From Capitol Hill, the Wall Street Journal reports
Republicans won a majority of seats in the House of Representatives with a victory in California, the Associated Press said late Wednesday, bolstering their ability to steer the agenda on Capitol Hill after two years of Democratic control of both chambers of Congress and the White House.
The Congressional Research Service released a report on health care provisions expiring at the end of this 117th Congress.
With midterm elections resulting in a narrowly divided Congress, the HHS will be free to focus on longstanding priorities for the health department, such as implementing drug negotiation policy within Medicare, HHS Secretary Xavier Becerra said at the HLTH conference in Las Vegas on Tuesday.
“In a way, we’re now going to be able to concentrate on the work we have to still execute on,” Becerra said,
Under the Inflation Reduction Act passed earlier this year, Congress granted Medicare the power to negotiate how much it pays for certain prescription drugs starting in 2026, and to receive rebates from pharmaceutical manufacturers that hike drug costs above the rate of inflation starting in 2023.
Of course, HHS and its partners have a lot of work on implementing the No Surprises Act. Health Payer Intelligence discusses the good faith estimate and advance explanation of benefits comments that an ERISA plan trade association, ERIC, submitted to the NSA regulators yesterday.
In other HLTH 2022 conference news,
Healthcare Dive tells us about Google’s plans for offering personal health records and Maven Clinic‘s efforts to build a maternal health business by, e.g., recently landing a $90 million Series E amid increasing investor focus on women’s health.
MedCity News informs us, “Cell and gene therapies are offering patients potentially curative treatments for a growing scope of diseases. Insurance companies are trying to figure out how to pay for them. Industry consultants speaking at the HLTH conference offered some strategies they see payers taking to these new therapies.”
From the federal employee benefits front,
Govexec collected all of its current Open Season articles for convenient access.
Reg Jones, writing in Fedweek, recommends that federal employees contemplating retirement should retire on December 31, 2022.
Govexec reports that the Postal Service is headed into its busy season with far fewer employees than past years.
From the Affordable Care Act front —
The FEHBlog ran across this updated reference chart on minimum essential coverage under the ACA.
The U.S. Preventive Services Task Force issued its 12th Annual Report to Congress which is titled “High-Priority Evidence Gaps for Clinical Preventive Services.”
From the public health front —
Forbes reports “Researchers at the University of Houston have developed a vaccine that could block the effects of fentanyl and prevent addiction, according to a new study that could unlock solutions to the opioid epidemic as more than 150 people die every day from overdoses connected to synthetic opioids.”
CNN reports “The five-year lung cancer survival rate has increased 21%, from 21% in 2014 to 25% in 2018, making what experts call “remarkable progress” – but it is still the leading cause of cancer death in the United States. However, in communities of color, a person’s odds of surviving five years after diagnosis are much lower, at only 20%, according to the 2022 State of Lung Cancer report, which was published by the American Lung Association on Tuesday.”
The National Institutes of Health tells us “COVID-19 Vaccines Are Safe for People Receiving Cancer Immunotherapy, Study Confirms.”
From the miscellany department —
Forbes informs us “UnitedHealth Group’s pharmacy benefit manager Optum Rx Tuesday said it will put three less expensive “biosimilar” versions of Abbvie’s pricey rheumatoid arthritis drug Humira ‘in the same position as the brand’ on the PBM’s preferred list of drugs known as a formulary.”
Over 200 members of the Senior Executive Service this year will receive Presidential Rank Awards, considered the highest honor for career civil servants.
President Joe Biden picked 233 winners across a total of 33 different agencies for the 2022 awards program, the Office of Personnel Management announced on Nov. 15.
“Each and every day, our federal employees are working to address the nation’s most pressing issues, developing technologies to improve millions of lives, and ultimately, achieving the seemingly unachievable on behalf of the American public,” OPM Director Kiran Ahuja said in a press statement. “This year’s Presidential Rank Awards reflect the Biden-Harris administration’s support for hardworking civil servants who exemplify strength, integrity, industry and a relentless commitment to public service through their exceptional leadership, contributions and accomplishments.”
Kudos to the winners.
From the Omicron and siblings front, the Wall Street Journal reports
Moderna Inc.’s new updated Covid-19 booster shot for the U.S. generated strong immune responses in people against Omicron subvariants, according to the first data from a company-sponsored study testing the new doses in volunteers.
Moderna said Monday that people receiving the updated booster shot had more than five times the neutralizing antibodies against Omicron subvariants BA.4 and BA.5 than people who received Moderna’s original booster shot, which targeted an earlier strain of the coronavirus.
“That really bodes well for the vaccine and public health,” Moderna President Stephen Hoge said in an interview.
From the conferences’ front —
The American Medical Association explains what happened on the closing day of the AMA’s interim meeting.
Healthcare Dive offers Dive Briefs from the HLTH conference about Included Health and Elevance Health. Fierce Healthcare adds “Mental health provider SonderMind acquired neuroscience company Total Brain with the goal of revolutionizing personalized therapeutic care and providing individual insights into mental wellbeing.”
“Amazon has launched a message-based virtual health service called Amazon Clinic a little more than two months after the retail giant shuttered its primary care delivery business Amazon Care.
“Amazon Clinic, which is currently live and available 24/7 through Amazon’s website and mobile app, is a marketplace for telemedicine providers, connecting consumers with virtual doctors who can diagnose, treat and prescribe medication for a range of common health conditions like acne, birth control and migraines, the retail giant said.
“Amazon Clinic will be available in 32 states at launch, with plans to expand to additional states in the coming months, according to a Tuesday blog post announcing the news. * * *
“Consultation cost will vary by provider, including follow-up messages with a clinician for up to two weeks after the consultation. Consultations start at $30.
“Amazon Clinic does not accept insurance. The company didn’t disclose whether that would change in the future.”
Nearly a decade after unsuccessfully attempting a merger, South Dakota-based Sanford Health and Minnesota’s Fairview Health Services said Tuesday they’re again in talks to combine.
The two regional health care giants say they intend to complete a merger next year. The new entity would be called Sanford Health and be run by Sanford’s current CEO. The deal would include the University of Minnesota hospitals, which Fairview purchased in 1997.
Financial details and any cost-cutting plans tied to the proposed merger were not immediately disclosed.
From the Food and Drug Administration front —
On Thursday [November 10], the FDA, in conjunction with the CDC, released results on youth tobacco use from the 2022 National Youth Tobacco Survey. Findings show that in 2022, more than one in 10 middle and high school students (3.08 million) had used a tobacco product during the past 30 days – including 16.5% of high school and 4.5% of middle school students. The full results are available here.
Today, the FDA announced an unprecedented advancement in foodborne illness prevention through the finalization of a rule to more effectively trace contaminated food through the food supply, whether sourced in the U.S. or abroad.
Also [t]oday, the FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status. Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.
From the No Surprises Act front, today was the deadline for the public to submit comments to the NSA regulators concerning two unnecessarily complicated consumer protections found in the law — the good faith estimate and the advance explanation of benefits. In the FEHBlog’s view, the NSA regulators would be well served if they limited those protections to surprise billing situations not elsewhere covered by the law, for example, (1) complicated procedures and (2) reoccurring services that take place over a prolonged period, e.g. chiropractor care, mental health care. The WEDI group, which is an advisor to the HHS Secretary, also offers useful comments on the matter.
From the Affordable Care Act front, the U.S. Preventive Services Task Force gave an inconclusive (I) grade today to screening for obstructive sleep apnea in adults. “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for obstructive sleep apnea in the general adult population.” The USPSTF previously graded the apnea screening service an I grade in January 2017.
The Earth is now home to eight billion people, the United Nations said, because people are living longer and fertility rates have surged in some countries. * * *
There were about 300 million people on Earth two millennia ago, according to the U.N. The population fluctuated in the centuries after that, largely because of plagues and natural disasters. Then the population accelerated, reaching one billion in 1804, four billion in 1974 and seven billion in 2011. * * *
Demographers project the world will reach its next population milestone—nine billion—around 2037.
The U.N. predicts that the global population will peak at around 10.4 billion during the 2080s and remain near that level until the start of the next century. Another forecast, from the Wittgenstein Centre for Demography and Global Human Capital at the University of Vienna, has it peaking at 9.67 billion in 2070, before a slow decline as fertility rates drop.
As the polls pretty much predicted, Tuesday’s midterms turned out to be very close in terms of the balance of power between the two parties. As of this writing [Wednesday evening] it’s still not clear which party controls the House and Senate. But in several states, there were important healthcare issues on the ballot that were settled more decisively. In South Dakota, voters approved an expansion of Medicaid benefits, adding itself to the list of many other states that have bypassed legislatures to expand the program by ballot initiative. Voters in Michigan, California and Vermont approved Constitutional amendments protecting abortion rights while voters in Kentucky rejected an amendment that would have stated abortion rights are not protected in the state. Meanwhile, in Arizona many of the headline races are still too close to call as of this writing, but one vote that isn’t is an overwhelming “Yes” for Proposition 209, which expands property and assets that can’t be collected against medical debt and also reduces the interest rate that can be charged on it.
From the Omicron and siblings front, protein-based Covid vaccine manufacturer Novovax reports on its third-quarter earnings and the value of its vaccine as a booster. In addition, Novovax says that it has delivered over 94 million doses of its vaccine worldwide.
From the U.S. healthcare business front, we have a trifecta from Healthcare Dive.
More than 30 healthcare associations and advocacy groups joined the American College of Emergency Physicians in asking President Joe Biden to prioritize finding solutions to the problem of overcrowded hospital emergency rooms.
Strained emergency departments are coping with an increase in boarding, a term for when patients are held in the ED longer than they should be because of a lack of available inpatient beds. The problem has led to gridlocked EDs filled with patients waiting, sometimes in life-threatening situations, the ACEP and other groups warned Monday in a letter to the president. “Boarding has become its own public health emergency,” the letter said.
The organizations urged the Biden administration to convene a summit of stakeholders from across the healthcare system to identify immediate and long-term solutions to the boarding problem.
Elevance Health inked a deal to acquire a specialty pharmacy that caters to patients with complex and chronic conditions like cancer and multiple sclerosis.
The insurer said BioPlus will complement its existing pharmacy benefit manager, IngenioRx, providing patients with specialty drugs and a whole-health approach.
After closing and integrating BioPlus into operations, the company will be able to leverage the insights from both pharmacy and medical benefits, Elevance announced on Wednesday.
Working together, BioPlus’ pharmacy team will be able to identify “a patient who may need behavioral health support or in-home care services” and “seamlessly connect that patient to services to address their whole health needs,” Elevance said.
The deal is expected to close in the first half of 2023. Financial terms of the deal were not disclosed.
Healthcare Dive also explains why Cigna invested $2.5 billion in Walgreen’s combined Village MD / Summit Health primary care company.
Unlike many other primary care physician groups, VillageMD is focused on the commercial market, which brings in two-thirds of its revenue. That plays to Cigna’s strength in the employer market, as the majority of its customers are commercial employers, according to Credit Suisse analyst A.J. Rice.
As part of its investment, Evernorth will develop value-based agreements with VillageMD. The two will work together to optimize sites of care and patient outcomes through VillageMD’s physician network and Evernorth’s health services businesses, which include pharmacy benefit manager Express Scripts, specialty pharmacy Accredo and virtual care provider MDLive.
Beckers Hospital Review discusses how CVS, Amazon and Walgreens are pushing into primary care, and home health care.
From the healthcare quality front
The HHS Agency for Healthcare Quality and Research’s Director offers a blog post about how “AHRQ’s Research and Tools Help Transform Delivery of Primary Care.”
Personal health record (PHR) use is key to driving patient engagement, with recent JMIR Cancerdata showing PHR use among colorectal cancer survivors increasing access to follow-up care and screening by more than 30 percentage points.
Additionally, PHR use increased the proportion of survivors who believed access to certain follow-up cancer screenings was important to their health and well-being, according to researchers from the Regenstrief Institute, the VA, and Indiana University’s schools of medicine and nursing.
PHRs are different from EHRs in that they are patient-facing and give users insights into their own health information. Most PHRs, particularly PHRs “tethered” to the EHR, come with some secure messaging and patient notification systems, giving the technologies even more patient engagement power.
Dave A. Chokshi, MD, MSc, FACP, senior scholar at CUNY School of Public Health and Health Policy and former Commissioner at the New York City Department of Health and Mental Hygiene, and Adam L. Beckman, BS, of Harvard’s Medical and Business Schools, identify five new hospital never events in a new JAMA Health Forumarticle. They say that hospitals should never:
Aggressively pursue medical debt against patients who cannot afford their bills
Spend less on community benefits than it earns in tax breaks from non-profit status
Flout federal requirements for hospitals to be transparent with patients about costs
Compensate hospital workers less than a living wage
Deliver racially segregated care
That approach could get the attention of hospitals.
More than three quarters, or 77%, of reproductive-aged women want birth control pills to be made available without a prescription, provided that research proves the pills safe and effective, a new survey shows.
“Oral contraceptives are the most commonly used method of reversible contraception in the U.S., and studies suggest that [over-the-counter] access would increase use of contraception and facilitate continuity of use in addition to saving time spent on travel, at a doctor’s office, and off work,” the report stated.
Under the Affordable Care Act, most private health insurance plans are required to cover FDA-approved birth control, but it must be prescribed. However, 41% of women at reproductive age are not aware of this. About 70% of women with private insurance said their health plan fully covered their birth control, but about a quarter said they had to pay some out-of-pocket.
The ACA rule also applies to FEHB plans. The FEHBlog is metaphysically certain the ACA regulators would extend this rule to over the counter contraceptive if the Food and Drug Administration can get its act together.
Forbes unpacks the colonoscopy study that the FEHBlog discussed in Monday’s post. The critical consideration is that “while colonoscopy may not be the gold standard it’s been made out to be, one or more colorectal cancer screening tools are essential to detect cancer and lower mortality rates.” Check it out.
Prof. Katie Keith writing in Health Affairs Forefront explores the final family glitch rule that the FEHBP mentioned in yesterday’s post. Two points suggest to the FEHBlog that the final rule will not materially impact the FEHB Program.
This situation—where employee-only coverage is affordable, but family coverage is not—is not uncommon. Most employers offer family coverage, but many do not subsidize it for family members which keeps the cost high for workers and their families.
That’s not the case in the FEHB Program. Moreover,
The final rule will not affect liability under the employer mandate, a fact confirmed by the IRS. Why not? The employer mandate requires certain large employers to offer coverage to employees and dependents. But penalties for violating the mandate are triggered only when an employee receives premium tax credits through the marketplace. The final rule extends premium tax credits to only the family members of workers who are not offered affordable job-based family coverage. It does not affect the eligibility of employees and thus does not implicate the employer mandate.
That’s an important consideration. Implementing the final rule is OPM’s responsibility as the FEHB Program’s regulator.
The White House on Tuesday said eligible Americans should get the updated COVID-19 boosters by Halloween to have maximum protection against the coronavirus by Thanksgiving and the holidays, as it warned of a “challenging” virus season ahead.
Dr. Ashish Jha, the White House COVID-19 coordinator, said the U.S. has the tools, both from vaccines and treatments, to largely eliminate serious illness and death from the virus, but stressed that’s only the case if people do their part. * * *
So far the Centers for Disease Control and Prevention says only about 11.5 million Americans have received the updated shots, which are meant to provide a boost of protection against both the original strain of COVID-19 and the BA.5 variant that is dominant around the world. Jha said studies suggest that if more Americans get the updated vaccines, “we could save hundreds of lives each day this winter.”
MedPage Today offers more information on this FDA decision and a modeling study of 1.2 million global Covid patients showing (1) “Long COVID — defined as one or more clusters of symptoms lasting three months or longer — occurred in about 6% of people with symptomatic SARS-CoV-2 infection” and (2) “at one year, 15% of long COVID patients had ongoing cognitive or respiratory problems or fatigue.”
In other public health news, NPR offers a transcript of a monkeypox discussion among NPR healthcare reports. The upshot is
Just a few months ago, it looked like the U.S. had lost its chance to get monkeypox under control. Cases were soaring, and vaccines were in short supply. But now the story has taken a turn and this time in a good direction. In fact, some disease experts are even raising the idea that the U.S. could nearly eliminate the virus.
Walmart is getting into clinical trials with the launch of the Walmart Healthcare Research Institute, as the retail giant focuses on high-margin businesses in healthcare.
Walmart said the venture is meant to improve diversity in clinical trials, focusing on interventions and medications that can make an impact in underrepresented communities. That includes older adults, rural residents, women and minority populations, the company said in a release.
It could also become a valuable stream of revenue for Walmart from drug companies looking for participants for potential trials and studies.
The NIH Directors’ Blog tells us about two NIH-supported chemists, Carolyn R. Bertozzi and K. Barry Sharpless, who won the 2022 Nobel Prize in Chemistry for their work in click chemistry.
This form of chemistry has made it possible for researchers to snap together, like LEGO pieces, molecular building blocks to form hybrid biomolecules, often with easy-to-track imaging agents attached. Not only has click chemistry expanded our ability to explore the molecular underpinnings of a wide range of biological processes, but it has provided us with new tools for developing drugs, diagnostics, and a wide array of “smart” materials.
Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer.
Moderna is getting $250 million from Merck to secure opt-in rights to the cancer vaccine candidate, called mRNA-4157. The two companies are jointly conducting a mid-stage clinical trial that combines the customized, mRNA-based vaccine with Merck’s checkpoint inhibitor Keytruda.
Results from this randomized study will be announced before the end of the year, but the timing of Wednesday’s deal suggests Merck and Moderna have seen enough encouraging data to advance mRNA-4157 into larger studies.
From the Rx coverage front, the HHS Agency for Healthcare Research and Quality updated its consumer tool “How To Create a My Medicines List,” previously known as “My Pills List.”
From the healthcare quality front, NCQA released a slide deck and recording of last week’s Future of HEDIS webinar focused on health equity.
From the maternity care front, Health Day reports on a March of Dimes report on maternity care deserts and related matters. Here’s the federal government’s maternity care map:
Maternity care deserts [red]: low access [orange]; moderate access [yellow]; full access [light purple] Source: U.S. Health Resources and Services Administration (HRSA), Area Health Resources Files, 2021
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!
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 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 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.
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
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.
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.”
Yesterday, the FEHBlog welcomed the first day of autumn when the autumnal equinox was at 9:04 pm today. To compound his error, the FEHBlog overlooked that yesterday was World Gratitude Day. The FEHBlog is grateful for his readers.
From Capitol Hill, Roll Call reports on the state of the continuing resolution to fund the federal government into mid-December.
Congressional leaders and appropriators are expected to spend the weekend haggling over the last details of the text Schumer is aiming to unveil Tuesday [following the Jewish New Year holiday], which he would offer as a substitute amendment.
On Thursday, authorizing committees agreed on a five-year reauthorization of FDA user fee programs, which could potentially be attached to the continuing resolution. Numerous other authorizations, funding “anomalies” and a supplemental aid package for Ukraine and other purposes were still being negotiated.
The House of Representatives is capable of acting quickly.
From the Omicron and siblings’ front
Beckers Hospital Review reports, “Retooled COVID-19 booster shots that target omicron subvariants could be authorized and available for children to receive within a month, the CDC said in a vaccination planning guide released Sept. 20.”
As some of us wonder how we’ll know when the coronavirus pandemic is over, a new report from the WHO called “Invisible Numbers” reminds us that noncommunicable diseases take more lives than infectious diseases (and make Covid-19 worse). To wit: Cardiovascular diseases including heart disease and stroke, cancer, diabetes, chronic respiratory diseases, and mental illness cause nearly three-quarters of deaths in the world and kill 41 million people every year. Some of the more striking findings:
* Every year 17 million people under age 70 die of noncommunicable diseases, 86% of whom live in low- or middle-income countries.
* Preventable risk factors include tobacco use, unhealthy diets, harmful use of alcohol, physical inactivity, and air pollution.
* NCDs cause 74% of all deaths, but interventions known to work could avert at least 39 million NCD deaths by 2030.
Cancer deaths in the United States are continuing to decline, according to a new report from the American Association for Cancer Research.
The report, published Wednesday, found that deaths from cancer have decreased by 2.3% every year between 2016 and 2019.
Overall, there has been a 32% reduction in the U.S. cancer death rate since 1991, which translates into approximately 3.5 million lives being saved, the report said.
Additionally, in 2022, there are more than 18 million cancer survivors living in the U.S., equivalent to 5.4% of the population, the report found. Fifty years earlier, there were just 3 million cancer survivors.
New results from a large prospective trial give a better idea of how a blood test that can detect multiple cancers performs in a “real-life” setting.
“As this technology develops, people must continue with their standard cancer screening, but this is a glimpse of what the future may hold,” commented study investigator Deborah Schrag, MD, MPH, chair, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York City.
The National Institutes of Health on Thursday announced more than $600 million in fresh funding for an expansive and ongoing push to unravel the mysteries of the human brain, bankrolling efforts to create a detailed map of the whole brain, and devise new ways to target therapeutics and other molecules to specific brain cell populations.
Scientists across the country are involved, from teams at the Salk Institute to Duke University to the Broad Institute of MIT and Harvard, among other places. If successful, they will help answer fundamental questions about the body’s most complex organ. What are all the cell types in the brain? How are they connected to one another? How do the workings of the brain change during disease, and what can we do about that?
So far, those questions have proven easier to ask than to answer, with researchers gleaning bits of information from individual studies, but the hope is that a broad-based effort will jump-start new revelations.
CVS Health is making progress toward its behavioral health goal of decreasing the suicide rate among Aetna members by 20 percent by 2025, but progress among adolescent members is lagging, the healthcare organization announced.
“Our members are not immune to the national suicide crisis reported by the CDC. Though we are on track lowering suicide attempts in adults, our goal will not be reached until we can say the same for adolescents,” said Sree Chaguturu, MD, executive vice president and chief medical officer at CVS Health.
The organization has been working toward this goal since 2017, its work running parallel to that of the American Foundation for Suicide Prevention (AFSP) which had the same goal.
As of March 2022, CVS Health saw suicide attempts among Aetna members drop by 15.7 percent when compared to the company’s 2019 rate.
CVS Health broke down the overall rate by age and found that the reductions were largely driven by decreases among members ages 18 and older. For individuals in this age range, suicide attempts dropped by 17.5 percent in 2021 and dropped another 34.1 percent through March 2022.
Having made progress toward the goal, however, the organization does not intend to slow down.
“We are doubling down on efforts to prevent suicide in teens by identifying those most at-risk and in need of intervention, reaching out to those discharged from the ER after a suicide attempt with resources and supporting parents and loved ones in prioritizing the mental health of their kids,” Chaguturu explained.
Specifically, Aetna saw an upward trend in suicide attempts among its adolescent members.
Members between the ages of 13 and 17 saw increases in suicide attempts. In 2021, the suicide rate among this population grew 43 percent. In the first three months of 2022, the suicide rate jumped another 32 percent.
“We are implementing evidence-based therapies and outreach programs to prevent suicidal ideation before it starts and get adolescents the clinical care they need when they are at risk,” said Cara McNulty, president of behavioral health and mental well-being at CVS Health. “Every suicide attempt prevented, life saved, and mental health resource sought is an important step to reducing death by suicide in the United States.”
Mazaal Tov to CVS Health for those successful and ongoing efforts.
The Society for Human Resources offers guidance on suicide prevention in the workplace.
From the No Surprises Act litigation front, STAT News explains
During a hearing yesterday, the Association of Air Medical Services indicated it was following in the footsteps of AHA and AMA and would likewise dismiss its claims now that the final rules are out. But the AAMS also said it was deliberating whether it would file a different lawsuit in a different court, while attorneys for AMA and AHA backpedaled and said they have no intentions of filing any new lawsuits anywhere.
Today we got some clarity when the Texas Medical Association filed a new lawsuit challenging the revised final independent dispute resolution rule issued in the summer. In addition, the American Hospital Association and the American Medical Association have announced that they are joining the case as friends of the court in support of the Texas Medical Association. The lawsuit was filed in the U.S. District Court for the Eastern District of Texas. And the beat goes on.
From the U.S. healthcare business front, the Wall Street Journal reports
The talks are serious and a deal to purchase Cano could be struck in the next several weeks, assuming the negotiations don’t fall apart, some of the people said. Cano shares, which had been down nearly 7%, turned positive and closed up 32% after The Wall Street Journal reported on the talks with Humana and other unnamed parties, giving the company a market value of roughly $4 billion.
Bloomberg subsequently reported CVS’s interest.
It couldn’t be learned which other potential buyers might be in the mix, but Cano could be Humana’s to lose as the health insurer has a right of first refusal on any sale, part of an agreement that was originally struck in 2019.
Miami-based Cano operates primary-care centers in California, Florida, Nevada, New Mexico, Texas, Illinois, New York, New Jersey and Puerto Rico, according to documentation from the company. It mainly serves Medicare Advantage members, a private-sector alternative to Medicare for seniors.
Healthcare startup Curative, best-known for providing COVID-19 testing, is introducing a health plan with no copays or deductibles.
The company is offering the new plan in the Austin, Texas, area, with plans to expand throughout Texas over the next year, Curative said Sept. 21. The announcement comes as the startup lays off 109 employees from its testing business in California.
In a news release, Fred Turner, co-founder and CEO of Curative, said the startup is on a mission to “drastically remake” the U.S. healthcare system.
“The only way to achieve true cost transparency is for all in-network services to be covered at $0 cost, so members actually know where they stand and can get the care they need without surprise bills or medical debt,” Mr. Turner said in the release.
According to the news release, Curative plan members will not owe any copay costs if they complete a baseline visit to evaluate preventive care and health literacy.
From the Postal Service front, Federal News Network reports
Postmaster General Louis DeJoy announced Wednesday that all Executive and Administrative Schedule (EAS) and Pay Band Non-bargaining unit employees will soon receive a 3% salary increase, “regardless of their current salary maximum.”
DeJoy, in a memo to USPS officers Wednesday, said the pay increase will go into effect Sept. 24 and will reflect on the employees’ Oct. 14 pay statement.
From Capitol Hill, Roll Call discusses the Senate Majority Leader’s plans for successfully passing the continuing resolution funding the federal government through December 16, 2022.
[I]n theory the tentative plan to start the process this Thursday could lead to a final Senate vote by next Friday, when the current fiscal year expires. It might even enable the House to take up the Senate-passed bill and clear it in time to beat the midnight deadline.
All that assumes everything goes according to plan and that there’s an acceptable stopgap funding package that can pass in both chambers. None of those details have been released, but top appropriators and other lawmakers said Wednesday there’s no talk yet of a very short-term CR to buy more time.
From the Omicron and siblings’ front —
Fierce Healthcare tells us about the possible blossoming of another Omicron variant BF.7
The Wall Street Journal reports on the rollout of nasal Covid vaccines in Asia “though just how effective they are remains to be seen.” These are adenovirus, not mRNA-based, vaccines. Nonetheless
Delivering a vaccine through the nose has the potential to build up a type of immune response known as mucosal immunity, or immunity in the upper airway tract, said David Curiel, professor of radiation oncology at Washington University School of Medicine who co-developed the Bharat vaccine. That is important because mucosal immunity could more effectively block infection and transmission of the coronavirus than the type of immunity induced by injected vaccines, he said.
In other virus news, Forbes offers an illuminating article by Gayle Smith, the CEO of the ONE Campaign, which fights to end extreme poverty and preventable disease. Ms. Smith writes on the emergence of polio.
The re-emergence of polio is worrisome, particularly considering the politicization of and uneven response to the Covid-19 pandemic. Panic, however, is unwise. What is needed is vigilance and vaccination coverage. Fortunately, there are millions of people who are living proof that polio vaccines work.
This is a moment when the world can do the right thing and eradicate a preventable disease. Since the mid-1950s, a concerted global effort has confined endemic polio to only two countries and proven that this is a virus we can defeat.
Going all the way is a moonshot and a win for the world. It is not without its challenges, of course. But it is far easier right now than defeating Covid, or malaria, or AIDS. One can only hope that ridding the world of a disease known as “infantile paralysis” might be something we can all agree on — if not for ourselves then for the children whose lives continue to be at risk.
Also, from the public health front, the National Institutes of Health helpfully informs us
In a large clinical trial that directly compared four drugs commonly used to treat type 2 diabetes, researchers found that insulin glargine and liraglutide performed the best of four medications approved by the U.S. Food and Drug Administration to maintain blood glucose levels in the recommended range. Blood glucose management is a key component of keeping people with type 2 diabetes healthy. All four medications evaluated were added to treatment with metformin, which is the first-line drug to treat type 2 diabetes. The trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health.
More than 37 million Americans have diabetes, and approximately 90 to 95% of them have type 2 diabetes. People with diabetes who keep their blood glucose levels in the near-normal range generally have a much lower risk of developing diabetes complications such as nerve, kidney, and eye diseases. Most people with type 2 diabetes require more than one medication to control blood sugar levels over time.
While there is general agreement among health care professionals that metformin combined with diet and exercise is the best early approach in diabetes care, there is no consensus on what to do next to best keep high blood glucose in check.
From the wellness front, Fierce Health relates that United Healthcare is expanding its relationship with exercise machine marker Peleton. As a result, UHC will be making Pelton’s fitness services available to as many as 10 million of its members.
From the federal compensation and benefits front
Govexec reports on locality pay developments, and Social Security changes that Congress may approve this year.
Reg Jones writing in FedWeek provides a personal story about federal survivor benefits worth a gander.