Midweek update

Federal employment benefits

Midweek update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill, the Hill catches us up on the news surrounding the continuing resolution funding the federal government through December 16. The CR remains on track to be signed into law by the weekend. Here are links to the Senate Appropriations Committees’ text of the continuing resolution, which is a substitute for HR and a section-by-section bill summary.

From the Omicron and siblings front, David Leonhardt, writing in his Morning column for the New York Times, answers current questions about Covid vaccinations and boosters.

From the Rx coverage front, Fierce Pharma reports

Japanese ophthalmology specialist Santen has earned an FDA approval for its eye drops. The U.S. regulator has signed off on Santen’s Omlonti to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Santen developed the drug, otherwise known as omidenepag isopropyl ophthalmic solution, along with another century-old Japanese firm, UBE Industries of Tokyo.

As a selective prostaglandin EP2 receptor agonist, Omlonti provides patients with primary open-angle glaucoma or ocular hypertension—both of which can cause blindness—a treatment with a unique mechanism of action, Santen said. 

“This approval is an important milestone in our ambition to tackle unmet needs in eye health,” Peter Sallstig, the chief medical officer of Santen, said in a release.

Known as Eybelis in Japan, the drops won approval there in 2018. On top of that, five more countries in Asia sanctioned the treatment last year. It is Santen’s first glaucoma offering in the U.S. Approximately 3 million people in the U.S. and 76 million worldwide have the two conditions, with numbers increasing as the global population ages, Santen said.

In other FDA developments, the agency today announced

proposed updated criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging. This proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans. 

More than 80% of people in the U.S. aren’t eating enough vegetables, fruit and dairy. And most people consume too much added sugars, saturated fat and sodium. The proposed rule is part of the agency’s ongoing commitment to helping consumers improve nutrition and dietary patterns to help reduce the burden of chronic disease and advance health equity. 

From the healthcare technology front, Fierce Healthcare tells us

Cigna is launching a new concierge care platform that aims to harness both the strengths of its health plan and its sister company, Evernorth.

The new offering, called Pathwell, integrates Evernorth’s data analytics, clinical expertise and digital solutions with the medical benefits and network of its health plan with the goal of providing a personalized, comprehensive care experience for members who are managing high-cost conditions. Pathwell will first target patients with musculoskeletal conditions and patients who take injectable or infused biologic drugs.

The Cigna team expects to build Pathwell out to other conditions in the future. The solution is now available in many U.S. commercial plans and will grow over the course of 2023.

Shawna Dodds, vice president of product development at Cigna, told Fierce Healthcare that combining the powers of the health plan and Evernorth allows the insurer to offer the choices members need to take charge of managing their own conditions.

“It’s combining the strategic assets that exist across those two companies to really bring the integrated experience to the consumer,” she said.

From the drug research front, STAT News warns that the positive trial results on Biogen’s new Alzheimer’s drug are not a reason by itself to pop the Champagne bottles.

The trumpeting from the companies Eisai and Biogen relied on data that showed that people receiving the therapy, lecanemab, saw a slower decline versus those on a placebo. That finding was based on a .45-point difference between the groups on an 18-point scale called the Clinical Dementia Rating sum of boxes, amounting to a 27% reduction in the rate of cognitive decline.

But translating what that statistical gobbledygook could mean for patients living with Alzheimer’s is a different challenge, one that physicians will have to navigate as they weigh whether to prescribe the treatment (presuming it wins regulatory approval) and for which patients.

The clinical significance of the trial data — as opposed to the statistical significance, which was proven by the study — will continue to be debated among neurologists and geriatricians as lecanemab moves through the regulatory approval process and into doctors’ offices. Insurers could also weigh in, assessing how widely they’re willing to cover the treatment and for which patients based on what kind of perceptible outcomes they think the data point to.

After all, what people want from any Alzheimer’s therapy is not measured by some “sum of boxes” or questionnaire but by the details of an individual life. Would this mean they could keep driving or working? Could they keep taking the dog for a walk without their family worrying about them getting lost? Could they hold on to the knowledge of who those family members are — and who they themselves are — for longer?

Mia Yang, a geriatrician at Wake Forest, noted that the impact of a .45-point difference on the scale depended on where someone was. Someone with a CDR score of 0.5, for example, might have some memory problems but could still keep up with daily activities. Someone with a score of 1, however, might start encountering some functional losses.

A half-point difference wouldn’t mean much for someone with more advanced Alzheimer’s, Yang said.

“I’m cautiously optimistic that it could be potentially meaningful for those folks who are in the mild stage,” Yang said about lecanemab. Indeed, the trial focused on people with early-stage Alzheimer’s.

From the US healthcare business front, Beckers Hospital CFO Report explores why nine hospitals closed this year. “From cash flow and staffing challenges to dwindling patient volumes, many factors lead hospitals to shut down.”

From the federal employee benefits front, Reg Jones, writing in Fedweek, discusses the Federal Employee Group Life Insurance Program known as FEGLI.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Yesterday, the FEHBlog welcomed the first day of autumn when the autumnal equinox was at 9:04 pm today. To compound his error, the FEHBlog overlooked that yesterday was World Gratitude Day. The FEHBlog is grateful for his readers.

From Capitol Hill, Roll Call reports on the state of the continuing resolution to fund the federal government into mid-December.

Congressional leaders and appropriators are expected to spend the weekend haggling over the last details of the text Schumer is aiming to unveil Tuesday [following the Jewish New Year holiday], which he would offer as a substitute amendment.

On Thursday, authorizing committees agreed on a five-year reauthorization of FDA user fee programs, which could potentially be attached to the continuing resolution. Numerous other authorizations, funding “anomalies” and a supplemental aid package for Ukraine and other purposes were still being negotiated. 

The House of Representatives is capable of acting quickly.

From the Omicron and siblings’ front

  • Beckers Hospital Review reports, “Retooled COVID-19 booster shots that target omicron subvariants could be authorized and available for children to receive within a month, the CDC said in a vaccination planning guide released Sept. 20.”

In other public health news, STAT News tells us

As some of us wonder how we’ll know when the coronavirus pandemic is over, a new report from the WHO called “Invisible Numbers” reminds us that noncommunicable diseases take more lives than infectious diseases (and make Covid-19 worse). To wit: Cardiovascular diseases including heart disease and stroke, cancer, diabetes, chronic respiratory diseases, and mental illness cause nearly three-quarters of deaths in the world and kill 41 million people every year. Some of the more striking findings:

* Every year 17 million people under age 70 die of noncommunicable diseases, 86% of whom live in low- or middle-income countries.

* Preventable risk factors include tobacco use, unhealthy diets, harmful use of alcohol, physical inactivity, and air pollution.

* NCDs cause 74% of all deaths, but interventions known to work could avert at least 39 million NCD deaths by 2030.

In that regard, ABC News reports

Cancer deaths in the United States are continuing to decline, according to a new report from the American Association for Cancer Research.

The report, published Wednesday, found that deaths from cancer have decreased by 2.3% every year between 2016 and 2019.

Overall, there has been a 32% reduction in the U.S. cancer death rate since 1991, which translates into approximately 3.5 million lives being saved, the report said.

Additionally, in 2022, there are more than 18 million cancer survivors living in the U.S., equivalent to 5.4% of the population, the report found. Fifty years earlier, there were just 3 million cancer survivors.

That’s remarkable.

In related medical research news,

Medscape reports

New results from a large prospective trial give a better idea of how a blood test that can detect multiple cancers performs in a “real-life” setting.

“As this technology develops, people must continue with their standard cancer screening, but this is a glimpse of what the future may hold,” commented study investigator Deborah Schrag, MD, MPH, chair, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City.

STAT News relates

The National Institutes of Health on Thursday announced more than $600 million in fresh funding for an expansive and ongoing push to unravel the mysteries of the human brain, bankrolling efforts to create a detailed map of the whole brain, and devise new ways to target therapeutics and other molecules to specific brain cell populations.

Scientists across the country are involved, from teams at the Salk Institute to Duke University to the Broad Institute of MIT and Harvard, among other places. If successful, they will help answer fundamental questions about the body’s most complex organ. What are all the cell types in the brain? How are they connected to one another? How do the workings of the brain change during disease, and what can we do about that?

So far, those questions have proven easier to ask than to answer, with researchers gleaning bits of information from individual studies, but the hope is that a broad-based effort will jump-start new revelations.

Hope springs eternal.

From the mental healthcare front —

Health Payer Intelligence explains

CVS Health is making progress toward its behavioral health goal of decreasing the suicide rate among Aetna members by 20 percent by 2025, but progress among adolescent members is lagging, the healthcare organization announced.

“Our members are not immune to the national suicide crisis reported by the CDC. Though we are on track lowering suicide attempts in adults, our goal will not be reached until we can say the same for adolescents,” said Sree Chaguturu, MD, executive vice president and chief medical officer at CVS Health.

The organization has been working toward this goal since 2017, its work running parallel to that of the American Foundation for Suicide Prevention (AFSP) which had the same goal.

As of March 2022, CVS Health saw suicide attempts among Aetna members drop by 15.7 percent when compared to the company’s 2019 rate.

CVS Health broke down the overall rate by age and found that the reductions were largely driven by decreases among members ages 18 and older. For individuals in this age range, suicide attempts dropped by 17.5 percent in 2021 and dropped another 34.1 percent through March 2022.

Having made progress toward the goal, however, the organization does not intend to slow down.

“We are doubling down on efforts to prevent suicide in teens by identifying those most at-risk and in need of intervention, reaching out to those discharged from the ER after a suicide attempt with resources and supporting parents and loved ones in prioritizing the mental health of their kids,” Chaguturu explained.

Specifically, Aetna saw an upward trend in suicide attempts among its adolescent members.

Members between the ages of 13 and 17 saw increases in suicide attempts. In 2021, the suicide rate among this population grew 43 percent. In the first three months of 2022, the suicide rate jumped another 32 percent.

“We are implementing evidence-based therapies and outreach programs to prevent suicidal ideation before it starts and get adolescents the clinical care they need when they are at risk,” said Cara McNulty, president of behavioral health and mental well-being at CVS Health. “Every suicide attempt prevented, life saved, and mental health resource sought is an important step to reducing death by suicide in the United States.”

Mazaal Tov to CVS Health for those successful and ongoing efforts.

The Society for Human Resources offers guidance on suicide prevention in the workplace.

From the No Surprises Act litigation front, STAT News explains

During a hearing yesterday, the Association of Air Medical Services indicated it was following in the footsteps of AHA and AMA and would likewise dismiss its claims now that the final rules are out. But the AAMS also said it was deliberating whether it would file a different lawsuit in a different court, while attorneys for AMA and AHA backpedaled and said they have no intentions of filing any new lawsuits anywhere.

Today we got some clarity when the Texas Medical Association filed a new lawsuit challenging the revised final independent dispute resolution rule issued in the summer. In addition, the American Hospital Association and the American Medical Association have announced that they are joining the case as friends of the court in support of the Texas Medical Association. The lawsuit was filed in the U.S. District Court for the Eastern District of Texas. And the beat goes on.

From the U.S. healthcare business front, the Wall Street Journal reports

Humana Inc. HUM 0.67%▲ and CVS Health Corp. CVS 0.06%▲ are circling Cano Health Inc., CANO 32.17%▲ according to people familiar with the situation, as healthcare heavyweights scramble to snap up primary-care providers.

The talks are serious and a deal to purchase Cano could be struck in the next several weeks, assuming the negotiations don’t fall apart, some of the people said. Cano shares, which had been down nearly 7%, turned positive and closed up 32% after The Wall Street Journal reported on the talks with Humana and other unnamed parties, giving the company a market value of roughly $4 billion.

Bloomberg subsequently reported CVS’s interest.

It couldn’t be learned which other potential buyers might be in the mix, but Cano could be Humana’s to lose as the health insurer has a right of first refusal on any sale, part of an agreement that was originally struck in 2019.

Miami-based Cano operates primary-care centers in California, Florida, Nevada, New Mexico, Texas, Illinois, New York, New Jersey and Puerto Rico, according to documentation from the company. It mainly serves Medicare Advantage members, a private-sector alternative to Medicare for seniors.

Beckers Payer Issues tells us

Healthcare startup Curative, best-known for providing COVID-19 testing, is introducing a health plan with no copays or deductibles. 

The company is offering the new plan in the Austin, Texas, area, with plans to expand throughout Texas over the next year, Curative said Sept. 21. The announcement comes as the startup lays off 109 employees from its testing business in California.

In a news release, Fred Turner, co-founder and CEO of Curative, said the startup is on a mission to “drastically remake” the U.S. healthcare system. 

“The only way to achieve true cost transparency is for all in-network services to be covered at $0 cost, so members actually know where they stand and can get the care they need without surprise bills or medical debt,” Mr. Turner said in the release. 

According to the news release, Curative plan members will not owe any copay costs if they complete a baseline visit to evaluate preventive care and health literacy. 

From the Postal Service front, Federal News Network reports

Postmaster General Louis DeJoy announced Wednesday that all Executive and Administrative Schedule (EAS) and Pay Band Non-bargaining unit employees will soon receive a 3% salary increase, “regardless of their current salary maximum.”

DeJoy, in a memo to USPS officers Wednesday, said the pay increase will go into effect Sept. 24 and will reflect on the employees’ Oct. 14 pay statement.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, NIH, Wellness–

Happy First Day of Autumn!

From Capitol Hill, Roll Call discusses the Senate Majority Leader’s plans for successfully passing the continuing resolution funding the federal government through December 16, 2022.

[I]n theory the tentative plan to start the process this Thursday could lead to a final Senate vote by next Friday, when the current fiscal year expires. It might even enable the House to take up the Senate-passed bill and clear it in time to beat the midnight deadline.

All that assumes everything goes according to plan and that there’s an acceptable stopgap funding package that can pass in both chambers. None of those details have been released, but top appropriators and other lawmakers said Wednesday there’s no talk yet of a very short-term CR to buy more time.

From the Omicron and siblings’ front —

  • Fierce Healthcare tells us about the possible blossoming of another Omicron variant BF.7
  • The Wall Street Journal reports on the rollout of nasal Covid vaccines in Asia “though just how effective they are remains to be seen.” These are adenovirus, not mRNA-based, vaccines. Nonetheless

Delivering a vaccine through the nose has the potential to build up a type of immune response known as mucosal immunity, or immunity in the upper airway tract, said David Curiel, professor of radiation oncology at Washington University School of Medicine who co-developed the Bharat vaccine. That is important because mucosal immunity could more effectively block infection and transmission of the coronavirus than the type of immunity induced by injected vaccines, he said.

In other virus news, Forbes offers an illuminating article by Gayle Smith, the CEO of the ONE Campaign, which fights to end extreme poverty and preventable disease. Ms. Smith writes on the emergence of polio.

The re-emergence of polio is worrisome, particularly considering the politicization of and uneven response to the Covid-19 pandemic. Panic, however, is unwise. What is needed is vigilance and vaccination coverage. Fortunately, there are millions of people who are living proof that polio vaccines work.

This is a moment when the world can do the right thing and eradicate a preventable disease. Since the mid-1950s, a concerted global effort has confined endemic polio to only two countries and proven that this is a virus we can defeat. 

Going all the way is a moonshot and a win for the world. It is not without its challenges, of course. But it is far easier right now than defeating Covid, or malaria, or AIDS. One can only hope that ridding the world of a disease known as “infantile paralysis” might be something we can all agree on — if not for ourselves then for the children whose lives continue to be at risk.

Also, from the public health front, the National Institutes of Health helpfully informs us

In a large clinical trial that directly compared four drugs commonly used to treat type 2 diabetes, researchers found that insulin glargine and liraglutide performed the best of four medications approved by the U.S. Food and Drug Administration to maintain blood glucose levels in the recommended range. Blood glucose management is a key component of keeping people with type 2 diabetes healthy. All four medications evaluated were added to treatment with metformin, which is the first-line drug to treat type 2 diabetes. The trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health.

More than 37 million Americans have diabetes, and approximately 90 to 95% of them have type 2 diabetes. People with diabetes who keep their blood glucose levels in the near-normal range generally have a much lower risk of developing diabetes complications such as nerve, kidney, and eye diseases. Most people with type 2 diabetes require more than one medication to control blood sugar levels over time. 

While there is general agreement among health care professionals that metformin combined with diet and exercise is the best early approach in diabetes care, there is no consensus on what to do next to best keep high blood glucose in check.

From the wellness front, Fierce Health relates that United Healthcare is expanding its relationship with exercise machine marker Peleton. As a result, UHC will be making Pelton’s fitness services available to as many as 10 million of its members.

From the federal compensation and benefits front

  • Govexec reports on locality pay developments, and Social Security changes that Congress may approve this year.
  • Reg Jones writing in FedWeek provides a personal story about federal survivor benefits worth a gander.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, No Surprises Act, Telehealth–

From Capitol Hill, Healthcare Dive reports

A group of 375 organizations sent a letter to the Senate on Tuesday urging lawmakers to act to pass legislation extending COVID-19-era telehealth flexibilities for another two years.

The letter was led by health IT and telehealth lobbies, but also joined by a number of health systems including Ascension and Cleveland Clinic, physician groups including the American Medical Association, tech companies including Amazon and Google and large employers including Walmart.

Without action, the policies — which threw open the doors to telehealth and led to skyrocketing utilization in the early days of the pandemic — will expire 151 days after the end of the COVID-19 public health emergency.

Health Payer Intelligence adds that according to a recently conducted survey on consumers enrolled in employer-sponsored health plans commissioned by AHIP:

First, most consumers across the political spectrum agreed that providers should not be permitted to charge unnecessary administrative fees and medical services mark-ups. Nearly eight out of ten respondents said that they supported this statement (78 percent), with three-quarters or more in each political party reporting this response.

Second, there was also strong bipartisan support for protections against hospital monopolies. Over three-quarters of consumers supported preventing hospitals from consolidation, mergers, and acquisitions that involved bringing other medical practices into one hospital system (76 percent). Consumers also indicated support for protections against site-based cost increases (75 percent).

Respondents wanted more transparency about healthcare deals. Slightly more than seven in ten consumers supported improving transparency around private-equity firms’ healthcare acquisitions.

Third, the researchers also found bipartisan alignment around telehealth. Slightly more than two-thirds of respondents agreed that the government should eliminate regulatory barriers to telehealth utilization (67 percent).

“Consumers value choice and flexibility in how they access health care. Telehealth proved to be an essential resource for consumers throughout the COVID-19 pandemic and should continue to play a role in the future of health care,” the survey stated.

To provide context, Beckers Hospital CFO Report informs us

HHS is set to extend the COVID-19 public health emergency [PHE] by its standing deadline of Oct. 13. 

HHS last renewed the PHE July 15 for another increment of 90 days with a pledge to provide states with 60 days’ notice if it decided to terminate the declaration or allow it to expire. Aug. 14, the date in which states would have 60 days’ notice, came and went without updates or notifications from the agency, suggesting the declaration will extend.

If renewed on the deadline of Oct. 13, the next deadline would be Jan. 11, 2023. * * *

For an overview of the flexibilities tied to the PHE and what occurs when the declaration ends, check out a comprehensive brief from Kaiser Family Foundation here.

In No Surprises Act news yesterday, the NSA regulators issued a request for information (RFI) from stakeholders and the general public. The RFI concerns the law’s requirement that health plans provide an advance explanation of benefits (AEOB) in response to a good faith estimate (GFE) of healthcare costs requested by the patient to their healthcare provider. The provider would submit the GFE request to the health plan. HIPAA governs many similar claims transactions involving providers and payers. Surprisingly, Congress did not add these claim transactions to HIPAA, which would have made perfect sense. The FEHBlog does not understand why the regulators have not asked Congress to take this necessary step. At first glance, the contemplated process strikes the FEHBlog as unnecessarily complicated if the object is to avoid patient surprises. Nevertheless, at least the regulators are seeking public input.

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

A research team funded by the National Institutes of Health has shown that commercially available rapid antigen tests can detect past and present variants of concern and has identified potential mutations that may impact test performance in the future. As new variants of the SARS-CoV-2 virus continue to emerge, concerns have been raised about the performance of rapid antigen tests.

The team, which was funded by NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, developed a method to evaluate how mutations to SARS-CoV-2 can affect recognition by antibodies used in rapid antigen tests. Since most rapid antigen tests detect the SARS-CoV-2 nucleocapsid protein, or N protein, the team directly measured how mutations to the N protein impacted diagnostic antibodies’ ability to recognize their target.

“Rapid antigen tests remain an important COVID-19 mitigation tool, and it is essential to ensure that these tests can detect the SARS-CoV-2 virus as it continues to evolve,” said Bruce J. Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and lead for the RADx Tech program at the NIH. “Considering the endless cycle of new variants, the data from this study will be useful for years to come.”

From the healthcare technology front, Fierce Healthcare informs us

[Cigna’s] Evernorth is expanding its digital health formulary yet again, adding five new solutions to the platform.

The formulary will now include Big Health’s Sleepio for insomnia and the tech company’s Daylight tool for anxiety. In addition, Evernorth said it will expand inclusion of Quit Genius’ tools to its platforms for alcohol use disorder and opioid use disorder.

Lastly, Evernorth will now include HealthBeacon’s Injectable Care Management System for inflammatory conditions, which is meant to assist patients in managing injectable medications. Glen Stettin, M.D., chief innovation officer at Evernorth, told Fierce Healthcare that all of the new tools fit key concerns for employers and plan sponsors, such as mental health and high-cost inflammatory conditions.

“Our clients care about areas where either lots of people need help and treatment or where they’re spending lots of money,” Stettin said.

From the federal employee benefits front, benefits expert Tammy Flanagan writing in Govexec discusses how federal employees should time their retirement.

Midweek Update

David Ermer–Congress, COVID-19, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–

From Capitol Hill, Fierce Healthcare tells us

The House unanimously passed the Improving Seniors’ Timely Access to Care Act on Wednesday via a voice vote. The legislation, which has new transparency requirements for MA plans, now heads to the Senate.

Lawmakers behind the legislation said in a joint statement the bill will “make it easier for seniors to get the care they need by cutting unnecessary red tape in the healthcare system,” said Reps. Suzan DelBene, D-Washington, Mike Kelly, R-Pennsylvania, Ami Bera, M.D., D-California, and Larry Bucshon, M.D., R-Indiana.

It’s worth noting that traditional Medicare has no prior authorization requirements. Beckers Payer Issues adds

Enrollees in Medicare Advantage were less likely to receive low-value care than those enrolled in traditional Medicare, a new study published in JAMA Open Network found. 

The study, published Sept. 9, found Medicare Advantage enrollees received 9.2 percent fewer low-value services than their counterparts using traditional Medicare. 

Low-value care is services that provide little clinical benefit or cause more harm than benefits for a patient. 

The study’s authors, lead by researchers from Humana and Boston-based Tufts University School of Medicine, compared enrollees in a large, national Medicare Advantage plan to a random sample of 5 percent of traditional Medicare beneficiaries. 

The study found among Medicare Advantage enrollees, those who had HMO plans were less likely to receive low-value care than those with PPO plans.

Read the full study here.

Hopefully, Congress will not throw out the baby with the bath water.

From the federal employee benefits front, FedWeek informs us

OPM has issued a reminder to agencies of their authority to verify that family members being covered under the FEHB actually are eligible, including the process to be used and the documentation required.

The notice calls attention to a revision of the FEHB handbook section on family member eligibility reflecting several instructions of recent years, including one telling agencies to tighten scrutiny of those covered and another laying out procedures for removing those deemed ineligible. That is a response to several inspector general reports warning that ineligible persons are being insured under the program, raising premium costs to the government and to other FEHB enrollees.

That directive, now part of the handbook, lists agency responsibilities to verify eligibility of family members during initial enrollment of newly hired employees and when family members are being added to an existing enrollment due to a “qualifying life event” such as marriage.

In the middle of the last decade, OPM added a standard contract provision to FEHB contract requiring carriers to share the cost of any family member eligibility audit that OPM undertakes. OPM has not yet exercised that provision.

It turns out that for the past two weeks federal employee benefits expert Reg Jones has been writing in Fedweek about federal employee retirement benefits. Today’s he discusses survivor benefits which includes a squib about perhaps the most unique and valuable survivor benefit — FEHB coverage for the survivor’s life with the full government contribution as explained here:

If your spouse receives a survivor annuity and was covered under either the Self Plus One or Self and Family option of your Federal Employees Health Benefits plan when you died, he or she and all eligible children can continue that coverage. If the annuity amount is less than the premiums required, your spouse will be able to make payments directly to OPM to cover the cost.

From the Omicron and siblings front, we have two thoughtful pieces from MedPage Today

In other virus news, the American Hospital Association reports

The recent paralytic polio case in an unvaccinated adult in Rockland County, N.Y. and wastewater samples from communities near the patient’s residence meet the World Health Organization’s criteria for circulating vaccine-derived poliovirus, the Centers for Disease Control and Prevention announced yesterday. Genetic sequences from the virus in the patient and wastewater specimens have been linked to wastewater samples in Jerusalem and London, indicating community transmission, CDC said.
 
Thirty other countries have circulating vaccine-derived poliovirus, which is not caused by the polio vaccine but occurs when local immunity to poliovirus is low enough to allow prolonged transmission of the original weakened virus in the oral polio vaccine. Oral polio vaccine has not been used or licensed in the U.S. since 2000 but continues to be used in some countries. N.Y. Governor Kathy Hochul last week declared a state of emergency to help expand vaccination efforts and surveillance. 
 
“Polio vaccination is the safest and best way to fight this debilitating disease and it is imperative that people in these communities who are unvaccinated get up to date on polio vaccination right away,” said Dr. José R. Romero, director of CDC’s National Center for Immunization and Respiratory Diseases. “We cannot emphasize enough that polio is a dangerous disease for which there is no cure.”

From the No Suprises Act front, Beckers Hospital CFO Report relates

The No Surprises Act, which prevents patients from receiving surprise bills from out-of-network providers at emergency rooms, could lead to an increase in emergency department visits, a new study from the Agency for Healthcare Research and Quality found. 

The study, published Sept. 12 in The American Journal of Medical Care, compared emergency department visits rates in 15 states that implemented bans on balance billing between 2007 and 2018 to rates in 16 states where these bills were not banned. 

The study’s authors found that state-level bans reduced spending per emergency room visit by 14 percent but increased emergency room visits by 3 percentage points. These visits were 9 percent less urgent than before the balance billing ban, according to an emergency department severity index. 

Based on the state-level analysis, the study’s authors, led by AHRQ researcher William Encinosa, PhD, conclude that the No Surprises Act, which took effect this year, could result in 3.5 million more emergency room visits annually. 

“Because individuals will no longer have the fear of a possible catastrophic surprise ED bill not covered by their insurer, they may be more inclined to go to the ED in marginal, less severe cases,” the authors wrote. 

Read the full study here.

In the FEHBlog’s opinion, the No Surprises Act is working well, and he does not foresee a surge in ER visits because going to the emergency room is no picnic.

In preventive services news, MedPage Today reports

The jury is still out on whether asymptomatic children and adolescents should be screened for diabetes, the U.S. Preventive Services Task Force (USPSTF) said.

In a new recommendation statement published in JAMA, the task force concluded that there is insufficient evidence to weigh the benefits and harms of screening for type 2 diabetes in this pediatric population, despite rising rates of disease.

“[T]here is inadequate evidence that screening and early intervention lead to improvements in health outcomes such as renal impairment, cardiovascular morbidity, mortality, and quality of life,” wrote Carol M. Mangione, MD, MSPH, of the University of California Los Angeles, and colleagues.

From the miscellany department —

  • The Department of Health and Human Services announced that today HHS “Secretary Xavier Becerra formally swore in Melanie Fontes Rainer as Director of the Office for Civil Rights (OCR). Director Fontes Rainer previously served as the Acting Director and was officially appointed to the role last month.  OCR is responsible for enforcing federal civil rights; conscience protections; the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules; and the Patient Safety and Quality Improvement Act and Patient Safety Rule – which together protect individuals’ fundamental civil rights and medical privacy.”
  • The Justice Department announced “the establishment of three Strike Force teams created to enhance the Department’s existing efforts to combat and prevent COVID-19 related fraud. “These Strike Force teams will build on the Department’s historic enforcement efforts to deter, detect, and disrupt pandemic fraud wherever it occurs,” said Attorney General Merrick B. Garland. “Since the start of this pandemic, the Justice Department has seized over $1.2 billion in relief funds that criminals were attempting to steal, and charged over 1,500 defendants with crimes in federal districts across the country, but our work is far from over. The Department will continue to work relentlessly to combat pandemic fraud and hold accountable those who perpetrate it.” The Strike Force teams will operate out of U.S. Attorney’s Offices in the Southern District of Florida, the District of Maryland, and a joint effort between the Central and Eastern Districts of California.”

The good news is there’s a cure for hepatitis C. The bad news is how hard it is to bring that miracle cure to the people who need it. For years experts assumed the drug’s astronomical price was the biggest barrier. So in 2019, Louisiana and Washington state adopted the “Netflix model,” as in paying a lower price for abundant access to the drug. Just last week the White House jumped on board for a national version.

But STAT’s Nicholas Florko has found that neither state is near its goal. In Washington, the treatment rate for Medicaid patients is now lower than before the initiative began, even with a lower price. “The further you get out in the population … the more you start to hit this population that is harder — harder to identify, more costly to convert to treatment,” Rena Conti of Boston University told Nick. Read his investigation here.

  • The National Institute of Health’s HEAL Program offers ways to build opioid use disorder prevention into everyday life.
  • Govexec discusses OPM’s efforts to “highlight ways federal employees can contribute to the White House’s fight against hunger and to improve Americans’ health and nutrition, including through an event later this month.”

Thursday Miscellany

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, SDOH, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the omicron and siblings front, AHIP informs us

Today the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the bivalent mRNA COVID-19 vaccines as a single-dose booster for all individuals ages 12 and older (Pfizer-BioNTech) and 18 and older (Moderna), at least two months following primary series or previous booster dose.  The ACIP recommendation for the bivalent boosters was approved by a vote of 13-1.

The Committee reviewed modeling data showing the vaccine has the potential to reduce hospitalizations and deaths, especially among high-risk groups.  The bivalent boosters are recommended for all those over age 12 who have completed a primary series, at least 2 months after the most recent dose. The modeling data indicates that the vaccine is safe and effective, and that booster strategies will be executed in an equitable manner.  Models also indicate that waiting until more trial data is available (in two to three months) could lead to preventable hospitalizations and deaths.

ACIP members expressed concern that many assumptions had been made with the modeling, and that the vaccine being recommended – which includes protections specific to the BA.4/BA.5 variants – has not been tested in humans.  Mouse models were used for data on this vaccine, in addition to extrapolations from human trials using the BA.1-specific vaccine. CDC pointed out that annual influenza vaccines are modified based on projected variants without direct clinical evidence. ACIP members also expressed concerns that the bivalent booster makes assumptions about future variants, which this booster may not protect against.

Earlier this week, the Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUAs) for both the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent Moderna vaccine is authorized for use as a single booster dose in individuals 18 years of age and older and the Pfizer bivalent vaccine is authorized for use as a single booster dose in individuals 12 years of age and older.  FDA also released fact sheets on both the Pfizer-BioNTech vaccine and the Moderna vaccine.

With the authorization, FDA has revised the EUAs to remove the use of the monovalent versions of the vaccines for booster administration for the age groups now covered by the bivalent booster products. ACIP also rescinded its recommendations for the monovalent booster vaccines.

Bivalent boosters may be available as early as next week.

The FEHBlog finds it noteworthy that the new bivalent booster replaces the monovalent booster.

STAT News offers FAQs on the new boosters.

STAT News also discusses the Omicron outlook for this autumn.

In a way, some physicians have said, Covid is becoming more like the other respiratory pathogens that most of us shake off but that can occasionally cause severe illness and death among the oldest adults or people who are already sick. So many more people are dying from Covid than from those other viruses, however, because of the massive number of cases that are still occurring overall.

Another trend that has continued into 2022 has been the racial and ethnic disparities associated with Covid. The gaps between different demographic groups’ death rates have shrunk over time, but at the peak of this summer’s wave, for example, death rates by age group among Hispanic adults were notably higher than those among white adults, federal data indicate.

One of the silver linings of the pandemic is that, unlike with some viruses, SARS-2 did not pose a particularly serious threat to children. That’s not to minimize the hospitalizations and deaths — as well as incidents of long Covid and MIS-C — that the virus did cause in pediatric populations. But overall, kids have faced much lower risks of severe outcomes from Covid than adults.

Still, something worrisome occurred this summer with kids and Covid, as hospitalizations reached their second highest peak of the entire pandemic, surpassing last summer’s Delta wave and only trailing the initial Omicron spike early this year.

The article’s experts encourage vaccinating children to stem this tide.

From the FEHB front, Govexec provides a handy just before and just after federal retirement checklist, and Fedweek helpfully delves into “What Counts and What Doesn’t for Keeping FEHB Coverage in Retirement,” which should be a key consideration for career feds.

From the public health front, the CDC reminds us September is Sepsis Awareness Month

Anyone can get an infection, and almost any infection, including COVID-19, can lead to sepsis. Sepsis is the body’s extreme response to an infection and is a life-threatening medical emergency.

September is Sepsis Awareness Month and CDC encourages patients and healthcare professionals to share Get Ahead of Sepsis resources, below, to learn how to protect themselves, their loved ones, and their patients from sepsis:

Patients and families:
* New this year is an updated patient and family brochure.
* Download and share any of CDC’s FREE patient education materials with your friends and loved ones to learn how to prevent infections, be alert to the signs and symptoms of sepsis, and act fast if sepsis is suspected.
* Share updated sepsis graphics on social media to educate friends and loved ones about sepsis.
* Are your children back to school? Talk to your child’s healthcare professional and school nurse about steps you can take to prevent infections that can lead to sepsis. Some steps include taking good care of chronic conditions and getting recommended vaccines.
Healthcare professionals:
New this year are two fact sheets for long-term care nurses and certified nurse assistants.
Download and share CDC’s FREE healthcare professional education materials with your colleagues to educate them about how to recognize signs and symptoms of worsening infection and sepsis, how to get ahead of sepsis, and what to do if they suspect sepsis.
Educate your patients and their families about:
o Preventing infections
o Keeping cuts clean and covered until healed
o Managing chronic conditions
o Recognizing early signs and symptoms of worsening infection and sepsis
o Seeking immediate care if signs and symptoms are present

This Sepsis Awareness Month, spread the word about sepsis—you can help save lives.

To learn more about sepsis and how to prevent infections, visit www.cdc.gov/sepsis or call 1-800-CDC-INFO.

From the miscellany department —

  • Medpage Today offers a special report about a ” New Behavioral Health Database Reveals Gaps in Care — Researchers behind it hope to provide the data needed to remedy the problem.”
  • STAT News reports “Drug treatment of veterans with opioid use disorder increased during the first year of the pandemic, according to a new study, suggesting that the rapid shift from in-person to telehealth visits at VA medical centers enabled patients to get access to care despite Covid-related disruptions.”
  • Fierce Healthcare tells us “Cigna’s Evernorth subsidiary is expanding its diabetes care value program to combine traditional pharmaceutical interventions with devices, tools and resources to help patients better understand and manage their diabetes.”
  • Healthcare Dive informs us that “To staunch the losses of rural hospital closures that endanger access to care for millions, federal regulators are hoping some facilities opt in to a new payment model, but providers say they want more flexibilities and clarity before making the pivot. * * * The new rule ‘maybe gets halfway there,’ Jennifer Findley, vice president of education and special projects at the Kansas Hospital Association, told Healthcare Dive. ‘It’s not as much as we were hoping for but it does give some more flexibility than what you have today.’”
  • Health Payer Intelligence reports “Chronic diseases are common among emergency department patients, particularly among seniors and those ages 45 to 64, according to a National Health Statistics Report. ‘Monitoring ED visits made by adults at highest risk of severe COVID-19-related illness is important for understanding the health burden of COVID-19 and for planning prevention strategies,’ the researchers explained. ‘Ongoing monitoring of the presence of these underlying chronic conditions at ED visits will continue to inform COVID-19 response efforts.’”
  • Also Health Payer Intelligence notes that “Three major social determinants of health factors are particularly predominant barriers to care for America’s seniors: economic instability, loneliness, and food insecurity, according to a study sponsored by Alignment Healthcare. Researchers from Toluna conducted an online survey from July 24 to August 13, 2022, which reached 2,600 seniors ages 65 and older. Most respondents identified as white. Half were in Medicare Advantage and this population was divided primarily between preferred provider organizations and health maintenance organizations.”

Midweek update

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Omicron and siblings front —

The New York Times reports

The Food and Drug Administration on Wednesday [August 31] authorized the first redesign of coronavirus vaccines since they were rolled out in late 2020, setting up millions of Americans to receive new booster doses targeting Omicron subvariants as soon as next week.

The new formulation arrives as roughly 90,000 infections and 475 deaths are still being recorded daily around the United States, more than two years into a pandemic that has killed more than a million Americans and driven a historic drop in life expectancy.

With winter approaching and the BA.5 variant of Omicron still circulating widely, federal officials hope the redesigned shots will help slow the pandemic’s seemingly relentless march. Yet many Americans appear to have become indifferent to the virus and its risks, making the task tougher than ever.

The new boosters are “bivalent,” meaning they contain a combination of the original formulation and one targeting BA.5, now the dominant version of the virus, as well as a sister subvariant of Omicron. One is made by Pfizer and its German partner BioNTech for use in people as young as 12, and the other by Moderna, for those 18 and older.

Here’s a link to the CDC’s 2021 U.S. life expectancy report which was released today.

Reuters adds

Advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Thursday [September 1] to vote on whether to recommend the use of two COVID-19 vaccine boosters tailored against the Omicron variant.

A recommendation in favor of the modified vaccines by Pfizer Inc and its German partner BioNTech SE , as well as Moderna Inc is expected to pave the way for a rollout next week.

Medpage Today offers background on tomorrow’s CDC Advisory Committee on Immunization Practices meeting.

ACIP will weigh in on newly authorized fall COVID boosters this week, in a manner unprecedented during the pandemic — without data from human clinical trials.

While most experts agree that there are no safety concerns, and many support the FDA’s attempt to keep up with viral variants, others have pointed out gray areas and open questions when it comes to Omicron-targeting bivalent vaccines.

That includes whether boosters with components targeting Omicron would offer a significant advantage in terms of efficacy — particularly, protection against infection — over boosting against the ancestral strain of the virus alone.

David Leonhardt, writing in his Morning column for the New York Times, provides his latest Covid poll which finds all Americans trending toward placing Covid in the rear view mirror.

A growing number of very liberal Americans have decided that it’s time to treat Covid as an unpleasant but manageable part of life, much as many other Americans — as well as people in other countries — decided months ago.

While the FEHBlog was pleased with the Times poll results, he thinks that Forbes hits the nail on the head with its opinion piece on how America can bring down its Covid death rate which took 383 lives yesterday.

Tragically, the vast majority of Covid-19 deaths are now preventable – if all Americans were up to date with vaccines, and if high-risk individuals got treated promptly after testing positive. If all that were to happen, Covid deaths in the U.S. would be nearly zero, as White House Covid-19 Response Team Coordinator Dr. Ashish Jha told the U.S. Chamber of Commerce Foundation recently.

What can the nation do to make that happen? Put simply, we must embrace the notion that Covid-19 deaths are largely preventable, not inevitable. Instead of trying to put those deaths out of mind, we should focus on what we can do to stop them.

Why are 400 Americans still dying each day? For starters, 15 million seniors have not received their first booster, and only 33% of Americans over 50 and 40% over 65 have received their second booster. In addition, over 20% of adults have not completed their primary vaccination series.

The health impacts of that inaction are sizable. The CDC estimates that among those 50 and older, the unvaccinated had a 29-fold increased risk of dying from Covid-19 and vaccinated people with only one booster had a 4-fold increased risk compared to those with two or more booster doses.

Meanwhile, access to the oral antiviral medication Paxlovid – which reduces the rates at which high-risk people get severe cases of Covid-19 or die from it – is the most limited in zip codes in which people were highly vulnerable to the virus. Moreover, access to and awareness of Evushield – which reduces the risk that immunocompromised people will develop symptomatic Covid-19 for up to six months – remains limited.

To keep Covid-19 and its impact in public consciousness, local health officials should publicly recognize when citizens in their communities lose their lives to the virus. For the same reason, local print and broadcast media should provide coverage of community memorials to those who have died. That should inspire citizens within communities to help each other fully access and use the tools available to all Americans, whether vaccines or treatments.

Local faith organizations, businesses, and other community leaders who have the trust of the population should redouble their efforts reminding individuals that their actions with respect to Covid-19 testing, vaccination, and treatment can make a tangible difference for their community.

Health care professionals should use every office visit, even if unrelated to Covid-19, to remind patients about the need to stay up to date with their vaccinations and have a plan to access treatment if they test positive and are eligible for treatment. The medical community’s attention to preventing and managing chronic conditions such as obesity and diabetes is now even more vital given their detrimental impact on Covid-19 outcomes.

Amen to that. Honestly, while the FEHBlog falls into the senior category, he has been delaying his second booster in order to receive the bivalent vaccine (or the Novovax booster which hasn’t been approved yet). The FEHBlog plans to make an appointment for the bivalent vaccine next week.

Finally, Healthcare Dive informs us

Americans may have to pay for their COVID-19 vaccinations as early as January as federal funding for vaccine purchase and distribution runs out and the shots shift to the commercial market, according to Dawn O’Connell, Assistant Secretary for Preparedness and Response at the HHS.

The announcement comes after the HHS hosted over 100 representatives from state and local governments, including various stakeholders, insurers and pharmaceutical companies in a planning meeting on Tuesday.

“While the federal government has been pleased to play this role, we have always known that we would not be in this business forever,” O’Connell said in a post on the ASPR site. “Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work.”

Read that as health plans may have to pay for their members’ Covid vaccinations next year. Conceding that the FEHBlog is not a Hyde amendment expert, he does not understand why the Senate leadership did not ram through more Covid funding in the massive budget reconciliation act.

Moving onto the country’s fentanyl crisis

CBS News tells us

The Drug Enforcement Administration issued an advisory Tuesday about an “emerging trend” of “brightly-colored” fentanyl pills being used to lure children and young people. What is often called “rainbow fentanyl” has been seized by law enforcement agencies in 18 states just this month, the DEA said.

The drugs, made to look like candy, comes in several forms, including “pills, powder and blocks that resembles sidewalk chalk,” the DEA said.

“Rainbow fentanyl — fentanyl pills and powder that come in a variety of bright colors, shapes, and sizes — is a deliberate effort by drug traffickers to drive addiction amongst kids and young adults,” DEA Administrator Anne Milgram said in a statement.

Regulatory Focus adds

The US Food and Drug Administration (FDA) said it plans to fight the current opioid crisis by going after online drug retailers and promoting the development of non-opioid alternatives.
 
On 30 August, the agency published its FDA Overdose Prevention Framework that largely aligns with the Department of Health and Human Service’s (HHS) 2021 Overdose Prevention Strategy. The framework echoes concepts in the HHS strategy, such as supporting primary prevention, encouraging harm reduction and advancing evidence-based treatments. FDA’s framework also includes the actions to protect the public from unapproved, diverted and counterfeit drugs with overdose risk.
 
In a blog post, FDA Commissioner Robert Califf said the agency needs new approaches to counter the rapid growth of illicit, chemically synthesized fentanyl, fentanyl analogs and methamphetamines on the market. Cracking down on such activities while securing the supply chain for approved opioids and other controlled substances is a top priority, he said.

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

Walgreens Boots Alliance has completed its majority stake acquisition in at-home care technology platform CareCentrix, the retail pharmacy giant announced Wednesday.

The $330 million investment gives Walgreens a 55% ownership of CareCentrix. Walgreens has the option to acquire the remaining equity in the future.

The investment, first announced in October, expands Walgreen’s reach in the health sector, especially in the areas of primary care, specialty pharmacy, post-acute and home care, the company said in a Wednesday release.

STAT News observes

Employers, who provide health coverage to roughly half the U.S. population, are acutely aware of where health care’s current cost trajectory is headed. In a recent survey of executives at 300 of the country’s largest employers, nearly 90% said they believe the cost of providing health benefits will become unsustainable within five to 10 years.

Yet instead of finding new ways to manage costs and help sustain this critical lifeline for America’s workers, many health systems continue to increase the prices they charge commercial insurers. And they can because, in many cases, newly consolidated health systems are the only game in town.

Employers and private insurers pay, on average, 224% of what Medicare would have paid for the same service at the same facility, despite new data showing that hospitals require payments that represent just 127% of Medicare to cover their expenses.

In federal employee compensation news, Federal News Network reports

President Joe Biden has formally announced his plans to give civilian federal employees a pay raise next year, starting on Jan. 1, 2023.

Most civilian employees under the General Schedule, as anticipated, will receive an average 4.6% federal pay raise in 2023, according to the alternative pay plan Biden submitted to congressional leaders Wednesday afternoon.

The president is specifically recommending a 4.1% across-the-board pay raise for federal employees in 2023, with an additional 0.5% average locality pay adjustment — resulting in a 4.6% average pay increase.

Biden said his alternative pay plan would help federal pay stay competitive with what workers with critical skills could earn in the private sector.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID treatment, COVID-19, Federal employment benefits, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

Roll Call reports from Capitol Hill

More than 3.5 million veterans who were exposed to toxic substances on overseas deployments will gain easier access to health and disability benefits under a bill that cleared the Senate Tuesday.

President Joe Biden is certain to sign the bill into law in the coming days.

The bill would make servicemembers who contracted any of 23 conditions — from brain cancer to hypertension — after being deployed to Iraq, Afghanistan and other combat zones automatically eligible for VA benefits. The measure is expected to cost nearly $280 billion over a decade, according to the Congressional Budget Office.

This law should save the FEHB Program money as the federal workforce has a large cadre of veterans who use veterans’ healthcare. VA facilities charge the FEHB and private sector plans for non-service connected health care. This law confirms that toxic substances treatment to service-connected care for which the VA is liable.

Govexec adds

The [VA] bill [also] authorizes leases for 31 new medical facilities at VA to help accommodate the expected surge in patients, which is expected to cost nearly $1 billion. The Congressional Budget Office found the slew of pay and other human resources changes would come with a $5.7 billion price tag over the next decade.

The bill will authorize the department to buy out the contract of health care professionals to recruit them to VA, so long as they make a four-year commitment to the department. VA will have $40 million per year for the buyouts. VA’s health care employees will be eligible for pay boosts worth 50% of their base salaries, up from the current cap of 30%. Overall pay would be capped at level two of the Executive Service pay scale, which is currently $203,000 per year. McDonough has called lifting the pay caps essential for VA’s recruiting and retention efforts and has aggressively pushed Congress to pass the reform.

With regard to the Schumer-Manchin reconciliation bill, the Hill reports that Senators Manchin and Simema are exchanging text on the bill.

From the Omicron and siblings front,

McKinsey and Company offer their assessment of when the Covid pandemic will end.

In this update, we discuss the outlook, the current and potential future use of boosters and therapeutics, and the shifts in response strategies to the COVID-19 crisis around the world. We also introduce the McKinsey COVID-19 Immunity Index—a tool for understanding a community’s current level of risk from the disease.

A group of physicians provides their observations in MedPage Today on how best to investigate the Paxolovid rebound issue.

The debate about “COVID-19 rebound” after nirmatrelvir/ritonavir (Paxlovid) treatment is one of these timely areas warranting further investigation. Continuing down the current path of uncertainty has consequences for how and by whom this antiviral should be used. However, by applying lessons learned from the early days of the pandemic — including acknowledging the importance of randomized controlled trials (RCTs) — we can avoid repeating the same mistakes. To do this, it is necessary to start by defining the question, identifying current knowledge gaps, and only then can one propose scientific solutions to bring a rapid resolution to the COVID-19 rebound controversy.

Paxlovid consists of two drugs: nirmatrelvir, which inhibits a SARS-CoV-2 protease inhibiting viral replication, and ritonavir, which slows the inactivation and breakdown of nirmatrelvir. Per a CDC health advisory released in May, COVID-19 rebound is defined as a return of symptoms or a “new positive viral test after having tested negative” occurring “2 to 8 days after initial recovery.” We just saw this over the weekend in the case of President Biden.

This definition of rebound is challenging and prone to inflating the incidence of rebound. It is possible some individuals identified as having “Paxlovid rebound” may have been experiencing a waxing and waning of COVID-19 symptoms while some unknown number of other reported rebound cases could be due to the known limitations of COVID-19 testing.

Precision Vaccinations tells us that in the near future the federal government will make the Omicron antibody based treatment known as Evusheld available through local pharmacies including “Albertsons, Acme, Jewel-Osco, Pavilions, Randalls, Safeway, Star Market, Vons, CPESN, Amber Specialty Pharmacy, Managed Healthcare Associates, and Thrifty White.”

Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK, and TACKLE principal investigator, commented in a press release, “Despite the success of vaccines, many individuals such as older adults, individuals with co-morbidities, and those who are immunocompromised, remain at risk for poor outcomes from severe COVID-19.”

“Additional options are needed to prevent disease progression and reduce the burden on healthcare systems, especially with the continued emergence of new variants.”

“The TACKLE (study) results show that one intramuscular dose of Evusheld can prevent these individuals from progressing to severe COVID-19, with earlier treatment leading to even better results.”

From the moneypox front, Fierce Healthcare reports

The White House has named Robert Fenton to serve as the response coordinator for the monkeypox outbreak, as calls for a larger federal role intensify. 

Fenton previously helped to coordinate COVID-19 vaccine distribution while working at the Federal Emergency Management Agency. He will work alongside Demetre Daskalakis, M.D., who will be the deputy coordinator. 

The coordinators will lead the administration’s efforts on “strategy and operations to combat the current monkeypox outbreak, including equitably increasing the availability of tests, vaccinations and treatments.” 

From the Affordable Care Act front, the International Foundation of Employee Benefit Plans informs us

The Internal Revenue Service (IRS) has issued Revenue Procedure 2022-34 providing the indexing adjustment for the required contribution percentage. For plan years beginning in 2023, the required contribution percentage is 9.12%, down from 9.61% in 2022. 

The affordability calculation can determine whether an individual can afford employer-sponsored health coverage and affect whether the individual would be eligible for a premium tax credit on the health insurance exchanges. This could affect employers that do not use a safe harbor method to determine whether the coverage they offer is affordable to employees.

For plan years beginning in 2023, employer-provided coverage is considered affordable for an employee if the employee required contribution is no more than 9.12% of that employee’s household income. Because applicable large employers generally do not know their employees’ household incomes, there are three safe harbor methods for calculating affordability.

In the FEHB Program, OPM must assure itself that the lowest premium nationwide FEHB plan premium for the self only option does not cost more than 9.12% of the lowest paygrade federal employee eligible to participate in FEHBP.

From the FEHB front, Fedweek columnist Reg Jones wraps up his series of federal employee and annuitant survivor benefits.

From the Medicare front, Healthcare Dive reports on provider reaction to yesterday’s final CMS rule on Medicare Part A payments to inpatient hospitals beginning October 1, 2022.

Providers remained largely unhappy early this week despite a final ruling issued by the CMS on Monday that increases inpatient payments to hospitals by more than was initially proposed.

Organizations like The American Hospital Association said it was “pleased” by the payment update, a 4.3% bump up from the proposed 3.2%, but added it “still falls short of what hospitals and health systems need to continue to overcome the many challenges that threaten their ability to care for patients and provide essential services for their communities.”

Group purchasing organization Premier agreed, saying the payment update “falls woefully short” of what is needed for health systems. “Coupled with record high inflation, this inadequate payment bump will only exacerbate the intense financial pressure on American hospitals,” SVP of Government Affairs Soumi Saha said in a statement.

Beckers Hospital review offers six takeaways from the final rule.

From the U.S. healthcare business front

Healthcare Dive reports

High operating expenses took their toll on hospitals and physician groups in June, producing negative year-over-year margins for a sixth consecutive month, a new report from Kaufman Hall found. Month-to-month increases in patient volumes were not enough to offset the growing cost of care, the advisory firm said Monday.

Compared with May, operating margins improved, contract labor costs fell as demand slowed, and expenses cooled slightly in the latest month. But the industry has yet to turn the corner on an “enormously difficult year,” the report said.

“Although hospitals are seeing improved volumes and reduced expenses month-over-month, they will likely end up with historically low margins for the remainder of the year,” Kaufman Hall predicted.

and

Louisiana-based Ochsner Health has officially merged with Rush Health Systems, giving the merged system seven hospitals and more than 30 clinics in the east Mississippi and west Alabama region, according to a Monday release.

New names and branding are being rolled out at regional hospitals under the new brand, Ochsner Rush Health, the release said. Ochsner Rush Health will have 250 staff and contracted physicians and 95 advanced practice providers.

Ochsner Rush Health is also boosting its minimum wage to $12 an hour, impacting more than 400 employees and representing a $1.5 million investment, according to the release.

From the public health front,

  • Healio offers a bleak outlook for chronic disease in the US over the next forty years “likely stressing an already burdened health care system.”
  • The Center for Disease Control points to its revamped diabetes website “for people with diabetes or who are at risk for diabetes, and their families and friends.”

From the judicial front,

STAT News tells us

In a significant victory for AbbVie, a U.S. appeals court panel declined to revive a lawsuit that accused the company of using a so-called patent thicket to forestall competition for its Humira medication, a franchise product that generates billions of dollars in sales each year.

The opinion shot down arguments by unions, insurers, and the city of Baltimore, which alleged that AbbVie “abused the patent system” and “erected significant barriers to entry to block biosimilar competition” by filing dozens of patents for the drug. Some of the 132 U.S. patents that the company holds on its medicine extend to 2034, although the basic patent expired in 2016.

The case has been closely tracked over concerns that the use of numerous patents — some of which may offer only marginal improvements or changes to a medicine — are exploited by pharmaceutical companies to protect monopolies at the expense of consumers. This has prompted the Food and Drug Administration and Patent and Trademark Office to jointly examine the issue.

Congress can change the patent system applicable to prescription drugs.

The American Hospital Association reports

The Department of Justice today filed a lawsuit challenging an Idaho law restricting abortion. The complaint seeks a declaratory judgment that the law conflicts with and is preempted by the Emergency Medical Treatment and Labor Act in situations where an abortion is necessary stabilizing treatment for an emergency medical condition. It also seeks an order permanently enjoining the law to the extent it conflicts with EMTALA, which requires hospitals that receive federal Medicare funds to provide necessary stabilizing treatment to patients who arrive at their emergency departments while experiencing a medical emergency.

The FEHBlog hopes that the federal court hearing the case seeks a decision from the Idaho Supreme Court on the scope of Idaho’s abortion law before proceeding with the case. The FEHBlog finds it hard to believe that any U.S. court would interpret its state’s abortion law as overriding obligations created by EMTALA and for that matter the Hippocratic Oath.

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, Medicare, OPM, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports that the Senate majority’s leadership is rallying the caucus to pass the Schumer – Manchin compromise reconciliation bill that would address climate and healthcare concerns while raising taxes. The goal is for the Senate to pass the bill next week which immediately precedes the Senate’s August recess.

The Hill adds that

A day after Sen. Joe Manchin (D-W.Va.) stunned Washington by endorsing hundreds of billions of dollars for President Biden’s domestic agenda, House Democrats are rallying behind the nascent package as a crucial — if incomplete — strategy for tackling the climate crisis and easing working class economic strains.

Both articles discuss the flies remain in the reconciliation ointment.

Govexec informs us

The odds that Congress would increase the average 4.6% pay raise planned for federal employees in 2023 got a little longer Thursday, after Senate appropriators revealed that they would effectively endorse President Biden’s pay increase proposal.” The Senate Appropriations Committee on Thursday revealed all of their initial versions of fiscal 2023 spending bills, including the package governing financial services and general government, which is the vehicle by which Congress weighs in on federal employee compensation. That bill makes no mention of changes to career federal employees’ pay, effectively endorsing the pay raise plan offered by Biden in his fiscal 2023 budget proposal.

Here is a link to the Senate Appropriations Committee’s press release unveiling those bills. What caught the FEHBlog’s eye is the statement in the press release that the Senate appropriations bills, like the House appropriations bills, do not include the Hyde amendments limiting federal funding of abortions to cases of rape, incest, or endangerment of the mother’s life. That tectonic change would draw the FEHBP into the post-Dobbs controversy.

From the Affordable Care Act front, Prof. Katie Keith does her usual outstanding job breaking down the proposed ACA Section 1557 individual non-discrimination rule in Health Affairs Forefront. In the FEHBlog’s view, the rule is unnecessarily complicated. It is the FEHBlog’s understanding that this HHS rule would not apply to FEHBP and that HHS would refer Section 1557 complaints involving FEHB plans to OPM. As the preamble points out, Section 1557 is a law that doesn’t need an implementing rule. Nevertheless, HHS recommends that other agencies with programs covered by Section 1557 adopt their own implementing rule using the HHS rule as a template.

The ACA regulators issued a 13-page long ACA FAQ 54 describing in detail the ACA rule requirements under which health plans must cover contraceptive drugs and services for women without cost sharing.

On a related note, Healthcare Dive tells us

Melanie Fontes Rainer is now acting director of HHS’ Office of Civil Rights. Fontes Rainer will replace Lisa Pino, who oversaw rulemaking related to patient safety, reproductive rights and other healthcare issues and issued policy regarding health equity, long COVID and firearm injury and death prevention, the agency said in an emailed statement.

From the federal employee benefits front, Fedweek explains the circumstances under which survivors of federal employees (as opposed to federal annuitants) are eligible for federal survivor benefits.

If you are an employee who was married when you die and you had at least 18 months of creditable civilian service, your spouse will be entitled to a survivor annuity.  * * * f you were enrolled in either the self plus one or self and family options of the Federal Employees Health Benefits program when you died, the person(s) on your enrollment could continue that coverage. If you weren’t enrolled in the program (or were enrolled but in the self only option), any otherwise eligible survivors would be out of luck.

From the Omicron and siblings front, the American Medical Association offers a helpful Q&A on Covid boosters.

From the monkeypox front, Reuters makes two reports

  • The United States has the capacity to conduct 60,000-80,000 tests for monkeypox virus per week, Health and Human Services Secretary Xavier Becerra said on Thursday. When the monkeypox outbreak began, the U.S. was able to conduct only 6,000 tests per week, Becerra told reporters during a telephone briefing.
  • The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it plans to make the rapidly spreading monkeypox disease a nationally notifiable condition. The designation, which is set to take effect on Aug. 1, updates criteria for reporting of data on cases by states to the agency and would allow the agency to monitor and respond to monkeypox even after the current outbreak recedes, the CDC said.

From the U.S. healthcare business front —

The American Hospital Association issued a report attacking the commercial health insurance industry, which in the FEHBlog’s view is akin to strangling the golden goose.

Healthcare Dive reports

Teladoc beat Wall Street expectations for revenue in the second quarter, with a topline of $592 million, up 18% year over year. Chronic care membership came in higher than analysts expected, while member utilization improved year over year.

But “all eyes” are on the vendor’s guidance for the rest of the year, which implies a third-quarter miss and a steep ramp-up for earnings in the fourth quarter, SVB Securities analyst Stephanie Davis wrote in a note on the results.

STAT News chimes in

Telehealth giant Teladoc is bracing for disappointing earnings this year as it faces headwinds that could also thwart competitors struggling to turn a profit — including increasingly frugal employers delaying or dropping contracts for virtual care.

“The challenge that we’re seeing is in these times of economic uncertainty, all purchases are just getting a significantly higher level of scrutiny,” CEO Jason Gorevic said in an earnings call Wednesday.

Gorevic also noted that declining yield on advertising suggests that individual patients may start spending less on direct-to-consumer services like BetterHelp, the company’s mental health care offering. Those hurdles aren’t unique to Teladoc. Competitors like Amwell and Talkspace could also have to grapple with cutbacks.

Healthcare Dive also delves into Amazon’s planned acquisition of One Medical. “The deal fast-tracks Amazon’s ambitions in healthcare, while giving One Medical a cushion in today’s tricky economic environment.”

Yesterday, the FEHB wrote about the hospitals receiving five stars from Medicare. Today Becker’s Hospital Review lists the 192 hospitals receiving a single start from that program.

Finally STAT News lists the 41 best books and podcasts on health and science to check out this Summer.

Thursday Miscellany

David Ermer–COVID-19, Federal employment benefits, Rx coverage, SDOH, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From the Omicron and siblings’ front —

MedPage Today reports “Second COVID booster shot boosted antibodies in Seniors — but small Israeli study did not determine how quickly response will wane.”

Becker’s Hospital Reviews tells us

At least 18 cases of the newest omicron subvariant BA.2.75 have been confirmed in seven U.S. states as of July 20, early disease surveillance data shows. 

Globally, researchers have identified 201 cases in more than a dozen countries as of July 12, according to data from outbreak.info, a platform that tracks data on coronavirus variants and is supported by the CDC and other national research groups. 

The subvariant has a large number of mutations that may make it more adept than BA.5 — the nation’s current dominant strain — at spreading quickly and evading immune protection. Experts say it’s still unclear whether BA.2.75 will compete against BA.5 or cause more severe illness, according to CNN.

This leads us to the Wall Street Journal’s editorial board comments

The President’s [Omicron] infection [disclosed today] demonstrates how hard it is to avoid the new and highly transmissible Covid variants. The White House has gone to great lengths to protect Mr. Biden, but there’s only so much staff can do if the President is going to do his job. 

Despite continuing pleas from the White House and public-health elite, vaccination by now provides little protection against transmission. * * * The evidence is that the vaccines do reduce the chances of getting serious Covid and being hospitalized, though many elderly patients who have been vaccinated are still dying from the virus.

While this quote is an opinion, not a news report, it struck a chord with the FEHBlog. The FEHBlog wishes the President a speedy recovery.

From the unusual viruses front, the Department of Health and Human Services offers a fact sheet on its response to the monkeypox outbreak.

In mergers and acquisitions news, Healthcare Dive informs us

Amazon has agreed to acquire primary care network One Medical for $18 a share, valuing the company at $3.9 billion.

The all-cash deal for San Francisco-based One Medical comes after months of speculation about a potential acquisition, reportedly drawing interest from companies including CVS Health, according to Bloomberg.

Analysts said a potential buyout for One Medical, which has grown rapidly since it was founded in 2007, could come at a significant premium. Amazon’s price of $18 a share represents a premium of 43% over its closing price of $10.18 a share on Wednesday.

STAT News explains why Amazon pursued adding One Medical to its healthcare portfolio.

With One Medical, Amazon is also tapping deeper into the vein of health care’s payment system. One Medical gets paid through two main avenues: commercial health insurers and Medicare. The Medicare side came from Iora, which One Medical bought for $1.4 billion last year.

Commercially insured patients, or those who get coverage through their jobs, are by far the most profitable within health care and overlap with a large chunk of Amazon’s subscription base. Even though One Medical focuses on less expensive primary care, there’s evidence One Medical charges some of the highest rates for those routine office visits and services, and that’s largely assisted by One Medical’s hospital partners.

Hospitals pay fixed sums to One Medical to care for patients, but they also “extend their health insurance contracts” to One Medical, the company said when it went public in 2020. The result: Hospitals that ink deals with One Medical get the most profitable patients in their market referred to them for more intensive services, and One Medical gets to piggyback off the lucrative payments that those dominant hospitals wring out of insurers.

STAT News concludes

Amazon’s success — and how disruptive it might prove to be to telehealth competitors — will depend in part on how well it integrates One Medical into its existing in-person and virtual offerings through Amazon Care. Analysts said that will become clear over the next year.

Whether it does draw patients away from traditional health care providers depends on their partnership with payers and their fees, said Aaron Neinstein, vice president of digital health for UCSF Health. “There’s no question that the One Medical annual fee is out of reach for most people in the U.S. Might Amazon change that or bundle it with Prime? Who knows.”F

Health Leaders Media reports that, notwithstanding the Federal Trade Commission’s nascent efforts,

Hospital and health system mergers and acquisitions in Q2 of 2022 have returned to trendlines that Kaufman Hall has been following since the beginning of the pandemic, the consulting firm said in its recently released M&A quarterly report.

During the second quarter of 2022, there were 13 hospital and health system M&A transactions, on-trend and only one transaction less than the 14 transactions reached in Q2 of 2021 and 2020. However, the total transacted revenue in the second quarter reached a “historic high” of $19.2 billion, more than doubling the $8.5 billion transacted revenue in the same quarter in 2021.

From the reports department and via Axios, the FEHBlog ran across this comprehensive McKinsey and Company report on the future of U.S. healthcare: what’s next for the industry post-Covid. Check it out.

From the Rx coverage front, DrugChannels calls our attention to this Amgen preview of 2022 trends in the biosimilars market. Adam Fein observes

As I predicted two years ago, the biosimilar boom is finally here. Prices are dropping while adoption accelerates. Prices are now declining by 9% to 22% annually. For therapeutic areas with biosimilars launched in the last three years, biosimilars’ market share averages 74%.  See Amgen slides 8 and 9.

Before the boom began, Dr. Scott Gottlieb, a former FDA commissioner, argued that we shouldn’t give up on biosimilars and prematurely regulate prices. As we can now see, Dr. Gottlieb was right. #NoTowel

From the SDOH front, Health Payer Intelligence explains

Race and ethnicity data collection is complex, but there are steps that health insurers—and the healthcare industry at large—can take to improve the process, according to a report from Urban Institute funded by Elevance Health (formerly Anthem).

From the miscellany department

  • Fierce Healthcare discusses a recent Fitch report on non-profit hospitals.

Labor, supply and capital cost increases have been rampant across the industry this year thanks to broader inflation pressures and other pandemic factors, the ratings agency wrote.

Reversing the margin trends will likely require nonprofit hospitals to take on a combination of rate hikes in the short term, “relentless” cost-cutting and productivity initiatives for the medium term and “transformational changes to the business model” for the long term, Fitch wrote.

Fortunately for those hospitals, many organizations already have the means to weather the storm as they overhaul their operations.

“The vast majority of our rated credits have strong balance sheets that will offset lower margins for a period of time and allow for operational improvements,” Fitch wrote. “Without more substantial changes to the current business model, or with additional coronavirus surges this fall or winter, this balance sheet cushion could eventually erode.”

Rate negotiations with payers will likely be an upward battle, the group wrote.

  • Healthcare Forefront points out the value of underutilized fentanyl test strips

Fentanyl test strips (FTS) are a simple, inexpensive, and evidence-based method of averting drug overdose. FTS are small strips of paper that can detect the presence of fentanyl in any drug batch—pills, powder, or injectables. This tool might be lifesaving for the teenager experimenting for the first time, the individual in the throes of a severe opioid use disorder, the concert-goer looking for a trip, the person using a preferred substance obtained from a new source, or the individual years into recovery. FTS also support the dignity and well-being of people who use drugs (PWUD), enabling them to make educated decisions about their safety.

And yet after years of press and discussions of the strips’ utility, FTS aren’t as widely available as one would expect them to be. It is time to take a more critical look at the importance of destigmatizing this tool and increasing its distribution and availability, while highlighting the grave risks in not doing so.

  • HealthDay gives us some good news.

U.S. hospitals became much safer places for patients over the past decade, with medical errors and adverse events declining significantly across the nation, federal government data show.

Between 2010 and 2019, patient safety dramatically improved among the four types of conditions for which people are most often hospitalized: heart attacks, heart failure, pneumonia and major surgical procedures.

“There has been a precipitous, very important drop in the number of these events, which to me validates the idea that these were preventable,” said senior researcher Dr. Harlan Krumholz, director of the Yale New Haven Hospital Center for Outcomes Research and Education in New Haven, Conn. “The status quo wasn’t written in stone. We have been able to actually make hospitals safer for those conditions.”

The new study relied on data gathered by the Medicare Patient Safety Monitoring Program, an effort created in the wake of a landmark 1999 Institute of Medicine report that drew national attention to patient safety in hospitals, the study authors said in background notes.

  • Fedweek reviews the steps that federal employees should take to position themselves for retirement.