Weekend update

CDC

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.

Thursday Miscellany

David Ermer–AHRQ, CDC, COVID-19, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the OPM front, an OPM press release informs us

The U.S. Office of Personnel Management (OPM) released government-wide results of the 2022 OPM FEVS today. The OPM FEVS is an employee survey that tracks how federal employees view their current work environment, including management, policies, and new initiatives. OPM FEVS is an unmatched government data asset that assists agencies to hire and support the skilled workforce needed to serve the American people.

According to Gallup, employee engagement for the total U.S. workforce has declined for the past two years by a total of four percentage points, the first time it has dropped in over a decade. The OPM FEVS government-wide employee engagement index dropped one percentage point from 2020 to 2021, and then stabilized above pre-pandemic levels at 71 percent in 2022. In 2019, this metric stood at 68 percent.

Additional highlights from the 2022 OPM FEVS government-wide results include:

* The Performance Confidence Index, which measures employees’ view that their work unit can achieve goals and produce at a high level, remains high at 84 percent.

* The 2022 OPM FEVS includes a new Diversity, Equity, Inclusion and Accessibility (DEIA) Index, which shows 69 percent of respondents report positive perceptions of agency practices related to DEIA.

* The 2022 OPM FEVS newly evaluates Innovation and to what extent leadership encourages and supports new ideas and innovative approaches. The survey scores show success and opportunities for innovation encouragement, with 64 percent of employees consistently looking for new ways to improve work and 56 percent noting that management encourages innovation.

In other encouraging news, Federal News Network reports

Suicides across the active duty U.S. military decreased over the past 18 months, driven by sharp drops in the Air Force and Marine Corps last year and a similar decline among Army soldiers during the first six months of this year, according to a new Pentagon report and preliminary data for 2022.

The numbers show a dramatic reversal of what has been a fairly steady increase in recent years.

The shift follows increased attention by senior military leaders and an array of new programs aimed at addressing what has been a persistent problem in all the services, although it’s unclear what impact any of the programs had or if pandemic-related restrictions played any role in the decline.

On a related note —

  • The actuarial consulting firm WTW released the employer survey findings

Two out of three U.S. employers (67%) plan to make employee mental health and emotional wellbeing programs and solutions one of their top three health priorities over the next three years. Additionally, the number of employers that intend to offer designated mental health days could triple from 9% currently to 30% in the next two years.

  • The U.S. Surgeon General offers best practices for designing employer-sponsored mental health programs.

From the Omicron and siblings, front MedPage Today tells us

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously Thursday to add COVID-19 vaccination to its panel of routine immunizations for both kids and adults. The 15-0 vote does not mandate vaccination for children or adults or prevent unvaccinated children from attending school; it’s simply an annual update to the child and adult immunization schedules, panelists pointed out.

The ACIP decision does mandate that health plans cover Covid vaccines without member cost sharing after the public health emergency expires, likely next year.

In other public health news, the Wall Street Journal reports

Physicians are reporting unseasonably high numbers of respiratory illnesses in children, straining many children’s hospitals before the typically busier winter months.

Juan Salazar, physician in chief at Connecticut Children’s Medical Center in Hartford, Conn., said a sharp increase in cases of respiratory syncytial virus, or RSV, has filled up hospital beds at his facility, creating capacity issues. 

RSV is an easily transmissible virus that infects the respiratory tract. The virus spreads through droplets from coughing and sneezing and on surfaces. Positive tests for RSV have been on the rise across the U.S., according to the Centers for Disease Control and Prevention. The rise in cases has come ahead of the typical winter peak for such illnesses, hospital officials said. 

For most people, RSV amounts to a cold, and nearly all children come in contact with the virus by the age of two, health authorities said. But it can be severe for some infants and older adults, especially for those that have pre-existing health conditions. 

Much like influenza, RSV cases were flattened during the first year of the Covid-19 pandemic. The respiratory virus that typically circulates in the fall and winter then rebounded in the summer of 2021.  

Is RSV the official name for the common cold? Calling Dr. Google. Perhaps people should choose to wear N-95 masks in the winter.

From the Rx coverage front

The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma) for the treatment of obesity.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, ICER’s Chief Medical Officer. “As such, obesity, and its resulting physical health, mental health, and social burdens is not a choice or failing, but a medical condition. The development of safe and effective medications for the treatment of obesity has long been a goal of medical research that now appears to be coming to fruition. With a condition affecting more than 40% of adults in the US, the focus should be on assuring that these medications are priced in alignment with their benefits so that they are accessible and affordable across US society.”

Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations

This report is worth a gander because OPM is requiring coverage of next-gen obesity drugs for 2023.

It turns out that October is health literacy month.

  • The Labor Department’s Assistant Secretary for Employee Benefits offers employees five tips for making health benefits work.
  • The HHS Agency for Healthcare Quality and Research gives healthcare providers a complete literacy manual, 2nd edition.

Of course, October is also breast cancer awareness month, and Yale New Haven hospital issued with newsletter with advice on that critical topic.

Breast cancer is the second most common cancer among American women, except for skin cancer – but millions of women are surviving the disease, thanks in part to regular screening, early detection and improvements in treatment.

“Compared to 15 or 20 years ago, the proportion of early-stage breast cancers we are seeing in our clinics is significantly higher. We can directly attribute this to the improvements in screening technologies, in mammography, tomosynthesis, breast MRI, breast ultrasound and computer-assisted detection methods over the years,” said Meena Moran, MD, chief of Breast Radiation Oncology for the Smilow Cancer Network. “Another major factor attributing to earlier detection over the last two decades is the overall increased awareness of breast cancer and the importance of screening in the general population.”

From the miscellany department —

  • The International Foundation of Employee Benefit Plans discusses “Optimizing Outcomes and Containing the Costs of Surgery.”
  • Reg Jones writing in the Federal Times, provides the math on calculating Social Security benefits, especially early retirement benefits.

Midweek update

David Ermer–CDC, CMS, COVID-19, Mental health care, NCQA, NIH, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

From the Omicron and siblings front —

Novovax announced that

the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”

Reuters adds

Moderna Inc said on Wednesday its COVID-19 vaccine booster targeting the BA.1 subvariant of Omicron generated a strong immune response against that variant, with antibody levels staying high for at least three months.

Omicron-tailored shots by Pfizer Inc  and Moderna are already authorized by regulators in several countries. The United States has given the go-ahead for booster vaccines that target the currently circulating BA.4 and BA.5 subvariants of Omicron.

The New York Times provides an update on the new Omicron variants, including this critical point

Fortunately, Paxlovid works against these new variants. The mutations that make them spread so quickly are changes to the surface of the virus where it locks onto cells and where antibodies attach to it. Paxlovid attacks the virus in a different way. It detects the virus after it’s inside the cell and is replicating, and these new subvariants seem to be just as vulnerable to Paxlovid as the earlier variants.

Health Payer Intelligence reports

Federal funding was crucial in enhancing access to coronavirus resources during the initial phases of the pandemic, but questions remain about what will occur when the public health emergency ends and how it will impact consumer healthcare spending, according to a Kaiser Family Foundation brief.

The end of the public health emergency is still undetermined. However, experts have projected that it will end in 2023. The scheduled termination has been pushed back multiple times. Its final termination will signal the end of various flexibilities and protections that have been tied to the declaration.

Additional Covid funding is likely to occur in the Congressional lame-duck session following the November 8 election, in the FEHBlog’s opinion.

From the U.S. healthcare business front —

Fierce Healthcare tells us

Patient volumes continue to remain below pre-pandemic levels for hospitals and health systems this year as COVID-19 likely accelerated a shift to outpatient settings, a new report finds. 

Consulting firm Kaufman Hall released its “2022 Healthcare Performance Improvement” report (PDF), which outlines the barriers hospitals and health systems face in a rough year financially. Another key obstacle continues to be workforce shortages, as more and more facilities shift resources to retain staff. 

“Healthcare leaders must navigate short-term challenges that continue to pressure revenue and expenses, while also adapting organizational strategy to match larger transformations in the way care is delivered,” said Kaufman Hall Managing Director Lance Robinson in a statement on the report. 

and offers a discussion of an expert-touted hybrid approach to compensating primary care providers. In the FEHBlog’s view, adequately paying PCPs is critically important to resolving SDOH and mental health issues adversely impacting our country.

In the regard

  • A National Institutes of Health study uncovered racial disparities in advanced cardiac care.
  • STAT News reports on another SDOH study

When Sarka Lisonkova and her colleagues set out to study disparities in the birth outcomes of people who’ve used methods like IVF, they figured that any inequities that existed would be narrower in this group. After all, it can be expensive to get pregnant with medical assistance, and wealth is tied to better outcomes.

Instead, the researchers reported Wednesday, the racial and ethnic disparities for some metrics were even wider for babies of parents who had used IVF or other fertility treatments than among children who were conceived “spontaneously.”

One key finding: while neonatal mortality rates were twice as high among spontaneously conceived children of Black women versus white women, they were four times as high among infants of Black women conceived through technologies like IVF, according to the researchers’ study, which was published in the journal Pediatrics.

  • The National Committee for Quality Assurance gives us an update on their efforts to stratify HEDIS measures results by racial and ethnic categories.

In other U.S. healthcare business news, Healthcare Dive reports

As the U.S. heads toward a possible recession, Elevance Health CEO Gail Boudreaux said the insurer is preparing for a possible economic decline.

“Certainly we’re mindful of an economic downturn. We’re planning for it in our businesses,” Boudreaux said on a Wednesday call with investors to discuss third-quarter earnings.

Job losses spurred by a recession could cut into commercial enrollment for insurers who generate revenue from selling health coverage to employers of all sizes. About half of the U.S. population relies on employer-based insurance for coverage.

Elevance’s profit climbed to $1.6 billion for the third quarter, a 7% increase compared with the prior-year period on a bigger membership base of 47.3 million members.

Becker’s Payer Issues tells us

Despite little growth in the cost of medical services over the last year, inflation has finally caught up with healthcare.

As of September, medical services costs have risen 6.5 percent year over year, according to a Bureau of Labor Statistics report released Oct. 13. 

Analysts like Fitch have said the rise in costs will lead to payers raising insurance premiums across the board because of the growing cost pressures on providers, including workforce disruptions.

Studies have already confirmed employers are preparing for higher healthcare expenditures next year because of inflation. Aon analysts said Aug. 18 that U.S. employers’ healthcare costs are expected to rise by an average of 6.5 percent, or $13,800 per employee, in 2023.

“The only 100 percent sure way to keep within budget as the medical industry (especially hospitals) demand more and more is to raise premiums, increase deductibles, higher copays and coinsurance,” James Gelfand, president of the ERISA Industry Committee, told The Washington Post Oct. 14. “Employers hate to do this, but the medical-industrial complex demands an ever-increasing share of workers’ wages.”

The rise in insurance costs could begin to appear when employees sign up for employer-sponsored coverage during their next enrollment period, a trend that could continue through at least 2024, according to the Post.

STAT News reports

A large commercial insurer’s decision to cover a controversial class of software-based treatments for psychiatric and other conditions could prove to be a landmark moment in the development of these so-called prescription digital therapeutics, which until now had been unable to secure coverage from insurers skeptical that the new technologies are as effective as their makers claim.

Pittsburgh-based Highmark quietly put in place a policy in August describing when these treatments may be “medically necessary,” which paves the way for the health insurer to be the first to cover the category for a population of millions of members.

The policy indicates Highmark’s intention to pay for claims only for prescription digital therapeutics cleared by the Food and Drug Administration when prescribed by a clinician within the appropriate specialty and used as indicated on product labels. Highmark is currently negotiating with product developers about how much it will pay for individual treatments and over details such as what constitutes an “episode of care,” said Matt Fickie, a senior director at Highmark, which has 6 million members in Pennsylvania, Delaware, West Virginia, and New York. “That’s the part that is sticky and that requires additional work,” he told STAT.

From the Rx coverage front —

STAT News informs us

After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births.

The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Makena.

The FDA successfully persuaded the panel that the medication should be withdrawn because the results of a clinical trial, which was required when the agency approved Makena [on an accelerated basis] in 2011, failed to show the expected benefit. For its part, Clovis maintained that a follow-up trial showed its drug did benefit a select subset of patients — including Black women — but struggled to convince the panel that the drug should remain available while a lengthy follow-up study is run to confirm its argument.

The sentiment among most panelists was reflected in remarks by Susan Ellenberg, a professor emeritus of biostatistics, medical ethics, and health policy at the Perelman School of Medicine at the University of Pennsylvania, who said “unmet need is not a basis for keeping a drug available when you don’t know if it works.”

The FDA Commissioner, Robert Califf, MD, is the final decision maker.

The NCQA has created

A new website adds two key resources in the fight against antibiotic resistance:

* A How-To Toolkit: Webinars and written summaries outline best practices, emerging trends and lessons from the field about savvy stewardship of antibiotics.

* An “Honor Roll”: Learn which health plans’ management of antibiotics leads the industry.

From the No Surprises Act front, CMS today issued updated guidance on how to initiate an NSA arbitration. The new guidance reflects the revised final independent dispute resolution rule published this past summer.

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.”

Weekend update

David Ermer–CDC, CMS, COVID-19, FDA, Medicare, Rx coverage–

Congress remains on the campaign trail this week.

From the public health front —

  • Fortune Well considers a change in the spread of Omicron. “COVID has splintered into multiple variants dominating different countries at the same time. Experts say these are some scenarios could play out.”
  • The American Medical Association answers patient FAQs about the upcoming winter in which Covid is not expected to eclipse the flu.
  • The FDA encourages Americans, including children, to get the flu vaccine.
  • Fortune Well provides advice on who is a candidate for the monkeypox vaccine now that this vaccine is more widely available.

The Bill and Melinda Gates Foundation says it will commit $1.2 billion to the effort to end polio worldwide.

The money will be used to help implement the Global Polio Eradication Initiative’s strategy through 2026. The initiative is trying to end the polio virus in Pakistan and Afghanistan, the last two endemic countries, the foundation said in a statement Sunday.

The money also will be used to stop outbreaks of new variants of the virus. The announcement was made Sunday at the World Health Summit in Berlin. 

The foundation says in a statement on its website that it has contributed nearly $5 billion to the polio eradication initiative. The initiative is trying to integrate polio campaigns into broader health services, while it scales up use of the novel oral polio vaccine type 2. 

The group also is working to make national health systems stronger so countries are better prepared for future health threats, the statement said. 

From the price transparency front, two consultants from the Berkley Research Group advise in Healthcare Dive

Payers can use hospital transparency data to gain insights regarding the rates hospitals have negotiated with other payers, which potentially can be used during contract negotiations. For example, payers can evaluate the negotiated rates for specific hospitals compared to their competitor health plans to gauge alignment with their proposed rates and discounts. This is illustrated in Figure 2, which shows the average negotiated rates for a CT scan of the abdomen (CPT 74177) for each payer who contracts with Loyola University Medical Center near Chicago, compared to the hospital’s standard billed charge for the procedure. As shown in the graph, the average negotiated rate as a percentage of billed charges (list price) ranges from 3% to 24% (about $200 to $1,800).

The article offers other approaches to using hospital transparency data, e.g., geographic methods.

From the Rx coverage front

Beckers Hospital Review tells us

CVS Health wants to be in charge of the “entire spectrum of someone’s health journey,” the company’s chief executive said at an Oct. 12 event in Boston reported on by the Boston Business Journal.

CEO Karen Lynch pointed to how the company already delivers medication at the pharmacy, finances treatments through insurance company Aetna, provides low-cost urgent care at its MinuteClinics, and now intends to give care at home through its planned $8 billion acquisition of Signify Health, she reportedly said at the Boston College Chief Executives Club meeting.

Ms. Lynch said the company also plans to expand into primary care and expects to announce an acquisition later this year, the Business Journal reported Oct. 13. CVS is rumored to be in exclusive talksto buy Cano Health, a primary care firm focused on seniors.

Ms. Lynch told the crowd CVS has advantages over fellow healthcare disruptor Amazon, which recently agreed to acquire primary care chain One Medical for $3.9 billion, according to the story. “[Customers] really want to trust and engage with companies that have earned the right to be in healthcare,” she said. “I think about Amazon as sort of a transactional company today.”

The American Hospital Association informs us

President Biden today directed the Center for Medicare and Medicaid Innovation to consider new payment and delivery models to lower drug costs and promote access to innovative drug therapies for beneficiaries, and report within 90 days on its plan and timeline for testing selected models. AHA will update members as more information on the plan becomes available.

The White House also released a fact sheet on this executive order.

The American Medical Association issued a research report titled “Competition in Commercial PBM Markets and Vertical Integration of Health Insurers with PBMs.” The report is chock-a-block full of various PBM rankings.

Speaking of the CMS innovation center, the American Hospital Association reports

The Centers for Medicare & Medicaid Services will extend through 2025 the Bundled Payments for Care Improvement Advanced model, which was set to expire this year. CMS launched the alternative payment model in 2018 to test whether bundling Medicare payments for certain inpatient and outpatient care reduces spending and improves quality. The agency expects early next year to request applications from Medicare providers, suppliers and accountable care organizations to participate in the two-year extension, which will include changes to the pricing methodology.

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.

Mid-week Update

David Ermer–ACA, AHRQ, CDC, COVID-19, COVID-19 vaccine, NCQA, NIH, OPM, Rx coverage, U.S. Healthcare–

Following up on this week’s posts

Forbes unpacks the colonoscopy study that the FEHBlog discussed in Monday’s post. The critical consideration is that “while colonoscopy may not be the gold standard it’s been made out to be, one or more colorectal cancer screening tools are essential to detect cancer and lower mortality rates.” Check it out.

Prof. Katie Keith writing in Health Affairs Forefront explores the final family glitch rule that the FEHBP mentioned in yesterday’s post. Two points suggest to the FEHBlog that the final rule will not materially impact the FEHB Program.

This situation—where employee-only coverage is affordable, but family coverage is not—is not uncommon. Most employers offer family coverage, but many do not subsidize it for family members which keeps the cost high for workers and their families.

That’s not the case in the FEHB Program. Moreover,

The final rule will not affect liability under the employer mandate, a fact confirmed by the IRS. Why not? The employer mandate requires certain large employers to offer coverage to employees and dependents. But penalties for violating the mandate are triggered only when an employee receives premium tax credits through the marketplace. The final rule extends premium tax credits to only the family members of workers who are not offered affordable job-based family coverage. It does not affect the eligibility of employees and thus does not implicate the employer mandate.

That’s an important consideration. Implementing the final rule is OPM’s responsibility as the FEHB Program’s regulator.

From the Omicron and siblings’ front —

The Associated Press reports

The White House on Tuesday said eligible Americans should get the updated COVID-19 boosters by Halloween to have maximum protection against the coronavirus by Thanksgiving and the holidays, as it warned of a “challenging” virus season ahead.

Dr. Ashish Jha, the White House COVID-19 coordinator, said the U.S. has the tools, both from vaccines and treatments, to largely eliminate serious illness and death from the virus, but stressed that’s only the case if people do their part. * * *

So far the Centers for Disease Control and Prevention says only about 11.5 million Americans have received the updated shots, which are meant to provide a boost of protection against both the original strain of COVID-19 and the BA.5 variant that is dominant around the world. Jha said studies suggest that if more Americans get the updated vaccines, “we could save hundreds of lives each day this winter.”

The American Hospital Association informs us

The Centers for Disease Control and Prevention today recommended Moderna’s bivalent COVID-19 vaccine booster for children aged 6-17 and Pfizer’s bivalent COVID-19 vaccine booster for children aged 5-11 after the Food and Drug Administration authorized them for these ages. CDC previously recommended the Pfizer bivalent booster for Americans 12 and older and the Moderna bivalent booster for adults. The boosters protect against the most recently circulating omicron variants as well as the original virus strain.

MedPage Today offers more information on this FDA decision and a modeling study of 1.2 million global Covid patients showing (1) “Long COVID — defined as one or more clusters of symptoms lasting three months or longer — occurred in about 6% of people with symptomatic SARS-CoV-2 infection” and (2) “at one year, 15% of long COVID patients had ongoing cognitive or respiratory problems or fatigue.”

In other public health news, NPR offers a transcript of a monkeypox discussion among NPR healthcare reports. The upshot is

Just a few months ago, it looked like the U.S. had lost its chance to get monkeypox under control. Cases were soaring, and vaccines were in short supply. But now the story has taken a turn and this time in a good direction. In fact, some disease experts are even raising the idea that the U.S. could nearly eliminate the virus. 

From the medical research front —

Healthcare Dive reports

Walmart is getting into clinical trials with the launch of the Walmart Healthcare Research Institute, as the retail giant focuses on high-margin businesses in healthcare.

Walmart said the venture is meant to improve diversity in clinical trials, focusing on interventions and medications that can make an impact in underrepresented communities. That includes older adults, rural residents, women and minority populations, the company said in a release.

It could also become a valuable stream of revenue for Walmart from drug companies looking for participants for potential trials and studies.

The NIH Directors’ Blog tells us about two NIH-supported chemists, Carolyn R. Bertozzi and K. Barry Sharpless, who won the 2022 Nobel Prize in Chemistry for their work in click chemistry.

This form of chemistry has made it possible for researchers to snap together, like LEGO pieces, molecular building blocks to form hybrid biomolecules, often with easy-to-track imaging agents attached. Not only has click chemistry expanded our ability to explore the molecular underpinnings of a wide range of biological processes, but it has provided us with new tools for developing drugs, diagnostics, and a wide array of “smart” materials.

Kudos to the winners.

STAT News reports

Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer.

Moderna is getting $250 million from Merck to secure opt-in rights to the cancer vaccine candidate, called mRNA-4157. The two companies are jointly conducting a mid-stage clinical trial that combines the customized, mRNA-based vaccine with Merck’s checkpoint inhibitor Keytruda.

Results from this randomized study will be announced before the end of the year, but the timing of Wednesday’s deal suggests Merck and Moderna have seen enough encouraging data to advance mRNA-4157 into larger studies.

From the Rx coverage front, the HHS Agency for Healthcare Research and Quality updated its consumer tool “How To Create a My Medicines List,” previously known as “My Pills List.”

From the healthcare quality front, NCQA released a slide deck and recording of last week’s Future of HEDIS webinar focused on health equity.

From the maternity care front, Health Day reports on a March of Dimes report on maternity care deserts and related matters. Here’s the federal government’s maternity care map:

Maternity care deserts [red]: low access [orange]; moderate access [yellow]; full access [light purple] Source: U.S. Health Resources and Services Administration (HRSA), Area Health Resources Files, 2021

Holiday weekend update

David Ermer–ACA, CDC, Congress, COVID-19, U.S. Healthcare–

Congress remains on the campaign trail this coming.

The Medicare Open Enrollment period begins on Saturday, October 15. The New York Times adds

Social Security will soon announce the largest inflation adjustment to benefits in four decades — a welcome development for millions of older Americans struggling to keep up with fast-rising living costs.

The cost-of-living adjustment for 2023 is likely to be around 8.7 percent, based on the latest government inflation figures. The final COLA, as the adjustment is known, will be released Thursday, when the federal government announces inflation figures for September. Medicare enrollees can anticipate some additional good news: The standard Part B premium, which is typically deducted from Social Security benefits, will decline next year.

The COLA, one of Social Security’s most valuable features, will give a significant boost to more than 70 million Americans next year. While retirement comes to mind when most people think about Social Security‌, the program plays a much broader role in providing economic security.

In August, the program paid benefits to 52.5 million people over age 65, but younger beneficiaries — survivors of insured workers and recipients of disability benefits‌ and Supplemental Security Income, the program for very low income people — added 17.9 million people to the total, according to Social Security Administration data.

The Federal Times discusses the upcoming open enrollment for the Federal Employee Dental and Vision Programs.

Twelve dental carriers provide 23 dental plan options available across the program. Seven dental carriers offer fourteen nationwide dental plan options available to all potential enrollees. Five vision carriers provide 10 nationwide vision plan options available to all potential enrollees.

The FEHB, FEDVIP, and FSAFeds Programs share the same open enrollment season, which this year will run from November 14 to December 12.

The health insurance marketplace open enrollment period begins on November 1, 2022, and ends on January 23, 2023.

From the public health front —

  • The New York Times discusses why Americans need a flu shot. As to timing

Immunity against the flu tends to wane over the course of a season. You have higher protection a couple of weeks after receiving the shot, compared with four or five months later, so it is a good idea to schedule your vaccine appointment close to the beginning of flu season, and not too early, Dr. Martin said. “I tend to get vaccinated in October so my antibodies are ramped up by the time holiday travel begins,” she said.

Some people wait longer, until November or December, especially if they are keeping a close eye on cases. But experts agree that it is important to receive the vaccine before cases start to surge. Your body needs at least two weeks after the shot to ramp up its defenses against the flu. People who are more susceptible to severe flu — especially older adults, pregnant women and very young children — should not delay their shots.

  • MedPage Today reports “Long COVID Persists in People With Symptomatic SARS-CoV-2 Infection — At one year, 15% of long COVID patients had ongoing cognitive or respiratory problems or fatigue.” Fierce Healthcare delves into health plan coverage of this tricky disease.
  • The New York Times offers expert opinions about various aspects of monkeypox.

From the healthcare personnel front, Healthcare Dive reports

Effective Oct. 17, [Amar] Desai who [currently is President and Chief Executive Officer, Optum Pacific West] will lead CVS’ newly created health care delivery division, overseeing implementation of CVS’ health services and care delivery strategy, according to a release from the Woonsocket, Rhode Island-based company. That includes CVS’ clinical delivery strategy in retail health, chronic disease management and behavioral health.

The division will work to link different aspects of CVS’ portfolio to develop payer-agnostic products and services, according to CEO Karen Lynch.

Good luck, Mr. Desai.

From the medical research front —

  • STAT News tells us about a large “gold-standard” European study concluding that colonoscopies are not all they have been cracked up to be in the U.S.

The trial’s primary analysis found that colonoscopy only cut colon cancer risk by roughly a fifth, far below past estimates of the test’s efficacy, and didn’t provide any significant reduction in colon cancer mortality. Gastroenterologists, including Bretthauer, reacted to the trial’s results with a mixture of shock, disappointment, and even some mild disbelief.

It’s the first randomized trial showing outcomes of exposing people to colonoscopy screening versus no colonoscopy. And I think we were all expecting colonoscopy to do better,” said Samir Gupta, a gastroenterologist at the University of California, San Diego and the VA who didn’t work on the trial. And, he said, it raises an uncomfortable question for doctors. “Maybe colonoscopy isn’t as good as we always thought it is.”

He stressed that the study does not invalidate colonoscopies as a useful screening tool. Colonoscopies are still a good test, Gupta said, but it may be time to reevaluate their standing as the gold standard of colon cancer screens. “This study provides clear data,” he said, “that it’s not as simple as saying, ‘Colonoscopy is the most sensitive test, and therefore it is the best.’ It still prevented cancers.”

The study has not shattered the FEHBlog’s confidence in the procedure, but it’s worth discussing the study with your physician down the line.

  • Bloomberg prognosis reports, “AstraZeneca Plc’s nasal spray vaccine failed to elicit a strong immune response to Covid-19 in a [small] early trial, a blow to the U.K. drU.K. giant’s ambitions for developing an alternative approach to preventing the disease.”

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.