Thursday Miscellany

COVID-19

Thursday Miscellany

David Ermer–AHRQ, Congress, COVID-19, FDA, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, Telehealth–
Photo by Josh Mills on Unsplash

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

The Treasury Department began taking special measures to keep paying the government’s bills on Thursday as the U.S. bumped up against its borrowing limit, kicking off a potentially lengthy and difficult debate in Congress over raising the debt ceiling. 

With the federal government constrained by the roughly $31.4 trillion debt limit, the Treasury Department began deploying so-called extraordinary measures. Those accounting maneuvers, which include suspending investments for certain government accounts, will allow the Treasury to keep paying obligations to bondholders, Social Security recipients and others until at least early June, the department said last week.  

That gives lawmakers on Capitol Hill and the Biden administration roughly five months to pass legislation raising or suspending the debt limit. In a letter to congressional leaders on Thursday, Treasury Secretary Janet Yellen said there was “considerable uncertainty” about how long extraordinary measures can last. 

“I respectfully urge Congress to act promptly to protect the full faith and credit of the United States,” Ms. Yellen said. 

From the OPM front, OPM issued “Guidance on Increasing Opportunities for Federal Internships, Fellowships, and Other Early Career Programs” and, according to MeriTalk, held a “virtual job fair organized today by Tech to Gov in partnership with the Office of Personnel Management (OPM) is targeting a wide range of Federal government technology and related positions as part of the government’s goal to restock its tech ranks amid a slowdown in hiring by the private sector.” As daily reports of layoffs at tech companies have been appearing in the news, OPM’s timing for the job fair is opportune.

Today, benefits expert Tammy Flanagan completed her three Govexec columns on federal employee and annuitant benefit changes for this year.

From the Omicron and siblings front,

MedPage Today tells us, “Real-World Data Support Bivalent COVID-19 Boosters in Older Adults — Study from Israel showa ed high level of protection in people 65 and up.” MedPage Today’s medical editor in chief Dr. Jeremy Faust comments

[T]he Israeli data really helps us understand that for 65-years-olds and over, getting a bivalent booster is going to protect against hospitalization. We don’t know how long that’s going to last, and that’s the key. If it turns out that the bivalent booster ends up having a much longer tail of effectiveness than the monovalent did, that’ll be good news, but it’ll depend upon what variants are circulating and other factors, but we are watching that.

Reuters adds

The European Union’s drug regulator has not identified any safety signals in the region related to U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech’s updated COVID-19 shot, the agency said on Wednesday.

On Friday, the U.S. Food and Drug Administration and the Centres for Disease Control and Prevention said that a safety monitoring system had flagged that the shot could possibly be linked to a type of brain stroke in older adults, according to preliminary data.

The FDA’s Vaccines and Related Biological Products Advisory Committee will consider this safety issue at a meeting on January 26.

Also from the FDA front, the Wall Street Journal informs us

U.S. drug regulators rejected Eli Lilly & Co.’s proposed new Alzheimer’s disease treatment, saying they need more data from clinical testing, according to the company.

The setback could delay a potential commercial introduction of the highly anticipated drug by at least several months, if the Food and Drug Administration eventually decides to approve it. * * *

The agency had recently approved another Alzheimer’s therapy. Earlier this month, the FDA gave early approval to a new Alzheimer’s drug from Eisai Co. and Biogen Inc.

Lilly had been hoping for an accelerated FDA approval of donanemab early this year. Now, a midyear filing of a standard drug application means an FDA decision could be pushed back into 2024, based on typical FDA timelines of taking six to 10 months to review new drug applications.

The American Hospital Association relates

In an online survey last November of 1,200 U.S. adults previously vaccinated against COVID-19, 62% had not yet received a bivalent booster dose, most often because they did not know they were eligible or the booster was available, or believed they were immune against infection, the Centers for Disease Control and Prevention reported today. After viewing information about eligibility and availability, over two-thirds of them planned to get a bivalent booster and 29% reported receiving the booster in a follow-up survey in December. To help increase bivalent booster coverage, the report recommends using evidence-based strategies to inform patients about booster recommendations and waning immunity.

From the No Surprises Act front, Healthcare Dive points out

  • Many Americans are still exposed to the potential for a surprise medical bill from an out-of-network ambulance ride, a research report published in Health Affairs found. About 28% of emergency trips in a ground ambulance resulted in a potential surprise bill, according to the research that analyzed commercial insurance claims.
  • About 85% of emergency transports were deemed out of network between 2014 and 2017, researchers found. But two-thirds of those trips are paid in full by insurers, eliminating the risk of a surprise bill.
  • The report shows the difference in pricing by ground ambulance ownership and how that affects patients’ financial exposure. * * *
  • Given the high prevalence for a potential surprise bill, protections like those afforded to consumers in the No Surprises Act may be necessary for both emergency and non-emergency transports, the authors said.

The FEHBlog is puzzled by the author’s extension of NSA protection to non-emergency transports, which the consumer should have time to manage. Congress should not overload the NSA system.

From the telehealth front, Healthcare Dive reports

  • Private insurers paid roughly the same for telehealth and in-person visits during the early days of the COVID-19 pandemic as virtual care surged, according to new research from the Kaiser Family Foundation.
  • Though it’s unclear how payment rates might have changed over the past two years, the findings call into question the argument that telehealth is saving the healthcare system money, researchers said.
  • However, researchers said that perks of telehealth included expanded access and convenience — cost benefits of which were not factored into the study.

Fierce Healthcare tells us

UnitedHealthcare is rolling out a new virtual behavioral health coaching program backed by Optum.

The offering is available as of Jan. 1 for 5 million fully insured members, and self-insured employers can purchase the program as an employer benefit. Through the program, adults with symptoms of mild depression, stress and anxiety can access support for their mental health needs through virtual modules as well as one-on-one video conferences, phone calls or messaging with coaches. * * *

Members who use virtual coaching can connect with a dedicated behavioral health coach for a 30-minute weekly audio or video call and can chat with their coach using in-app messaging between sessions.

The program lasts eight weeks, and each member will complete an assessment at the onset to identify their individual needs. Coaches use cognitive behavioral therapy techniques to assist the patient in crafting an action plan that is personalized to them.

In other UHC news, Beckers Payer Issues relates

The largest employer of physicians in the United States is not HCA, the VA, or Kaiser Permanente — it’s UnitedHealth Group’s Optum.

With at least 60,000 employed or aligned physicians across 2,000 locations in 2023, Optum has cemented itself at the forefront of the quickly changing healthcare delivery landscape. For comparison, Bloomberg reported in 2021 that Ascension employs or is affiliated with 49,000 physicians, HCA has 47,000 and Kaiser has 24,000.

Given that the Affordable Care Act limits health insurers, but not healthcare providers, profits, UHC made a smart move, in the FEHBlog’s opinion.

From the Rx coverage front, STAT News tells us

In a bid to blunt competition and address rising drug costs, Sanofi is offering a warranty that will cover the cost for any hospital if a specific medicine fails to work, marking only the second time a major pharmaceutical company has taken such a step.

In this instance, Sanofi designed a warranty program for its Cablivi medication, which is used to treat aTTP, a rare, life-threatening autoimmune blood disorder that is considered a medical emergency. The cost will be refunded for up to six doses for patients who fail to initially respond or up to 12 doses for patients whose condition worsens.

The move comes after Pfizer began offering warranties for two of its medicines, the first of which debuted in August 2021. At the time, the Pfizer effort was the first of its kind in the pharmaceutical industry. Unlike the Sanofi warranty, however, the Pfizer programs offer refunds to patients — not hospitals — if the medicines fail to work sufficiently.

Although the approaches vary, both companies are signaling their interest in differentiating themselves from competitors, not just responding to complaints about the rising cost of medicines, according to Emad Samad, president of Octaviant Financial, a firm that is promoting the use of warranties in the pharmaceutical industry.

How would these warranties redound to the benefit of third party payers?

From the miscellany front

  • Cigna offers a paper about “Digging into the Unique Drivers and Healthy Behaviors That Impact Vitality.”
  • The U.S. Preventive Services Task Force released a chart of its most impactful 2022 recommendations.
  • Fierce Healthcare reports, “The number of providers serving as [Medicare] accountable care organizations increased slightly this year thanks to the start of a new advanced model and a slew of reforms meant to reverse a slide in participation.”
  • Mercer Consulting digs into “must do” valued based care strategies.
  • The MIT Technology Review considers the prospect of gene editing for the masses using CRISPR 3.0
  • STAT News discusses the “hot mess” of legal issues associated with the FDA’s recent decision to make abortion drugs available at pharmacies.

Midweek Update

David Ermer–CDC, Congress, COVID-19, Medicare, NIH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill, Roll Call reports that Senator Joe Manchin (D W Va) “has talked “briefly” with Speaker Kevin McCarthy about a bill he co-sponsored with Sen. Mitt Romney, R-Utah, in the last Congress to create a “rescue committee” for every endangered government trust fund, like the Social Security, Medicare and highway trust funds.

The Concord Coalition, a nonpartisan research group, named Romney and Manchin as its 2022 Economic Patriot Awards honorees because of their work on the legislation. 

The bill, which they have yet to reintroduce in the 118th Congress, would allow the top four congressional leaders to appoint three members each for every rescue committee and give lawmakers on the panels 180 days to come up with policy solutions for solvency.

Any legislation the rescue committees produce would be subject to expedited procedures for floor consideration; it couldn’t be amended but would require 60 Senate votes to advance to final passage. 

Keep hope alive.

From the Omicron and siblings front —

The Wall Street Journal reports

Moderna Inc. plans to expand its mRNA vaccine production capacity, saying shots targeting different pathogens can be made in the same facility, Chief Executive Stephane Bancel said.

“This is what gives me hope, not only for [coronavirus] variants, but also for other vaccines,” Mr. Bancel said on a panel at the World Economic Forum in Davos, Switzerland.  * * *

The company was able to roll out booster shots adapted to the Omicron variant in 60 days, according to Mr. Bancel.

That would be helpful assuming the FDA and CDC are on board.

The American Hospital Association lets us know

The Centers for Disease Control and Prevention yesterday released a dashboard tracking hospitalization rates for laboratory-confirmed COVID-19, flu and Respiratory Syncytial Virus by age group, sex, race/ethnicity, state and season based on data from select counties in 13 states, which the agency will update weekly. CDC also released another dashboard tracking weekly emergency department visits for COVID-19, flu and RSV by age group and percent of all ED visits based on data from the National Syndromic Surveillance Program.

In other vaccine news, the National Institutes of Health announced today

An investigational HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined. The HPX3002/HVTN 706, or “Mosaico,” Phase 3 clinical trial began in 2019 and involved 3,900 volunteers ages 18 to 60 years in Europe, North America and South America. Based on the DSMB’s recommendation, the study will be discontinued. Participants are being notified of the findings, and further analyses of the study data are planned.

Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, sponsored the Mosaico study with funding support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial was conducted by the NIAID-funded HIV Vaccine Clinical Trials Network, based at the Fred Hutchinson Cancer Research Center in Seattle. The U.S. Army Medical Research and Development Command provided additional study support.

Keep trying.

Also from the public health front

Gallup informs us “The percentage of Americans reporting they or a family member postponed medical treatment in 2022 due to cost rose 12 points in one year, to 38%, the highest in Gallup’s 22-year trend.” The story concludes

With high inflation creating moderate to severe hardship for a majority of Americans in the second half of 2022, their reports of delaying medical care in general due to cost — as well as delaying care for a serious condition — rose sharply to new highs. Young adults, those in lower-income households and women were especially likely to say they or a family member had put off medical care.

No bueno.

From the U.S. healthcare business front, McKinsey & Co. tells us

When we last looked at the trajectory of the US healthcare industry in our July 2022 article, “The future of US healthcare: What’s next for the industry post-COVID-19?,” we had emerging concerns about what persistent inflation could cause.1 It is now clear that inflation is not transitory and that the economic outlook has meaningfully darkened.2 These economic troubles, combined with a healthcare-worker shortage and endemic COVID-19, are clouding the industry outlook. In an accompanying article, we update how these changes could affect payers, providers, healthcare services and technology (HST), and pharmacy services.

Check it out.

From the Medicare front, Fierce Healthcare relates

Enrollment in Medicare Advantage (MA) has topped 30 million, according to new data from the Centers for Medicare & Medicaid Services.

This represents coverage across 776 contracts, according to the data, as of Jan. 1 payments, which reflect enrollments accepted through Dec. 2. Enrollment in standalone prescription drug plans was also about 22.7 million, bringing total enrollment across all types of private Medicare plans to nearly 50.3 million.

This represents growth of about 2 million from 2022. An analysis from the Kaiser Family Foundation found that enrollment in MA plans was about 28 million last year. 

Tuesday’s Tidbits

David Ermer–COVID-19, FDA, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–

From the Omicron and siblings front

  • The New York Times accurately describes this Covid winter as a bump rather than a surge.
  • The Washington Post discusses a large medical study that supports the need for pregnant women to be vaccinated against Covid.

On a related note the Wall Street Journal reports

An experimental vaccine from Moderna Inc. significantly reduced the risk of a viral respiratory disease among older adults in a large clinical trial, the latest promising sign in drugmakers’ efforts to fight the deadly RSV virus. * * *

The results are the latest for an experimental RSV vaccine. Also developing shots are GSK PLC, Pfizer Inc. and Johnson & Johnson. 

Meanwhile, Sanofi SA and AstraZeneca PLC have co-developed an antibody-based drug to be used for the prevention of RSV in infants. They applied for FDA approval of the drug and expect a decision in the third quarter of 2023.

From the FEHB front, Reg Jones, a retired OPM FEHB contracting officer, provides an “insiders look at FEHB” in FedWeek. His first observation is

First, when the FEHB became law some 60 years ago, I think it would have been better if there had only been a single risk pool. In other words, no Self Only, Self Plus One, and Self and Family options. Because there are these distinctions, enrollees have ever since wanted to further carve up the risk pool, creating subcategories, such as employees vs. retirees or retirees with or without Medicare as their primary insurer.

While the FEHBlog fully agrees with Mr. Jones about the value of risk pooling to FEHB, the self only, self plus one, and self and family choices are enrollment choices that affect the premiums paid but not the risk pool. OPM does break out risk pools by plan option, e.g., Standard, Basic, Elevate.

Mr. Jones is concerned about the risk pool splitting occasioned by the creation of the new Postal Service Health Benefits Program. The FEHBlog has stated his belief that OPM could have avoided this outcome by allowing FEHB plans to offer Medicare Part D EGWPs back in 2005. The FEHBlog expects that once FEHB enrollees see the lower premiums in PSHBP, Medicare D EGWPs will be added to FEHB and before the PSHBP and FEHB will become one again.

Mr. Jones also presses concern about access to medically necessary benefits which coincidentally is a topic that STAT News addressed today stemming from the Institute for Clinical and Economic Research’s publication of its “Second Annual Assessment of Barriers to Fair Access Within US Commercial Insurance Prescription Drug Coverage.” Here is a summary of the ICER Assessment’s results:

The assessment found a high level of alignment between coverage policies and fair access criteria across the formularies with the highest number of covered lives of large private payers and the VHA in the United States.  Across all relevant payer policies, ICER gave concordance ratings of 70% (59/84) for cost-sharing policies of drugs that ICER found to be reasonably priced, 96% (310/322) for clinical eligibility criteria, 98% (316/322) for step therapy criteria and 100% (322/322) for prescriber restrictions.

In the exploratory transparency analysis for select migraine and ulcerative colitis (UC) drugs aimed at discerning whether prospective plan members can find information about cost-sharing and clinical eligibility, payers were found to provide relatively good transparency into their formularies (16/18 payers met transparency criteria) but only 10/18 payers provided adequate transparency into their clinical coverage policies. In an exploratory analysis for documentation burden which reviewed the number of questions on prior authorization forms, prior authorization policies for UC and migraine drugs had a median number of questions from 25 to 36 and a range of questions from 22 to 71.

One of the most notable results of this effort is the change in coverage policies made by five payers for 11 drugs following receipt of draft results of the assessment. These changes all served to bring coverage into alignment with fair access criteria.

Note bene

ICER will host a public webinar at 12:00 p.m. ET on January 18, 2023 to discuss the key conclusions and policy implications of this assessment. Webinar presenters will include:

  • Sarah Emond, MPP, Executive Vice President and Chief Operating Officer, ICER
  • Mary B. Dwight, Senior Vice President and Chief Policy & Advocacy Officer, Cystic Fibrosis Foundation 
  • Meghan Buzby, Executive Director, Coalition for Headache and Migraine Patients (CHAMP) 

Register here for the webinar.

Also from the Rx coverage front

Fierce Healthcare reports “California has filed suit against a slew of major drugmakers and pharmacy benefit managers, alleging that they acted unlawfully to drive up the cost of insulin.”

Pharmacy Times informs us

The FDA has approved a label update for semaglutide (Rybelsus; Novo Nordisk) that allows the drug to be used in addition to diet and exercise as a first-line option to improve glycemic control in adults with type 2 diabetes.

This update removes a previous limitation that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes. With its initial FDA approval in 2019, semaglutide became the first and only glucagon-like peptide-1 (GLP-1) analog in pill form.

“The removal of the limitation of use is an important step forward for people living with type 2 diabetes and provides the option for Rybelsus to be taken earlier,” said Aaron King, MD, a family medicine and diabetes specialist, in a press release. “By taking Rybelsus first, people with type 2 diabetes, in conjunction with their care teams, are now able to utilize this medicine early in their diabetes treatment journeys.”

On a related note, the Wall Street Journal tells us

Parents and doctors are looking for new strategies to help adolescents with obesity. One controversial approach drawing the interest of some families is intermittent fasting, which limits people to eating for just a part of the day or week. 

Intermittent fasting has gained traction among adults who use it to try to manage weight and improve health. Doctors have largely avoided trying it with adolescents out of concern that introducing a fasting period to their schedules might result in nutritional gaps or trigger eating disorders when teens are rapidly growing and developing.

Now, a small number of doctors and researchers are evaluating types of intermittent fasting in adolescents, searching for solutions as rates of obesity and Type 2 diabetes rise. One pediatric endocrinologist in Los Angeles is launching a clinical trial looking at eating within a set time window in adolescents with obesity. Researchers in Australia are completing a separate trial, the results of which they expect to publish later this year.

Healthcare Dive and Fierce Healthcare offer tidbits from the medical technology front. Healthcare IT News considers whether telehealth can be used for preventive care.

From the U.S. healthcare front,

  • Beckers Hospital Review lists Healthgrades’ Top 50 Hospitals.
  • Insurance News Net fills us in on AHIP’s foci for 2023. “Access and affordability are the top two concerns of the health insurance industry as we move into a new year.”
  • You can scan Fierce Healthcare’s Fierce 15 of 2023 honorees here.

Happy King Day Weekend

David Ermer–CDC, COVID-19, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Because there is no CDC interpretative summary of Covid stats on a holiday weekend, here is a link to the CDC’s Covid data tracker, which updates on Thursday. The FEHBlog sees more of the same which would be expected when a disease reaches the endemic phase.

In other Omicron news

  • MedPage Today reports, “An early signal of stroke risk was detected in older adults who received Pfizer-BioNTech’s bivalent COVID-19 vaccine, the FDA and CDC announced in a joint statement late on Friday, yet the agencies found no link in further analyses and are not recommending a change in COVID-19 vaccination practice.” Agency experts will discuss this data “an already-scheduled January 26 meeting of FDA’s Vaccines and Related Biological Products Advisory Committee.”
  • Because the FEHBlog is in that Pfizer cohort, he will keep an eye on this meeting. Attending the meeting is Dr. Paul Offit who explains in Medscape his expert opinion that the bivalent booster’s administration should be limited to older and immunocompromised people. It’s an interesting read for a concerned layperson.
  • WebMD tells us, “The evidence is piling up that physical activity can lower the risk of getting very sick from COVID. The CDC, based on a systematic review of the evidence, has reported that “physical activity is associated with a decrease in COVID-19 hospitalizations and deaths, while inactivity increases that risk.” Other research has linked regular physical activity with a lower risk of infection, hospitalization, and death from COVID. The latest such study from Kaiser Permanente suggests that exercise in almost any amount [e.g., a 10-minute weekly walk] can cut the risk of severe or fatal COVID even among high-risk patients like those with hypertension or cardiovascular disease.

Here’s the CDC’s Fluview ,which is updated for today. “Seasonal influenza activity continues but is declining in most areas.” Good news.

In OPM News

  • The Chair and Ranking Member of the Senate Committee that oversees OPM who requested this week’s report GAO report on family member eligibility are not happy with its conclusions.
  • Federal News Network reports on OPM’s long-term efforts to advance diversity, equity, inclusion and accessibility for the federal workforce.

In other agency news

  • Politico discusses efforts to help the CDC reform itself.
  • STAT News reports, “The Democrats leading the Federal Trade Commission are hoping to expand the agency’s authority to crack down on unfair business practices — and the shift could have major implications for its ongoing scrutiny of pharmacy benefit managers.”
  • HR Dive notes that the EEOC’s “draft Strategic Enforcement Plan (SEP) for 2023-2027 appeared in the Federal Register and stakeholders may comment through Feb. 9.”
  • Govexec reports, “The federal government is expecting to run up against its borrowing limit as soon as June, Treasury Department Secretary Janet Yellen told Congress on Friday, kicking off a legislative fight that could result in significant disruptions to government operations and the U.S. economy.”

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

Healthcare giant UnitedHealth Group beat analyst expectations for the fourth quarter of 2022 with revenue of $82.8 billion, up more than 12% year over year, according to results released premarket Friday.

Industry experts have expressed concern about potential recessionary pressures and upset care utilization patterns headed into 2023. But UnitedHealth’s earnings, which are considered a bellwether for the health insurance sector’s performance, may prove to be a positive sign for payers.

Thursday Miscellany

David Ermer–COVID-19, Government Contracting, Medicare, Mental health care, NIH–
Photo by Josh Mills on Unsplash

From the public health front, the Wall Street Journal reports

The cancer mortality rate in the U.S. has dropped by a third in the past three decades, a report showed, but an increase in advanced prostate cancer diagnoses threatens to reverse some hard-won gains.  

The American Cancer Society said Thursday that changes in preventive measures and screening in the past decade drove important trends in U.S. cancer incidence and outcomes. Cervical cancer rates dropped 65% from 2012 to 2019 among women in their early 20s after a generation of young women were vaccinated against human papillomavirus, or HPV, for the first time.

But a decline in the use of a controversial test for prostate cancer likely led to more men getting diagnosed at later stages, the report found, with the highest incidence and mortality among Black men. The ACS said it would invest in research on prostate cancer and programs to boost access to quality screening and treatment. 

“There’s a significant call to arms,” said Karen Knudsen, ACS’s chief executive officer. “We are not catching these cancers early when we have an opportunity to cure men of prostate cancer.” 

The report was published in the journal CA: A Cancer Journal for Clinicians. The authors at ACS analyzed federal and state cancer registries for data on cancer rates through 2019 and federal mortality data through 2020, the report said.

From the Omicron and siblings front, Bloomberg Prognosis tells us

The effects of long Covid tend to resolve within a year of mild infection, with vaccinated people at lower risk of breathing difficulties compared with unvaccinated people, according to a study.

Researchers examined the health records of almost 2 million people in Israel who tested for Covid-19 over a 19-month period. Over 70 long Covid conditions were analyzed within a group of infected and matched uninfected members. They also compared conditions in vaccinated versus unvaccinated people.

Their study published in the BMJ medical journal found most symptoms that developed after a mild infection lingered for several months, but returned to normal within a year.

“The long Covid phenomenon has been feared and discussed since the beginning of the pandemic,” the researchers wrote. “This nationwide dataset of patients with mild Covid-19 suggests that mild disease does not lead to serious or chronic long term morbidity.” 

Previous studies have indicated that vaccination tends to lead to milder cases of Covid infection and long Covid

From the Rx coverage front, STAT News informs us

Medicare officials have taken a step toward making a cutting-edge cancer treatment called CAR-T cell therapy available in doctor offices, in anticipation of the procedure being used for increasingly common cancer types.

CAR-T is a relatively new medical procedure that uses a person’s own cells to fight their cancer, and it offers hope of a cure for those who have run out of options. It’s a complex procedure with a lot of serious side effects that must be closely monitored, so it’s typically provided at hospitals in the inpatient setting, sometimes outpatient, and almost never in doctor offices.

There are multiple barriers to offering CAR-T cell therapies in doctor offices, according to James Essell, medical director of the Blood Cancer Center at OHC and chair of cellular therapy for the US Oncology Network, a large network of independent doctors that includes OHC. Insurers restrict coverage to facilities that specialize in the procedure, and it’s financially risky for practices. Treating a few patients would require a practice to shell out well more than $1 million for the drugs alone, and the process of getting paid is arduous and not guaranteed, Essell said. * * *

Since the first CAR-T drug, Novartis’ Kymriah, was approved in 2017, the procedure has primarily been available at major academic hospitals. That puts the treatments out of reach for patients who don’t live near those facilities. Essell said less than 20% of patients who are eligible for the treatments are able to get them. Physician practices could help make the treatment available to the other 80%.

“You really need to get this out of the university centers to allow more patients to receive this care,” he said.

Mercer Consulting discusses strategies for providing access to and managing the cost of highly expensive gene therapies.

The second half of 2022 was marked by significant activity in the gene therapy market, with several landmark FDA approvals, including Hemgenix, a $3.5M gene therapy indicated for treatment of Hemophilia B. With this hefty price tag, Hemgenix wins the title of most expensive drug in the world, knocking down the previous title holder, the $2.1M gene therapy called Zolgensma, indicated for spinal muscular atrophy. * * *

As Hemgenix and other high-cost gene therapies enter the market, employers should create a long-term comprehensive approach to managing these therapies from a clinical and cost perspective by exploring a broad spectrum of strategies. A key first step in tailoring strategies specific to your plan involves assessing the likelihood of these claims occurring in your plan’s population; ideally, such assessments should be conducted on a regular basis as the member population changes. Once you get a better understanding of your unique population and the potential risk for these claims, inventory and evaluate available vendor strategies for gaps and opportunities. This step may include reviewing your medical carrier’s utilization management programs, network strategy, and care management programs, checking for availability of outcomes-based reimbursement and other payment models, and exploring alternative approaches to funding these claims. Lastly, as the market continues to evolve, regularly engage with your medical and pharmacy vendor on availability of new strategies.

The American Hospital Association adds

The Centers for Medicare & Medicaid Services yesterday released a memo and timeline outlining how it will approach implementing the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, which will negotiate prices with drug makers for certain high-cost, sole-source drugs and apply them beginning in 2026. According to the memo, CMS plans to actively engage hospitals and other stakeholders in the policymaking process.

From the medical research front, the National Institutes of Health discusses an ongoing study on the use of deep brain stimulation to treat severe opioid addiction.

From the litigation front, a divided panel of the U.S. Court of Appeals for the Sixth Circuit today upheld a lower court’s preliminary injunction of the federal government’s government contractor mandate but similar to the approach taken by the 5th Circuit limited the scope of the protection of the injunction to the plaintiffs, here the States of Kentucky, Ohio, and Tennessee. For more information, here’s the Volokh Conspiracy article on the decision. The 5th, 6th, and 11th Circuits have all ruled against the government contractor mandate, which the Safer Federal Workforce Task Force has put on ice.

Midweek update

David Ermer–COVID-19, Federal employment benefits, Government Contracting, OPM, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the federal employment front —

  • Govexec explains how federal employees can calculate their 2023 pay raises.
  • The Federal Times discusses how the Secure 2.0 Act, part of the Consolidated Appropriations Act 2023, affects federal employee retirement programs.

Healthcare Dive identifies key trends for payers and providers in 2023.

This year’s outlook for a large chunk of the healthcare sector remains negative as inflation and pricier labor create difficult operating conditions for nonprofit providers, Moody’s Investor Service said. 

As a result, health systems and hospitals are likely to clash with insurers over desired rate increases to offset higher expenses and providers will look to increase their revenue as much as possible by bargaining for higher rates.

Becker’s Hospital CFO Report fills us in on the highlights of a Fitch Ratings webinar on healthcare

Five things to know:

  1. There will continue to be “extremely contentious” negotiations between healthcare providers and payers, Mr. Holloran said. An “above average” exiting of contracts and networks is expected.
  2. There will be far more labor strikes in 2023 with “very contentious” labor negotiations, Mr. Holloran said. Unions will be quick to move as healthcare systems seek to recruit and retain “on steroids.”
  3. Regional differences will continue to emerge. The fast-growing Southern states of Florida, Texas and Georgia will see significant capital expenditure, for example, while regions with declining populations and others will seek to tighten such expenses.
  4. There will be increased merger and acquisition activity even as the Biden administration takes a harder look at potential anti-competitive behavior. “We know everyone is talking to everyone else” about ways in which they can partner, Mr. Pascaris said. “It’s a very interesting time for M&A as increased levels of stress will likely include greater levels of M&A.”
  5. Healthcare systems cannot spend their way out of financial difficulties because the cost of labor will remain very high. The 75/75 conundrum where most systems’ revenues are fixed at 75 percent and most have a similar 75 percent fixed expense in terms of salaries and supplies is an “unstainable” model, Mr. Holloran said.

From the public health front,

  • The Secretary of Health and Human Services extended the Omicron public health emergency for another 90 days today.
  • STAT News explores “What’s standing in the way of wastewater data becoming a more mainstream public health tool.”

Moderate-to-severe hearing loss was linked with a higher prevalence of dementia, a cross-sectional study of Medicare beneficiaries showed.

Among 2,413 older adults in the National Health and Aging Trends Study (NHATS), dementia prevalence among people with moderate-to-severe hearing loss was higher than it was among people with normal hearing (prevalence ratio 1.61, 95% CI 1.09-2.38), reported Nicholas Reed, AuD, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, and colleagues.

But among people with moderate-to-severe hearing loss in the study, hearing aid use was associated with a lower prevalence of dementia compared with no hearing aid use (prevalence ratio 0.68, 95% CI 0.47-1.00), they wrote in a JAMA research letter.

The findings support a recent systematic review and meta-analysis that showed treating hearing loss led to cognitive benefits. They also support the availability of over-the-counter hearing aid, which people with mild-to-moderate hearing loss now can purchase directly due to new regulations.

Given the FEHB’s demographics, FEHB plans should take a look at improving health aid coverage for 2024.

From the U.S. healthcare business front

  • Fierce Healthcare reports on today’s events at the J.P. Morgan Healthcare conference.
  • The following Fierce Healthcare report from the conference caught the FEHBlog’s eye today

Fertility benefits are becoming a major lever in the ongoing talent wars, and that’s good news for Progyny.

The eight-year-old company, which provides family building and fertility benefits for employees at large firms, launched with five clients and 110,000 covered lives. Today, Progyny has more than 370 clients with 5.4 million covered lives.

“In the past year given the current macroeconomic environment, inflationary economy an a potential looming recession, despite all that, for Progyny and its members, it’s proven to be a resilient space. People aren’t foregoing and or deferring family building, in light of all those things, and companies aren’t deferring their decisions,” Pete Anevski, Progyny’s CEO, told Fierce Healthcare on the conference sidelines.

From the telehealth front, McKinsey and Company explain how healthcare organizations can tackle the following problem:

Using national claims data,3 we estimate that more than 50 million in-person visits per year could be converted to virtual or telemedicine visits if adoption were extended equally across patient segments. In general, patient segments with limited access to in-person care (for example, those in rural counties and those with lower incomes) have relatively fewer virtual visits. While many believe virtual care can improve access for the underserved, the current imbalance in usage suggests that US healthcare stakeholders could consider designing virtual-care models that address structural barriers so that virtual care is more widely accessible.

Check it out.

Federal procurement contracts, including FEHB contracts, include a clause requiring contractors to support government efforts to combat human trafficking. During the human trafficking awareness month, the Government Accountability Office reports

Tens of millions of people are victims of human trafficking each year, according to one international organization’s estimate. Human trafficking victims are often held in slave-like conditions and forced to work in the commercial sex trade or other types of servitude. The U.S. government has also found forced labor overseas in various industries producing goods imported into the U.S., such as agricultural and seafood industries.

Several U.S. government entities work with international entities to combat human trafficking. Today, for National Human Trafficking Awareness Day (January 11), our blog post looks at our work reviewing these efforts and our snapshot highlighting areas where continued attention is needed.

Tuesday’s Tidbits

David Ermer–COVID-19, FDA, NIH, OPM, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the FEHB front, Federal News Network provides an update on the GAO report on FEHB that was mentioned in yesterday’s post.

The Office of Personnel Management, the agency that runs the health insurance program for federal employees and retirees, does not have a clear way to identify and remove FEHB enrollees’ family members who are erroneously part of the program, according to the Government Accountability Office.

“The longer OPM delays its efforts to establish a monitoring mechanism to identify and remove ineligible members from FEHB, the more ineligible members and related improper payments in the program may continue to accrue, costing the program millions, or up to approximately one billion dollars per year, according to OPM’s own estimate,” GAO said in a Jan. 9 report.

OPM said it has received the final report and is planning to flesh out a larger response soon.

OPM’s Healthcare and Insurance Office “will be evaluating potential action items, including timelines, and will provide a comprehensive response to GAO within 180 days upon evaluation of the recommendations,” OPM spokesperson Viet Tran told Federal News Network.

From the public health front,

January is Cervical Cancer Awareness Month, and Patient Engagement HIT tells us

Nearly one in 10 women have never had a common cervical cancer screening, like a Pap test, with issues such as limited health literacy and poor access to care getting in the way, according to a Harris Poll conducted on behalf of BD (Becton, Dickinson and Company).

These trends are more common in racial minorities, with Black and Hispanic women being more likely to say they have never had a Pap test. Compared to the 6% of White women who said they’ve never had a Pap test, 12% of Hispanic women and 13% of Black women said the same. * * *

receipt of Pap tests is extremely low, the survey of 872 women ages 18 to 64. Overall, 71 percent of respondents have delayed getting a Pap test, with 15 percent saying their last OB/GYN check-up was three years ago.

Although not explicitly explored in the survey, it’s key to note that timeline aligns with the outbreak of the COVID-19 pandemic when access to primary and preventive care stalled. * * *

The good news is, around three-quarters of all respondents, regardless of race, said they have resolved to get back on track with their primary and preventive care, including Pap tests and HPV screenings, in the new year.

But doing so will require some leg work from the healthcare industry, which should note some patient health literacy and convenient care access snags getting in the way.

Even though nearly every respondent said they are knowledgeable about women’s health (91 percent), a whopping 81 percent admitted they don’t know how often they should get a Pap test and 51 percent said they were unaware of how often they should get an HPV test.

The survey also found consumer support for an at-home screening test. Kaiser Permanente and MD Anderson Center offer their views on at-home screening, and MD Anderson reminds us

The best protection for both men and women against HPV and related cancers[, i.e. cervical cancer,] is the HPV vaccine. All males and females ages 9-26 should get the HPV vaccine. It is most effective when given at ages 11-12. Unvaccinated men and women ages 27-45 should also talk to their doctor about the benefits of the vaccine.

MedPage Today reports

Adhering to healthy eating patterns was associated with lower risk of total and cause-specific mortality, a prospective cohort study with up to 36 years of follow-up showed.

Among 75,230 women from the Nurses’ Health Study and 44,085 men from the Health Professionals Follow-up Study, those who scored in the highest quintile for healthy eating patterns recommended by the Dietary Guidelines for Americans (DGAs) had a 14% to 20% lower risk of total mortality versus those in the lowest quintile, reported Frank Hu, MD, PhD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Internal Medicine opens in a new tab or window.

The pooled multivariable-adjusted hazard ratios of total mortality with four healthy eating patterns were (P<0.001 for trend for all):

  • Healthy Eating Index 2015 (HEI-2015): HR 0.81 (95% CI 0.79-0.84)
  • Alternate Mediterranean Diet (AMED): HR 0.82 (95% CI 0.79-0.84)
  • Healthful Plant-Based Diet Index (HPDI): HR 0.86 (95% CI 0.83-0.89)
  • Alternate Healthy Eating Index (AHEI): HR 0.80 (95% CI 0.77-0.82)

This lower risk was consistent across all racial and ethnic groups.

NIH’s NIAAA Director provides tips for a successful dry January. Good luck to all those who made this resolution because

Taking a break from alcohol for an entire month provides one with an opportunity to assess their patterns of alcohol consumption and how it affects them physically and mentally. It gives a person a chance to cultivate alternatives for relaxing, socializing, and coping with stress. As a result, many people experience benefits such as improved sleep and waking without the fatigue, malaise, and upset stomach of a hangover. Some also find that without the extra calories due to alcohol they lose weight. Participants in Dry January also describe positive effects on their relationships. And an added bonus is saving money.

STAT News brings us up to date on mpox.

From the Omicron and siblings front,

  • Becker’s Hospital Review provides some geographic details on the current winter’s Covid surge.
  • The National Institutes of Health announced “The antiviral treatment Paxlovid reduced the risk of hospitalization or death from SARS-CoV-2 Omicron variants in older adults by 44%. Wider use of Paxlovid may help temper a winter surge of COVID-19, as some other treatments are no longer effective.”
  • Politico reports on progress being made to end the Covid public health emergency later this year.

From the Food and Drug Administration front,

  • STAT News interviews the FDA Administrator Robert Califf on the Congressional investigative report concerning the Aduhelm fiasco.
  • The FDA announced that “In 2022,  the Center for Drug Evaluation and Research approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs, as noted in our annual New Drug Therapy Approvals report. We also approved drugs in new settings, such as for new uses and patient populations.” 

From the Rx coverage front, Drug Channels delves into major prescription benefit manager formulary exclusions lists for 2023.

From the medical research front, the National Institutes of Health announced, “Researchers developed a blood test that could detect Alzheimer’s disease-promoting compounds in the blood long before symptoms emerged. The findings may lead to early diagnostic tests for Alzheimer’s and other neurodegenerative diseases.”

From the U.S. healthcare business front

  • Fierce Healthcare’s lead article on the ongoing JP Morgan healthcare conference concerns CVS’s Heath’s foray into primary care.
  • Healthcare Dive adds, “CVS Health is exploring an acquisition of value-based primary care chain Oak Street Health, according to a Monday Bloomberg report. The two are in ongoing talks and could reach a deal within weeks that values Oak Street at more than $10 billion including debt, according to Bloomberg, which cited sources familiar with the matter a deal.”
  • Healthcare Dive informs us that “Teladoc Health shared an early look at its financial results at JPMorgan’s healthcare conference on Monday, indicating between $633 million and $640 million in revenue for the fourth quarter, a little higher than consensus estimates from analysts. The virtual care giant projected total 2022 revenue between $2.4 billion and $2.41 billion, according to its regulatory filing. Teladoc’s direct-to-consumer mental health unit, BetterHelp, is expected to contribute roughly $1 billion of that topline.”
  • STAT News reports, “Rising labor costs have been the main financial concern for hospitals over the past year, but those costs have peaked and are now a lot lower, according to hospital system executives who presented during the J.P. Morgan Healthcare Conference.”

From the post-Dobbs front, STAT News tells us about telehealth provider reactions to the Justice Department’s announcement last week permitting abortion drugs to be sold by mail and the FDA’s opportunity for pharmacies to sell those drugs.

From the Supreme Court front, STAT News relates

The U.S. Supreme Court rejected a bid by Pfizer to use a copay-assistance program to help Medicare beneficiaries pay for an expensive heart drug. The company argued the program would not violate kickback laws, a controversial issue that forced numerous drugmakers to pay large fines. Last July, an appeals court panel upheld a lower court ruling that such programs would violate federal law, but Pfizer filed a petition to the Supreme Court that contended such interpretations are “staggeringly overbroad.” Pfizer maintained there was no “corrupt intent” in offering assistance and that Medicare beneficiaries would be denied needed medicines they would otherwise not be able to afford.

It’s up to Congress to fix this problem.

Weekend Update

David Ermer–CDC, Congress, COVID-19, FDA, U.S. Healthcare–

Here is Roll Call’s 2023 Congressional calendar.

The Senate is on a State work break until January 23.

The House of Representatives will be in session this week for floor business. The Wall Street Journal adds

The House will dive into its first week of substantive work with bills to cut Internal Revenue Service funding and investigate economic competition from China, after a leadership election that underscored Republican divides and the fragile position of Speaker Kevin McCarthy (R., Calif.). * * *

On Monday, the House will vote on a set of chamber rules for the 118th Congress that will enshrine some of the pledges regarding legislative procedure Mr. McCarthy made to win over holdouts in his speaker election. The rules package will also make key changes to the operations of the Office of Congressional Ethics, which conducts initial reviews of allegations of impropriety against lawmakers. 

“We’ll pass the rules package tomorrow, and we’ll get moving on doing what the American people elected us to do,” said Rep. Jim Jordan (R., Ohio), the incoming Judiciary Committee chairman and a prominent McCarthy ally, in an interview Sunday on Fox News. “In a two-year time span, we have seen a border that is no longer a border. We have seen a military that can’t meet its recruitment goals. We’ve seen terrible energy policy, terrible education policy…We’re going to unite around fixing those problems.”

Democrats said they hoped to find areas of bipartisan agreement. “Clearly we are going to have strong disagreements at times, but we can agree to disagree without being disagreeable,” said House Minority Leader Hakeem Jeffries (D., N.Y.) on NBC on Sunday.

The Journal also provides greater insight into the availability of the new Alzheimer’s disease drug that the FDA approved last week.

A sweeping Medicare rule issued last year [following the Aduhlem fiasco] will keep the newly approved Alzheimer’s disease drug Leqembi out of reach of most U.S. patients for months to come. 

The Food and Drug Administration on Friday approved Eisai Co. and Biogen Inc.’s Leqembi, known generically as lecanemab, for the treatment of people with early-stage Alzheimer’s disease, the vast majority of whom are insured by Medicare. However, Medicare won’t pay for the drug unless patients are enrolled in government-sanctioned clinical trials, and no such studies are ongoing or planned. 

The Alzheimer’s Association patient-advocacy group asked the Centers for Medicare and Medicaid Services in December to reconsider its policy, a process that could take as long as six to nine months if it chooses to do so. 

As many as 85% of patients who could benefit from Leqembi are insured by Medicare, said Ivan Cheung, Eisai’s global Alzheimer’s disease officer. Eisai projects that 100,000 patients could be using the drug by its third year on the market, assuming that Medicare officials lift coverage restrictions, Mr. Cheung said. 

From the public health front, Forbes delves into Omicron XBB 1.5. As the FEHBlog noted last Friday new Covid cases and hospitalizations are up because winter has arrived. Forbes reminds us

From Dec. 21 to 27, 2022, 5,613 people were admitted with positive COVID tests, compared to 6,519 from Dec. 28 to Jan. 3. However this is still a far cry, down 69.7%, from the peak seven-day average in mid-January 2022 when 21,525 were admitted with COVID.

Last year’s Omicron alpha phase dwarfs the current surge which the FEHBlog attributes to the fact that Paxlovid did not reach the market until December 22, 2021.

Forbes also offers parents information about signs and symptoms of invasive strep cases currently afflicting children.

NPR Shots reports on the worthy efforts of various physicians to improve the care of miscarrying patients.

“Fewer abortions will mean more pregnancies, and more pregnancies will mean more miscarriages,” said Dr. Sarah Prager, a professor of obstetrics and gynecology at the University of Washington and a co-author of the guidelines on miscarriage management for the American College of Obstetricians and Gynecologists.

Around 15% of known pregnancies end in miscarriage, and the first medical professional many of those patients see will be in an emergency room. Yet, by and large, she says, “emergency medicine physicians aren’t trained in managing miscarriage and don’t see it as something they should own.”

For more than a decade, Prager has been trying to change that through her work with the TEAMM Project, the nonprofit she co-founded on the premise that “many people experience miscarriage before they’re established with an OB-GYN.” Short for Training, Education and Advocacy in Miscarriage Management, TEAMM has conducted in-person workshops for clinicians at more than 100 sites in 19 states on all aspects of miscarriage care — everything from the use of ultrasound to diagnose fetal death to the three treatment options miscarrying patients should be offered when they come in for care.

From the medical trial front, the Wall Street Journal points out a significant issue with cancer treatment trials.

After Mikhail Rubin learned his lethal blood disease had progressed, he decided that he wanted a stem-cell transplant through a clinical trial. But there was an obstacle: his age.

Mr. Rubin, who is now 72, was too old to participate. Many cancer trials cap enrollment at age 65. Even when trials for older people are available, oncologists are reluctant to enroll elderly patients because frailties might make them less resilient against side effects from toxic treatments, according to a 2020 study in an American Cancer Society journal. People over 70 represent a growing share of the cancer-patient population but are vastly underrepresented in clinical trials, the study said.

“How can we make decisions for people over 70 if people over 70 are not included in the trials that we use to base our decision making?” said Dr. Mina Sedrak, deputy director of the Center for Cancer and Aging at City of Hope, a cancer center near Los Angeles and an author of the paper.

Fair question, Dr. Sendrak.

From the health plan consumer app front, Fierce Healthcare tells us

Elevance Health is making the latest expansion to its Sydney member app with the addition of a new Nutrition Tracker tool.

The tracker uses artificial intelligence to recognize foods in photographs taken by a member’s smartphone camera. It can log individual foods as well as entire meals using this functionality, the insurer, formerly Anthem, said.

Once the information on a meal is logged, it can quickly be added to the member’s health record and then be shared with their provider, with consent, allowing for personalized feedback from their medical team.

Anil Bhatt, global chief information officer at Elevance Health, told Fierce Healthcare that the insurer wants Sydney to be able to offer as much valuable information to the member “at their fingertips” as possible. Elevance Health regularly gathers consumer feedback on features that would most benefit them.

Finally the FEHBlog noticed that NPR Shots is offering useful advice for white collar workers.

After staring at a computer screen for hours at a time, the body often gives us a clue that it is stressed: nagging neck and back pain.

To fix the problem, you might have gotten advice to focus on posture or ergonomics, but exercise research points to another strategy as well – taking short spurts of movement throughout the day to release tension and stress in the body. 

“As a society, the assumption is that we have pain because of poor posture and slouching,” says Kieran O’Sullivan, an associate professor of physiotherapy at the University of Limerick’s School of Allied Health in Ireland. “But [the issue] isn’t as neat and tidy as we thought. We have been trying all these fixes [with ergonomics] and it has arguably not fixed the problem. I think it is more about needing breaks from the working day with … movement.”

Here’s how researchers think quick hits of movement – sometimes called exercise “snacks” – may help prevent pain. When the brain senses physical or emotional stress, the body releases hormones that trigger muscles to become guarded and tight. Exercise counters that stress response by increasing blood flow to muscles, tendons and ligaments and sending nutrients to the spine’s joints and discs. 

Check it out.

Friday Stats and More

David Ermer–CDC, COVID-19, FDA, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the Centers for Disease Control’s weekly interpretative summary of its Covid statistics:

New Cases — “As of January 4, 2023, the current 7-day average of weekly new cases (67,243) increased 16.2% compared with the previous 7-day average (57,847). A total of 101,094,670 COVID-19 cases have been reported in the United States as of January 4, 2023. * * *

The most prevalent Omicron lineages this week are BQ.1.1, projected to be 34.4% (95% PI 26.7-
43%); XBB.1.5, projected to be 27.6% (95% PI 14.0-46.5); and BQ.1, projected to be 21.4% (95% PI 16.1-27.7%). XBB, BA.5, BN.1, BF.7, and BA.2.75 are all projected to be between 1% and 5% of circulating viruses.”

New Hospitalizations — “The current 7-day daily average for December 28, 2022–January 3, 2023, was 6,519. This is a 16.1% increase from the prior 7-day average (5,613) from December 21–27, 2022.”

New Deaths — “The current 7-day average of new deaths (390) increased 8.3% compared with the previous 7-day average (360). As of January 4, 2023, a total of 1,091,184 COVID-19 deaths have been reported in the United States.”

Vaccinations — “As of January 4, 2023, 665.1 million vaccine doses have been administered in the United States. Overall, about 229.3 million people, or 69.1% of the total U.S. population, have completed a primary series. More than 48.2 million people, or 15.4% of the U.S. population ages five years and older, have received an updated (bivalent) booster dose.”

Politico observes

Though Covid hospitalizations appear to be on the rise nationwide, experts don’t project this Omicron subvariant alone to cause a spike — forecasts from early data suggest they’ll remain fairly steady, Céline Gounder, an infectious disease specialist and senior fellow at the Kaiser Family Foundation, said. * * *

The prediction matches the data from Singapore, where a related subvariant recently became dominant but didn’t result in a spike in hospitalizations and deaths — though that country’s vaccination rate is higher than that of the U.S.

But some individuals — particularly people who are older or pregnant or have weakened immune systems — are at heightened risk from the virus, regardless of larger population trends.

“I’m a bit concerned with it just because it’s coupled with the extremely low booster rates of those over 65,” Katelyn Jetelina, epidemiologist and professor at the University of Texas Health Science Center, said. “Our most vulnerable aren’t as protected.”

The FEHBlog was encouraged to read this American Hospital Association post about a National Institutes for Health / HHS trial:

The Department of Health and Human Services will launch this month a COVID-19 Home Test to Treat telehealth pilot program in Berks County, Pa. Program organizers will work this year with public health departments to expand the program to 100,000 people in vulnerable communities. Telehealth services provider eMed will implement the program, and UMass Chan Medical School will analyze the impact on participating communities.

“At-home testing for COVID-19 is now widely available in the United States, as are antiviral treatments, and this program combines easy home access to both,” said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering, which will launch the program with HHS’ Administration for Strategic Preparedness and Response.

NPR adds

“What is clearer now, compared to even a year ago, is that we can really blunt the worst of [Omicron] by doing the things that we know work,” Dr. Ashish Jha, the White House coronavirus response coordinator, told NPR in an interview.

That includes getting vaccinated and boosted, especially if you’re older. Most deaths from COVID-19 are occurring in people age 65 or older.

Other precautions include avoiding crowded, poorly ventilated parties, restaurants, bars and other places; testing before gathering; and, yes, putting that mask back on in risky situations. And if you do get sick, check with your doctor about getting treatment quickly.

“It is a time not to let your guard down,” warns Dr. Tina Tan, an infectious disease specialist at Northwestern University.

The good news is the worst appears to be over from the RSV surge that has been making life miserable for many children and their parents. RSV cases have been falling steadily since the end of November, according to the Centers for Disease Control and Prevention.

At the same time, the flu — which also came roaring back this fall after mostly disappearing for the previous two years — looks like it’s finally receding in most places, according to the latest data out Friday from the CDC.

From Capitol Hill, Roll Call reports that Rep. Kevin McCarthy (R CA) has been elected House of Representatives speaker. The 118th Congress, therefore, is in session.

From the Rx coverage front —

STAT News reports

The Food and Drug Administration on Friday approved a new Alzheimer’s disease treatment that moderately slows cognitive decline in people with early-stage disease.

The [intravenously administered] drug, called Leqembi [scientific name lecanemab], was developed by Eisai, the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago.

Leqembi will cost $26,500 per year for a person of average weight, Eisai said. The drug has the potential to be a commercial blockbuster, but only if Medicare can be convinced to pay for it. Unless Medicare changes the way it pays for drugs like Leqembi, Eisai expects a relatively slow rollout. * * *

Eisai restricted the study of Leqembi to people with mild cognitive impairment or early stage Alzheimer’s that also have evidence of amyloid buildup in the brain, confirmed by an imaging scan. The FDA-approved label reflects the same narrowed patient population, estimated to encompass approximately 1 million people in the U.S., or just under 20% currently living with an Alzheimer’s diagnosis.

The label also mandates that patients undergo three additional brain scans during the first 14 weeks of treatment as a precautionary step to monitor for potentially serious brain swelling or bleeding episodes. * * *

Technically, the FDA granted accelerated approval to Leqembi, a faster path to the market based on preliminary evidence that the drug eliminates toxic amyloid. It’s the same controversial, regulatory shortcut that the FDA used to approve Aduhelm. But unlike Biogen, Eisai within days is expected to submit the cognition data from its positive, confirmatory study to the FDA, which will then consider the drug for full, or final, approval.

BioPharma Dive tells us, “The Food and Drug Administration is set to decide by April 13, 2023, whether to approve Alvotech’s biosimilar to AbbVie’s top-selling drug Humira, pending a facility inspection the company said Thursday it is trying to schedule early next year.” This keeps the drug on track to be on the market when the Humira patents are lifted on July 1, 2023.

According to a press release issued on January 5, 2023:

Synergie Medication Collective is a new medication contracting organization founded by a group of Blue Cross and Blue Shield affiliated companies to serve both Blues and select independent health plans. Synergie is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans. These high-cost treatments include multi-million-dollar gene therapies and infusible cancer drugs and represent a substantial portion of overall drug spend, with significant growth in future spend anticipated.

Synergie aims to significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders. With a core philosophy that prioritizes partnership and transparency, Synergie aims to play a key role in ensuring affordable access to treatment for millions of people. * * *

Synergie Medication Collective will go to market in January of 2023.

STAT News reports

For only the second time since launching nearly two years ago, the AMR Action Fund has announced an investment in a fledgling biotech company as it tries to underwrite efforts to develop badly needed medicines for combating antibiotic resistance.

In its latest move, the fund is providing $7.5 million to BioVersys, which is developing an antibiotic to combat a type of bacteria that affects people with compromised immune systems and is increasingly responsible for infections in hospitalized patients. The drug, which is about to enter Phase 2 testing, is targeting hospital-acquired pneumonia, pneumonia associated with ventilators, and blood stream infections that originate from pneumonia.

From the health plan design front, EBRI released a study on cost-sharing trends for medical services from 2013-2020.

From the healthcare business front —

Beckers Hospital Review informs us.

VillageMD, which is majority owned by Walgreens Boots Alliance, completed its acquisition of Summit Health-CityMD Jan. 3, adding more than 2,800 providers to its ranks. 

News of the deal’s completion comes roughly two months after it was announced. On Nov. 7, VillageMD said it entered a definitive agreement to acquire Summit Health-CityMD for $8.9 billion with investments from Walgreens Boots Alliance and Evernorth, the health services portfolio of Cigna.

VillageMD, established in 2013, operates standalone Village Medical practices, full-size Village Medical practices alongside Walgreens pharmacies, and primary care in the home and virtually. 

The combination of Summit Health-CityMD and VillageMD creates one of the largest independent provider groups in the country, according to the companies’ news release. With the buy, VillageMD more than doubles its locations from more than 250 to more than 680 in 26 markets and grows its ranks by more than 2,800 providers. VillageMD declined to share the precise number of providers it now employs, but did say it employs more than 20,000 people. 

The addition also strengthens VillageMD’s footprint in five states. Summit Health and CityMD have locations in New York, New Jersey, Connecticut, Pennsylvania and Central Oregon. 

Fierce Healthcare discusses the Federal Trade Commission’s proposed rule banning post-employment non-compete clauses in employment agreements on healthcare.

Noncompete agreements have become so ubiquitous that a proposed rule published by the Federal Trade Commission (FTC) yesterday [January 5] will affect almost all industries, experts say.

Healthcare will be no exception, Carrie Amezcua, an attorney with the law firm Buchanan Ingersoll & Rooney, told Fierce Healthcare. She said healthcare industry executives should keep a close eye on the debate about the rule.

The public has 60 days to submit comments before the FTC can make it final.

“It could still change—it could still be challenged actually—because it goes too far from what the FTC has the authority to do,” said Amezcua, who usually represents employers in disputes over noncompete agreements.

Backlash to the rule has already begun. In a statement, the U.S. Chamber of Commerce called the regulation “blatantly unlawful.” * * *

Amezcua added: “Insurers are not exempt from the FTC Act. They would be subject to this rule in its final form. And right now, it is written as a complete ban on noncompete agreements, post-employment. You could still have a noncompete during your employment. But you can’t have the provision that says you can’t work for another company for two years after you leave.”

In closing, FedSmith updates us on federal retirement statistics for those interested.

Thursday Miscellany

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

From Capitol Hill, the Wall Street Journal reports

Rep. Kevin McCarthy stepped up negotiations with Republican detractors, offering fresh concessions to win support after a third day of House speaker votes yielded no movement toward a winner in the GOP-controlled chamber.

Mr. McCarthy and some of his detractors appeared to be coalescing around a deal, stepping up the pace of discussions as the House marked its 11th round of votes with no winner, the most since just before the Civil War. While most Republicans backed Mr. McCarthy over three days of tallies, 20 continued to oppose him, and it wasn’t known if enough detractors would potentially change their votes to give Mr. McCarthy the gavel. All Democrats supported their pick, Rep. Hakeem Jeffries of New York. 

Shortly after 8 p.m., lawmakers voted 219-213 to adjourn until Friday at noon, with Republicans in favor and Democrats opposed.

Voting is expected to continue into the weekend.

From the Affordable Care Act front, the FEHBlog discovered today that on December 12, 2022, the Department of Health and Human Services announced the maximum 2024 out-of-pocket limits for in-network care offered by FEHB and other group health plans.

[T]he 2024 maximum annual limitation on cost sharing is $9,450 for self-only coverage and $18,900 for other than self-only coverage. This represents an approximately 3.8 percent increase above the 2023 parameters of $9,100 for self-only coverage and $18,200 for other than self-only coverage.

The announcement also covers other ACA topics: the premium adjustment percentage, reduced maximum annual limitation on cost sharing, and required contribution percentage, which apply to marketplace plans.

From the New Year front —

  • Mercer offers strategic planning guidance for health plan and human resources executives.
  • STAT News identifies three drug pricing issues to watch this year — 1. Inflation Reduction Act implementation; 2. Medicare’s lecanemab coverage decision, and 3. Insulin cost protections.
  • Tammy Flanagan writes in Govexec about Federal “Employee Benefit Changes for 2023; How new pay rates, Social Security earnings limits and other factors could affect your retirement planning.” 
  • Bloomberg Prognosis offers a January guide to weight loss.
    • Healio adds, “More physical activity was associated with a lower risk for type 2 diabetes regardless of age, sex, BMI or sedentary time, according to an analysis published in The Journal of Clinical Endocrinology & Metabolism.”

    From the telehealth front —

    Healthcare Dive tells us

    Teladoc Health announced on Thursday it’s launching a new app allowing users to access its full range of services in one place and under one account.

    The app, which includes primary care, mental health and chronic condition management, is meant to integrate all of Teladoc’s assets in one personalized platform, making care navigation and selection easier for consumers,

    Teladoc Chief Medical Officer Vidya Raman-Tangella told Healthcare Dive. The app is available to a select number of Teladoc’s existing clients this month. Teladoc plans to make the app available to the full market later this year.

    Fierce Healthcare adds “Teladoc’s full suite of services will be available in the Spanish language on the mobile app and the website, marking a critical shift with more than 40 million people in the United States reporting they speak Spanish at home.”

    CMS announced adding “a new telehealth indicator on clinician profile pages on Medicare Care Compare and in the Provider Data Catalog (PDC). The new indicator helps beneficiaries and caregivers more easily find clinicians who provide telehealth services.”

    From the post-Dobbs front, the Hill reports

    Two of the biggest pharmacy chains in the country are planning to seek the certification needed to dispense abortion pills in the states where it is legal, according to spokespeople for the companies.

    The decisions by Walgreens and CVS are likely to provide a boost to a new Food and Drug Administration (FDA) policy announced Tuesday that will allow retail pharmacies to dispense mifepristone from a certified prescriber if they meet certain criteria. 

    Until 2021, mifepristone could only be dispensed in person by a physician. The FDA temporarily lifted that requirement because of the COVID-19 pandemic, and the Biden administration made the change permanent in December 2021, paving the way for doctors to prescribe the drug digitally and then mail the pills to patients.