From the Federal Employee Benefits Open Season front, the FEHBlog has noticed that OPM expanded the number of FEHB and FEDVIP public use files available on its website. “The purpose of the OPM FEHB and FEDVIP Plan and Benefits Information (PBI) Public Use Files (PUFs) is to provide information to the public on FEHB and FEDVIP plans, including information on rates and benefits.” Check it out.
The FEHBlog also has noticed that many FEHB plans promptly posted Open Season information on their websites. In particular, the three largest FEHB carriers, Blue Cross FEP, GEHA, and Kaiser Permanente have done so. That’s a heavy, yet helpful, lift so kudos to the carriers.
From the public health front
The New York Times brings us up to date on the polio vaccination campaign in New York State.
The specter of polio becoming endemic in America again was once unthinkable. But as state public health officials embark on an urgent campaign to get more people vaccinated, the low rates among preschoolers in some pockets are evidence of both the challenges they face and the threat to the state’s youngest children — the very age group among whom polio is most likely to spread.
This gap stems from the fact that the polio vaccine is required for school admission.
A bipartisan group of lawmakers has proposed legislation to help create drugs that can fight drug-resistant pathogens as the treatments for life-threatening problems from respiratory infections to sepsis stop working.
But a classic end-of-year congressional quagmire — a tight calendar, a heated election season, fights over spending, and inertia — threatens to stymie progress before the end of the year.
Fingers crossed for passage in the lame duck session.
The National Institutes of Health released its monthly NIH News in Health, which is worth a click.
Fierce Healthcare relates “Francisco Partners, an investment firm, signed a definitive agreement to acquire bSwift from CVS Health.” The acquistion agreement is expected to close by year end and “bSwift will continue to partner with CVS Health and its subsidiary Aetna, an insurance provider, by sharing benefits solutions with its employees and clients.”
From the telehealth front, we have another positive survey report from mHealth Intelligence. “ccording to new research findings from the JD Power 2022 US Telehealth Satisfaction Study, telehealth has become more than a temporary replacement for in-person care due to high consumer preference and its role in expanding access to mental health treatment.”
From the Monday miscellany front —
BioPharma Dive identifies five Food and Drug Administration decisions to watch out for this quarter. “The regulator could soon approve medicines from Apellis, Gilead and GSK, as well as decide on whether to pull a controversial preterm birth drug from the market.”
The Office of National Coordinator for Health Information Technology issued eight information blocking regulatory reminders for October 6, the end of the phase in period for that rule.
Medscape reports on an HHS Office of Inspector General report criticizing the efficiency of the FDA’s accelerated drug approval program.
In granting accelerated approvals, the FDA sets timelines for drugmakers to carry out confirmatory trials. But these target dates are often missed. OIG staff evaluated 104 cases of accelerated approvals for which confirmatory trials have not been completed and found that as of May 5, 2022, 35 drug studies had missed their original target completion dates. * * *
In its report, the OIG staff offered a deep look at the four drugs in which confirmatory trials were furthest past their original completion deadlines:
* Mafenide acetate (Sulfamylon), a topical antimicrobial treatment for burns that was approved in 1998. The trial is 140 months past its original deadline.
* Midodrine hydrochloride (Proamatine), a treatment for postural hypotension that was approved in 1996. The trial is 85 months past its original deadline.
* Pralatrexate (Folotyn), a treatment for T-cell lymphoma that was approved in 2009. The trial is 72 months past its original deadline.
When the justices return to the bench next week to begin the 2022-23 term, members of the public will be able to attend oral arguments for the first time since the COVID-19 pandemic began in 2020. The court also announced on Wednesday that it will continue to provide a live audio feed of oral arguments, a practice that it began during the pandemic.
Masking will be optional at oral arguments, the court said in a press release, and the court’s building will otherwise remain closed to the public.
From the Omicron and siblings front, Forbes reports
As COVID-19 regulations continue to ease across the U.S., some Americans want more protection. Nearly two-thirds (63%) of adults familiar with the recently updated booster shot, which specifically targets the virus’ Omicron variant, say they are likely to get one.
That’s according to the latest Forbes Health-Ipsos Monthly Health Tracker, which polled 1,120 adults between Sept. 27 and 28, 2022. Of those in favor of the new shot, 25% say they are “somewhat likely” to get it, while 38% indicate they are “very likely” to get the booster.
Additionally, about 9% of polled individuals have already received the latest booster, and 28% say they aren’t likely to get this particular booster at all.
Perhaps it’s time for health plans to reach out to members on the bivalent booster.
From the healthcare costs front, the Congressional Budget Office offers “Policy Approaches to Reduce What Commercial Insurers Pay for Hospital and Physician Services.” How timely!
A new report finds that 1,216 pharmaceuticals increased their prices past the inflation rate of 8.5% from July 2021 to July 2022, with an average hike of 31.6%.
NPR shots provides patient and expert reaction to the FDA’s decision to approve a new drug to treat amyotrophic lateral sclerosis (“ALS”).
The Food and Drug Administration has approved a controversial new drug for the fatal condition known as ALS, or Lou Gehrig’s disease.
The decision is being hailed by patients and their advocates, but questioned by some scientists.
Relyvrio, made by Amylyx Pharmaceuticals of Cambridge, Mass., was approved based on a single study of just 137 patients. Results suggested the drug might extend patients’ lives by five to six months, or more. * * *
A much larger study of Relyvrio, the Phoenix Trial, is under way. But results are more than a year off.
The Institute for Clinical and Economic (ICER) review adds
Yesterday, the FDA approved Relyvrio, Amylyx Pharma’s therapy for amyotrophic lateral sclerosis (ALS). According to ICER’s analysis, the therapy would only achieve traditional thresholds of cost-effectiveness if priced between $9,100 to $30,700 per year.
We also recommended that manufacturers should seek to set prices of new medications that will foster affordability and access for all patients by aligning prices with the patient-centered therapeutic value of their treatments, and not based on the price of existing ALS medications. This is especially important for ALS since new drugs are anticipated to be used in combination with other very expensive drugs, creating the highest risk for financial toxicity due to health care costs.
From the telehealth front, mHealth Intelligence informs us
While researching the effects of telehealth and in-person care within a large integrated health system, a study published in JAMA Network Open found that virtual care methods can expand healthcare capabilities, performing on par or better than in-person care on most quality measures evaluated.
Researchers conducted a retrospective cohort study that included 526,874 patients, 409,732 of whom received only in-person care, and 117,142 participated in telehealth visits. Of those who received only in-person care, 49.7 percent were women, 85 percent were non-Hispanic, and 82 percent were White. Of those who received care via telehealth, 63.9 percent were women, 90 percent were non-Hispanic, and 86 percent were White.
Researchers noted that patients in the in-person-only group performed better on medication-based measures. But only three of the five measures had significant differences: patients with cardiovascular disease (CVD) receiving antiplatelets, those with CVD receiving statins, and those with upper respiratory infections avoiding antibiotics.
Researchers also noted that patients participating in telehealth performed better than those in the -person-only group on four testing-based measures. These four measures included patients with CVD with lipid panels, patients with diabetes with hemoglobin A1c testing, patients with diabetes with nephropathy testing, and blood pressure control.
Further, those participating in telehealth performed better than their counterparts on seven counseling-based measures, including cervical cancer screening, breast cancer screening, colon cancer screening, tobacco counseling and intervention, influenza vaccination, pneumococcal vaccination, and depression screening.
Based on these study findings, researchers concluded that telehealth could augment care for various conditions, especially chronic diseases. The study also supplies information that could assist providers in determining an ideal ratio of in-person and telehealth visits.
But researchers also noted several limitations associated with the study. These included their inability to control for the number of in-person and telehealth visits, potential inaccuracies associated with the EMR data used, and sampling limitations.
From the cyberpolicy front, let’s remember, “Cybersecurity Awareness Month, every October, is a collaboration between government and private industry to raise awareness about digital security and empower everyone to protect their data from digital forms of crime.”
CISA adds that the agency “postpone[d] the 5th Annual National Cybersecurity Summit due to the mission-critical work of preparing for the potential impact of Hurricane Ian in the region. The summit was originally scheduled to occur on October 4. Visit CISA’s National Cybersecurity Summit webpage and follow CISA on social media for the latest news and updated registration information when it’s available.”
From the cyber vulnerabilities front —
Cybersecurity Dive informs us in an article posted on September 30
Microsoft is investigating reports of two zero-day vulnerabilities affecting Microsoft Exchange Server 2013, 2016 and 2019, according to a blog post issued Friday. The vulnerabilities do not affect Microsoft Exchange Online Customers.
The first vulnerability, CVE-2022-41040, is a server-side request forgery vulnerability, Microsoft said. The second, CVE-2022-41082, allows remote-code execution when a threat actor has access to PowerShell.
Microsoft confirmed it was aware of limited targeted incidents with attackers using the two vulnerabilities to compromise systems. During the incidents, an attacker can use CVE-2022-41040 to allow an authenticated attacker to remotely trigger CVE-2022-41082.
The Health Sector Cybersecurity Coordination Center issued an alert on the Microsoft zero day vulnerabilities.
Currently, the full impact to the Healthcare and public health (HPH) sector is unknown; however, the threat actors actively exploiting these vulnerabilities make the HPH sector a potential target.
CISA issued an alert titled “Microsoft Releases Guidance on Zero-Day Vulnerabilities in Microsoft Exchange Server.”
CISA’s other vulnerability advisories issued last week include the following
From the ransomware front, Cybersecurity Dive reports
U.S. businesses were targeted by nearly half of all publicly acknowledged ransomware attacks globally between January 2020 and July 2022, according to data collected by NordLocker and published Tuesday in a report.
Of the 5,200 cases recorded on ransomware groups’ sites, U.S. organizations accounted for almost 2,400 incidents. Businesses in California, Texas, Florida and New York suffered the greatest number of ransomware attacks, but Michigan businesses were hit hardest when the rate is adjusted by the number of active businesses in each state.
Small- and medium-sized businesses with two to 200 employees suffered the most attacks during the period, accounting for 46%, or 2,300 ransomware attacks total, according to the report.
Another interesting research is the prediction that ransomware gangs may move away from encrypting altogether and switch to pure data exfiltration and file deletion to cut out the ransomware developer. This idea stems from a new file deletion/corruption feature in a data theft tool used by a BlackMatter affiliate.
From the cyberdefenses front —
Health IT Security offers six healthcare cybersecurity strategies for successful CISOs; Mastering effective communication, implementing a risk-based healthcare cybersecurity approach, and attracting top cyber talent are all parts of a CISO’s job description.”
The Wall Street Journal reports “Heightened Cyber Threat Brings CIOs, CISOs Closer; The work dynamic between IT and cyber leaders is changing as digital fortification becomes more urgent. ‘Everybody’s top of mind is cybersecurity,’ says one CISO.”
The Journal adds “A mix of regulation, investor demands and insurance requirements is pushing companies to elevate the oversight of cybersecurity, officials from the U.S. and other countries say.”
Cybersecurity Dive tells us about “six things that businesses need to know about the changing privacy landscape. New bills are proposed every day, and while only a few will become official policy, there may be important trends that impact businesses.”
Federal employees and retirees will spend an average of 8.7% more on their health insurance premiums in 2023, a figure that marks the highest cost increase in more than a decade.
On average, federal employees enrolled in “self-only” plans will pay an additional $8.11 per bi-weekly pay period, while feds in “self plus one” insurance plans will pay $20.34 more per pay period. Federal workers enrolled in family coverage will pay an average of $20.87 more per pay period in 2023.
For the Federal Employees Dental and Vision Insurance Program, the average premium for dental plans will increase by 0.21%, while the overall average premium for vision coverage will decrease by 0.41%.
If you follow the FEHBlog’s U.S. healthcare cost posts, you know that this FEHB premium increase is in line with what other large employers are experiencing. As readers know, the 8.7% average increase assumes no one changes plans in Open Season. The FEHBlog thinks that OPM emphasizes this number to encourage federal employees and annuitants to shop for lower-priced coverage.
From the Omicron and siblings front, here is the CDC’s weekly interpretative summary of its Covid statistics, which the FEHBlog continues to track.
As of September 28, 2022, the current 7-day moving average of daily new cases (47,112) decreased 13.1% compared with the previous 7-day moving average (54,202).
CDC Nowcast projections* for the week ending October 1, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are five sublineages designated as Omicron: BA.5, BA.4.6, BF.7, BA.2.75, and BA.4. The predominant Omicron lineage is BA.5, projected to be 81.3% (95% PI 79.6-83.0%).
The current 7-day daily average for September 21–27, 2022, was 3,733. This is a 7.4% decrease from the prior 7-day average (4,029) from September 14–20, 2022.
The current 7-day moving average of new deaths (344) decreased 6.7% compared with the previous 7-day moving average (368).
As of September 28, 2022, 619.8 million vaccine doses have been administered in the United States. Overall, about 264.1 million people, or 79.5% of the total U.S. population, have received at least one dose of vaccine. About 225.3 million people, or 67.9% of the total U.S. population, have completed a primary series.
Of those who have completed a primary series, about 110.0 million people have received a booster dose,* and more than 7.5 million people have received an updated (bivalent) booster dose. But 49.8% of the total booster-eligible population has not yet received a booster dose.
The House cleared a temporary spending bill needed to avoid a partial government shutdown ahead of Friday night’s deadline, giving lawmakers a reprieve until after the midterm elections when they’ll need to figure out a longer-term funding plan for the fiscal year ending Sept. 30, 2023.
The measured passed on a 230-201, mostly party-line vote and will now be sent to President Joe Biden’s desk where he’s expected to sign it later on Friday. The Senate passed the measure Thursday, 72-25, after that chamber resolved some last-minute holds.
The extension is through December 16, 2023.
Pension and Investments Online reports “More than 14 months after her nomination, the Senate on Thursday confirmed Lisa M. Gomez as assistant secretary of labor for the Employee Benefits Security Administration in a 49-36 vote.” EBSA is one of the Affordable Care Act and No Surprises Act regulators, which impacts FEHB. Good luck.
From the U.S. healthcare business front, Healthcare Dive informs us that the Justice Department has not appealed a September 19, 2022, federal district court rejecting the federal government’s challenge to United Healthcare’s acquisition of Change Healthcare.
[T]he DOJ could still appeal the UnitedHealth-Change ruling. Its earlier deal reached with UnitedHealth doesn’t prevent DOJ from appealing.
“In any challenge to a merger, it is always beneficial for those challenging it to seek to have the merger enjoined before the matter actually closes,” Jim Burns, a partner at Williams Mullen and chair of its Antitrust and Trade Regulation Practice Group, told Healthcare Dive.
But all signs indicate that the DOJ has decided not to appeal, a former government official with antitrust expertise told Healthcare Dive.
To alleviate other antitrust concerns, UnitedHealth agreed to divest ClaimsXten to private equity group TPG Capital.
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.
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.
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.
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.”
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.
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.
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.”
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.
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.
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.
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.
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.
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.
Federal News Network reports that its popular journalist on federal employment matters, Mike Causey, passed away at age 82 shortly after completing a broadcast.
Causey was a popular figure in the newsroom, who loved to share a funny story or joke, often approaching with a mischievous gleam in his eye. Colleagues appreciated his soft-spokenness and gentle demeanor. “Mike was someone who offered kindness and a warm smile to everyone he encountered,” said federal workforce reporter Drew Friedman.
A peerless reporter, Causey cultivated a large and devoted readership that followed him from medium to medium. He knew nuances of topics such as the best day to retire or the shrewdest Thrift Savings Plan strategy better than anyone. His writing was marked by an easy, accessible, occasionally humorous style undergirded by thorough, factual reporting. Causey is widely acknowledged as having coined the term, “inside the beltway.”
Now there’s a phrase that the FEHBlog frequently used without knowing its connection to Mike Causey. RIP.
Fierce Healthcare released its list of the most influential minority executives in healthcare for 2022. Congratulations to the winners.
The Segal Company released its 2023 Health Care Costs Survey. “Health care spending in 2021 spiked an average of 14% per covered participant, the highest increase in a decade. The surge was primarily driven by the return of previously deferred medical care and the uptick of COVID-19 vaccines and therapeutics, according to data released” by Segal in this survey.
RevCycle Intelligence informs us “Inflation and rising labor costs will increase US national healthcare spending by $370 billion in the next five years, according to a McKinsey report. Consumer prices are rising faster than healthcare inflation, but general inflation has recently driven up healthcare supply input costs.”
Whoa, Nelly, the FEHBlog sees a common theme here. The cost curve is up.
From the Omicron and siblings front, WebMD tells us
Pfizer/BioNTech and Moderna, the two biggest COVID vaccine makers for the United States, are both seeking emergency authorization from the FDA for bivalent vaccine boosters for children.
Pfizer’s booster would be for children 5 to 11 who have completed a primary vaccination series, the company said in a Monday news release. Moderna’s updated boosters would be for children ages 6 to 17 who have completed a primary vaccination series, the company tweeted on Friday.
For the Moderna booster, children 12 to 17 would receive the same dose as older people, while children 6 to 11 would get a half dose from the same vial, the CDC said in a Sept. 20 update to its fall vaccination planning guide.
“If authorized by FDA, CDC anticipates a recommendation for bivalent COVID-19 vaccine as a booster for pediatric age groups in early to mid-October,” the CDC document said.
From the substance use disorder front, the Hill reports
President Biden on Friday announced that his administration would distribute $1.5 billion to states and territories, including tribal lands, to fund responses to opioid overdoses and support recovery.
The U.S. Department of Health and Human Services (HHS) will disseminate the funding through the Substance Abuse and Mental Health Services Administration’s (SAMHSA) State Opioid Response and Tribal Opioid Response grant programs as part of National Recovery Month. * * *
Along with the new funding, the Biden administration published new guidance to facilitate greater access to FDA-approved naloxone products, which treat opioid overdoses in emergency situations, and guidance for employers to create “Recovery-Ready Workplaces.”
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.
From the cybersecurity policy front, CISA announced the speakers scheduled for its Fifth National Cybersecurity Summit to be held in Atlanta, GA, on October 4, 2022. You may attend in person or virtually. You can register here: CISA’s 5th Annual National Cybersecurity Summit Tickets | Eventbrite There’s no charge to attend this summit.
From the cyberbreach front, Cybersecurity Dive reports “Uber details how it got hacked, claims limited damage; While there’s no evidence the rideshare company’s codebase was altered, the attacker did gain access to Slack, vulnerability reports and financial data.” The FEHBlog called attention to the Uber breach in last week’s post.
From the cybervulnerability front
Health IT Security informs us, “The Health Sector Cybersecurity Coordination Center (HC3) warned the healthcare sector of a new monkeypox-themed phishing scheme targeting healthcare providers.”
HC3 also released a PowerPoint presentation on a Chinese State-Sponsored Threat Act APT41 and recent activity.
CISA added another known exploited vulnerability to its catalog.
Vulture Beat discusses “Keeper Security[‘s] * * * second annual 2022 U.S. Cybersecurity Census Report, which maps the transforming landscape of cybersecurity based on expert insights from 500+ IT decision-makers in U.S. businesses. This year’s findings clearly show that while cybersecurity is a key priority, staying a step ahead of bad actors is a continuous challenge -– and many businesses are not keeping pace. According to survey respondents, U.S. businesses experience 42 cyberattacks each year. Of those, about three cyberattacks are successful. The overwhelming majority of respondents expect the total number of attacks will increase over the next year, with 39% predicting the number of successful cyberattacks will also increase.
CISA announced that “Microsoft has released a security update to address a vulnerability in Microsoft Endpoint Configuration Manager, versions 2103-2207. An attacker could exploit this vulnerability to obtain sensitive information. CISA encourages users and administrators to review Microsoft’s Security Advisory for CVE-2022-37972 and apply the necessary updates.
From the ransomware front, all we have this week is the Bleeping Computer’s reliable and comprehensive The Week in Ransomware.
From the cyberdefenses front, the FEHBlog was very impressed by the Wall Street Journal article about zero-trust architecture.
The companies that should know best how to fight hackers, tech firms, have reached an arresting conclusion: The weakest link in security, as it’s been since the Trojan War, is humans.
Increasingly, they are taking a new approach: Trust no one.
The philosophy, known as zero-trust architecture, assumes that no matter how robust a company’s external defenses are, hackers can get in. So companies need to make sure that even users inside a network can’t do serious damage. * * *
“Zero trust is based on the idea that you don’t trust anything in your system anymore,” says Anshu Sharma, chief executive of Skyflow, a startup that uses zero-trust principles to safeguard personal data for other companies. “Just because you’re in the building, you don’t get access to important stuff.”
Many of the design principles that guide engineers building zero-trust systems are easy to understand. If you’ve found yourself having to log back into corporate systems or your bank’s website more often of late, that’s a version of the zero-trust tactic of regularly “rotating” the credentials that allow people and computers to access other systems. The idea is that even if attackers got in with your account, they’d have limited time to do damage.
Another zero-trust principle, known as behavioral analysis, is that software should monitor the behavior of those on a network and flag anyone doing something unusual, like trying to make an extra-large bank withdrawal. (This is the same kind of analysis that leads your bank to send you a text if you make an out-of-character credit-card purchase, for example, when you’re traveling to a new city.)
The consistent theme is that every component of a system should be skeptical, even if you’ve identified yourself and gained access, that you are who you say you are and are doing what you should be doing.
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