integrating all the different IT systems from the providers the company has bought, Trip Hofer, the CEO of Optum Behavioral Health Solutions, said at the news outlet’s VALUE conference. For example, Optum in 2022 acquired Kelsey Seybold Clinic, a medical group in Houston with 500 healthcare professionals.

“Kelsey Seybold says, ‘Trip, here’s my issue. I have access problems for depression, stress and anxiety for adults.’ And I’m like, ‘Well, we have a ton of solutions for you,'” Mr. Hofer said, according to the March 27 story. “Six months later, we still can’t get it implemented because it’s like, ‘Well, how do I get data back to them?'”

Deborah Fernandez-Turner, DO, deputy chief psychiatric officer of CVS payer subsidiary Aetna, said at the conference that it’s time-consuming and complex to build behavioral health into payer-provider companies.

CVS, for instance, has started bringing mental health providers and virtual behavioral health access into its MinuteClinics, according to the story.

Keep on truckin’

The FEHBlog had planned to discuss the OPM-AHIP carrier conference in this post. However, the second day of the conference was postponed today due to a power outage affecting the webinar operations. The second day will be rescheduled, and the FEHBlog will bring readers up to date then.

Midweek Update

David Ermer–Uncategorized–

This afternoon, the Affordable Care Act regulators issued FAQ 58 guiding health plans, including FEHB plans, on handling the end of the Covid public health emergency (PHE), which will happen on May 11.

Coverage of Covid diagnostic tests after May 11 (Bold items are the government’s, and italicized items are the FEHBlogs:

Section 6001 of the [Families First Coronavirus Relief Act] FFCRA requires plans and issuers to cover COVID-19 diagnostic tests that meet statutory requirements and certain associated items and services without imposing any cost-sharing requirements, prior authorization, or other medical management requirements. However, that requirement is applicable only to diagnostic tests and associated items and services furnished during any portion of the PHE beginning on or after March 18, 2020. Therefore, a plan or issuer is not required under section 6001 of the FFCRA to cover COVID-19 diagnostic tests and associated items or services furnished after the PHE ends.

Any plan or issuer that provides coverage for COVID-19 diagnostic testing furnished after the PHE ends, including over-the-counter (OTC) COVID-19 diagnostic tests purchased after the PHE ends, is not prohibited from imposing cost-sharing requirements, prior authorization, or other medical management requirements for those items and services under section 6001 of the FFCRA. However, plans and issuers are encouraged to continue to provide this coverage, without imposing cost sharing or medical management requirements, after the PHE ends

The Departments do not explain the closing sentence.

Coverage of approved Covid vaccines post-PHE

On May 12, approved Covid vaccines will be subject to the Affordable Care Act’s preventive services mandate. Consequently, they remain fully covered with no cost sharing when delivered in-network. Out-of-network coverage depends on the plan brochure (FEHB) or SPD (ERISA) language.

HSA, HRA, and FSA reimbursement of Covid testing and treatment is unaffected by the end of the PHC

Notice to members

The Departments encourage plans and issuers to notify participants, beneficiaries, and enrollees of key information regarding coverage of COVID-19 diagnosis and treatment, including testing. This includes the date when the plan or issuer will stop coverage if the plan or issuer chooses to no longer cover COVID-19 diagnostic tests or when the plan or issuer will begin to impose cost-sharing requirements, prior authorization, or other medical management requirements on COVID-19 tests, to the extent applicable under the plan or coverage. The Departments also encourage plans and issuers to continue covering benefits for COVID-19 diagnosis and treatment and for telehealth and remote care services after the end of the PHE.

The Departments then provide specific guidance to ERISA plans concerning notice, COBRA, etc. Nevertheless, the FEHBlog suggests that FEHB plans treat this as a requirement in the absence of OPM guidance.

In other top news of relevance to the FEHBP:

  • The Food and Drug Administration gave Narcan nasal spray over-the-counter status. Narcan’s manufacturer expects that OTC Narcan, which can save the lives of people struck down by an opioid overdose, will appear on pharmacy shelves in September, according to the Wall Street Journal.
  • Beckers Hospital News tells us,
    • “UnitedHealthcare, Aetna and Cigna are moving to trim their prior authorization programs, which providers have criticized as burdensome, The Wall Street Journal reported March 29. 
    • “Starting in the third quarter of 2023, UnitedHealthcare will remove several procedures and medical devices from its list of services requiring prior authorization, according to the report. It also said it would eliminate many prior authorization requirements for gold-card doctors and hospitals beginning next year. 
    • “We’re not deaf to the complaints out there,” Philip Kaufman, UnitedHealthcare’s chief growth officer, told the Journal. “We’ve taken a hard look at ourselves and this process.”
    • “The payer processes about 13 million prior authorization requests a year out of about 600 million claims, according to the report. Officials said the changes are projected to reduce the number of prior authorization to about 10 million per year. 
    • “Cigna said it has been removing prior authorization requirements for about 500 services and devices since 2020, according to the report. Aetna said it is working to automate and simplify the prior authorization process. 
    • “American Medical Association President Jack Resneck Jr., MD, told the Journal he is cautiously optimistic about UnitedHealthcare’s changes but wants to see the details to be sure they will bring meaningful improvements.”
  • FedWeek points out the OPM Inspector General issued an evaluation report on telehealth utilization during the pandemic earlier this month.
    • “In a sampling of telehealth claims, auditors found more than 2,000 related to services that “could not be performed via telehealth”—including for laser surgery, anesthesia, injections and colonoscopies—and billing for procedures incompatible with the provider’s specialty.
    • “However, OPM management disagreed with the IG’s recommendations in those areas, for example pointing out that telehealth is a well-established concept. 
    • “The IG in turn disagreed, saying that “While telehealth is not a new offering in the FEHB, the variety of services offered and the technologies utilized have increased. When combined with the overall increase in telehealth utilization, we believe increased scrutiny and increased protections are both warranted moving forward.”

In U.S.healthcare business news, Healthcare Dive informs us

CVS closed its $8 billion acquisition of Signify on Wednesday. In a statement, CVS CEO Karen Lynch said the transaction will advance the company’s value-based care strategy by enhancing its presence in the home.

CVS and Signify will work on care delivery and engagement particularly for Medicare Advantage customers, according to a release on the deal’s close.

In conference news, Fierce Healthcare continues to report from the ViVE 2023 healthcare tech conference here and here. The FEHBlog will summarize his thoughts on the OPM carrier conference in Thursday’s post.

Tuesday’s Tidbits

David Ermer–Uncategorized–
Photo by Patrick Fore on Unsplash

In FEHB news, Federal News Network interviews Kevin Moss, editor of Consumers’ Checkbook Guide to Health Plans for Federal Employees, about OPM’s approving the use of Medicare Part D EGWPs in FEHB plans for 2024. Mr. Moss shares the FEHBlog’s excitement about this cost-saving development. Two nifty features of Medicare Part D EGWPs in contrast to Medicare Advantage Prescription Drug plans are that Medicare Part A only annuitants can enroll in them and the Plan’s prescription drug benefits can gap fill them. However, Mr. Moss indicates for 2024 and beyond, the gaps in Part D coverage are fewer. In addition, the OPM AHIP carrier conference, which begins tomorrow, will feature a session on Medicare Part EGWPs.

The carrier conference also provides a session on Social Determinants of Health. In addition, the Agency for Healthcare Quality and Research reminded us today about the availability of its October 2022 National Healthcare Quality and Disparities Report.

From the public health front —

  • WebMD tells us
    • “Good news and bad news on the long COVID front: Certain groups of people – like women, smokers, and those who had severe COVID-19 infections – are at a higher risk of long COVID, a review of more than 800,000 patients has found. 
    • “That’s the bad news. Yet, researchers also found that patients who had at least two doses of the COVID vaccine had a significantly lower risk of getting long COVID down the line.”
  • The NIH Directors Blog discusses using a whole-person approach to lifting the burden of chronic pain from service members and veterans. This approach is currently in use at VA facilities.
  • Healio tells us about a retrospective atrial fibrillation (AF) diagnosis study.
    • “In a retrospective study, Turakhia and colleagues analyzed patient information from five U.S. medical claims data sets from 2012 to 2017. Researchers estimated undiagnosed AF based on the observed incidence of ischemic stroke, systemic embolism and AF incidence after a stroke or systemic embolism.
    • “The estimated U.S. prevalence of AF (diagnosed and undiagnosed) in the third quarter of 2015 was 5,628,000 cases, of which 11% were undiagnosed. 
    • “The assumed 2‐year undiagnosed AF prevalence was 23% of the total prevalent patients with AF. Compared with diagnosed patients, those who remained undiagnosed tended to be women, to be older, to have more comorbidities and to have higher CHA2DS2‐VASc scores.” 
    • “Together with the known burden of AF, this expanding unmet need underscores the critical importance of early detection. Our data can support both disease surveillance and future research and policy initiatives aimed at addressing this diagnostic gap.”

From the U.S. healthcare business front —

  • The American Hospital Association reports
    • “Hospital operating margins dipped again in February to -1.1% and continue to remain negative, though with less month-to-month variation, according to the latest report on hospital finances from Kaufman Hall. Costs of goods and services are now increasing faster than labor, with both labor and non-labor expenses per adjusted discharge 21% higher than in February 2020.
    • “Due to external economic factors, relatively flat margins are likely to continue in the near term,” the report states.”
  • STAT News notes
    • “The tech-forward insurer Oscar Health has tapped former Aetna CEO Mark Bertolini to be its new chief executive, a move to jump-start the business as it seeks to win new customers and become profitable.
    • “Bertolini, 66, is a progressive thinker in the use of technology to deliver health services and has already been advising Oscar for the past 18 months. His appointment gives him an opportunity to put a stamp on the future of digital services and analytics in the industry he has served for four decades.
    • “I’m returning to the health care industry because I believe there is still work to be done,” Bertolini said during a conference call to announce his appointment on Tuesday. He said Oscar presents a unique opportunity to challenge the status quo in the industry and accelerate the shift toward a more “consumer-oriented” business model.”
  • Fierce Healthcare is covering the 2023 ViVE conference currently being held in Nashville, TN, here and here. “Focused on digital health innovation, the conference, sponsored by HLTH and the College of Healthcare Information Management Executives (CHIME), had 5,000 attendees in 2022,” its inaugural year, and 7,500 attendees this year.
    • “On Monday morning, a heavily armed attacker entered a Christian school in Nashville and fatally shot three 9-year-old children and three adults.
    • In a joint statement from conference co-organizers CHIME and HLTH, the organizations said they have committed to a combined $50,000 donation “on behalf of ViVE for the victims and their families of today’s tragic Covenant School shooting.”
  • STAT News offers a special report on the wisdom of using artificial intelligence to replace medical transcription.

In a noteworthy legal development, the American Hospital Association informs us

The AHA and AHIP today filed a [joint] friend-of-the-court brief in a False Claims Act case before the U.S. Supreme Court, arguing that the federal government’s erroneous construction and expansion of the FCA threatens the legitimate business activities of every government contractor, hospital, health care provider, health insurance provider and grant recipient in the nation.

In a separate statement, the organizations said, “While AHA and AHIP may not always share the same opinion on matters of litigation and policy, we agree that the current regulatory landscape and construction of the False Claims Act (FCA) creates an untenable situation for health care providers and health insurance providers. “If the government’s argument is accepted, our members will be forced to spend more on litigation and less on patient care.”

“We urge the Supreme Court to adopt an interpretation of the FCA that does not undermine the ability of our members to ensure that Americans have access to high-quality, affordable health care.”

Amen to that.

Monday Roundup

David Ermer–Congress, Government Contracting, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Politico points out that

The Senate Finance Committee will hold a hearing Thursday on the impact PBMs — the pharmaceutical middlemen that negotiate drug discounts with drugmakers and design prescription drug benefits for health plans — have on the health system.

The House Energy and Commerce Health Subcommittee is also expected to look into how much value PBMs add as part of a broader discussion about fairness in the healthcare market, according to a memo shared with [Politico].

In related news, CMS “released several Prescription Drug Data Collection (RxDC) resources on the Registration for Technical Assistance Portal (REGTAP). To view the documents, click on the link next to each document title. You may already have the links in your bookmarks.”

This guidance applies to the 2022 RxDC report that health plans must submit by June 1, 2022. Health plans submitted the first RxDc report for the 2021 reporting year last January. The No Surprises Act calls for a standard June 1 submission date for the RxDC report for the previous reporting year.

CMS also announced that the public has sixty days (to May 26) to comment on the revised Reporting Instructions.

The FEHBlog recently discovered this CMS REGTAP portal. As you can see, this portal is not just for Medicare and Medicaid. The portal includes a link to get an email announcement when REGTAP changes. REGTAPs emails are handy and not overwhelming.

From the Rx coverage front —

STAT News adds an interesting perspective on last week’s Senate hearing on Moderna Covid vaccine pricing

What, [Chairman Bernie] Sanders asked [Moderna CEO Stephane Bancel], if instead of purchasing medicines after they had been developed at high prices, the government instead paid for companies’ research, enough to ensure they make a reasonable profit? Then, Sanders said, the medicines could be made available inexpensively to anyone who needed them.

Bancel, clearly baffled by what sounded a lot like the government seizing the means of pharmaceutical production, simply said it was impossible to evaluate such a plan without details.

As much as the plan sounds like socialism, in a world where substantial quantities of new medicines are purchased by government programs, Sanders’ idea is pretty close to the way defense companies work: The government pays them substantial amounts of money to develop jet fighters, satellites, and aircraft carriers. This system is certainly not cheap, but it represents an alternative to the way medicines are developed. * * *

Whether this is a good idea or not, it probably won’t happen. Because not only is Congress unlikely to fund a $200 billion-a-year effort to replace industry research on new medicines, it won’t fund a $20 billion effort to get the government in the game, either.

Beckers Hospital Review informs us

Walgreens and Village Medical have launched a new pilot program that helps patients manage new medications prescribed during their hospital stay. 

The program, launched as a pilot in Florida and Texas, helps Walgreens and Village Medical patients manage their new prescriptions and existing ones after they are discharged from a hospital, according to a March 23 release from Walgreens. 

The aim of the program is to improve patient outcomes and decrease costs associated with hospital readmissions.

From the substance use disorder front, STAT News reports

Public health workers will soon have a new tool at their disposal to thwart a spreading danger to users of illicit drugs: xylazine test strips.

The new testing kits will allow health departments, grassroots harm-reduction groups, and individual drug users to test substances for the presence of xylazine, a sedative often referred to as “tranq.”

The toxin is increasingly common in the U.S. illicit-drug supply — especially in the Philadelphia area, but increasingly in other cities, too. Xylazine, which is typically used as a sedative in veterinary settings, can cause people to stop breathing, and also often causes severe skin wounds when injected.

While helpful for public health workers, will drug users take the time to do both tests when the two potentially fatal drugs usually are combined? FEHBlog expects that a fentanyl and xylazine test strip will be on the market soon.

From the U.S. healthcare business front —

  • Hospitals strongly oppose MEDPAC’s recommendation that Medicare Part A make a low reimbursement increase for the new federal government fiscal year, while some healthcare economists support MEDPAC’s proposal.
  • Healthcare Dive tells us
    • “CVS plans to close its acquisition of home healthcare provider Signify Health on or around Wednesday, subject to certain conditions, the company announced Monday.
    • “CVS agreed to acquire Signify for $30.50 a share in cash in September in a transaction worth roughly $8 billion.
    • “That deal will close this week as long as CVS and Signify can meet or waive the remaining conditions in their merger agreement, according to CVS. A CVS spokesperson declined to share details on the remaining conditions.
  • Beckers Hospital Review notes that another well know CEO has ripped a page out of the Mark Cuban playbook.
    • “Love.Life, a health and wellness company co-founded and run by former Whole Foods CEO John Mackey, acquired Plant Based TeleHealth, a telehealth service focusing on the prevention and reversal of chronic conditions.
    • “The company will rebrand as Love.Life Telehealth. The company offers virtual visits to patients with chronic conditions and promotes healthy behaviors, according to a March 21 Love.Life news release.
    • “Patients can sign up for half-hour appointments for $175 or hourlong appointments for $350.”
    • “Love.Life is about making lasting health and vitality achievable, and acquiring Plant Based TeleHealth accelerates our ability to help more people without geographic limitations,” Mr. Mackey said. “Appointments are available now, and we’re excited to offer telehealth services as part of the comprehensive medical offering available in our physical locations, which will begin opening in 2024.”

Weekend update

David Ermer–Congress, Federal employment benefits, OPM, U.S. Healthcare–
The Bluebonnet — Texas state flower

The House of Representatives and the Senate are in session this week for Committee business and floor voting. Both bodies are on a State/district work break for the first two weeks of April.

Last Friday, OPM released to FEHB carriers its technical guidance supporting its call letter for 2024 benefit and rate proposals.

Federal News Network offers a long look at OPM’s process to implement the Postal Service Health Benefits Program.

OPM and AHIP will hold their annual conference for FEHB carriers on Wednesday and Thursday this week. The agenda can be found here. The 2024 call letter and PSHBP implementation are agenda topics.

From the healthcare front —

NPR Shots discusses

Fortune Well highlights the value of common mental health care drugs.

STAT News reports

Millions of diabetes cases may be missed under the current U.S. screening guidelines, especially among Asian Americans, according to a new study. A better way to test for the condition would be to leave body weight out of it, the researchers suggest.

Current guidelines from the U.S. Preventive Services Task Force recommend screening adults ages 35-70 who are considered overweight or obese (having a body mass index over 25).

However, racial and ethnic minority groups, especially Asian people, tend to develop diabetes at lower BMIs, so to identify more people with the condition across groups, all adults ages 35-70 regardless of their weight should be screened, researchers said in a study Friday in the American Journal of Preventive Medicine.

NPR Shots also invites us to meet the amazing “glass-half-full girl” whose brain was rewired as an infant after losing the left hemisphere.

In most people, speech and language live in the brain’s left hemisphere. Mora Leeb is not most people.

When she was 9 months old, surgeons removed the left side of her brain. Yet at 15, Mora plays soccer, tells jokes, gets her nails done, and, in many ways, lives the life of a typical teenager.

“I can be described as a glass-half-full girl,” she says, pronouncing each word carefully and without inflection. Her slow, cadence-free speech is one sign of a brain that has had to reorganize its language circuits.

Yet to a remarkable degree, Mora’s right hemisphere has taken on jobs usually done on the left side. It’s an extreme version of brain plasticity, the process that allows a brain to modify its connections to adapt to new circumstances.

Because it’s Sunday, here are two opinion pieces

  • The New York Times shares expert opinions on preparedness for the next pandemic.
  • Three professors of surgery at the University of California Medical Center defend the current United Network for Organ Sharing (UNOS).
    • As a private, nonprofit organization under contract with the federal government to manage the national organ transplant system, UNOS spearheads the complex, multidisciplinary organ procurement, matching, and delivery processes. With its contract up for renewal this spring, UNOS has come under heavy scrutiny, including in a recent guest column published in the New York Times, in which UNOS and other system organizations’ performances were blamed for the death of a kidney transplant candidate. This is just one example in a series of accusations made across news media, social media, and even in Congress.
    • Painting with such a broad and biased stroke creates an unfair representation of our highly nuanced organ transplant system and the people who run it. As transplant surgeons with a long history of involvement with the system — including one of us (Roberts) serving as a past Board President of UNOS/Organ Procurement and Transplantation Network (OPTN) — we have intimate knowledge of both its successes and its shortcomings. While UNOS has room to improve operationally — and is working to do so — we clearly see the organization’s life-changing results in our operating rooms and offices. More work lies ahead, however, such as addressing the fact that a rising number of organs are recovered but not transplanted.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front —

Cybersecurity Dive tells us

U.S. corporate leaders need to embrace cybersecurity as an issue of central importance to the success of their businesses, Cybersecurity and Infrastructure Security Agency Director Jen Easterly said.

Easterly, in a Thursday appearance before the Economic Club of New York, told attendees that top corporate executives, including CEOs and corporate board members, need to understand the risks posed by cybersecurity and take an active role in. 

Speaking just weeks after the Biden administration unveiled the national cybersecurity strategy, Easterly said this is not an issue the government can fix on its own, but businesses will need to play an important role in solving.  

Nextgov adds

[T]he House Committee of Oversight and Accountability heard testimony from Acting National Cyber Director Kemba Walden on how to implement the National Cybersecurity Strategy.

In opening statements, Walden outlined several pillars the national strategy plans to rely on when incorporating stronger defenses into U.S. digital networks. These include forming international partnerships, investing in a workforce, incentivizing stronger cybersecurity requirements, disrupting threat actors, and implementing stronger security measures. 

The paramount principle guiding the strategy, however, iealth s imparting more responsibility on the federal government and Big Tech players to safeguard U.S. networks.

“The biggest, most capable and best positioned actors in our digital ecosystem can and should shoulder a greater share of the burden for managing cyber risk and keeping us all safe––and that includes the federal government,” Walden said.

Health IT Security informs us

The Cybersecurity and Infrastructure Security Agency (CISA) released an updated version of its Cybersecurity Performance Goals (CPGs), a set of voluntary practices that critical infrastructure organizations may adopt to mitigate cyber risk.

CISA initially released the CPGs in October 2022 in response to President Biden’s National Security Memorandum on Improving Cybersecurity for Critical Infrastructure Control Systems. The updated version has been reorganized according to stakeholder feedback.

The CPGs are now more closely aligned with the National Institute of Standards and Technology (NIST) Cybersecurity Framework (CSF) functions (Identify, Protect, Detect, Respond, and Recover) to help organizations more easily navigate the CPGs and prioritize investments accordingly.

From the cyber breaches front —

Health IT Security highlights

The Federal Bureau of Investigation (FBI) Internet Crime Complaint Center (IC3) issued its 2022 Internet Crime Report, which revealed key trends that emerged in the cyber threat landscape last year. The IC3 received 800,944 complaints in 2022, signifying a 5 percent decrease from 2021.

Despite this decrease, the potential total loss grew from $6.9 billion in 2021 to more than $10.2 billion in 2022. Ransomware alone racked up $34.3 million in losses in 2022.

“While the number of reported ransomware incidents has decreased, we know not everyone who has experienced a ransomware incident has reported to the IC3,” the report noted.

“As such, we assess ransomware remains a serious threat to the public and to our economy, and the FBI and our partners will remain focused on disrupting ransomware actors and increasing the risks of engaging in this activity.”

The healthcare sector reported the most ransomware attacks to IC3 in 2022 compared to any other critical infrastructure, accounting for 210 of the 870 complaints tied to critical infrastructure. IC3 data shows that 14 of the 16 critical infrastructures had at least one member that fell victim to a ransomware attack last year.

CBS News brings us up to date on the recent DC Health Link breach.

Cybersecurity Dive relates

  • Exploits of zero-day vulnerabilities fell by almost a third in 2022, but it was still the second highest year on record, according to Mandiant research released Monday.
  • Mandiant tracked 55 zero-day vulnerabilities that were exploited in 2022, including three instances linked to financially motivated ransomware threat actors. 
  • Products from the three largest vendors — Microsoft, Google and Apple — were the most commonly exploited for the third year in a row, according to Mandiant.

Health IT Security adds

Microsoft has observed an increase in distributed denial of service (DDoS) attacks against healthcare organizations in recent months, a blog post by the Azure Network Security Team explained. Microsoft observed an increase from 10-20 DDoS attacks against healthcare applications hosted in Azure in November 2022 to 40-60 attacks daily in February 2023.

As previously reported, HHS warned the healthcare sector earlier this year about pro-Russian hacktivist group KillNet, a threat group known to target the sector with DDoS attacks.

“While KillNet’s DDoS attacks usually do not cause major damage, they can cause service outages lasting several hours or even days,” HHS stated at the time.

From the ransomware / data retrieval and extortion front

Tech Republic reports

Ransomware groups are pulling no punches in their attempts to force compromised organizations to pay up. A report released Tuesday by Unit 42, a Palo Alto Networks threat intelligence team, found that attackers are increasingly harassing victims and associated parties to make sure their ransom demands are met.

For its new 2023 Ransomware and Extortion Threat Report, Unit 42 analyzed approximately 1,000 incidents that the team investigated between May 2021 and October 2022. Around 100 cases were analyzed for insight into ransomware and extortion negotiations. Most of the cases were based in the U.S., but the observed cybercriminals conducted attacks against businesses and organizations around the world.

By the end of 2022, harassment was a factor in 20% of the ransomware cases investigated by Unit 42, a significant jump from less than 1% in mid 2021.

Bleeping Computer’s The Week in Ransonware tells us

This week’s news has been dominated by the Clop ransomware gang extorting companies whose GoAnywhere services were breached using a zero-day vulnerability.

Over the past month, one hundred new companies have been added to Clop’s data leak site, with the extortion gang threatening to leak data if a ransom is not paid.

From the cybersecurity defenses front —

The Healthcare Cybersecurity Coordination Center released a mobile device security checklist.

Mobile devices are prevalent in the health sector, and due to their storage and processing of private health information (PHI) as well as other sensitive data, these devices can be a critical part of healthcare operations. As such, their data and functionality must be protected. This document represents a basic checklist of recommended items for health sector mobile devices to maintain security, including data in motion and at rest, as well as the capabilities of the device itself.\

CISA “released the Untitled Goose Tool to help network defenders detect potentially malicious activity in Microsoft Azure, Azure Active Directory (AAD), and Microsoft 365 (M365) environments. The Untitled Goose Tool offers novel authentication and data gathering methods for network defenders to use as they interrogate and analyze their Microsoft cloud services.” 

CISA also announced

In today’s blog post, Associate Director of the Joint Cyber Defense Collaborative (JCDC) Clayton Romans highlighted recent successes of pre-ransomware notification and its impact in reducing harm from ransomware intrusions. With pre-ransomware notifications, organizations can receive early warning and potentially evict threat actors before they can encrypt and hold critical data and systems for ransom. Using this proactive cyber defense capability, CISA has notified more than 60 entities of early-stage ransomware intrusions since January 2023, including critical infrastructure organizations in the Energy, Healthcare and Public Health, Water and Wastewater Systems sectors, as well as the education community.

The pre-ransomware notification was cultivated with the help of the cybersecurity research community and through CISA’s relationships with infrastructure providers and cyber threat intelligence companies.

For more information, visit #StopRansomware. To report early-stage ransomware activity, visit Report Ransomware. CISA also encourages stakeholders and network defenders to review associate director Romans’ post, Getting Ahead of the Ransomware Epidemic: CISA’s Pre-Ransomware Notifications Help Organizations Stop Attacks Before Damage Occurs, to learn more about CISA’s Pre-Ransomware Notification Initiative.

Cyberscoop explains how “the FBI Breachforum’s bust is causing chaos in the cybercrime underground. The dramatic fall of one of the preeminent cybercrime communities on the web will have major implications for the cybercrime markets.”

Friday Factoids

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

From the public health report, here are the CDC’s Covid Data Tracker and the CDC’s FluView this week. Covid cases and hospitalizations continue to trend down, while Covid deaths leveled off after reaching a pandemic low last week. FluView notes, “CDC estimates that, so far this season [which runs from October through April], there have been at least 26 million illnesses, 290,000 hospitalizations, and 18,000 deaths from flu.”

The American Hospital Association adds

The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations. The Biden Administration plans to end the COVID-19 PHE declaration on May 11. The COVID-19 EUA declaration for COVID-19 diagnostics, personal protective equipment, other medical devices, and drug and biological products will remain in effect until there is no longer a “significant potential” for a COVID-19 PHE or the authorized devices or products have been approved.

From the Covid vaccine mandate front, per Fierce Healthcare, the U.S. Court of Appeals for the 5th Circuit held en banc (all of the active judges not a three judge panel), held that Feds for Medical Freedom have standing to challenge the Covid vaccine mandate on federal employees. This means that the nationwide preliminary injunction that has blocked enforcement of the mandate remains in force.

As you may recall, earlier this week, a panel of the U.S. Court of Appeals for the D.C. Circuit reached the opposite result. Such a split in decisions from different circuits is grounds for the Supreme Court to review the case, if requested (cert petition). It remains to be seen whether the end of the public health emergency also will bring down the curtain on the various Covid vaccine mandate challenges.

In other litigation news, Beckers Hospital Reviews brings us up to date on Cigna’s efforts to prevent a former executive from joining CVS Health.

From the opioids PHE front, the Wall Street Journal reports that the U.S. government has begun deploying X-ray scanners for trucks crossing the border from Mexico, first in Brownsville, Texas:

The scanners in Brownsville beam energy at a truck in varying levels of intensity. Beaming less energy at the cab allows drivers to stay inside, speeding the process. Directing more energy at the trailer produces an image of the truck that officials can use to spot suspect material within. Sometimes the payload is illicit drugs including fentanyl. * * *

The U.S. aims to deploy 123 large-scale scanners along the border by fiscal 2026, growing its ability to perform nonintrusive scans to 70% of cargo vehicles and 40% of passenger vehicles, according to the White House Office of National Drug Control Policy. Historically, the U.S. has only performed such scans on 17% of cargo vehicles and 2% of passenger vehicles, the office said.

Adding more scanning technology has to be part of an effort that includes trying to reduce drug demand and the odds overdoses will prove fatal, said David Luckey, a senior Rand Corp. researcher. He co-led a team that produced a report last year for a commission on synthetic opioids that includes members of Congress and law-enforcement agencies.

“There’s no silver bullet,” he said.

From the No Surprises Act front, HHS Secretary Xavier Becerra told the Senate Budget Committee on March 22

Becerra said the agency has received more than 10 times as many No Surprises Act claims than it expected when the law was first implemented. Many of these claims are frivolous, he said, because there is no cost to payers or providers to file a claim. 

“Everyone’s just filing all sorts of claims, and these arbitrators are trying to figure out what cases to handle,” Mr. Becerra said. “That’s what’s bogging down the system. 

The  agency is staying true to Congress’ intent with the law, Mr. Becerra said, but more legislative action is needed to deal with the high number of claims. 

“What we’re trying to do is have a system that works. I plead with you to help us make sure that we get to the legitimate cases, so a provider that’s looking for real payment, or an insurer that’s saying, You’re asking for too much,’ we can adjudicate that,” Mr. Becerra said. 

The FEHBlog is metaphysically certain that providers are submitting 99.4% of the faulty arbitration claims. While the law is working for patients, Congress should tweak that law as the good Secretary requests.

From the U.S. healthcare business front, Fierce Healthcare informs us

Average physician pay fell by 2.4% from 2021 to 2022, and that decline in physician compensation comes at a time when U.S. healthcare workers are facing significant challenges, including economic strains, a growing physician shortage issue and high rates of work-related burnout, according to the sixth annual Physician Compensation Report from professional medical network Doximity. 

Fierce Healthcare’s report is chock-a-block full of summary data from this report.

In other news

  • The New York Times reports
    • The prevalence of autism spectrum disorder in American children rose between 2018 and 2020, continuing a long-running trend, according to a study released by the Centers for Disease Control and Prevention on Thursday. In 2020, an estimated one in 36 8-year-olds had autism, up from one in 44 in 2018. The prevalence was roughly 4 percent in boys and 1 percent in girls.
    • The rise does not necessarily mean that autism has become more common among children, and it could stem from other factors, such as increased awareness and screening.
    • “I have a feeling that this is just more discovery,” said Catherine Lord, a professor of psychiatry at the University of California, Los Angeles medical school, who was not involved in the research. “The question is what’s happening next to these kids, and are they getting services?”
  • HR Dive discusses a recent survey on employee use of employer-sponsored mental health benefits.
  • CNBC tells us
    • Drugmakers Sanofi and Regeneron * * * released data on a jointly developed drug that shows promise in treating COPD.
    • The drug is already approved for asthma and some skin conditions, such as eczema, but it could become the first new treatment in over a decade for COPD. 
    • The results are a win for Dupixent, as competing COPD drugs from drugmakers such as AstraZeneca and GSK struggle to make successful strides toward approval. 

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC —

Fedweek reports on Postal Services Health Benefit Program developments. The headline is that OPM expects “lots of questions” about the new program, which will launch in 2025. The good news for OPM and everyone effect affected is that the law requires the Postal Service to stand up a PSHBP education program this summer, which includes PSHBP navigators similar to the approach taken with the ACA marketplace.

FedWeek also tells us that the U.S. Court of Appeals for the D.C. Circuit rejected on procedural grounds a federal employee challenge to the Biden Administration’s Covid vaccine mandate for federal employees. The mandate has been blocked by a preliminary injunction in another federal judicial circuit. In any event, the vaccine mandates will end on May 12, the day after the Covid public health emergencies end.

From Capital Hill –

Fierce Healthcare informs us

A key Senate committee advanced legislation to ban pharmacy benefit manager tactics, such as spread pricing and clawback fees, and heighten transparency of the industry. 

The Senate Commerce Committee passed the PBM Transparency Act of 2023 by a vote of 18 to 9 on Wednesday, advancing the reform legislation to the full Senate. Lawmakers said the legislation is meant to address a source of unfair and deceptive practices that increase drug prices. 

Senators Chuck Grassley (R Iowa) and Maggie Hanson (D NH) have “introduced the Healthy Moms and Babies Act to improve maternal and child health care. The United States has a maternal health crisis that particularly affects women of color and those living in rural America. The Healthy Moms and Babies Act would achieve its goal by

  • Coordinating and providing “whole-person” care, supporting outcome-focused and community-based prevention, and supporting stillbirth prevention activities and expanding the maternal health workforce.  
  • Modernizing maternal health care through telehealth to support women of color and women living in rural America. 
  • Reducing maternal mortality and high-risk pregnancies including C-section births, and improving our understanding of social determinants of health in pregnant and postpartum women.

STAT News relates

The future of Alzheimer’s treatments and coverage hung heavily over lawmakers’ Wednesday [March 22 Senate Finance Committee] hearing with Health and Human Services Secretary Xavier Becerra.

Dotted throughout the hearing room for Becerra’s testimony on the president’s proposed health care budget for 2024 were purple-clad advocates for Alzheimer’s disease treatments, who Democrats and Republicans alike acknowledged repeatedly throughout the hearing. But while senators from both parties pushed for speedy approvals and Medicare coverage of new drugs for the disease, they unsurprisingly diverged on how to manage the costs.

At the center of discussions was a controversial Medicare decision, last year, not to cover Biogen’s Aduhelm except through clinical trials, a decision later extended to Eisai’s Leqembi. The Food and Drug Administration approved both via the accelerated pathway, with limited data on either drug’s effectiveness. The drugmakers are required to follow up with more extensive data proving each medicine’s benefit.

CMS expects to revisit this Medicare decision publicly this summer.

Beckers Hospital Reviews highlights

For about an hour and a half on March 22, four pharmaceutical supply experts outlined ideas to lawmakers to reform the nation’s slippery access to critical drugs. 

The FDA reports 130 drugs are currently in shortage; the American Society of Health-System Pharmacists says there are 302. Recently, the availability of vital drugs for cancer patients and emergencies has shrunk, and the closure of a U.S. drugmaker could put more out of stock. 

The hearing waded through causes of shortages — including manufacturing delays and opaque supply data. Some members on the Senate Committee on Homeland Security and Governmental Affairs pushed back on some pitched solutions, such as changing FDA practices and working to control drug prices.

In 2022, the number of new drug shortages increased by 30 percent, according to a report released by the Senate Committee on Homeland Security and Governmental Affairs hours before the hearing began.

“Colleagues and other hospitals have asked me to respond to the never-ending game of drug shortage Whac-A-Mole,” Andrew Shuman, MD, chief of the clinical ethics service center for bioethics and social sciences in medicine for the University of Michigan Medical School in Ann Arbor, said during the hearing. 

The House Ways and Means Committee’s Health subcommittee held a hearing yesterday on healthcare costs. The American Hospital Association submitted  a letter to the subcommittee that “shared how rising labor and other costs for hospitals and health systems are exacerbating workforce shortages and delaying patient access to care.”

Looking forward, Mercer Consulting identifies innovation in cancer treatment and prevention as the next frontier and McKinsey and Co. explores the pharmacy of the future.

From the miscellany department —

  • Medscape reports
    • “Use of nirmatrelvir-ritonavir (Paxlovid) in older adults with risk factors for severe disease was associated with a roughly 25% lower risk of a post-COVID condition (PCC), a retrospective study of Veterans Affairs data showed.
    • “In the cohort of over 280,000 patients with a confirmed COVID case, 13% of those prescribed nirmatrelvir-ritonavir went on to develop a PCC over the following 6 months compared with 18% of those who were not prescribed the antiviral (relative risk [RR] 0.74, 95% CI 0.72-0.77), Ziyad Al-Aly, MD, of the VA St. Louis Health Care System in St. Louis, and colleagues reported.” Fehblog observation: Go Paxlovid!
  • Per Beckers Hospital Review
    • 42% of adults in the U.S. are living with obesity, meaning they have a body mass index of 30 or higher, according to an analysis from NORC at the University of Chicago. 
    • Researchers used 2013 to 2021 data from the CDC’s Behavioral Risk Factor Surveillance System to estimate obesity rates at the national and state level. To account for any reporting biases in the BMI measure, NORC adjusted BMI distribution to that of the National Health and Nutrition Examination Survey for corresponding time periods. NORC also created an interactive map to present its findings. 
    • The article lists estimated state obesity rates for 2019 to 2021, ranked from highest (Mississippi – 51%) to lowest (Colorado 34%). FEHBlog observation At least one-third of every state’s population is morbidly obese, and yet we wonder why the life expectancy of Americans is dropping.
  • Medscape notes
    • For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large US trial.
    • The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.
    • The study was published by JAMA Network Open on March 22.
    • “These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in US health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington. (FEHBlog observation: Good idea.)

Midweek Update

David Ermer–CDC, Congress, COVID-19, FDA, OPM, Rx coverage, SDOH, U.S. Healthcare–

From Washington, DC —

Roll Call reports on the state of the debt ceiling negotiations and Senator Bernie Sanders’s encounter today with the Moderna CEO Stéphane Bancel at a Senate hearing that Senate Sanders chaired. The FEHBlog can’t understand why Senator Sanders and his majority colleagues are flipping their lids over a $100 price per vial increase on a low-cost vaccine.

Fierce Healthcare tells us,

The Medicare Payment Advisory Commission’s recent breakdown of the hospital sector’s financial viability largely struck a different tone from the doom and gloom industry groups have voiced as of late.

The independent commission advises Congress on year-to-year Medicare policy adjustments, which are largely based on data from 2020 and 2021, preliminary data for 2022 and trend projections for upcoming years. It released its annual report to Congress last week.

With the exception of additional support for safety-net providers—which industry group America’s Essential Hospitals (AEH) has already criticizedfor “overlooking” uncompensated care delivered to non-Medicare patients—the group largely told Congress that most hospitals will manage their finances and recommended that lawmakers stay the course with 2024’s inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) rules.

“The Commission anticipates that a 2024 update to hospital payment rates of current law plus 1% would generally be adequate to maintain FFS beneficiaries’ access to hospital inpatient and outpatient care and keep IPPS and OPPS payment rates close to the cost of delivering high-quality care efficiently,” the group wrote in its report (PDF).

This decision must have the American Hospital Association flipping its lid.

The Department of Health and Human Services announced an organ procurement and transplantation network modernization initiative that “includes the release of new organ donor and transplant data; prioritization of modernization of the OPTN IT system; and call for Congress to make specific reforms in the National Organ Transplant Act.” More background on his announcement is available at Roll Call.

From the Rx coverage front

STAT News reports

An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients.

By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 3-5 vote (with one abstention) the same experts concluded that the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval.

The FDA is not required to follow the recommendation of its outside advisors, but often does. The mixed votes suggest the FDA will likely grant Biogen accelerated approval for tofersen based on preliminary evidence. This would allow the company to market the drug while it collects additional data to confirm its benefit.

Benefits Pro offers guidance on employer-sponsored health plan coverage of the new weight loss drugs, Mounjaro, Saxenda, and Wegovy. OPM has already decided that FEHB carriers will oprovidecoverage of one or more of these drugs in their 2024 formularies. Currently, carriers are developing their 2024 benefit and rate proposals.

The FEHBlog has flipped his lid because he discovered that OPM hhadrefreshed its FEHB carrier website. This merits further investigation.

The Wall Street Journal reports

Federal health regulators are nearing a decision on whether to authorize a second round of the Omicron-targeted booster shots for the elderly and other people at high-risk of severe Covid-19, people familiar with the agency’s deliberations said.

Food and Drug Administration officials could make the decision within a few weeks, the people said.

The officials are moving toward authorizing the second jabs of the Omicron-targeted shots for people who are 65 years and older or who have weakened immune systems, though the officials haven’t reached a final decision and could change their mind, one of the people said.

The Centers for Disease Control and Prevention would then have to recommend the shots for them to become widely available. 

From the primary care front, Healthcare Finance informs us

People are shifting away from traditional primary care providers, with about three in 10 foregoing primary care altogether between 2016 and 2022, according to FAIR Health’s new analysis of private claims data.

That number, though, ranged from a high of 43% in Tennessee to a low of 16% in Massachusetts, suggesting significant regional variations. Of the providers who performed primary care services in that time, 56% were physicians, while 44% were nonphysicians. * * *

The analysis pointed to evidence showing that primary care improves health regardless of age, sex, race, ethnicity, education, employment, income, health insurance and smoking status. It has also been reported that a gain of 10 additional primary care physicians per 100,000 people is associated with an increase in life expectancy by 51.5 days.

Guiding members to primary care providers is a vital health plan task, in the FEHBlog’s opinion.

From the miscellany department —

  • Health IT Analytics highlights, “Researchers from Utica University recently leveraged socioeconomic data to gain insights into generational poverty and other health equity barriers that impact patients’ ability to prioritize their health to improve clinical outcomes.”Hela
  • Health Payer Intelligence relates, “The National Alliance of Healthcare Purchaser Coalitions (National Alliance) has announced the publication of its playbook which aims to encourage biosimilar adoption among employers.”
  • EHR Intelligence informs us, “Nuance Communications, a Microsoft company, has announced Dragon Ambient eXperience (DAX) Express, the first clinical documentation application to combine conversational and ambient artificial intelligence (AI) with OpenAI’s newest model, ChatGPT-4.:

Tuesday’s Tidbits

David Ermer–COVID-19, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the U.S. healthcare business front, the Justice Department and the other state government appellants have voluntarily dismissed their appeal of an October 2022 district court decision permitting United Healthcare’s acquisition of Change Healthcare to proceed. That acquisition closed within days after that. The appellants had challenged the merger as an antitrust violation.

From the Omicron and siblings front —

U.S. News and World Report tells us

Globally, the number of COVID-19 deaths reported to the World Health Organization in the past four weeks was lower than when the organization first called COVID-19 a pandemic three years ago. The trends are leading experts to be hopeful that the coronavirus pandemic will end in 2023.

“I’m confident that this year we will be able to say that COVID-19 is over as a public health emergency of international concern,” WHO Director-General Tedros Adhanom Ghebreyesus said at a Friday press briefing.

But as attention shifts away from COVID-19, data collecting and sharing is suffering. Many of the trackers people came to rely on during the worst days of the pandemic have shut down, with the CDC announcing last week that it’s “COVID Data Tracker Weekly Review” will end on May 12 – one day after the Biden administration plans to let the COVID-19 emergency declarations expire.

Medscape adds expert U.S. opinions on the endemic status of the disease in the U.S.

Reuters reports

U.S. President Joe Biden on Monday signed a bill that requires declassification of information related to the origins of the coronavirus that causes COVID-19, the White House said.

Biden said he shared Congress’ goal of releasing as much information as possible about the origin of COVID-19.

“In implementing this legislation, my administration will declassify and share as much of that information as possible, consistent with my constitutional authority to protect against the disclosure of information that would harm national security,” Biden said in a statement.

The bill sailed through the Senate and House of Representatives without opposition before being sent to the White House.

From the opioid epidemic front, the Drug Enforcement Administration issued the following public warning about

A sharp increase in the trafficking of fentanyl mixed with xylazine. Xylazine, also known as “Tranq,” is a powerful sedative that the U.S. Food and Drug Administration has approved for veterinary use.  

“Xylazine is making the deadliest drug threat our country has ever faced, fentanyl, even deadlier,” said Administrator Milgram. “DEA has seized xylazine and fentanyl mixtures in 48 of 50 States. The DEA Laboratory System is reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.”

Xylazine and fentanyl drug mixtures place users at a higher risk of suffering a fatal drug poisoning. Because xylazine is not an opioid, naloxone (Narcan) does not reverse its effects. Still, experts always recommend administering naloxone if someone might be suffering a drug poisoning. People who inject drug mixtures containing xylazine also can develop severe wounds, including necrosis—the rotting of human tissue—that may lead to amputation.

According to the CDC, 107,735 Americans died between August 2021 and August 2022 from drug poisonings, with 66 percent of those deaths involving synthetic opioids like fentanyl. The Sinaloa Cartel and Jalisco Cartel in Mexico, using chemicals largely sourced from China, are primarily responsible for the vast majority of the fentanyl that is being trafficked in communities across the United States.

FDA recently communicated to health care providers about the risks to patients exposed to xylazine in illicit drugs. A copy of that communication can be found here: FDA alerts healthcare professionals of risks to patients exposed to xylazine in illicit drugs.

From the obesity treatment front, Reuters reports

Novo Nordisk’s best-selling diabetes treatment drug Ozempic is back on the shelves in the United States after months of shortage, the U.S. Food and Drug Administration (FDA) website showed on Friday.

The main active ingredient in Ozempic is semaglutide, also the key ingredient in Novo’s obesity drug Wegovy, which has been seeing supply shortage due to high demand.

The company said the 0.25 mg, 0.5 mg and the 1 mg doses of Ozempic are available for patients. The 2 mg dose, however, has limited availability until the end of this month, largely due to the demand coupled with overall global supply constraints.

The U.S. Department of Labor has sent its annual report on self-funded group health plans to Congress.