Tuesday Tidbits

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

November is awareness month for diabetes and C. Diff. Looking back at October, Medscape informs us

Maintaining a healthy body weight, being physically active, and following a healthy dietary pattern can help women live longer after breast cancer diagnosis, according to a major new analysis of the latest research.

From the Federal Employee Benefits Open Season front, the Federal Times offers its consumer guide.

It was a big day on the Medicare front —

The American Hospital Association reports

The Centers for Medicare & Medicaid Services [CMS] late today posted a final rule on its website that will increase Medicare hospital outpatient prospective payment system rates by a net 3.8% in calendar year 2023 compared to 2022. This update is based on a market basket percentage increase of 4.1%, reduced by 0.3 percentage points for productivity. [AHA calls the increase insufficient.] * * *

CMS finalized the payment policy for CY 2023 of average sales price (ASP) +6% for drugs and biologicals acquired through the 340B Program as a result of the unanimous Supreme Court decision in American Hospital Association v. Becerra.

CMS also finalized proposals to establish the Rural Emergency Hospital (REH) model, a new provider type for eligible critical access hospitals and small rural hospitals beginning in Jan. 1, 2023. The rule finalized proposals related to model payment, covered services, conditions of participation, and quality measurements.

[and]

The Centers for Medicare & Medicaid Services today released on its website its calendar year 2023 final rule for the physician fee schedule. The rule will cut the conversion factor to $33.06 in CY 2023 from $34.61 in CY 2022, which reflects the expiration of the temporary 3% statutory payment increase; a 0.00% conversion factor update; and a budget-neutrality adjustment.

From HHS.gov

For a fact sheet on the CY 2023 OPPS/ASC Payment System Final Rule (CMS-1772-FC), please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-2

For a fact sheet on Rural Emergency Hospitals, please visit: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-1

For a fact sheet on the CY 2023 Physician Fee Schedule Final Rule, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule

For a fact sheet on final changes to the CY 2023 Quality Payment Program, please visit: https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2136/2023%20Quality%20Payment%20Program%20Final%20Rule%20Resources.zip 

For a fact sheet on final changes to the Medicare Shared Savings Program, please visit: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule-medicare-shared-savings-program

For a CMS blog on behavioral health poliices, please visit: https://www.cms.gov/blog/strengthening-behavioral-health-care-people-medicare-0?check_logged_in=1

What’s more, Beckers Hospital Review informs us

CMS evaluated two and a half years of readmission cases for Medicare patients through the Hospital Readmissions Reduction Program and penalized 2,273 hospitals that had a greater-than-expected rate of return, according to a Nov. 1 report from Kaiser Health News.

The average payment reduction was 0.43 percent, the lowest rate reduction since 2014. Reductions will be applied to each Medicare payment to the affected hospitals from Oct. 1 through next September. It is expected to cost the hospitals $320 million over the 12-month period. 

The report notes that the COVID-19 pandemic caused turmoil in hospitals and that CMS decided to exclude the first half of 2020 from the report due to the chaos. CMS also excluded Medicare patients who were readmitted with pneumonia across all three years because of the difficulty distinguishing them from COVID patients. 

From the Affordable Care Act preventive services front, Healio tells us

The U.S. Preventive Services Task Force has released two final recommendations on the use of hormone therapy for the primary prevention of chronic conditions in postmenopausal people.

The recommendations advocate against the use of menopausal hormone therapy (MHT) through a combination of estrogen and progestin in postmenopausal people, and MHT through estrogen alone in postmenopausal people who have had a hysterectomy.

Both are D-grade recommendations and are consistent with the USPSTF’s previous recommendations on the treatment made back in 2017.

James Stevermer, MD, MSPH, a task force member, also noted in the press release that the recommendations are only for those who are considering hormone therapy to prevent chronic conditions following menopause. 

“Those who wish to manage symptoms of menopause with hormone therapy are encouraged to talk with their health care professional,” he said.

From the prescription drug and vaccine development front —

STAT News reports

Pfizer’s maternal vaccine against the respiratory syncytial virus [RSV] reduced the rate of severe illness in newborns by 81.8%, the company said Tuesday, meeting the goal of a pivotal study.

The company said that it plans to file the data on the vaccine with regulators by the end of the year and that it expects an eight-month review.

RSV is a common cause of illness and infection in young infants. By giving the vaccine during pregnancy, researchers hope antibodies generated by mothers would be transferred to infants. Currently, the pertussis vaccine and the influenza vaccine are given during pregnancy for this reason.

Bloomberg Prognosis tells us

Vertex Pharmaceuticals, a Boston-based biotech company, * * * is testing a non-opioid drug for acute pain. Vertex’s drug, VX-548, aims to block the Nav1.8 sodium channel, which acts like a gate allowing pain signals to travel from the nerves to the brain.

VX-548 met its goals in late-stage trials evaluating the drug in people who underwent a bunionectomy or an abdominoplasty, the formal name for a tummy tuck. Vertex will run the same studies with more patients before seeking regulatory approval. The company hasn’t disclosed when data will be available beyond saying the trials will be quick since patients receive the drug for only 48 hours. Vertex is also testing VX-548 in nerve pain and eventually wants to see if it works for chronic pain.

If VX-548 passes its next big tests, it could offer a new option for people recovering from surgery or other medical procedures. Of course, plenty of other pain drugs that looked promising early on in testing never reached the market.

Fortunately, scientists are investing time and money on a variety of alternatives for pain.

From the Rx coverage front, BioPharma Dive relates

Eli Lilly’s new diabetes medicine Mounjaro outpaced Wall Street sales forecasts during the third quarter, fueled by strong patient demand and widening insurer coverage.

U.S. sales of the drug totaled $97 million between July and September, Mounjaro’s first full quarter on the market since its May 13 approval by the Food and Drug Administration. Payments related to a collaboration agreement with Mitsubishi Tanabe Pharma in Japan pushed global revenue for the quarter to $187 million, well above the consensus analyst forecast of $82 million.

“We have seen unprecedented demand for Mounjaro’s Type 2 diabetes launch in the U.S.,” said Anat Ashkenazi, Lilly’s chief financial officer, on a Tuesday call with analysts. 

Lilly is also conducting a study to support an FDA marketing application for Mounjaro to be prescribed for weight loss.

Notably, Mounjaro showed a potent effect in reducing trial participants’ weight, a benefit that was also observed in a large study specifically assessing it as an obesity treatment. While it’s currently only approved to treat Type 2 diabetes, its potential as a medicine for both chronic conditions has made it one of Lilly’s most important products.

Lilly is currently conducting a second study in obesity and plans to complete an approval application in that indication should results, expected in April next year, also prove positive. 

In U.S. healthcare business news, MedTech Dive reports

Johnson & Johnson agreed to acquire Abiomed, a Danvers, Mass.-based maker of heart pumps, for $16.6 billion. 

The deal will contribute to J&J’s cardiovascular portfolio, complementing its Biosense Webster electrophysiology business, BTIG Analyst Marie Thibault wrote in a research note on Tuesday. 

The deal has already been approved by both companies’ boards of directors and is expected to close before the end of the first quarter of 2023.

Finally, check out the NIH Director’s blog discussing “How the Brain Differentiates the ‘Click,’ ‘Crack,’ or ‘Thud’ of Everyday Tasks.”

If you’ve been staying up late to watch the World Series, you probably spent those nine innings hoping for superstars Bryce Harper or José Altuve to square up a fastball and send it sailing out of the yard. Long-time baseball fans like me can distinguish immediately the loud crack of a home-run swing from the dull thud of a weak grounder. 

Our brains have such a fascinating ability to discern “right” sounds from “wrong” ones in just an instant. This applies not only in baseball, but in the things that we do throughout the day, whether it’s hitting the right note on a musical instrument or pushing the car door just enough to click it shut without slamming.

Now, an NIH-funded team of neuroscientists has discovered what happens in the brain when one hears an expected or “right” sound versus a “wrong” one after completing a task. It turns out that the mammalian brain is remarkably good at predicting both when a sound should happen and what it ideally ought to sound like. Any notable mismatch between that expectation and the feedback, and the hearing center of the brain reacts.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Omicron and siblings front, the National Institutes of Health announced

As SARS-CoV-2 — the coronavirus that causes COVID-19 — continues to spread, its genetic material mutates, leading to viral variants. These changes happen most often in the virus’s spike protein, which allows the virus to attach to and invade cells.

Because most COVID-19 vaccines are targeted to the spike protein, antibodies resulting from vaccinations provide less immune protection against variants. This increases people’s risk of getting COVID-19 despite vaccination.

Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) are exploring a different idea for vaccines. Instead of focusing on the SARS-CoV-2 spike protein, they are studying the virus’s nucleocapsid (N) protein, which rarely mutates.1 The N protein could be the key to creating a future universal vaccine to fight emerging variants.

Fingers crossed.

In other public health news, the American Hospital Association tells us

Overall cancer death rates continued to decline between 2015 and 2019 for men, women and children and all major racial and ethnic groups, according to the latest Annual Report to the Nation on the Status of Cancer. The overall death rate fell an average 2.3% per year in men and 1.9% per year in women, led by declining rates for lung cancer and melanoma. Death rates increased in men for cancers of the pancreas, brain, bones and joints and in women for cancers of the pancreas and uterus. New cancer cases remained stable for men and children between 2014 and 2018, but increased for women, adolescents and young adults. This year’s report also highlights trends in pancreatic cancer, as well as racial and ethnic disparities in incidence and death rates. 

MedCity News points out three reasons why Americans are underutilizing primary care.

From the Federal Employee Benefits Open Season front, OPM informed agency benefit officers

Please see the attached document listing the 84 FEHB plan choices where the enrollee share of premiums for the Self Plus One enrollment type is higher than for the Self and Family enrollment type for the 2023 plan year.

Please share this information with your employees and inform them that enrollees who wish to cover one eligible family member may elect either the Self and Family or Self Plus One enrollment type.

Enrollees should carefully check the 2023 rates of their current plan and any other plan choices they are considering for 2023.  For enrollees wishing to change, they must do so during Open Season, which is held from November 14th through December 12th.

In all of these cases, the self and family premium exceeds the self plus one premium. Nevertheless, these anomalies occur because FEHB family sizes are small and the self plus one government contribution is lower than the self plus family government.

A FedWeek expert identifies eight mistakes to avoid when shopping for a health plan during the Open Season.

The Kaiser Family Foundation released its 2022 Employer Health Benefits Survey.

In 2022, the average annual premiums for employer-sponsored health insurance are $7,911 for single coverage and $22,463 for family coverage. These amounts are each similar to the average premiums in 2021. In contrast to the lack of premium growth in 2022, workers’ wages increased 6.7% and inflation increased 8%.2 This difference may be due to the fact that many of the premiums for 2022 were finalized in the fall of 2021, before the extent of rising prices became clear. As inflation continues to grow at relatively high levels, we could potentially observe a higher increase in average premiums for 2023 than we have seen in recent years.

In other federal employment news,

  • FedWeek offers federal and postal employees advice on getting a head start on planning for retirement.

More federal employees are working onsite and more often this year than last, continuing a downward trend since the mid-2020 peak in offsite work caused by the pandemic, the Federal Employee Viewpoint Survey showed.

Thirty-six percent said they are present at their worksite all of the time, up from 29 percent in 2021 and 17 percent in 2020, while 18 percent said they had not been present onsite this year, down from 22 and 30 percent. The percentage who said they are onsite less than a quarter of the time fell over the three years from 24 to 20 and now 15.

While the share of full-time telework is down, many of those who are continuing to telework do so a substantial portion of their time, however. Those reporting that they telework three or four days a week now stands at 25 percent, up from 11-12 percent in the prior years, while those doing it one or two days a week stands at 17 percent, up from 8 and 10 percent.

and shares statistics on federal employee use of the new paid parental leave benefit as reported in the Federal Employees Viewpoint Survey — “Four percent of employees took at least some of that time over the last year.”

From the Affordable Care Act front, the Kaiser Family Foundation released its annually updated fact sheet on Preventive Services Covered by Private Health Plans under the ACA. “This fact sheet summarizes the federal requirements for coverage for preventive services in private plans, major updates to the requirement, and recent policy activities on this front.”

From the telehealth front —

  • Beckers Hospital Review offers an interview on the topic of “Telesitting, remote maternity care: Where telehealth is going next at Kaiser Permanente.”
  • Fierce Healthcare informs us “COVID-era emergency department patients who had follow-up appointments via telehealth more often returned to the ED or were hospitalized than those who followed up with doctors in person, according to a new retrospective study [published in JAMA Network Open]. * * * The researchers noted their investigation had several limitations, such as no data on certain “complex” social determinants of health like unemployment and whether patients received a follow-up outside of the health system. The findings “need to be considered in the context of a substantial body of science demonstrating the benefits of telemedicine,” such as those that found lower rates of rehospitalization in certain chronic condition populations tied to telehealth use.”
  • Healthcare Dive reports “Teladoc reported better than expected revenue in the third quarter, on the back of its mental health business, BetterHelp, and issued moderate fourth-quarter guidance, leading some industry watchers to say the telehealth vendor is setting itself up for achievable growth after uncertainty contributed to stock losses this year.”

In other U.S. healthcare business news

  • Politico brings us up to date on the low participation rate in the new federal designation of rural emergency hospitals. It’s back to the drawing board.
  • Beckers Payer Issues reports that CareFirst and Johns Hopkins Medicine “have signed a multiyear contract following a dispute over reimbursement rates that would have left hundreds of thousands of people out of network.” Cheers to that.
  • MedTech Dive informs us, “Labcorp lowers 2022 forecasts after Q3 profit falls on labor costs, declining COVID-19 revenue.”
  • Employers should know that the Equal Employment Opportunity slide has updated its workplace notice. HR Dive warns us, “Hang new EEO poster ‘as soon as possible,’ EEOC advises. An EEOC spokesperson also told HR Dive how employers with remote and hybrid employees should handle the poster.”

From the Rx coverage front

  • Reuters relates that “The U.S. Food and Drug Administration has delayed a meeting of its advisory panel to discuss Perrigo Co Plc’s (PRGO.N) over-the-counter (OTC) contraceptive, the drugmaker said on Wednesday. The meeting, scheduled for Nov. 18, was delayed to review additional information, and no new date has yet been set, in a setback for what was expected to be the first approved daily OTC birth control pill in the United States.”
  • STAT News calls our attention to this news

Amid sporadic shortages of a drug that is essential in preparing patients for lifesaving, cancer-fighting treatments, one manufacturer has returned to the market — but is selling its medicine for 10 to 20 times the prices offered by the only other companies with available supplies.

Over the past week, Areva Pharmaceuticals began marketing vials of fludarabine at a wholesale price of $2,736, a much steeper cost than the $272 charged for the same dosage by Fresenius Kabi and the $109 price tag from Teva Pharmaceuticals, according to data from IBM Micromedex, which gathers pricing data that is reported by manufacturers.

The move comes as hospitals around the U.S. grapple with persistent shortages of fludarabine, an older chemotherapy that is used during the run-up to bone marrow transplants in patients with a form of leukemia. More recently, the drug has also become a crucial tool in readying patients to undergo CAR-T cell therapy, a customized approach to fighting some cancers that involves re-engineering patient cells.

That’s a big bowl of wrong.

Let’s conclude with this wonderful piece of Govexec miscellany explaining the genesis of federal government shutdowns in the late 1970s.

Midweek update

Lincoln Memorial in the Fall

From the Federal Employee Benefits Open Season front —

  • FedWeek offers its Open Season report.

  • My Federal Retires explains Open Season options available to those with Medicare coverage.
  • Govexec promotes healthcare flexible savings accounts, which are only available to federal and Postal employees. The FEHBlog was surprised to learn that “less than 20% of active feds have an FSA.” The article explains the mechanics of the FSA, among other things.

In other federal employee benefits news, Reg Jones, writing in the Federal Times, tells us how to calculate federal disability retirement benefits and answers a question about survivor annuitant coverage.

In other OPM news, Govexec tells us how the OPM Director is celebrating Work and Family Month.

From the Omicron and siblings front, Beckers Hospital Review informs us that “Omicron subvariants BQ.1 and BQ.1.1 — dubbed “escape variants” for their immune evasiveness — are steadily gaining prevalence in the U.S. and now account for more than 16 percent of all COVID-19 cases confirmed nationwide, CDC data shows.”

Beckers adds

Data analysis from the Los Angeles-based Smidt Heart Institute at Cedars-Sinai found heart attack deaths rose significantly with COVID-19 surges, including omicron surges.

Heart attack deaths were on the decline before the pandemic. However, during COVID-19 surges, deaths increased — especially among individuals ages 25-44, according to an Oct. 24 release shared with Becker’s.

In other public health news

A new national study has suggested that chemical hair straighteners could pose a small risk for uterine cancer. Rates of the disease are still relatively low, said Dr. Alexandra White, head of the environment and cancer epidemiology group of the National Institute of Environmental Health Sciences and the lead author on the study. The research also did not definitively show that hair straighteners cause cancer. But the findings are cause for concern, she said.

Rates of uterine cancer have been increasing in the United States, particularly for Black and Hispanic women. The number of cases diagnosed each year rose to 65,950 this year, compared to 39,000 15 years ago. Black women are also more likely to have more aggressive cases of the cancer, Dr. White said, and the study showed they were disproportionately more likely to use hair straighteners.

If you have used chemical hair straighteners, you do not need to seek out medical attention or consult your doctor unless you have symptoms for uterine cancer, said Dr. Otis Brawley, an oncologist at Johns Hopkins University. But women should regularly see a gynecologist, and be aware of the risk factors and early signs of the disease. [The article also explains uterine cancer risk factors and symptoms.]

Roll Call tells us

The Biden administration is preparing a comprehensive initiative to fight hepatitis C that would streamline testing and treatment and secure an agreement with drugmakers to bring down the cost of treatment of the disease, which has spiked during the pandemic.

Francis Collins, special project adviser to President Joe Biden and former longtime director of the National Institutes of Health, said Monday the administration hopes to secure some funding this year for the yet to be formally unveiled initiative.

He said he has briefed Biden on the plan, and the Office of Management and Budget is “enthusiastic about figuring out how to fit this into the budgetary requests.”

The National Institutes of Health announced

Long-term use of electronic cigarettes, or vaping products, can significantly impair the function of the body’s blood vessels, increasing the risk for cardiovascular disease. Additionally, the use of both e-cigarettes and regular cigarettes may cause an even greater risk than the use of either of these products alone. These findings come from two new studies supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).  

From the Food and Drug Administration front —

BioPharma Dive informs us

The Food and Drug Administration on Tuesday approved a first-of-its-kind treatment for multiple myeloma from Johnson & Johnson, but put restrictions on its use due to the drug’s potentially dangerous side effects.

Healthcare providers offering the drug, which will be sold as Tecvayli, will need to follow guidelines set up in a Risk Evaluation and Mitigation Strategy, or REMS. Prescribers and pharmacies must be certified in the Tecvayli REMS program, which will focus on monitoring and counseling for patients.

The FDA has required REMS for dozens of medicines since the program was authorized by Congress in 2007. The list includes Bristol Myers Squibb’s cell therapy Abecma, which won approval for multiple myeloma last year.

Fierce Pharma relates

AstraZeneca’s long-troubled cancer immunotherapy tremelimumab has finally secured its first FDA approval, but the regulatory blessing comes in what could be an increasingly competitive tumor type.

To be sold under the brand name Imjudo, tremelimumab has won an FDA go-ahead in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi for treating unresectable hepatocellular carcinoma, the most common type of liver cancer.

The FDA nod officially puts an end to the streak of clinical trial failures that tremelimumab endured over recent years in multiple cancer types, including non-small cell lung cancer, head and neck cancer and bladder cancer. But while the CTLA-4 inhibitor has now crossed the regulatory finish line, a commercial fight lies ahead.

From the Medicare front – –

  • STAT News discusses a new CMS policy aimed at controlling dialysis prices.
  • Fierce Healthcare tells us “Starting next year, insurers will not be able to air any television ads for Medicare Advantage (MA) plans before getting approval from federal regulators.” Tough break for Joe Namath.  

From the ACA marketplace front —

  • The Department of Health and Human Services discusses its plans for the upcoming Open enrollment period.
  • Benefits Pro discusses the popularity of alternative health reimbursement accounts which allow employers to offer marketplace coverage to their employees.

Speaking of account-based health plans, the Plan Sponsors Council of America released its 2022 benchmarking survey of health savings accounts.

From the U.S. healthcare business front —

  • Health Data Management assesses whether Amazon and Walmart can build effective value based care models.

Monday Roundup

Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, Govexec takes “a closer look at 2023 FEHB premiums.”

On a related note, Health Payer Intelligence informs us

Member experience is key to member retention and, in order to boost member experience, payers must consider whether they are offering easy access to care and straightforward care navigation, according to an Accenture report.

The organization surveyed nearly 21,000 Americans who are consumers of both payers and providers.

Reg Jones, writing in the Federal Times, answers a “lightning round” of cost of living adjustment questions posed by federal and postal employees and annuitants.

In other OPM news, Federal News Network reports

With a fast-approaching deadline to apply for a Public Service Loan Forgiveness limited-time waiver, the Office of Personnel Management said agencies should help federal employees with their applications.

If they have the documentation available, agencies can certify a current employee’s entire work history, including that individual’s time working previously at other agencies.

“The federal employee should present a separate PSLF form for each federal agency and period of employment for which they are seeking certification and the agency official should certify each form as appropriate,” OPM wrote in an Oct. 24 memo.

Employment certification forms are just one of the requirements to apply for the temporary PSLF waiver, which expires on Oct. 31.

From the Omicron and siblings front, the New York Times reports

Younger people have also been less likely to receive boosters than the original vaccinations, and only about one-third of people of all ages have received any booster, The New York Times vaccine tracker indicates. But seniors, who constitute 16 percent of the population, are more vulnerable to the virus’s effects, accounting for three-quarters of the nation’s 1.1 million deaths.

“From the beginning, older people have felt the virus was more of a threat to their safety and health and have been among the earliest adopters of the vaccine and the first round of boosters,” said Mollyann Brodie, the executive director of public opinion at Kaiser Family Foundation, which has been tracking vaccination rates and attitudes.

Now Kaiser’s most recent vaccine monitor survey, published last month, has found that only 8 percent of seniors said they had received the updated bivalent booster, and 37 percent said they intended to “as soon as possible.” As a group, older adults were better informed than younger respondents, but almost 40 percent said they had heard little or nothing about the updated bivalent vaccine, and many were unsure whether the C.D.C. had recommended it for them.

(Currently the C.D.C. recommends that individuals over age 5 receive the bivalent vaccine, which is effective against the original strain of Covid-19 and the Omicron variant, if two months have passed since their most recent vaccination or booster.)

The article adds

Kaiser surveys have found that doctors and other health care professionals are trusted sources of information, and the older population is in frequent contact with them.

“If more providers recognized that four in 10 older adults don’t realize there’s a new booster and they should get it, that’s a lot of opportunity to make an impact,” Dr. Brodie said.

While on patient-provider communications, the Washington Post points out a free National Institute of Aging online resource that helps older adults prepare for doctor’s visits.

From the telehealth front, mHealth Intelligence reports

Telehealth usage has dropped significantly since its peak during the pandemic, with visit volumes falling 37 percent from 73.7 million in the second quarter of 2020 to 46.4 million in the first quarter of 2022, according to a new report by market research firm Trilliant Health.

Further, telehealth’s popularity among patients appears to be waning. Less than half (48.7 percent) of patients who used telehealth in 2021 did so once, and only 6 percent used the care modality five to six times last year.

This data “suggests that expanded availability of virtual care options has not had a widespread impact on consumer preferences,” said Sanjula Jain, Ph.D., senior vice president of market strategy and chief research officer at Trilliant Health, in an email. * * *

Though the overall shifts in telehealth use indicate a move back to in-person care, certain sub-groups continue to flock to telehealth.

Telehealth continues to be widely used to access behavioral healthcare services, the report shows. In Q1 2019, 32.4 percent of all telehealth visits were related to behavioral healthcare. That figure spiked to 59.9 percent by Q1 2022.

For providers, “behavioral health presents the greatest opportunity, and deploying virtual behavioral health services can be a good way to reach broader populations, engage existing customers while bringing in new ones, and provide new revenue opportunities via engagement in other care services,” Jain said.

In addition, telehealth-enabled prescribing is on the rise, according to the report. Around 35 percent of antidepressants and anti-anxiety drugs were prescribed via telehealth in 2020 and 2021, compared to 1 percent in 2019.

In studies news, STAT News discusses the importance of fine-tuning artificial intelligence tools before releasing them for patient use and the cardiovascular differences between women and men.

Weekend update

Congress remains on the campaign trail this week.

This is Red Ribbon Week, “an ideal way for people and communities to unite and take a visible stand against drugs.”

Speaking of illegal drugs, the Wall Street Journal tells the stories of three “high achieving” New York City dwellers who died on one day in March 2021 due to fentanyl-laced cocaine delivered by a single dealer.

New York City authorities have been warning of the risks of unknowingly taking fentanyl in cocaine and of its increased presence in cocaine seized by police. Health officials put up posters and sent drink coasters to clubs warning cocaine users to start with a small dose and to have naloxone, an opioid reversal drug, on hand to counter an overdose. They are handing out fentanyl testing strips that can be used to test cocaine and other drugs for fentanyl’s presence.

Multiple people died within hours from tainted cocaine in Long Island, N.Y., and in Newport Beach, Calif., last year. Nine were killed in Washington, D.C., in January. Law-enforcement officials said dealers often use coffee grinders or other basic equipment to cut drugs and prepare them for sale, which can result in deadly batches.

From the FEHB front, Tammy Flanagan, writing in Govexec, advises federal and postal employees and annuitants on how to prepare for the upcoming Federal Employee Benefits Open Season. The FEHBlog’s advice is to stack your plan’s summary of benefits and coverage which is available on all FEHB plan websites against other plans in which you are interested. The summary of benefits and coverage, which is an Affordable Care Act requirement, is four double-sided pages including consumer-tested practical information.

From the Omicron and siblings’ front

  • STAT News reports “FDA’s vaccines chief [Peter Marks, MD] sees the possibility of more Covid boosters — sooner than he’d like.”

Pfizer is considering hiking the price of its COVID-19 vaccine by roughly four times what it currently charges as it prepares for sales in the U.S. to shift from government contracts to the private market.

The pharmaceutical company is targeting between $110 and $130 per adult vaccine dose after that transition, said Angela Lukin, Pfizer’s head of global primary care and U.S. president, on an analyst and investor call Thursday.

“We feel confident that this range will be seen as highly cost effective and definitely one that will help to enable and ensure appropriate access and reimbursement to the vaccine,” Lukin said on the call. Discussions with insurers are still in early stages, she added.

No doubt this charming development seeks to pressure Congress to add more federal Covid dollars in the lame-duck session following the November 8 Congressional election.

In other vaccine news, MedPage Today reports

  • The CDC’s vaccine advisors updated their recommendations to clarify when to administer the 20-valent conjugate pneumococcal vaccine (PCV20; Prevnar 20) in adults who previously received the 13-valent conjugate vaccine (PCV13; Prevnar 13).
  • Three doses of hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG; Heplisav-B) notched a perfect mark when it came to seroprotection for people with HIV who had never before been vaccinated against the hepatitis B virus (HBV), early results of a phase III trial showed.

In prescription drug development news, Fierce Healthcare points out “three drugs are set for FDA determinations soon.” The article explains why Optum says payers should take notice.

From the monkeypox front, Medpage Today adds

Cases of monkeypox are continuing to decline in the U.S., but the disease is still disproportionately affecting people of color, a White House official said.

“In the U.S., about 27,635 cases were reported as of yesterday,” Demetre Daskalakis, MD, White House National Monkeypox Response deputy coordinator, said at an online briefing Thursday. “We continue to have a decrease over time — we’re about 85% down from where we were at the peak of the outbreak. So that’s a lot of hopeful news, that we continue to see monkeypox going under better and better control.”

From the mental healthcare front, the Department of Health and Human Services “through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced more than $100 million this week in funding from the Bipartisan Safer Communities Act (BSCA) to states and territories for mental health emergency preparedness, crisis response, and the expansion of 988 Suicide & Crisis Lifeline services. BSCA, signed into law by President Biden earlier this year, provided unprecedented funding to address the nation’s mental health crisis and make our communities safer.”

From the maternal care front, Health Payer Intelligence informs us Blue Cross and Blue Shield of Michigan has “decided to go beyond traditional maternal healthcare benefits, such as prenatal and postpartum care coverage. They teamed up with a virtual care provider for women and family health, Maven, to offer a suite of solutions that integrated family care and maternal healthcare.”

From the SDOH front, Beckers Payer Issues relates

In a letter to HHS Secretary Xavier Becerra and Management and Budget Office Director Shalanda Young, AHIP explained its vision for how demographic data can be improved and standardized across the healthcare system. 

Five things to know about the association’s recommendations for improving demographic data:  

1. Current challenges with demographic data include the lack of specificity for questions on race. AHIP highlights that current census and HHS standards do not include an option for people to identify as Arab, Middle Eastern or North African. Additionally, AHIP recommends options should be tailored to the local area, depending on the populations that live there. 

2. Current demographic questions do not have an “I choose not to respond” option. AHIP advises that a lack of information about how demographic information is used can lead to a lack of trust from patients. 

3. Current regulations that require multiple providers and payers to collect demographic information lead to inconsistent results and greater burden on patients, AHIP says.

4. To reduce burdens on providers and patients, AHIP wants demographic data to be electronic and able to be shared with other places in the healthcare system with patient consent. 

5. AHIP wants a wide range of government agencies to adopt its recommendations for demographic data collection, which include questions on race, ethnicity, language preference, sexual orientation, gender, diability status, veteran status and spirtual beliefs. 

Read the full letter here.

Interesting approach.

From the miscellany department —

  • STAT New discusses weaknesses in traditional Medicare catastrophic coverage. FEHBlog suggests that Congress stop permitting Medicare supplemental plans to impose pre-existing condition limitations unless circumscribed by state law.
  • The Society for Human Resources Management tells us

Employee 401(k) contributions for 2023 will top off at $22,500—a $2,000 increase from the $20,500 cap for 2022—the IRS announced on Oct. 21. Plan participants age 50 or older next year can contribute an additional $7,500, up $1,000 from 2022. * * *

he limit on total employer-plus-employee contributions to defined contribution plans will increase to $66,000 in 2023, up by $5,000 from $61,000 in 2022. “This limit usually increases by $1,000 at a time but now it’s jumping five steps in one year,” Sit said.

The IRS announced the 2023 adjustments for 401(k) and similar defined contribution plans, and for defined benefit pension plan, in Notice 2022-55.

  • The American Hospital Association reports “The AHA and American Medical Association Oct. 19 filed a friend-of-the-court brief in support of a Texas Medical Association lawsuit claiming the revised independent dispute resolution process for determining payment for out-of-network services under the No Surprises Act skews the arbitration results in commercial insurers’ favor in ways that violate the compromise Congress reached in the Act.”
  • Business Insurance tells us “The U.S. Department of Justice has asked for more details on CVS Health Corp.’s proposed $8 billion deal to buy Signify Health, in a possible indication that the transaction will face a longer deal review rather than a quick approval, Reuters reports. The deal, announced last month, was expected to face a tough antitrust review even though the two companies do not compete directly in any market, according to experts.”
  • Following up on last Thursday’s post, RSV is a type of common cold according to the CDC.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

Let’s lead off with the OPM Inspector General’s new annual report on top management challenges facing the agency. This is the first such report of the current Inspector General Krista Boyd. The report’s FEHB Program concerns focus on prescription drug spending, eligibility issues, and the Postal Service Health Benefits Program.

As the FEHBlog has noted, FEHB prescription drug spending is not a unique FEHB issue. While the Inspector General’s report calls attention to these statistics:

As in prior years, drug costs continue to increase in the FEHBP. Currently, total FEHBP drug
costs (excluding drugs administered in an inpatient hospital setting) represent approximately 32
percent of total health care costs. Approximately 23 percent of total FEHBP health care costs are
attributable to the pharmacy benefit alone (drugs dispensed through outpatient pharmacies). As
of 2021, FEHBP pharmacy benefits represented more than $13 billion annually.

To place these statistics in context, the FEHB again calls attention to the fact that the FEHB Program has a large cadre of annuitants with primary Medicare Parts A and B coverage. This group understandably does not enroll for Medicare Part D prescription drug coverage. As a result, Medicare picks up the bulk of cost of FEHB hospital and doctor expenses for this group, while FEHB covers virtually of the pharmacy spending for this group. The FEHBlog is unaware of any other large employer in this situation because employers who have retiree health coverage generally rely on Medicare Advantage plans.

The saving grace found in Congress’s design of the FEHB Program is that all enrollees are in one risk pool per plan option which allows carriers to compete and also use group insurance principles to spread costs among all enrollees. Medicare prime annuitant and younger enrollees subsidize the more costly people in the middle.

The FEHBlog agrees with the Inspector General that the FEHB has eligility issues principally because OPM in contrast to every other employer in the U.S. reports enrollment and premiums separately. Typically health plans receive enrollment rosters known as HIPAA 820 standard electronic transactions that list each enrolled individual and the premium paid for that individual. This allows the health plan to systematically compare the roster and premiums against their records. A plan for example would know that OPM is paying it for self only coverage when according to the plan’s records the member has self plus one coverage.

OPM has been building a master enrollment index which is one of the steps that OPM has been taking in the right direction. In the FEHBlog’s opinion, implementing the HIPAA 820 standard transaction would take eligibility off of the Inspector General list of management challenges.

As for the Postal Service Health Benefits Program, the FEHBlog has confident that OPM, with support from the Postal Service and carriers, to launch the PSHBP on time January 1, 2025.

Here’s a Govexec article on the report which takes a broader perspective.

From Omicron and siblings front —

  • STAT News reports on the federal government’s and drug manufactures efforts to close the developing treatment gap for immunocompromised folks who contract certain strains for Omicron, e.g., BA 4.2.y and BQ.1

[Monoclonal antibody] Evusheld is still effective against many variants, but it is not possible for physicians to know which strains a patient using it as prophylaxis could be exposed to, an AstraZeneca spokesperson told STAT.

“Variants are rarely dominant for more than a few months — they tend to either evolve further into different subvariants or are replaced by newer variants,” the spokesperson said, adding the company is running early studies on other antibody options. * * *

Complicating the matter, the next potential monoclonal antibody — an Eli Lilly treatment dubbed bebtelovimab — could be ready within two months, but it has already been shown ineffective against the other fast-rising variant, BQ.1. The federal government has purchased 60,000 bebtelovimab doses for uninsured and under-insured patients, according to two people familiar with the HHS monoclonal antibody planning.

In the HHS meeting, officials discussed the prospect that BA.4.6’s rise could render Evusheld ineffective within two months. They laid out the timelines for as many as six potential alternates in the pipeline, according to two people familiar with the discussion.

a new national biodefense strategy, aiming to adapt lessons drawn from the rocky response to the Covid-19 pandemic as it prepares the country for future public health emergencies.

The strategy, which has been long anticipated, includes such goals as strengthening public health workforces both in the United States and globally, and establishing international mechanisms to bolster laboratory safety.

The government’s plan outlines policy targets for more than 20 federal agencies to help the country and world try to prevent epidemics, detect them faster, respond when they occur, minimize their impact, and recover, senior administration officials said on a call with reporters Monday as they previewed the strategy. Oversight for the strategy will be at the White House, under the national security advisor.

  • On a related note, Insurance News Net discusses the pandemic’s adverse impact on the life insurance industry, and Healthcare Dive tells us “The HHS’ current management of the strategic national stockpile and its subsequent relaying of information to Congress is fractured and needs updates to ensure the country is prepared for future public health emergencies, according to a report from the Government Accountability Office.”

From the SDOH front, MedPage Today delves into a CDC Vital Signs reports released yesterday

Influenza-associated hospitalization rates were nearly 80% higher among Black adults compared with white adults from 2009-2010 to 2021-2022, according to a CDC Vital Signs report released Tuesday.

These rates were also 30% higher among American Indian/Alaska Native (AI/AN) adults and 20% higher among Hispanic adults compared with white adults, reported Carla L. Black, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues.

Furthermore, vaccination coverage for influenza has been “consistently lower among Black, Hispanic, and American Indian and Alaska Native adults since 2010,” she noted on a call with reporters.

During the 2021-2022 flu season, vaccination coverage was lower among Hispanic (37.9%), AI/AN (40.9%), Black (42.0%), and other/multiple race (42.6%) adults compared with coverage among white (53.9%) and Asian (54.2%) adults, Black and team said.

From the IRS front, the Service issued its annual notice of inflation adjustments to tax items for the 2023 tax year. The Wall Street Journal adds “The Internal Revenue Service adjusted key tax code parameters for 2023 to reflect higher inflation, raising the standard deduction and the income thresholds where tax rates take effect.” The notice also includes many inflation adjustments to tax-exempt or deductible employees benefits. You will find a handy table of contents at the front of the notice.

From the miscellany department

  • The Justice Department on the Food and Drug Administration’s behalf has asked various federal courts to shut down the e-cigarette operations of six manufacturers.
  • The Justice Department also announced Sutter Health’s agreement “to pay $13 million to settle allegations that it billed government health programs for lab tests performed by others,” said U.S. Attorney Stephanie M. Hinds. ‘Government health care programs [including the FEHB in this case] must be protected, and this office will investigate and pursue health care providers that fail to provide the services paid for by public health care programs.’”

Apple will reportedly enter the health insurance business in 2024 in partnership with a major payer, Forbes reported Oct. 18.

CCS Insight’s chief analyst predicts the tech giant will power the new offering through health data collected by Apple Watches, such as blood pressure, blood oxygen levels, ECG readings and body temperature. The analyst said having access to this data from the beginning gives the company an advantage toward entering the market and cutting costs.

Apple is already a flagship partner in John Hancock’s Vitality program and UnitedHealthcare’s commercial plans.

  • Reg Jones writing in the Federal Times explains how to enroll for Medicare Part without incurring a late enrollment penalty. It’s not hard if you know the rules.

Monday Roundup

Photo by Sven Read on Unsplash

From the FEHB Open Season front, OPM issued today its annual open season benefits administration letter identifying FEHB and FEDVIP contract changes for 2023 A/K/A, the Significant Changes letter and appendix. OPM also released its Federal Benefits Fast Facts for the upcoming Open Season.

The Federal Times offers an Open Season overview.

From the No Surprises Act front, Newfront, an insurance brokerage, issued an important reminder on the revised NSA consumer notice that health plans must post by January 1, 2023. Here are the current and future notices.

From the Covid vaccine mandate front, the Miller & Chevalier law firm tells us

On October 14, 2022, the Safer Federal Workforce Task Force released a roadmap for federal contractors of anticipated guidance on how federal agencies would be handling the implementation and enforcement of the federal contractor vaccine mandate and workplace safety requirements of Executive Order 14042, “Ensuring Adequate Safety Protocols for Federal Contractors.”  The Task Force — created by President Biden to provide guidance to federal agencies on handling operational issues related to the COVID-19 pandemic — anticipates a “potential narrowing of the existing nationwide injunction on October 18, 2022.” As a result, the Task Force anticipates the release of three documents: (1) notice from the Office of Management and Budget (OMB) to federal agencies regarding compliance with injunctions and the inclusion of vaccine mandate clauses in future solicitations and contracts; (2) updates to Task Force guidance on safety protocols for covered contractor and subcontractor workplace locations, including a timeline for implementation; and (3) additional guidance from OMB on “timing and considerations for provision of written notice from agencies to contractors regarding enforcement of contract clauses” implementing vaccine and workplace safety mandates. Notably, until OMB issues the guidance above, agencies are directed not to take any steps to require compliance with the Task Force guidance or enforce any contract clauses implementing the requirements of Executive Order 14042.

This Task Force guidance stems from an August 26, 2022, U.S. Court of Appeals for the 11th Circuit opinion replacing the lower court’s nationwide injunction with an injunction applying to the plaintiffs. However, several other U.S. Courts of Appeals are hearing cases involving this mandate so we may be waiting a while for the OMB guidance.

Also, from the Omicron and siblings front, Beckers Hospital Review discusses the new Omicron variants BQ.1 and BQ1.1.

CDC estimates indicate a new omicron variant, BQ.1, and its descendent BQ.1.1 account for 11.4 percent of cases nationwide. The pair have been dubbed “escape variants” for their ability to escape immunity and are currently most prevalent in New York and New Jersey, where they account for nearly 20 percent of new infections. * * *

Experts are optimistic that the bivalent omicron boosters will offer protection against BQ.1 and BQ.1.1 since they’re descendants of BA.5. (Updated boosters are designed to target the original SARS-CoV-2 strain, BA.4 and BA.5.)

“The bad news is that there’s a new variant that’s emerging and that has qualities or characteristics that could evade some of the interventions we have. But, the somewhat encouraging news is that it’s a BA.5 sublineage, so there are almost certainly going to be some cross protection that you can boost up,” Dr. Fauci said. 

From the monkeypox front, the American Hospital Association reports

The Centers for Disease Control and Prevention today reported the first U.S. monkeypox case in a health care worker since the outbreak began in May. The report describes how an emergency department nurse in Florida was exposed to the virus through a needlestick, and recommends approaches to preventing infections in health care workers. CDC also released a report describing five patients who acquired ocular monkeypox, a rare but sight-threatening condition, including four who were hospitalized. The report recommends health care providers advise monkeypox patients to practice hand hygiene and avoid touching their eyes, and consider urgent ophthalmologic evaluation and monkeypox-directed treatment for patients with ocular signs and symptoms.

From the influenza front —

Beckers Hospital Review relates

The U.S. is seeing flu activity rise earlier than usual, with Southern states reporting the highest levels of activity, according to the CDC’s latest FluView report for the week ending Oct. 8. 

Overall, activity remains low, “but increasing in most of the country,” the CDC said. HHS region 4 (Kentucky, Tennessee, Mississippi, Alabama, Georgia, South Carolina, North Carolina, Florida) and region 6 (New Mexico, Texas, Oklahoma, Arkansas, Louisiana) are reporting the highest levels of flu activity. 

Furthermore, STAT News “talked on Friday with Lynnette Brammer, a flu epidemiologist and team lead for domestic surveillance in the CDC’s influenza division, to get a sense of what the agency is seeing.”

Thinking about this flu season and what you’re seeing so far, what’s your best guess for what’s ahead?

Our syndromic surveillance methods are much trickier to try and interpret now, with Covid in the picture. It just muddies the water, basically.

We’ll have to see if the flu and Covid circulate at the same time. Right now, it looks like Covid is still trending down in a lot of the country, but flu’s going up in a lot of the country.

If individuals start to feel crappy this winter, how will they know if it’s a cold? Flu? Covid?

I think testing is going to be really important given that, for flu and Covid, there are treatments that — particularly for high-risk people — can make a huge difference in how well they are able to get through their illness. So it’s going to be really important to test so physicians can know the appropriate treatment for their patients.

In related news, the Government Accountability Office released a report on routine vaccination rates in our country.

U.S. school children generally have higher rates of vaccination to protect them from preventable illness compared with adults.

We found gaps in adult rates for flu, shingles, tetanus, and pneumococcal (prevents pneumonia and more) vaccines. Among other things:

Adults were about 40% more likely to get the tetanus and pneumococcal vaccines than the shingles vaccine

Vaccination rates for Black or African American and Hispanic or Latino adults were about 13% below that of White adults for each vaccine

Health and Human Services is using social media and its website to raise public awareness on the importance of being vaccinated.

From the ACA reporting front, the Internal Revenue Service issued its Forms 1095-B and 1095-C for 2022. The Service also released an employee fringe benefits guide for federal, state, and local government employers.

From the Rx coverage front, BioPharma Dive predicts “five questions facing drugmakers as third-quarter earnings begin. Alzheimer’s study results, drug pricing law, bring new questions for many of the industry’s top companies.”

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and Thursday as the first day of the week, the FEHBlog presents his weekly chart of new Covid cases for 2022.

The CDC’s weekly interpretation of its Covid statistics reports

As of October 12, 2022, the current 7-day moving average of daily new cases (38,949) decreased 11.9% compared with the previous 7-day moving average (44,233). 

CDC Nowcast projections* for the week ending October 1, 2022 estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are eight designated as Omicron: BA.5, BA.4.6, BQ.1.1, BQ.1, BF.7, BA2.75.2, BA.2.75, and BA.4. The predominant Omicron lineage is BA.5, projected to be 67.9% (95% PI 64.1-71.4%).

The Wall Street Journal points out

New offshoots of the Omicron Covid-19 variant that virus experts say appear to spread easily are on the rise in the U.S., the latest federal data show, underscoring how the virus is mutating and presenting new risks as it proliferates.

Two of the Omicron subvariants, both related to the BA.5 version that drove the most recent U.S. surge, are called BQ.1 and BQ.1.1. They were estimated to represent a combined 11.4% of U.S. Covid-19 cases by mid-October, according to estimates the Centers for Disease Control and Prevention released Friday. * * *

Virus experts said that, because the newer subvariants remain in the Omicron family, updated Covid-19 vaccines in the U.S. should be an important shield against severe illness and death, though data is limited. The bivalent shots were designed to fight the original virus strain as well as the BA.4 and BA.5 Omicron subvariants.

Here is the CDC’s “Daily Trends in Number of New COVID-19 Hospital Admissions in the United States” chart.

The CDC’s summary explains “The current 7-day daily average for October 5–11, 2022, was 3,268. This is a 4.4% decrease from the prior 7-day average (3,419) from September 28–October 4, 2022.”

The Wall Street Journal adds

Nationally, key metrics such as hospitalizations have largely been on a downward trajectory since late July, following a BA.5-fueled summertime surge, but with some recent signs of wavering. Wastewater virus readings have been choppy in recent weeks due to a climb in the Northeast, according to data from Biobot Analytics. The Northeast has also seen a recent rise in new Covid-19 hospital admissions, federal data show.

The FEHBlog presents his weekly chart of new Covid deaths for 2022

The CDC’s summary explains “The current 7-day moving average of new deaths (328) decreased 8.5% compared with the previous 7-day moving average (359).”

The Wall Street Journal adds

The country has recently averaged about 330 newly reported Covid-19 deaths each day, a continued burden falling heavily on the elderly and people with underlying health issues, including compromised immune systems. * * *

The interplay of a changing virus and fading immune protection from earlier infections and vaccine shots has left people vulnerable to repeated cases. These can lead in some cases to long-running symptoms. But virus experts say built-up protections from vaccines and prior infections still matter and can help limit hospitalizations and deaths.

The FEHBlog presents his weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 through the 41st week of 2022:

The CDC’s summary explains

As of October 12, 2022, 627.9 million vaccine doses have been administered in the United States. Overall, about 265.1 million people, or 79.9% of the total U.S. population, have received at least one dose of vaccine. About 226.2 million people, or 68.1% of the total U.S. population, have completed a primary series.

It strikes the FEHBlog as odd that the CDC’s Covid daily reporting does not include dispensing of oral antiviral drugs for Covid treatment, a vital component of the Covid suppression strategy.

Yesterday, the Secretary of Health and Human Services renewed the Covid public health emergency for another 90 days. The American Hospital Association comments

The AHA had urged HHS to renew the public health emergency to continue critical flexibilities hospitals depend on to deliver needed care, and minimize additional disruptions to an “increasingly fragile” health care delivery system.

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

UnitedHealth beat Wall Street expectations on both earnings and revenue in the third quarter with revenue of $80.9 billion, up 12% year over year. The healthcare giant increased its 2022 earnings expectations as a result.

Minnetonka, Minnesota-based UnitedHealth chalked the rise up to an increase in members served by payer UnitedHealthcare and growth in value-based care arrangements and care delivery platforms at Optum. Both businesses reported double-digit growth.

On a call with investors Friday morning, CFO John Rex said that UnitedHealth expects Change Healthcare — the data analytics business UnitedHealth acquired earlier this month despite a challenge from regulators — to be accretive to Optum’s earnings next year, not in 2022 as previously expected.

From the FEHB front

  • Kaiser Health News reports on a “New Generation of Weight Loss Medications Offer Promise — But at a Price.” FEHB plan enrollees will find expanded coverage of the drugs for 2023 due to a sensible OPM requirement in the 2023 call letter.

In other open season news, the Department of Health and Human Services issued a press release on the Medicare Open Enrollment period, which begins on Saturday, October 15.

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new Covid cases.

The CDC’s Covid Data Tracker Weekly Review was not issued today because Monday is a federal holiday.

The Covid Weekly Tracker tells us that the daily average of new Covid hospital admissions is 3,35.

Here is the FEHBlog’s latest weekly chart of new Covid deaths.

New York Times columnist David Leonhardt, who is going on a book tour that ends in late January 2023, reports

“A large chunk of deaths are preventable right now with Paxlovid alone,” Dr. Ashish Jha, the White House Covid response coordinator, told me. He predicted that if every American 50 and above with Covid received a course of either Paxlovid or a treatment known as monoclonal antibodies, daily deaths might fall to about 50 per day, from about 400 per day in recent months. * * *

recent analysis of about 568,000 patients by Epic Research found that 0.016 percent of Covid patients over 50 who received Paxlovid died. The death rate for patients who did not get the drug was more than four times higher, or 0.070 percent. And yet the Epic data showed that only about 25 percent of patients eligible to receive Paxlovid actually did, even though the drug is widely available and free for patients.

Perhaps the most shocking statistic about Paxlovid’s underuse — and Jha used the word “shocking” when describing it to me — is that a smaller share of 80-year-olds with Covid in the U.S. is now receiving the drug than 45-year-olds with Covid, according to data he has seen. Many doctors are evidently worried about side effects or rebound cases among their more vulnerable patients.

Even in rebound cases, however, symptoms tend to be milder than they would have been without Paxlovid. After Dr. Anthony Fauci, another White House adviser, who’s 81, contracted Covid in June and then took Paxlovid, he experienced a rebound — and also believed that the drug kept him out of the hospital.

“Medicine is about weighing costs and benefits,” Wachter said. “The recommendation should be clear and unambiguous for people at high risk: The benefits of the drug outweigh the downsides.”

In contrast, STAT News reports

A Merck pill used to combat Covid-19 failed to demonstrate it can lower the risk of hospitalization compared with a placebo among adults at a higher risk from the disease, according to the results of a large study conducted in the U.K.

The preliminary results of the randomized trial, which involved more than 25,000 participants, showed that taking molnupiravir did speed time to recovery by about six days, which means that patients did get some relief. Otherwise, though, the study failed to reach an outcome that had been used late last year by regulators — such as those in the U.S. and U.K. — to authorize the medicine to thwart the pandemic.

The findings also contradict the results of a much smaller study conducted by Merck and its partner, Ridgeback Therapeutics, which found a lower risk of hospitalization or death in high-risk patients by roughly 30%, after initially showing a 50% lower risk. Unlike the latest trial, which is called Panoramic, the Merck trial called Move-Out excluded patients who had been vaccinated against the coronavirus.

Here is the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 through the 40th week of 2022:

In addition, here are two related CDC charts.

The American Hospital Association adds

COVID-19 vaccinations are associated with over 650,000 fewer hospitalizations and 300,000 fewer deaths in the Medicare population through December 2021, saving an estimated $16 billion in direct medical costs, the Department of Health and Human Services reported today. 

“This report reaffirms what we have said all along: COVID-19 vaccines save lives and prevent hospitalizations,” said HHS Secretary Xavier Becerra. “We now have updated COVID vaccines designed to protect you against the Omicron strain of COVID that makes up almost all COVID cases in the U.S. … Over 90 percent of Americans live within 5 miles of where they can access these vaccines for free. I urge everyone eligible to get an updated COVID vaccine to protect yourself ahead of the fall and winter.”

Govexec tells us The Office of Personnel Management on Thursday announced that it authorized paid leave for federal workers to obtain the latest round of boosters for the COVID-19 vaccine.

From the FEHB front, Health Payer Intelligence reviews 2023 Blue Cross FEP benefit changes and makes other Open Season observations.

In OPM news, the GSA announced that its Technology Modernization Fund will be investing in OPM’s website.

OPM.gov Modernization

It can be challenging for federal employees, job seekers, and HR professionals to navigate OPM.gov’s 20,000 pages to find what they need. With a $6 million TMF investment, OPM will update both the technology behind and the content on the OPM.gov website. This will allow OPM to implement an updated and more secure Content Management System (CMS) hosted on OPM’s cloud environment, ensuring that users have intuitive and accessible web tools.

“A user-friendly website plays a critical role in OPM’s mission to communicate the federal government’s policies, services, and benefits more clearly and effectively,” said OPM Director Kiran Ahuja. “This investment will improve the government’s ability to recruit job seekers, supply the federal workforce with relevant career-related information, and make it easier for public servants to manage their benefits.”

Hope springs eternal.

From the mental healthcare front, Fierce Healthcare informs us

A mental health crisis besets young adults in the United States to such an extent that more than a third (35%) of individuals ages 18 through 29 years old said that they could not work nor engage in other activities of daily living, according to a new survey by the Kaiser Family Foundation (KFF) and CNN.

Meanwhile, 90% of all Americans believe that the country faces a mental health crisis.

Age 30 seems to be the cutoff separating severe crisis caused by mental health problems, and conditions not as dire. For instance, 34% of those 18 through 29 consider their mental health to be “only fair” or “poor”; 19% of those 30 and over feel that way. Fifty-two percent of young adults said that they’d always or often felt anxious in the last year, while 28% of older adults felt that way.

A third of young adults felt depressed (33%) or lonely (32%) in the last year; for older adults it was 18% for both depressed and lonely. 

These survey figures, particularly the first one, are hard to believe, but undoubtedly our country needs more mental health therapists and better treatments.

From the Rx coverage front, the Food and Drug Administration announced that the agency has

approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age. 

“Pertussis disease is a highly contagious respiratory illness affecting all age groups. However, babies are at highest risk for getting pertussis and having serious complications from it,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.” 

Pertussis is a common respiratory disease in the United States, resulting in frequent outbreaks. It is also called whooping cough because of the “whooping” sound that someone makes when gasping for air after a fit of coughing. Most serious pertussis cases, hospitalizations and deaths occur in infants younger than two months of age who are too young to be protected by the childhood pertussis vaccine series. According to the Centers for Disease Control and Prevention (CDC), 4.2% of the total cases of pertussis reported in the United States in 2021 were in infants younger than 6 months of age and approximately 31% required hospitalization. When the Boostrix vaccine is given during pregnancy, it  boosts antibodies in the mother, which are transferred to the developing baby. 

Good news.

From the healthcare business front, Fierce Healthcare reports

Yale New Haven Health has signed an agreement to acquire two Connecticut health systems, Waterbury HEALTH and Eastern Connecticut Health Network), from Prospect Medical Holdings.

The deal would give Connecticut’s largest health system the businesses, real estate, physician clinic operations and outpatient services of three hospitals: 357-bed Waterbury Hospital, 249-bed Manchester Memorial Hospital and 102-bed Rockville General Hospital. Also included are Prospect Provider Group of Connecticut and Visiting Nurse and Health Services of Connecticut, according to a release.

Thursday Miscellany

From the FEHB front, the Federal Times discusses one of OPM’s 2023 FEHB initiatives, coverage of gender-affirming care.

OPM announced

The Office of Personnel Management (OPM) migrated from the legacy application responsible for the financial management activities of over $1.1+ trillion-dollar trust fund assets to a modernized financial system platform that is managed and maintained by the Department of the Treasury, Bureau of the Fiscal Service’s Administrative Resource Center (ARC).

The partnership between OPM and ARC will result in millions of taxpayer dollars saved, and enable a modernized, secure financial management solution and re-engineered processes to support the administration of the earned benefits program which includes retirement, health, and life insurance. As a result, millions of federal employees, retirees, and their families should have increased confidence in the programs that ensure they can meet their retirement and healthcare and life insurance needs.

Here’s the related ARC press release. ARC is a federal government center of excellence. The FEHBlog is interested in reading more details on the benefits of this new system.

From the public policy front, here are links to AHIP’s press releases from this week on the ACA individual non-discrimination rule, Section 1557, and its favorable reaction to CMS’s idea to create a national provider directory.

Healthcare Dive tells us

A regulatory deadline kicked in Thursday requiring providers and other healthcare entities to be able to share a significantly larger scope of data with patients, despite major provider groups arguing they’re not ready to comply.

As of Thursday, information blocking regulations apply to all electronic health information in a record that qualifies as protected health information under the Health Insurance Portability and Accountability Act.

Previously, providers only had to make available data elements in a specific dataset called United States Core Data for Interoperability.

Time will tell us about the rule’s effect.

From the Medicare front, Forbes offers a deep dive into 2023 adjustments to the Medicare Parts B and D beneficiary income premium adjustments known as IRMMA. IRMAA impacts many federal annuitants, which causes an ongoing material reduction in new federal annuitants signing in for Part B. The kick in the pants is that when an annuitant’s income declines below that IRMMA level which typically happens over time, the Part B premium is unaffordable due to the late enrollment penalty.

From the public health front —

The Centers for Disease Control is calling attention to its patient and provider education materials on sepsis.

The American Hospital Association informs us

More than 2.5 million students in grades 6-12 reported using electronic cigarettes in the past 30 days when surveyed this year, including 14% of high school students and 3% of middle school students, the Centers for Disease Control and Prevention reported today. One in four students who used e-cigarettes used them daily, 8 in 10 used flavored e-cigarettes and over half used disposable e-cigarettes. Since 2014, U.S. youth have used e-cigarettes more than any other tobacco product.

“It’s critical that we work together to prevent youth from starting to use any tobacco product — including e-cigarettes — and help all youth who do use them, to quit,” said Deirdre Lawrence Kittner, director of CDC’s Office on Smoking and Health. 

For more information, see the CDC fact sheet for health care providers and tools to help teens quit.

From the Rx coverage front,

The New York Times informs us

A new medication for A.L.S., the devastating neurological disorder that causes paralysis and death, will have a list price of $158,000 a year, its manufacturer disclosed Friday.

The treatment, to be marketed as Relyvrio, is a combination of two existing drugs and will be available to patients in the United States in about four to six weeks, according to officials of the company, Amylyx Pharmaceuticals.

The Institute for Clinical and Economic Research has observed

Last week, the FDA approved Relyvrio, Amylyx Pharma’s therapy for amyotrophic lateral sclerosis. Even in the absence of definitive proof of efficacy, there are clear benefits to ensuring patients with a rapidly fatal disease have early access to a safe therapy. In a situation like this, we believe the manufacturer has an obligation to price responsibly. ICER concluded that an annual price of $9,100 to $30,700 would be reasonable if the therapy actually works. While awaiting proof, we believe that patients would benefit from a price closer to the price of production of Relyvrio.

Ruh roh.

Fierce Health reports

Beginning this month, the Pennsylvania-based plan and Mark Cuban’s drug company (MCCPDC) will begin to let members and community organizations know about their collaboration and how they can access low-cost drugs, according to a press release. In 2023, Capital Blue Cross members will be able to use their insurance cards at the company’s online pharmacy. 

The online pharmacy launched earlier this year, aiming to disrupt skyrocketing prescription drug prices in the U.S. It currently offers nearly 1,000 generic prescription drugs that it says reflect manufacturer prices plus a 15% fee.  * * *

While initially, MCCPDC was planning to launch its own pharmacy benefit manager, it then scrapped those plans, announcing its first PBM partnership last week. The PBM has no rebates and no spread pricing. Some experts have cautioned that while the company’s effort is effective, it isn’t tackling a more pressing problem—brand-name drug prices, given generic drugs are up to 85% less expensive. The company is hoping to offer brand-name drugs down the line, CNBC reports.