Monday Roundup

U.S. Healthcare

Monday Roundup

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

and

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.

Friday Factoids

David Ermer–CDC, COVID treatment, COVID-19, Mental health care, Patient safety, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Becker’s Hospital Review reports

The weekly rate of emergency department visits and hospitalizations for flu, COVID-19 and respiratory syncytial virus peaked in early December, new CDC data shows. 

The CDC unveiled two data dashboards Jan. 17 that track emergency department visits and hospitalizations for COVID-19, flu and RSV. 

ED visits for flu, RSV and COVID-19 peaked the week ending Dec. 3, hitting a weekly total of 235,850 before falling through December and the first half of January. The nation’s current weekly total was 72,119 as of Jan. 14, according to the ED dashboard. The dashboard uses information from the CDC’s National Syndromic Surveillance Program, which receives data from 73 percent of the nation’s EDs. 

The combined hospitalization rate for flu, RSV and COVID-19 peaked at 22.5 admissions per 100,000 in the week ending Dec. 3. This figure now sits at 9.4 per 100,000 for the week ending Jan. 7, though the CDC said reporting delays may affect the most recent week’s data.

RSV hospitalizations peaked in mid-November, while flu hospitalizations peaked in early December, CDC data shows. COVID-19 admissions also appear to be leveling off nationwide, even as the highly transmissible omicron subvariant XBB.1.5 gains prevalence. This trend suggests the U.S. will see more of a COVID-19 “bump” this winter versus a full-fledged surge, experts told The New York Times.

The CDC’s weekly interpretative review of its Covid stats focuses on these new dashboards this week. The agency’s weekly Fluview report informs us “Seasonal influenza activity continues to decline across the country.”

The Wall Street Journal adds

Three years after health authorities announced the first known Covid-19 case in the U.S., the virus behind the disease remains persistent but thus far hasn’t triggered the severity of the waves seen in prior winters.

A recent climb in hospitalizations and Covid-19 wastewater readings—two key metrics for spotting trends—appears to have stalled following the quick rise of the Omicron XBB.1.5 subvariant. The U.S. was gripped in significantly more deadly waves at this point in the last two winters, though currently there are still hundreds of deaths reported each day. * * *

At least for now, it appears unlikely new variants are going to cause as substantial illnesses and deaths as the virus did early on and in the prior winter waves, said Jay Varma, a physician and epidemiologist who directs Weill Cornell Medicine’s Center for Pandemic Prevention and Response in New York City. He cautioned that more severe mutations could still emerge. “We seem to have settled into somewhat of a detente with the virus,” he said.

Although the FEHBlog will continue to track Omicron and siblings developments, he has decided to replace Friday Stats and More with Friday Factoids.

Medscape tells us

Public health officials have said for some time that use of Paxlovid, approved under an FDA emergency use authorization (EUA) in December 2021, remains far below the proportion of Americans who could potentially benefit from the therapy.

What’s driving the lackluster uptake remains unknown, so Medscape Medical News took a deeper dive into the challenges surrounding Paxlovid prescribing.

Older Americans remain one of the groups at highest risk for COVID-19 adverse outcomes, including hospitalization and severe illness. However, the survey found that providers also remain reluctant to prescribe Paxlovid in this population for multiple reasons. * * *

The survey found that almost half of patients were on a medication that is contraindicated with Paxlovid and that could not be discontinued (44%). Another finding was that almost the same proportion were on a medication that is contraindicated with Paxlovid, but the risk of discontinuing that medication was too high (41%). Also, the researchers found some patients were on a medication that could interact with Paxlovid, but it was unclear how to manage the interaction (29%).

[Medscape medical editor in chief Dr. Eric Topol said that doctors, in some cases, may be overly concerned about the drug interactions. “There’s a straightforward workaround strategy for nearly all the drug interactions — most commonly statins — which can easily be stopped for 5 days,” he said.

Another concern preventing Paxlovid prescription is renal impairment, the survey reveals. More than one third of respondents, 37%, said they did not prescribe the protease inhibitor combination because of concerns over this condition, which can lower how efficiently medications are cleared by the body.

That’s a helpful study.

In other survey news, MedPage Today informs us

Fewer emergency department (ED) visits end with a prescription for opioids, CDC survey data showed.

The percentage of ED visits with an opioid prescribed at discharge fell from 12.2% in 2017-2018 to 8.1% in 2019-2020, reported Loredana Santo, MD, MPH, and Susan Schappert, MA, of the National Center for Health Statistics in Hyattsville, Maryland, in NCHS Data Briefopens in a new tab or window.

The rate of prescribing at discharge also dropped: in 2019-2020, opioids were prescribed at 36.4 ED visits per 1,000 adults, lower than 50.5 per 1,000 in 2017-2018. The decline was similar for both men and women.

In U.S. healthcare business news —

  • Cigna points out the value of integrated health plans a/k/a health plans without carveouts.

A study released today by Cigna (NYSE: CI), a global health service company, finds that triple integration of medical, pharmacy and behavioral benefits resulted in lower health care costs for employers. Conducted by Aon plcThis link will open in a new tab., a leading global professional services firm, the Value of Integration StudyThis link will open in a new tab. [PDF] shows that Cigna’s integrated employer clients saved $148 per member per year in 2021. 

Using a similar study method, Cigna then evaluated the financial impact of engaging employees to participate in health improvement programs, such as wellness coaching. The results show even greater client savings for Cigna integrated employer clients, exceeding $1,400 per member per year.

In addition, Cigna found that when individuals with specific high-cost conditions and therapies were enrolled in a triple-integrated health plan and needed specialty medicines, the savings for the health plan were:

  • Nearly $9,000 per member per year, increasing to more than $11,000 per member when the specialty drug is for an inflammatory condition like rheumatoid arthritis; and
  • Almost $17,500 per year for members who took specialty drugs and have a confirmed depression diagnosis.
  • Medpage Today reports, “Switching to [employer-sponsored] high-deductible health plans (HDHPs) spelled trouble when it came to diabetes complications, a retrospective cohort study found.” The report studies health savings account (HSA) – eligible HDHPs versus traditional low-deductible plans. The FEHBlog doesn’t understand why the HSAs don’t balance out the two types of coverage. The article doesn’t compute.
  • STAT News relates, “More than a dozen of the country’s large not-for-profit hospital systems descended on this year’s J.P. Morgan Healthcare Conference with a subtle but clear message for bankers and municipal investors: Higher costs in 2022 slowed them down, but they are adamant about increasing revenue by expanding their footprints and hiking prices.” Charming.
  • Fierce Healthcare calls our attention to

A new behavioral health solution launched this week aims to make it easier for insurers to connect members with tools that may benefit their mental health care.

Lucet represents the combination of New Directions Behavioral Health and Tridiuum and is a spinout from the Blues network, where its core product cut its teeth. Lucet’s Navigate & Connect platform harnesses a large team of care navigators with an advanced technology stack that allows insurers to better optimize care and access for members.

Shana Hoffman, president and CEO of Lucet, told Fierce Healthcare that the platform enables faster connections to appointments and helps cut through the noise on which solutions a plan may want to bring into the fold.

“What we’re bringing to the market is really an operating system platform for health plans that allows them to reliably connect members to care,” Hoffman said.

  • Health Affairs Forefront analyzes “The Fair Price For One-Time Treatments; How Can We Overcome Existing Market Price Distortions?” Check it out.

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.

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.

Monday Roundup

David Ermer–CMS, Congress, Electronic health records, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, the Wall Street Journal reports

House Republicans passed a rules package Monday dictating the terms of the next session of Congress, the first test for House Speaker Kevin McCarthy (R., Calif.) in keeping his raucous conference united.  

The rules package, a required step before moving on to legislation, is typically passed on the first day of a new Congress. But it was delayed by the GOP fight to elect a new speaker. Mr. McCarthy prevailed early Saturday morning on the 15th ballot over four days, after making a series of concessions to holdouts. 

The package passed 220 to 213, with all Democrats and one Republican, Rep. Tony Gonzales of Texas, opposing the measure. It is customary for the minority party to oppose the legislation. 

The package, which includes standard rules on decorum, also restores what is known as the motion to vacate the chair, a procedure that would allow one Republican member to ask for a vote to remove the speaker. It also outlines several Republican priorities around spending, such as banning consideration of any bill that has the net effect of increasing mandatory spending. 

The Journal adds

House Republican leaders chose Rep. Jason Smith (R., Mo.) to run the House Ways and Means Committee, giving him a prime perch to shape the party’s approach to tax, trade and health policy. 

As chairman, Mr. Smith will lead a committee with broad power over economic policy and healthcare that is poised to receive an influx of new Republican members.

From the other side of Capitol Hill, Healthcare Dive informs us

Longtime Congressman Sen. Bernie Sanders, I-Vt., is expected next month to take the helm of the Senate’s Health, Education, Labor and Pensions Committee, bringing the Medicare-for-All proponent center stage in one of the nation’s most broadly influential health policy forums.

The anticipated appointment comes after the current committee chair Sen. Patty Murray, D-Wash., announced that she was stepping down to head the Senate Committee on Appropriations. Sanders has been on the Senate’s Health, Education, Labor and Pensions Committee, or HELP, since 2007, but the chance to lead the committee will give Sanders sway on some of his most prominent healthcare policy positions.

High healthcare costs — including prescription drugs like insulin —nursing education and elder care are issues Sanders anticipates focusing on, calling the national healthcare system dysfunctional, unsustainable and disgraceful in a Jan. 1 video.

From the FEHB front —

OMB’s Office of Information and Regulatory Affairs (OIRA) posted the federal government’s fall 2022 regulatory agenda on January 4. Here are the three FEHB rulemakings:

  • OPM proposes to modify its FEHB enrollment regulations regarding the effective date of coverage. The regulatory changes would allow, at an employing agency’s discretion, FEHB Coverage to become effective upon a new employee’s start date if their election is received before that date. The regulatory changes would promote the recruitment of new Federal employees and align with the best practices of the private sector. Publication of the proposed rule is scheduled for March 2023.
  • OPM and the three other No Surprises Act regulators plan to release a proposed rule on the law’s complicated good faith estimate and advance explanation of benefits provisions in August 2023.
  • As previously noted in the FEHBlog, OPM has passed along its interim final rule to implement the Postal Service Health Benefits Program to OIRA for final regulatory review. The statutory deadline for promulgating the rule is April 6, 2023. OPM clearly will meet that deadline.
  • Here is the complete list of OPM rule-makings in process or recently completed.

The Government Accountability Office released a report titled “Federal Employees Health Benefits Program: Additional Monitoring Mechanisms and Fraud Risk Assessment Needed to Better Ensure Member Eligibility.” The report summary tells us

More than 8 million federal employees and their families receive health insurance benefits under the Federal Employees Health Benefits program.

In 2021, the Office of Personnel Management began requiring some new program enrollees to verify that their family members are eligible. But OPM doesn’t have a process to identify and remove ineligible family members who are already enrolled in the program. As a result, the program may be spending almost $1 billion per year on payments for ineligible members.

We recommended that OPM take steps to remove ineligible family members and assess fraud risks associated with ineligible program members.

In the middle of the last decade, OPM added an FEHB contract provision requiring carriers to share OPM’s expenses to arrange for a family member eligibility audit, which is a common practice among employers. This struck the FEHBlog as a proven approach to identifying ineligible family members. Why not give it a go?

The Centers for Medicare and Medicaid Services released updated guidance for its Section 111 reporting program, which applies to FEHB carriers and other employer-sponsored health plans.

From the public health front —

Medpage Today tells us

In contrast to previous recommendations, pediatricians and other pediatric healthcare providers are advised to provide “immediate, intensive obesity treatment to each patient” as soon as they receive a diagnosis, according to new guidance from the American Academy of Pediatrics (AAP).

The guidance, published in Pediatrics, marks the AAP’s first clinical practice guideline outlining evidence-based evaluation and treatment for children and adolescents with overweight (defined as a body mass index [BMI] at or above the 85th percentile and below the 95th percentile) or obesity (defined as a BMI at or above the 95th percentile), though the organization previously published recommendations on prevention and treatment in 2007.

“This is one of the most important messages that differentiates our current clinical practice guidelines from the prior recommendations, and that is to say 15 years of data have taught us that ‘watchful waiting’ only leads to greater increase in child BMI, accumulation of comorbidities, and more challenges in trying to reverse some of this,” author Sarah Armstrong, MD, co-director of the Duke Center for Childhood Obesity Research in Durham, North Carolina, told MedPage Today.

In a number of key action statements, the guideline authors state that pediatricians and other providers should refer children ages 6 years and older — and potentially those ages 2 to 5 years — with overweight or obesity to intensive health behavior and lifestyle treatment.

Additionally, healthcare providers should offer weight-loss pharmacotherapy, according to medication indications, risks, and benefits, as an adjunct to health behavior and lifestyle treatment to adolescents ages 12 and older, Armstrong and colleagues noted. They should also offer referrals for evaluation for metabolic and bariatric surgery to adolescents ages 13 and older with severe obesity (BMI ≥35 or 120% of the 95th percentile for age and sex, whichever is lower).

The Wall Street Journal reports

This flu season hit earlier and harder than those of the past couple of years, doctors say. The reason is likely because of the cyclical nature of the flu and the lifting of Covid precautions such as working from home, wearing masks and having smaller social gatherings, says Robert Frenck, a pediatrician in the division of infectious diseases at Cincinnati Children’s hospital in Ohio. 

We asked doctors what to expect this year if the influenza virus causes illness in your household.

Check out the Q&A.

Politico Pulse calls attention to the fact that

Doctors are frustrated that patients are getting test results before they can explain them, POLITICO’s Ben Leonard reports.

A recently implemented federal [information blocking] rule requires HHS to ensure that patients receive test results as soon as they become available, but doctors argue that they often need to add context and support to results before patients view them — even as technology has made the results easier to share.

The disagreement, with doctors on one side and HHS and patient advocates on the other, has raised a key question: How should patients get bad news, especially in the rapidly evolving world of telehealth?

Before this rule was in effect, a member of the FEHBlog’s family received an email on a Sunday morning suggesting that she log into the patient portal. She promptly did so and was faced with confusing test results. See Seinfeld. Can’t doctors give patients a choice at the time of portal registration to get the log on email or wait to hear the results from a medical professional in non-emergency circumstances?

From the U.S. healthcare business front —

STAT News tells us

Moderna disclosed Monday that it plans to price its Covid-19 vaccine at anywhere from $110 to $130 per dose when the company pivots from a focus on government contracts to commercial distribution efforts.

The timing was not offered, but the company is holding talks with hospitals, pharmacy chains and pharmacy benefit managers. In setting such a price, Moderna will pursue the same path as Pfizer, which last year also announced plans to charge $110 to $130 a dose this year for its own Covid-19 shot. The Moderna pricing was first reported by The Wall Street Journal and confirmed by a company spokesperson.

The 41st JP Morgan healthcare conference is being held this week in San Francisco. “Fierce Healthcare will be covering the day’s biggest news as it happens. Check back here for updates, and catch Fierce Biotech’s reporting here and Fierce Pharma’s reporting here.”

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.