Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

From Capitol Hill, Politico points out that

The Senate Finance Committee will hold a hearing Thursday on the impact PBMs — the pharmaceutical middlemen that negotiate drug discounts with drugmakers and design prescription drug benefits for health plans — have on the health system.

The House Energy and Commerce Health Subcommittee is also expected to look into how much value PBMs add as part of a broader discussion about fairness in the healthcare market, according to a memo shared with [Politico].

In related news, CMS “released several Prescription Drug Data Collection (RxDC) resources on the Registration for Technical Assistance Portal (REGTAP). To view the documents, click on the link next to each document title. You may already have the links in your bookmarks.”

This guidance applies to the 2022 RxDC report that health plans must submit by June 1, 2022. Health plans submitted the first RxDc report for the 2021 reporting year last January. The No Surprises Act calls for a standard June 1 submission date for the RxDC report for the previous reporting year.

CMS also announced that the public has sixty days (to May 26) to comment on the revised Reporting Instructions.

The FEHBlog recently discovered this CMS REGTAP portal. As you can see, this portal is not just for Medicare and Medicaid. The portal includes a link to get an email announcement when REGTAP changes. REGTAPs emails are handy and not overwhelming.

From the Rx coverage front —

STAT News adds an interesting perspective on last week’s Senate hearing on Moderna Covid vaccine pricing

What, [Chairman Bernie] Sanders asked [Moderna CEO Stephane Bancel], if instead of purchasing medicines after they had been developed at high prices, the government instead paid for companies’ research, enough to ensure they make a reasonable profit? Then, Sanders said, the medicines could be made available inexpensively to anyone who needed them.

Bancel, clearly baffled by what sounded a lot like the government seizing the means of pharmaceutical production, simply said it was impossible to evaluate such a plan without details.

As much as the plan sounds like socialism, in a world where substantial quantities of new medicines are purchased by government programs, Sanders’ idea is pretty close to the way defense companies work: The government pays them substantial amounts of money to develop jet fighters, satellites, and aircraft carriers. This system is certainly not cheap, but it represents an alternative to the way medicines are developed. * * *

Whether this is a good idea or not, it probably won’t happen. Because not only is Congress unlikely to fund a $200 billion-a-year effort to replace industry research on new medicines, it won’t fund a $20 billion effort to get the government in the game, either.

Beckers Hospital Review informs us

Walgreens and Village Medical have launched a new pilot program that helps patients manage new medications prescribed during their hospital stay. 

The program, launched as a pilot in Florida and Texas, helps Walgreens and Village Medical patients manage their new prescriptions and existing ones after they are discharged from a hospital, according to a March 23 release from Walgreens. 

The aim of the program is to improve patient outcomes and decrease costs associated with hospital readmissions.

From the substance use disorder front, STAT News reports

Public health workers will soon have a new tool at their disposal to thwart a spreading danger to users of illicit drugs: xylazine test strips.

The new testing kits will allow health departments, grassroots harm-reduction groups, and individual drug users to test substances for the presence of xylazine, a sedative often referred to as “tranq.”

The toxin is increasingly common in the U.S. illicit-drug supply — especially in the Philadelphia area, but increasingly in other cities, too. Xylazine, which is typically used as a sedative in veterinary settings, can cause people to stop breathing, and also often causes severe skin wounds when injected.

While helpful for public health workers, will drug users take the time to do both tests when the two potentially fatal drugs usually are combined? FEHBlog expects that a fentanyl and xylazine test strip will be on the market soon.

From the U.S. healthcare business front —

  • Hospitals strongly oppose MEDPAC’s recommendation that Medicare Part A make a low reimbursement increase for the new federal government fiscal year, while some healthcare economists support MEDPAC’s proposal.
  • Healthcare Dive tells us
    • “CVS plans to close its acquisition of home healthcare provider Signify Health on or around Wednesday, subject to certain conditions, the company announced Monday.
    • “CVS agreed to acquire Signify for $30.50 a share in cash in September in a transaction worth roughly $8 billion.
    • “That deal will close this week as long as CVS and Signify can meet or waive the remaining conditions in their merger agreement, according to CVS. A CVS spokesperson declined to share details on the remaining conditions.
  • Beckers Hospital Review notes that another well know CEO has ripped a page out of the Mark Cuban playbook.
    • Love.Life, a health and wellness company co-founded and run by former Whole Foods CEO John Mackey, acquired Plant Based TeleHealth, a telehealth service focusing on the prevention and reversal of chronic conditions.
    • “The company will rebrand as Love.Life Telehealth. The company offers virtual visits to patients with chronic conditions and promotes healthy behaviors, according to a March 21 Love.Life news release.
    • “Patients can sign up for half-hour appointments for $175 or hourlong appointments for $350.”
    • “Love.Life is about making lasting health and vitality achievable, and acquiring Plant Based TeleHealth accelerates our ability to help more people without geographic limitations,” Mr. Mackey said. “Appointments are available now, and we’re excited to offer telehealth services as part of the comprehensive medical offering available in our physical locations, which will begin opening in 2024.”

Monday Roundup

Photo by Sven Read on Unsplash

From the end of the public health emergency front –

CMS issued a comprehensive fact sheet titled “CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency.” Notwithstanding the title, the fact sheet includes sections on how the end of the PHE impacts

Private Health Insurance

Vaccines: Most forms of private health insurance must continue to cover COVID-19 vaccines furnished by an in-network health care provider without cost sharing. People with private health insurance may need to pay part of the cost if an out-of-network provider vaccinates them.

Testing: After the expected end of the PHE on May 11, 2023, mandatory coverage for over-the- counter and laboratory-based COVID-19 PCR and antigen tests will end, though coverage will vary depending on the health plan. If private insurance chooses to cover these items or services, there may be cost sharing, prior authorization, or other forms of medical management may be required.

Treatments: The transition forward from the PHE will not change how treatments are covered, and in cases where cost sharing and deductibles apply now, they will continue to apply.

Private Health Insurance and Telehealth

As is currently the case during the PHE, coverage for telehealth and other remote care services will vary by private insurance plan after the end of the PHE. When covered, private insurance may impose cost-sharing, prior authorization, or other forms of medical management on telehealth and other remote care services.

For additional information on your insurer’s approach to telehealth, contact your insurer’s customer service number located on the back of your insurance card.

Fierce Healthcare reports

Telehealth providers and advocates are balking at proposed telemedicine rules released by the Drug Enforcement Administration (DEA) late Friday. If made permanent, the rules would be a marked change from the suspension of the  Ryan Haight Online Pharmacy Consumer Protection Act, which propelled a telepsychiatry boom during the COVID-19 pandemic.

Under the proposed rule released by the DEA, developed in concert with the U.S. Department of Health and Human Services (HHS) and in coordination with the U.S. Department of Veterans Affairs, some medications would require an in-person doctor’s visit. Controlled substances including stimulants like Adderall and opioids such as oxycodone and buprenorphine used to treat opioid use disorder (OUD) would require at least one in-person visit.

The DEA created a 30 day public comment period for this proposed rule.

From the U.S. healthcare business front, STAT News tells us about this surprising twist

On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles. * * *

The company’s lawyers indicated in the bankruptcy hearing that Lucira was not able to find anyone willing to buy the company prior to the Chapter 11 filing. With the only authorized at-home flu test on the American market, it’s an open question whether the company’s continued operations will allow the company to survive or will entice another party to buy Lucira.

The FEHBlog’s guess is that drug manufacturers will be lined up at the bankruptcy courthouse door to place a bid on the company if allowed.

BioPharma Dive informs us

  • “Cancer drug developer Seagen is in early talks to be acquired by Pfizer, according to The Wall Street Journal, which cited people familiar with the situation. A deal still may not be reached, the Journal said.
  • “Last summer, the Journal reported Seagen, a Washington-based company currently worth more than $30 billion, was considering selling to Merck & Co. for upwards of $40 billion. But as Bloomberg would later report, the deal stalled out because of disagreements over price. Since then, Seagen has brought on a new CEO, the longtime Novartis executive David Epstein, who played an integral role in ramping up the Swiss pharmaceutical giant’s cancer drug division.
  • “Should Pfizer acquire Seagen, it would gain access to a slate of experimental medicines as well as four marketed products that, together, generated $2 billion in revenue last year. Pfizer recorded $100 billion in product revenue in 2022, but estimates sales from its COVID-19 vaccine and Paxlovid therapy will fall significantly in the coming months. It also expects to lose around $17 billion in annual revenue between 2025 and 2030 due to the expiration of key patents.”

From the Rx coverage front —

  • The Wall Street Journal fills us in on the side effects of the new semaglutide weight loss drugs. For example, “Semaglutide spurs weight loss by stimulating the release of insulin and lowering blood sugar. It also delays stomach emptying, which causes people to feel full quickly and stay sated for longer stretches. When a patient comes off the drug, their normal appetite returns. * * * “People who stopped taking semaglutide gained back, on average, two-thirds of the weight they lost within a year, according to a study published in August 2022 in the journal Diabetes, Obesity, and Metabolism.”
  • The Journal also reports that “Amyloid Gains Converts in Debate Over Alzheimer’s Treatments; Dispute has far-reaching consequences, including whether Medicare will pay for new anti-amyloid drugs [e.g., Aduhelm and Leqembi].” Nevertheless, “Dr. [David] Knopman [,a Mayo Clinic neurologist,] said that Leqembi’s success is only a partial vindication of the amyloid hypothesis, which in the minds of many doctors promised to stop Alzheimer’s in its tracks or even reverse certain symptoms.” 

From the mental health care front, David Leonhardt, the New York Times Morning columnist, “examines the raging debate about smartphones and teenage mental health.”

I called Lisa Damour last week and asked what advice she would give to parents. Damour is a psychologist who has written two best-selling books about girls and just published a new book, “The Emotional Lives of Teenagers.” She is no anti-technology zealot. She thinks social media can have benefits for teenagers, including connections with peers. But she also sees reason for concern.

Her first piece of advice is not to blame teenagers. They didn’t invent smartphones, and earlier generations would have used those phones in the same ways that today’s teens are.

Her second piece of advice might be summarized as: less. She believes teenagers should rarely have their phones in their bedrooms, especially not at night. A phone is too disruptive to sleep, and sleep is too important to mental health.

Parents can also introduce digital technology in stages, recognizing that a 13-year-old brain is different from a 17-year-old brain. For younger teens, Damour suggests a phone that can send and receive texts but does not have social media apps.

From the miscellany department –

  • Beckers Hospital Review provides details on the business model of One Medical, which became part of Amazon last week.
    • The company employs primary care providers across more than 125 clinics in 19 markets, according to its website. One Medical then partners with local hosptials and health systems to provide specialty care.
    • One Medical offers a subscription-based membership — for $199 a year (though Amazon is now offering a promotion for $144 annually) — that gives patients access to its digital health platform, with 24-7 access to virtual care and online appointment booking and prescription renewals. The company still bills those patients’ insurance for the visits.
  • Govexec reports “The federal employees appeals board is setting new precedents restricting when agencies can fire employees who were injured on the job, issuing new rulings on cases that languished for years while the agency was rendered partially incapacitated.”
  • The Wall Street Journal tells us “The White House said there is no consensus within the Biden administration over the origins of the Covid-19 virus, a day after the disclosure of an Energy Department assessment that the pandemic likely originated with a leak from a Chinese lab.” 

Strap Yourself In

Photo by Josh Mills on Unsplash

In the 1980s and 1990s, the Washington Post had a television critic named John Carmody who would warn readers at the beginning of his column to “strap yourselves into your breakfast nook” when he had big news. So strap yourselves in, and here goes. (The photo to the right is a rough approximation of a breakfast nook, a concept which has fallen out of style evidently.

Over the next 18 to 24 months, according to the Wall Street Journal, Humana will withdraw from the employer health benefits market to focus on the government health programs market.

Humana, which currently offers many FEHB HMO plans, placed the FEHB Program in the “bye-bye” employer health benefits market even though the employer is the federal government. The FEHBlog, and Congress for that matter, prefer to view the FEHB Program as part of the employer market.

In short, Humana could have justified staying in FEHB but chose not to do so. The decision is worth pondering, particularly if you have a long-term perspective.

In other U.S. healthcare business news —

  • Healthcare Dive reports on earnings announcements from telehealth vendors Teladoc and Amwell.
    • In related telehealth news, Forbes informs us about a “new survey out from Rock Health.”
      • “While 80% of respondents said they had used telemedicine, there were only two categories where a majority of people preferred telemedicine over in-person care: prescription refills and minor illnesses. More than 60% of people surveyed preferred in-person visits for mental health and chronic condition care, while more than 70% wanted an in-person annual wellness visit. The starkest divide was on physical therapy: 80% of people preferred in-person visits, while only 20% preferred telemedicine.”
  • Biopharma Dive reports on Moderna’s earnings announcement.
    • In other vaccine news, CNN tells us
      • “The independent vaccine advisers to the US Centers for Disease Control and Prevention voted unanimously Wednesday in favor of the two-dose Jynneos mpox vaccine for adults at risk of catching the disease during an outbreak.”
      • “If the CDC agrees with the committee’s recommendation, there will be a recommendation in place to give the vaccine to people who are at risk for mpox during future outbreaks.”
      • “Even as mpox cases continue to fall, the CDC is encouraging people who are at risk to get vaccinated.”

From the preventive services front —

  • The U.S. Preventive Services Task Force issued for public comment a draft research plan regarding preventive interventions for perinatal depression. The public comment deadline is March 22, 2023.
  • The Mercer consulting firm offers useful observations on how employers and health plans can optimize their investments in preventive care.

From the Rx coverage front, Beckers Hospital Review tells us that the Centers for Medicare and Medicaid Services will not change its Medicare coverage policy on Aduhelm, an Alzheimer’s Disease treatment, based on the recent FDA approval of Leqembi.

CMS said in April 2022 that it would limit Aduhelm coverage to clinical trials only, which partly blocked the drugmaker’s efforts to sell the drug it once deemed a blockbuster. Leqembi will be subject to the same coverage plan. 

“We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable,” CMS said in a Feb. 22 statement. “After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration.”

If “any new evidence” becomes available or an amyloid-targeting Alzheimer’s drug receives traditional approval, CMS said it may reconsider its coverage decision.  

As readers know, CMS’s Medicare coverage decision on these drugs effectively controls the market for these drugs.

From the miscellany department

  • Affordable Care Act FAQ 57 was issued yesterday. This FAQ concerns implementation guidance for the No Surprise Act’s anti-gag clause provision.
  • FedSmith identifies five milestones toward federal retirement.
  • Kaiser Family Foundation has created federal and state litigation trackers regarding reproductive rights.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the U.S. healthcare business front, the Wall Street Journal reports Inc. will be able to close its purchase of 1Life Healthcare Inc., the operator of the One Medical line of primary-care clinics, without a legal challenge by antitrust enforcers.

The Federal Trade Commission won’t sue in time to block the $3.9 billion deal, including debt, but will continue its investigation of the merger, an agency spokesman said. The decision clears a path for Amazon to substantially expand its healthcare offerings and operate physical medical clinics. Amazon has invested in the healthcare space for years, including with an online pharmacy and other health ventures.

“The FTC’s investigation of Amazon’s acquisition of One Medical continues,” FTC spokesman Douglas Farrar said. “The commission will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.”

Becker’s Hospital Review offers two articles on Mark Cuban’s Cost Plus Drug Co.

  • In one article, BHR observes
    • As news outlets, celebrities, swingers on Reddit and people on Twitter praise Cost Plus Drug for its low prices on hundreds of generics, some of its products are more expensive than options at local pharmacies, KHN reported using GoodRx data. 
    • For example, one presentation of amoxicillin-clavulanate, an antibiotic currently in shortage, is $267.60 at Cost Plus Drug Co. and $109.44 at the average community pharmacy. 
    • Mr. Cuban told the outlet that its analysis was not comprehensive because of the company’s pricing model, which is a 15 percent markup, $3 for labor per drug and $5 for shipping. Because the shipping cost is overall and not for each medication, Mr. Cuban said his pharmacy can still offer a cheaper sale. 
  • In the other article, BHR informs us that the Cost Plus Drug Co., which already has business arrangements with three prescription drug managers, is contacting independent pharmacies for business.

From the public health front, February is Low Vision Awareness Month.

  • The BrightFocus Foundation proclaimed
    • Global vision and brain research non-profit BrightFocus Foundation celebrates the U.S. Food and Drug Administration’s (FDA) approval of Syfovre (pegcetacoplan injection), the first-ever treatment to slow the progression of vision loss from geographic atrophy, an advanced form of dry age-related macular degeneration and a leading cause of blindness. 
    • “Today’s FDA approval of Syfovre provides hope to the more than five million people worldwide who are at risk of permanent vision loss from geographic atrophy,” said BrightFocus President and CEO Stacy Pagos Haller. “This first-of-its-kind treatment is a momentous step forward in vision research and will make a meaningful difference in the lives of millions of people.” 
    • An estimated one million people in the U.S. have geographic atrophy, an advanced and severe form of age-related macular degeneration in which regions of cells in the retina waste away and die (atrophy). This progressive and irreversible disease can lead to permanent vision loss. Nearly 20 million adults in the U.S. have some form of age-related macular degeneration (AMD), almost double the previous estimate of 11 million people, according to a new report.    
    • People living with geographic atrophy often experience emotional hardships including anxiety, feeling powerless, and frustration. Approximately one in three have recently withdrawn from their social lives because of their disease, and BrightFocus offers a free AMD community group and educational audio chats for affected individuals.
    • Syfovre is expected to be available by the beginning of March through select specialty distributors and specialty pharmacies nationwide.

The New York Times Morning column criticizes the public health system for undertreating people with opioid use disorder, obesity and mental health issues, among other problems.

Similarly, HHS’s Agency for Healthcare Research and Quality calls attention to the underuse of cardiac rehabilitation in our country.

From the Rx coverage front —

  • BioPharma Dive explains that while the last decade’s lapse of patents impacted blockbuster small-molecule drugs, this decade’s lapse impacts specialty drugs such as Humira and Keytruda. Time will tell whether patients will convert to biosimilar drugs as quickly as they converted to generic drugs when patents lapse.
  • STAT News reports on “A battle between Vertex and insurers [over copay assistance accumulators] is leaving cystic fibrosis patients with crushing drug costs. Copay assistance accumulators prevent co-pay assistance from accumulating toward the plan’s out-of-pocket payments maximum required by the Affordable Care Act.
  • The Institute for Clinical and Economic Research related a final evidence report on treatments for multiple sclerosis.

From the medical research front, STAT News reports

An experimental antibody that delivers lethal radiation directly to the bone marrow improved the outcomes of stem cell transplants for older patients with relapsed leukemia — and may change the way transplant medicine is practiced.

The antibody-radiation treatment, called Iomab-B, is being developed by Actinium Pharmaceuticals, a small drugmaker based in New York.

In the results of a Phase 3 clinical trial presented Saturday, 22% of patients with acute myeloid leukemia who were administered Iomab-B to prepare their bone marrow for transplants had durable remissions lasting six months or more. None of the patients in the study who received conventional care prior to transplant achieved durable remissions.


From the miscellany / tidbits department

  • The U.S. Preventive Services Task Force proposes to renew the following Grade A recommendation:
    • The USPSTF recommends that all persons planning to or who could become pregnant take a daily supplement containing 0.4 to 0.8 mg (400 to 800 μg) of folic acid.
    • The public comment period on this renewal is open until March 20, 2023/
  • Beckers Payer Issues reports
    • Anthem BCBS ColoradoIndianaMissouri and Nevada are rolling out virtual primary care to more members.
    • Eligible commercial members will gain access to a virtual care team that conducts an initial health screening, creates a personalized care plan, and then provides care services, according to a Feb. 7 news release.
    • The virtual care services will take place through Anthem’s app, Sydney Health. The app offers 24/7 medical text chat, preventive wellness visits, support services, including new prescriptions and refills, and in-network referrals.
    • Virtual primary care is now available to eligible individuals enrolled in Anthem’s fully insured plans and certain large group administrative services clients.

Tuesday Tidbits

Photo by Laura Ockel on Unsplash

From the Omicron and siblings front, HealthDay tells us

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

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

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

From the public health front —

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

From the healthcare quality front

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

From the Medicare front —

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

In hospital pricing transparency news —

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

From the HR department

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

From the tidbits department

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

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Capitol Hill, STAT News reports

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

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

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

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

From the Omicron and siblings front —

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

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

MedPage Today informs us,

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

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

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

From the miscellany department —

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

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

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

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

The International Foundation of Employee Benefit Plans tells us,

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

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

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

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

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

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

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

Happy Groundhog Day

The Hill reflects on the history of Groundhog Day. By the way, “on Thursday, Punxsutawney Phil predicted six more weeks of winter.”

Each year on the first Friday in February, [February 3, 2023], the National Heart, Lung, and Blood Institute, The Heart Truth® and others around the country celebrate National Wear Red Day® to bring greater attention to heart disease as a leading cause of death for Americans and steps people can take to protect their heart. Promote Wear Red Day in your community with resources such as printable stickers, posters, and social media graphics, including customizable ones.

From Capitol Hill, Roll Call tells us that “Senate committees will be able to get to work next week after the Senate adopted resolutions constituting their membership for the 118th Congress before departing Thursday afternoon.”

STAT News interviews the Chair and Ranking Member of the Senate’s Health, Education, Labor and Pensions Committee, Senators Bernie Sanders and Bill Cassidy respectively.

Both senators cited addressing the national shortage of nurses as high on the bipartisan to-do list. The chairman also said he thinks expanding community health centers and improving dental coverage could get both parties’ buy-ins, while Cassidy pointed to mental health care legislation and probing the rollout of efforts to eliminate patients’ surprise medical bills.

Unsurprisingly, however, Sanders’ top priority is slashing drug costs — and he’s banking on voter polling to push GOP members, or at least put them in an uncomfortable spot with constituents. 

From the Medicare front, Health Payer Intelligence provides an overview of reactions to yesterday’s CMS 2024 Medicare Advantage Advance Notice with changes for Medicare Advantage plans and Medicare Part D.

The Kaiser Family Foundation offers a detailed study of prior authorization requests for Medicare Advantage enrollees in 2021. Adverse decisions on prior authorization requests. The number of requests varied by Medicare Advantage carrier. Six percent of all prior authorizations were partially or entirely denied. 11% of prior authorization requests were appealed, and 82% of appeals were decided in the Medicare Advantage enrollee’s favor. What an interesting batch of percentages.

From the U.S. healthcare business front, BioPharma Dive reports

Sales of Eli Lilly’s new diabetes drug Mounjaro grew strongly in the final quarter of 2022, the company reported Thursday, challenging the market position of competing medicines from rival Novo Nordisk. 

Fourth quarter sales totaled $279 million, bringing the total for 2022 to $483 million following the drug’s June launch. The fast sales put Mounjaro, approved to improve blood sugar control in people with Type 2 diabetes, on pace to quickly reach blockbuster status. Studies have shown the drug to have a powerful weight-loss effect as well, supporting Lilly’s current efforts to expand the drug’s approval to include obesity treatment.  * * *

On an earnings call Thursday, Lilly executives said the company is having trouble keeping Mounjaro production high enough to match patient demand. More manufacturing capacity is being added, with a site in North Carolina expected to start production sometime later this year, CFO Anat Ashkenazi said on the call.

Russ Roberts spoke with Dr. Vinay Prasad on this week’s Econtalk episode. The topic is “Pharmaceuticals, the FDA, and the Death of Duty.” During the episode, Dr. Prasad identified Dr. Bernard Fisher as one of his heroes. Dr. Fisher passed away in 2019 at age 101. I had never heard of Dr. Fisher, but his story should be shared.

Healthcare Dive informs us.

Healthcare consumers appear to be increasingly comfortable switching providers when their current one isn’t meeting their needs, according to a report from Accenture. About 30% of patients selected a new provider in 2021 — up from 26% in 2017, the report found. A quarter switched providers in 2021 because they were unhappy with their care — up from 18% in 2017. Switching providers is especially true among younger generations, like Gen Zers and millennials, who were six times more likely to switch providers than older people, according to the report.

From the miscellany department —

  • Health Affairs Forefront delves into the data produced to date by the government’s payer transparency rules.
  • Fierce Healthcare tells us about a recent expansion of CVS Health’s virtual primary care service.
  • Benefit consultant Tammy Flanagan writing in Govexec, follows the path of a federal employee’s retirement application.

Monday Roundup

Photo by Sven Read on Unsplash

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

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

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

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

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

Makes sense to the FEHBlog.

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

From the U.S. healthcare business front —

Fierce Healthcare informs us

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

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

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


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

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

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

Fierce Healthcare points out a twist in the second story.

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

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

This background information can fill knowledge gaps for employers too.

From the Rx coverage front —

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

Final Evidence Report on Fezolinetant for Vasomotor Symptoms Associated with Menopause

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

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

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

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

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

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

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

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

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

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

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

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

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

Thursday Miscellany

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.

Tuesday’s Tidbits

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.