The House of Representatives and the Senate are on District / State work breaks for the next two weeks.

OMB’s Office of Information and Regulatory Affairs concluded on March 29 its work on OPM’s Postal Service Health Benefits Program interim final implementation rule. The rule will be published in the Federal Register this week.

On Friday, the Justice Department noticed an appeal to the U.S. Court of Appeals for the Fifth Circuit from the Northern District of Texas’s ruling on the role of USPSTF in the ACA preventive services mandate provision. The motion to stay is stepping up the plate.

From the Omicron and siblings front, Fortune Well discusses a new Omicron variant.

XBB.1.16, dubbed “Arcturus” by variant trackers, is very similar to U.S. dominant “Kraken” XBB.1.5—the most transmissible COVID variant yet, Maria Van Kerkhove, COVID-19 technical lead for the WHO, said earlier this week at a news conference. 

But additional mutations in the virus’s spike protein, which attaches to and infects human cells, has the potential to make the variant more infectious and even cause more severe disease. For this reason, and due to rising cases in the East, XBB.1.16 is considered “one to watch,” Van Kerkhove says.

It’s a warning we’ve heard before about other Omicron spawn—XBB.1.5 in particular. The variant, which rose to prominence late last year and early this year, elicited warnings that it could cause more severe disease, based on new mutations it had developed. 

It was a fate that didn’t play out—though the variant certainly took the lead when it came to transmissibility. XBB.1.5 accounted for just under half of all globally sequenced cases in early March, according to the WHO.

Only time will tell when it comes to what, if any, differences in severity XB.1.16 will display. Mutations that seem concerning in theory aren’t always concerning in real life because of the highly complex nature of population immunity.

The FEHBlog does plan to lose sleep over XB1.16.

In other public health news, the American Medical Association identifies six things that doctors wish their patient knew about better nutrition.

From the end of the public health emergency front, Healthcare Dive is following the unwinding of the great Medicaid expansion that occurred during the pandemic.

In the U.S. healthcare business news, Healthcare Dive tells us

• Uber Health is foraying deeper into healthcare with a new feature that allows providers to order prescriptions to be dropped off at patients homes same-day.
• The same-day prescription delivery is meant to help patients adhere to a medication schedule, Uber said Thursday. The service is made possible through an integration of Uber Health’s dashboard with ScriptDrop, a tech platform connecting patients and pharmacies with couriers nationwide.
• The company also said it expects to soon launch delivery of healthy food and over-the-counter medicine for patients, including Medicare Advantage and Medicaid beneficiaries.

In OPM news, the agency per Govexec “on Friday published new guidance tasking agencies with updating their policies to ensure that they afford a “non-discriminatory and inclusive” work environment to all employees, particularly transgender and other gender non-conforming workers.”

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.

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.

The Washington Post shows how one of its staff photographers found enduring traces of the sixteenth President across our country.

The House of Representatives is on a District work break for the next weeks while the Senate is engaged in Committee business and floor voting on Capitol Hill.

On Wednesday, February 15, the Senate Foreign Relations Committee will hold a hearing “to examine countering illicit fentanyl trafficking.” The Wall Street Journal adds

A veterinary tranquilizer that can cause serious wounds for regular users is spreading menace within the illicit drug supply. 

Xylazine, authorized only for animals, is one ingredient in an increasingly toxic brew of illicit drugs that killed a record of nearly 107,000 people in the U.S. in 2021. It is typically mixed with fentanyl, a synthetic opioid that itself has broadly infiltrated U.S. drug supply, including in supplies of cocaine and methamphetamine. Taken together, the volatile mixing means drug users often don’t know what’s in the substances they take. 

Dealers may mix xylazine into fentanyl to save money, federal law-enforcement authorities said. The drug—known as “tranq” among some users—can be purchased at low prices from Chinese suppliers and offset some of the opioid in the mix. Its presence in the drug supply is part of the arms race between criminals seeking to enhance their products and authorities trying to disrupt the market. Public-health authorities are working on ways to monitor the constantly changing drug market.

For users, xylazine can also lengthen a high—with serious risks. The overdose-reversal drug naloxone that can be critical to saving fentanyl users doesn’t work against xylazine. And users can become physically dependent on xylazine in addition to fentanyl, complicating treatment. 

No bueno.

From the Omicron and siblings front, NPR Shots tells us

In another sign of the changing state of the pandemic, an invaluable source of information about the virus over the last three years is shutting down, NPR has learned.

The Johns Hopkins Coronavirus Resource Center plans to cease operations March 10, officials told NPR.

“It’s bittersweet,” says Lauren Gardner, an engineering professor who launched the project with one of her students on March 3, 2020. “But it’s an appropriate time to move on.

Agreed.

From the No Surprises Act front, the American Hospital Association has removed from its reports on Judge Kernodle’s February 6 opinion the erroneous statement the Judge had struck down the entire rule. The FEHBlog has redlined the Judge’s edits to the Public Health Service Act provisions in the NSA’s August 26 Independent Dispute Resolution Rule for your edification. As of Friday, February 10, the Justice Department has not noticed an appeal from this final judgment. The government has sixty days to notice an appeal.

From the public health front, the New York Times reports

In the United States, the richest mothers and their newborns are the most likely to survive the year after childbirth — except when the family is Black, according to a groundbreaking new study of two million California births. The richest Black mothers and their babies are twice as likely to die as the richest white mothers and their babies. * * *

The study, published last month by the National Bureau of Economic Research, includes nearly all the infants born to first-time mothers from 2007 to 2016 in California, the state with the most annual births. For the first time, it combines income tax data with birth, death and hospitalization records and demographic data from the Census Bureau and the Social Security Administration, while protecting identities. * * *

Rich and poor mothers were equally likely to have high-risk pregnancies, but the poor mothers were three times as likely to die — even within the same hospitals. Rich women’s pregnancies “are not only the riskiest, but also the most protected,” the paper’s authors wrote.

This finding suggests that the American medical system has the ability to save many of the lives of babies with early health risks, but that those benefits can be out of reach for low-income families.

* * *

There is clear evidence that Black patients experience racism in health care settings. In childbirth, mothers are treated differently and given different access to interventions. Black infants are more likely to survive if their doctors are Black. 

the richest white Californians in this study still gave birth to less healthy babies than the richest Swedish women. Their newborns were more likely to be premature or underweight. The two groups had roughly equal maternal death rates.

“That finding really does strongly suggest that it’s something about the care model,” said Dr. Neel Shah, chief medical officer of Maven Clinic for women’s and family health and a visiting scientist at Harvard Medical School. “We have the technology, but the model of prenatal care in the United States hasn’t really gotten an update in the last century.”

What is a new model of prenatal care? The Mayo Clinic and the ACOG, among others, have ideas.

Becker’s Hospital Review and Fierce Healthcare report on the President’s State of the Union address from a healthcare standpoint. At the same time, the Society for Human Resources management does the same for workplace policies.

Bloomberg adds

The federal budget deficit is widening rapidly, according to the latest estimates by the Congressional Budget Office, raising the risk of the Treasury running out of cash earlier than expected amid a debt-ceiling standoff.

The excess of spending over receipts totaled $459 billion for the first four months of the fiscal year, which started Oct. 1, according to CBO estimates released on Wednesday. That’s a $200 billion increase over the same period a year earlier. * * *

Among the causes of the drop in revenue, the CBO noted that the Treasury is no longer receiving as much from the Federal Reserve, which is now paying out more in interest to commercial banks on the reserves they park at the Fed. 

Corporate-tax revenue has also dipped, while individual income-tax refunds rose, the CBO also said. Meantime, spending on areas including Social Security, Medicare and Medicaid have jumped over the fiscal year through January, the agency said.

From the U.S. healthcare business front —

CVS Health announced “strong fourth quarter and full-year 2022 results” and “entering into a definitive agreement under which CVS Health will acquire [primary care provider] Oak Street Health in an all-cash transaction at $39 per share, representing an enterprise value of approximately $10.6 billion.” As the Sopranos would say that’s a lot of boxes of ziti.

STAT News and Healthcare Dive explore the transaction. Of immediate note from Healthcare Dive

In a statement, the companies said they expect the transaction to close this year, subject to closing conditions. ​​​​​However, it will likely face regulatory scrutiny. One antitrust advocacy group is already opposing the deal. * * *

In addition, CVS is still trying to close its $8 billion buy of home health provider Signify Health. The deal, which CVS said it expects to close in the first half of 2023, is under Department of Justice review, and a new buy could threaten that process, bankers told Axios. * * *

STAT News also highlights five health tech startups targeting chronic kidney disease — Monogram Health, Cricket Health, Strive Health, Healthmap Solutions, and Square Knot Health.

From the FDA / Rx Coverage front

The American Medical Association tells us

The Food and Drug Administration Friday cleared for commercial distribution a test to diagnose multiple respiratory viral and bacterial infections in respiratory specimens from patients with suspected COVID-19 or other respiratory infections. The BioFire SPOTFIRE Respiratory Panel is the first COVID-19 test cleared with a Clinical Laboratory Improvement Amendments waiver, meaning any laboratory with at least a CLIA certificate of waiver can perform the test.

GenomeWeb adds

“We believe the BioFire Spotfire solution is a real game changer in patient care, allowing physicians to give patients an accurate and rapid diagnosis, using only one test, during the actual patient visit,” Pierre Boulud, chief operating officer, clinical operations at BioMérieux, said in a statement. “Our syndromic offer[ing] will cover most patient care settings in the US, expanding our business coverage and opportunities dramatically.”

According to BioMérieux’s website, the Spotfire R Panel uses a nasopharyngeal swab sample to detect as many as 15 targets including SARS-CoV-2, the cause of COVID-19. Other viral targets include influenza A and B virus, parainfluenza virus, respiratory syncytial virus (RSV), human rhinovirus, human metapneumovirus, seasonal coronavirus, and adenovirus. Bacterial targets include Bordetella pertussis, B. parapertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae. The panel’s full commercial launch in the US is expected in April.

That’s cool.

BioPharma Dive informs us,

One of the nation’s largest healthcare insurers has changed its policy for a new and in-demand ALS medicine, deciding not to cover it due to “a lack of clinical efficacy data.”

Cigna considers the medicine, called Relyvrio, to be “experimental, investigational or unproven” and now won’t cover it for the treatment of ALS, or amyotrophic lateral sclerosis. Relyvrio was developed by the Massachusetts-based biotechnology company Amylyx Pharmaceuticals, and approved by the Food and Drug Administration last September.

At the time of the FDA action, the New York Times reported

A new medication for A.L.S., the devastating neurological disorder that causes paralysis and death, will have a list price of $158,000 a year, its manufacturer disclosed Friday.

The treatment, to be marketed as Relyvrio, is a combination of two existing drugs and will be available to patients in the United States in about four to six weeks, according to officials of the company, Amylyx Pharmaceuticals.

Relyvrio was approved by the Food and Drug Administration on Thursday, even though the agency’s analysis concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance.

The F.D.A. decided to greenlight the drug instead of waiting until 2024 for results of a large clinical trial partly because the treatment is considered to be safe. The agency said that although the evidence of effectiveness was uncertain, “given the serious and life-threatening nature of A.L.S. and the substantial unmet need, this level of uncertainty is acceptable in this instance.”

Amylyx officials predicted that most patients would pay little or nothing for the treatment because the company expects insurers, both private and public, to cover it. Amylyx plans to provide it free to uninsured patients experiencing financial hardship.

Still, the list price is much higher than that recommended by the Institute for Clinical and Economic Review, a nonprofit organization that evaluates the value of medicines. In a statement, the group’s chief medical officer, Dr. David Rind, said that while “there are clear benefits to patients with a rapidly fatal disease to have early access to a safe therapy,” his organization had concluded that “an annual price of $9,100 to $30,700 would be reasonable if the therapy actually works.”

Dr. Rind added that “while awaiting proof, we believe that patients would benefit from a price closer to the price of production of Relyvrio rather than a price more than five times higher than the top of a value-based range.”

It’s complicated.