Monday Roundup

Congress

Monday Roundup

David Ermer–AHRQ, CMS, Congress, COVID-19, FDA, Federal employment benefits, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From our Nation’s capital, OPM released its Fiscal Year 2024 Congressional Budget Justification document, which is part of the federal budget process. Of interest to the FEHBlog is this OPM goal:

Improve customer experience by making it easier for Federal employees, annuitants, and other eligible persons to make a more informed health insurance plan selection. 

By September 30, 2023, complete user-centered design and develop a minimum viable product for a new, state-of-the-art Decision Support Tool that will give eligible individuals the necessary information to compare plan benefits, provider networks, prescription costs, and other health information important to them and their families.

Federal News Network tells us about a related Office of Management and Budget analytical perspective on federal workforce issues.

The Office of Management and Budget, in one of its analytical perspectives supplementing the Biden administration’s 2024 budget request, said federal workers’ pay is “increasingly hamstrung” by statutory requirements “that curb the ability of agencies to reward talent, including for specialized occupations, in a national competitive job environment.”

From the Rx coverage front —

The Wall Street Street Journal reports

Eisai Co.’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year. 

Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.

An estimated 167,954 veterans receiving care through the VA have Alzheimer’s dementia, according to government estimates. To qualify for Leqembi, patients must be over 65, have early-stage symptoms and elevated brain amyloid, sticky protein fragments, which the drug is designed to remove.

STAT News describes the VA’s step as “unexpected,” which is an understatement because CMS does not plan to issue a Medicare national coverage decision until mid-year. STAT News adds

The [VA] published a guide on its formulary saying coverage will extend to any veteran who meets specified criteria, including an MRI scan within the previous year, amyloid PET imaging consistent with Alzheimer’s and a staging test indicating mild Alzheimer’s dementia. There is also a long list of criteria that would exclude veterans.

The agency can negotiate prices for drugs, but the price it will pay for Leqembi was not listed and the Eisai spokesperson did not offer a cost. Leqembi has an annual wholesale price of $26,500, although the Institute for Clinical and Economic Review recently said the treatment should cost between $8,900 and $21,500 per year to be considered cost effective.

Under federal law, the VA can bill other health plans (including FEHB but not Medicare) for non-service related care such as this drug. For this reason, this VA action opens the back door to FEHB coverage of Leqembi.

From the end of the public health emergency front —

The Society for Human Resource Management offers its take on how employers should prepare for the end of the PHE, now less than two months away.

The American Hospital Association points out

The Food and Drug Administration will end 22 COVID-19-related policies when the public health emergency ends May 11 and allow 22 to continue for 180 days, including temporary policies for outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective equipment practices for sterile compounders not registered as outsourcing facilities, the agency announced. FDA plans to retain 24 COVID-19-related policies with “appropriate changes” and four whose duration is not tied to the PHE, including its recently revised policy for COVID-19 tests. 

From the Rx business front —

BioPharma Dive informs us

Pfizer has agreed to buy Seattle-based Seagen for $43 billion in a blockbuster deal that would unite the pharmaceutical giant with a biotechnology company that pioneered a new type of tumor-killing medicine.

The acquisition is the largest Pfizer has attempted since its 2009 purchase of Wyeth, and is the most sizable in the drug industry by value since AbbVie’s $63 billion buyout of Allergan in 2019.

Acquiring Seagen gives Pfizer control of the top-selling lymphoma medicine Adcetris as well as a pipeline of cancer treatments that’s yielded three new drug approvals in the past three years. Seagen specializes in a type of cancer therapy known as an antibody-drug conjugate, and has steadily improved on the technology since its founding in 1997.

STAT News relates

Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion.

The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.

The French pharma giant will now own TZield outright, paying $25 per share to acquire Provention — a 273% premium over Friday’s closing stock price.

In recognition of Patient Safety Awareness Week

  • The HHS Agency for Healthcare Quality and Research’s Director Robert O. Valdez, Ph.D., M.H.S.A. explains how AHRQ is sharpening its focus on diagnostic safety.
  • Beckers Hospital Review reports
    • The pediatric mental health crisis is the most pressing patient safety concern in 2023, the Emergency Care Research Institute said on March 13. 
    • The ECRI, which conducts independent medical device evaluations, annually compiles scientific literature and patient safety events, concerns reported to or investigated by the organization, and other data sources to create its top 10 list.
    • Here are the 10 patient safety concerns for 2023, according to the report: 
      • 1. The pediatric mental health crisis
      • 2. Physical and verbal violence against healthcare staff
      • 3. Clinician needs in times of uncertainty surrounding maternal-fetal medicine
      • 4. Impact on clinicians expected to work outside their scope of practice and competencies
      • 5. Delayed identification and treatment of sepsis
      • 6. Consequences of poor care coordination for patients with complex medical conditions
      • 7. Risks of not looking beyond the “five rights” to achieve medication safety
      • 8. Medication errors resulting from inaccurate patient medication lists
      • 9. Accidental administration of neuromuscular blocking agents
      • 10. Preventable harm due to omitted care or treatment
  • The U.S. Department of Labor announced on March 10
    • the launch of a series of online dialogues to gather ideas and other public input on how health policies can support workers’ mental health most effectively.
    • The crowdsourcing will focus on four areas of concern for people with mental health conditions, including benefits policies that meet their needs, access to workplace care and supports, the reduction of related social stigmas, disparities faced by people in underserved communities, shortages of behavioral health professionals, and the establishment of state resource systems.
    • Part of the department’s ePolicyWorks initiative, the dialogues will remain open until April 3. Input received will inform the next meeting of the Mental Health Matters: National Task Force on Workforce Mental Health Policy
  • Healthexec calls attention to FDA recalls of certain eyedrops.

From the value-based care front, Health Payer Intelligence notes

CareFirst BlueCross BlueShield (CareFirst) has formed a strategic alliance with Aledade, Inc. (Aledade), offering independent primary care physicians tools and resources to improve healthcare affordability and effectiveness, supporting CareFirst member physicians in achieving value-based care goals.

Through this value-based relationship, CareFirst member physicians can leverage specialists, including onsite business support for physician practices, a technology platform that works with more than 100 different EHRs, and healthcare regulatory and policy expertise.

From the medical debt front, Healthcare Dive reports

  • Hospitals are a prime source of medical debt in America that hits underserved populations hardest, despite charity care programs and financial assistance policies, according to a new analysis from the Robert Wood Johnson Foundation.
  • Of the 15% of U.S. adults with past-due medical debt, almost two-thirds owe some or all of that debt to hospitals, according to research from the Urban Institute. That medical debt disproportionately affects underserved populations, such as low-income individuals and people with disabilities, researchers found.
  • While medical debt remains a persistent financial burden in the U.S., a new analysis from the Urban Institute highlights how targeting hospital billing could ameliorate the problem.

Weekend update

David Ermer–Congress, Rx coverage, U.S. Healthcare–
Bluebonnets — The Texas State Flower

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

HHS’s Agency for Healthcare Quality and Research reminds us that we observe Patient Safety Awareness Week from March 12 through March 18.

HR Dive reminds us that March 2023 marks the thirtieth anniversary of Congress enacting the Family and Medical Leave Act.

From the public health front —

  • The American Medicare Association explains what doctors wish patients knew about falling U.S. health expectancy and identifies steps patients can take to lower high blood pressure.
  • Fortune Well informs us, “Researchers have found long-term evidence that actively monitoring localized prostate cancer is a safe alternative to immediate surgery or radiation.”
  • A Fortune Well reporter shares lessons learned from wearing a continuous glucose monitor for a decade.

From the Rx coverage front, STAT News reports

The emergence of highly effective obesity drugs has spurred renewed efforts to get Medicare to pay for weight loss medications, but a group of health policy experts is sounding caution.

Even a small amount of uptake would create significant costs for Medicare, likely leading the federal insurer to raise premiums in the long run, the researchers said in a perspective piece Saturday in the New England Journal of Medicine.

The chronic medications may also have fewer benefits and more risks for older people — the population that Medicare serves, they wrote.

OPM advised FEHB carriers in a January 2023 carrier letter

FEHB Carriers must have adequate coverage of FDA approved anti-obesity medications on the formulary to meet patient needs and must make available their exception process to members. Carriers must cover at least one anti-obesity drug from the GLP-1 class for weight loss and cover at least 2 additional oral anti-obesity drug options. As new anti-obesity drugs are approved by the FDA, OPM expects Carriers to evaluate and update their coverage of anti-obesity drugs. Carriers should provide access to a range of obesity drugs on the formulary in order to satisfy OPM’s requirement in Carrier Letter 2022-02 that Carriers must ensure non-discriminatory access to safe, clinically appropriate drug therapy for members with chronic conditions. This includes drug therapies indicated for adolescents age 12 years and older.

In cases where utilization management edits are applied, the process and evidence-based criteria for coverage must be transparent, readily accessible, and follow OPM required turnaround timelines for standard and expedited reviews. We recognize the progress made in covering anti-obesity medications; our goal is to have all Carriers offer adequate coverage.

From the medicare practice front —

  • RevCycle Intelligence relates, “Providers are Increasingly Billing Outpatient Visits at Higher Levels; The share of outpatient visits billed at the two highest complexity levels increased from 24 percent in 2004 to 43 percent in 2021,” and “A study finds that outpatient surgery rates for 4 common procedures rose significantly during the pandemic, while barriers prevent greater uptake for other surgical operations.
  • In an intriguing contrast of news —
    • RevCycle Intelligence highlights, “New data shows that 46% of patients rely on online provider reviews for provider selection. With loyalty on the back burner, a poor patient experience could prompt consumers to look elsewhere.”
    • Meanwhile, the Wall Street Journal reports
      • “Doctor-rating websites regularly fail to mention such black marks on physicians’ records, according to research published in November in the Journal of Empirical Legal Studies. 
      • “The researchers compared two groups of online reviews. One group consisted of ratings for 221 doctors in Illinois and Indiana who had paid medical-malpractice claims and had disciplinary actions against them. The other group had ratings for 221 doctors in the same two states with clean records. Based on their findings across five online rating services—Healthgrades.com, RateMDs.com, Vitals.com, WebMD and Yelp.com—the researchers reported no significant difference in the two groups’ ratings. 
      • “If you have a physician with both discipline and medical-malpractice claims, you should probably be looking for someone else, but that information is not easy to find,” says David Hyman, an author of the study and a health-law and policy professor at Georgetown University Law Center. 
      • “Of the five websites in the study, only Healthgrades reports medical-malpractice claims and disciplinary actions, but it misses 90% of those claims and actions, according to the study authors.”

Director Ahuja appears before Congress

David Ermer–Congress, COVID-19, OPM–
Photo by Michele Orallo on Unsplash

On Thursday, OPM Director Kiran Ahuja appeared at a hearing before the House Oversight and Accountability Committee for around three hours of questioning. Federal News Network tells us

This week, the Oversight and Accountability Committee held seven hearings in the span of just two days. Members are probing fraudulent payments of pandemic relief programs, advances in artificial intelligence (AI) and inflation, to name just a handful.

The FEHBlog listened to the hearing. Much of the questioning at the hearing stems from OPM’s struggles with federal retirement program administration. OPM must deal with an unnecessarily complicated retirement system that Congress created. Congress could solve OPM’s administration/customer service problem by simplifying federal employee retirement laws.

In FEHB news, Ms. Ahuja announced

  • OPM will issue the Postal Service Health Benefits Program (“PSHBP”) interim final implementation rule in April 2023. Bear in mind that the statutory deadline is April 6, 2023.
  • OPM expects to solve its FEHB eligibility issues by ending the current decentralized approach to FEHB enrollment under which federal agencies hold primary responsibility. Remember that half of the enrollment, the annuitants, already are centralized in the OPM annuitant payroll office. Nevertheless, OPM plans to roll out its new 100% centralized approach with the PSHBP for 2025 and subsequently extend it to legacy FEHB.
  • OPM works “hand in glove” with the Postal Service to implement the PSHBP.
  • Like FedWeek (as discussed in FEHBlog posts earlier this week), Congress does not understand the FEHB’s hardcore transparent prescription drug pricing program for experience-rated carriers. Director Ahuja did not trumpet OPM’s game-changing decision to allow integrated Medicare Part D EGWPs for 2024.

It’s worth adding that the Federal Times has recognized that OPM has improved FEHB infertility treatment benefits for 2024 and that Govexec.com includes an article about the OPM call letter for 2024 benefit and rate proposals, which includes a misunderstanding of Medicare programs being integrated into FEHB for greater savings.

OPM is encouraging FEHB carriers to offer Medicare Advantage Prescription Drug Employer Group Waiver Plans, which are designed to maximize value to enrolled individuals under FEHB and Medicare. These are special plans more generous than standard Medicare Advantage plans.

In recent years, a growing number of FEHB carriers have offered such plans. They must provide benefits that are at least the same as those offered by other Medicare plans.

Over the past decade, FEHB plans have been integrating Medicare Advantage / Prescription Drug Plans. These are known as MAPDs. Annuitants with Medicare Part A and B coverage can opt into these MAPD plans and receive a Part B premium subsidy, among other benefits.

In a January 2023 carrier letter and the February 2023 call letter, OPM informed carriers of a new opportunity to offer Medicare Part D EGWPs. These “new to FEHB” Part D prescription drug plans, which can be integrated with FEHB Rx benefits, are open to all Medicare prime annuitants, including Medicare Part A only members.

With the current integrated MAPD plans, opting-in annuitant members must pay the Medicare Part B premium adjusted for the Plan subsidy. With the Part D PDPs / EGWPs, the Plan covers the Part D premiums for the participating members.

In regular Friday post news, here are links to the CDC’s Covid Data Tracker, which continues to show downward trends in new cases, hospitalizations and deaths, and the CDC’s weekly Fluview, which indicates, as folks know, that the flu epidemic is over.

The FEHBlog also suggests that readers listen to the 15-minute long, eye-opening Wall Street Journal podcast on fentanyl test strips.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, FDA, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From our Nation’s capital, the President presented his Fiscal Year 2024 budget to Congress today. Roll Call informs us

    While spending would increase by $1.9 trillion over a decade, revenue would increase by $4.7 trillion, for over $2.8 trillion in a 10-year deficit reduction. But according to the Office of Management and Budget’s numbers, the budget shortfall would still total more than $17 trillion over the next decade even if Biden’s plans were fully implemented, which seems unlikely.

    The Wall Street Journal adds, “Biden’s budget shows the rising cost of leaving Medicare and Social Security untouched. In the President’s blueprint, the two programs plus interest consume a sharply growing share of economic output.

    and

    The President’s proposed spending and tax increases will face an unfriendly reception among Republicans in Congress, as lawmakers gear up for a fight over the debt ceiling that could come before the Sept. 30 end of the fiscal year. GOP leaders in the House have called for unspecified spending cuts as a condition of raising the federal debt limit. But the president has said he won’t negotiate over raising the debt ceiling.

    Republicans plan to release their own budget proposal in the coming months, though they haven’t agreed on a plan.

    The President will make public more budget details over the next few days. Until then, it’s worth noting that the budget includes the following healthcare proposal

    The budget proposes $11 billion for a five-year effort the White House hopes will eliminate hepatitis C in the U.S., said Dr. Francis Collins, the former National Institutes of Health director who is spearheading the initiative. Drugs to treat the disease have been on the market since 2013, but normally retail for about $24,000 per patient. 

    In related news, the American Hospital Association tells us,

    “The Centers for Disease Control and Prevention [CDC] today recommended screening all U.S. adults at least once in their lifetime for hepatitis B using three laboratory tests. It also expanded risk-based testing recommendations to certain populations and activities with increased risk for the hepatitis B virus.”

    The FEHBlog is unsure how this meshes with the ACA’s preventive services mandate because the current US Preventive Services Task Force recommendation is Grade B for “screening for hepatitis B virus (HBV) infection in adolescents and adults at increased risk for infection.” The CDC’s new recommendation is significantly broader.

    The Office of Personnel Management released on March 7 “a new memorandum today detailing a vision for the future of the workforce: a Federal government with a workforce that is inclusive, agile and engaged, with the right skills to enable mission delivery.”

    From the public health front —

    • The Kaiser Family Foundation notes ten numbers to mark the third anniversary of the Covid pandemic
    • The Dana Farber Cancer Institute highlights a comprehensive article about colon cancer in young adults.
    • The Food and Drug Administration “published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.
    • The New York Times reports, “A review of poisonings among children 5 and younger found that opioids contributed to nearly half of the deaths from 2005 to 2018, largely from accidental overdoses, according to new research. * * * The study, published on Wednesday in the journal Pediatrics, analyzed 731 poisoning-related deaths that occurred from 2005 to 2018 across 40 states.”

    From weight loss drugs front —

    • STAT News continues its reporting on obesity drugs. The latest article concerns “‘Emotional hunger’ vs. ‘hungry gut’: The attempt to subtype obesity and tailor treatments.”
    • Medscape provides the account of a physician who took the new obesity drugs, specifically Ozempic. This article is particularly worth a gander.

    From the SDOH front, Mercer Consulting lays out its latest “Must-Do Strategy: Lean in on Benefits Strategy to Support DEI Goals.”

    From the miscellany department

    • Cigna offers its insights on how to choose among virtual care, urgent care centers, and emergency rooms.
    • Beckers Hospital Review notes
      • “In a March 8 Twitter thread, the FDA acknowledged it’s aware of a potential drug supply disruption after Gurnee, Ill.-based Akorn Operating Co. closed in late February. 
      • “The FDA clarified that the ongoing shortage is of a specific albuterol inhalation solution used in nebulizers, typically in hospitals, for patients having trouble breathing, not in inhalers at the consumer level. The agency said it is working with manufacturers to ease the shortage and “reiterated that outsourcing facilities may compound the specific product.”

    Finally, following up on the FEHBlog’s message to Congress about FEHB prescription drug costs, OPM stated its position against carving out prescription drug coverage from FEHB carrier responsibilities in the agency’s FY 2018 annual financial report on page 123:

    OPM does not concur with OIG’s suggestion that OPM continue to pursue efforts towards a prescription carve-out program. The Federal Employees Health Benefits (FEHB) Program is a market-based program that provides complete health benefits within each FEHB plan. The FEHB Program is not a self-funded plan and its statutory framework does not contemplate it to be the direct payer of benefits. Each FEHB Program plan offers comprehensive medical services including services provided by physicians and other health care professionals, hospital services, surgical services, prescription medications, medical supplies and devices, and mental health services. FEHB Program plans compete to offer all of these benefits in a high quality manner at the most competitive price possible.

    Carving out pharmacy benefits or any of the other services normally covered under an FEHB Program contract and administering the benefit as a separate contract or program, could undermine the fundamental market-based nature ofthe FEHB Program. It would be disruptive and could lead to a reduction in plan participation, and limit the ability of FEHB carriers to focus on comprehensively improving the health of the population. There would likely be less effective

    coordination of medical and pharmacy claims, and potentially less effective, one-size-fits-all pharmacy utilization and disease management programs. OPM is now assessing carrier performance on the basis of clinical quality measures that require tight coordination between medical and pharmacy benefits. A carved out pharmacy benefit is not consistent with or supportive of plan performance assessment, and may impair achievement of OPM’s long-term population health goals. As an example, carriers being held accountable for controlling diabetes and hypertension in the population they serve cannot do so readily if they do not have control over pharmacy benefit design and real time access to adherence data.

    To control the cost of prescription drugs, OPM works with carriers to better manage pharmacy networks, focus on drug utilization techniques, coordinate coverage of specialty drugs between the medical and pharmacy benefit, optimize the prescription drug benefit via formulary design, and implement effective cost comparison tools for members and prospective enrollees. Additionally, OPM notes that the most recent drug trend reported by FEHB carriers showed a significantly slower rate of growth compared with previous years, in line with industry trends.

    This statement continues to warm the FEHBlog’s heart.

    Tuesday’s Tidbits

    David Ermer–Congress, FDA, Mental health care, NIH, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
    Photo by Patrick Fore on Unsplash

    From our Nation’s Capital, Roll Call fills us in on the debt ceiling negotiations. Significantly,

    ​Economists at Moody’s Analytics estimate that the Treasury Department will run out of borrowing room by mid-August if Congress doesn’t act to raise or suspend the statutory debt limit by then.

    The “x date” after which Treasury may not be able to pay all of the federal government’s bills appears to be Aug. 18, specifically, according to Moody’s economists Mark Zandi, Christian deRitis and Bernard Yaros. 

    The trio laid out various scenarios and potential consequences of failure to lift the $31.4 trillion debt ceiling in a new paper this week, on a topic that was examined more closely Tuesday afternoon in a Senate Banking subcommittee hearing led by Sen. Elizabeth Warren, D-Mass. Zandi is among those slated to testify.

    The propspect of a mid-August explosion may encourage Congress to suspend the debt ceiling suspension until the end of the federal fiscal year, September 30, and focus on negotiating the interrelated 2024 appropriations and the debt ceiling topics.

    The President provided highlights of the Medicare proposals in his 2024 fiscal year budget. The American Hospital Association explains

    The president’s fiscal year 2024 budget will propose policies to keep Medicare’s Hospital Insurance Trust Fund solvent for at least an additional 25 years by directing additional Medicare taxes and savings from prescription drug reforms to the HI Trust Fund, the White House announced today. According to the latest annual report by the Medicare Trustees, the fund currently has sufficient funds to pay full benefits until 2028. 

    Among other Medicare provisions, the president’s budget will propose to eliminate cost-sharing for three behavioral health visits per year; require parity between physical health and mental health coverage; lower out-of-pocket costs for drugs subject to price negotiation; and cap Part D cost-sharing for certain generic drugs, the White House said.

    The president’s FY 2024 budget is expected to be publicly released on March 9, with additional detail on March 13. AHA members will receive additional information on the president’s budget as those details are released.

    Congress shared the budget with the Congressional Budget Office to analyze whether this plan will work.

    Federal News Network reports on a recent GAO report about OPM.

    The Office of Personnel Management is at “significant risk” of being unable to help agencies address governmentwide skills gaps, if it can’t first do a better job of addressing its internal skills gaps, GAO said in a report published last week.

    Persistent internal skills gaps “could compromise OPM’s ability to implement its strategic objectives related to closing governmentwide skills gaps,” GAO said in the Feb. 27 report.

    Although OPM has made progress in some areas of workforce management, such as creating an internal committee to hire and train new staff members, the agency is struggling to clearly identify and address several skills gaps within its own staff. * * *

    Ron Sanders, former chairman of the Federal Salary Council and former associate director for HR policy at OPM, said the results of the GAO report were “unsurprising,” but that the reason behind the challenges may be difficult to measure.

    “I think the skills gaps and have more to do with intangibles than they do with specific functional specializations,” Sanders, current president and CEO of Publica Virtu LLC, said in an interview with Federal News Network. 

    Hang in there, OPM, which has a lot on its plate, as we all do.

    Healthcare Dive tells us

    • The Federal Trade Commission will give the public an additional 30 days to comment on a sweeping proposal to ban employers from imposing noncompete contracts on their workers. 
    • The agency said interested parties have requested an extension, though acknowledged others oppose the delay. The public now has until April 19 to comment on the proposed rule, the FTC said on Monday.  
    • FTC Commissioner Christine Wilson said in a separate statement that she would have supported an even longer extension since the proposal is “a departure from hundreds of years of precedent.” 

    MedCity News writes about the state of No Surprises Act rulemaking. Of note,

    What the industry really needs from the government agencies at this point is a road map, or, as the Workgroup for Electronic Data and Interchange (WEDI) said in a recent letter to the secretary of HHS, a “glide path” that explains how the industry and the government will develop standards and operating rules together. In the letter, WEDI asked for the government’s expectations on vetting and testing standards and an estimate on timelines for implementing NSA regulations.

    The FEHBlog heartily agrees with WEDI. Congress should consider amending certain provisions, particularly the good faith estimate and advance explanation of benefit provisions which should be amendments to the HIPAA electronic transaction standards and narrowed in scope.

    From the Food and Drug Administration front —

    • STAT News provides an interview with Food and Drug Commissioner Dr. Robert Califf. For example

    FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools. But he also said he saw it as an example of a drug company filling the void left by health systems that aren’t teaching doctors and trainees how to use new medicines.

    “I think it’s a shame that you would need to depend on a pharmaceutical company for an educational program about something that’s affecting half of Americans,” Califf said during a meeting with STAT reporters and editors.

    But, he said, “we also live in a practical real world. You might argue that if health systems did their jobs, you would have no need for educational programs from drug companies. But talk to people who practice medicine who are part of these big health systems and ask them how much help they get and guidance on what to do from the health systems they work for. I say this being a card-carrying lover of academic health systems, but that’s not where the money goes in academic health systems.”

    • Beckers Hospital Review informs us,

    The FDA is set to decide whether to fully approve Leqembi, Eisai and Biogen’s Alzheimer’s treatment by July 6, CNBC reported March 6.

    Leqembi is an antibody treatment that targets brain plaque associated with Alzheimer’s. The drug is administered intravenously twice a month and in clinical trials has shown it can slow early Alzheimer’s disease by 27 percent; however, the deaths of three trial participants may be tied to brain swelling caused by the drug.

    The FDA approved the drug on an expedited basis in January, but CMS has made it accessible to patients only in clinical trials. CMS plans to provide broader coverage if Leqembi is fully approved, according to CNBC.

    Covis Pharma Group said it will stop selling its drug to prevent preterm births, after a study couldn’t confirm the medicine worked and U.S. health regulators were taking steps that could have it pulled.

    Makena was the only drug approved by the Food and Drug Administration to reduce the risk of preterm birth in women with a history of early deliveries.

    Covis said Tuesday it wants to work with the FDA to set a wind-down period for the drug so that patients aren’t abruptly taken off of it. The company said it was acting after experts advising the agency recommended it pursue Makena’s withdrawal from the market.

    Eli Lilly and Company (NYSE: LLY) today [March 3] announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio® (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence. High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3).1 This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.

    From the U.S. Healthcare business front —

    • Beckers Hospital Review tells us,
      • “The first hospitals seeking CMS’ new rural emergency hospital designation have submitted their applications, Kaiser Health News reported March 6. 
      • “Hospitals that convert receive a 5 percent increase in Medicare payments as well an average annual facility fee payment of about $3.2 million, according to the report. In return, the hospitals must close their inpatient beds and focus solely on outpatient and emergency care.”
    • Healthcare Dive informs us
      • “Regional health system Atrium Health [headquartered in Charlotte, NC] is partnering with tech retailer Best Buy to co-design hospital-at-home programming, bolster Atrium’s existing hospital-at-home program and sell to other hospital clients down the line.
      • The partnership, announced Tuesday, aims to combine Atrium’s hospital-at-home program and existing telemedicine infrastructure with Best Buy Health, the retailer’s healthcare vertical that includes care-at-home business Current Health, along with its home installation and supply chain capabilities.
      • “The Atrium and Best Buy partnership seeks to improve some aspects of hospital-at-home programs that can be particularly tricky for operators, like patient education and technology installation in the home.
    • Beckers Hospital Review tells us, “Mark Cuban Cost Plus Drug Co. has entered into an agreement with IBSA Pharma to sell Tirosint, a medication for hypothyroidism. It will be the first brand-name drug offered by Mr. Cuban’s pharmacy.”

    From the medical and pharmaceutical research and studies front —

    • The Wall Street Journal relates
      • “Some doctors are urging patients to cut back their consumption of sugar substitutes as questions mount about their health effects. 
      • “In the latest study, published February in the journal Nature Medicine, Cleveland Clinic researchers found that the commonly used zero-calorie sweetener erythritol was associated with an increased risk of heart attacks, strokes and death within three years.
      • “Erythritol, a sugar alcohol produced naturally in the body, is used as a sugar substitute in low-calorie and low-carb products, often in those marketed as keto-friendly, such as ice cream, baked goods and condiments. It is also often mixed with other sweeteners. 
      • “As low-carb and ketogenic diets have grown popular, people have turned to nonsugar-sweetened products for a hit of sweetness with less sugar and carbs. Yet, researchers are warning that sugar substitutes might pose their own health concerns.”
    • Medscape considers whether Vitamin D is a viable prevention strategy for dementia.
    • The NIH Director’s Blog discusses the importance of dental/oral health care to overall health and well-being.
    • Securian Financial announced
      • “Fully 73% of Generation Z employees and 74% of Millennial employees have utilized mental health benefits offered by their employers, while 58% of Generation X employees and 49% of Baby Boomer employees have used the benefits.
      • Additionally, while 65% of Generation Z and 60% of Millennial workers say it’s “very important” for their employers to provide mental wellness benefits, just 49% of Generation X and 45% of Baby Boomer workers say the same.”
    • BioPharma Dive points out
      • “An experimental medicine for a rare blood vessel disorder [pulmonary arterial hypertension, or PAH, which is caused by a thickening of the blood vessels around the lungs] improved patients’ exercise capacity and potentially slowed the disease’s progression, according to detailed results from a late-stage clinical trial that were revealed on Monday.
      • “The drug, called sotatercept and owned by Merck & Co., was the principal prize of an $11.5 billion acquisition the pharmaceutical company negotiated more than a year ago.
      • “Data from the trial were presented at a medical conference and published in The New England Journal of Medicine. They have been highly anticipated since October when Merck said the study, dubbed STELLAR, was a success.”
    • The National Institutes of Health (NIH) announced
      • “Researchers at the National Institutes of Health show the benefits of screening adult patients in remission from acute myeloid leukemia (AML) for the residual disease before receiving a bone marrow transplant. The findings, published in JAMA(link is external), support ongoing research aimed at developing precision medicine and personalized post-transplant care for these patients.
      • About 20,000 adults in the United States are diagnosed each year with AML, a deadly blood cancer, and about one in three live past five years. A bone marrow transplant, which replaces unhealthy blood-forming cells with healthy cells from a donor, often improves these chances. However, research has shown that lingering traces of leukemia can make a transplant less effective. 
      • “Researchers in the current study wanted to show that screening patients in remission for evidence of low levels of leukemia using standardized genetic testing could better predict their three-year risks for relapse and survival. To do that, they used ultra-deep DNA sequencing technology to screen blood samples from 1,075 adults in remission from AML. All were preparing to have a bone marrow transplant. The study samples were provided through donations to the Center for International Blood and Marrow Transplant Research.

    Weekend update

    David Ermer–Congress, HSA, Rx coverage–
    Bluebonnets — The Texas State Flower– already starting to bloom in Austin

    From Capitol Hill, the House of Representatives and the Senate will be in session for Committee business and floor voting this week.

    From the public health front —

    • McKinsey & Co. offers “insights to discover why it’s impossible to experience good health alone, and what shifts you can make now to strengthen your social world” in order to combat loneliness.
    • Fortune Well discusses “[a] ‘super strain’ of an antibiotic-resistant stomach bug [XBR Shingella] that is on the rise in the U.S.” Fortunately, the CDC offers ways to prevent a Shingella infection:
      • Carefully washing your hands with soap and water before sexual activity, eating or preparing food, and after going to the bathroom, changing a diaper, or cleaning up after someone who went to the bathroom;
      • Throwing away diapers in a covered, lined garbage can;
      • Cleaning up mess from diapers thoroughly and promptly;
      • Avoid swallowing water from lakes, ponds, and swimming pools and
      • Refraining from sex when you have diarrhea, and for two weeks after diarrhea resolves.

    From the Rx coverage front —

    • The Wall Street Journal reports
      • The way doctors treat diabetes is changing.
      • For years, people with Type 2 diabetes who needed to take drugs to lower their blood-sugar levels started with an old medicine called metformin. New guidelines now recommend patients can start with one of the newer diabetes medicines, which can also reduce weight and protect the heart and kidney.
      • These newer diabetes drugs belong to two classes known by the acronyms SGLT-2 and GLP-1 for how they work.
      • The goal of the changes was to make treatment more specific to the patient rather than focused on the drug, said Dr. Nuha Ali El Sayed, an endocrinologist at the Joslin Diabetes Center in Boston who is vice president of healthcare improvement at the American Diabetes Association.
    • MedPage Today offers doctors ways to handle the current Adderall shortage.

    From the worldwide healthcare front (and many FEHB plans (particularly nationwide plans) offer worldwide coverage), Beckers Hospital Review discusses  “Newsweek‘s 2023 list of top 250 global hospitals.”

    From the plan design front, Financial Advisor points out an EBRI report on health savings accounts.

    The New York Times Morning Column considers a renewed interest in workplace personality tests.

    “Covid has opened our eyes to the fact that there are different ways in which we can work,” said David Noel, a human resources executive at Scotiabank, a Toronto-based bank with 90,000 employees. Partly for that reason, Scotiabank has begun to put more weight on personality tests, and less weight on résumés, when it makes hiring decisions.

    In the post-pandemic era, personality tests seem to have a new relevance. They can help determine who will thrive in which work arrangements and what personality mix can maximize a team’s chance of success. Some advocates of the tests argue that they can also increase the diversity of a company’s work force by reducing the focus on standards that have traditionally benefited white men. Since Scotiabank began using personality tests more heavily in its campus hiring program, the share of its new employees who are Black has risen to 6 percent, from 1 percent.

    Thursday Miscellany

    David Ermer–Congress, Medicare, NCQA, Rx coverage, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From Capitol Hill, the Wall Street Journal reports that “Sen. Joe Manchin, who has been a crucial vote in shaping major pieces of President Biden’s agenda, urged Democratic colleagues to hold talks with Republicans on cutting federal spending, ahead of a summer deadline to reach a deal on raising the country’s debt ceiling.”

    From the public health front —

    The Wall Street Journal informs us

    A larger share of people are being diagnosed with colorectal cancer at a younger age and at a more dangerous stage of the disease, a report showed. Doctors aren’t sure why.

    The American Cancer Society said Wednesday that about 20% of new colorectal cancer diagnoses were in patients under 55 in 2019, compared with 11% in 1995. Some 60% of new colorectal cancers in 2019 were diagnosed at advanced stages, the research and advocacy group said, compared with 52% in the mid-2000s and 57% in 1995, before screening was widespread.   

    Cases and death rates for colorectal cancer have continued a decadeslong decline overall thanks to screening, better treatments and reductions in risk factors such as smoking, the ACS report’s authors said. But the shift of the burden toward younger people and diagnoses at more advanced stages has oncologists on alert. 

    “The improvements have slowed, and they’ve slowed because of this opposite trend we’re seeing in young people,” said Kimmie Ng, director of the Young-Onset Colorectal Cancer Center at Dana-Farber Cancer Institute in Boston. “More and more are getting diagnosed with cancer that might not be curable.” 

    The U.S. Preventive Serves Task Force is routinely reevaluating its 2018 grade A recommendation to screen pregnant women/persons for syphilis.

    From the medical device front —

    MedTech Dive tells us

    • The number of remote patient monitoring (RPM) reimbursement claims hit a new high in 2022, according to a report by Definitive Healthcare.
    • By November, the volume of claims across the 10 Centers for Medicare & Medicaid Services’ codes for RPM was already 27% above the total for all of 2021, adding to the growth seen since the start of 2019.
    • Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.

    and

    Medicare will cover continuous glucose monitors for a broader group of patients, starting in April, according to an updated policy published by the Centers for Medicare and Medicaid Services. 

    The policy change included broader language and also came earlier than expected, making it a “welcome surprise,” and could double the market for the devices, J.P. Morgan analyst Robbie Marcus wrote in a research note. * * *

    In an earlier draft of coverage guidelines, CMS had suggested covering the devices for people with diabetes who take daily insulin, or who have a history of problematic hypoglycemia. Now, the policy includes people withnon-insulin treated diabetes and a history of recurrent level 2 or at least one level 3 hypoglycemic event.

    From the Rx coverage front, the Congressional Research Service issued an “In Focus” report about “Selected Issues in Pharmaceutical Drug Pricing.”

    From the healthcare quality front, NCQA posted slides and a recording from its latest Future of HEDIS webinar on February 28.

    From the U.S. healthcare business front —

    Healthcare Dive relates

    • The Cleveland Clinic reported a $1.2 billion net loss for 2022 as expenses climbed from the prior year. Expenses ticked up in every key category in 2022, including salaries and wages, supplies and pharmaceuticals, Cleveland Clinic’s latest financial report shows.    
    • Cleveland Clinic grew 2022 revenue roughly 5% to $13 billion from the prior year, but didn’t outpace expenses as costs increased nearly 14% to $12.4 billion before interest, depreciation and amortization.    
    • Investment income helped pull the Midwest provider into the red as non-operating losses totaled $1 billion.  

    and

    Oak Street Health’s losses grew in 2022 to almost $510 million as the value-based primary care company, which is pending an acquisition by CVS Health, continued to aggressively pursue growth.

    In comparison, Oak Street, which operates a network of clinics for seniors on Medicare, reported a loss of $415 million in 2021.

    The company opened 40 new centers over 2022 and ended the year with 169 facilities in 21 states, serving some 224,000 patients.

    STAT News reports

    In what may well be the latest fad in hospital consolidation, two not-for-profit health systems located across the country from one another are seeking to link up — this time, to create a system with roughly $11 billion in revenue.

    UnityPoint Health and Presbyterian Healthcare Services announced Thursday they’ve inked a letter of intent to explore a merger. Hospital mergers often involve partners in the same region so they can gain leverage with insurers, but in this case, UnityPoint is in the Midwest, whereas all nine of Presbyterian’s hospitals are several states away in New Mexico.  

    The deal illustrates not only health systems’ insatiable desire to get bigger in a tough operating environment, but their evolving strategy for doing so. Antitrust regulators have sunk deals involving partners they said would command too much market share in a given region, so hospitals are doing the next-best thing: seeking partners in far-flung states. 

    Healthcare Dive adds

    • Walmart plans to expand its network of medical centers in 2024, including a launch into two new states, as retail health giants race to build out their primary care footprints.
    • The company announced Thursday it plans to open 28 new Walmart Health centers in 2024, bringing its number of total locations to more than 75.
    • Walmart Health will open clinics in Missouri and Arizona for the first time, while deepening its presence in Texas by expanding in the Dallas area and growing into Houston, according to the announcement.

    Weekend update

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

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

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

    From the Covid front, the Wall Street Journal reports

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

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

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

    From the miscellany department —

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

    Happy Presidents’ Day

    David Ermer–Congress, COVID treatment, COVID-19, OPM, Rx coverage, U.S. Healthcare–
    Mount Rushmore

    The House of Representatives and the Senate are on District/State work breaks this week.

    Govexec alerts us, “Labor Secretary Marty Walsh will be leaving the Biden administration in mid-March to become executive director of the National Hockey League Players’ Association.” 

    Federal News Network offers an update on implementing the Postal Service Health Benefits Program that takes effect on January 1, 2025. The article expresses concern about a tight timeline for implementation. The article does not consider OPM’s January 2023 decision to allow FEHB plans to offer Medicare Part D EGWPs in 2024. That welcome decision puts the new PSHBP and the existing FEHB on a similar footing.

    While the new PSHBP will be more tightly integrated with Medicare Part B., the benefits of that phased in change will develop over time. For example, although the Postal Services will offer a one-time, penalty-free Part B Special Open Enrollment Period next year for annuitants over 65 who did not elect Part B, early retirees under 65 and active employees over age 64 on January 1, 2025, will be exempt from the PSHBP’s mandatory Part B election requirement.

    In other FEHB news, AHIP has made available a topic overview for the March 29 – 30 OPM AHIP FEHB Carrier Conference.

    In OPM news, Meritalk breaks down last week’s inaugural DEIA Annual Report from OPM’s Office of Diversity, Equity, Inclusion, and Accessibility (ODEIA).

    From the Omicron and siblings front, the Wall Street Journal and Fierce Healthcare report on the Covid death rate. The Journal points out, “Deaths caused by Covid are heavily concentrated among the elderly, an analysis of CDC data shows. In recent weeks people 75 years and older have represented about seven of every 10 Covid-19 deaths.” Fierce Healthcare provides this perspective:

    The JAMA Network Open study concluded that “COVID-19 due to the Omicron variant was associated with a higher risk of in-hospital mortality compared with patients with influenza. This indicates that the SARS-CoV-2 Omicron variant should still be taken seriously, and improved prevention and treatment strategies are still highly relevant, although overburdening of the health care system has become less likely over time.”

    Fortune Well tells us about the importance of cardiac care following even a mild case of Covid.

    In a bid to determine why and how COVID can affect the heart, Dr. Andrew Marks, a cardiologist and biophysics professor at Columbia University, and Steven Reiken, a research scientist in his lab, studied heart tissue from people who died of COVID, in addition to the hearts of mice that had been infected with COVID.

    Among their findings, which they’ll present Monday at the 67th Annual Biophysical Society Meeting in San Diego:

    • Heart tissue from humans shows increased levels of oxidative stress and inflammation, and changes in calcium levels due to damage to the system that regulates them in the heart. Such alterations can lead to arrhythmia or heart failure, according to the researchers.
    • Chest pain and tachycardia, or an unusually fast heartbeat, are common long-term among COVID survivors.
    • Heart tissue from mice shows an increased percentage of fibrosis and dilation of fibers—a common signal of early cardiomyopathy, which makes it more difficult for the heart to pump blood and can result in heart failure.
    • The death of heart cells and blood clots in the hearts of mice who had been infected with COVID-19 were also observed.

    “Doctors should be aware of heart changes related to COVID-19 infections and should be looking for them,” Marks says. He hopes his research leads to increased awareness among medical providers of the virus’s potentially stealthy cardiac fallout—and, eventually, treatments for those whose hearts have been damaged by the pathogen.

    MedPage Today adds

    People who took the antiviral Paxlovid to treat COVID-19 infections were not more likely to get back-to-back bouts of the virus, a new study shows.

    The findings offer clarity amid concerns that the use of Paxlovid, which works by stopping the spread of the virus in the body, increased the risk of COVID-19 rebound.

    “Rebound is a re-emergence of symptoms and an uptick in viral load after a period of recovery,” the Center for Infectious Disease Research and Policy explained in a summary of the study.

    Researchers found that patients who received Paxlovid, another antiviral called Lagevrio, or no antiviral medication had rebounds at similar rates, ranging from 4.5% to 6.6%.

    From the medical research front, the Wall Street Journal reports

    A fist that opened and shut. A once-limp arm that moved from her side. Two women whose strokes left them with partial paralysis for years saw life trickle back to their limbs when electric pulses were delivered to the back of their spinal cord as part of a pilot study. 

    Neurologists said the approach, reported Monday in the journal Nature Medicine, could be transformative for stroke survivors, many of whom have some arm impairment after the event.

    “I think it is amazing,” said Helmi Lutsep, a neurologist at Oregon Health & Science University, who wasn’t involved with the study. “I think patients will be thrilled if this comes to fruition.” 

    The pilot study was convincing but it would take much larger studies and a decade or more to know if stroke patients generally could benefit, according to Nick Ward, a neurologist at the University College London who wasn’t involved with the study.  

    From the U.S. healthcare business front, the Wall Street Journal informs us why “Walgreens CEO Bets on Doctors Over Drugstores in Search for Growth; Rosalind Brewer is shifting the chain’s focus to medical clinics,” like Village MD.

    The strategy is guided by Ms. Brewer’s belief that the nation’s second-largest drugstore chain is in a business that she says no longer works. Industry growth is chronically slow, she said. Meanwhile, a shortage of workers is further cutting into revenue because the chain has had to reduce pharmacy hours.  

    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.”