Midweek update

Federal employment benefits

Midweek update

David Ermer–ACA, CDC, CMS, COVID-19, FDA, Federal employment benefits, HSA, NIH, OPM, U.S. Healthcare–
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

David Ermer–CDC, COVID-19, Federal employment benefits, OPM, Telehealth, U.S. Healthcare–
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

David Ermer–ACA, CDC, CMS, Congress, COVID-19, Federal employment benefits, Medicare, Mental health care, OPM, Rx coverage, SDOH, U.S. Healthcare–

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

David Ermer–CDC, COVID-19, Federal employment benefits, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–
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

David Ermer–ACA, CDC, COVID vaccine mandate, COVID-19, Federal employment benefits, Government Contracting, No Surprises Act, Rx coverage, U.S. Healthcare–
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

David Ermer–CDC, COVID-19, Federal employment benefits, Medicare, OPM, Rx coverage, U.S. Healthcare–

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

David Ermer–CDC, COVID-19, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–

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. * * *

A 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

David Ermer–CDC, CMS, Federal employment benefits, Medicare, Rx coverage, Uncategorized–

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.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, Electronic health records, Federal employment benefits, Medicare, Mental health care, OPM, Telehealth, U.S. Healthcare–

From the Federal Employee Benefits Open Season front, OPM released its Open Season press announcement today. Its lede is

Thousands of Enrollees Are Leaving Valuable Savings on the Table During Open Season
Enrollees should use Open Season as a period to conduct a wellness or financial check-up and reassess their health needs and coverage

Among other guidance, OPM recommends

Below we’ve provided sample questions to help you assess how you can utilize Open Season to review your benefits and needs to make an informed decision on coverage:

What are my and/or my family’s expected health care needs for 2023? 

* Questions while reviewing your FEHB plan: Am I expecting a new baby? Do I need surgery? Will my medication need change? Does my plan provide a pharmacy mail order option for prescriptions?

* Questions while reviewing FEDVIP: Do I want coverage for my routine dental care? Will I need a crown or root canal? Does my child need braces? Do I need glasses and/or contact lenses? Am I considering laser vision correction surgery?

* Questions while reviewing FSAFEDS: Do I have out-of-pocket expenses I need to consider, such as deductibles, copays, day care, elder care, or over-the-counter drugs and medicines? Do I have medical expenses that may not be covered by my FEHB plan? Do I plan to send my children (under 13) to in-home care or summer camp? 

OPM does not mention the availability of the FEHB plan’s summary of benefits and coverage (“SBC”), an Affordable Care Act requirement. The FEHBlog recalls visiting friends in Denver who were preparing for their employers’ open season by comparing these short but comprehensive SBCs. For example, the SBCs include a broken-out estimate of the plan’s cost-sharing for having a baby, receiving diabetes treatment for a year, and fixing a broken bone. In addition, the federal government consumer tested the SBCs.

FEHB plans update their SBCs annually in advance of Open Season and post them on their websites, usually on the page with forms and brochures.

The Washington Post has an article on the 2023 Open Season, and Federal News Network offers “a few” other expert views on the 2023 Open Season. Fierce Healthcare adds

Open enrollment is coming soon, and foremost on everybody’s mind as these windows draw nearer is just how much health insurance will cost, according to a survey by Gravie and Wakefield Research.

“Consumers are concerned about the high costs of health coverage impacting their access to healthcare, increasing medical debt and the lack of mental health coverage,” according to a press release from the two companies.

From the Omicron and siblings’ front —

  • Beckers Hospital Review tells us

The CDC revised its “up to date” COVID-19 vaccination term Sept. 30 to include the primary series and the recently authorized omicron-targeting booster.  * * *

The CDC’s website still deems people who are not immunocompromised as “fully vaccinated” two weeks after their second dose of Moderna or Pfizer’s series or two weeks after receiving J&J’s COVID-19 vaccine. 

[However, last Friday’s] decision could update the “fully vaccinated” term that experts have urged regulators to update.

  • HealthLeaders Media reports “Treating COVID-19 patients with Paxlovid significantly reduces hospitalizations and deaths, according to a recent large-scale study by Epic Research.”

AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each new Omicron subvariant.

But that win streak may slowly come to a close as the FDA told healthcare providers on Monday that one of the emerging subvariants, BA.4.6, renders Evusheld almost completely useless.

Nationally, BA.4.6 currently makes up about 13% of new cases, compared to just 1% of cases at the beginning of July, according to the CDC. But in some regions, like in Iowa, Missouri, Kansas and Nebraska, the BA.4.6 subvariant makes up more than 20% of all Covid-19 cases.

  • David Leonhardt writing in the New York Times Morning column discusses “A Public Health Success Story; We revisit the subject of Covid and racial inequities”. Check it out.
  • The NIH Directors Blog considers “Understanding Long-Term COVID-19 Symptoms and Enhancing Recovery.”

From the mental healthcare front, MedPage Today reports

Suicide risk was higher in people recently diagnosed with dementia, especially younger patients, a case-control study in England showed.

Compared with people who didn’t have dementia, suicides rose in people who received a dementia diagnosis in the past 3 months (adjusted OR 2.47, 95% CI 1.49-4.09), according to Danah Alothman, BMBCh, MPH, of the University of Nottingham in England, and colleagues.

For people under age 65, suicide risk within 3 months of diagnosis was 6.69 times (95% CI 1.49-30.12) higher than in patients without dementia, the researchers reported in JAMA Neurology

From the U.S. healthcare business front, Bloomberg reports on giant drug manufacturer Pfizer’s future

Pfizer Inc. emerged from the Covid-19 pandemic as the world’s most visible drugmaker, but its success has left investors impatient for an encore.

The windfall from the pharmaceutical giant’s Covid vaccine almost doubled its revenue in just one year. And now the shot, coupled with Pfizer’s Covid antiviral pill, is poised to make up more than half of its expected $100 billion of sales in 2022. That’s left Pfizer flush with cash — $28 billion it could spend on the kinds of deals that for decades fueled its growth into an American colossus.

The pressure is clearly on for Pfizer to show that the muscle it built during the pandemic won’t atrophy. Big Pharma companies don’t normally double revenue so quickly, and nobody expects that kind of growth to continue. But one thing’s clear: Pfizer can’t go back to the sluggish path it was on for years.

The American Hospital Association informs us

Operating margins for U.S. hospitals and health systems were down 24% in August compared to a year ago, driven in large part by a 7.2% increase in labor expenses, according to data from over 900 hospitals reported yesterday by Kaufman Hall.

“Nine months into a challenging year, margins have fluctuated wildly,” the report notes. “Although most metrics improved from July to August, organizations are still operating with negative margins and well below pre-pandemic levels.”

From the Medicare front, the American Hospital Association adds

Effective Oct. 1 for five years, the Centers for Medicare & Medicaid Services will pay average sales price plus 8%, rather than ASP plus 6%, for biosimilars whose average sales price does not exceed the price of the reference biological product. The payment increase was included in the Inflation Reduction Act of 2022. For new biosimilars that qualify, the five-year period will begin on the first day of the calendar quarter for which ASP payment for that biosimilar begins under Medicare Part B.

From the electronic health records front, STAT News reports

Epic Systems has revamped its widely criticized sepsis prediction model in a bid to improve its accuracy and make its alerts more meaningful to clinicians trying to snuff out the deadly condition.

Corporate documents obtained by STAT show that Epic is now recommending that its model be trained on a hospital’s own data before clinical use, a major shift aimed at ensuring its predictions are relevant to the actual patient population a hospital treats. The documents also indicate Epic is changing its definition of sepsis onset to a more commonly accepted standard and reducing its reliance on clinician orders for antibiotics as a way to flag the condition.

The changes follow the publication of a series of investigations by STAT that found an earlier version of Epic’s tool resulted in high rates of false alarms at some hospitals and failed to reliably flag sepsis in advance. One of the investigations found that the model’s use of antibiotics as a prediction variable was particularly problematic, resulting in late alarms to physicians who had already recognized the condition and taken action to treat it.

Fierce Healthcare looks into “How Google, Mayo Clinic and Kaiser Permanente tackle AI bias and thorny data privacy problems.”

From the telehealth front, Healthcare Dive reports

Telehealth utilization varied by region from June to July of 2022 and rose 1.9% nationally, according to Fair Health’s monthly tracker data out Monday. 

In the West, Midwest and South, telehealth utilization rose 5.7%, 2.5% and 4.9%, respectively, from June to July. In the Northeast, telehealth use fell 3.3% during that period.

Mental health conditions remained the top diagnoses nationally, and psychiatrists also delivered more virtual care in some regions.

Monday Roundup

David Ermer–Congress, Federal employment benefits, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, the FEHBlog has noticed that OPM expanded the number of FEHB and FEDVIP public use files available on its website. “The purpose of the OPM FEHB and FEDVIP Plan and Benefits Information (PBI) Public Use Files (PUFs) is to provide information to the public on FEHB and FEDVIP plans, including information on rates and benefits.” Check it out.

The FEHBlog also has noticed that many FEHB plans promptly posted Open Season information on their websites. In particular, the three largest FEHB carriers, Blue Cross FEP, GEHA, and Kaiser Permanente have done so. That’s a heavy, yet helpful, lift so kudos to the carriers.

From the public health front

  • The New York Times brings us up to date on the polio vaccination campaign in New York State.

The specter of polio becoming endemic in America again was once unthinkable. But as state public health officials embark on an urgent campaign to get more people vaccinated, the low rates among preschoolers in some pockets are evidence of both the challenges they face and the threat to the state’s youngest children — the very age group among whom polio is most likely to spread.

This gap stems from the fact that the polio vaccine is required for school admission.

A bipartisan group of lawmakers has proposed legislation to help create drugs that can fight drug-resistant pathogens as the treatments for life-threatening problems from respiratory infections to sepsis stop working.

But a classic end-of-year congressional quagmire — a tight calendar, a heated election season, fights over spending, and inertia — threatens to stymie progress before the end of the year.

Fingers crossed for passage in the lame duck session.

  • The National Institutes of Health released its monthly NIH News in Health, which is worth a click.

From the U.S. healthcare business front —

  • Fierce Healthcare relates “Francisco Partners, an investment firm, signed a definitive agreement to acquire bSwift from CVS Health.” The acquistion agreement is expected to close by year end and “bSwift will continue to partner with CVS Health and its subsidiary Aetna, an insurance provider, by sharing benefits solutions with its employees and clients.”

From the telehealth front, we have another positive survey report from mHealth Intelligence. “ccording to new research findings from the JD Power 2022 US Telehealth Satisfaction Study, telehealth has become more than a temporary replacement for in-person care due to high consumer preference and its role in expanding access to mental health treatment.”

From the Monday miscellany front —

  • BioPharma Dive identifies five Food and Drug Administration decisions to watch out for this quarter. “The regulator could soon approve medicines from Apellis, Gilead and GSK, as well as decide on whether to pull a controversial preterm birth drug from the market.”
  • The Office of National Coordinator for Health Information Technology issued eight information blocking regulatory reminders for October 6, the end of the phase in period for that rule.
  • Medscape reports on an HHS Office of Inspector General report criticizing the efficiency of the FDA’s accelerated drug approval program.

In granting accelerated approvals, the FDA sets timelines for drugmakers to carry out confirmatory trials. But these target dates are often missed. OIG staff evaluated 104 cases of accelerated approvals for which confirmatory trials have not been completed and found that as of May 5, 2022, 35 drug studies had missed their original target completion dates. * * *

In its report, the OIG staff offered a deep look at the four drugs in which confirmatory trials were furthest past their original completion deadlines:

* Mafenide acetate (Sulfamylon), a topical antimicrobial treatment for burns that was approved in 1998. The trial is 140 months past its original deadline.

* Midodrine hydrochloride (Proamatine), a treatment for postural hypotension that was approved in 1996. The trial is 85 months past its original deadline.

* Pralatrexate (Folotyn), a treatment for T-cell lymphoma that was approved in 2009. The trial is 72 months past its original deadline.

Hydroxyprogesterone caproate (Makena), a drug to reduce risk of preterm birth that was approved in 2011. The trial is 64 months past its original deadline.