Tuesday’s Tidbits

U.S. Healthcare

Tuesday’s Tidbits

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Healthcare Dive tells us

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

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

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

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

From the Food and Drug Administration front —

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

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

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

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

  • Beckers Hospital Review informs us,

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

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

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

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

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

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

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

From the U.S. Healthcare business front —

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

From the medical and pharmaceutical research and studies front —

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

Monday Roundup

David Ermer–Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

As a loyal Wall Street Journal subscriber, I was invited to attend the Wall Street Journal’s Health Forum today gratis. I did so virtually.

Journal reports interviewed health experts, such as Chelsea Clinton and Food and Drug Commissioner Dr. Robert Califf, as well as the chief executive officers of Moderna, Biogen, One Medical, and Mass General Brigham, among others

One session concerned aging. A reporter interviewed three experts, who argued among themselves. Death and taxes, right?

The FEHBlog enjoyed the opportunity to listen to the Health Forum. He continues to think that FEHBP plans who don’t try to connect their members with in-network primary care providers are missing the boat.

Also, from the public health front, the Washington Post reports

Diabetes and obesity are rising among young adults in the United States, an alarming development that puts them at higher risk for heart disease, according to a study of 13,000 people between 20 and 44 years old.

The authors of the study, published Sunday in a major medical journal, warn the trends could have major public health implications: a rising generation dying prematurely of heart attacks, strokes and other complications. And Black and Hispanic people, particularly Mexican Americans, would bear the brunt.

“We’re witnessing a smoldering public health crisis,” Rishi K. Wadhera, assistant professor of medicine at Harvard Medical School and one of the study authors, wrote in an email.

The Wall Street Journal adds

WW International Inc., known as WeightWatchers, is buying digital health company Sequence, marking the diet company’s move into the hot market for diabetes and obesity drugs including Ozempic and Wegovy.

Sequence is a subscription service that offers telehealth visits with doctors who can prescribe the drugs. WeightWatchers, which has long promised to help customers lose weight through food-tracking and lifestyle changes, is moving to also offer customers a medical weight-loss approach. 

STAT News notes

The obesity revolution is just getting started. Long framed as a failure of willpower and the price of poor lifestyle decisions, obesity is now more often viewed as a biological disease — one that new drugs can treat. But as people clamor for Ozempic and Mounjaro, conceived to treat diabetes, concern is rising that in the rush to prescribe them, the root causes of obesity may be overlooked, including environmental factors. And eating-disorder experts worry people’s body images could be further stigmatized.

This is a moment reminiscent of other pharma turning points, such as when Valium and Prozac changed how people perceived anxiety and depression. But both the social media buzz and pharma’s marketing — including attempts to shape medical school curricula, STAT has learned — raise fears that treating obesity could be taken too far, draining health care dollars along the way. Read more from STAT’s Elaine Chen and Matthew Herper in the first of a series. 

and

Lilly decided to reduce its insulin prices to avoid Inflation Reduction Act penalties.

Eli Lilly would’ve had to pay Medicaid about $150 for each vial of insulin used in the program if it hadn’t dramatically cut the list prices for some of its older products this week.

The company was about to run into a Medicaid penalty for hiking the price of its drugs faster than the rate of inflation. Now that it plans to lower the list price of the insulin Humalog 70%, it won’t trigger that penalty. Lilly also is lowering the price of Lispro, a biosimilar of Humalog, to $25 a vial.

In other Rx coverage news, USA Today tells us

More than a quarter of Americans over 40 take medications to lower their cholesterol, most of them statins. But not everyone can tolerate statins or wants to. 

Now a new study confirms that bempedoic acid, approved in 2020, not only lowers cholesterol but also reduces the risk for heart attack and stroke.

Statins will remain the first therapy patients are given to lower cholesterol. But the news means more people will likely be prescribed a once-daily pill of bempedoic acid.

Bempedoic acid is sold under the brand name Nexletol from Esperion Therapeutics of Ann Arbor, Michigan. It is sold with another drug, ezetimibe as Nexlizet.

From the U.S. healthcare business front, Healthcare Dive informs us

  • Transcarent, a healthcare platform for self-insured employers, has agreed to acquire the majority of on-demand virtual care platform 98point6, including its almost 100-clinician physician group, in a deal worth up to $100 million.
  • Transcarent will get 98point6’s self-insured employer business, affiliated physician group and a software license, while the remaining 98point6 will rebrand as 98point6 Technologies and focus on licensing its software to third-party providers.
  • Seattle-based 98point6 bills itself as an artificial intelligence-enabled chatbot that collects patient information and summarizes it for a physician, who continues the conversation. The transaction is expected to close by the end of March.

Friday Factoids

David Ermer–COVID-19, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Here are links to the CDC’s Covid Data Tracker and its last weekly interpretative review of those statistics. From now until the interpretative review ends, the interpretative review will be offered every other week, except when that Friday is the beginning of a federal three-day weekend. Good timing for this change because we just started the three-day weekend drought, which ends with Memorial Day.

The summary notes, “At this point in the pandemic, COVID-19 cases, hospitalizations, and deaths have been decreasing for several weeks, and much of the country has protection against circulating strains either through vaccination, previous infection, or a combination of both.” Nevertheless, the CDC urges folks to be vaccinated or stay current on vaccinations because the virus can change.

The CDC’s Fluview says, “Seasonal influenza activity remains low nationally.”

From the Rx coverage, Ed Silverman writing in STAT News comments

Now that Eli Lilly slashed the price for some of its insulin products, the moves raised questions about what will happen to other efforts to provide low-cost insulin, Kaiser Health News explains. Civica, a nonprofit, plans to begin selling biosimilar insulin for roughly $30 per vial by 2024 — $5 more than the new price of Lilly’s generic insulin. And the Mark Cuban Cost Plus Drug Co. plans to sell low-cost insulin. But drug pricing experts predict Lilly’s moves will not undercut those efforts. And these other initiatives to bring lower-cost insulin to market, in turn, would put pressure on Lilly to keep its prices down.

The FEHBlog agrees with these comments. Cost curve down.

From the U.S. healthcare business front, Healthcare Dive informs us

  • VillageMD, the clinical network majority owned by Walgreens, has acquired a medical group in Connecticut that operates more than 30 locations across the state.
  • On Friday, VillageMD said it snapped up Starling Physicians, which operates primary care and multi-specialty practices, for an undisclosed sum.
  • The acquisition expands VillageMD to more than 700 medical centers, as Walgreens continues to invest in expanding its clinical footprint.

Tammy Flanagan, writing in Govexec, points out irrevocable benefits decisions, e.g., FEHBP, that a federal or postal employee must make at the time they decide to take a CSRS or FERS retirement

Thursday Miscellany

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

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

From the public health front —

The Wall Street Journal informs us

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

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

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

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

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

From the medical device front —

MedTech Dive tells us

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

and

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

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

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

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

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

From the U.S. healthcare business front —

Healthcare Dive relates

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

and

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

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

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

STAT News reports

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

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

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

Healthcare Dive adds

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

Call Letter Released

David Ermer–Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

On Tuesday, March 1, OPM issued its call letter for 2024 FEHB Program benefit and rate proposals. The benefit and rate proposal submission deadline is May 31, 2023. For sports fans, the call letter issuance is akin to the beginning of the NFL’s League Year. The only difference is that the FEHB Programs year begins sometime in the first quarter, while the NFL’s League Year begins on March 15.

The next step is for OPM to issue its technical guidance, which allows the carrier to begin drafting its benefit and rate proposal. The technical guidance comes out two or three weeks after the call letter. ,The sooner the better for carriers.

Happily, OPM moved its FEHB carrier conference from late April to late March, which better coincides with the call letter and technical guidance release. The carrier conference was moved from late March to late April in the pandemic years of 2021 and 2022.

The FEHBlog is pleased with the call letter’s substance. OPM called for assisted reproductive coverage across the FE. Asam, and as previously mentioned, OPM provided guidance on implementing the agency’s January 2023 decision to allow carriers to offer Part D EGWPs for 2024. Part D EGWPs allow carriers to integrate their prescription drug benefits with Medicare Part D for Medicare Part A only and Medicare Parts A and B annuitant members. Sweet.

The other big news for today, according to Forbes, is that

Pharmaceutical giant Eli Lilly announced Wednesday that it’s reducing prices of its most commonly prescribed insulin products by 70% and capping out-of-pocket costs for patients to $35 per month. The company has taken heat in recent years over the pricing of the life-saving drug for diabetics and the move follows action by Congress to reduce the cost of insulin for Medicare patients in the Inflation Reduction Act.

Eli Lilly’s website adds

People who rely on insulin to manage diabetes care deserve affordable access, but systemic barriers stand in the way. Through significant investments in research and solutions that offer more affordable options, we’re working to help. 

In 2020, we launched the Lilly Insulin Value Program—allowing anyone eligible to purchase their monthly prescription of Lilly insulin for $35 or less. Now, we’re announcing updates that make accessing $35-a-month Lilly insulin even easier, including:

  • An automatic $35 max out-of-pocket monthly cost for people with commercial insurance at the majority of retail pharmacies 
  • An easy-to-download savings card that provides a $35 max out-of-pocket monthly cost for people who are uninsured or need to use a non-participating retail pharmacy 

Those who need a savings card can visit our Insulin Value Program site, answer two questions, and immediately download it. The only exclusions to this $35 Lilly insulin solution are people enrolled in federal government insurance programs. Federal law provides that Medicare Part D beneficiaries also pay no more than $35 per month for insulin.

Beyond the changes listed above, we’ve also made significant price reductions to our branded and non-branded insulins.

The exclusion for federal government insurance programs stems from the federal health programs anti-kickback act, which does not include the FEHB Program because it is an employer-sponsored program. The Lilly site does not include the FEHB Program in its nonexclusive list of those government insurance programs — “Medicaid, Medicare, Medicare Part D, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any State Patient or Pharmaceutical Assistance Program.” OPM does allow members to receive patient assistance for drug coverage as discussed in the call letters discussion of copay accumulator and maximizer programs.

STAT News offers more details on this development.

In other Rx coverage news —

  • Becker’s Hospital Review discusses a manufacturing issue causing a shortage in the asthma inhaler drug, albuterol.
  • The Institute for Clinical and Economic Research published an “Evidence Report on Lecanemab [Brand Name Leqembi] for Alzheimer’s Disease. ”
    • Currently available evidence is rated as promising but inconclusive to determine whether lecanemab provides a net health benefit over supportive care; the evidence suggests the drug would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —
    • At the March 17 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate over the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money
  • Eisai charges $26,000 per month for this drug with FDA approval, while its Medicare coverage is limited to clinical trials.

House Republicans have launched an investigation into the companies that manage drug benefits, dialing up the scrutiny of the middlemen who play an important role in how much medicines cost.

The House Oversight and Accountability Committee said Wednesday that it has sent letters to CVS Health Corp.’s CVS Caremark, Cigna Group’s Express Scripts and UnitedHealth Group Inc.’s OptumRx—the largest pharmacy-benefit managers—seeking documents about the drug-price rebates they negotiate and fees they charge.

The committee also said it has sent requests to the Centers for Medicare and Medicaid Services and other federal agencies asking for their contracts with the PBMs.

“Greater transparency in the PBM industry is vital to determine the impact that their tactics are having on patients, the pharmaceutical market and healthcare programs administered by the federal government,” said Rep. James Comer (R-Ky.), who chairs the oversight committee.

The committee is especially interested in how PBMs affect drug costs overall and the prices patients pay at the pharmacy counter and in their health-insurance premiums in particular, according to a committee staffer.

From the artificial intelligence front, Forbes informs us

Every week, Eli Gelfand, chief of general cardiology at Beth Israel Deaconess Medical Center in Boston, wastes a lot of time on letters he doesn’t want to write — all of them to insurers disputing his recommendations. A new drug for a heart failure patient. A CAT scan for a patient with chest pain. A new drug for a patient with stiff heart syndrome. “We’re talking about appeal letters for things that are life-saving,” says Gelfand, who is also an assistant professor at Harvard Medical School.

So when OpenAI’s ChatGPT began making headlines for generally coherent artificial intelligence-generated text, Gelfand saw an opportunity to save some time. He fed the bot some basic information about a diagnosis and the medications he’d prescribed (leaving out the patient’s name) and asked it to write an appeal letter with references to scientific papers.

ChatGPT gave him a viable letter — the first of many. And while the references may sometimes be wrong, Gelfand told Forbes the letters require “minimal editing.” Crucially, they have cut the time he spends writing them down to a minute on average. And they work. * * *

The fax machine isn’t going away anytime soon, says Nate Gross, cofounder and chief strategy officer of Doximity, a San Francisco-based social networking platform used by two million doctors and other healthcare professionals in the U.S. That’s why Doximity’s new workflow tool, DocsGPT, a chatbot that helps doctors write a wide range of letters and certificates, is connected to its online faxing tool.

“Our design thesis is to make it as easy as possible for doctors to interface with the novel digital standards, but also be backwards compatible with all the old stuff that healthcare actually runs on,” says Gross.

Often referred to as a “LinkedIn For Doctors,” Doximity has a $6.3 billion market cap and generates most of its revenue ($344 million in its fiscal year 2022) from pharma companies looking to advertise and health systems looking to hire. But it also offers a range of tools for doctors to help “cut through the scut” – medical slang for reducing administrative burden. The basic versions are generally free with upsells for enterprise integrations, says Gross.

Health plans use form letters too.

Monday Roundup

David Ermer–CMS, COVID-19, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
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.” 

Friday Factoids

David Ermer–CDC, COVID-19, Electronic health records, FDA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Errata — In Thursday’s post, the FEHBlog’s item on the CDC action concerning Alzheimer’s Drug coverage in Medicare should say that the CDC was NOT changing its position that such coverage is limited to clinical trials.

From the No Surprises Act front, U.S. District Judge Jeremy Kernodle modified the NSA’s independent dispute resolution (IDR) arbitration rule on February 6 so it does not skew in favor of the statutory qualifying payment amount. The FEHBlog personally marked up the relevant portion of the IDR rule to show the edits. The FEHBlog, who represents health plans, does not find the edits earthshaking.

The NSA regulators sensibly told the NSA arbitration community to stop issuing arbitration awards while considering the next steps. This afternoon, the American Hospital Association tells us that an interim step was announced.

Effective Feb. 27, certified independent dispute resolution entities will resume issuing payment determinations for payment disputes involving out-of-network services and items furnished before Oct. 25, 2022, the Centers for Medicare & Medicaid Services announced. CMS has posted guidance for certified IDRs issuing payment determinations for items and services furnished before Oct. 25, 2022.
 
“The standards governing a certified IDR entity’s consideration of information when making payment determinations in these disputes are provided in the October 2021 interim final rules, as revised by the [February 2022] opinions and orders of the U.S. District Court for the Eastern District of Texas ” CMS said. [This refers to the FEHBlog’s edited portion of the IDR rule without the Judge’s Feburary 6, 2023 edits.]
 
The agency said IDRs will hold issuance of payment determinations for items or services furnished on or after Oct. 25, 2022 until the departments of Health and Human Services, Labor,The and the Treasury issue further guidance.
 

There you go.

From the public health front, the CDC’s Covid Data Tracker new cases, hospitalizations, and deaths continue their downward trend, while the CDC’s weekly interpretative review of its Covid data notes that “As of February 23, 2023, there are 67 (2.1%) counties, districts, or territories with a high COVID-19 Community Level, 655 (20.3%) with a medium Community Level, and 2,498 (77.6%) with a low Community Level [of the disease].

Sign of the times — the CDC Weekly Review is moving to a bi-weekly schedule.

The CDC’s FluView, which will shut down at the traditional end of the flu season, reports, “Seasonal flu activity is low nationally.”

Meanwhile, the Food and Drug Administration announced issuing

an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes. 

In other public health news

  • Healio informs us
    • People with many low-risk sleep factors had reduced all-cause, CV and cancer mortality risk vs. those with one or no low-risk sleep factors, according to data slated for presentation at the American College of Cardiology Scientific Session.
    • “We saw a clear dose-response relationship, so the more beneficial factors someone has in terms of having higher quality of sleep, they also have a stepwise lowering of all cause and cardiovascular mortality,” Frank Qian, MD, an internal medicine resident physician at Beth Israel Deaconess Medical Center and a clinical fellow in medicine at Harvard Medical School, said in a press release. “These findings emphasize that just getting enough hours of sleep isn’t sufficient. You really have to have restful sleep and not have much trouble falling and staying asleep.”
  • The Washington Post reports
    • One in five Americans will experience major depressive disorder in their lifetime, and many will not find relief from current therapies. But now researchers have identified an unexpected source of the problem: inflammation.
    • Inflammation in the body may be triggering or exacerbating depression in the brains of some patients. And clinical trial data suggests that targeting and treating the inflammation may be a way to provide more-precise care.
    • The findings have the potential to revolutionize medical care for depression, an often intractable illness that doesn’t always respond to conventional drug treatments. While current drug treatments target certain neurotransmitters, the new research suggests that in some patients, depressive behaviors may be fueled by the inflammatory process.
  • The Powerline Blog shares eye-catching charts on the U.S. population’s gray wave.

From the wearables front —

  • mHealth Intelligence relates
    • In 2023, about 40 percent of U.S. adults are using healthcare-related applications, and 35 percent are using wearable healthcare devices, a new survey shows.
    • Released by Morning Consult, the survey polled 2,201 adults between Jan. 23 and Jan. 25. The results were compared to a previous Morning Consult poll conducted in December 2018 among 2,201 adults.
    • The 2023 survey shows gains in health app and wearables use. While health app use jumped 6 percentage points from 2018, wearables use increased by 8 percentage points.
    • Health app and wearables use varied across age groups, according to the survey. Forty-seven percent and 40 percent of respondents aged 18 to 34 used health apps and wearables, respectively, compared to 30 percent and 25 percent of adults over 65.
    • Of those who said they used health apps and wearables, most use them daily.
  • Bloomberg adds that “Apple Makes Major Progress on No-Prick Blood Glucose Tracking for Its Watch.” Completion of the moonshot project remains “years away.”

From the miscellany department

  • Beckers Hospital Review relies on the Harvard Business Review to identify “four measures needed to create shoppable healthcare beyond price transparency.”

Strap Yourself In

David Ermer–FDA, Federal employment benefits, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
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.

Midweek Update

David Ermer–CMS, COVID treatment, FDA, Medicare, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Affordable Care Act front, the WTW consulting firm informs us

Group health plans and health insurance issuers will not be required to submit certain information on air ambulance services by March 31, 2023 (the deadline included in an example in the proposed regulations). The Centers for Medicare & Medicaid Services has informally confirmed that since final regulations have not yet been issued, no reporting is required in 2023.

Also following up on recent posts, Healthcare Dive tells us that

Amazon completed its $3.9 billion acquisition of primary care chain One Medical on Wednesday, significantly increasing its healthcare offerings with the addition of physical medical clinics.

and

UnitedHealth has closed its $5.4 billion acquisition of home health business LHC Group, continuing a trend of payers elbowing into direct care delivery.

In other U.S. healthcare business news, Forbes points out that

Aledade, a startup that helps primary care doctors enter into value-based contracts with insurers, has acquired artificial intelligence software company Curia. The acquisition follows a pilot program, where Aledade used Curia’s predictive algorithms to identify 8,000 patients to get them enrolled in a special end-of-life care program. 

In a bit of good regulatory news for the FEHB Program, the CMS has delayed for up to one year final rulemaking on a civil monetary penalty rule for Medicare secondary payer violations. The proposed rule issued in Feburary 2020 treated FEHB plans and other group health plans inequitably as compared to non-group health plans, including trial lawyers. The FEHBlog is glad that CMS is trying to create a fair rule.

In other regulatory news, the Food and Drug Administration announced filing civil monetary penalty complaints against four e-cigarette manufacturers.

From the medical research front, MedPage Today reports

Patients with mild to moderate COVID-19 treated with the oral antiviral ensitrelvir within 5 days of symptom onset saw their symptoms resolve a day earlier, according to data from a phase II/III randomized trial.

Median time to symptom resolution was 24.3 hours earlier for patients treated with 125-mg ensitrelvir compared with those receiving placebo (P=0.04), reported Takeki Uehara, PhD, senior vice president of drug development and regulatory science at Shionogi and Co. in Osaka, Japan, during the Conference on Retroviruses and Opportunistic Infections. * * *

Ensitrelvir is a novel 3C-like protease inhibitor that targets the SARS-CoV-2 virus. “Because of its mode of action, ensitrelvir maintains antiviral activities across various different types of variants, including recently circulating Omicron variants,” Uehara said.

Of note, follow-up of patients continued out to 3 months and 6 months to evaluate the drug’s effectiveness on long COVID.

and

An important new study came out last week in the New England Journal of Medicine (NEJM), which found that a candidate vaccine against RSV was highly effective in preventing lower respiratory tract (read: lung) disease [in adults]. The study also found the vaccine prevented severe disease.

The study has many of the features you want to see from a well-conducted study: the vaccine was compared to placebo and the study was blinded, meaning that participants and the scientists carrying out the analysis were not aware of who got what. The study had nearly 25,000 participants and was carried out across 17 nations.

The vaccine was found to be over 80% effective against lower respiratory tract disease (the main outcome the study was designed to measure) and 94% effective against severe disease. This is great news.

.From the Rx coverage front —

  • Bloomberg relates “Eli Lilly & Co said on Tuesday that all doses of its new diabetes drug Mounjaro are now available after social-media enthusiasm about the drug’s weight-loss benefits sparked a two-month-long shortage.”

while

  • The Wall Street Journal reports
    • Drugs like Ozempic have become so popular among people seeking to lose weight that they are now in short supply for patients with diabetes who depend on the medicines.
    • Diabetes patients said they are spending hours trying to find nearby pharmacies that have their prescriptions in stock. If they don’t, some patients have had to reduce dosing of Ozempic and similar drugs to stretch out their supplies, or switch to alternative drugs.
    • The shortfalls are making it harder for people with diabetes to keep their blood-sugar levels low and limit their risk of complications like kidney disease and damage to blood vessels, doctors said.  * * *
    • Novo Nordisk A/S, which sells Ozempic, has been moving to expand production capacity. People may still experience periodic shortages, however, Chief Executive Lars Fruergaard Jorgensen said, because the work hasn’t been finished while demand may remain high. 
  • Biopharma Dive tells us
    • By and large, doctors appear to be comfortable prescribing biosimilar drugs, the copycat version of biologic medicines like inflammatory disease drug Humira or eye treatment Lucentis. But they aren’t yet sure the discounts offered are enough to justify switching patients who are stable on the brand-name products, according to an annual report from healthcare distributor Cardinal Health released Wednesday. * * *
    • [A] majority of physicians from the three Humira-prescribing specialties [rheumatology, gastroenterology and dermatology] said they were “very” or “somewhat” comfortable prescribing biosimilars, including 100% of gastroenterologists. Among the ophthalmologists, 48% said they were “uncomfortable from a clinical standpoint” among their primary concerns prescribing biosimilars.
    • When asked which patients they are most likely to prescribe a biosimilar, the most common response among the Humira-prescribing specialists was “existing patients for whom payers have mandated a biosimilar,” suggesting that insurers’ policies will drive uptake. However, 40% of rheumatologists said “new patients” would be the most likely people to get a biosimilar prescription.
  • Drug Channels offers its annual update on copay assistance accumulator and maximizer programs.

From the miscellany department –

  • The Milbank Memorial Fund issued a Baseline Scorecard Tracking Support for High Quality Primary Care. The baseline leaves a lot of room for improvement.
  • Fierce Healthcare informs us that CMS recently has issued price transparency warnings to hospitals, 300 of which have been satisfactorily resolved.
  • Health Payer Intelligence reports
    • While Medicare Advantage enrollment has increased by 1.5 million beneficiaries in 2023, this marks a slower growth compared to the last three years, according to data from Chartis.
    • The analysis reflects Medicare Advantage enrollment, plan, and pricing data from January 2019 to January 2023.
    • Between 2019 and 2023, Medicare Advantage enrollment has grown by 2.1 percent. As of January 2023, 46 percent of all Medicare beneficiaries are enrolled in Medicare Advantage, translating to 29.5 million people. * * *

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, FDA, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the U.S. healthcare business front, the Wall Street Journal reports

Amazon.com 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.

Amazing.

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 Colorado, Indiana, Missouri 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.