Thursday Miscellany

Rx coverage

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the American Hospital Association reports

The Senate today voted 72-25 to pass and send to the House a continuing resolution that would extend current federal funding levels for health care and other programs through Dec. 16. Current government funding expires at midnight Sept. 30.

The legislation also would extend through Dec. 16 two expiring programs that help maintain access to care in rural communities: the Medicare-dependent Hospital and enhanced Low-volume Adjustment programs. AHA will continue to advocate for long-term extension of these programs. Among other provisions, the continuing resolution would reauthorize the Food and Drug Administration’s user fee programs, and provide emergency funding for Ukraine and disaster assistance.

A proposal dealing with energy-permitting plans was dropped from the measure on Tuesday, speeding passage of the legislation. The House is expected to pass the measure by Friday. 

Roll Call provides more background on the CR.

The American Hospital Association also tells us

The House voted 220-205 today to pass legislation to hold employer-based health plans more accountable for improper denials of mental health and substance use benefits. The Mental Health Matters Act (H.R.7780) would give the Department of Labor more authority to enforce plan requirements under the Mental Health Parity and Addiction Equity Act and Employee Retirement Income Security Act, ban forced arbitration agreements when plans improperly deny benefits and ensure a fair standard of review by the courts. The bill also would provide grants to develop, recruit and retain school-based mental health professionals and link schools with local mental health systems, among other provisions.

Fierce Healthcare provides more color on this troubling bill.

The ERISA Industry Committee (ERIC)—which represents large employer plan sponsors—wrote a letter Monday to all House members calling for them to oppose (PDF) the Mental Health Matters Act when it comes up for a vote later this week. The letter comes as Congress is considering how to improve pay parity between behavioral and physical health amid reports of some insurers not following requirements in the Affordable Care Act. 

“This bill includes provisions that weaponize the Department of Labor (DOL) to sue employers rather than helping them come into compliance,” the letter said. * * *

[I]t remains unclear whether the Senate will take it up. The Senate Finance Committee is considering action to tackle pay parity but so far has not released any legislation. Chairman Ron Wyden, D-Oregon, previously told Fierce Healthcare that he is still working on legislation to tackle the issue, including taking aim at “ghost networks” where providers listed in directories don’t take new patients.

Earlier this month, Healthcare Dive reported that

The Senate Finance Committee released a bipartisan-supported discussion draft bill that aims to increase mental health access and improve mental health workforce shortages.

The draft bill proposes to fill the gap in mental healthcare worker shortages by funding training for 400 additional Medicare Graduate Medical Education psychiatric slots for residencies per year beginning Oct. 1, 2024. Over a decade, 4,000 psychiatric residencies would be supported by the funding, according to the bill.

The Senate’s focus on access to care makes much more sense than the House’s punitive approach, particularly considering the unnecessary complexity of the federal mental health parity law.

From the Omicron and siblings front, MedPage Today discusses nasally administered Covid vaccines now under development. “The idea is that mucosal vaccines could bolster immunity at these viral entry points, stopping the pathogen from implanting, multiplying, and transporting itself throughout the body.” Finger crossed.

From the monkeypox front, CNBC reports

A single dose of the two-dose monkeypox vaccine provides some protection against the virus, according to CDC data.

People at risk of monkeypox who have not received a shot are 14 times more likely to get infected, the preliminary data found.

These are the first real-world findings on how well the vaccine is working in the current outbreak.

 The CDC is still recommending that everyone at risk receive two doses of the vaccine.

From the Food and Drug Administration front —

STAT News informs us

The Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals on Thursday, providing a desperately-needed new treatment option for a devastating disease.

The medicine, to be sold as Relyvrio, is not a cure for ALS but proved to moderately slow the progression of the neurological disease, which causes the destruction of neurons in the brain and spinal cord, resulting in weakened muscles, paralysis, and death.

Amylyx did not immediately disclose how much it will charge for Relyvrio. “Amylyx’s goal is that every person who is eligible for Relyvrio will have access as quickly and efficiently as possible,” the company’s co-CEOs said in a statement, “as we know people with ALS and their families have no time to wait.”

Healio relates

The FDA approved bevacizumab-adcd for the treatment of six cancer types, according to a press release from the biosimilar’s manufacturer.

Bevacizumab-adcd (Vegzelma, Celltrion USA), a biosimilar to bevacizumab (Avastin, Genentech), is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and prohibits it from binding to VEGFR-1 and VEGFR-2 on the surface of endothelial cells.

FDA approved bevacizumab-adcd for metastatic colorectal cancer; recurrent or metastatic nonsquamous non-small cell lung cancer; metastatic renal cell carcinoma; recurrent glioblastoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.

In medical research news, STAT News tells us

After a steep drop in its stock price and with mounting competition from rivals, genomics giant Illumina on Thursday launched a new line of high-powered DNA sequencers, ratcheting up the race to read genetic information accurately and cheaply.

The new instruments, dubbed the NovaSeq X Series, can churn out up to 20,000 human genomes in a year, 2.5 times the max output of the company’s current machines, executives announced. The cost of generating this data has dropped, too, from about $5 per billion DNA bases on Illumina’s last line of high-end sequencers to as low as $2 on the new products.

That will bring the cost of reading a whole human genome on the company’s equipment from about $600 to $200, which could help make sequencing more mainstream in everyday medicine. While the price of sequencing isn’t the only obstacle to using genomics to improve human health, it remains a major factor.

Intriguing.

From the Medicare front, the Centers for Medicare and Medicaid Services (CMS) announced 2023 Medicare Advantage plan and Part D prescription drug plan premiums in advance of the Medicare Open Enrollment, which runs from October 15 through December 7, 2022.

The projected average premium for 2023 Medicare Advantage plans is $18 per month, a decline of nearly 8% from the 2022 average premium of $19.52. Medicare Advantage plans will continue to offer a wide range of supplemental benefits in 2023, including eyewear, hearing aids, preventive and comprehensive dental benefits, access to meals (for a limited duration), over-the-counter items, and fitness benefits.

[T]he average basic monthly premium for standard Part D coverage is projected to be $31.50, compared to $32.08 in 2022. 

To view the premiums and costs of 2023 Medicare Advantage and Part D plans, please visit: https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin. Select the various 2023 landscape source files in the downloads section of the webpage. 

For state-by-state information, important dates and enrollment resources for Medicare Advantage and Part D in 2023, please visit: https://www.cms.gov/files/document/2023-medicare-advantage-and-part-d-state-state-fact-sheets.pdf

For more information on the Medicare Advantage Value-Based Insurance Design Model, including plan participation, please visit: https://innovation.cms.gov/innovation-models/vbid.

From the telehealth front, the Wall Street Journal reports a tragic story —

Cerebral treated a 17-Year-Old without His parents’ consent. They found out the day he died.
Telehealth startup didn’t use software to flag minors, according to employees and documents; company says it complies with state rules and the case is an outlier.

Anthony Kroll signed up for Cerebral in December and uploaded his Missouri intermediate driver’s license showing he was 17. Missouri law prohibits clinicians from providing mental-health treatment to people under 18 without parental consent. 

Anthony told a Cerebral clinician he had suicidal thoughts, and she prescribed him an antidepressant that carries a warning label for adolescents, according to medical records reviewed by the Journal. Cerebral didn’t notify his family. 

His parents, Wendi and Todd Kroll, said they didn’t know their son was suicidal or was seeking mental-health treatment. “I had no idea he was even on [medication] until the day he died,” Mrs. Kroll said, adding that she found the pill bottle at their home a few hours before her son died by suicide.

A Cerebral spokesman said Anthony misrepresented his age, the company regrets he received care without parental consent, and the treatment he received was appropriate. “This case is an unfortunate outlier,” the spokesman said. “Any loss of life is tragic, and we extend our deepest condolences to the family.” 

From the miscellany department

  • The GAO released a report titled “Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning Technologies for Medical Diagnostics.” ” Machine learning technologies can help identify hidden or complex patterns in diagnostic data to detect diseases earlier and improve treatments. We identified such technologies in use and development, including some that improve their own accuracy by learning from new data. But developing and adopting these technologies has challenges, such as the need to demonstrate real-world performance in diverse clinical settings.”
  • Federal News Network tells us

Agencies may soon get some more specific guidance on how best to implement President Joe Biden’s sweeping executive order on diversity, equity, inclusion and accessibility in the federal workforce.

The Chief Diversity Officers Executive Council, a governmentwide panel composed of agencies’ chief diversity officers and led by the Office of Personnel Management, held its first-ever meeting on Sept. 29.

“This has been a really long time coming,” OPM Director Kiran Ahuja said in an exclusive interview with Federal News Network.

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.

Tuesday’s Tidbits

David Ermer–CMS, Congress, Medicare, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Capitol Hill, the Wall Street Journal reports

Sen. Joe Manchin (D., W.Va..) on Tuesday threw in the towel on including his contentious proposal to speed up permitting of energy projects in a must-pass funding bill, clearing the way for the Senate to advance the legislation needed to keep the government open. 

With the permitting language out, the Senate voted 72 to 23 to advance the stopgap bill, which would extend current government funding levels until Dec. 16 and prevent a partial shutdown this weekend, when the fiscal year ends. The bill now moves to final passage in the Senate and will also need approval in the House, which returns Wednesday, before heading to President Biden’s desk. * * *

The resolution would also reauthorize the Food and Drug Administration’s user-fee agreements for prescription drugs, generic drugs and medical devices, preserving their access to U.S. patients. The legislation has to pass by the end of September to avoid funding gaps for the FDA.

The resolution includes funding for assistance to Ukraine but not for Covid and monkeypox expenses, also requested by the White House.

From the monkeypox front, STAT News reports that responding to the disease is stretching thin the resources of public health clinics serving the LGBTQ+ communities.

Today was filled with surprises.

  • The Centers for Medicare and Medicaid Services beat OPM to the punch by announcing 2023 Medicare Part B premiums before OPM announced 2023 FEHB and FEDVIP premiums. “The standard monthly premium for Medicare Part B enrollees will be $164.90 for 2023, a decrease of $5.20 from $170.10 in 2022. The annual deductible for all Medicare Part B beneficiaries is $226 in 2023, a decrease of $7 from the annual deductible of $233 in 2022.”
  • BioPharma Dive reports “In a surprise result, Alzheimer’s drug from Eisai and Biogen shows benefit in a large trial; The drug, called lecanemab, met the study’s main and secondary goals, reducing clinical decline [by 27%] over 18 months compared to a placebo.” The announcement’s timing is exquisite because, for 2022, CMS jacked up the Medicare premiums in anticipation of massive costs from what turned out to be a failed Alzheimer’s drug, Aduhelm, also from Biogen. The popping of the Aduhelm balloon resulted in the Medicare Part B premium and deductible decreases for 2023. FEHB carriers need to keep an eye on this drug’s progress because FEHB plans have large cadres of annuitants with Part A but not Part B due to IRMAA.

From the No Surprises Act front, the American Hospital Association reports

The AHA, American Medical Association and Medical Group Management Association today urged the Centers for Medicare & Medicaid Services not to include a convening/co-provider framework when implementing the Advanced Explanation of Benefits and insured good faith estimate provisions under the No Surprises Act. The groups urged the agency to instead allow each billing provider to submit their own good faith estimate to the health plan to create an AEOB; and to leverage existing provider and health plan workflows, standards and technologies for claim submission and adjudication to support accurate AEOBs for patients.

“Our organizations appreciate the opportunity to work with CMS on the No Surprises Act’s price transparency provisions implementation, and we are committed to working closely with our members to ensure that they have the information and tools to successfully implement the new requirements,” the letter adds. “Additionally, we remain committed to ensuring that patients have access to complete and accurate out-of-pocket cost information for scheduled care and working with you to develop efficient methods of delivering this information.”

This sensible idea would align the GFI with regular EOBs, thereby facilitating the use of electronic claims technology.

From the benefit design front, Fierce Healthcare reports

Walmart, the largest employer in the U.S., is teaming up with fertility startup Kindbody to offer benefits under its insurance plan that will help its workers expand their families.

Walmart Associates and their dependents who are enrolled in a self-insured Walmart medical plan will now have access to Kindbody’s services including fertility assessments and education, fertility preservation, genetic testing, in vitro fertilization (IVF) and intrauterine insemination (IUI).

Walmart’s employees will have access to more than 30 state-of-the-art Kindbody clinics across the U.S., including a new clinic and IVF lab in Rogers, Arkansas that will provide comprehensive virtual, at-home and in-clinic care. The new facility is expected to open later this year.

The expanded services build on Walmart’s Center of Excellence (COE) model, which provides benefit support and coverage for certain heart, spine and joint surgeries and cancer treatments.

“Providing access to high-quality health care is very important to us, and we’ve heard from our associates that improved access to fertility, surrogacy and adoption support is a priority for them and their families,” said Kim Lupo, senior vice president, Walmart Global Total Rewards in a statement. “Through Kindbody, Walmart associates in every corner of the country will have access to a variety of services to aid in their family-planning journey.

From the studies/research department

  • Beckers Payer Issues informs us, “Alabama, Hawaii, Florida, New York and New Jersey are the states with the highest incidences of low-value care, a new study published in Health Affairs found.”
  • The National Institutes of Health (NIH) announced “a new program to better understand the function of every human gene and generate a catalog of the molecular and cellular consequences of inactivating each gene. The Molecular Phenotypes of Null Alleles in Cells (MorPhiC) program, managed by the National Human Genome Research Institute, aims to systematically investigate the function of each gene through multiple phases that will each build upon the work of the previous.” Wow.
  • NIH also tells us, “People with opioid use disorder who received telehealth services during the COVID-19 pandemic were more likely to stay on their medications and less likely to overdose. The findings support continuing the expanded telehealth access that began during the pandemic.”

From the tidbits department

  • The US Preventive Services Task Force today reaffirmed an A grade recommendation for screening for syphilis infection in asymptomatic, nonpregnant adolescents and adults who are at increased risk for infection. The initial recommendation for this screening was made in 2016.
  • Beckers Health IT explores the significant business benefits of United Healthcare’s recent antitrust litigation victory, which allows UHC’s acquisition of change healthcare to proceed.
  • Healthcare Dive reports

The American Hospital Association, along with a coalition of other healthcare organizations, wants the HHS to postpone an information blocking deadline slated to start Oct. 6, according to a Monday letter sent to Secretary Xavier Becerra.

By that date, providers, health IT developers and others must start sharing all electronic protected health information in a designated record,effectively prohibiting entities from information blocking.

The groups warn they’re not prepared to meet the deadline and are struggling to interpret a clear definition of electronic health information or technical infrastructure to support secure exchanges, according to the release.

 

Weekend update

David Ermer–ACA, Congress, COVID treatment, COVID-19, Rx coverage–
Photo by Dane Deaner on Unsplash

Happy New Year. Shanah Tovah.

The House of Representatives and the Senate are scheduled to be in session this week for Committee business and floor voting. Congress is set to go on an election break on September 30, the end of the federal fiscal year. Due to the incentive to get on the campaign trail, the FEHBlog expects Congress to wrap up by the end of next weekend a continuing resolution funding the federal government through December 16. The Senate version of the continuing resolution will be released tomorrow as negotiations are ongoing.

From the Omicron and siblings front, the Department of Health and Human Services announced how the federal government supports the Covid treatment market as its funding shifts to the private sector.

From the Rx coverage front, STAT News tells us

Brand-name drugmakers increased wholesale prices by 4.9% in the second quarter this year, up slightly from 4.4% a year ago. But when accounting for inflation, wholesale prices fell by 3.7%. Inflationary pressures are likely to push wholesale prices still higher, STAT writes, citing a new analysis. At the same time, net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — dropped by 0.8%, but after considering inflation, net prices actually fell 7.9% compared with 3.8% in this year’s first quarter. This was the largest quarterly decline in real terms seen by analysts at SSR Health, which conducted the analysis.

From the litigation front, Health Affairs Forefront provides helpful background on a September 7 decision from a Texas district federal court holding the Appointments clause of the U.S. Constitution bars the federal government from treating U.S Preventive Services Task Force recommendations as binding on health plans. The lawsuit also involves a Religious Freedom Restoration Act (“RFRA”)claim. The Court has reserved a ruling on appropriate remedies. The FEHBlog expects that the Appointments clause challenge will not survive appellate review but who knows what can happen with an RFRA claim. Another remaining issue is the plaintiffs’ challenge to the contraceptive mandate.

From the maternal care front, MedCity News informs us

Racial disparities in maternal health complications grew amid Covid-19, BCBS report finds
Pregnancy-related complications increased 9% between 2018 and 2020 among all women, but the rate of change is even more significant among women of color. The disparities exist regardless of having commercial insurance or Medicaid. * * *

The fact that racial disparities exist regardless of commercial insurance or Medicaid coverage suggests that the issues are due to broader health challenges, including underlying conditions, racial inequities and biases in the healthcare system, according to the report.

To combat these disparities, BCBS listed several actions players in the healthcare industry can take. This includes adding nurse-midwives and birthing centers to provider networks, expanding coverage for postpartum care to one year after giving birth and using value-based contracts for maternal health.

BCBS doesn’t just call on healthcare leaders to act, but the government as well. In the report, the payer urges Congress to pass the Congressional Black Maternal Health Caucus’ Momnibus package, which provides steps to improve health outcomes for pregnant women and mothers of color. BCBS also asks for states to extend Medicaid coverage from 60 days to a full year postpartum, an option provided through the American Rescue Plan Act.

One’s race or ethnicity should not determine how likely you are to suffer from pregnancy-related complications. We must address deep-rooted issues like implicit bias and systemic racism that cause these disparities in the first place,” [Dr. Adam] Myers said in a news release.

Friday Stats and More

David Ermer–CDC, COVID-19, 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 chart of weekly new Covid cases 2022:

The bulge on the left side of the chart is the original Omicron. The CDC’s weekly interpretation of its Covid stats adds

As of September 21, 2022, the current 7-day moving average of daily new cases (54,186) decreased 10.6% compared with the previous 7-day moving average (60,593).

CDC Nowcast projections* for the week ending September 24, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are five lineages designated as Omicron: BA.5, BA.4.6, BA.4, BF.7, and BA.2.75. The predominant Omicron lineage is BA.5, projected at 83.1% (95% PI 81.3-84.7%).

The New York Times asks

Where is Pi?

Last year, the World Health Organization began assigning Greek letters to worrying new variants of the coronavirus. The organization started with Alpha and swiftly worked its way through the Greek alphabet in the months that followed. When Omicron arrived in November, it was the 13th named variant in less than a year.

But 10 months have passed since Omicron’s debut, and the next letter in line, Pi, has yet to arrive.

That does not mean SARS-CoV-2, the coronavirus that causes Covid-19, has stopped evolving. But it may have entered a new stage. Last year, more than a dozen ordinary viruses independently transformed into major new public health threats. But now, all of the virus’s most significant variations are descending from a single lineage: Omicron.

“Based on what’s being detected at the moment, it’s looking like future SARS-CoV-2 will evolve from Omicron,” said David Robertson, a virologist at the University of Glasgow.

Here is the CDC’s latest chart of daily new Covid hospitalization trends:

The weekly CDC review adds

The current 7-day daily average for September 14–20, 2022, was 3,971. This is a 9.9% decrease from the prior 7-day average (4,410) from September 7–13, 2022.

CDC’s Coronavirus Disease 2019-Associated Hospitalization Surveillance Network (COVID-NET) shows that COVID-19-associated hospitalizations continue to affect adults ages 65 years and older. Since early April 2022, more than 50% of all COVID-19-associated hospitalizations occurring every week are among adults ages 65 years and older. Before April 2022, adults ages 65 years and older had not comprised more than half of all COVID-19-associated hospitalizations since January 2021.

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

The weekly CDC review adds “The current 7-day moving average of new deaths (347) decreased 12.2% compared with the previous 7-day moving average (396).”

Here is the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era, the 51st week of 2020, and the recently end 38th week of 2022.

The weekly CDC review adds

As of September 21, 2022, 616.2 million vaccine doses have been administered in the United States. Overall, about 263.8 million people, or 79.5% of the total U.S. population, have received at least one dose of vaccine. About 225.0 million people, or 67.8% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 109.6 million people have received a booster dose,* and 4.4 million people have received an updated (bivalent) booster dose. But 49.9% of the total booster-eligible population has not yet received a booster dose. Booster dose eligibility varies by age and health condition. Learn more about who is eligible.

It’s worth noting that according to the CDC’s Covid Data Tracker 92.3% of Americans 65 and older have received the first two vaccination doses; 71% of this cadre as received one booster dose, and 43% of this cadre, including the FEHBlog, has received two booster doses. Given the COVID-NET news above, these are the most important statistics.

In CDC Communities Level news, the weekly CDC review points out

As of September 22, 2022, there are 226 (7.0%) counties, districts, or territories with a high COVID-19 Community Level, 1,005 (31.2%) counties with a medium Community Level, and 1,986 (61.7%) counties with a low Community Level. Compared with last week, this represents a large decrease (−6.3 percentage points) in the number of high-level counties, a moderate decrease (-4.7 percentage points) in the number of medium-level counties, and a large increase (+11.0 percentage points) in the number of low-level counties. 

In other virus news, the New York Times reports

With monkeypox cases on the decline nationally, federal health officials expressed optimism on Thursday that the virus could be eliminated in the United States, though they cautioned that unless it was wiped out globally, Americans would remain at risk.

“Our goal is to eradicate; that’s what we’re working toward,” Dr. Demetre Daskalakis, the deputy coordinator of the White House monkeypox response team, said during a visit to a monkeypox vaccination clinic in Washington. He added, “The prediction is, we’re going to get very close.”

From the Rx coverage front, EndPoint News informs us

Drug pricing experts generally agree that bluebird bio’s two recently approved gene therapies and their multimillion-dollar price tags aren’t going to be one-offs as a wave of new cell and gene therapies makes its way to the market.

The FDA’s recent approvals for bluebird’s $2.8 million Zynteglo — with ICER supporting the price and an 80% rebate if patients don’t achieve transfusion independence — and the $3 million Skysona, approved under accelerated approval, are likely to be the norm for gene therapy prices moving forward, particularly if they can reduce costs elsewhere in the health care ecosystem, experts said.

Daniel Ollendorf, director of value measurement & global health initiatives at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, told Endpoints News in a phone interview that the trend behind multimillion-plus gene therapies is an extension of what began with Novartis’ $2.1 million spinal muscular atrophy gene therapy Zolgensma, which is still priced at about half of the 10-year current cost of chronic SMA therapy, and became a blockbuster for Novartis last year with more than $1.35 billion in annual sales.

But the expectation is that these high list prices will come with risk-sharing agreements and refunds if the products don’t work so payers don’t have to bear the full brunt of the financial risk, Ollendorf said. And he noted that some gene therapies don’t lend themselves as well to tracking milestones, but that isn’t the case for observing transfusion independence in those receiving Zynteglo.

From the maternity care front, Health Payer Intelligence tells us

Payers are implementing new programs that capitalize on telehealth and partnerships with technology companies to better engage pregnant members and improve maternal health outcomes. * * *

AHIP encouraged payers to integrate health technologies like telehealth into perinatal and maternal health to close access gaps to obstetric care in rural and underserved communities.

Perinatal telehealth interventions to improve outcomes can include videoconferences to replace or supplement in-person visits and enable consultation with specialists remotely, AHIP mentioned.

In the postpartum period, telehealth and other tools can be implemented to drive earlier postpartum follow-up visits and provide access to lactation consultants (tele-lactation).

Within the last year, Capital District Physicians’ Health Plan and Harvard Pilgrim Health Care partnered with digital family health platform Ovia to help members navigate fertility, pregnancy, and early parenting.

Through this partnership, members will gain access to three mobile apps – Ovia Fertility, Ovia Pregnancy, and Ovia Parenting in an effort to reduce maternity costs and improve maternal outcomes such as lowering c-section rates, preterm delivery, and neonatal intensive care unit (NICU) stays.

From the human interest front, Forbes explains “Why Billionaire Eric Schmidt Is Backing A High School Senior Making A Cancer-Detecting Toothbrush And Other Brilliant Teens.”

Tuesday Tidbits

David Ermer–ACA, CDC, Congress, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Govexec lays out what appears to be an unnecessarily complicated path to a continuing resolution funding the federal government for 10 weeks into the new federal fiscal year beginning October 1. The Senate majority leadership crafted the rocky path that stems from the compromise which lead to Congressional passage of the budget reconciliation act earlier this summer.

From the No Surprises Act front, the American Medical Association informs us

The AHA and American Medical Association today moved to dismiss their challenge to the federal government’s September 2021 interim final rule governing the No Surprises Act’s independent dispute resolution process.

The groups challenged the rule in a District of Columbia court last December, but the lawsuit became moot when the Administration released a revised final rule on Aug. 26. However, the AHA and AMA remain concerned that the final rule continues to favor insurers and does not line up with what Congress intended when it passed the law.

In a joint statement the AHA and AMA said, “No patient should fear receiving a surprise medical bill. That is why the AHA and AMA strongly supported the No Surprises Act to protect patients from unexpected medical bills and keep them out of the middle of any billing disputes between providers and commercial health insurance companies. Congress enacted the law with a balanced, patient-friendly approach, and it should be implemented that way. We have serious concerns that the August 2022 final rule departs from Congressional intent just as the September 2021 interim final rule did. Hospitals and doctors intend to make our voices heard in the courts very soon about these continued problems.”

The AHA and AMA’s suit did not seek to prevent the law’s core patient protections from moving forward. It sought only to force the Administration to bring the regulations in line with the law before the dispute negotiations begin.

The AHA / AMA lawsuit is consolidated with a suit filed by an air ambulance association which may explain why these two large provider associations are dismissing its case rather than amending their complaint. The FEHBlog does not understand why the provider associations refuse to give the new rule a chance before bringing another expensive lawsuit.

From the U.S. healthcare business front —

Fierce Healthcare reports

Walgreens Boots Alliance on Tuesday said it will buy the remaining stake in specialty pharmacy company Shields Health Solutions for approximately $1.37 billion.

Walgreens last year spent $970 million to increase its stake in the company to 71%, according to Reuters, with the possibility of taking full ownership over the pharmacy company.

The transaction is expected to be completed by the end of the year. * * *

As a specialty pharmacy, Shields offers medications with unique handling, administration and monitoring requirements. Specialty drugs are used to treat complex or rare conditions such as cancer, hepatitis and transplants. Shields currently names 30 health systems as partners, including 1,000 hospitals.

and

Employer health startup Transcarent is making its next move with the launch of its new pharmacy program.

Transcarent’s Pharmacy Care offering is designed to be fully transparent and integrate with its other platforms. The goal, executives said, is to break through the noise for members and make it easier for them to understand their pharmacy benefits while offering employers full control over formulary, benefit design and data.

The platform is available to self-funded employers as well as health systems, Transcarent said in an announcement. Snezana Mahon, Transcarent’s chief operating officer, told Fierce Healthcare that the company’s employer clients have felt the market changes and are seeking a way to “coexist” in a world where there are traditional pharmacy benefits, cash pay and coupon cards all working together.

From the healthcare quality front, Beckers Hospital Review calls attention to

A new data visualizer shows the 10 most similar hospitals to any one benchmark hospital, challenging traditional, ordinal rank lists like those from U.S. News & World Report.

SimilarityIndex | Hospitals comes from Trilliant Health Labs, which created the tool so health economy stakeholders can learn how similar a selected benchmark hospital is to — or different from — highly regarded U.S. hospitals. 

Users can compare hospitals to find peers in either quality alone or aggregate — the latter reflects an equally weighted combination of measurements in the categories of hospital quality (including 30-day mortality and readmission rates), outpatient service line, financial (including operating margin and average inpatient service costs), patient mix and market share.

Nifty.

From the public health front —

The US Preventive Services Task Force (USPSTF) today posted for public comment draft recommendations on screening for anxiety, depression, and suicide risk in adults.

For the first time, the task force is recommending screening all adults aged 64 and younger for anxiety — including pregnant and postpartum women.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit, the task force notes in a draft recommendation statement posted on its website.

The recommendation applies to adults aged 19-64 years who do not have a diagnosed mental health disorder or are not showing recognized signs or symptoms of anxiety.

The public comment deadline is October 17.

  • The Wall Street Journal offers advice on timing the annual flu shot and the upcoming flu season in general.
  • The CDC released a vital signs report warning that rates of screening and treatment of children with sickle cell anemia for life-threatening problems are far too low.

Two recommended healthcare measures to prevent complications in children with sickle cell anemia are:

* Transcranial doppler (TCD) ultrasound screening, which identifies children with increased risk for stroke.

* Hydroxyurea therapy, which reduces the occurrence of several complications, including severe acute pain episodes and acute chest syndrome, which can result in lung injury and trouble breathing.

Far too few patients are receiving these potentially lifesaving prevention measures, recommended by an expert panel in 2014. 

  • The CDC also called attention to its website about gestational diabetes.

From the Rx coverage front, Bio Pharma Dive relates

The Food and Drug Administration on Friday [September 16] granted accelerated approval to a personalized gene therapy for an ultra-rare childhood brain disease, called cerebral adrenoleukodystrophy or CALD.

Built from a patient’s own stem cells, the therapy is the first medicine to be made available in the U.S. for CALD, which affects young boys and typically results in severe disability or death. It was developed by the biotechnology company Bluebird bio and will be sold as Skysona.

Its approval is Bluebird’s second in four weeks, following an Aug. 17 FDA decision on another gene therapy from the company for the blood disorder beta thalassemia. * * *

In the U.S., an estimated 50 boys are born each year who will go on to develop CALD. Bluebird expects to treat about 10 annually.

Meant to be a one-time infusion, Skysona will cost $3 million. The price tag makes the therapy one of the most expensive ever launched on a single-use basis, exceeding the $2.8 million cost of Bluebird’s other gene therapy. * * *

Bluebird expects Skysona to be available by the end of the year, and is planning to work with a “limited number” of centers that are experienced in treating CALD and in stem cell transplantation, including Boston Children’s Hospital and CHOP [Children’s Hospital of Philadelphia].

[Due to the small number of patients, t]he company is not putting in place “outcomes-based” coverage agreements with insurers for Skysona as it did with its other gene therapy, for which it’s offering to reimburse part of the cost if patients don’t continue to benefit.

From the surveys department —

A majority of healthcare executives think value-based-care has replaced fee-for-service billing, a new survey found. 

Of 160 C-suite executives and other high-level staff surveyed, just 4 percent said they think payers use traditional fee-for-service billing with no connection to quality and value. The majority of executives think payers use FFS models with connections to the quality and value of care taken into account. 

The survey, conducted by business intelligence firm Morning Consult and health tech company Innovaccer, found just 1 percent of executives think FFS billing with no connection to value will be in use in 2025. 

According to a Sept.14 news release, payers report that FFS billing with no account for value makes up more than 10 percent of billing, higher than providers estimated. 

“So, providers think the transition to value has substantially occurred, when in fact we’re only at the very beginning,” Brian Silverstein, MD, Innovaccer’s chief population health officer, said in the release. “The amount of financial risk providers have is going to increase significantly in the next few years.”

  • Beckers Hospital Review tells us “Patients who are publicly insured or uninsured are more likely to be treated unfairly in healthcare settings compared to patients with private insurance, according to a report from the Urban Institute with support from the Robert Wood Johnson Foundation.”

In closing Federal News Network shares the list of deserving federal employees receiving the 2022 Partnership for Public Service’s Samuel J. Heyman Service to America Medals — affectionately known as the Sammies. These awards “often dubbed the “Oscars” of federal service” will be presented at a gala tonight. Hearty congratulations to the award winners and the other nominees.

Monday Roundup

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare, Wellness–

From Capitol Hill, Govexec informs us that

Congress is looking to fund federal agencies at their current spending levels through mid-December, with momentum growing for a 10-week stopgap bill to avoid a government shutdown on Oct. 1. 

Lawmakers must clear several hurdles before voting on a continuing resolution to kick off fiscal 2023, but they could act as soon as this week. Senate Majority Leader Chuck Schumer, D-N.Y., said last week he would work with Republicans to “avoid even a hint of a shutdown,” though several disagreements remain. Negotiations appear to have settled on a CR that would fund agencies through approximately Dec. 16, but lawmakers have yet to determine exactly which provisions will be added to it. 

From the federal appointment front, STAT News reports

President Joe Biden on Monday appointed longtime biologist and former government scientist Renee Wegrzyn as the first director of the nascent Advanced Research Projects Agency for Health.

Biden’s announcement comes as ARPA-H advocates debate where the multibillion-dollar agency should be headquartered and which elusive disease areas should be prioritized. The president officially launched the agency in March with $1 billion in initial funding allotted by Congress, but the search for its inaugural director has taken months.

Wegrzyn, 45, currently works at Boston-based Ginkgo Bioworks, a company focused on biological engineering, but has prior experience in two government agencies Biden has said he hopes to emulate with ARPA-H — the Pentagon’s Defense Advanced Research Projects Agency and the Intelligence Advanced Research Projects Activity.

Good luck, Dr. Wegryzn.

From the omicron and siblings front

The American Hospital Association tells us

Insured and uninsured Americans can receive the new bivalent Pfizer or Moderna COVID-19 booster and other COVID-19 vaccines at no cost as long as the federal government continues to purchase and distribute them, the Centers for Medicare & Medicaid Services announced today.

The Centers for Disease Control and Prevention this month recommended Pfizer’s updated COVID-19 vaccine booster for Americans aged 12 and older and Moderna’s updated COVID-19 vaccine booster for Americans aged 18 and older at least two months after completing a primary COVID-19 vaccine series or booster. Authorized by the Food and Drug Administration, the updated boosters are bivalent, meaning they help protect against the most recently circulating omicron variants as well as the original virus strain.

Americans can find local sites administering the new COVID-19 vaccine booster here. For more on provider requirements and payment, visit the CDC COVID-19 Vaccination Program and CMS toolkit.

The Wall Street Journal reports

Illness caused by Covid-19 shrank the U.S. labor force by around 500,000 people, a hit that is likely to continue if the virus continues to sicken workers at current rates, according to a new study released Monday.

Millions of people left the labor force—the number of people working or looking for work—during the pandemic for various reasons, including retirement, lack of child care and fear of Covid. The total size of the labor force reached 164.7 million people in August, exceeding the February 2020 prepandemic level for the first time. The labor force would have 500,000 more members if not for the people sickened by Covid, according to the study’s authors, economists Gopi Shah Goda of Stanford University and Evan J. Soltas, at the Massachusetts Institute of Technology.

“If we stay where we are with Covid infection rates going forward, we expect that 500,000-person loss to persist until either exposure goes down or severity goes down,” said Mr. Soltas. That assumes that some of those previously sickened eventually return to work.

The authors “provide the most credible evidence to date about labor-market impacts for a large set of workers,” said Aaron Sojourner, an economist at the W.E. Upjohn Institute for Employment Research, who wasn’t involved in the study.

From the U.S. healthcare business front —

Healthcare Dive relates

Escalating costs for labor, drugs, supplies and equipment are adding to the long-term pressures facing rural hospitals, raising the risk of more closures that could jeopardize patient access to care, the American Hospital Association warned in a new report. 

Many hospitals were already in difficult financial positions before the COVID-19 pandemic began, due to challenges including low patient volume and reimbursement, geographic isolation, staffing shortages and aging infrastructure, the AHA said. From 2010 through 2021, 136 rural hospitals closed, according to data from the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. In 2020, when the pandemic hit, a record 19 rural hospitals closed.

The public health emergency put additional pressure on margins and patient volumes. “While rural hospitals were partially buoyed by the Provider Relief Fund and other sources of COVID-19 assistance that limited closures in 2021, the financial outlook for many rural hospitals moving forward is precarious,” the AHA said.

Revcycle Intelligence reports

Private equity acquisition of physician practices in dermatology, gastroenterology, and ophthalmology was associated with increased healthcare spending and utilization, according to a study published in JAMA Health Forum. * * *

Following a private equity acquisition, physician practices saw consistent growth in spending during the next eight quarters. Acquired practices saw a mean increase of $71 in charges per claim or a 20.2 percent increase. In addition, practices saw an increase of $23 in the allowed amount per claim—an 11 percent increase.

Patient utilization of healthcare services grew as well after practices underwent acquisitions.

Across the eight post-acquisition quarters, the mean number of unique patients increased by 25.8 percent. This increase was mainly driven by more new patient visits, which rose by 37.9 percent. The number of encounters grew by 16.3 percent and the number of evaluation and management (E/M) visits increased by 37.1 percent.

The increase in patient visits may reflect changes in management and practice operations or overutilization of profitable services and low-value care, the study suggested. This could lead to higher healthcare spending without corresponding benefits.

Additionally, researchers said the growing number of visits was consistent with private equity firms’ common strategy to maximize revenue through a fee-for-service delivery system.

Ruh roh on both counts.

Healthcare Finance adds

Quality can go a long way in determining if a consumer is willing to pay more for their healthcare, as indicated by new survey responses published by revenue cycle company AKASA.

Out of more than 2,000 respondents, the survey found that 57% would pay more for a higher quality of care. Out of all categories in the survey, care quality was the only area in which a majority said they would be willing to pay more.

Forty-seven percent said they would pay more for the ability to work with the care team of their choice. Forty-one percent said they would pay more for the ability to work with hospitals of their choice, while the same percentage said they’d pony up more cash for better location proximity or convenience.

In public health news, the American Hospital Association celebrates the fact that

The United Network for Organ Sharing, which serves as the nation’s transplant system under contract with the federal government, Friday reported its millionth U.S. organ transplant. UNOS and the Organ Donation and Transplantation Alliance credited the organ donation and transplantation community, including transplant hospitals, with making the historic milestone possible. The first successful transplant took place at Peter Bent Brigham Hospital (now Brigham and Women’s Hospital) in Boston in 1954.

UNOS and the Alliance encourage the transplant community to join Living It Forward, a national initiative to commemorate the achievement and accelerate the path forward to the next million transplants. They also encourage members of the public to register as organ donors, noting that each donor can save up to eight lives and help up to 75 people through tissue donation. Over 100,000 people remain on the transplant waitlist.

From the Rx coverage front, BioPharma Dive tells us that

The Food and Drug Administration on Friday approved Bristol Myers Squibb’s psoriasis pill Sotyktu, the first medicine of its type and the last of three potential blockbuster drugs the company sought to bring to market this year.

Sotyktu will compete with biologic drugs like AbbVie’s Humira and Amgen’s Enbrel, but as a pill could be more attractive to patients who don’t want to inject themselves regularly. Importantly, Sotyktu’s labeling doesn’t require patients to first try biologic drugs, giving doctors an opportunity to prescribe it widely.

Approval came after Phase 3 testing in which the pill, also known as deucravacitinib, was tested against a placebo as well as another oral therapy, Amgen’s Otezla. In patients with moderate-to-severe plaque psoriasis, Sotyktu outperformed both on two commonly used measures for assessing skin clearing: PASI and sPGA.

“All in all, the overall efficacy and safety profile as a new first-in-class agent for plaque psoriasis bodes well for it becoming the standard of care,” said Samit Hirawat, Bristol Myers Squibb’s chief medical officer, setting a high bar for his company’s commercial expectations.

In wellness news, Healio informs us that

Widespread adoption of simple lifestyle changes, including switching to a well-known eating plan, could reduce risk for CV events and death for millions of adults with stage 1 hypertension, researchers reported.

“Millions of working-age people are walking around with elevated BP, which is symptomless but is also a leading preventable cause of disability and death,” Kendra D. Sims, PhD, MPH, a postdoctoral fellow at the University of California, San Francisco (UCSF) School of Medicine who presented the findings at the American Heart Association Hypertension Scientific Sessions, told Healio. “Our study found that 27,000 CVD events and 2,800 deaths could be prevented during the next 10 years if people with elevated BP follow through with recommended lifestyle changes. We would then save $1.6 billion in associated health care costs. The largest benefit comes from eating more fruits and vegetables and less salt, as outlined in the Dietary Approaches to Stop Hypertension (DASH) diet.

Midweek Update

David Ermer–CDC, COVID-19, HSA, Mental health care, Rx coverage, U.S. Healthcare–

OPM announced today that the next Federal Benefits Open Season will be held from November 14 through December 12, 2022. The announcement tells us that OPM expects to post 2023 FEHB and FEDVIP premiums on its website in “late September.”

From the Omicron and siblings front, the Wall Street Journal offers a helpful set of FAQs on the new bivalent mRNA boosters that are currently rolling out for administration.

From the monkeypox front, the Food and Drug Administration announced action to expand testing for the disease.

From the public health front, McKinsey and Company released its

United States of Health Dashboard. [McKinsey describes the tool as] an easy-to-use data visualization tool that enables users to explore the impact of disease and ill health within individual states, the dashboard is informed by key metrics encompassing maternal and neonatal health, behavioral health, communicable disease, chronic disease, and environmental health. It measures the total loss of healthy years of life, assuming full health (also known as “the burden of disease”), that affect a state’s population over the course of one year.

The dashboard is designed to help current and newly tapped state leaders, public-health agencies, and other stakeholders identify the highest-priority areas for investment by offering insights into key questions such as: How do behavioral health challenges affect a state’s population? How well is chronic disease managed and infectious disease controlled? How do mothers and their newborn infants fare? How well are health risks in the environment managed? And which populations are most significantly impacted by these metrics?

For example, here is a link to the Texas dashboard.

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

September is Suicide Prevention Awareness Month, with National Suicide Prevention Week running Sept. 4-10. In recognition of the effort to reduce the occurrence of suicide and destigmatize the conversation around it, AHA is proud to highlight resources available to our members and the public at large.

HR Director offers an interesting article about how HR professionals can approach this issue.

In the roughly dozen years since [he dealth with an employee suicide], [Matthew] Burr has advised every one of his clients (which include schools, financial firms and manufacturers, among other companies) to establish an EAP. Aside from a couple smaller companies, which have anywhere from five to 10 employees, every client has taken his advice. They were truly grateful to have done so ahead of the COVID-19 pandemic, so their employees had support systems already in place during the unprecedented time.

From the U.S. healthcare business front

  • Healthcare Dive reports that Walmart and UnitedHealthcare have teamed up to offer a Medicare Advantage plan under a ten-year-long contract. “Ultimately, the goal is to serve hundreds of thousands of seniors and Medicare beneficiaries in value-based arrangements through multiple Medicare Advantage plans.
  • Beckers Hospital Review tells us “Cost Plus Drug Co. founder Mark Cuban expects his online pharmacy to soon grow past 1 million customers, the billionaire of Shark Tank fame said Sept. 6 during Vox‘s Code Conference.  ‘By the time I get back, we should, hopefully, be past a million patients in seven months,’ Mr. Cuban told Vox‘s Recode, referring to the late-January launch of Cost Plus Drug Co., according to CNET.”
  • Reuters reports, not surprisingly, that “CVS Health Corp’s (CVS.N) plan to buy healthcare services company Signify Health for about $8 billion will face a tough U.S. antitrust review even though the two companies do not compete directly in any markets, three experts said Tuesday.”

From the Rx coverage, BioPharma Dive discusses the near term future of biosimilar drugs.

From the health savings account front, Voya Financial discusses “five HSA funding strategies companies [or FEHB plans’ can employ to help boost employee saving.”

Tuesday’s Tibits

David Ermer–ACA, CMS, Congress, COVID-19, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Fierce Healthcare points out four legislative items that providers should be tracking for the remainder of this year.

From the Omicron and siblings front, the Washington Post reports

Cold weather favors the coronavirus. But as summer gives way to fall, infectious-disease experts are guardedly optimistic that the spread of covid-19 this autumn and winter won’t be as brutal as in the previous two years of the pandemic.

Coronavirus scenarios from multiple research teams, shared in recent weeks with federal officials, foresee stable or declining hospitalizations in early fall. The scenarios show the possibility of a late-fall surge. A new variant remains the biggest wild card. But several factors — including the approval this week of reformulated boosters and the buildup of immunity against the latest strain of the virus — could suppress some of the cold-season spread, experts say.

In related news, the Wall Street Journal informs us

U.S. health authorities plan to recommend that people get Covid-19 boosters once a year, starting with the new shots now rolling out, a shift from their current practice of issuing new advice every several months.

The annual cadence would be similar to that of flu shots, White House officials said Tuesday, though elderly people and those with weakened immune systems may need more frequent inoculations. 

A shift to annual Covid-19 boosters would be a departure from current practice and comes after many people in the U.S. have ignored calls to get a first or second booster, partly due to fatigue with repeat inoculations. 

“Barring any new variant curveball,” said White House coronavirus coordinator Ashish Jha, “for a large majority of Americans, we are moving to a point where a single annual Covid shot should provide a high degree of protection all year.”

A very sensible approach, indeed!

From the healthcare business front, Healthcare Dive tells us

Amazon and One Medical said Friday that antitrust regulators want more information about the online retailer’s proposed $3.9 billion acquisition of the primary care group. 

The Federal Trade Commission sent a second request for information on Friday, One Medical said in a filing with the U.S. Securities and Exchange Commission.

A second request from the FTC means the two cannot move forward with the deal “until the companies have substantially complied with the additional investigatory request,” according to the FTC.

Amazon and One Medical will “promptly respond” to the second request, the primary care group said in the SEC filing.

In July, Amazon agreed to purchase One Medical for $3.9 billion in an all-cash deal.

From the tidbits department

  • Drug Channels surveys the upcoming Humira price war as biosimilar competitors take the field.
  • CMS posted new information about available group health plan defenses to CMS contractor assertions that the GHP has failed to properly coordinate its benefits with Medicare.
  • Beckers Payer Issues offers expert opinions on the impact of the transparency in coverage rule on consumerism now that the three machine-readable files of health plan pricing data have been posted for two months. For example, “Neil Mayle is the founder and president of Visible Charges, a Cambridge, Mass.-based company that provides clients with curated datasets of both payer- and provider-negotiated service prices. * * * ‘I think we’ve gone from nothing to a lot,’ Mr. Mayle said. ‘We haven’t gone to perfect.'” Of course, it was only the first of three stages in transparency in coverage rule disclosures.
  • The FEHBlog noticed today these CMS and DOL fact sheets on the No Surprises Act which are worth a gander.

.

Friday Stats and More

David Ermer–CDC, COVID-19, Rx coverage, U.S. Healthcare–

Because it’s the beginning of the three day weekend, the Centers for Disease Control did not publish its weekly review of CDC Covid statistics. The FEHBlog values that weekly review because it complements the FEHBlog’s own Covid charts which are based on the CDC’s Covid Data Tracker and use Thursday as the first day of the week. So without further ado, here are the FEHBlog’s three Covid charts for this week, the 35th week of 2022:

It’s always worth noting that the peaks on the left sides of the top two charts reflect the grand daddy of surges, the first Omicron wave. With respect to Covid vaccines, Revcycle Intelligence reports that the American Medical Association has added eight new CPT-4 codes to its procedures manual to cover physician services for the new Covid bivalent boosters.

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

CVS Health Corp. is in advanced talks to acquire the home-healthcare company Signify Health Inc. for around $8 billion, according to people familiar with the matter.

CVS appears to have beat out other heavy hitters including Amazon.com Inc. and UnitedHealth Group Inc., which had been circling Signify for a deal that could be announced soon. UnitedHealth never submitted an official bid, one of the people said.

There is still no guarantee that CVS will reach a deal for Signify, which has been exploring strategic alternatives since earlier this summer.

While Signify’s deadline for bids is Tuesday, September 6, Signify could strike a deal before then.

UHC is not sitting on its hands though. According to MedPage Today

UnitedHealth Group’s healthcare services division, Optum, will reportedly acquire Kelsey-Seybold for approximately $2 billion, according to the Star Tribune.

The acquisition of Kelsey-Seybold, a physician group based in Houston that includes cancer and women’s health centers, two ambulatory surgery centers, and a sleep center, was first announced in April, but few details have emerged since, the Star Tribunereported.

However, Optum, based in Eden Prairie, Minnesota, did provide a statement to MedPage Today about incorporating Kelsey-Seybold’s operations and staff into the Optum network.

From the rather quiet monkeypox front, STAT News raises a new concern.

A new study is raising concerns about the effectiveness of the monkeypox vaccine being used in the United States and other parts of the world.

The work, which has not yet been peer-reviewed, found that two doses of the vaccine induced relatively low levels of neutralizing antibodies against the monkeypox virus, and those antibodies had poor neutralizing capacity.

The researchers noted the so-called correlates of protection — what is needed, in terms of immune system weaponry, to be protected against monkeypox — are not known. Still, the evidence of low levels of neutralizing antibodies raises questions about how much protection is generated by two doses of the vaccine, marketed as Jynneos in the U.S. and made by the Danish manufacturer Bavarian Nordic. * * *

The study also casts a shadow over the recent decision by the U.S. government and others to stretch vaccine supplies by giving people one-fifth of a regular dose — and to do so by intradermal (into the skin) rather than subcutaneous (under the skin) injection. Intradermal administration, which requires smaller doses to be protective, has been shown to be effective in other disease outbreaks with other types of vaccine.

From the opioid epidemic front, STAT News features an interview with Rahul Gupta, M.D., “the director of the White House Office of National Drug Control Policy and the first doctor to hold that position.”

Gupta’s selection as director of the White House Office of National Drug Control Policy, however, has ushered in a new era of federal drug policy. As the first doctor to hold the position, he says he will embrace new strategies, including harm reduction tactics, which aim to reduce drug users’ risk of overdose, death, and disease in lieu of a hardline, abstinence-only attitude.

Still, though, addiction treatment is dogged by stigma, underuse of existing medications, and ongoing debate about certain harm-reduction techniques. The debate came to a head last week in California, where Gov. Gavin Newsom vetoed a bill to allow supervised injection sites — essentially clinics where people can use illicit drugs under medical supervision so as to prevent overdose.

Gupta sat down with STAT this week to discuss the ongoing crisis and the Biden administration’s efforts to address it. While circumspect about Newsom’s decision, Gupta did take several positions that are far more aggressive than any of his predecessors: Calling out doctors for their role in poor treatment outcomes; arguing that the addiction medication buprenorphine is widely misunderstood; and advocating for contingency management, a new addiction intervention that offers rewards — often cash — in exchange for cessation of drug use.

From the public health front, the Food and Drug Administrations discusses “Using A Whole-Of-Governments Approach to Combating Illicit Health Products.” Among other steps, “the agency has partnered with the Organisation of Economic Co-Operation and Development (OECD) Task Force on Countering Illicit Trade, which has been studying the problem of illicit trade for 15 years.” 

From the Rx coverage front, Endpoints News informs us

Last July, the cost-effectiveness drug watchdog ICER released a preliminary draft report that Vivus’ Qsymia was the most cost-effective option for weight loss. That decision has now been validated.

ICER made its final determination Wednesday [August 31] that Qsymia, the brand name for the appetite suppressant phentermine combined with anticonvulsant topiramate, was more cost-effective for weight loss than other competitors such as Novo Nordisk’s Saxenda (liraglutide) and Wegovy (semaglutide) or Currax Pharmaceuticals’ Contrave (bupropion/naltrexone). * * *

ICER reviewers also added that if Qsymia wasn’t performing well in certain patients, Contrave may be the next best cost-effective option. The reviewers noted in their report that there were a few limitations to analysis, including the full impact of the drugs in patients with chronic kidney diseases or conditions where weight loss may be beneficial.