Thursday Miscellany

Thursday Miscellany

Photo by Josh Mills on Unsplash

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

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

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

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

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

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

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

From the Omicron and siblings front, WebMD tells us

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

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

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

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

In FDA / drug development news —

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

From the U.S. healthcare business front —

Healthcare Dive relates

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


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

From the healthcare studies front —

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

From the healthcare quality front, Beckers Hospital Review relates

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

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

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

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

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

Keep on truckin’

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

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From our Nation’s capital, the Wall Street Journal reports

President Biden said Tuesday he would nominate Julie Su, the No. 2 official at the Labor Department, to lead the agency, maintaining continuity within a department that played a prominent role in averting a rail strike last year.

Ms. Su, the current deputy secretary, was widely seen as the leading candidate to succeed departing Secretary Marty Walsh. Asian-American lawmakers and advocacy groups threw their support behind her, lobbying Mr. Biden to tap his first Asian-American cabinet secretary. Ms. Su, age 54, is Chinese-American.

The nomination now heads over to the Senate for its approval. The Secretary of Labor, the HHS Secretary, and the Treasury Secretary / IRS form the agencies responsible for the overseeing the Affordable Care Act.

From the Food and Drug Administration (FDA) front —

Endpoint News informs us

Pfizer and BioNTech are seeking full [FDA marketing] approval for their Omicron-targeted bivalent Covid shot, and they’re following an FDA advisory committee’s advice on “harmonizing” vaccine compositions.

The partners have filed a supplemental BLA for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as both a primary dose or a booster for patients over the age of 12. That means unvaccinated children and adults could skip the original primary series and receive a bivalent shot first.

The move is in response to an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) vote last month, intended to clear up confusion around varying primary and booster dose formulations and utilize vaccines that better target currently circulating strains of Covid.

MedPage Today relates

In two somewhat close votes, an FDA panel of outside experts recommended the agency approve Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, despite concerns over the potential risk for Guillain Barré syndrome.

By a tally of 7-4 for safety and efficacy (with one abstention in each case), the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said the evidence favors the RSV prefusion F protein vaccine (RSVPreF) — which carries a proposed trade name of Abrysvo — for reducing RSV-related lower respiratory tract infections in adults 60 and up.

However, VRBPAC members showed reservations ranging from the largely health study population, rather than the more vulnerable group of older adults who need the vaccine most, to the limited number of events for the main outcomes.

The Wall Street Journal reports

Federal regulators approved a drug to treat a debilitating disease using data collected about patients over decades, creating an opening for researchers of other rare conditions who often struggle to prove their treatments work.

The Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc.’s drug Skyclarys, or omaveloxolone, for treating the neurological disorder Friedreich’s ataxia in adults and adolescents age 16 and older.

The FDA last year said results from a single clinical trial didn’t sufficiently demonstrate the drug slows the progression of a disease that causes progressive damage to the spinal cord, muscle weakness, and movement problems and often kills people by age 35Instead of running another trial, Reata submitted additional data including an analysis from a so-called natural history study that has continued to collect information about patients for more than two decades.

“Data created by patient communities can be regulatory grade,” said Annie Kennedy, chief of policy, advocacy and patient engagement at the EveryLife Foundation for Rare Diseases, a nonprofit advocacy group. “This approval is proof of that principle.”

MedPage Today adds

The FDA issued an import alert Tuesday to clamp down on the illegal importation of xylazine, an animal tranquilizer showing up more and more in illicit drugs.

“This action aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals,” the agency said in a press release.

Veterinarians legitimately use drug products containing xylazine to sedate large animals such as horses and deer, but it is not safe for use in people and may cause serious and life-threatening side effects, the FDA noted. However, “it has been identified as a contaminant found in combination with opioids such as illicit fentanyl, and in combination with other illicit products that contain stimulants such as methamphetamine and cocaine. People who use illicit drugs may not be aware of the presence of xylazine.”

From the U.S. healthcare front —

The American Health Association points out

Hospitals continue to experience the same challenges that made 2022 the worst financial year since the start of the COVID-19 pandemic, including higher labor expenses and lower patient volumes, according to the latest report on hospital finances from Kaufman Hall. Hospital operating margins fell from -0.7% in December 2022 to -1% in January 2023, following persistent negative margins throughout last year. Notably, drug expenses have increased 12% compared to YTD 2020. 

“While we have seen a stabilization in operating margins over the past several months, the trendline continues to show that hospitals will be in a tough spot financially for the foreseeable future,” said Erik Swanson, senior vice president of data and analytics for Kaufman Hall. “With future COVID surges possible and challenging financial months ahead for hospitals, managing cash on hand will be critical to weathering the storm.”

The Wall Street Journal explains how doctors are diagnosing patients with artificial intelligence.

From the mental health care front —

  • The Kaiser Family Foundation provides good news about the rapidly growing use of the 988 National Suicide Prevention and Crisis Hotline. “Since the launch of 988, Lifeline has received over 2.1 million contacts—consisting of over 1.43 million calls, over 416,000 chats, and more than 281,000 texts.” But, of course, the KKF study also notes some problems.
  • MedCity News tells us about a newly formed collaboration consisting of Bicycle Health, Wellpath and the Federal Bureau of Prisons that will provide virtual opioid use disorder services to those living in the Bureau’s residential reentry centers in 42 states.
  • STAT New discusses the downfall of Mindstrong, a mental health care tech / app company.
  • The Washington Post offers an intriguing look at how the human brain ages.

Midweek Update

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 PeopleThis 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.


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.

Monday Roundup

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.


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.

Stillmost 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.

Friday Factoids

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From Capitol Hill, Fierce Healthcare tells us

Two top senators have reintroduced legislation that would introduce several reforms to pharmacy benefit managers, including prohibiting clawbacks of pharmacy payments. 

Sens. Maria Cantwell, D-Washington, and Chuck Grassley, R-Iowa, reintroduced on late Thursday the Pharmacy Benefit Manager Transparency Act and the Prescription Pricing for the People Act. The move shows the lawmakers are not backing down from going after PBMs in the latest Congress. 

Congress is a piker compared to OPM, which has been successfully “going after PBM’s” for over a decade.

From the public health front

  • All of the Omicron metrics are trending down. “As of January 25, 2023, there are 118 (3.7%) counties, districts, or territories with a high COVID-19 Community Level, 855 (26.6%) with a medium Community Level, and 2,242 (69.6%) with a low Community Level.”
  • Overall, about 268.9 million people or 81% of the total U.S. population, have had a single dose of Covid vaccine, “About 229.6 million people, or 69.2% of the total U.S. population, have completed a primary series.* More than 41.6 million people, or 19.9% of the eligible U.S. population ages five years and older, have received an updated (bivalent) booster dose.”
  • The CDC’s Weekly FluView again headlines, “Seasonal influenza activity continues to decline across the country.”
  • Turning to our longest-standing public health emergency, the U.S. Drug Enforcement Administration informs us

Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.

While scientists have not conducted much research on its effects, anecdotal reports suggest that users experience symptoms similar to those encountered via opioids, namely depression of the central nervous system. More specifically, effects associated with xylazine use include dry mouth, drowsiness, hypertension, respiratory depression, and even coma. Users can develop a physical dependence to xylazine, reporting withdrawal symptoms more serious than from heroin or methadone, such as sharp chest pains and seizures.

Note: Since xylazine is not an opioid, naloxone does not reverse its effects.

  • The Food and Drug Administration proposed changing from “time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.”
  • Bloomberg relates, “Americans aren’t exercising enough.  Less than a third of US adults meet suggested benchmarks for aerobic and muscle-building activities set out by health officials, according to a new study released on Thursday.”

From the Rx coverage front, STAT News reports, “After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs.” Time will tell.

From the electronic health records front —

  • MedCity News identifies five ways to inject intelligence into the prior authorization process.
  • Fierce Healthcare points out that

“A new report from the Georgetown University Center for Children and Families seeks to make several reforms to the Transparency in Coverage rule to ensure the data are more usable and accessible by researchers. The goal is to ensure that the data can be used to help regulators and lawmakers target policies that can boost coverage affordability. 

“’The good news is that many of the access and usability problems stem from the technical specifications provided by the Centers for Medicare & Medicaid Services [CMS],’ the report said. ‘Most can be fixed through administrative action and better enforcement, with minimum cost burdens for the plans and issuers.’”

From the U.S. healthcare business front —

  • MedCity News informs us that health insurers continue to receive a C grade from Leapfrog.
  • Fierce Healthcare tells us, “The Minnesota attorney general’s office has formally asked Sanford Health and Fairview Health Services to postpone the March 31 closing date of their proposed merger as it seeks more information on the repercussions of the deal, Chief Deputy Attorney General John Keller said during a public meeting held Wednesday evening. The Midwest nonprofit health systems had announced their 58-hospital merger plans in November, saying at the time that joining together would expand care quality and access across their rural and urban markets. The resulting organization would employ nearly 80,000 people.”
  • Healthcare Dive reports, “In a lawsuit filed Thursday, Cigna alleged that Amy Bricker’s appointment to chief product officer of CVS’s consumer segment places the payer’s trade secrets at risk and violates her noncompete agreement.” 
  • The Wall Street Journal reports that CVS and Walmart pharmacies will follow Walgreen’s lead by reducing their retail pharmacy hours. “CVS, in a recent notice to field leaders, said most of its reduced hours will be during times when there is low patient demand or when a store has only one pharmacist on site, which the company said is a “top pain point,” for its pharmacists.” Walmart will be closing its pharmacy at 7 pm rather than 9 pm.

Happy Days are Here Again!

OPM Headquarters a/k/a the Theodore Roosevelt Building

The FEHBlog was delighted to read today that OPM is encouraging FEHB carriers that OPM is encouraging FEHB carriers to incorporate Medicare Part D EGWPs in their plans for 2024. The FEHBlog has been encouraging this step for years, as readers must know.

The Medicare Part D EGWPs will cushion the FEHBP against the expenses of drugs to treat Alzheimer’s Disease and other illnesses that impact annuitants over age 65. While there are many factors at play in determining premiums, this factor standing alone would lower premiums. Thank you, OPM.

From the Omicron and siblings front, the New York Times virus briefing newsletter wished its readers well today.

Now, after three years, we’re pausing this newsletter. The acute phase of the pandemic has faded in much of the world, and many of us have tried to pick up the pieces and move on. We promise to return to your inbox if the pandemic takes a sharp turn. But, for now, this is goodbye.

The American Hospital Association informs us

In a study released today by the Centers for Disease Control and Prevention [CDC}, a single bivalent COVID-19 vaccine booster provided additional protection against omicron XBB variants in adults who previously received two to four monovalent vaccine doses. XBB-related variants account for over half of currently circulating COVID-19 variants in the United States.

“All persons should stay up to date with recommended COVID-19 vaccines, including receiving a bivalent booster dose when eligible,” the authors conclude.


The CDC yesterday launched a website to help consumers locate no-cost COVID-19 testing through its Increasing Community Access to Testing program, which includes pharmacies, commercial laboratories and other sites that bill the tests to government and private insurers and focus on vulnerable communities. The tests may include laboratory-based nucleic acid amplification tests and rapid antigen point-of-care tests, with results typically provided in 24-48 hours.

From the public health front

  • The Hill tells us about a CDC internal reorganization.
  • The HHS Agency for Healthcare Quality and Research provides us with an infographic and report about the three most commonly treated illnesses among older adults — hypertension, hyperlipidemia, and arthritis / other joint disorders
  • Fierce Healthcare relates, “The Biden administration is planning to release three to four new payment models on advance primary care and another enabling states to assume the total cost of care for Medicare, a top official shared.”
  • HHS’s HEAL Program Director, Dr. Rebecca Baker, discusses “Research That Offers Hope to End Addiction Long-Term.”

From the U.S. healthcare business front

Healthcare Dive reports

Elevance Health, one of the nation’s largest insurers, added more members in 2022, fueled by growth in its government business thanks to continued relaxed eligibility rules on enrollment.  

Elevance ended the year covering 47.5 million people, a nearly 5% increase from the prior-year period, driven largely by growth in Medicaid members.

In turn, total revenue climbed 13% to nearly $157 billion for the year as the insurer collected higher premium revenue from its Medicaid plans.   

Net income dipped about 1% to $6 billion for the full year as expenses climbed about 14%.  


The CMS announced Wednesday that a record-breaking 16.3 million people signed up for Affordable Care Act marketplace plans during the 2023 open enrollment season, a result of extended pandemic-era subsidies enacted by the American Rescue Plan.

Over 1.8 million more people enrolled in marketplace coverage compared to last year — a 13% increase, and the most amount of plan selections of any year since the launch of the ACA marketplace a decade ago, according to the CMS. The record-breaking enrollment numbers include 3.6 million first-time marketplace enrollees.

STAT News tells us

The claims have become almost ubiquitous. Hospital CEO after hospital CEO stands at a podium and promises the merger being announced will improve quality and lower costs.

Once deals close, though, there tends to be little, if any, follow-up to determine whether those things actually happened. A new Journal of the American Medical Association study adds to the growing body of evidence that they don’t. The authors looked across a large swath of the country’s hospitals and physicians found that while quality did improve marginally, the prices paid for services delivered by health system hospitals and doctors was significantly higher than their non-system peers.

“You start to feel really hopeful when you hear about this, ‘Yeah, we can really improve health care,’ and then when you look at it, it’s just not there,” said Nancy Beaulieu, a study author and research associate in Harvard Medical School’s department of health care policy.

Ruh roh.

On related note, Fierce Healthcare informs us

A top insurance lobbying group plans to press Congress this session to adopt legislation that expands the footprint of site-neutral payment reform, setting up a likely clash with hospital groups. 

The Blue Cross Blue Shield Association (BCBSA), which represents 38 Blues plans, released several policy priorities for the current Congress as part of a new report Tuesday. Some of the policies focus on changing Medicare reimbursement rates to pay the same amount to clinics whether they are independent or affiliated with a hospital. Other reforms focus on prescription drugs and spurring more participation in value-based care. 

“We’re very concerned about the increasing acquisition of physician practices by hospitals in the healthcare system,” said Kris Haltmeyer, vice president of policy analysis for BCBSA, during a reporter briefing Tuesday. 

One of the association’s major priorities is to pass a bill that would remove a grandfathering provision in the 2015 Balanced Budget Act. The provision shielded certain hospital outpatient departments from billing limits established in the law, with the exception of emergency departments. 

The association also wants to require off-campus hospital sites to get a different national provider identifier than the main facility campus. They should also use a different claim form for any professional service rendered in an office or clinic owned by a hospital but not on the campus. 

Go get ’em.

Monday Roundup

Photo by Sven Read on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

Most people would get one Covid-19 shot annually—as they do with the flu shot—under Food and Drug Administration proposals for simplifying the nation’s Covid-19 vaccine procedures.

The drug regulator also proposed that people getting vaccinated for the first time receive vaccines that target both Omicron and the original strain of the coronavirus. 

The proposals, outlined in materials the FDA released Monday, would mark the biggest changes to Covid-19 vaccinations since boosters rolled out and are a sign of the nation’s shift to a more endemic-like approach to the coronavirus.

Vaccine experts who advise the FDA are scheduled to meet Thursday to discuss the proposals. The advisers are scheduled to vote on whether to give the bivalent shot as the initial inoculation, as is already allowed in Europe.

Makes sense to the FEHBlog.

From the OPM front, the House Oversight and Reform Committee Chairman James Comer (R-Ky.) has sent OPM Director Kiran Ahuja a letter demanding documents and a staff briefing on the recent GAO report criticizing OPM’s internal controls over family member eligibility in the FEHBP. Here’s a little free advice for my favorite agency. Rather than coming up with your own solutions, adopt solutions that have been proven to work in the private sector — the HIPAA 820 standard enrollment transaction which ties premium payments to enrollees and dependent eligibility verification audits based on statistical sampling.

From the U.S. healthcare business front —

Fierce Healthcare informs us

Elevance Health has inked a deal to acquire Blue Cross and Blue Shield of Louisiana, with the Pelican State insurer joining the Anthem Blue Cross affiliated plans.

The acquisition builds on an existing partnership between the two insurers, according to the announcement. The two jointly own Healthy Blue, a plan that serves Medicaid and dual-eligible beneficiaries. 

The combination will also allow BCBSLA to accelerate its push toward improved access, affordability and quality for its 1.9 million members, thanks to the capabilities of Elevance Health’s Carelon subsidiary, the companies said. More than $4 billion has been invested in Carelon over the past several years, building out its behavioral health, complex and chronic care programs and digital health models.


CVS Health has named two key leaders for its pharmacy and consumer products business, including a returning face to the company, according to a report from Bloomberg.

David Joyner, a former executive at the company, will make a return as the leader of its pharmacy services segment, which includes the Caremark pharmacy benefit manager, people familiar with the matter told the outlet. Joyner left CVS three years ago and will succeed Alan Lotvin, M.D., who is set to retire.

In addition, former Express Scripts President Amy Bricker will join the company as the chief product officer for the consumer segment, which centers on developing new products for CVS’ consumer health brands, Bloomberg reported.

Fierce Healthcare points out a twist in the second story.

That Bricker had departed Express Scripts, a subsidiary of Cigna, was revealed last week when the PBM announced it had named a new president, veteran supply chain leader Adam Kautzner. What was next for Bricker, however, was conspicuously absent from the announcement.

The FEHBlog often counsels clients on Family and Medical Leave Act issues. He had no idea until today that the Labor Department offers helpful information to healthcare provider and employees on this law. For example,

This background information can fill knowledge gaps for employers too.

From the Rx coverage front —

  • The Washington Post reports on the reaction to “the American Academy of Pediatrics guidelines, based on decades of scientific research, call[ing] for early and aggressive treatment, instead of “watchful waiting.” They urge intensive therapy for children as young as 6, weight loss drugs for those as young as 12 and surgery for teens as young as 13.”
  • The Institute for Clinical and Economic Research released a

Final Evidence Report on Fezolinetant for Vasomotor Symptoms Associated with Menopause

— Independent appraisal committee voted that evidence is not yet adequate to demonstrate a net health benefit for fezolinetant when compared to no pharmacological treatment —

—  Using point estimates from short-term clinical trials, analyses suggest this drug would achieve common thresholds for cost-effectiveness if priced between $2,000 – $2,600 per year for women who cannot or choose not to take menopausal hormone therapy —

— All stakeholders have a responsibility and an important role to play in ensuring that women have access to effective new treatment options for symptoms of menopause

The ICER upshot is “Given that many patients may benefit from readily available, effective, and low cost [menopausal hormone therapy] MHT, clinical experts agreed that it would be reasonable for payers to require prescriber attestation that patients are not appropriate candidates for MHT prior to prescribing fezolinetant.”

From the SDOH front, Health Leaders Media tells us about new ICD-10 diagnosis codes with an SDOH emphasis which will take effect on April 1, 2023.

From the telehealth front, U.S. News reports,

Despite distance and occasional technical glitches, a new study finds that most patients like seeing a surgeon for the first time via video.

The study was published Jan. 19 in the Journal of the American College of Surgeons. * * *

The study included 387 patients who participated in first-time visits between May 2021 and June 2022 at general surgery clinics across the Vanderbilt system. Researchers used a standard questionnaire to look at the quality of shared decision-making and asked patients and surgeons open-ended questions about their consultations.

In all, 77.8% of patients had an in-person visit, while 22.2% saw their doctor remotely.

Both groups reported high levels of quality communication during these appointments.

Levels of shared decision-making and quality of communication were similar between remote visits and in-person care, the study found.

In responding to the open-ended questions, patients praised the convenience and usefulness of telehealth appointments. Researchers received some negative comments about technical difficulties and not being physically present.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill, Politico reports tonight

Top appropriators struck a deal Tuesday night on a government funding framework critical to finalizing a mammoth year-end spending package.

In a statement, retiring Senate Appropriations Chair Patrick Leahy (D-Vt.) said appropriators have “reached a bipartisan, bicameral framework that should allow us to finish an omnibus appropriations bill that can pass the House and Senate and be signed into law by the President.”

Leading negotiators didn’t release those government funding totals in announcing the deal, but appropriators have largely settled on an $858 billion defense budget in recent weeks.

That’s good news. Presumably, Congress still plans to extend the continuing resolution from December 16 to December 23 this week in order to allow time to write and pass the omnibus bill.

From the Omicron and siblings front, Healthcare Dive reports that

In the two years since the COVID-19 vaccine became available for U.S. patients, the country’s vaccination program prevented more than 18.5 million hospitalizations and 3.2 million deaths, according to new research from the Commonwealth Fund and Yale School of Public Health.

Many millions of infections were prevented, preserving hospital resources for patients who otherwise would not have received timely care, the researchers said. The vaccine also saved the country $1.15 trillion in medical costs, kept children in school and allowed businesses to reopen, the study said. 

To arrive at its findings, the study used a computer model of disease transmission, comparing the pandemic trajectory to a simulated scenario without a vaccination program. The results can be used to inform future evidence-based decisions on vaccine use to reduce disease burden, the researchers said.

The FEHBlog has no doubt that the rapidly developed mRNA vaccines pulled us out of a jam in winter 2020 while Paxlovid and other anti-virals saved us from the monstrous Omicron surge in winter 2021.

From the CMS front —

  • CMS has activated the Ground Ambulance and Patient Billing Advisory Committee required by the No Surprises Act. The Committee’s report likely will be released in the second quarter of 2023.
  • CMS released a readout from “We Can Do Better: Advancing Maternity Care Together – the first CMS convening on maternal health since the agency launched its Maternity Care Action plan in July 2022 as part of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. Attendees discussed key actions to improve the health of pregnant and postpartum individuals – including the need for a robust and diverse maternity care workforce and the ability for consumers to easily identify health systems engaged in improving maternal care.”
  • CMS also called attention to the “recently released proposed rule that, if finalized, would modify the current National Council for Prescription Drug Programs (NCPDP) retail pharmacy standards for electronic transactions and expand the applicability of the Medicaid pharmacy subrogation transaction to all health plans.”
  • In related news, EHR Intelligence tells us, “In a recent letter, Health Level Seven International (HL7) called on the National Committee on Vital and Health Statistics (NCVHS) to include FHIR as a data standard for electronic clinical attachments. NSG encourages the public to submit comments on the proposed rule by January 9th, 2023.” The original version of HIPAA enacted over 25 years ago called for this attachments standard, which has been a thorn in CMS’s side.

In other HHS news —

  • HHS’s Agency for Healthcare Quality and Research informs us that the U.S. Preventive Services Task Force has proposed to keep in place the grade A recommendation “that clinicians prescribe pre-exposure prophylaxis with effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV infection.” The original PREP recommendation was made in 2018.
  • The American Hospital Association relates “The Substance Abuse and Mental Health Services Administration today proposed updating opioid treatment program standards and admission criteria to expand access to treatment. According to the agency, the rule would expand the definition of OTP practitioner to include any provider appropriately licensed to dispense and/or prescribe approved medications; no longer require one year of opioid addiction for admission; add evidence-based delivery models such as telehealth; expand patient access to take-home methadone doses, and no longer require annual reports from practitioners with a waiver to prescribe buprenorphine to up to 275 patients. The agency will accept comments on the proposed rule through Feb. 14.” That makes sense to the FEHBlog.

From the drug development front —

The Wall Street Journal reports

A customized Moderna Inc. MRNA 19.63%increase; green up pointing triangle vaccine helped ward off the recurrence of melanoma in a mid-stage trial, a milestone in long-running efforts to use the shots as treatments and a big step in the biotech’s ascent.

The combination of Moderna’s personalized cancer vaccine and MerckMRK 1.78%increase; green up pointing triangle & Co.’s Keytruda cancer immunotherapy reduced patients’ risk of relapse or death by about 44%, versus Keytruda alone, in the 150-volunteer study, the companies said Tuesday.

The results, which the companies said were statistically significant but haven’t been reviewed by independent scientists, suggest promise for an emerging but unproven class of vaccines that aim to treat diseases rather than prevent infections like typical shots.

MedCity News reports

Multiple myeloma can be treated by several drugs but relapse in this type of blood cancer is common and when that happens, patients need other treatment options. Johnson & Johnson is looking to fill that need with a drug that addresses a novel target. The pharmaceutical company is seeking regulatory approval for this molecule and the most up to date clinical data supporting the application were presented during the annual meeting of the American Society of Hematology (ASH).

Patients in the Phase 1/2 clinical trial had some of the toughest cases that progressed after treatment with at least three different therapies, according to Ajai Chari, director of clinical research in the multiple myeloma program at Mount Sinai and an investigator in the study. Despite that, treatment with the J&J drug, talquetamab, led to response rates of up to 74%.

From the healthcare business front, Fierce Healthcare tells us

Operating margins for the three largest for-profit hospital chains exceeded pre-pandemic levels in the third quarter, according to a new analysis that comes as hospital lobbies are pushing for financial relief from Congress. 

The analysis, released Monday by the Kaiser Family Foundation, looked at the latest financial performance for large hospital chains HCA Healthcare, Tenet Healthcare and Community Health Systems. * * *

Kaiser’s analysis comes a day after The Wall Street Journal published a report that showed hospitals received billions of dollars in aid, with some going to profitable systems that didn’t need it. Part of the problem was a mismatch in the federal government’s allocation of the $175 billion Provider Relief Fund passed by Congress at the onset of the pandemic in early 2020, the report said. 

From the tidbits department, the FEHBlog learned at the ABA Washington Health Law Summit today

  • The third Texas Medical Association case filed November 30 and pending before District Judge Kernodle concerns the manner in which the qualifying payment amount is calculated – a new issue which nevertheless could have been joined to the second lawsuit. Go figure.
  • In 2018, Congress passed a law called the Eliminating Kickbacks in Recovery Act (“EKRA”), 18 U.S.C. § 220. The Epstein, Becker and Green law firm explains, “EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports

A top Senate Democrat said that his party planned to introduce an omnibus spending bill Monday, aiming to pressure Republicans to accept a deal or risk an alternative that would freeze government spending at current levels for the full year and cut off the ability to reallocate money in military and other programs.

Senate Appropriations Committee Chairman Patrick Leahy (D., Vt.) said that the measure would provide military funding at the level Congress is authorizing in its separate defense policy bill—some $858 billion, or roughly a 10% increase—while also paying for what he called a needed increase to nondefense programs.

“This is a reasonable path forward, and I suggest my Republican friends take it,” Mr. Leahy said. * * *

If no deal is reached as the end of the year approaches, lawmakers have said they might need to fall back to a so-called continuing resolution, which funds the government at current levels. Various lawmakers have floated stretching funding into early 2023 or for the full fiscal year, which ends in September. 

The path forward was unclear, as neither House Speaker Nancy Pelosi (D., Calif.) nor Senate Majority Leader Chuck Schumer (D., N.Y.) announced votes on an omnibus bill for next week.

The Journal adds,

House lawmakers on Thursday passed a defense policy bill [discussed in yesterday’s FEHBlog post] that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. * * * The legislation is expected to pass the Senate by the end of next week before heading to President Biden’s desk for his signature.

STAT News tells us

Key decision makers in Congress are closer than they’ve been in years to revamping the way the government regulates some of the diagnostic tests that patients use to make crucial decisions about their health care [due to the Theranos fiasco].

If the VALID act passes, the FDA wouldn’t regulate every single clinical test, but only tests considered “high risk” to patients, where the risk to patients of an inaccurate result could cause serious or irreversible harm.

One example would be a test for breast cancer that could lead a patient to have a mastectomy, Boiani said. Another would be a genetic test that could determine which cancer treatment patients receive, said Jeff Allen, the president and CEO of Friends of Cancer Research.

From the Federal Employee Benefits Open Season front, Tammy Flanagan writing in Govexec and Drew Friedman writing in Federal News Network offer last minute decision-making tips.

Investment News provides advice on income adjusted Medicare premium issues.

Most Medicare beneficiaries will pay the standard Part B premium of $164.90 per month in 2023, down slightly from this year’s monthly premium of $170.10. Medicare Part B covers doctors’ fees and out-patient services. Coupled with a huge 8.7% cost-of-living adjustment in Social Security benefits next year, most retirees will enjoy larger monthly net Social Security benefits after automatic deductions for their Part B premiums in 2023.

But about 8%, or about 5 million, of the nearly 63 million Medicare beneficiaries will pay more than the standard monthly premium for both Part B and Part D prescription drug plans based on their income. My husband and I are among them.

For 2023, single beneficiaries with incomes of $97,000 or more and married couples with joint incomes of $194,000 or more pay a Medicare premium surcharge, officially known as an income-related monthly adjustment amount, or IRMAA. The thresholds increased from $91,000 and $182,000, respectively, in 2022, meaning some beneficiaries may avoid IRMAA surcharges altogether in 2023 or pay less than this year due to the inflation adjustments of the income tiers that trigger those surcharges.

In other health benefits news, Insurance News Net informs us

The average per-employee cost of employer-sponsored health insurance rose by 3.2% in 2022, according to Mercer’s 2022 National Survey of Employer-Sponsored Health Plans, released today.

US employers expect a sharper increase of 5.4% in 2023 — and faster cost growth in the years ahead seems likely

 For now, most employers are prioritizing enhancing benefits to attract and retain workers over cost-cutting; enhancements range from adding perks to improving healthcare affordability

 Mental health remains a top concern of employers and employees – and virtual mental healthcare is proving key to improving access to services

From the Rx development and coverage front, we have three reports from STAT News —

  • Well, this government action didn’t take long. STAT News relates “The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.”
  • Also according to STAT News, “A year ago, the [Purchaser Business Group on Health] coalition created Emsana Health that, in turn, hatched the EmsanaRx pharmacy benefit manager. [Beginning March 1, 2023,] EmsanaRx will run the technology to ensure prescriptions handled by Cuban Cost Plus Drugs are paid and fulfilled, and report all this information back to the [self-funded] employer. In exchange, EmsanaRx will take a flat 1.5% fee for legal, administrative, and data sharing services, but not charge more than $3 for each insurance claim and will pass along any rebates collected.”
  • Finally from STAT News, “Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, according to the official who oversees the program. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, administrator for the Centers for Medicare and Medicaid Services, said Thursday at the Milken Institute Future of Health Summit when asked about how the agency will approach lecanemab. “We will look at it as new data comes.”

From the public health front —

An outside group [the Reagan Udall Foundation] that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. * * *

In a statement, FDA Commissioner Robert M. Califf said he will review the report and make decisions about the future of the agency with input from experts inside and outside the FDA.

  • The Congressional Research Service issued an “In Focus” report on “Regulating Reproductive Health Services After Dobbs v. Jackson Women’s Health Organization.”
  • Health Payer Intelligence tells us

Overall, major health outcomes measures are trending in a negative direction, according to America’s Health Rankings Annual Report for 2022.

The Annual Report examines 23 measures to assess health outcomes trends nationwide, including measures for eight chronic conditions. The data for these measures primarily represented 2021 outcomes, but some measures drew from 2018, 2019, 2020, and 2022.

A Morning Consult online survey conducted in October 2022 informed the results as well as racial and ethnic subpopulation data and a total of 80 national and state measures to assess the state of healthcare in the US.

Based on the findings, the coronavirus pandemic has continued to have ripple effects on healthcare. The top three major trends in health outcomes are:

  • Increased drug deaths
  • Increased non-medical drug use
  • Increased premature death

Midweek update

From Capitol Hill, the Wall Street Journal reports

Republicans won a majority of seats in the House of Representatives with a victory in California, the Associated Press said late Wednesday, bolstering their ability to steer the agenda on Capitol Hill after two years of Democratic control of both chambers of Congress and the White House.

The Congressional Research Service released a report on health care provisions expiring at the end of this 117th Congress.

Healthcare Dive adds

With midterm elections resulting in a narrowly divided Congress, the HHS will be free to focus on longstanding priorities for the health department, such as implementing drug negotiation policy within Medicare, HHS Secretary Xavier Becerra said at the HLTH conference in Las Vegas on Tuesday.

“In a way, we’re now going to be able to concentrate on the work we have to still execute on,” Becerra said,

Under the Inflation Reduction Act passed earlier this year, Congress granted Medicare the power to negotiate how much it pays for certain prescription drugs starting in 2026, and to receive rebates from pharmaceutical manufacturers that hike drug costs above the rate of inflation starting in 2023.

Of course, HHS and its partners have a lot of work on implementing the No Surprises Act. Health Payer Intelligence discusses the good faith estimate and advance explanation of benefits comments that an ERISA plan trade association, ERIC, submitted to the NSA regulators yesterday.

In other HLTH 2022 conference news,

  • Healthcare Dive tells us about Google’s plans for offering personal health records and Maven Clinic‘s efforts to build a maternal health business by, e.g., recently landing a $90 million Series E amid increasing investor focus on women’s health.
  • MedCity News informs us, “Cell and gene therapies are offering patients potentially curative treatments for a growing scope of diseases. Insurance companies are trying to figure out how to pay for them. Industry consultants speaking at the HLTH conference offered some strategies they see payers taking to these new therapies.”

From the federal employee benefits front,

  • Govexec collected all of its current Open Season articles for convenient access.
  • Reg Jones, writing in Fedweek, recommends that federal employees contemplating retirement should retire on December 31, 2022.
  • Govexec reports that the Postal Service is headed into its busy season with far fewer employees than past years.

From the Affordable Care Act front —

  • The FEHBlog ran across this updated reference chart on minimum essential coverage under the ACA.
  • The U.S. Preventive Services Task Force issued its 12th Annual Report to Congress which is titled “High-Priority Evidence Gaps for Clinical Preventive Services.”

From the public health front —

  • Forbes reports “Researchers at the University of Houston have developed a vaccine that could block the effects of fentanyl and prevent addiction, according to a new study that could unlock solutions to the opioid epidemic as more than 150 people die every day from overdoses connected to synthetic opioids.”
  • CNN reports “The five-year lung cancer survival rate has increased 21%, from 21% in 2014 to 25% in 2018, making what experts call “remarkable progress” – but it is still the leading cause of cancer death in the United States. However, in communities of color, a person’s odds of surviving five years after diagnosis are much lower, at only 20%, according to the 2022 State of Lung Cancer report, which was published by the American Lung Association on Tuesday.”
  • The National Institutes of Health tells us “COVID-19 Vaccines Are Safe for People Receiving Cancer Immunotherapy, Study Confirms.”

From the miscellany department —

  • Forbes informs us “UnitedHealth Group’s pharmacy benefit manager Optum Rx Tuesday said it will put three less expensive “biosimilar” versions of Abbvie’s pricey rheumatoid arthritis drug Humira ‘in the same position as the brand’ on the PBM’s preferred list of drugs known as a formulary.”
  • MedTech Dive discusses how Labcorp, Abbott, BD, and Siemens plan to expand the home testing market
  • NCQA looks back at its recent Health Innovation Summit.