President Biden on Friday issued an executive order implementing his plan to provide federal civilian employees with an average 4.6% pay raise in January.
As proposed in his fiscal 2023 budget plan last March, the raise provides federal workers with a 4.1% across-the-board raise to basic pay, as well as an average 0.5% increase in locality pay. * * *
The Office of Personnel Management now must publish pay tables outlining the pay raise across all General Schedule pay grades and locality pay areas. Once updated, they will be available on the OPM website. The pay raise will go into effect for the first full pay period of 2023.
From the public health front —
The Wall Street Journal spoke with ear, nose, and throat specialists about they treat their own flu and colds.
McKinsey Consulting suggests the secret to great health is escaping the healthcare matrix. “The blueprint for achieving a lifetime of great health is increasingly clear and within our control. But unlocking it requires challenging the orthodoxies currently guiding individuals and institutions.”
From the Rx coverage front —
The Wall Street Journal delves into health plan strategies for covering million-dollar-plus gene therapies.
A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription.
Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.
HRT said it would give away one-tenth of its product and sell the rest to pharmacies, public-sector employees and groups that work with drug users at-cost, about $18 a dose. HRT said it plans to produce 2 million doses a year. * * *
Emergent BioSolutions Inc., maker of the Narcan brand of naloxone nasal spray, said earlier this month that its application for over-the-counter status had received an expected approval date of March 29. The company’s two-dose prescription-only nasal spray was selling at pharmacies recently at a cash price of more than $100 without insurance.
Pocket Naloxone Corp. is applying for a nasal-swab version of the drug it said would be cheaper than nasal-spray versions. The startup said earlier this month that it submitted results to the FDA showing that its drug works more quickly than prescription versions. * * *
Other nonprofits are also working to lower drug prices. Civica Rx, a nonprofit founded in 2018, introduced a cancer drug this year with a recommended price of $171 a month versus more than $3,000 a month without discounts for an older version charged to patients on Medicare Part D. Medicines360, a women’s health group, developed a hormonal intrauterine birth-control device it said it sells to safety-net clinics for $100, about a 90% discount.
From Capitol Hill, the American Hospital Association tells us
The Senate today passed (68-29) an amended version of the $1.7 trillion omnibus appropriations bill that funds the federal government through the end of the current fiscal year. The legislation also includes many provisions affecting hospitals and health systems.
The Senate also passed another short-term continuing resolution through Dec. 30 to allow time for the more than 4,000-page legislation to be enrolled and for President Biden to sign it. This ensures there will be no interruption of services or federal shutdown.
The omnibus spending bill, which includes relief from Medicare cuts and extensions of rural and telehealth programs, as well as the Dec. 30 continuing resolution, now go to the House, which is expected to consider them today . The president is expected to sign the short-term continuing resolution before current funding for the government expires at 11:59 p.m. ET on Dec. 23, and to sign the omnibus later next week.
The Wall Street Journal adds, “House Majority Leader Steny Hoyer (D., Md.) said the House would vote on the bill Friday.”
In other 2023 Consolidated Appropriations Act or omnibus news
The Hill reports on “last minute” changes to the omnibus, including provisions assisting nursing and pregnant workers.
Mercer Consulting alerts us to a two-year-long extension of telehealth flexibilities available to high deductible plans with health savings accounts.
Think Advisor and the Wall Street Journal provide an overview of the Secure 2.0 Act provisions in the omnibus. The Secure 2.0 Act affects 401(k) plans offered to employees and IRAs. The key provision that takes effect for 2023 is an increase in the required minimum distribution age from 72 to 73.
The Wall Street Journal reviews the other omnibus provisions affecting businesses.
While the respiratory “tripledemic” continues to slam emergency rooms and children’s hospitals, there are two glimmers of hope on the horizon, according to a Dec. 22 report in The New York Times.
COVID-19, the flu and respiratory syncytial virus attack the body in different ways, and there are varying levels of disease severity across the U.S. Today, some scientists say RSV has peaked in most parts of the country.
“I think it’s likely that the RSV season has peaked in most parts of the country,” said Virginia Pitzer, ScD, an infectious disease epidemiologist at New Haven, Conn.-based Yale School of Public Health. “I think that there is a light at the end of the tunnel.”
Additionally, there’s reason to believe next winter won’t be as burdensome for the American population and healthcare organizations.
Ironically, the safety precautions used to help stem the pandemic in the past couple of years have also kept adults and children from being exposed to the viruses that typically circulate this time of year, said Dr. Pitzer.
“There was a bit of a buildup of susceptibility at the population level,” she added. “It’s a worse than normal winter, but one that hopefully will not be repeated next year.”STS
The Society for Healthcare Epidemiology of America today recommended hospitals and health systems no longer routinely screen symptom-free patients for COVID-19 upon admission or before procedures and rely instead on enhanced layers of infection prevention interventions.
“The small benefits that could come from asymptomatic testing at this stage in the pandemic are overridden by potential harms from delays in procedures, delays in patient transfers, and strains on laboratory capacity and personnel,” said Thomas R. Talbot, M.D., MPH, the chief hospital epidemiologist at Vanderbilt University Medical Center, and a member of the SHEA Board of Directors. “Since some tests can detect residual virus for a long period, patients who test positive may not be contagious.”
[According to a CDC report, a] baby born in the U.S. in 2021 has a life expectancy of 76.4 years, down from 77 years in 2020 and the lowest level the CDC has recorded since 1996. The age-adjusted death rate for Covid rose by 22.5% between 2020 and 2021, while death rates from unintentional injuries — one-third of which come from overdoses — rose by 12.3%.
HHS’s Agency for Healthcare Quality and Researched refreshed its Healthcare Cost and Utilization Project Fast Stats website. The site provides “summary statistics on inpatient stays, emergency department visits, and priority topics, by select characteristics.”
From the OPM front, OPM’s medical director, Dr. Ron Kline announced today on Linked In that he is leaving OPM to take a new position beginning January 17, 2023 as
the Chief Medical Officer of the Quality Measurement and Value-Based Incentives Group (QMVIG) at the Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS).
QMVIG is responsible for developing, evaluating and supporting the implementation of quality measurement programs across the entire federally-supported health care continuum. This includes Medicare’s Quality Payment Program and the Inpatient (i.e. Hospital) Quality Reporting Program. These measures and policies guide these innovative programs to improve healthcare quality for all Americans.
Best wishes, Dr. Kline, and thanks for your work with the FEHB over the past 3 1/2 years.
From the Rx coverage and medical research fronts –
The Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday.
The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 per year. ICER’s calculations, which could change in response to public comment over the next month, are based on metrics meant to quantify the value of improvements to quality of life.
Eisai, which is leading the effort to commercialize lecanemab, has not disclosed how much it will charge for the medicine, saying only that it will prize affordability and access. That will soon change, as the drug, a twice-monthly infusion, is expected to win a preliminary Food and Drug Administration approval by Jan. 6. * * *
Lecanemab’s safety has come into sharp focus over the past two months after three patients died of major brain bleeds.
The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of etranacogene dezaparvovec (Hemgenix, CSL Behring,) for hemophilia B. ICER also updated the previous Hemophilia A assessment on valoctocogene roxaparvovec (Roctavian™, BioMarin).
Key recommendations stemming from the roundtable discussion include:
The value of high-impact single and short-term therapies should not be determined exclusively by estimates of long-term cost offsets, particularly when the existing standard of care is acknowledged to be priced significantly higher than reasonable cost-effective levels.
Payers should work with manufacturers to develop and implement outcomes-based agreements to address the uncertainty and the high cost of gene therapies for hemophilia.
At least one national payer has suggested to patient representatives that step therapy with emicizumab is being considered prior to provision of coverage for Roctavian. Clinical experts and patient experts view this approach as lacking any clinical justification and appears to be only a method for trying to avoid the high one-time fee for gene therapy while assuming that patients may switch insurers before the cost-saving potential of gene therapy is fully realized. In short, step therapy does not appear to be a reasonable consideration for this treatment.
ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.
Scientists used patient stem cells and 3D bioprinting to produce eye tissue that will advance understanding of the mechanisms of blinding diseases. The research team from the National Eye Institute (NEI), part of the National Institutes of Health, printed a combination of cells that form the outer blood-retina barrier—eye tissue that supports the retina’s light-sensing photoreceptors. The technique provides a theoretically unlimited supply of patient-derived tissue to study degenerative retinal diseases such as age-related macular degeneration (AMD).
If you haven’t yet tried ChatGPT, OpenAI’s new artificial-intelligence chatbot, it will blow your mind. Tell the bot to write you anything—an email apologizing to your boss, an article about the world’s richest hamster, a “Seinfeld” script set in 2022—and it spits out text you’d think was written by a human. Knowledge of the topic, proper punctuation, varied sentence structure, clear organization. It’s all there.
From Capitol Hill, the Wall Street Journal reports
Senators were bracing for a late night in the Capitol, as the timing of votes on the $1.65 trillion omnibus spending bill and possible amendments remained uncertain and the Friday night deadline to avoid a government shutdown crept closer.
The Senate could start voting on amendments later Wednesday, teeing up a late night or early morning of voting, even as they also attend an address to Congress in the evening by Ukrainian President Volodymyr Zelensky. Adding to the pressure, senators are looking to get out of town ahead of winter storms expected in coming days.
“We’re still working on an agreement to vote on amendments and pass the omnibus tonight,” Senate Majority Leader Chuck Schumer (D., N.Y.) said Wednesday night. “We aren’t there yet, we’re making progress.” Once the Senate passes the measure, it would move to the House, which is expected to approve it quickly.
Congress again rebuffed the White House’s request for new dollars to combat the coronavirus. Last month, Biden administration officials urged lawmakers to approve about$9.25 billion in emergency funds to help ensure access to vaccines and treatments while supporting new research into long covid.
The battle over more funds has been ongoing since the spring, and Republicans have refused to budge, with one Senate GOP aide telling The Health 202 that they want further explanations on how the federal government has spent billions previously allocated for its pandemic response.
A long list of measures aimed at tackling the ongoing opioid crisis is in the bill, including $1,575,000,000 in state grants to go toward substance abuse prevention and treatment. It also incorporates significant provisions of the Mainstreaming Addiction Treatment Act, including the elimination of a DEA requirement that clinicians get an extra certification to prescribe buprenorphine, and the NOPAIN Act, which improves access to FDA-approved non-opioid therapies for outpatient surgical procedures.
STAT News explains how the omnibus breathes new life into Medicare’s hospital-at-home program.
What’s more, this week the Senate confirmed the nominations of Rob Schriver to be OPM Deputy Director and Richard Revesz to be director of OMB’s Office of Information and Regulatory Affairs.
From the judicial front –
The Society for Human Resource Management tells us, “The 5th U.S. Circuit Court of Appeals recently ruled that the federal government cannot enforce a COVID-19 vaccine mandate on federal contractors. The court’s Dec. 19 decision found that the Biden administration overstepped its authority with the vaccine mandate.”
Healthcare Dive discusses the latest hearing before Judge Kernodle in the second Texas Medical Association challenge to the No Surprises Act independent dispute resolution rule. The FEHBlog finds this to be a premature lawsuit at best.
The nose knows why some people still can’t smell long after recovering from Covid-19.
A haywire immune response in the olfactory system was found to explain why some people still can’t smell long after symptoms of the disease have abated, according to a small, peer-reviewed study published Wednesday in the journal Science Translational Medicine. In some cases, the immune or inflammatory response was detected in patients with smell loss up to 16 months after recovery from Covid-19.
Compared with people who can smell normally, patients with long-term smell loss had fewer olfactory sensory neurons, cells in the nose responsible for detecting smells and sending that information to the brain. Patients with lingering loss of smell had an average of 75% fewer of the neurons compared with healthy people, said Brad Goldstein, a study co-author and sinus surgeon at Duke University.
“We think the reduction of sensory neurons is almost definitely related to the inflammation,” Dr. Goldstein said.
HHS announced “making an additional supply of Tamiflu available to jurisdictions to respond to an increased demand for the antiviral during this flu season, including through the Strategic National Stockpile (SNS). Jurisdictions will work with their ASPR Regional Teams to evaluate any requests for Tamiflu through the SNS, ensuring that states, territories, and tribes receive the assistance they need without affecting our nation’s preparedness for a future pandemic flu.”
Beckers Hospital Review discusses how five payers are addressing maternal health.
A JAMA article examines whether “the new CDC Opioid Prescribing Guidelines will help correct the course in pain care.”
From the drug development and distribution front
The Institute for Clinical and Economic Research “posted its revised Evidence Report assessing the comparative clinical effectiveness and value of the following treatments for multiple sclerosis (MS):
Monoclonal Antibodies
natalizumab (Tysabri®, Biogen)
ofatumumab (Kesimpta®, Novartis)
ocrelizumab (Ocrevus®, Genentech)
rituximab (Rituxan®, Genentech, and biosimilars)
ublituximab (TG Therapeutics)
Oral Therapies
dimethyl fumarate (Tecfidera®, Biogen, and generics)
diroximel fumarate (Vumerity®, Biogen)
monomethyl fumarate (Bafiertam®, Banner Life Sciences)
As enthusiasm mounts for a new experimental antibody that appears to slow cognitive decline in some Alzheimer’s patients, a third death linked to the drug during its clinical testing may amplify concerns about its safety. Science has obtained medical records showing a 79-year-old Florida woman participating in an ongoing trial of the antibody died in mid-September after experiencing extensive brain swelling and bleeding, as well as seizures. Multiple neuroscientists who reviewed the records at Science’s request believe her death was likely caused by the antibody, lecanemab.
“The brain swelling and the microhemorrhages … could be a serious side effect of the study medication,” and should be evaluated by trial investigators, says Ellis van Etten, a neuroscientist and neurologist at Leiden University.
Pfizer has started dosing patients in a Phase 2 study of its entry into a closely watched class of drugs for treating diabetes and obesity.
The dosing of the first patient with the drug, dubbed PF-07081532, triggered a $10 million payment to partner Sosei Heptares, the Japanese drugmaker said Wednesday. Pfizer scientists working with Sosei’s technology discovered the medicine, and Pfizer is responsible for developing it.
Pfizer aims to bring a once-daily oral treatment into a class of medicines known as GLP-1 agonists, which stimulate the body to produce insulin by acting on natural body hormones known as glucagon-like peptides. Most of the approved GLP-1 agonists must be injected.
Leaders in Congress have reached a sweeping deal to ease Medicare pay cuts to doctors, make major changes to post-pandemic Medicaid policy, and to help prepare for future pandemics.
Lawmakers are aiming to pass a health care policy package along with legislation to fund the federal government by Friday. The details of the omnibus spending package were confirmed by two lobbyists and two congressional aides.
The bill’s text is not yet finalized, and the deal is still subject to changes.
Details may be found in the article.
Following up on last Friday’s post on emergency medical care, MedPage Today counters
The New York Timesreported last week that a newly released federal government study believes that up to 250,000 people die in the U.S. annually due to misdiagnoses made in emergency rooms.
However, in a large document obtained by Inside Medicine that is not yet public, one expert contributing to an internal review of the report prior to its publication found a “fatal flaw” in the methodology behind some of the most crucial and eye-catching findings. Other major concerns were brought up by other reviewers and technical experts, which the study authors did not fully address prior to the release of the report. The technical expert concerned about the “fatal flaw” wrote that results were, “Headline grabbing, yes, but this is at best gravely misleading, given the concerns….”
Emergency medicine organizations have already pointed out major problems in the report. One thing not yet pointed out is that the magnitude of the findings fail every whiff test imaginable. If the findings of the report were somehow to be true, that would mean that 8.6% of all deaths in the U.S. — that is, 250,000 out of 2.9 million deaths (2019, the last pre-pandemic year) — are caused by mistakes and misses in ERs. That’s preposterous, on its face. * * *
This report seems unfamiliar with the idea that what we seek in medicine is net benefit. This report counts only the misses, but none of the saves ERs routinely make by following evidence-based medicine developed by emergency physicians, cardiologists, neurologists, and other experts working together. This report seems to think that abiding by the principle of balancing risks and harms is somehow synonymous with medical error. * * *
Nearly 40% of Americans struggle to understand their medical bills, a recent survey showed. But the respondents also shared a few ways providers and insurers could step in to make bills less confusing.
The survey was released Friday by AKASA, an AI developer for healthcare operations. It was conducted online in March by YouGov and included responses from 2,026 U.S. adults. * * *
How can providers and insurers help? Survey respondents shared several ways:
About 27% said it would be beneficial to receive a call from the physician’s office or hospital staff before the medical procedure, explaining terms of payments and the payment plans available.
Another 12% said they’d like an online calculator that can show cost ranges for procedures.
About 11% said it would be helpful to receive an email from their insurer that walks through the bill after they receive care.
About 9% said they’d like the payer to call and walk them through the bill.
Another 9% said they want access to live online customer service through their health plan’s website.
Additionally, 8% want a call from the physician’s office or hospital staff that explains the bill after receiving services.
From the Rx coverage front, STAT News discusses current prescription drug shortages.
Medicines to lower fevers, clear congestion and ease aches and pains are in high demand this winter as the U.S. is experiencing a surge in pediatric cases of RSV, influenza and Covid-19. Parents and caregivers are struggling to find over-the-counter fever reducers such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil) as well as amoxicillin, an antibiotic prescribed to treat common childhood ailments such as ear or upper respiratory infections. Both CVS Health Corp. and Walgreens Boots Alliance Inc. announced they have imposed purchase limits on children’s cold and flu medicines. * * *
Manufacturers are producing at full capacity [in contrast to the baby formula shortage] and directing inventory to where it is most needed, the Consumer Healthcare Products Association, which represents producers of over-the-counter medications. “However, we understand it might be frustrating for parents to quickly locate these products from their usual pharmacy or retailer due to intermittent out-of-stocks,” the group said. A spokeswoman for Johnson & Johnson, whose brands include pain relievers Tylenol and Motrin, said that while some products might be less readily available, the company isn’t experiencing widespread shortages of children’s Tylenol or Motrin.
From the mental health care front —
The Department of Health and Human Services announced “the annual release of the Department’s National Plan to Address Alzheimer’s Disease: 2022 Update – PDF. Through the National Plan, HHS and its federal partners work to improve the trajectory of Alzheimer’s disease and related dementias (ADRD) research, support people living with dementia and their caregivers, and encourage action to reduce risk factors.”
HR Dive explains how employers can help resolve the “unspoken crisis” in men’s mental health.
From the fraud, waste, and abuse front, Fierce Healthcare reports
In a development in what’s being billed as one of the largest healthcare fraud schemes ever, a federal grand jury [on November 14] convicted the owner of a laboratory that performs sophisticated genetic tests of bilking Medicare out of hundreds of millions of dollars.
The crime involved telemarketers allegedly lying to Medicare recipients by ensuring them that they were covered for expensive genetic cancer tests, according to the Department of Justice (DOJ). * * *
The convicted individual—Minal Patel, 44, of Atlanta, the owner of LabSolutions LLC—personally pocketed $27 million of the $187 million that the scheme raked in from Medicare from July 2016 through August 2019.
Patient brokers, call centers and telemedicine companies also allegedly cashed in, as Patel paid them kickbacks and bribes after the Medicare beneficiaries agreed to take the tests, DOJ said. The patient brokers allegedly obtained signed doctors’ orders recommending the tests from telemedicine companies. Patel made the patient brokers sign contracts that misleadingly stated that the brokers were performing legitimate advertising services for LabSolutions.
At last week’s ABA Health Law Section Washington Health Law Summit, the FEHBlog learned about a recent federal anti-health care fraud law called the Eliminating Kickbacks in Recovery Act (“EKRA”). The law is directed at patient brokers, laboratories etc. in situations involving, for example, opioid misuse or this one. EKRA criminalizes fraud against private sector health plans as well as the federal treasury. Here’s a law firm’s article about EKRA if you are interested.
From the U.S. healthcare business front, Fierce Healthcare informs us
Two South [New] Jersey hospitals have signed a letter of intent to merge into a system of more than 10,000 employees and over $2.2 billion in annual revenues.
Camden, New Jersey-based Cooper University Health Care and Cape May Court House, New Jersey-based Cape Regional Health System said in a Wednesday announcement they’ll be working toward a definitive merger agreement in March and then regulatory approvals that “could take until the first quarter of 2024.”
Should the agreement come to pass, the joined system would comprise 900 licensed beds across the organizations’ two flagship hospitals, six urgent care centers and over 130 ambulatory locations across eight counties.
From the federal employment front, Federal News Network relates
Leaders in the Biden administration called for “major reforms” to the federal pay system, building on a not-so-new conversation around issues with the compensation system for much of the federal workforce.
The current structure for determining pay for the 1.5 million federal employees on the General Schedule is inherently flawed, the President’s Pay Agent said in its annual report to the president.
“As has been noted in earlier pay agent reports and discussed in other venues, we believe there is a need to consider major legislative reforms of the white-collar federal pay system, which continues to utilize a process requiring a single percentage adjustment in the pay of all white-collar civilian federal employees in each locality pay area without regard to the differing labor markets for major occupational groups,” the pay agent said in the Dec. 19 report. “The current pay comparison methodology used in the locality pay program ignores the fact that non-federal pay in a local labor market may be very different between different occupational groups. As currently applied, locality payments in a local labor market may leave some mission-critical occupations significantly underpaid while overpaying others.”
The pay agent, composed of Office of Personnel Management Director Kiran Ahuja, Labor Secretary Marty Walsh and Office of Management and Budget Director Shalanda Young, issued its annual report ahead of the planned 4.6% pay raisefor the federal workforce in 2023.
From Capitol Hill, the Wall Street Journal reports
A top Senate Democrat said that his party planned to introduce an omnibus spending bill Monday, aiming to pressure Republicans to accept a deal or risk an alternative that would freeze government spending at current levels for the full year and cut off the ability to reallocate money in military and other programs.
Senate Appropriations Committee Chairman Patrick Leahy (D., Vt.) said that the measure would provide military funding at the level Congress is authorizing in its separate defense policy bill—some $858 billion, or roughly a 10% increase—while also paying for what he called a needed increase to nondefense programs.
“This is a reasonable path forward, and I suggest my Republican friends take it,” Mr. Leahy said. * * *
If no deal is reached as the end of the year approaches, lawmakers have said they might need to fall back to a so-called continuing resolution, which funds the government at current levels. Various lawmakers have floated stretching funding into early 2023 or for the full fiscal year, which ends in September.
The path forward was unclear, as neither House Speaker Nancy Pelosi (D., Calif.) nor Senate Majority Leader Chuck Schumer (D., N.Y.) announced votes on an omnibus bill for next week.
House lawmakers on Thursday passed a defense policy bill [discussed in yesterday’s FEHBlog post] that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. * * * The legislation is expected to pass the Senate by the end of next week before heading to President Biden’s desk for his signature.
Key decision makers in Congress are closer than they’ve been in years to revamping the way the government regulates some of the diagnostic tests that patients use to make crucial decisions about their health care [due to the Theranos fiasco].
If the VALID act passes, the FDA wouldn’t regulate every single clinical test, but only tests considered “high risk” to patients, where the risk to patients of an inaccurate result could cause serious or irreversible harm.
One example would be a test for breast cancer that could lead a patient to have a mastectomy, Boiani said. Another would be a genetic test that could determine which cancer treatment patients receive, said Jeff Allen, the president and CEO of Friends of Cancer Research.
From the Federal Employee Benefits Open Season front, Tammy Flanagan writing in Govexec and Drew Friedman writing in Federal News Network offer last minute decision-making tips.
Investment News provides advice on income adjusted Medicare premium issues.
Most Medicare beneficiaries will pay the standard Part B premium of $164.90 per month in 2023, down slightly from this year’s monthly premium of $170.10. Medicare Part B covers doctors’ fees and out-patient services. Coupled with a huge 8.7% cost-of-living adjustment in Social Security benefits next year, most retirees will enjoy larger monthly net Social Security benefits after automatic deductions for their Part B premiums in 2023.
But about 8%, or about 5 million, of the nearly 63 million Medicare beneficiaries will pay more than the standard monthly premium for both Part B and Part D prescription drug plans based on their income. My husband and I are among them.
For 2023, single beneficiaries with incomes of $97,000 or more and married couples with joint incomes of $194,000 or more pay a Medicare premium surcharge, officially known as an income-related monthly adjustment amount, or IRMAA. The thresholds increased from $91,000 and $182,000, respectively, in 2022, meaning some beneficiaries may avoid IRMAA surcharges altogether in 2023 or pay less than this year due to the inflation adjustments of the income tiers that trigger those surcharges.
In other health benefits news, Insurance News Net informs us
US employers expect a sharper increase of 5.4% in 2023 — and faster cost growth in the years ahead seems likely
For now, most employers are prioritizing enhancing benefits to attract and retain workers over cost-cutting; enhancements range from adding perks to improving healthcare affordability
Mental health remains a top concern of employers and employees – and virtual mental healthcare is proving key to improving access to services
From the Rx development and coverage front, we have three reports from STAT News —
Well, this government action didn’t take long. STAT News relates “The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.”
Also according to STAT News, “A year ago, the [Purchaser Business Group on Health] coalition created Emsana Health that, in turn, hatched the EmsanaRx pharmacy benefit manager. [Beginning March 1, 2023,] EmsanaRx will run the technology to ensure prescriptions handled by Cuban Cost Plus Drugs are paid and fulfilled, and report all this information back to the [self-funded] employer. In exchange, EmsanaRx will take a flat 1.5% fee for legal, administrative, and data sharing services, but not charge more than $3 for each insurance claim and will pass along any rebates collected.”
Finally from STAT News, “Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, according to the official who oversees the program. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, administrator for the Centers for Medicare and Medicaid Services, said Thursday at the Milken Institute Future of Health Summit when asked about how the agency will approach lecanemab. “We will look at it as new data comes.”
An outside group [the Reagan Udall Foundation] that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. * * *
In a statement, FDA Commissioner Robert M. Califf said he will review the report and make decisions about the future of the agency with input from experts inside and outside the FDA.
The Congressional Research Service issued an “In Focus” report on “Regulating Reproductive Health Services After Dobbs v. Jackson Women’s Health Organization.”
The Annual Report examines 23 measures to assess health outcomes trends nationwide, including measures for eight chronic conditions. The data for these measures primarily represented 2021 outcomes, but some measures drew from 2018, 2019, 2020, and 2022.
A Morning Consult online survey conducted in October 2022 informed the results as well as racial and ethnic subpopulation data and a total of 80 national and state measures to assess the state of healthcare in the US.
Based on the findings, the coronavirus pandemic has continued to have ripple effects on healthcare. The top three major trends in health outcomes are:
From Capitol Hill, the Wall Street Journal reports
Senate Democrats celebrated their win in Georgia giving them 51 seats next year, a result that enhances their power by allowing them to more easily advance President Biden’s nominees while also providing slightly more flexibility on legislation.
Sen. Raphael Warnock’s win in a runoff election over GOP challenger Herschel Walker comes after two years in which Vice President Kamala Harris provided a tiebreaking vote in the 50-50 Senate. * * *
Since early 2021, the two parties have been operating under a power-sharing agreement with evenly divided committees, which has prevented Democrats from issuing subpoenas to witnesses without GOP support. When nominees have tied in a committee vote, Democrats have been forced to hold an extra procedural vote to finalize their nomination. The Warnock victory will give Democrats a narrow majority on each panel.
“It’ll be easier for Democrats to move forward with some of their nominees, particularly in the judiciary, and that makes it more difficult for us,” said Sen. Mitt Romney (R., Utah).
The newly minted defense authorization bill for fiscal 2023 [NDAA], made public Tuesday night, provides a shot in the arm to the U.S. defense budget but bars the military from discharging any more troops who refuse COVID-19 vaccine shots in their arms. * * *
[This bill has been approved by a House-Senate conference committee.] The House is expected to vote on the NDAA as soon as Thursday and the Senate to soon follow suit, perhaps next week.
The bill would authorize a 4.6 percent across the board pay increase for military personnel and civilians. However, House and Senate negotiators removed a House-passed “inflation bonus” of an additional 2.4 percent for troops and Defense Department civilians making less than $45,000 a year. * * *
Also of note, the bill would ban contractors across the government from using Chinese-made semiconductors, after a lengthy phase-in period, an aide with knowledge of the provision said Tuesday. Many federal contractors and other businesses say they are unclear how they will comply.
Govexec offers two more insights on the NDAA
Congressional negotiators on Tuesday night finally revealed a compromise version of the annual defense policy bill with the aim of passing it through both the House and Senate this week. But to some lawmakers, federal employee groups and good government experts’ chagrin, the measure did not include [Insight link] a provision aimed at blocking Republican-led efforts to strip potentially tens of thousands of federal employees of their civil service protections.
and
The authorization bill compromise text contains provisions [Insight link] that seek to increase transparency and accountability of investigations into Inspectors Generals [IG] and operations of the Council of Inspectors General on Integrity Efficiency (and its integrity committee, specifically); ensure IGs are only removed for justiciable and compelling reasons (and Congress is notified); and limit who can serve as acting IGs. There are also stipulations for notifying Congress when an agency doesn’t provide requested information or assistance to an IG and providing more training opportunities for IGs.
In an effort to address persistent watchdog job vacancies, the bill’s text states: “If the president fails to make a formal nomination for a vacant inspector general position that requires a formal nomination by the president to be filled within the period beginning on the later of the date on which the vacancy occurred or on which a nomination is rejected, withdrawn, or returned, and ending on the day that is 210 days after that date, the president shall communicate, within 30 days after the end of such period and not later than June 1 of each year thereafter, to the appropriate congressional committees.”
From the federal employee benefits front —
FedWeek gives us last minute guidance on the Federal Employee Benefits Open Season that ends next Monday December 12.
The Wall Street Journal offers ideas for use of flexible spending account dollars. The article make a point that was not on the FEHBlog’s radar screen:
This year’s December FSA spending crunch could be worse than usual. While you’re meant to empty your FSA every year, during the pandemic the government relented on this rule, allowing FSA savers to roll over what they saved in 2020 and 2021, with some accounts swelling to more than $7,000.
That special treatment is set to end in 2022, meaning if you have been accumulating money in your FSA, you may need to empty our account by Dec. 31 or you risk losing it all. “Some people might be in for a rude surprise,” says Spiegel.
Employers are permitted to give workers a little wiggle room—but not much. Some plans include a rollover provision that allows account holders to carry forward a small portion of their savings, although this amount is limited to $570 for 2022. Other plans may allow a spending grace period of up to 10 weeks.
From the infectious disease front —
The Wall Street Journal brings us up to date on Omicron treatments.
The Hill reports on the state of the flu and RSV surges. “Dr. Andrew Pekosz, a virologist and professor at Johns Hopkins Bloomberg School of Public Health, believes the U.S. is still in the “early stages” of a surge in influenza cases, he told Nexstar. * * * “With RSV we seem to be hitting a plateau,” said Pekosz. “Case numbers have not increased significantly for a couple of weeks, but they’re still at a very high level. So the burden of RSV is still great, but we may be closer to the peak there than we are with flu.”
Forbes relates, “A newly discovered immune response inside the nose could explain why respiratory illnesses like RSV, Covid, the common cold and flu thrive in winter, according to research published Tuesday in The Journal of Allergy and Clinical Immunology, a finding that challenges the conventional wisdom that infections spread because people are stuck indoors and signposts ways to develop new treatments.”
From the Rx development and coverage front
MPR informs us “The Food and Drug Administration (FDA) has granted Fast Track designation to PH10 for the treatment of major depressive disorder (MDD). * * * Results showed that treatment with PH10 significantly reduced depressive symptoms as early as 1 week based on the 17-item Hamilton Depression Scale (HAM-D-17) scores compared with placebo (P =.022). The intranasal spray was found to be well tolerated, with no serious adverse events reported.”
Touted by celebrities, raved about by TikTok users, and advertised by med spas, a new class of drugs for treating diabetes and obesity has exploded in popularity for its weight-loss effects, leading to rippling shortages across several of the medications.
Amid the surge in demand, Eli Lilly and pharmacies have started to tighten access to the latest of this type of drug, tirzepatide, focusing on giving it to people with type 2 diabetes, the only population it’s authorized for so far. But that’s left another set of patients scrambling — people with clinical obesity who turned to the medication as one of their few options for treatment. * *
There’s much overlap between the two conditions, said Beverly Tchang, an endocrinologist and assistant professor of clinical medicine at Weill Cornell Medicine. “Obesity can lead to diabetes, diabetes can lead to obesity,” she said. “They’re very much intertwined, and to treat one but not the other seems inequitable.” Tchang treats both types of patients and feels the drug shouldn’t be conserved for one group at the expense of the other.
From the telehealth front, mHealth Intelligence explains
FAIR Health’s Monthly Telehealth Regional tracker reported no change in telehealth usage in September compared with August and noted that COVID-19 fell in its rankings on top telehealth diagnoses lists in all regions and at the national level.
The FAIR Health Monthly Telehealth Regional tracker is a complimentary service that analyzes how telehealth activity and use change monthly by tracking various factors such as claim lines, procedure codes, and diagnostic categories. It represents the privately insured population, including Medicare Advantage but excluding Medicare Fee-for-Service and Medicaid beneficiaries.
MedPage Today informs us “Drug overdose deaths in pregnancy or the postpartum period increased sharply in the U.S. in recent years, with the rise most pronounced at the start of the COVID-19 pandemic in 2020, researchers reported. * * * Jacob S. Ballon, MD, MPH, of Stanford University in California, noted that the study authors did not provide explanations for why the overdose-related death rate rose sharper among the pregnant and postpartum group during the study period, but said it will likely be the basis for further research. “[It’s] an interesting signal,” said Ballon, who was not involved with the study. “But now what do we do with that to explain it or make some sense of it?”
Increased delays in discharging patients who require additional care after a hospital stay could slow their recovery, potentially harming health outcomes and quality of life, the American Hospital Association cautioned in a report released Tuesday.
The inability to discharge patients is putting additional strain on hospitals operating with thin workforces, and health systems are bearing the cost of care for patients who stay excess days without appropriate reimbursement, the AHA said.
The association has urged Congress to help offset the costs of care for patients’ additional days in the hospital by creating a temporary per diem Medicare payment targeted to acute, long-term care, rehabilitation and psychiatric facilities.
Imagine going into your doctor’s office and facing not a staff of overworked doctors and nurses, but an inviting conversation. A talk with a healthcare professional who has plenty of time, isn’t in a hurry and is ready to listen to a recital of the different aches and pains of your life. Someone with expertise in medications dedicated to making your life easier and healthier. A professional who makes and then hands you a cup of coffee before you even start talking.
With that conversation–easy, low stress–you can begin a level of trust with your doctor’s office that you might not have had before. And the person listening may, in conjunction with the doctors and nurses, find some better paths to helping you get healthier, even if you suffer from a chronic disease.
That’s the vision that Fergus Hoban has for the American healthcare system. His company, UpStream, provides integrated services for primary care physicians, both independently and as part of networks or bigger healthcare systems. Centered around a prescribing pharmacist, a team of nurses and other professionals work with doctors to provide better care for Medicare patients while at the same time lowering costs.
LHC Group and UnitedHealth Group have extended their merger agreement as the feds take a deeper look at the deal.
The agreement was extended until March 28, 2023, and the two companies now expect the merger to close in the first quarter of 2023, according to a filing with the Securities and Exchange Commission.
That the insurance giant intended to acquire LHC, a home health provider, was announced in March, and the deal is valued at about $5.4 billion. UnitedHealth said it plans to fold LHC into its Optum subsidiary as part of its provider arm, Optum Health, which is one of the country’s largest employers of physicians.
LHC Group would add 30,000 employees who provide more than 12 million home health services annually.
Health Payer Intelligence also tells us about positive provider and payer reactions to the CMS proposed rule to promote widespread use of electronic prior authorizations. As noted here yesterday, “[t]he proposed rule would require the implementation of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard Application Programming Interface (API) and mandates that payers have to explain the specific reason behind a prior authorization denial. Expedited prior authorizations will have to occur within 72 hours and non-urgent prior authorizations will have to be turned around in seven calendar days.”
From the Federal employee benefits front, Fedweek offers year-end benefits and tax guidance to federal and postal employees and annuitants.
From the medical research and development front,
STAT News reports, “A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab, according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it.”
The protein apolipoprotein E (APOE) plays a key role throughout the body. It helps to transport cholesterol and other fatty molecules, or lipids. The gene that produces APOE comes in a few different varieties. The most common is called APOE3.
The most notorious is APOE4, which has long been linked to an increased risk of dementia in Alzheimer’s disease. People who inherit one copy of the APOE4 gene have up to a fourfold greater risk of developing Alzheimer’s disease dementia. Inheriting two copies of APOE4 elevates the risk up to twelvefold. But despite years of study, scientists have little understanding of how APOE4 affects the human brain and boosts dementia risk. * * *
[NIH] Researchers found evidence that the Alzheimer’s-related gene APOE4 disrupts cholesterol management in the brain and weakens insulation around nerve fibers.
A drug that affects cholesterol led to improved learning and memory in mice with the gene, pointing to a potential new approach for treating dementia in Alzheimer’s disease.
New research has bolstered a once-gutsy idea: Bugs in the digestive system may play a role in depression.
Two studies published Tuesday in the journal Nature Communications found a link between several types of bacteria in the gut and depressive symptoms. Trillions of microorganisms including bacteria, fungi and yeast live in the digestive tract. Research exploring whether they might affect an array of diseases has increased in recent years.
The new studies, conducted among thousands of people in two cities in the Netherlands, are among the largest to date demonstrating potential associations between gut microbiota and mental health.
“Ten years ago if you’d said there was something linking depression and the microbiome, you’d be carried out with a straitjacket,” said Jos Bosch, an associate professor of psychology at the University of Amsterdam who co-wrote both studies. “Now absolutely, it’s very clear there’s a link.”
. . . Researchers who conducted the studies in the Netherlands called their findings a preliminary step toward identifying biological indicators and therapies for depression. The precise relationship between depression and microbes in the gut couldn’t be determined, they said. Depression can cause a person to eat less healthily, Dr. Bosch pointed out, which can lead to changes in the composition of microorganisms in the gut.
“Causality is a bit up in the air,” he said.
From the mental healthcare front, Fierce Healthcare tells us
While mental health and substance abuse issues have only grown thanks to the pandemic, a bright spot may be forming: The number of providers available to treat these concerns is increasing, a new study shows.
The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual “America’s Health Rankings” report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%.
In 2020, 13.2% reported frequent mental distress, and that rose to 14.7% in 2021, according to the report.
At the same time, drug-related deaths spiked. The report found that deaths increased by 20% nationwide between 2019 and 2020, reaching 27.9 deaths per 100,000. This is the largest year-over-year increase in more than a decade, according to the report.
The report also found that disparities within drug deaths increased in tandem. Such deaths increased by 45% among multiracial populations and by 43% among Black populations. Drug-related deaths were highest among American Indian/Alaskan Native populations, occurring at a rate nine times higher than the lowest group, Asian patients.
However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.
There are now 305 mental health providers per 100,000, according to the report.
Having one or more outpatient behavioral health treatment (OPBHT) visits was associated with lower healthcare costs among patients with newly diagnosed behavioral health conditions, a JAMA Network Open study found.
Adults with a behavioral health condition incur 2.8 to 6.2 times greater medical costs than those without one, and nearly a quarter of adults had a behavioral health condition as of 2018. However, behavioral health condition diagnoses are often delayed, and most individuals receive little or no treatment each year.
During 2021, drugmakers substantially raised prices on seven widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $805 million last year, according to a new report.
The drug for which spending increased the most due to a price increase was Xifaxan, which is used to treat both irritable bowel syndrome and a complication of cirrhosis. Salix Pharmaceuticals, a unit of Bausch Health, raised the wholesale price by 7.9%. The net price — after rebates and discounts — rose by 12%, most likely because the company offered fewer concessions than previously.
Consequently, spending for this drug climbed by $174.7 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost effectiveness of medicines. The report noted that the manufacturer disputed the net price and budget impact, which was provided by the SSR Health market research firm, but did not provide corrected estimates.
Of course, PBM formularies are designed to correct these issues.
Emergent BioSolutions Inc., maker ofNarcan, a nasal-spray form of naloxone, said Tuesday that the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray.
The company said it had been working on the application for several months. Emergent said the FDA’s priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of competitors that have announced their planned foray into the market.
The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of overdose-reversal medications such as Narcan to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.
Last week, FDA Commissioner Robert Califf said naloxone—which binds to opioid receptors to reverse the effects of opioids—should be as ubiquitous as defibrillators.
From the fraud, waste, and abuse front, mHealth Intelligence reports
As telehealth use exploded across healthcare programs provided by federal agencies, a report by a watchdog committee shows several program integrity risks linked to telehealth billing, including duplicate billing and ordering unnecessary durable medical equipment or laboratory tests.
They found that approximately 37 million individuals used telehealth services from March 2020 through February 2021 in the selected programs administered by the six federal agencies. This represents a massive increase from the 3 million individuals in these programs who used telehealth services the year prior.
In most programs, telehealth was used primarily to access office visits with a primary care provider or specialist and for behavioral health services, like individual and group therapy and substance use disorder treatment.
Overall, the agencies spent more than $6.2 billion on telehealth services, with Medicare accounting for the highest expenditure at $5.1 billion, followed by TRICARE and the Federal Employees Health Benefits Program, which together spent $1 billion.
But the OIGs found several similar program integrity risks associated with billing for telehealth services across multiple programs. These included “upcoding” telehealth visits by billing for visits longer than they lasted, duplicate billing for the same service, ordering unnecessary durable medical equipment, supplies, or laboratory tests, and billing for services inappropriate or ineligible for telehealth.
From the plan design front, Fierce Healthcare relates
The Biden administration released a proposal which, if finalized, would mandate Medicare Advantage (MA), Medicaid managed care, Affordable Care Act (ACA) plans and state Medicaid agencies implement electronic prior authorization systems by 2026.
The proposed rule, released Tuesday by the Centers for Medicare & Medicaid Services (CMS), will require payers and states to streamline prior authorization processes and improve the electronic exchange of health data by 2026. It also contains incentives for hospitals and physicians to adopt electronic prior authorization.
“The prior authorization and interoperability proposals we are announcing today would streamline the prior authorization process and promote healthcare data sharing to improve the care experience across providers, patients and caregivers,” CMS Administrator Chiquita Brooks-LaSure said in a statement.
It is the revised version of a Trump administration rule originally finalized in late 2020 but withdrawn after concerns about costs and a short deadline. That rule only applied to Medicaid managed care, the Children’s Health Insurance Program and ACA plans, while the new version would apply also to MA plans.
From Capitol Hill, Roll Call reports the FY 2023 National Defense Authorization Act is expected to rescind the Defense Secretary’s 2021 Covid vaccine mandate for U.S. service members. “Congressional leaders are aiming to introduce the final compromise NDAA version as soon as Tuesday, with House floor action possible later in the week.”
From the infectious disease front —
Bloomberg Prognosis tells about a study confirming the Paxlovid rebounds have been blown out of proportion.
Pfizer has asked the Food and Drug Administration for an emergency use authorization applicable to its bivalent Omicron vaccine designed for children at least six months old and not over four years old.
The Health and Human Services Secretary has confirmed reported plans to end the mpox public health emergency when the current declaration expires at the end of January 2023. “But we won’t take our foot off the gas – we will continue to monitor the case trends closely and encourage all at-risk individuals to get a free vaccine.”
MedPage Today interviews Demetre Daskalakis, MD, MPH, the deputy coordinator of the White House Monkeypox Response Team, about the course of the illness since it erupted in the summer
Influenza hospitalizations this early in the season are higher than they have been in a decade, according to the CDC, with 14 pediatric deaths reported so far.
“Since October 1, there have already been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu,” said CDC Director Rochelle Walensky, MD, MPH, on a call with reporters on Monday, held in part to kick off National Influenza Vaccination Week. * * *
This year, influenza vaccines are “well matched to the viruses currently circulating,” she added. The flu shots contain protection for two influenza A and two influenza B virus strains. Of influenza A viruses detected and subtyped this season, 79% have been A(H3N2) and 21% have been A(H1N1).
The CDC recommends influenza vaccination particularly for children, immunocompromised individuals, pregnant women, and people 65 and over.
It was not clear if the pediatric deaths reported so far this season involved unvaccinated children, but Fryhofer noted that previous data showed about 80% of influenza deaths occur in unvaccinated persons.
Pregnant women who get the flu shot also protect their newborns, who are not eligible for vaccination before they are 6 months of age, Fryhofer said. “If you’re not doing it for you, do it for your baby.”
For context, here are the flu case and death statistics from the last flu season before Covid struck, October 2019 through March 2020.
2019 – 2020 Winter CDC Fluview
3/28/20
Flu Deaths
24,000
Flu Cases
39,000,000
The flu is a highly contagious, dangerous disease.
NPR Shots offers consumer advice should they counter pharmacy shelves with a low or no supply of anti-fever drugs.
From the telehealth front, Health Leaders Media tells us
According to a survey commissioned by America’s Health Insurance Plans, almost 70% used telehealth in the past year because it’s more convenient than in-person care, and almost 80% say telehealth makes it easier to seek out care.
Almost 50% used telehealth because they were unable to make an in-person appointment, while 24% said they wanted to save money.
Some 36% used telehealth just once over the past year, while 53% used it between two and five times.
From the mental healthcare front, Health Payer Intelligence reports
CareFirst BlueCross BlueShield (CareFirst) is providing community-based organizations with nearly $8 million in grants to help improve behavioral healthcare access and quality for underserved youth.
The COVID-19 pandemic exacerbated the mental and behavioral health crisis among children, adolescents, and families. In response, CareFirst is investing in 19 community-based organizations in Maryland, Washington, DC, and Northern Virginia.
“CareFirst recognizes that behavioral health is an essential part of overall health, which includes a continuum of conditions ranging from severe mental health disorders to the emotional, psychological, and social factors that affect a person’s overall wellbeing,” Destiny-Simone Ramjohn, PhD, vice president of community health and social impact at CareFirst, said in the press release.
Kudos
From the Rx coverage front, Fierce Healthcare informs us
Express Scripts, which is part of Cigna’s Evernorth subsidiary, said Monday that it will add biosimilars for Humira to its largest formularies as preferred products available for patients with inflammatory conditions. Like other major PBMs, Express Scripts sees significant potential in biosimilars to help address the massive costs associated with specialty drugs.
Specialty drugs account for just 2% of prescriptions but drive half of drug spending.
In October 2021, Express Scripts announced that it would put Semglee, the first Food and Drug Administration-approved interchangeable insulin biosimilar, on its National Preferred Formulary for 2022. The company estimates that this move generated $20 million in savings in the first year.
From the federal government employee benefits front, Federal News Network relates
The Office of Personnel Management plans to suspend applications for the Federal Long Term Care Insurance Program for two years beginning Dec. 19, in anticipation of a sizeable rate hike.
OPM announced the unusual measure last month in the Federal Register, and noted that federal workers who submit their applications by the deadline will still be considered for enrollment. FLTCIP was created in 2002 and assists with health care costs for participants who need help with daily personal functions, or who have a severe cognitive illness, and covers home care, nursing home or assisted living benefits.
“OPM is suspending applications for coverage in FLTCIP to allow OPM and the FLTCIP carrier to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency wrote.
The program will continue to operate normally for current enrollees, although they will not be able to apply to increase their coverage. There are currently around 267,000 federal workers and retirees participating in the insurance plan, and OPM typically receives only a few thousand applications to enroll per year.
The decision to suspend applications for the program came after John Hancock Life and Health Insurance Co., the contractor that administers the program, informed OPM that it is likely that there will a premium increase sometime next year.
Finally, the Wall Street Journal offers an interesting article about medical research that is “uncovering links between your ‘subjective age’ [as opposed to your chronological age] and your future health and longevity.”
The continuing resolution funding the federal government expires at 11:59 pm on Friday December 16.
The Federal Employee Benefits Open Season ends at 11:59 pm, in the location of the enrollee’s electronic enrollment system, on Monday, December 12, 2022.
The Medicare Open Enrollment period ends this Wednesday, December 7.
From the Rx coverage front, the Wall Street Journal reports on
A shortage in the weight loss drug Wegovy, “missing out on hundreds of millions of dollars in sales and squandering a head start before a rival could begin selling a competing product. * * * [Wegovy manufacturer’ Novo lists Wegovy at $1,349 a month. Some commercial insurers cover the drug.” OPM has encouraged FEHB carriers to offer coverage of this drug.
A CVS Health effort to improve pharmacy efficiency with “a system [currently being tested] that allows pharmacists to process prescriptions in part remotely, a move it said could improve store working conditions and the experience for customers as the company grapples with a shortage of pharmacists.”
From the mental healthcare front, Health Payer Intelligence tells us
Mental healthcare services utilization and network size have grown significantly since 2019 among Blue Cross Blue Shield of Massachusetts (“Blue Cross”) members, according to data from Blue Cross.
Mental healthcare services utilization grew by 100 percent in the timeframe that Blue Cross examined. At the same time, Blue Cross’s mental healthcare network grew by 46 percent.
“As the need for mental health services continues to grow, access to convenient and affordable care is critical,” said Andrew Dreyfus, president and chief executive officer of Blue Cross. “By expanding and diversifying our mental health network, we’re ensuring that our members are able to find and receive the high-quality care they need, when they need it.”
The mental healthcare provider network swelled to a total of 18,000 clinicians. With the growth in utilization, Blue Cross plans to expand its network further. The payer will do this by working with national mental healthcare provider groups as well as expanding its virtual care mental health groups in 2023. * * *
Also worth reading is this Journal article about a 24-year-old military wife who went through drug addiction hell and came out a new person with help from her family, the Missouri prison where she was housed, and a fellow inmate. The article illustrates the importance of Blue Cross of Massachusett’s efforts to expand mental health coverage and various efforts to reduce drug addiction and overdose deaths.
From the medical research front, the Wall Street Journal offers an essay about breast cancer written by a medical historian and breast cancer patient Dr. Lindsey Fitzharris. What grabbed the FEHBlog’s eye is the article’s conclusion:
The cofounders of BioNTech recently announced that vaccines targeting cancer may be available before the end of the decade. Researchers at Duke University are already developing a vaccine that targets mutations commonly arising in people with certain types of advanced breast cancer. Using the same mRNA technology deployed against Covid-19, these types of vaccines would not be administered prophylactically but, rather, used as a treatment to trigger a stronger immune response in patients with locally recurrent or metastatic disease. When it comes to conquering breast cancer, future medical historians will have plenty to write about.
From the innovation front, Senior Living explains how to use Apple AirPods as hearing aids. MedTech Dive adds
Apple AirPods Pro earbuds have the potential to be a hearing aid for adults with mild to moderate hearing loss, according to a paper published in iScience.
Researchers found the earbuds meet four of the five standards for personal sound amplification products and perform comparably to hearing aids in terms of speech perception in quiet environments.
The study suggests that some consumer earbuds can function as hearing aids to potentially further lower the cost and address the stigma associated with the technology.
It’s also worth calling attention to the HHS Agency for Healthcare Quality and Research’s Effective Health Care Program’s website.
The Effective Health Care (EHC) Program improves the quality of health care by providing the best available evidence on the outcomes, benefits and harms, and appropriateness of drugs, devices, and health care services and by helping health care professionals, patients, policymakers, and health care systems make informed health care decisions. The EHC Program achieves this goal by partnering with research centers, academic institutions, health professional societies, consumer organizations, and other stakeholders to conduct research, evidence synthesis, evidence translation, dissemination, and implementation of research findings.
From the Federal Employees Benefit Open Season front, Tammy Flanagan, writing in Govexec, explains the relationship between FEHB and Medicare coverage for the benefit of annuitants over age 65.
From the OPM front, Govexec and Federal News Network discuss an OPM management report released yesterday that includes more details on OPM’s 2022 Federal Employee Viewpoint Survey.
From Capitol Hill, Medpage Today informs us that “Telehealth, Mental Health Likely Topics for the New Congress in 2023, Experts Say.” In this regard, today the bipartisan leadership of the Senate Finance Committee “released a [fifth and final mental health parity] discussion draft including policies aimed at improving mental health parity in Medicare and Medicaid and helping to put access to mental health and substance use disorder (SUD) services on par with physical health care. Mental health parity includes a set of laws aimed at ensuring mental and physical health care are covered equally by health insurance. * * * The full text of the discussion draft is available here. A summary of all provisions released by the committee as a part of the bipartisan mental health effort, including mental health parity, is available here.”
COVID-19 hospitalizations have ticked up nationwide in recent weeks amid concerns of a potential winter surge, according to data tracked by The New York Times.
As of Nov. 29, the nation’s daily hospitalization average was 31,125, up 12 percent over the last 14 days. This figure is still down significantly from the more than 800,000 daily hospitalizations recorded during the peak of last winter’s omicron surge.
People with acute respiratory illness during the pandemic suffered similar levels of poor well-being in the months afterward whether they tested positive for SARS-CoV-2 or not, a registry study showed.
In a cohort of people who all had initial symptoms suggestive of COVID-19, those who had moderate to severe scores at 3 months on the pain, mood, and other quality-of-life measures on the Patient-Reported Outcomes Measurement Information System (PROMIS) scale were actually less likely to have tested positive for the coronavirus as to have had other causes of illness (39.6% vs 53.5%, P<0.001).
From the public health front —
MedPage Today explains how patients can try to distinguish among different respiratory illnesses, including RSV and the flu because at home testing is unavailable.
The Biden administration looks to end its public health emergency declaration for mpox — the virus formerly known as monkeypox until recently — a sign that officials believe they’ve brought the unprecedented outbreak under control, POLITICO’s Adam Cancryn reports.
Health officials are likely to issue a 60-day notice later this week for winding down the declaration, two people with knowledge of the matter told POLITICO, putting it on track to expire by Jan. 31. The decision isn’t yet final and could still change, the people cautioned. * * *
Some administration officials see the potential unwinding of the mpox emergency declaration as a test run for eventually ending the yearslong Covid emergency — a more complex challenge — that Biden aides expect to happen at some point next year.
From the Affordable Care Act and No Surprises Act front
The American Hospital Association (“AHA”) informs us
The Centers for Medicare & Medicaid Services seeks public input on topics related to essential health benefits — items and services that all non-grandfathered health plans in the individual and small group markets must cover under the Affordable Care Act. The agency is requesting feedback on how essential health benefits may need to be updated to reflect changes in medical evidence and scientific advancement, address gaps in coverage and health equity, or remove barriers to accessing services. In particular, CMS seeks feedback on essential health benefits related to maternal health, behavioral health and prescription drug coverage. The agency will publish the request for information in the Dec. 2 Federal Register, with comments accepted for 60 days.
and
AHA today urged the Centers for Medicare & Medicaid Services not to establish a national directory of health care providers and services (NDH) at this time.
“The AHA shares CMS’ goals to improve patient access to provider information and to facilitate health information exchange and data reporting,” the association wrote. “We appreciate the commitment CMS has invested in striving to meet these objectives. However, we are concerned that adding one more provider directory requirement will not support patients in accessing the information they need about their care providers. In fact, adding an additional data source without sufficiently addressing how or why it differs from the myriad provider directories already in existence could further complicate patients’ ability to access accurate information. Meanwhile, such a requirement would add considerable, duplicative burden on providers. Additionally, we have significant reservations about the current state of readiness of the essential technology needed for a centralized data hub such as the NDH.”
Mercer Consulting offers insights on the prescription drug and healthcare spending reports that health plans must submit to the federal government by December 27. Jingle bells.
Healthcare Dive reports that the Texas Medical Association has filed another lawsuit challenging different aspect of the independent dispute resolution rule. Haven’t the TMA lawyers heard about the opportunity available under the Federal Rules of Civil Procedure to amend their existing complaint?
The Food and Drug Administration approved the first therapy using bacteria from stool samples to treat a bowel disorder on Wednesday, paving the way for several similar treatments in development.
The drug, called Rebyota, is given as a one-dose treatment for Clostridium difficile infections, commonly known as C. diff., in which the toxin-producing bacteria disrupts the normal balance in a person’s digestive system. Rebyota is designed to restore balance by introducing good bacteria taken from donor stool samples.
“We are delighted that FDA has approved the first fecal microbiome restoration therapy for recurrent C. diff. This is an enormous step forward for the nearly 200,000 people who battle rCDI each year,” said Christian John Lillis, the executive director of the C. diff advocacy organization the Peggy Lillis Foundation.
Amgen released detailed data on Thursday suggesting an early-stage drug can induce significant weight loss in patients with obesity, with less frequent dosing than current treatments but a safety profile that remains unclear.
The results for the molecule, codenamed AMG133, throw Amgen in a long-gestating race with other major drugmakers that burst into the popular press this year.
Eli Lilly and the diabetes giant Novo Nordisk both market drugs that were recentlyshown to lower body weight by around 15% to 20% after a little over a year. (Lilly’s is currently approved only for diabetes, but it plans to submit for obesity next year.) The injectables have been highly sought after by both obesity specialist physicians, who have long searched in vain for something safe and effective to offer their patients, and celebrities hoping to look svelte in their next appearance.
From the miscellany department —
Beckers Hospital Review interviews a Kaiser Permanente expert about their successful use of remotely monitoring patients with diabetes and high blood pressure. The monitors deliver their results to Kaiser Permanente’s electronic health records for 40,000 members. Kudos.
Beckers also lets us know about large hospital systems that are having a profitable 2022.
Elon Musk’s brain-machine interface company Neuralink aims to put its first implant in a human subject in the next six months, he said during an event Wednesday.
Musk said the company has been “working hard to be ready for our first human,” and has submitted most of the required paperwork to the Food and Drug Administration to launch a study in humans. The company — which is designing a device to translate the brain’s signals into actions — also announced it will first focus specifically on two applications: restoring human vision, and helping people who can’t move their muscles to control devices like smartphones or even return the ability to move to people with severed spinal cords, Musk said.
Though it’s starting with certain parts of the brain, Musk said Neuralink’s long-term goal is to create a system that can translate impulses from the entire brain into actions.
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