FEHBlog

Thursday Miscellany

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

From our Nation’s capital

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

From the medical research front

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

From the U.S. healthcare business front —

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

From the miscellany department —

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

Midweek Update

David Ermer–Congress, COVID-19 vaccine, No Surprises Act, U.S. Healthcare–

From Washington D.C., Roll Call tells us

The federal government will run out of cash to pay all its bills sometime between July and September unless the statutory debt limit is lifted, the Congressional Budget Office [CBO] warned Wednesday.

The report by the nonpartisan budget scorekeeper could put pressure on a divided Congress to reach a deal to increase, or at least suspend, the debt limit before adjourning for the annual August recess.

[A] separate CBO report issued Wednesday underscores the challenges for both parties in making the math add up. Deficits over the next decade are now projected to grow by $3.1 trillion, or 20 percent, during the next decade from the agency’s forecast last May. 

STAT News “sat down with AMA President Jack Resneck on the sidelines of the [AMA’s Washington., D.C.] conference to talk about legislative reforms, physician burnout, and where the doctors’ lobby goes from here.” The Q&A made the FEHBlog crack up

What is the AMA stance on implementation of the law to end surprise medical bills for patients?

There’s a lot about the way those [HHS] rules were first written that went way outside of congressional intent. They put major thumbs on the scale of basically moving towards the insurers’ notion of what that value should be.

There’s so many things about those rules that basically would encourage insurers to either just say “Oh, I can pay so much less through this arbitration system that I’m just going to purposely not contract with any physicians” … or just unilaterally, dramatically lower payment rates in a way that threatens practices.

What nonsense!

Medical Economics shares a letter to Congress from a group of medical associations on the topic of value-based care.

The National Academies issued a report on “Achieving Whole Health.”

Whole health is physical, behavioral, spiritual, and socioeconomic well-being as defined by individuals, families, and communities. Whole health care is an interprofessional, team-based approach anchored in trusted relationships to promote well-being, prevent disease, and restore health. It aligns with a person’s life mission, aspiration, and purpose. It shifts the focus from a reactive disease-oriented medical care system to one that prioritizes disease prevention, health, and well-being. It changes the health care conversation from “What’s wrong with you?” to “What matters to you?”

The Office of Personnel Management released

its inaugural report: Government-wide DEIA: Our Progress and Path Forward to Building a Better Workforce for the American People. This report highlights accomplishments aligned with the Government-wide Strategic Plan to Advance DEIA in the Federal Workforce and preview priorities for 2023 consistent with Executive Order (EO) 14035.

“Whether you want to cure diseases, protect and preserve our national parks, combat climate change, or embark on missions to discover new galaxies, the Federal government is full of opportunity for the best and brightest to serve our country,” said OPM Director Kiran Ahuja. “In order to recruit and sustain the best talent, we must ensure every service-minded individual feels welcome and supported in contributing their talents to the Federal workforce. This inaugural report highlights progress made to advance diversity, equity, inclusion, and accessibility in the workplace, and we look forward to continuing the work to break down barriers to serve and help build a Federal government that draws from the strength and diversity of its people.”

Tomorrow, February 16, at 10 am ET, the Senate Commerce, Science, and Transportation Committee will hold a hearing titled “Bringing Transparency and Accountability to Pharmacy Benefit  Managers.”

This hearing will address how the “Pharmacy Benefit Manager Transparency Act” will bring transparency into PBM business practices and prohibit unfair or deceptive PBM conduct that drives up costs for consumers. The bipartisan S. 127, Pharmacy Benefit Manager Transparency Act of 2023, was introduced by Chair Cantwell and Sen. Chuck Grassley (R-Iowa), on January 27, 2023.

From the Omicron and siblings front —

STAT News reports

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution.

The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage. For those lacking sufficient insurance, the company will tap a patient assistance program. “Everyone in the U.S. will have access to Moderna’s Covid-19 vaccine regardless of their ability to pay,” the company said.

The about-face came on the same day that Sen. Bernie Sanders (I-Vt.), who chairs the Senate Committee on Health, Education, Labor, and Pensions, accused the company of “corporate greed” and scheduled a hearing next month to examine the initial decision to charge Americans for its Covid-19 shot. Moderna Chief Executive Officer Stéphane Bancel is among those expected to testify. * * *

A spokesman for America’s Health Insurance Plans, an industry trade group, suggested that health insurers will still get a bill. He sent a note saying the Advisory Committee on Immunization Practices (which advises the CDC) recently updated its list of recommended Covid vaccines and that, while beneficiaries pay nothing in cost sharing after commercialization, health plans are picking up the full cost.

No doubt about the validity of AHIP’s point.

Medscape notes, “The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.”

From the public health front —

  • The White House announced
    • “the Consumer Financial Protection Bureau (CFPB) released a new report that shows that the number of Americans with medical debt on their credit reports fell by 8.2 million from the first quarter of 2020 to the first quarter of 2022. Today’s report is consistent with a recent report from the Centers for Disease Control and Prevention (CDC) that found that the number of Americans who are part of families having trouble paying their medical bills declined by 5.5 million between 2020 and 2021. One driver of these declines is the significant increase in the number of insured Americans over this period, a result of the President’s strategy of protecting and strengthening the Affordable Care Act (ACA) and lowering health care costs. The decline also reflects continued actions by the CFPB to highlight problems with inaccurate reporting of debt in collections and put the industry on notice to correct their behavior.”
  • The Wall Street Journal reports “More older women with low-risk breast cancer could forgo radiation after surgery to avoid further side effects and costs, research showed, as some doctors work to limit tough treatments without hurting survival.” STAT News also offers an article on this topic.
  • The National Cancer Institute posts on a variety of cancer topics. For example
    • “The Food and Drug Administration (FDA) approved tucatinib (Tukysa) with trastuzumab (Herceptin) to treat HER2-positive advanced colorectal cancer. The approval was based on the MOUNTAINEER trial, in which nearly 40% of participants’ tumors shrank after receiving the drugs.”

In other health care cost news —

Beckers Payer Issues relates

Employer-sponsored plans pay much higher rates for physician-administered drugs than Medicare, a research letter published Feb. 10 in JAMA Health Forum found. 

Researchers at the Healthcare Cost Institute compared per-unit prices for the 10 most expensive and 10 most common physician-administered drugs from 2016 to 2020. 

For the most commonly used drugs, employer-sponsored plans paid prices up to 3,350 percent higher than Medicare. For midazolam, employer-sponsored plans paid 30 times more than Medicare for the same drug, and they paid 20 times more for ondansetron. 

For the most expensive drugs, employer-sponsored plans did not pay as extreme markups, the researchers found. Markups were  54 percent more than Medicare at the high end, and employer-sponsored plans paid similar prices to Medicare rates for some drugs. 

Read the full study here. 

Thank heavens OPM is allowing FEHB plans to offer Medicare Part D EGWPs for the Medicare prime members next year.

Health Payer Intelligence informs us “Out-of-pocket costs for buprenorphine prescriptions for opioid use disorder treatment decreased between 2015 and 2020, but costs varied by payer, according to a study published in JAMA Network Open.”

From the U.S. healthcare business front

Beckers Payers Issues advises

The nation’s largest payers have filed their fourth quarter earnings reports, revealing which have the most U.S. commercial members.
Commercial includes fully- and self-insured members

Commercial enrollment rankings in 2022:

  1. Elevance Health: 31.4 million
  2. UnitedHealth Group: 26.7 million
  3. Cigna: 22 million
  4. CVS Health (Aetna): 17 million
  5. Centene: 2.5 million
  6. Humana: 986,000

Healthcare Dive reports

  • After more than two decades together, CommonSpirit Health and AdventHealth are dissolving their joint venturemanaging hospital operations in Colorado and western Kansas. 
  • The management company, Centura, operates one of the largest hospital networks in the region, with 20 hospitals and a network of outpatient practices.
  • In a release on Tuesday, the systems said the partnership had reached its “natural maturity.” CommonSpirit and AdventHealth didn’t lay out a timeline for the transition.

and

Elevance has closed its deal to acquire specialty pharmacy BioPlus, the insurer announced Wednesday, after first announcing the buy in November 2022.

The acquisition builds off the Indianapolis-based insurer’s promise to acquire companies around its health services business, with Elevance CEO Gail Boudreaux announcing at a November industry conference that the insurer planned to grow “very aggressively” into adjacent care services.

Beckers Hospital Review tells us

Walgreens has agreed to buy the assets of defunct digital pharmacy Medly for $19.35 million, according to a bankruptcy court filing.

Medly declared bankruptcy in December, months after its founder stepped down and it laid off more than half its staff. A judge approved the acquisition of Medly’s assets, including its files, inventory and intellectual property, Feb. 7 in U.S. Bankruptcy Court for the District of Delaware.

Medly raised $100 million in 2020, positioning itself as a digital competitor to retail pharmacies such as Walgreens and CVS.

Tuesday Tidbits

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

From the Omicron and siblings front, HealthDay tells us

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

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

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

From the public health front —

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

From the healthcare quality front

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

From the Medicare front —

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

In hospital pricing transparency news —

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

From the HR department

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

From the tidbits department

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

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Sven Read on Unsplash

From our Nation’s capital, Federal News Network informs us

The Office of Management and Budget filled a key personnel and performance leadership role with a familiar name.

Federal News Networks has confirmed that Loren DeJonge Schulman is starting as the new associate director for performance and personnel management today.

She replaces Pam Coleman, who left in August after 20 months in that role.

DeJonge Schulman joins OMB from the Partnership for Public Service where she was vice president of research, evaluation and modernizing government for the last two-plus years. In that role, she helped lead the Best Places to Work in Government rankings and focused on issues around improving federal workforce management.

The U.S. Office of Personnel Management announced

The U.S. Office of Personnel Management (OPM) has announced the Finalists for this year’s Presidential Management Fellows (PMF) Program. Of the more than 10,000 individuals from around the world who applied for the program, 850 Finalists were chosen. The large number of applications to this competitive program marks a record number of applications over the past ten years.  

“Presidential Management Fellows are the next generation of government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2023 PMF finalists. We cannot wait to see what you will accomplish in public service.”  * * *

PMFs are appointed to a two-year, full-time Federal position with salary and benefits, where they apply their skills while engaging in leadership development training that includes experiential learning, cohort-based interactive training, and optional rotational experiences. 

In Omicron and siblings news, BioPharma Dive informs us

The U.S. has agreed to buy 1.5 million additional doses of Novavax’s COVID-19 vaccine as part of preparations for the government’s planned transition from bulk purchases to private market sales.

The agreement, announced Monday by Novavax, will support development of an updated version of the company’s shot in line with the Food and Drug Administration’s plan to annually match COVID vaccines to the most prevalent virus variants. It will also aid the company in developing smaller dose vials, which are less logistically challenging.

Novavax did not disclose the cost of the purchases, which are funded under an existing $1.6 billion contract with the government. Its shot uses a vaccine technology that has long been a mainstay and that the company claims remains an important option for those who cannot or will not take the messenger RNA-based shots from Pfizer and Moderna.

From the public health front —

  • The Washington Post discusses a horrifying CDC report on the mental health of high school students.
    • “Teen girls across the United States are ‘engulfed in a growing wave of violence and trauma,’ according to federal researchers who released data Monday showing increases in rape and sexual violence, as well as record levels of feeling sad or hopeless.”
    • In its report, the CDC steered attention to the nation’s schools, saying activities there can make a profound difference in the lives of teens. It recommended improved access to mental health services, more classroom management training for teachers, school clubs that foster gay-straight alliances, high-quality health education and enforcement of anti-harassment policies. Ideally, schools would take on multiple initiatives.”
  • NBC News reports “A handful of factors, such as education, income and job type, may increase the likelihood that people in their mid-50s will still be mentally sharp, a new study finds.”

From the No Surprises Act front, Healthcare Dive adds

One in five Americans still report receiving surprise bills, despite the ban. That’s in part because the law has notable exceptions — for example, ground ambulances were excluded from the ban, though they’re a frequent source of the bills.

In January, the HHS said it’s received significantly more requests to resolve payment disputes than the department expected.

STAT News delves into the ground ambulance billing issue today. It’s worth noting at the risk of belaboring the obvious that air ambulances are considerably more expensive than ground ambulances.

The FEHBlog was surprised to read about the number of arbitration requests in January given the Texas Medical Association’s contention that the new $350 per party arbitration fee would suppress the numbers of arbitrations. In the FEHBlog’s view, providers should place more focus on the open negotiation phase of the process.

From the electronic health records front, HealthITBuzz alerts us

A little over a year ago, we announced the completion of a critical 21st Century Cures Act requirement by publishing the Trusted Exchange Framework and Common Agreement (TEFCA). This milestone established a clear infrastructure model and governing approach for nationwide health information exchange.

Today, we marked the next major milestone during an event at the U.S. Department of Health and Human Services (HHS) headquarters, which recognized the first set of networks to be approved to implement TEFCA as prospective Qualified Health Information Networks (QHINs). Once fully onboarded, the organizations will officially be “designated” as QHINs. At this event, HHS Secretary Becerra recognized and congratulated CommonWell Health Alliance, eHealth Exchange, Epic TEFCA Interoperability Services, Health Gorilla, Kno2, and KONZA for their willingness to voluntarily step up and meet the rigorous TEFCA eligibility requirements, terms and conditions of TEFCA participation, and commitment to a 12-month go-live timeline. Collectively, the QHIN applicants have networks that cover most U.S. hospitals, tens of thousands of providers, and process billions of annual transactions across all fifty states.

Bravissimo.

From the U.S. healthcare business front —

Cigna announced a rebranding of its businesses: The Cigna Group, the global health company; Cigna Healthcare, the health benefits provider; and Evernorth Health Services, the pharmacy, care and benefits solutions provider.

Politico, upon examining whether a new CMS policy can save rural hospitals, offers us a mixed bag:

The Rural Emergency Hospital designation, aimed at sustaining emergency rooms, outpatient care and clinics, will be a major consideration for a significant number of hospitals, according to a new report from Chartis, a health care consulting group.

The policy changes are among the largest made to the rural health system in years. Through Medicare, hospitals that agree to the program requirements are guaranteed a set amount of money for facilities and a boosted Medicare reimbursement rate.

About 400 hospitals are “most likely” to consider conversion, according to the analysis, with about 80 of those “ideal” candidates for the change — often facilities on the brink of closing without growing revenues.

Several dozen hospitals are expected to move toward the new designation in the next 12 to 18 months “because they’re right on the ropes,” Michael Topchik, national leader of the Chartis Center for Rural Health, told Pulse.

Another group will wait and see how the first group does under the new rules, he said.

Still, most of the nearly 1,600 rural hospitals aren’t interested. The designation requires giving up inpatient care, a key part of many hospitals’ business and a handful of financial incentives offered through other rural health programs.

That doesn’t mean rural hospitals are thriving, though. Closures slowed significantly during the pandemic, likely because of the government’s infusion of resources through the pandemic, but are again ticking up.

Fierce Healthcare reports

Sanford Health and Fairview Health Services have agreed to push back their planned megamerger by two months.

The health systems said in a statement that they jointly determined they should “voluntarily” move the expected closure date for the deal to May 31, according to a report in MPR News. The merger was originally set to close March 31, but Minnesota Attorney General Keith Ellison asked the two providers to delay.

The deal includes 58 hospitals, and, if the two systems are joined, they would employ more than 80,000 people.

Happy Lincoln’s Birthday

David Ermer–Uncategorized–

    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.

    Cybersecurity Saturday

    David Ermer–Cybersecurity–

      From the cybersecurity policy front, Cybersecurity Dive informs us

      National Cyber Director Chris Inglis will retire from his position Feb. 15, ending a more than four decade career in national security. 

      Kemba Walden, principal deputy national cyber director and a former legal executive at Microsoft, will become acting director until Biden names a nominee for the post. The NCD post requires Senate confirmation. 

      From the cyber vulnerabilities front —

      • The Health Sector Cybersecurity Coordination Center (HC3) issued a PowerPoint presentation titled “2022 Healthcare Cybersecurity Year in Review and a 2023 Look-Ahead.”
      • HC3 also released its January 2023 Cybersecurity Vulnerability Bulletin.
      • The Cybersecurity and Infrastructure Agency (CISA) added three known exploited vulnerabilities to its catalog.
      • The Government Accountability Office produced a report titled “Challenges in Protecting Cyber Critical Infrastructure.”

      From the ransomware front —

      CISA announced on February 8

      CISA and the Federal Bureau of Investigation (FBI) released a joint Cybersecurity Advisory, ESXiArgs Ransomware Virtual Machine Recovery Guidance. This advisory describes the ongoing ransomware campaign known as “ESXiArgs.” Malicious cyber actors may be exploiting known vulnerabilities in unpatched and out-of-service or out-of-date versions of VMware ESXi software to gain access to ESXi servers and deploy ESXiArgs ransomware. The ransomware encrypts configuration files on ESXi servers, potentially rendering virtual machines unusable.

      As detailed in the advisory, CISA has created and released an ESXiArgs recovery script at https://github.com/cisagov/ESXiArgs-Recover. CISA and FBI encourage organizations that have fallen victim to ESXiArgs ransomware to consider using the script to attempt to recover their files.

      Here’s a Cybersecurity Dive report on this topic.

      CISA announced on February 9

      CISA, the National Security Agency (NSA), the Federal Bureau of Investigation (FBI), the Department of Health and Human Services (HHS), and Republic of Korea’s Defense Security Agency and National Intelligence Service have released a joint Cybersecurity Advisory (CSA), Ransomware Attacks on Critical Infrastructure Fund DPRK Espionage Activities, to provide information on ransomware activity used by North Korean state-sponsored cyber to target various critical infrastructure sectors, especially Healthcare and Public Health (HPH) Sector organizations.

      The authoring agencies urge network defenders to examine their current cybersecurity posture and apply the recommended mitigations in this joint CSA, which include:

      • Train users to recognize and report phishing attempts.
      • Enable and enforce phishing-resistant multifactor authentication. 
      • Install and regularly update antivirus and antimalware software on all hosts. 

      See Ransomware Attacks on Critical Infrastructure Fund DPRK Espionage Activities for ransomware actor’s tactics, techniques, and procedures, indicators of compromise, and recommended mitigations. Additionally, review StopRansomware.gov for more guidance on ransomware protection, detection, and response.

      Bleeping Computer tells us

      Royal Ransomware is the latest ransomware operation to add support for encrypting Linux devices to its most recent malware variants, specifically targeting VMware ESXi virtual machines.

      BleepingComputer has been reporting on similar Linux ransomware encryptors released by multiple other gangs, including Black Basta, LockBit, BlackMatter, AvosLocker, REvil, HelloKitty, RansomEXX, and Hive.

      The new Linux Royal Ransomware variant was discovered by Will Thomas of the Equinix Threat Analysis Center (ETAC), and is executed using the command line.

      Cyberscoop considers whether “After the Hive takedown, could the LockBit ransomware crew be the next to fall?”

      Here is a link to Bleeping Computers The Week in Ransomware.

      From the cyber defenses front —

      • The Wall Street Journal offers its quarterly cybersecurity insurance update.
      • ZDNet reports, “Reddit was hit with a phishing attack. How it responded is a lesson for everyone. A quick and transparent response shows that there’s a correct way to respond to cybersecurity incidents.”
      • An ISACA expert asks, “How does one fix people?” and answers, “Through governance, processes and planning. Governance, processes and planning are all essential components of effective cybersecurity management.”

      Friday Factoids

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

      Based on the CDC’s Covid Data Tracker, the CDC’s weekly review tells us

      New Cases – As of February 8, 2023, the current 7-day average of weekly new cases (40,404) decreased 1.0% compared with the previous 7-day average (40,815). 

      New Hospitalizations — The current 7-day daily average for February 1–7, 2023, was 3,665. This is an 6.2% decrease from the prior 7-day average (3,907) from January 25–31, 2023.

      New Deaths — The current 7-day average of new deaths (453) decreased 9.7% compared with the previous 7-day average (502).

      Vaccinations — As of February 8, 2023, 670.3 million vaccine doses have been administered in the United States. Overall, about 229.8 million people, or 69.2% of the total U.S. population, have completed a primary series. About 52.5 million people, or 15.8% of the U.S. population, have received an updated booster dose.

      Communities Levels — As of February 9, 2023, there are 91 (2.8%) counties, districts, or territories with a high COVID-19 Community Level, 715 (22.2%) with a medium Community Level, and 2,407 (74.8%) with a low Community Level. Compared with last week, the number of counties, districts, or territories in the high level decreased by 1.2%, in the medium level decreased by 3.2%, and in the low level increased by 4.3%. 

      The weekly report explains why immunocompromised folks with weakened immune systems should create a Covid action plan.

      The CDC’s weekly flu report informs us “Seasonal influenza activity is low nationally.” Nevertheless the CDC adds

      CDC reported 9 new flu-related pediatric deaths this week, bringing the total for the season to 106, the highest number of flu deaths in children since the start of the COVID-19 pandemic. Most of these children were not vaccinated. This tragic milestone underscores the importance of vaccinating children against flu. Flu vaccination uptake in children is lower by about 6 percentage points than it was prior to the COVID-19 pandemic. While flu activity has returned to low levels this season, CDC continues to recommend flu vaccination as long as flu viruses are spreading.

      During the most recent 10 flu seasons, the number of pediatric flu deaths in a season has ranged from 1 (2020-2021) to 199 (2019-2020). Prior to the pandemic, the record low for pediatric deaths was 37, which was during the 2011-2012 season.

      AHIP reports,

      The Centers for Disease Control and Prevention (CDC) has added COVID-19 vaccinations for children, adolescents, and adults to its immunization schedule.  Adding these vaccines to the schedule formalizes guidance for health care providers and schools.

      • CDC recommends that healthy children 6 months to 4 years old receive a primary series of two doses of the Moderna or Pfizer-BioNTech monovalent COVID-19 vaccine followed by a third dose of a bivalent vaccine.
      • CDC recommends that children aged 5 to 12 years receive two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine followed by a bivalent shot.
      • CDC recommends children ages 12 and older should get either two doses of the Moderna, Pfizer-BioNTech, or Novavax vaccine, followed by a bivalent booster.
      • Immunocompromised children should receive three doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine as a primary series instead of two shots, and should receive a bivalent booster.
      • CDC recommends healthy adults receive a primary COVID-19 vaccination of two doses of the Moderna, Pfizer-BioNTech or Novavax vaccine and a bivalent booster, similar to children.  Some adults may choose to receive a Novavax booster instead if they would not like the Moderna or Pfizer-BioNTech shot, or if those boosters are not available. 
      • CDC recommends immunocompromised adults receive either two doses of the Novavax vaccine, or three doses of the Pfizer-BioNTech or Moderna vaccine and a bivalent booster.

      CDC also recommends that adults who received the one-dose Johnson & Johnson vaccine receive one booster dose, followed by a bivalent booster.

      MedPage Today offers a report on

      The topic [of] highlights from ACIP’s new adult schedule for 2023, published in the Annals of Internal Medicine, and why this new schedule may be a collector’s item.

      It’s a new year, which means a new ACIP adult immunization schedule — a valuable resource collating ACIP’s most up-to-date vaccination recommendations.

      Here are this year’s five most important changes:

      • COVID vaccines now front and center
      • New emphasis on polio vaccination
      • Inclusion of some nonvaccine products (such as monoclonal antibody products)
      • Pharmacists group has approved the schedule for the first time
      • New shared clinical decision-making option for pneumococcal vaccines

      From the No Surprises Act front, the American Hospital Association relates

      Following a Feb. 6 court decision that vacated nationwide the federal government’s revised independent dispute resolution process for determining payment for out-of-network services under the No Surprises Act, the Centers for Medicare & Medicaid Services today instructed certified IDR entities to hold all payment determinations until the departments of Health and Human Services, Labor, and the Treasury issue further guidance. Certified IDR entities have also been instructed to recall any payment determinations issued after Feb. 6, 2023. 

      “The Departments are currently reviewing the court’s decision and evaluating current IDR processes, guidance, templates, and systems for updates that will be necessary to comply with the court’s order,” CMS said. “The Departments will provide specific directions to certified IDR entities for resuming the issuance of payment determinations that are consistent with the court’s judgment and order. Certified IDR entities should continue working through other parts of the IDR process, including eligibility determinations, as they wait for additional direction from the Departments.”

      The FEHBlog notes that while the court ordered changes to the IDR rule which favor the plaintiffs, the court did not vacate the IDR rule. The FEHBlog does not otherwise doubt the veracity of this report.

      From the Rx coverage and research front —

      • BioPharma Dive reports “Pfizer and partner BioNTech on Friday started the first human trial of a messenger RNA-based vaccine for shingles, believing their shot can be easier to take, and more efficiently produced, than the one available for use [Shingrix]. 
      • Medscape alerts us that a new vibrating, drug-free pill to relieve constipation is on the market.

      From the healthcare quality front, NCQA puts us on notice that

      This year’s HEDIS public comment is open Monday, February 13–Monday, March 13.

      We’re seeking advice on:

      • Revisions to diabetes measures.
      • Expansion of race and ethnicity stratifications in select HEDIS measures.
      • Advancing gender-inclusion measurement in two HEDIS measures.
      • Retirement of several measures.

      This year’s public comment will go live at Monday, February 13, 9:00 AM ET.

      We’ll post the link and more details here, so check back.

      To hear NCQA leaders discuss HEDIS public comment, attend our Tuesday, February 28 Future of HEDIS webinar.

      From the U.S. healthcare business front —

      Kaiser Permanente released its 2022 financial results

      Total operating revenues for 2022 were $95.4 billion compared to $93.1 billion in 2021. Total operating expenses were $96.7 billion compared to $92.5 billion in the prior year. There was an operating loss of $1.3 billion for the year compared to operating income of $611 million in 2021. * * *

      Strong economic headwinds in the financial markets drove a loss in total other income and expense of $3.2 billion in 2022 compared to a gain of $7.5 billion in 2021. For 2022, there was a net loss of $4.5 billion compared to net income of $8.1 billion in 2021.

      Capital spending totaled $3.5 billion, consistent with the $3.5 billion spent the prior year. During 2022, Kaiser Permanente opened 4 new medical offices. Kaiser Permanente now has 737 medical offices, 39 owned hospitals, and 43 retail and employee clinics.

      “Clinical staff shortages, COVID-19 care and testing, higher costs of goods and services, and deferred care drove Kaiser Permanente’s expenses beyond revenue,” said chair and chief executive officer Greg A. Adams. “Rather than pull back amid financial pressures, we made the decision to continue our long-term and strategic investments in care and service improvements while carefully managing resources. Our staff and physicians worked hard to meet our members’ needs and I am grateful for their outstanding contributions.”

      Fierce Healthcare reports

      Major for-profit hospital chain Tenet Healthcare is projecting growth in 2023 thanks to less reliance on contract labor and growth in its surgery subsidiary.

      The chain announced in its earnings release that it generated $102 million in profits with $4.9 billion in net revenue for the fourth quarter of 2022. It also released the full year financial guidance for 2023, projecting adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) to be $3.16 to $3.36 billion.

      “Our momentum going into 2023 positions us for continued growth as we remain focused on expanding our industry-leading ambulatory business and investing in technology, innovation and talent,” said CEO Saum Sutaria in a statement.

      Beckers Hospital Review identifies six considerations related to the fact that 43% of rural hospitals are in the red.

      Reuters reports “AstraZeneca (AZN.L) on Thursday said it was poised to grow in 2023 and beyond, banking on its burgeoning line-up of cancer, metabolic and rare disease drugs to pick up the pace from dwindling COVID product sales.”

      Thursday Miscellany

      David Ermer–Congress, COVID-19, Federal employment benefits, HSA, Telehealth, Wellness–
      Photo by Josh Mills on Unsplash

      From Capitol Hill, STAT News reports

      The Senate Judiciary Committee on Thursday passed legislation to prevent drug companies from gaming the patent system to delay competition from cheaper generics, but members in both parties said they still have concerns about the reforms.

      It’s unclear when the bills might advance in either chamber. 

      The Congressional Research Service released an analysis of healthcare coverage spending in 2021.

      Meanwhile, the Health Affairs Council on Healthcare Spending and Value updates us on the recommendations proposed in its 2018 Road Map for Action.

      From the Omicron and siblings front —

      The Department of Health and Human Services (HHS) announced that its Secretary Xavier Becerra had given the States 90 days advance notice of the end of the Covid public health emergency on May 11, 2023.

      To help you and your communities in your preparations for the end of the COVID-19 PHE, I have attached a fact sheet to this letter that includes information on what will and will not be impacted by the end of the COVID-19 PHE.2 In the coming days, the Centers for Medicare & Medicaid Services (CMS) will also provide additional information, including about the waivers many states and health systems have adopted and how they will be impacted by the end of the COVID-19 PHE. I will share that resource with your team when available.

      MedPage Today informs us,

      Early treatment with a single dose of pegylated interferon lambda in a highly vaccinated population of COVID-19 outpatients decreased the risk for hospitalization and emergency department (ED) visits lasting more than 6 hours, the phase III TOGETHER trial found.

      Among nearly 2,000 participants with acute COVID symptoms and a risk factor for severe illness, 2.7% of those who received pegylated interferon lambda within a week of symptoms required hospitalization or ED visits, as compared with 5.6% of those given placebo (relative risk [RR] 0.49, 95% Bayesian credible interval [CrI] 0.30-0.76), reported Gilmar Reis, MD, PhD, of McMaster University in Hamilton, Ontario, and colleagues.

      Results were similar regardless of vaccination status (over 80% were vaccinated), and the treatment effect with the long-acting form of interferon lambda-1 was more pronounced in those who received the subcutaneous injection with 3 days of their symptoms.

      From the miscellany department —

      HHS released initial guidance for Medicare’s Prescription Drug Inflation Rebate Program created by last year’s Inflation Reduction Act.

      Under the Medicare Prescription Drug Inflation Rebate Program, drug companies who raise prices faster than the rate of inflation will be required to pay rebates to the Medicare Trust Fund. Below is a timeline of key dates for implementing the Medicare Prescription Drug Inflation Rebate Program:

      • October 1, 2022: Began the first 12-month period for which drug companies will be required to pay rebates to Medicare for raising prices that outpace inflation on certain Part D drugs.
      • January 1, 2023: Began the first quarterly period for which drug companies will be required to pay rebates for raising prices that outpace inflation on certain Part B drugs.
      • April 1, 2023: People with Traditional Medicare and Medicare Advantage may pay a lower coinsurance for certain Part B drugs with price increases higher than inflation.
      • 2025: CMS intends to send the first invoices to drug companies for the rebates.

      The law has a circular aspect because the government needs a much lower general inflation index to get the full bang for the buck from this program. The notice also poses issues for public input.

      The International Foundation of Employee Benefit Plans tells us,

      The International Foundation has been tracking fertility and family-forming benefits over the past seven years. According to Employee Benefits Survey: 2022 Results, 40% of U.S. organizations currently offer fertility benefits (an increase from 30% in 2020).
      Overall:

      • 28% cover fertility medications (8% covered in 2016, 14% in 2018, 24% in 2020)
      • 30% cover in vitro fertilization (IVF) treatments (13% in 2016, 17% in 2018, 24% in 2020)
      • 16% cover genetic testing to determine infertility issues (11% in 2018, 12% in 2020)
      • 17% cover non-IVF fertility treatments (6% in 2016, 11% in 2018, 11% in 2020).

      In 2016, only 2% of organizations covered egg harvesting/freezing services. That jumped to 6% in 2018, 10% in 2020 and even higher in 2022, with 14% reporting that they cover the benefit.

      Healthcare Dives points out, “National telehealth utilization increased 1.9% month-over-month among the privately insured population in November 2022, following one month of decline, according to a new analysis from Fair Health’s monthly tracker.” The bump is attributable to the tripledemic.

      Fierce Healthcare relates, “UnitedHealthcare is rolling out a new wearables-based rewards program for members and their spouses. In UnitedHealthcare Rewards, eligible members can earn up to $1,000 per year by using wearable devices to complete health goals and activities, the insurance giant announced Wednesday.”

      Health Payer Intelligence notes that “High deductible health plan (HDHP) enrollment hit a record high in 2021, with nearly six out of ten employer-sponsored health plan members enrolled in a high deductible health plan, according to a ValuePenguin survey.”

      Benefits consultant Tammy Flanagan writing in Govexec, explains how federal employees can get the full advantage out of the Thrift Savings Plan, which is part of the Federal Employees Retirement System.

      Midweek update

      David Ermer–Uncategorized–
        Photo by Manasvita S on Unsplash

        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.

        Tuesday’s Tidbits

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

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

        In other regulatory news, Health Payer Intelligence reports

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

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

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

        From the Omicron and siblings front —

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

        From the public health front,

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

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

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

        From the U.S. healthcare business front

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