From Capitol Hill, Federal News Network discusses two bipartisan bills affecting federal hiring practices and federal retirement annuities that are under active consideration.
From the Postal Service Health Benefits Program front, it appears to the FEHBlog that OPM has been adding to its PSHBP FAQs without giving the public an online heads-up when an addition occurs, e.g., last updated xx/xx/xxxx.
From the public health front
The U.S. Preventive Services Task Force released for public comment a draft inconclusive (“I”) recommendation “that the current evidence is insufficient to assess the balance of benefits and harms of screening for lipid disorders in children and adolescents age 20 years or younger.” This proposed action would confirm the ongoing vitality of a 2016 recommendation. The public comment deadline is February 21.
The National Institutes of Health discusses its approach to “shouldering the burden of rare diseases.” NIH notes “While individually each disease is rare, collectively rare diseases are common: More than 10,000 rare diseases affect nearly 400 million people worldwide. In the United States, the prevalence of rare diseases (over 30 million people) rivals or exceeds that of common diseases such as diabetes (37.3 million people), Alzheimer’s disease (6.5 million people), and heart failure (6.2 million people).”
STAT News discusses legal developments in the FDA’s practices of approving “orphan drugs” to treat rare diseases. “In an unexpected move, the Food and Drug Administration will continue to apply exclusive marketing rights for so-called orphan drugs under its existing regulations, rather than take a broader approach suggested by a federal court in a highly controversial case involving one such medicine.”
Fierce Healthcare reports “The White House, federal agencies and lawmakers today marked the elimination of the DATA-Waiver Program, better known as the X-Waiver requirement, with calls for providers to begin incorporating opioid use disorder treatment buprenorphine in everyday patient care. The X-Waiver requirement only permitted doctors who had received specialized training and federal permissions to prescribe the opioid partial agonist, which is a controlled substance.”
From the Rx coverage front —
Segal Consulting offers plan sponsors its analysis of weight loss drugs to treat diabetes and obesity.
Fierce Healthcare tells us about Amazon’s new RxPass program and adds that Optum Rx “launched a new tool that aims to make it easier to compare the direct-to-consumer price for generic drugs to the price with insurance.” RxPass is not available to Medicare or Medicaid beneficiaries and “is not currently available to send medications to California, Louisiana, Maryland, Minnesota, New Hampshire, Pennsylvania, Texas, and Washington.”
From Capitol Hill, Roll Call reports that Senator Joe Manchin (D W Va) “has talked “briefly” with Speaker Kevin McCarthy about a bill he co-sponsored with Sen. Mitt Romney, R-Utah, in the last Congress to create a “rescue committee” for every endangered government trust fund, like the Social Security, Medicare and highway trust funds.
The Concord Coalition, a nonpartisan research group, named Romney and Manchin as its 2022 Economic Patriot Awards honorees because of their work on the legislation.
The bill, which they have yet to reintroduce in the 118th Congress, would allow the top four congressional leaders to appoint three members each for every rescue committee and give lawmakers on the panels 180 days to come up with policy solutions for solvency.
Any legislation the rescue committees produce would be subject to expedited procedures for floor consideration; it couldn’t be amended but would require 60 Senate votes to advance to final passage.
Moderna Inc. plans to expand its mRNA vaccine production capacity, saying shots targeting different pathogens can be made in the same facility, Chief Executive Stephane Bancel said.
“This is what gives me hope, not only for [coronavirus] variants, but also for other vaccines,” Mr. Bancel said on a panel at the World Economic Forum in Davos, Switzerland. * * *
The company was able to roll out booster shots adapted to the Omicron variant in 60 days, according to Mr. Bancel.
That would be helpful assuming the FDA and CDC are on board.
The Centers for Disease Control and Prevention yesterday released a dashboard tracking hospitalization rates for laboratory-confirmed COVID-19, flu and Respiratory Syncytial Virus by age group, sex, race/ethnicity, state and season based on data from select counties in 13 states, which the agency will update weekly. CDC also released another dashboard tracking weekly emergency department visits for COVID-19, flu and RSV by age group and percent of all ED visits based on data from the National Syndromic Surveillance Program.
In other vaccine news, the National Institutes of Health announced today
An investigational HIV vaccine regimen tested among men who have sex with men (MSM) and transgender people was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined. The HPX3002/HVTN 706, or “Mosaico,” Phase 3 clinical trial began in 2019 and involved 3,900 volunteers ages 18 to 60 years in Europe, North America and South America. Based on the DSMB’s recommendation, the study will be discontinued. Participants are being notified of the findings, and further analyses of the study data are planned.
Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, sponsored the Mosaico study with funding support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial was conducted by the NIAID-funded HIV Vaccine Clinical Trials Network, based at the Fred Hutchinson Cancer Research Center in Seattle. The U.S. Army Medical Research and Development Command provided additional study support.
Keep trying.
Also from the public health front
Gallup informs us “The percentage of Americans reporting they or a family member postponed medical treatment in 2022 due to cost rose 12 points in one year, to 38%, the highest in Gallup’s 22-year trend.” The story concludes
With high inflation creating moderate to severe hardship for a majority of Americans in the second half of 2022, their reports of delaying medical care in general due to cost — as well as delaying care for a serious condition — rose sharply to new highs. Young adults, those in lower-income households and women were especially likely to say they or a family member had put off medical care.
No bueno.
From the U.S. healthcare business front, McKinsey & Co. tells us
From the Medicare front, Fierce Healthcare relates
Enrollment in Medicare Advantage (MA) has topped 30 million, according to new data from the Centers for Medicare & Medicaid Services.
This represents coverage across 776 contracts, according to the data, as of Jan. 1 payments, which reflect enrollments accepted through Dec. 2. Enrollment in standalone prescription drug plans was also about 22.7 million, bringing total enrollment across all types of private Medicare plans to nearly 50.3 million.
This represents growth of about 2 million from 2022. An analysis from the Kaiser Family Foundation found that enrollment in MA plans was about 28 million last year.
From the public health front, the Wall Street Journal reports
The cancer mortality rate in the U.S. has dropped by a third in the past three decades, a report showed, but an increase in advanced prostate cancer diagnoses threatens to reverse some hard-won gains.
The American Cancer Society said Thursday that changes in preventive measures and screening in the past decade drove important trends in U.S. cancer incidence and outcomes. Cervical cancer rates dropped 65% from 2012 to 2019 among women in their early 20s after a generation of young women were vaccinated against human papillomavirus, or HPV, for the first time.
But a decline in the use of a controversial test for prostate cancer likely led to more men getting diagnosed at later stages, the report found, with the highest incidence and mortality among Black men. The ACS said it would invest in research on prostate cancer and programs to boost access to quality screening and treatment.
“There’s a significant call to arms,”said Karen Knudsen, ACS’s chief executive officer. “We are not catching these cancers early when we have an opportunity to cure men of prostate cancer.”
The report was published in the journal CA: A Cancer Journal for Clinicians. The authors at ACS analyzed federal and state cancer registries for data on cancer rates through 2019 and federal mortality data through 2020, the report said.
From the Omicron and siblings front, Bloomberg Prognosis tells us
The effects of long Covid tend to resolve within a year of mild infection, with vaccinated people at lower risk of breathing difficulties compared with unvaccinated people, according to a study.
Researchers examined the health records of almost 2 million people in Israel who tested for Covid-19 over a 19-month period. Over 70 long Covid conditions were analyzed within a group of infected and matched uninfected members. They also compared conditions in vaccinated versus unvaccinated people.
Their study published in the BMJ medical journal found most symptoms that developed after a mild infection lingered for several months, but returned to normal within a year.
“The long Covid phenomenon has been feared and discussed since the beginning of the pandemic,” the researchers wrote. “This nationwide dataset of patients with mild Covid-19 suggests that mild disease does not lead to serious or chronic long term morbidity.”
Previous studies have indicated that vaccination tends to lead to milder cases of Covid infection and long Covid
Medicare officials have taken a step toward making a cutting-edge cancer treatment called CAR-T cell therapy available in doctor offices, in anticipation of the procedure being used for increasingly common cancer types.
CAR-T is a relatively new medical procedure that uses a person’s own cells to fight their cancer, and it offers hope of a cure for those who have run out of options. It’s a complex procedure with a lot of serious side effects that must be closely monitored, so it’s typically provided at hospitals in the inpatient setting, sometimes outpatient, and almost never in doctor offices.
There are multiple barriers to offering CAR-T cell therapies in doctor offices, according to James Essell, medical director of the Blood Cancer Center at OHC and chair of cellular therapy for the US Oncology Network, a large network of independent doctors that includes OHC. Insurers restrict coverage to facilities that specialize in the procedure, and it’s financially risky for practices. Treating a few patients would require a practice to shell out well more than $1 million for the drugs alone, and the process of getting paid is arduous and not guaranteed, Essell said. * * *
Since the first CAR-T drug, Novartis’ Kymriah, was approved in 2017, the procedure has primarily been available at major academic hospitals. That puts the treatments out of reach for patients who don’t live near those facilities. Essell said less than 20% of patients who are eligible for the treatments are able to get them. Physician practices could help make the treatment available to the other 80%.
“You really need to get this out of the university centers to allow more patients to receive this care,” he said.
Mercer Consulting discusses strategies for providing access to and managing the cost of highly expensive gene therapies.
The second half of 2022 was marked by significant activity in the gene therapy market, with several landmark FDA approvals, including Hemgenix, a $3.5M gene therapy indicated for treatment of Hemophilia B. With this hefty price tag, Hemgenix wins the title of most expensive drug in the world, knocking down the previous title holder, the $2.1M gene therapy called Zolgensma, indicated for spinal muscular atrophy. * * *
As Hemgenix and other high-cost gene therapies enter the market, employers should create a long-term comprehensive approach to managing these therapies from a clinical and cost perspective by exploring a broad spectrum of strategies. A key first step in tailoring strategies specific to your plan involves assessing the likelihood of these claims occurring in your plan’s population; ideally, such assessments should be conducted on a regular basis as the member population changes. Once you get a better understanding of your unique population and the potential risk for these claims, inventory and evaluate available vendor strategies for gaps and opportunities. This step may include reviewing your medical carrier’s utilization management programs, network strategy, and care management programs, checking for availability of outcomes-based reimbursement and other payment models, and exploring alternative approaches to funding these claims. Lastly, as the market continues to evolve, regularly engage with your medical and pharmacy vendor on availability of new strategies.
The Centers for Medicare & Medicaid Services yesterday released a memo and timeline outlining how it will approach implementing the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, which will negotiate prices with drug makers for certain high-cost, sole-source drugs and apply them beginning in 2026. According to the memo, CMS plans to actively engage hospitals and other stakeholders in the policymaking process.
From the medical research front, the National Institutes of Health discusses an ongoing study on the use of deep brain stimulation to treat severe opioid addiction.
From the litigation front, a divided panel of the U.S. Court of Appeals for the Sixth Circuit today upheld a lower court’s preliminary injunction of the federal government’s government contractor mandate but similar to the approach taken by the 5th Circuit limited the scope of the protection of the injunction to the plaintiffs, here the States of Kentucky, Ohio, and Tennessee. For more information, here’s the Volokh Conspiracy article on the decision. The 5th, 6th, and 11th Circuits have all ruled against the government contractor mandate, which the Safer Federal Workforce Task Force has put on ice.
From the FEHB front, Federal News Network provides an update on the GAO report on FEHB that was mentioned in yesterday’s post.
The Office of Personnel Management, the agency that runs the health insurance program for federal employees and retirees, does not have a clear way to identify and remove FEHB enrollees’ family members who are erroneously part of the program, according to the Government Accountability Office.
“The longer OPM delays its efforts to establish a monitoring mechanism to identify and remove ineligible members from FEHB, the more ineligible members and related improper payments in the program may continue to accrue, costing the program millions, or up to approximately one billion dollars per year, according to OPM’s own estimate,” GAO said in a Jan. 9 report.
OPM said it has received the final report and is planning to flesh out a larger response soon.
OPM’s Healthcare and Insurance Office “will be evaluating potential action items, including timelines, and will provide a comprehensive response to GAO within 180 days upon evaluation of the recommendations,” OPM spokesperson Viet Tran told Federal News Network.
From the public health front,
January is Cervical Cancer Awareness Month, and Patient Engagement HIT tells us
Nearly one in 10 women have never had a common cervical cancer screening, like a Pap test, with issues such as limited health literacy and poor access to care getting in the way, according to a Harris Poll conducted on behalf of BD (Becton, Dickinson and Company).
These trends are more common in racial minorities, with Black and Hispanic women being more likely to say they have never had a Pap test. Compared to the 6% of White women who said they’ve never had a Pap test, 12% of Hispanic women and 13% of Black women said the same. * * *
receipt of Pap tests is extremely low, the survey of 872 women ages 18 to 64. Overall, 71 percent of respondents have delayed getting a Pap test, with 15 percent saying their last OB/GYN check-up was three years ago.
Although not explicitly explored in the survey, it’s key to note that timeline aligns with the outbreak of the COVID-19 pandemic when access to primary and preventive care stalled. * * *
The good news is, around three-quarters of all respondents, regardless of race, said they have resolved to get back on track with their primary and preventive care, including Pap tests and HPV screenings, in the new year.
But doing so will require some leg work from the healthcare industry, which should note some patient health literacy and convenient care access snags getting in the way.
Even though nearly every respondent said they are knowledgeable about women’s health (91 percent), a whopping 81 percent admitted they don’t know how often they should get a Pap test and 51 percent said they were unaware of how often they should get an HPV test.
The survey also found consumer support for an at-home screening test. Kaiser Permanente and MD Anderson Center offer their views on at-home screening, and MD Anderson reminds us
The best protection for both men and women against HPV and related cancers[, i.e. cervical cancer,] is the HPV vaccine. All males and females ages 9-26 should get the HPV vaccine. It is most effective when given at ages 11-12. Unvaccinated men and women ages 27-45 should also talk to their doctor about the benefits of the vaccine.
Adhering to healthy eating patterns was associated with lower risk of total and cause-specific mortality, a prospective cohort study with up to 36 years of follow-up showed.
Among 75,230 women from the Nurses’ Health Study and 44,085 men from the Health Professionals Follow-up Study, those who scored in the highest quintile for healthy eating patterns recommended by the Dietary Guidelines for Americans (DGAs) had a 14% to 20% lower risk of total mortality versus those in the lowest quintile, reported Frank Hu, MD, PhD, of the Harvard T.H. Chan School of Public Health in Boston, and colleagues in JAMA Internal Medicine opens in a new tab or window.
The pooled multivariable-adjusted hazard ratios of total mortality with four healthy eating patterns were (P<0.001 for trend for all):
Healthy Eating Index 2015 (HEI-2015): HR 0.81 (95% CI 0.79-0.84)
Alternate Mediterranean Diet (AMED): HR 0.82 (95% CI 0.79-0.84)
Healthful Plant-Based Diet Index (HPDI): HR 0.86 (95% CI 0.83-0.89)
Alternate Healthy Eating Index (AHEI): HR 0.80 (95% CI 0.77-0.82)
This lower risk was consistent across all racial and ethnic groups.
NIH’s NIAAA Director provides tips for a successful dry January. Good luck to all those who made this resolution because
Taking a break from alcohol for an entire month provides one with an opportunity to assess their patterns of alcohol consumption and how it affects them physically and mentally. It gives a person a chance to cultivate alternatives for relaxing, socializing, and coping with stress. As a result, many people experience benefits such as improved sleep and waking without the fatigue, malaise, and upset stomach of a hangover. Some also find that without the extra calories due to alcohol they lose weight. Participants in Dry January also describe positive effects on their relationships. And an added bonus is saving money.
Becker’s Hospital Review provides some geographic details on the current winter’s Covid surge.
The National Institutes of Health announced “The antiviral treatment Paxlovid reduced the risk of hospitalization or death from SARS-CoV-2 Omicron variants in older adults by 44%. Wider use of Paxlovid may help temper a winter surge of COVID-19, as some other treatments are no longer effective.”
Politico reports on progress being made to end the Covid public health emergency later this year.
From the Food and Drug Administration front,
STAT News interviews the FDA Administrator Robert Califf on the Congressional investigative report concerning the Aduhelm fiasco.
The FDA announced that “In 2022, the Center for Drug Evaluation and Research approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs, as noted in our annual New Drug Therapy Approvals report. We also approved drugs in new settings, such as for new uses and patient populations.”
From the Rx coverage front, Drug Channels delves into major prescription benefit manager formulary exclusions lists for 2023.
From the medical research front, the National Institutes of Health announced, “Researchers developed a blood test that could detect Alzheimer’s disease-promoting compounds in the blood long before symptoms emerged. The findings may lead to early diagnostic tests for Alzheimer’s and other neurodegenerative diseases.”
From the U.S. healthcare business front
Fierce Healthcare’s lead article on the ongoing JP Morgan healthcare conference concerns CVS’s Heath’s foray into primary care.
Healthcare Dive adds, “CVS Health is exploring an acquisition of value-based primary care chain Oak Street Health, according to a Monday Bloomberg report. The two are in ongoing talks and could reach a deal within weeks that values Oak Street at more than $10 billion including debt, according to Bloomberg, which cited sources familiar with the matter a deal.”
Healthcare Dive informs us that “Teladoc Health shared an early look at its financial results at JPMorgan’s healthcare conference on Monday, indicating between $633 million and $640 million in revenue for the fourth quarter, a little higher than consensus estimates from analysts. The virtual care giant projected total 2022 revenue between $2.4 billion and $2.41 billion, according to its regulatory filing. Teladoc’s direct-to-consumer mental health unit, BetterHelp, is expected to contribute roughly $1 billion of that topline.”
STAT News reports, “Rising labor costs have been the main financial concern for hospitals over the past year, but those costs have peaked and are now a lot lower, according to hospital system executives who presented during the J.P. Morgan Healthcare Conference.”
From the post-Dobbs front, STAT News tells us about telehealth provider reactions to the Justice Department’s announcement last week permitting abortion drugs to be sold by mail and the FDA’s opportunity for pharmacies to sell those drugs.
From the Supreme Court front, STAT News relates
The U.S. Supreme Court rejected a bid by Pfizer to use a copay-assistance program to help Medicare beneficiaries pay for an expensive heart drug. The company argued the program would not violate kickback laws, a controversial issue that forced numerous drugmakers to pay large fines. Last July, an appeals court panel upheld a lower court ruling that such programs would violate federal law, but Pfizer filed a petition to the Supreme Court that contended such interpretations are “staggeringly overbroad.” Pfizer maintained there was no “corrupt intent” in offering assistance and that Medicare beneficiaries would be denied needed medicines they would otherwise not be able to afford.
Mercer Marsh Benefits presents the top five trends from its 2023 employer-sponsored health plan survey of 225 insurers located in 56 countries:
Per-person medical cost increases are back to pre-pandemic levels. 68% of insurers expect plan sponsors to prioritize improvements. This is even though double-digit medical cost increases are forecast for some markets.
COVID-19 continues to impact the claims experience. 55% of insurers report an increase in the later-stage illness diagnosis due to deferred care.
Plan modernization has begun. To make coverage more inclusive for those who identify as LGBTQ+, one in two insurers have changed or expect to change eligibility requirements and eligible expenses.
The mental health gaps persist. 16% of insurers report not providing plans that cover mental health services (versus 26% in 2022).
Plan management requires greater rigor. More than one in five insurers in Asia are adjusting their medical plan premiums based on an individual’s COVID-19 vaccination status.
All five main points ring true, but the prime examples for the fourth and fifth points don’t fit the FEHB market.
The American Medical Association points out six often overlooked steps to better health while Rebecca G. Baker, Ph.D., the director of the NIH HEAL Initiative®looks back at a virtual stakeholder briefing to visit the initiative’s progress in resolving chronic pain and opioid misuse issues and to describe future plans.
From the public health front, the New York Times reports about
a large study published on Tuesday found a surprising trend among adolescents who repeatedly visited the hospital. The patients most likely to reappear in emergency rooms were not patients who harmed themselves, but rather those whose agitation and aggressive behavior proved too much for their caregivers to manage.
In many cases, repeat visitors had previously received sedatives or other drugs to restrain them when their behavior became disruptive. * * *
The results suggest that researchers should focus more attention on families whose children have cognitive and behavioral problems, and who may turn to emergency rooms for respite, Dr. [Anna] Cushing [an author of the study] said.
“I’m not sure we’ve been spending as much time talking about these agitated and behaviorally disregulated patients, at least on a national scale,” she said.
The JAMA study found that overall visits to pediatric emergency rooms for mental health crises increased 43 percent from 2015 to 2020, rising by 8 percent per year on average, with an increase in emergency visits for every category of mental illness. By comparison, emergency room visits for all medical causes rose by 1.5 percent annually.
Nearly one-third of visits were related to suicidal ideation or self-harm, and around one-quarter of patients presented with mood disorders, followed by anxiety disorders and impulse control disorders. Around 13 percent of patients made a repeat visit within six months.
There are few things more stressful than getting a serious medical diagnosis, but pandemic-era changes in virtual care are prompting more patients to obtain a second opinion without leaving home.
Why it matters: The telehealth explosion made it easier to get advice from top doctors across the country — and for health systems to grow business beyond their physical footprints and even treat some of the people seeking consultations.
Case in point: The Clinic, a joint venture between Cleveland Clinic and telehealth giant Amwell, launched in 2020 just before the pandemic began.
The idea was to pair the Cleveland Clinic brand with Amwell’s virtual tools and its existing connections with private insurers to make it easier for patients to get their records reviewed, said Frank McGillin, CEO of The Clinic.
In litigation news, Health Payer Intelligence relates
A United States district court has ruled against Blue Cross Blue Shield of Illinois (BCBSIL), stating that the payer cannot exclude coverage for medically necessary gender-affirming care in its employer-sponsored ERISA health plans.
Lambda Legal and Sirianni Youtz Spoonemore Hamburger PLLC filed a class action lawsuit against BCBSIL on behalf of a 17-year-old transgender man, CP, and his parents. According to the lawsuit, the payer administered discriminatory exclusions of gender-affirming care, violating the anti-discrimination of the Affordable Care Act (ACA), known as Section 1557. * * *
The court determined that BCBSIL is a “health program or activity” that receives federal funds and thus cannot discriminate based on race, national origin, sex, age, or disability in its role in administering ERISA health plans.
From Capitol Hill, the American Hospital Association tells us
The Senate today passed (68-29) an amended version of the $1.7 trillion omnibus appropriations bill that funds the federal government through the end of the current fiscal year. The legislation also includes many provisions affecting hospitals and health systems.
The Senate also passed another short-term continuing resolution through Dec. 30 to allow time for the more than 4,000-page legislation to be enrolled and for President Biden to sign it. This ensures there will be no interruption of services or federal shutdown.
The omnibus spending bill, which includes relief from Medicare cuts and extensions of rural and telehealth programs, as well as the Dec. 30 continuing resolution, now go to the House, which is expected to consider them today . The president is expected to sign the short-term continuing resolution before current funding for the government expires at 11:59 p.m. ET on Dec. 23, and to sign the omnibus later next week.
The Wall Street Journal adds, “House Majority Leader Steny Hoyer (D., Md.) said the House would vote on the bill Friday.”
In other 2023 Consolidated Appropriations Act or omnibus news
The Hill reports on “last minute” changes to the omnibus, including provisions assisting nursing and pregnant workers.
Mercer Consulting alerts us to a two-year-long extension of telehealth flexibilities available to high deductible plans with health savings accounts.
Think Advisor and the Wall Street Journal provide an overview of the Secure 2.0 Act provisions in the omnibus. The Secure 2.0 Act affects 401(k) plans offered to employees and IRAs. The key provision that takes effect for 2023 is an increase in the required minimum distribution age from 72 to 73.
The Wall Street Journal reviews the other omnibus provisions affecting businesses.
While the respiratory “tripledemic” continues to slam emergency rooms and children’s hospitals, there are two glimmers of hope on the horizon, according to a Dec. 22 report in The New York Times.
COVID-19, the flu and respiratory syncytial virus attack the body in different ways, and there are varying levels of disease severity across the U.S. Today, some scientists say RSV has peaked in most parts of the country.
“I think it’s likely that the RSV season has peaked in most parts of the country,” said Virginia Pitzer, ScD, an infectious disease epidemiologist at New Haven, Conn.-based Yale School of Public Health. “I think that there is a light at the end of the tunnel.”
Additionally, there’s reason to believe next winter won’t be as burdensome for the American population and healthcare organizations.
Ironically, the safety precautions used to help stem the pandemic in the past couple of years have also kept adults and children from being exposed to the viruses that typically circulate this time of year, said Dr. Pitzer.
“There was a bit of a buildup of susceptibility at the population level,” she added. “It’s a worse than normal winter, but one that hopefully will not be repeated next year.”STS
The Society for Healthcare Epidemiology of America today recommended hospitals and health systems no longer routinely screen symptom-free patients for COVID-19 upon admission or before procedures and rely instead on enhanced layers of infection prevention interventions.
“The small benefits that could come from asymptomatic testing at this stage in the pandemic are overridden by potential harms from delays in procedures, delays in patient transfers, and strains on laboratory capacity and personnel,” said Thomas R. Talbot, M.D., MPH, the chief hospital epidemiologist at Vanderbilt University Medical Center, and a member of the SHEA Board of Directors. “Since some tests can detect residual virus for a long period, patients who test positive may not be contagious.”
[According to a CDC report, a] baby born in the U.S. in 2021 has a life expectancy of 76.4 years, down from 77 years in 2020 and the lowest level the CDC has recorded since 1996. The age-adjusted death rate for Covid rose by 22.5% between 2020 and 2021, while death rates from unintentional injuries — one-third of which come from overdoses — rose by 12.3%.
HHS’s Agency for Healthcare Quality and Researched refreshed its Healthcare Cost and Utilization Project Fast Stats website. The site provides “summary statistics on inpatient stays, emergency department visits, and priority topics, by select characteristics.”
From the OPM front, OPM’s medical director, Dr. Ron Kline announced today on Linked In that he is leaving OPM to take a new position beginning January 17, 2023 as
the Chief Medical Officer of the Quality Measurement and Value-Based Incentives Group (QMVIG) at the Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS).
QMVIG is responsible for developing, evaluating and supporting the implementation of quality measurement programs across the entire federally-supported health care continuum. This includes Medicare’s Quality Payment Program and the Inpatient (i.e. Hospital) Quality Reporting Program. These measures and policies guide these innovative programs to improve healthcare quality for all Americans.
Best wishes, Dr. Kline, and thanks for your work with the FEHB over the past 3 1/2 years.
From the Rx coverage and medical research fronts –
The Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday.
The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 per year. ICER’s calculations, which could change in response to public comment over the next month, are based on metrics meant to quantify the value of improvements to quality of life.
Eisai, which is leading the effort to commercialize lecanemab, has not disclosed how much it will charge for the medicine, saying only that it will prize affordability and access. That will soon change, as the drug, a twice-monthly infusion, is expected to win a preliminary Food and Drug Administration approval by Jan. 6. * * *
Lecanemab’s safety has come into sharp focus over the past two months after three patients died of major brain bleeds.
The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of etranacogene dezaparvovec (Hemgenix, CSL Behring,) for hemophilia B. ICER also updated the previous Hemophilia A assessment on valoctocogene roxaparvovec (Roctavian™, BioMarin).
Key recommendations stemming from the roundtable discussion include:
The value of high-impact single and short-term therapies should not be determined exclusively by estimates of long-term cost offsets, particularly when the existing standard of care is acknowledged to be priced significantly higher than reasonable cost-effective levels.
Payers should work with manufacturers to develop and implement outcomes-based agreements to address the uncertainty and the high cost of gene therapies for hemophilia.
At least one national payer has suggested to patient representatives that step therapy with emicizumab is being considered prior to provision of coverage for Roctavian. Clinical experts and patient experts view this approach as lacking any clinical justification and appears to be only a method for trying to avoid the high one-time fee for gene therapy while assuming that patients may switch insurers before the cost-saving potential of gene therapy is fully realized. In short, step therapy does not appear to be a reasonable consideration for this treatment.
ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.
Scientists used patient stem cells and 3D bioprinting to produce eye tissue that will advance understanding of the mechanisms of blinding diseases. The research team from the National Eye Institute (NEI), part of the National Institutes of Health, printed a combination of cells that form the outer blood-retina barrier—eye tissue that supports the retina’s light-sensing photoreceptors. The technique provides a theoretically unlimited supply of patient-derived tissue to study degenerative retinal diseases such as age-related macular degeneration (AMD).
If you haven’t yet tried ChatGPT, OpenAI’s new artificial-intelligence chatbot, it will blow your mind. Tell the bot to write you anything—an email apologizing to your boss, an article about the world’s richest hamster, a “Seinfeld” script set in 2022—and it spits out text you’d think was written by a human. Knowledge of the topic, proper punctuation, varied sentence structure, clear organization. It’s all there.
From Capitol Hill, the Wall Street Journal reports
The Senate passed an $858 billion defense-policy bill [National Defense Authorization Act] on Thursday that authorizes U.S. military leaders to purchase new weapons and would increase pay for service members, checking a major item off Congress’s year-end to-do list.
The House passed the legislation last week with 350 votes in favor and 80 votes against. It now goes to President Biden’s desk for his signature.
The Journal also provides information on the NDAA’s key provisions.
The Senate late Thursday approved a measure to fund the government through Dec. 23, securing a one-week deadline extension that gives Democrats and Republicans one final opportunity to work out a longer-term spending deal.
The 71-19 vote — coming a day after the House adopted it — sends the stopgap to President Biden and staves off a federal government shutdown that otherwise would have occurred after midnight this Friday.
From the Omicron and siblings front, the American Hospital Association informs us,
The Department of Health and Human Services today recommended governors take certain actions to prepare for a potential further increase in COVID-19 cases and hospitalizations this winter, and has pre-positioned N-95 masks, gloves, gowns and ventilators at strategic locations should states need them, the Biden Administration announced.
The Administration also announced that all U.S. households can now order four more free at-home COVID-19 tests, which will begin shipping the week of Dec. 19.
The number of U.S. deaths dropped this year, but there are still more than there were before the coronavirus hit.
Preliminary data — through the first 11 months of the year — indicates 2022 will see fewer deaths than the previous two COVID-19 pandemic years. Current reports suggest deaths may be down about 3% from 2020 and about 7% vs. 2021.
The percentage of adolescents reporting substance use in 2022 largely held steady after significantly declining in 2021, according to the latest results(link is external) from the Monitoring the Future survey(link is external) of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States. Reported use for almost all substances decreased dramatically from 2020 to 2021 after the onset of the COVID-19 pandemic and related changes like school closures and social distancing. In 2022, reported use of any illicit drug within the past year remained at or significantly below pre-pandemic levels for all grades, with 11% of eighth graders, 21.5% of 10th graders, and 32.6% of 12th graders reporting any illicit drug use in the past year.
The Monitoring the Future survey is conducted each year by researchers at the University of Michigan, Ann Arbor, and funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
From the Rx coverage front –
BioPharma Dive takes a “deep dive” reporting on a recently approved drug called to treat ALS or Lou Gehrig’s disease. “Amylyx Pharmaceuticals’ Relyvrio is in high demand in clinics across the U.S. Though some patients are already getting it, insurance and out-of-pocket costs remain a source of anxiety. * * * In the clinical trial that led to its approval, Relyvrio appeared to slow the functional decline associated with ALS. The trial also found patients treated with the drug lived a median of five months longer than those given a placebo. While Relyvrio’s benefits have been called modest, the drug has become a vital source of hope for many ALS patients.”
Yet another competitor for the top-selling inflammatory disease drug Humira will be waiting in the wings after Fresenius Kabi won U.S. approval of its copycat version called Idacio.
The Food and Drug Administration cleared the medicine for all the eligible indications of Humira, Fresenius Kabi said Wednesday. Due to a previous patent settlement with AbbVie, the company won’t launch Idacio in the U.S. until July.
Idacio, developed by Fresenius Kabi SwissBioSim, is currently available in 37 countries after initially launching in 2019. Fresenius Kabi said it has made selling biosimilars worldwide a priority.
Health Affairs Forefront offers Parts 1 and 2 of its insights on drug pricing reform enacted this past summer’s federal budget reconciliation act.
From the regulatory front
The FEHBlog noticed that the HHS press release concerning the 2024 Medicare Part D proposed rule (posted yesterday) lacked links to the proposed rule and the fact sheets. So here are the missing links:
Health Affair’s Forefront’s second article on Monday’s proposed 2024 ACA benefit and payments parameter rule is here. This article concerns risk adjustment.
From the telehealth front, Health Payer Intelligence relates that
Most patients who had a telehealth visit didn’t need an in-person follow-up appointment in the next three months, according to new research from Epic. The trend was reflected in almost every specialty included in the study.
For specialties that required follow-ups, the additional visits were likely due to patients needing additional, not duplicative, care, Epic researchers said. That’s because high follow-up rates were only present in specialties that require regular hands-on care, such as obstetrics and surgery.
The study is the latest addressing whether telehealth results in duplicative care, instead of replacing an in-person encounter. The question is being debated by lawmakers as they consider how much telehealth flexibility should be allowed once the COVID-19 public health emergency expires.
ElliQ, [which is] a voice-operated care companion for the elderly, is getting an update with 2.0 hardware and software including a companion app for family members and caregivers.
The robot, called the first proactive AI care companion and a Time Best Invention of 2022, was developed to address the loneliness epidemic in older adults and has shown the ability to decrease loneliness by 80%, according to the company. * * *
Interventions like the ones ElliQ performs are shown to improve the quality of life for seniors living alone by 80% through increasing fitness and facilitating social connections, according to a recent McKinsey report.
The first ElliQ impact studies have shown that 80% of users report a reduction in loneliness, 82% experienced better mental health and 90% feel overall better since using the robot.
From the Federal employee benefits front, Fedweek offers year-end benefits and tax guidance to federal and postal employees and annuitants.
From the medical research and development front,
STAT News reports, “A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab, according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it.”
The protein apolipoprotein E (APOE) plays a key role throughout the body. It helps to transport cholesterol and other fatty molecules, or lipids. The gene that produces APOE comes in a few different varieties. The most common is called APOE3.
The most notorious is APOE4, which has long been linked to an increased risk of dementia in Alzheimer’s disease. People who inherit one copy of the APOE4 gene have up to a fourfold greater risk of developing Alzheimer’s disease dementia. Inheriting two copies of APOE4 elevates the risk up to twelvefold. But despite years of study, scientists have little understanding of how APOE4 affects the human brain and boosts dementia risk. * * *
[NIH] Researchers found evidence that the Alzheimer’s-related gene APOE4 disrupts cholesterol management in the brain and weakens insulation around nerve fibers.
A drug that affects cholesterol led to improved learning and memory in mice with the gene, pointing to a potential new approach for treating dementia in Alzheimer’s disease.
New research has bolstered a once-gutsy idea: Bugs in the digestive system may play a role in depression.
Two studies published Tuesday in the journal Nature Communications found a link between several types of bacteria in the gut and depressive symptoms. Trillions of microorganisms including bacteria, fungi and yeast live in the digestive tract. Research exploring whether they might affect an array of diseases has increased in recent years.
The new studies, conducted among thousands of people in two cities in the Netherlands, are among the largest to date demonstrating potential associations between gut microbiota and mental health.
“Ten years ago if you’d said there was something linking depression and the microbiome, you’d be carried out with a straitjacket,” said Jos Bosch, an associate professor of psychology at the University of Amsterdam who co-wrote both studies. “Now absolutely, it’s very clear there’s a link.”
. . . Researchers who conducted the studies in the Netherlands called their findings a preliminary step toward identifying biological indicators and therapies for depression. The precise relationship between depression and microbes in the gut couldn’t be determined, they said. Depression can cause a person to eat less healthily, Dr. Bosch pointed out, which can lead to changes in the composition of microorganisms in the gut.
“Causality is a bit up in the air,” he said.
From the mental healthcare front, Fierce Healthcare tells us
While mental health and substance abuse issues have only grown thanks to the pandemic, a bright spot may be forming: The number of providers available to treat these concerns is increasing, a new study shows.
The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual “America’s Health Rankings” report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%.
In 2020, 13.2% reported frequent mental distress, and that rose to 14.7% in 2021, according to the report.
At the same time, drug-related deaths spiked. The report found that deaths increased by 20% nationwide between 2019 and 2020, reaching 27.9 deaths per 100,000. This is the largest year-over-year increase in more than a decade, according to the report.
The report also found that disparities within drug deaths increased in tandem. Such deaths increased by 45% among multiracial populations and by 43% among Black populations. Drug-related deaths were highest among American Indian/Alaskan Native populations, occurring at a rate nine times higher than the lowest group, Asian patients.
However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.
There are now 305 mental health providers per 100,000, according to the report.
Having one or more outpatient behavioral health treatment (OPBHT) visits was associated with lower healthcare costs among patients with newly diagnosed behavioral health conditions, a JAMA Network Open study found.
Adults with a behavioral health condition incur 2.8 to 6.2 times greater medical costs than those without one, and nearly a quarter of adults had a behavioral health condition as of 2018. However, behavioral health condition diagnoses are often delayed, and most individuals receive little or no treatment each year.
During 2021, drugmakers substantially raised prices on seven widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $805 million last year, according to a new report.
The drug for which spending increased the most due to a price increase was Xifaxan, which is used to treat both irritable bowel syndrome and a complication of cirrhosis. Salix Pharmaceuticals, a unit of Bausch Health, raised the wholesale price by 7.9%. The net price — after rebates and discounts — rose by 12%, most likely because the company offered fewer concessions than previously.
Consequently, spending for this drug climbed by $174.7 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost effectiveness of medicines. The report noted that the manufacturer disputed the net price and budget impact, which was provided by the SSR Health market research firm, but did not provide corrected estimates.
Of course, PBM formularies are designed to correct these issues.
Emergent BioSolutions Inc., maker ofNarcan, a nasal-spray form of naloxone, said Tuesday that the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray.
The company said it had been working on the application for several months. Emergent said the FDA’s priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of competitors that have announced their planned foray into the market.
The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of overdose-reversal medications such as Narcan to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.
Last week, FDA Commissioner Robert Califf said naloxone—which binds to opioid receptors to reverse the effects of opioids—should be as ubiquitous as defibrillators.
From the fraud, waste, and abuse front, mHealth Intelligence reports
As telehealth use exploded across healthcare programs provided by federal agencies, a report by a watchdog committee shows several program integrity risks linked to telehealth billing, including duplicate billing and ordering unnecessary durable medical equipment or laboratory tests.
They found that approximately 37 million individuals used telehealth services from March 2020 through February 2021 in the selected programs administered by the six federal agencies. This represents a massive increase from the 3 million individuals in these programs who used telehealth services the year prior.
In most programs, telehealth was used primarily to access office visits with a primary care provider or specialist and for behavioral health services, like individual and group therapy and substance use disorder treatment.
Overall, the agencies spent more than $6.2 billion on telehealth services, with Medicare accounting for the highest expenditure at $5.1 billion, followed by TRICARE and the Federal Employees Health Benefits Program, which together spent $1 billion.
But the OIGs found several similar program integrity risks associated with billing for telehealth services across multiple programs. These included “upcoding” telehealth visits by billing for visits longer than they lasted, duplicate billing for the same service, ordering unnecessary durable medical equipment, supplies, or laboratory tests, and billing for services inappropriate or ineligible for telehealth.
From the plan design front, Fierce Healthcare relates
The Biden administration released a proposal which, if finalized, would mandate Medicare Advantage (MA), Medicaid managed care, Affordable Care Act (ACA) plans and state Medicaid agencies implement electronic prior authorization systems by 2026.
The proposed rule, released Tuesday by the Centers for Medicare & Medicaid Services (CMS), will require payers and states to streamline prior authorization processes and improve the electronic exchange of health data by 2026. It also contains incentives for hospitals and physicians to adopt electronic prior authorization.
“The prior authorization and interoperability proposals we are announcing today would streamline the prior authorization process and promote healthcare data sharing to improve the care experience across providers, patients and caregivers,” CMS Administrator Chiquita Brooks-LaSure said in a statement.
It is the revised version of a Trump administration rule originally finalized in late 2020 but withdrawn after concerns about costs and a short deadline. That rule only applied to Medicaid managed care, the Children’s Health Insurance Program and ACA plans, while the new version would apply also to MA plans.
Congressional leaders and top appropriators are set to meet as early as Wednesday to work through differences on a potential omnibus spending agreement, Senate Majority Leader Charles E. Schumer said Tuesday.
President Joe Biden and Vice President Kamala Harris, along with a few top White House aides, met with Speaker Nancy Pelosi, House Minority Leader Kevin McCarthy, Senate Minority Leader Mitch McConnell and Schumer earlier Tuesday to discuss the lame-duck agenda.
Schumer said the leaders had a “productive discussion” about funding the government, and said all four leaders aim to come together to pass an omnibus.
“We all agreed that it should be done this year, we all agreed we have to work together and everyone has to give a little bit,” he said. “We also…said we would all work toward getting an omnibus as opposed to a CR.”
The prospects of a lame duck omnibus remain murky as Republicans and Democrats have not reached a topline spending agreement. The current continuing resolution runs out Dec. 16, though lawmakers have discussed a stopgap extension of perhaps a week to buy extra time.
The FEHBlog sees these developments as a good sign.
From the Omicron and siblings front, MedPage Today informs us
What happens to people who get reinfected with SARS-CoV-2, the virus that causes COVID-19? A recent paper in Nature Medicinehas been misinterpreted by some as providing evidence that repeat infections are somehow worse than first-time infections.
Here’s the actual situation: second infections are far less dangerous than first infections, with respect to severe, critical, and fatal COVID-19. This is true regardless of vaccination status.
Health Payer Intelligence offers three interesting survey findings about health insurance in our country
“Health insurance coverage disruptions were associated with higher mortality risks for people with private and public insurance, a JAMA Health Forum study found.”
“In two-adult families with and without children, the majority of members had the same type of health insurance coverage, whether they had group plans, non-group plans, or Me,dicaid” according to a brief from the Employee Benefit Researcher Institute (EBRI).
From the public health front, the FEHBlog ran across The PCORI Health Care Horizon Scanning System identifies and monitors developing innovations with potential to change health care. This database can be used by patients, care partners, and others to track advancements in care options.
The rate of gun deaths in the U.S. reached a 28-year high in 2021 after sharp increases in homicides of Black men and suicides among white men, an analysis of federal data showed.
A record 48,953 deaths in the U.S., or about 15 fatalities per 100,000 people, were caused by guns last year, said the analysis published Tuesday in the journal JAMA Network Open. Gun deaths declined in the 1990s, but have been rising steadily over the past decade and skyrocketed during the Covid-19 pandemic, said researchers who conducted the analysis.
Gun-related deaths of women and children have risen, the analysis said, but men remain far more likely to die from guns.
“The disparities are so marked,” said Chris Rees, a co-author of the study and an assistant professor of pediatrics and emergency medicine at Emory University School of Medicine.
The Pentagon is looking to hire hundreds of clinicians and mental health professionals in the coming months, as part of the initial cohort of its worldwide suicide prevention workforce.
Deputy Defense Secretary Kathleen Hicks, speaking Tuesday at a Washington Post Live event, said DoD is building up a “first of its kind” suicide prevention workforce that will eventually reach an end strength of 2,000 personnel.
Hicks said hiring, onboarding and training the suicide prevention workforce is “at the top of the list” of priorities for Defense Secretary Lloyd Austin. This DoD workforce, she added, is expected to outpace any similar effort led by universities or state governments.
“This prevention workforce will be a first of its kind, and we’re going to do it right here in the United States military, because that’s what we owe our people and their families,” Hicks said.
From the medical research and development front, the Wall Street Journal reports
Researchers released new details from a study of a closely watched drug for Alzheimer’s disease on Tuesday, shedding more light on the drug’s risks and benefits as U.S. health regulators weigh approving it.
Eisai Co. and Biogen Inc.’s drug, called lecanemab, slowed cognitive decline by 27% compared with a placebo over 18 months in a study of more than 1,700 people with early-stage Alzheimer’s, researchers reported in the New England Journal of Medicine on Tuesday.
The drug’s effect was moderate, and was associated with swelling and bleeding in the brain, the researchers said. They recommended further, longer study of the drug.
Some 17.3% of patients taking lecanemab had signs of brain bleeding, compared with 9% in the placebo group. Brain swelling occurred in 12.6% of people getting the drug, versus 1.7% who got placebos.
The study data have been eagerly anticipated by Alzheimer’s researchers since Eisai disclosed high-level results in September, raising the hopes of doctors and patients that a new treatment proven to help Alzheimer’s patients is on the horizon.
The companies have asked the U.S. Food and Drug Administration to conditionally approve lecanemab based on an earlier study showing that the drug reduced levels of a protein in the brain called amyloid associated with Alzheimer’s. The agency is expected to make a decision by Jan. 6.
Eisai, which is leading the development of lecanemab, has said it plans to seek full approval using the new study data.
The NIH DIrector’s Blog tells us about the NIH clinical center doctors who are testing 3D-printed miniature, single-use ventilators. Cool.
Google’s health division has inked its first commercial agreement to use its mammography AI research model in real-world clinical practice, with the goal of improving breast cancer screening, Google Health announced Monday.
Google Health has partnered with cancer detection and therapy medtech iCAD on the 5-year deal. Under the agreement, iCAD will work to validate and incorporate Google’s mammography AI — which Google has been building and testing for several years — into its products for use in clinical practices.
From the U.S. healthcare business front, the Wall Street Journal reports
Apoorva Mehta, a co-founder of Instacart Inc., is working on his next act after saying earlier this year that he would step down as executive chairman from the startup he built into a grocery delivery giant once it goes public.
Mr. Mehta earlier this month raised $30 million for Cloud Health Systems, a new healthcare startup aiming to offer consumers medical consultations and other health-related services, according to people familiar with the matter.
When many people are looking to enroll in health benefits, they turn to Google as a source of key information on eligibility, the application process and in-network providers.
In this spirit, the Google Search team has quietly rolled out multiple features for its search engine that aim to make it easier for users to access key information about obtaining Medicaid and Medicare benefits, as well as which doctors locally accept those types of coverage.
The article offers more details on these new Google tools.
From the Omicron and siblings front
Beckers Hospital Review informs us “The CDC has begun tracking omicron subvariant XBB, which is now estimated to account for 3.1 percent of U.S. cases”[, somewhat higher in New York, New Jersey and New England states]. * * * Health experts anticipate the U.S. will see an increase in COVID-19 cases in the winter months as a collection of omicron subvariants circulates, though they have remained optimistic it will be less severe than last winter’s omicron surge.”
The National Institutes of Health discusses its research on the ability of the human body’s immune system to remember a previous Covid infection or vaccination to help ward off, or minimize symptoms during, a future infection.
Fierce Healthcare reports “The U.S. came in dead last compared to 20 other countries when it came to preventing deaths from COVID-19 as well as all-cause deaths, and it appears that relatively low vaccination rates might have played a part in those poor showings, a new study finds. * * * The U.S. continued to experience significantly higher COVID-19 and excess all-cause mortality compared with peer countries during 2021 and early 2022, a difference accounting for 150,000 to 470,000 deaths,” authors of the research letter published in JAMA Network wrote. ‘This difference was muted in the 10 states with highest vaccination coverage; remaining gaps may be explained by greater vaccination uptake in peer countries, better vaccination targeting to older age groups, and differences in health and social infrastructure.’”
From the public health front
Axios tells us “The RSV season normally runs from December to April, peaking in February and March, but this year has seen an earlier onset. [Dr.] Fauci noted that both the RSV and flu seasons have arrived earlier than usual this year. Asked by [Meet the Press host Margaret] Brennan whether the U.S. is “in the worst of it” right now, Fauci replied, “I hope so.”
The American Hospital Association relates “The World Health Organization today recommended a new name for monkeypox that is intended to mitigate a rise in related racist and stigmatizing language associated with the ailment. The WHO’s newly recommended preferred term is “mpox.” The organization recommends a one-year transition period to mitigate confusion that could be caused by the change and allow for ICD and publication updates. The Biden administration voiced its support for the change, stating, ‘We welcome the change by the World Health Organization. We must do all we can to break down barriers to public health, and reducing stigma associated with disease is one critical step in our work to end mpox.’” The FEHBlog also will begin to refer to chickenpox as cpox.
From the regulatory front, MedPage Today informs us
In an effort to enhance care coordination for patients with substance use disorder (SUD), HHS, acting through its Office for Civil Rights and in collaboration with the Substance Abuse and Mental Health Services Administration, proposed changes to “Part 2” rules to better align privacy measures with those of HIPAA on Monday.
If implemented, the proposed rule would allow Part 2 programs to use and share patients’ records following a single signed consent by the patient “for all future uses and disclosures for treatment, payment, and healthcare operations.”
The proposal also aims to strengthen protections around disclosure of SUD treatment records to guard against discrimination and stigma.
The changes were initially called for in the CARES Act of 2020, provisions of which required the HHS secretary to better align the 42 CFR part 2 rule, better known as “Part 2,” with HIPAA’s Privacy, Security, Breach Notification, and Enforcement Rules.
“This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure,” said HHS Secretary Xavier Becerra in a press release.
From the medical research front, we learn from STAT News that
A drug developed by Axsome Therapeutics significantly reduced a common side effect of Alzheimer’s disease — agitation — the company announced Monday.
The therapy, AXS-05, met its primary goal of delaying time to relapse and preventing patients from relapsing. Patients taking the drug had a 3.6-fold lower risk of relapse overall, compared to placebo.
People with Alzheimer’s disease can get restless, upset, or even aggressive as the disease gets worse. Axsome’s trial also showed an improvement on a scale commonly used to measure overall agitation.
* * *
The Food and Drug Administration has granted Axsome breakthrough therapy status for AXS-05 in Alzheimer’s agitation, which could help the company secure an accelerated, additional approval. Company officials said they plan to wait to see data from another Phase 3 trial called ADVANCE-2 before filing a drug application, according to a third-quarter earnings call transcript from Sentieo.
Dr. Thomas Perls has for decades studied so-called super agers, people who live deep into their 90s and beyond, essentially unburdened by the typical diseases of old age. He is convinced that the secret to this remarkable longevity is buried in people’s genes and passed down through generations.
But which genes harbor this power? And if researchers pinpoint the right genes amid thousands in a person’s body, could that knowledge be harnessed to develop drugs that mimic those genes and allow more people to enjoy longer, healthier lives?
That’s the premise behind an ambitious new trial, the SuperAgers Family Study, (superagersstudy.org) that aims to enroll 10,000 people who are 95 years old or older and their children.
From the benefit design front, Beckers Payer Issues offers more insights from a recent AHIP study of prior authorization practices:
Gold-card programs give providers exemptions from certain prior authorization requirements, but providers who have discontinued these programs have found them administratively difficult to implement, according to a Nov. 14 America’s Health Insurance Plans survey. * * *
Here are the top three reasons insurers said they discontinued gold card programs, according to the report:
1. Administratively difficult to implement: 75 percent
2. Reduced quality/patient safety: 50 percent
3. Higher costs without improved quality: 25 percent
From the healthcare business front, Healthcare Dive reports
[Telehealth vendor] Amwell is in advanced discussions to acquire online therapy app Talkspace for roughly $200 million, according to a report from Israeli business publication Calcalist.
The telemedicine company is in talks to pay $1.50 per share for Talkspace, Calcalist reported on Sunday. The price tag would represent a 150% premium over Talkspace’s share price at Friday’s close.
The reported transaction reflects a sharp decline in Talkspace’s value since the therapy company went public last summer at a $1.4 billion valuation.
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