McKinsey & Co. offers “insights to discover why it’s impossible to experience good health alone, and what shifts you can make now to strengthen your social world” in order to combat loneliness.
Fortune Well discusses “[a] ‘super strain’ of an antibiotic-resistant stomach bug [XBR Shingella] that is on the rise in the U.S.” Fortunately, the CDC offers ways to prevent a Shingella infection:
Carefully washing your hands with soap and water before sexual activity, eating or preparing food, and after going to the bathroom, changing a diaper, or cleaning up after someone who went to the bathroom;
Throwing away diapers in a covered, lined garbage can;
Cleaning up mess from diapers thoroughly and promptly;
Avoid swallowing water from lakes, ponds, and swimming pools and
Refraining from sex when you have diarrhea, and for two weeks after diarrhea resolves.
For years, people with Type 2 diabetes who needed to take drugs to lower their blood-sugar levels started with an old medicine called metformin. New guidelines now recommend patients can start with one of the newer diabetes medicines, which can also reduce weight and protect the heart and kidney.
The goal of the changes was to make treatment more specific to the patient rather than focused on the drug, said Dr. Nuha Ali El Sayed, an endocrinologist at the Joslin Diabetes Center in Boston who is vice president of healthcare improvement at the American Diabetes Association.
MedPage Today offers doctors ways to handle the current Adderall shortage.
From the worldwide healthcare front (and many FEHB plans (particularly nationwide plans) offer worldwide coverage), Beckers Hospital Review discusses “Newsweek‘s 2023 list of top 250 global hospitals.”
From the plan design front, Financial Advisor points out an EBRI report on health savings accounts.
The New York Times Morning Column considers a renewed interest in workplace personality tests.
“Covid has opened our eyes to the fact that there are different ways in which we can work,” said David Noel, a human resources executive at Scotiabank, a Toronto-based bank with 90,000 employees. Partly for that reason, Scotiabank has begun to put more weight on personality tests, and less weight on résumés, when it makes hiring decisions.
In the post-pandemic era, personality tests seem to have a new relevance. They can help determine who will thrive in which work arrangements and what personality mix can maximize a team’s chance of success. Some advocates of the tests argue that they can also increase the diversity of a company’s work force by reducing the focus on standards that have traditionally benefited white men. Since Scotiabank began using personality tests more heavily in its campus hiring program, the share of its new employees who are Black has risen to 6 percent, from 1 percent.
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
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.”
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
“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.”
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.
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.”
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 bodymay be triggering or exacerbating depression in the brains ofsome 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.”
Beckers Hospital Review relies on the Harvard Business Review to identify “four measures needed to create shoppable healthcare beyond price transparency.”
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.
“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.
The FEHBlog recalls pointing out a Social Determinants of Health Atlas a few years ago. Check out the CDC’s list of health mapping tools that are now available.
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.
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.
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.
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.”
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 hourstrying 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.
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.
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.
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.
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, KHNreported 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.
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/
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.
The House of Representatives and the Senate are on District/State work breaks this week.
Govexec alerts us, “Labor Secretary Marty Walsh will be leaving the Biden administration in mid-March to become executive director of the National Hockey League Players’ Association.”
Federal News Network offers an update on implementing the Postal Service Health Benefits Program that takes effect on January 1, 2025. The article expresses concern about a tight timeline for implementation. The article does not consider OPM’s January 2023 decision to allow FEHB plans to offer Medicare Part D EGWPs in 2024. That welcome decision puts the new PSHBP and the existing FEHB on a similar footing.
While the new PSHBP will be more tightly integrated with Medicare Part B., the benefits of that phased in change will develop over time. For example, although the Postal Services will offer a one-time, penalty-free Part B Special Open Enrollment Period next year for annuitants over 65 who did not elect Part B, early retirees under 65 and active employees over age 64 on January 1, 2025, will be exempt from the PSHBP’s mandatory Part B election requirement.
In other FEHB news, AHIP has made available a topic overview for the March 29 – 30 OPM AHIP FEHB Carrier Conference.
In OPM news, Meritalk breaks down last week’s inaugural DEIA Annual Report from OPM’s Office of Diversity, Equity, Inclusion, and Accessibility (ODEIA).
From the Omicron and siblings front, the Wall Street Journal and Fierce Healthcare report on the Covid death rate. The Journal points out, “Deaths caused by Covid are heavily concentrated among the elderly, an analysis of CDC data shows. In recent weeks people 75 years and older have represented about seven of every 10 Covid-19 deaths.” Fierce Healthcare provides this perspective:
The JAMA Network Open study concluded that “COVID-19 due to the Omicron variant was associated with a higher risk of in-hospital mortality compared with patients with influenza. This indicates that the SARS-CoV-2 Omicron variant should still be taken seriously, and improved prevention and treatment strategies are still highly relevant, although overburdening of the health care system has become less likely over time.”
Fortune Well tells us about the importance of cardiac care following even a mild case of Covid.
In a bid to determine why and how COVID can affect the heart, Dr. Andrew Marks, a cardiologist and biophysics professor at Columbia University, and Steven Reiken, a research scientist in his lab, studied heart tissue from people who died of COVID, in addition to the hearts of mice that had been infected with COVID.
Heart tissue from humans shows increased levels of oxidative stress and inflammation, and changes in calcium levels due to damage to the system that regulates them in the heart. Such alterations can lead to arrhythmia or heart failure, according to the researchers.
Chest pain and tachycardia, or an unusually fast heartbeat, are common long-term among COVID survivors.
Heart tissue from mice shows an increased percentage of fibrosis and dilation of fibers—a common signal of early cardiomyopathy, which makes it more difficult for the heart to pump blood and can result in heart failure.
The death of heart cells and blood clots in the hearts of mice who had been infected with COVID-19 were also observed.
“Doctors should be aware of heart changes related to COVID-19 infections and should be looking for them,” Marks says. He hopes his research leads to increased awareness among medical providers of the virus’s potentially stealthy cardiac fallout—and, eventually, treatments for those whose hearts have been damaged by the pathogen.
People who took the antiviral Paxlovid to treat COVID-19 infections were not more likely to get back-to-back bouts of the virus, a new study shows.
The findings offer clarity amid concerns that the use of Paxlovid, which works by stopping the spread of the virus in the body, increased the risk of COVID-19 rebound.
“Rebound is a re-emergence of symptoms and an uptick in viral load after a period of recovery,” the Center for Infectious Disease Research and Policy explained in a summary of the study.
Researchers found that patients who received Paxlovid, another antiviral called Lagevrio, or no antiviral medication had rebounds at similar rates, ranging from 4.5% to 6.6%.
From the medical research front, the Wall Street Journal reports
A fist that opened and shut. A once-limp arm that moved from her side. Two women whose strokes left them with partial paralysis for years saw life trickle back to their limbs when electric pulses were delivered to the back of their spinal cord as part of a pilot study.
Neurologists said the approach, reported Monday in the journal Nature Medicine, could be transformative for stroke survivors, many of whom have some arm impairment after the event.
“I think it is amazing,” said Helmi Lutsep, a neurologist at Oregon Health & Science University, who wasn’t involved with the study. “I think patients will be thrilled if this comes to fruition.”
The pilot study was convincing but it would take much larger studies and a decade or more to know if stroke patients generally could benefit, according to Nick Ward, a neurologist at the University College London who wasn’t involved with the study.
From the U.S. healthcare business front, the Wall Street Journal informs us why “Walgreens CEO Bets on Doctors Over Drugstores in Search for Growth; Rosalind Brewer is shifting the chain’s focus to medical clinics,” like Village MD.
The strategy is guided by Ms. Brewer’s belief that the nation’s second-largest drugstore chain is in a business that she says no longer works. Industry growth is chronically slow, she said. Meanwhile, a shortage of workers is further cutting into revenue because the chain has had to reduce pharmacy hours.
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