Congress remains on a District / State work break which concludes next Monday following the Easter and Passover holidays.
OPM has rescheduled the second day of the 2023 OPM AHIIP carrier conference for April 20, 2023 from 11 am to 4:15 pm ET.
From the public health front —
NPR Shots discusses the simple intervention that may keep Black moms healthier — daily home-administered blood pressure readings.
Blood pressure is just one way to measure a person’s health, but during pregnancy and soon after, it’s a critical metric. Unchecked, high blood pressure can contribute to serious complications for the pregnant woman and baby, and increase the risk of death.
Politico tells about new efforts underway to solve the crisis in mental health problems among children and adolescents that accompanied the Covid pandemic.
Sen. Bob Casey (D-Pa.) plans to introduce three bills aimed at improving mental health care for kids, one of his aides told POLITICO. One bill, set to be reintroduced soon, would create grants for children’s mental health services and make them more accessible. Another would help gather more accurate national data on mental health and children, and the third would focus on the mental health of kids in foster care.
And children’s health providers tell government leaders it’s now critical that the federal government step up support for an overburdened system, arguing for increased funding for graduate medical education programs and boosted government reimbursement rates for mental health services.
From the Rx coverage front —
USA Today discusses challenges related to using the new generation of weight loss drugs. “Drugmakers are working hard to convince Americans they need their next-generation weight loss medications. But many come with side effects – and the fact we don’t really know what happens long-term.”
The Wall Street Journal offers an essay about potential uses for inhalable therapies beyond asthma.
“We’re pushing the boundaries of delivery,” said Philip Santangelo, a professor of biomedical engineering at Emory University.
Respiratory diseases that spread through the air are a key target. Dr. Santangelo and colleagues are developing inhalable drugs that use an RNA-editing tool known as CRISPR-Cas13 and messenger RNA to kill viruses such as Covid-19, influenza and respiratory syncytial virus or RSV. Using nebulizers that dispense medicine as mist via a mask, they have tested the delivery of some of the medicines on rhesus monkeys, cows, horses and pigs. The tests in pigs showed that getting the drugs to the lungs reduces the severity and spread of infections, Dr. Santangelo said.
From the medical research front —
Forbes reports, “Researchers have uncovered an unusual way some cancer cells make nutrients they need to grow, a discovery that could hold the key to starving one of America’s deadliest cancers [pancreatic] with a drug we already possess and raising hopes for a powerful new treatment against a disease that is often caught late and has one of the lowest survival rates of any cancer.”
Fortune Well discusses new developments in cancer testing via blood studies.
The various Covid-19 pandemic-related mandates are tied to the end of the public health emergency and the end of the national emergency. The Administration has told us to expect the end of both emergencies on May 11.
Congress has passed a bill (House Joint Resolution 7) which the President has agreed to sign ending the national emergency upon signing. Mercer Consulting explains:
During the NE, group health plans have been required to extend certain participant deadlines that would have expired during the “Outbreak Period,” which began March 1, 2020, and will end 60 days after the end of the NE. These deadlines related to:
Special enrollment rights under HIPAA
COBRA elections, payments and notifications
Benefit claims, appeals and external reviews
Employers will have less time to prepare for the end of the Outbreak Period relief if, as the pending legislation would require, the NE ends before May 11, 2023. Other COVID-19 relief measures, described in this post, are tied to the PHE and are not impacted by the pending legislation.
This week, regulators provided FAQs and a blog to assist employers preparing for the NE and PHE to end. The FAQs provide many helpful examples illustrating how the extended deadlines available during the Outbreak Period will wind down. However, the FAQs assume that the NE will end on May 11 and the Outbreak Period 60 days later, on July 10. Assuming President Biden signs the legislation ending the NE earlier than May 11, the dates in the FAQs will need to be adjusted.
Any deadline adjustments for these three mandates impact employers directly and group health plans indirectly. The three mandates had have had limited FEHBP impact.
Following up on Thursday’s post, MedPage Today offers a broader perspective on Thursday’s Senate Finance Committee PBM hearing. The hearing’s theme was “transparency.” For over ten years, OPM has required FEHB carriers covering most enrollees to use a strict drug pricing transparency system. This has allowed the FEHB to avoid certain practices criticized at the hearing, such a spread pricing, and it facilitates OPM Inspector General audits of the PBMs. However, it takes Congress to address the key economic concern about rebates inflating drug prices discussed at the hearing:
Karen Van Nuys, PhD, of the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California in Los Angeles, highlighted her 2021 JAMA Internal Medicine research letter that found that Medicare would have saved $2.6 billion in 2018 on 184 drugs if patients had purchased them without insurance at Costco.
CMS finalized its Medicare Advantage and Medicare Part D payment policies for 2024 today. Of note, Fierce Healthcare reports,
The Biden administration finalized a proposal to raise Medicare Advantage payments by 3.32% in 2024, slightly above the 1% raise that it proposed.
The final payment rule released Friday comes after an intense lobbying campaign from insurers who claimed that the original advance notice released in February would amount to a cut to plans. The agency also finalized changes to the MA risk adjustment model, but will instead phase the changes in over three years as opposed to implementation next year.
CMS also offered a fact sheet on the final actions.
From the SDOH front, Health Payer Intelligence informs us
OMB’s 1997 Statistical Policy Directive No. 15: Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity (Directive No. 15). The directive regulates consistency in federal data-sharing and the 1997 iteration emphasized that data gathering practices should seek to mirror the nation’s diversity.
OMB’s directive requires that data collection include two category options for ethnicity (Hispanic or Latino and Not Hispanic or Latino) and five for race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, and white). In contrast, the Centers for Disease Control and Prevention (CDC) includes over 900 categories for these two designations.
The directive does not include any requirement to indicate sexual orientation and gender identity (SOGI) data. Very few regulations or standardizing entities do.
OMB will release changes to Directive No. 15 in 2024.
Several associations, including AHIP and BCBSA, have commented on the importance of OMB including changes to Directive No. 15 that facilitate health insurer efforts to reduce social determinants of health-related health disparities.
The Senate Finance Committee held a hearing today on “Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers.” Fierce Healthcare reports
Sen. Ron Johnson, R-Wisconsin, said during the hearing that “this whole area is ripe for gamesmanship.” He then asked Matthew Gibbs, PharmD and Capital Rx President, what Capital Rx’s model would bring to the table that sets it apart from other players like Amazon or Mark Cuban Cost Plus Drug that are aiming to shake up the traditional PBM space.
Gibbs emphasized Capital Rx’s focus on transparency, something that sets it apart in the broader market.
“Using a price index like NADAC, which is published by CMS, they actually do the survey of the pharmacies, and getting it more robust so that it’s not voluntary—today it’s a voluntary survey—and getting responses to that will lead us to the actual drug costs,” Gibbs said. “And then you can have your nuances of Costco, Mark Cuban. And the person can actually go in and look and actually be informed about the real prices once and for all. The only way is to level set.”
“We have the tools already,” he said. “We just need to employ them.”
Meanwhile, the National Council of State Legislatures discusses the wide variety of state laws being imposed on PBMs, which only complicates matters.
In Affordable Care Act New, MedPage Today reports, “A federal judge on Thursday struck down the Affordable Care Act (ACA) provision requiring all insurers to cover certain preventive services free of charge, angering the law’s supporters.” The FEHBlog won’t delve into this case now because he expects the U.S. Court of Appeals for the Fifth Circuit to promptly stay this decision.
From the Omicron and siblings front, WebMD tells us
The CDC has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time.
“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website now explains.
16.4% of people in the U.S. have gotten the latest booster that was released in September, CDC data shows.
MedPage Today opines on a World Health Organization “Booster Update: Here’s What They Got Right and Wrong.”
On May 9 and May 10, an FDA advisory panel will discuss whether to recommend the agency approve what could be the first over-the-counter birth control pill.
The pill, a 0.075-milligram norgestrel tablet [manufactured by French drugmaker Laboratoire HRA Pharma], “is proposed for nonprescription use as a once-daily oral contraceptive to prevent pregnancy,” according to a document published March 29 on the Federal Register.
“Johnson & Johnson will stop developing its experimental vaccine for respiratory syncytial virus in an unexpected retreat from a high-profile research effort that had put the pharmaceutical giant among the leading companies seeking to win the first approval of a preventive shot.
“The company said Wednesday it will discontinue a 23,000-person Phase 3 trial, called Evergreen, of its RSV vaccine in adults following a review of its drug pipeline. The company does not plan to develop the shot for pregnant women or infants, a spokesperson confirmed.
“J&J’s pullback comes amid a restructuring of its infectious disease division, which was reported by Fierce Pharma in February. Its decision also thins the RSV vaccine competition, leaving GSK and Pfizer in the lead with shots that are currently under review by the Food and Drug Administration. Moderna is also developing an RSV vaccine and could file for approval this year.”
Walgreens’ growing U.S. healthcare segment is continuing to bolster the retail health chain’s financial performance. The business, which includes value-based provider VillageMD, recorded $1.6 billion in sales in the second quarter, an increase of $1.1 billion from last year.
VillageMD sales were up 30%, including a boost from its recent acquisition of medical group Summit Health. Specialty pharmacy Shields Health Solutions grew sales 41%, while at-home care provider CareCentrix’s sales were up 25%.
Thanks in part to a jump in revenue in its healthcare segment, Walgreens’ results beat Wall Street expectations even as profit declined more than 20% amid lower COVID-19 vaccine volumes and test sales, higher salary costs, opioid litigation charges and costs associated with its $3.5 billion investment in its Summit acquisition.
Oak Street Health disclosed on Thursday that the antitrust waiting period for its planned sale to CVS Health has expired.
CVS and Oak Street filed the required notification forms under the Hart-Scott-Rodino Act with the Department of Justice and Federal Trade Commission on Feb. 24. The waiting period under the HSR Act ended Monday, according to a new proxy filing from Oak Street.
The disclosure means the $10.6 billion deal has cleared one regulatory hurdle — companies can’t consummate mergers until the HSR waiting period expires — but regulators could still challenge the acquisition on antitrust grounds in the future.
From the healthcare studies front —
Bloomberg tells us the story behind a breast cancer scare. Last week, I noticed a breast cancer study report that struck the FEHBlog as overblown, and it turns out that this report is the breast cancer scare that Bloomberg discusses.
“Losing weight — even if some pounds are gained back — may help your heart over the long term, according to a study published Tuesday in the journal Circulation: Cardiovascular Quality and Outcomes.
“The findings may be welcome news to those who have found it difficult to keep weight off and feared the risks thought to be associated with gaining weight back.
“In the new study, researchers analyzed data from 124 clinical trials with a total of more than 50,000 participants. They found that risk factors for heart disease and Type 2 diabetes decreased for people who lost weight through intensive behavioral programs. The diminished risk persisted for years after they were done with the programs, even if some, but not all, of the weight came back.”
“The whole time your weight is less than it would otherwise have been, your risk factors for heart disease are lower than they would have been,” co-author Susan Jebb, a professor of diet and population health at the University of Oxford in the United Kingdom, said in an email.
The Centers for Disease Control announced
The expanded availability of opioid use disorder-related telehealth services and medications during the COVID-19 pandemic was associated with a lowered likelihood of fatal drug overdose among Medicare beneficiaries, according to a new study.
“The results of this study add to the growing research documenting the benefits of expanding the use of telehealth services for people with opioid use disorder, as well as the need to improve retention and access to medication treatment for opioid use disorder,” said lead author Christopher M. Jones, PharmD, DrPH, Director of the National Center for Injury Prevention and Control, CDC. “The findings from this collaborative study also highlight the importance of working across agencies to identify successful strategies to address and get ahead of the constantly evolving overdose crisis.”
From the healthcare quality front, Beckers Hospital Review relates
CVS and Optum have struggled to integrate behavioral health into their payer-provider models, Behavioral Health Business reported.
For Optum, the challenges lie in integrating all the different IT systems from the providers the company has bought, Trip Hofer, the CEO of Optum Behavioral Health Solutions, said at the news outlet’s VALUE conference. For example, Optum in 2022 acquired Kelsey Seybold Clinic, a medical group in Houston with 500 healthcare professionals.
“Kelsey Seybold says, ‘Trip, here’s my issue. I have access problems for depression, stress and anxiety for adults.’ And I’m like, ‘Well, we have a ton of solutions for you,'” Mr. Hofer said, according to the March 27 story. “Six months later, we still can’t get it implemented because it’s like, ‘Well, how do I get data back to them?'”
Deborah Fernandez-Turner, DO, deputy chief psychiatric officer of CVS payer subsidiary Aetna, said at the conference that it’s time-consuming and complex to build behavioral health into payer-provider companies.
CVS, for instance, has started bringing mental health providers and virtual behavioral health access into its MinuteClinics, according to the story.
Keep on truckin’
The FEHBlog had planned to discuss the OPM-AHIP carrier conference in this post. However, the second day of the conference was postponed today due to a power outage affecting the webinar operations. The second day will be rescheduled, and the FEHBlog will bring readers up to date then.
The Senate Finance Committee will hold a hearing Thursday on the impact PBMs — the pharmaceutical middlemen that negotiate drug discounts with drugmakers and design prescription drug benefits for health plans — have on the health system.
The House Energy and Commerce Health Subcommittee is also expected to look into how much value PBMs add as part of a broader discussion about fairness in the healthcare market, according to a memo shared with [Politico].
In related news, CMS “released several Prescription Drug Data Collection (RxDC) resources on the Registration for Technical Assistance Portal (REGTAP). To view the documents, click on the link next to each document title. You may already have the links in your bookmarks.”
This guidance applies to the 2022 RxDC report that health plans must submit by June 1, 2022. Health plans submitted the first RxDc report for the 2021 reporting year last January. The No Surprises Act calls for a standard June 1 submission date for the RxDC report for the previous reporting year.
CMS also announced that the public has sixty days (to May 26) to comment on the revised Reporting Instructions.
The FEHBlog recently discovered this CMS REGTAP portal. As you can see, this portal is not just for Medicare and Medicaid. The portal includes a link to get an email announcement when REGTAP changes. REGTAPs emails are handy and not overwhelming.
From the Rx coverage front —
STAT News adds an interesting perspective on last week’s Senate hearing on Moderna Covid vaccine pricing
What, [Chairman Bernie] Sanders asked [Moderna CEO Stephane Bancel], if instead of purchasing medicines after they had been developed at high prices, the government instead paid for companies’ research, enough to ensure they make a reasonable profit? Then, Sanders said, the medicines could be made available inexpensively to anyone who needed them.
Bancel, clearly baffled by what sounded a lot like the government seizing the means of pharmaceutical production, simply said it was impossible to evaluate such a plan without details.
As much as the plan sounds like socialism, in a world where substantial quantities of new medicines are purchased by government programs, Sanders’ idea is pretty close to the way defense companies work: The government pays them substantial amounts of money to develop jet fighters, satellites, and aircraft carriers. This system is certainly not cheap, but it represents an alternative to the way medicines are developed. * * *
Whether this is a good idea or not, it probably won’t happen. Because not only is Congress unlikely to fund a $200 billion-a-year effort to replace industry research on new medicines, it won’t fund a $20 billion effort to get the government in the game, either.
Walgreens and Village Medical have launched a new pilot program that helps patients manage new medications prescribed during their hospital stay.
The program, launched as a pilot in Florida and Texas, helps Walgreens and Village Medical patients manage their new prescriptions and existing ones after they are discharged from a hospital, according to a March 23 release from Walgreens.
The aim of the program is to improve patient outcomes and decrease costs associated with hospital readmissions.
From the substance use disorder front, STAT News reports
Public health workers will soon have a new tool at their disposal to thwart a spreading danger to users of illicit drugs: xylazine test strips.
The new testing kits will allow health departments, grassroots harm-reduction groups, and individual drug users to test substances for the presence of xylazine, a sedative often referred to as “tranq.”
The toxin is increasingly common in the U.S. illicit-drug supply — especially in the Philadelphia area, but increasingly in other cities, too. Xylazine, which is typically used as a sedative in veterinary settings, can cause people to stop breathing, and also often causes severe skin wounds when injected.
While helpful for public health workers, will drug users take the time to do both tests when the two potentially fatal drugs usually are combined? FEHBlog expects that a fentanyl and xylazine test strip will be on the market soon.
From the U.S. healthcare business front —
Hospitals strongly oppose MEDPAC’s recommendation that Medicare Part A make a low reimbursement increase for the new federal government fiscal year, while some healthcare economists support MEDPAC’s proposal.
Healthcare Dive tells us
“CVS plans to close its acquisition of home healthcare provider Signify Health on or around Wednesday, subject to certain conditions, the company announced Monday.
“CVS agreed to acquire Signify for $30.50 a share in cash in September in a transaction worth roughly $8 billion.
“That deal will close this week as long as CVS and Signify can meet or waive the remaining conditions in their merger agreement, according to CVS. A CVS spokesperson declined to share details on the remaining conditions.
Beckers Hospital Review notes that another well know CEO has ripped a page out of the Mark Cuban playbook.
“Love.Life, a health and wellness company co-founded and run by former Whole Foods CEO John Mackey, acquired Plant Based TeleHealth, a telehealth service focusing on the prevention and reversal of chronic conditions.
“The company will rebrand as Love.Life Telehealth. The company offers virtual visits to patients with chronic conditions and promotes healthy behaviors, according to a March 21 Love.Life news release.
“Patients can sign up for half-hour appointments for $175 or hourlong appointments for $350.”
“Love.Life is about making lasting health and vitality achievable, and acquiring Plant Based TeleHealth accelerates our ability to help more people without geographic limitations,” Mr. Mackey said. “Appointments are available now, and we’re excited to offer telehealth services as part of the comprehensive medical offering available in our physical locations, which will begin opening in 2024.”
Last Friday, OPM released to FEHB carriers its technical guidance supporting its call letter for 2024 benefit and rate proposals.
Federal News Network offers a long look at OPM’s process to implement the Postal Service Health Benefits Program.
OPM and AHIP will hold their annual conference for FEHB carriers on Wednesday and Thursday this week. The agenda can be found here. The 2024 call letter and PSHBP implementation are agenda topics.
Millions of diabetes cases may be missed under the current U.S. screening guidelines, especially among Asian Americans, according to a new study. A better way to test for the condition would be to leave body weight out of it, the researchers suggest.
Current guidelines from the U.S. Preventive Services Task Force recommend screening adults ages 35-70 who are considered overweight or obese (having a body mass index over 25).
However, racial and ethnic minority groups, especially Asian people, tend to develop diabetes at lower BMIs, so to identify more people with the condition across groups, all adults ages 35-70 regardless of their weight should be screened, researchers said in a study Friday in the American Journal of Preventive Medicine.
NPR Shots also invites us to meet the amazing “glass-half-full girl” whose brain was rewired as an infant after losing the left hemisphere.
In most people, speech and language live in the brain’s left hemisphere. Mora Leeb is not most people.
When she was 9 months old, surgeons removed the left side of her brain. Yet at 15, Mora plays soccer, tells jokes, gets her nails done, and, in many ways, lives the life of a typical teenager.
“I can be described as a glass-half-full girl,” she says, pronouncing each word carefully and without inflection. Her slow, cadence-free speech is one sign of a brain that has had to reorganize its language circuits.
Yet to a remarkable degree, Mora’s right hemisphere has taken on jobs usually done on the left side. It’s an extreme version of brain plasticity, the process that allows a brain to modify its connections to adapt to new circumstances.
Because it’s Sunday, here are two opinion pieces
The New York Times shares expert opinions on preparedness for the next pandemic.
Three professors of surgery at the University of California Medical Center defend the current United Network for Organ Sharing (UNOS).
As a private, nonprofit organization under contract with the federal government to manage the national organ transplant system, UNOS spearheads the complex, multidisciplinary organ procurement, matching, and delivery processes. With its contract up for renewal this spring, UNOS has come under heavy scrutiny, including in a recent guest column published in the New York Times, in which UNOS and other system organizations’ performances were blamed for the death of a kidney transplant candidate. This is just one example in a series of accusations made across news media, social media, and even in Congress.
Painting with such a broad and biased stroke creates an unfair representation of our highly nuanced organ transplant system and the people who run it. As transplant surgeons with a long history of involvement with the system — including one of us (Roberts) serving as a past Board President of UNOS/Organ Procurement and Transplantation Network (OPTN) — we have intimate knowledge of both its successes and its shortcomings. While UNOS has room to improve operationally — and is working to do so — we clearly see the organization’s life-changing results in our operating rooms and offices. More work lies ahead, however, such as addressing the fact that a rising number of organs are recovered but not transplanted.
Fedweek reports on Postal Services Health Benefit Program developments. The headline is that OPM expects “lots of questions” about the new program, which will launch in 2025. The good news for OPM and everyone effect affected is that the law requires the Postal Service to stand up a PSHBP education program this summer, which includes PSHBP navigators similar to the approach taken with the ACA marketplace.
FedWeek also tells us that the U.S. Court of Appeals for the D.C. Circuit rejected on procedural grounds a federal employee challenge to the Biden Administration’s Covid vaccine mandate for federal employees. The mandate has been blocked by a preliminary injunction in another federal judicial circuit. In any event, the vaccine mandates will end on May 12, the day after the Covid public health emergencies end.
A key Senate committee advanced legislation to ban pharmacy benefit manager tactics, such as spread pricing and clawback fees, and heighten transparency of the industry.
The Senate Commerce Committee passed the PBM Transparency Act of 2023 by a vote of 18 to 9 on Wednesday, advancing the reform legislation to the full Senate. Lawmakers said the legislation is meant to address a source of unfair and deceptive practices that increase drug prices.
Senators Chuck Grassley (R Iowa) and Maggie Hanson (D NH) have “introduced the Healthy Moms and Babies Act to improve maternal and child health care. The United States has a maternal health crisis that particularly affects women of color and those living in rural America. The Healthy Moms and Babies Act would achieve its goal by
Coordinating and providing “whole-person” care, supporting outcome-focused and community-based prevention, and supporting stillbirth prevention activities and expanding the maternal health workforce.
Modernizing maternal health care through telehealth to support women of color and women living in rural America.
Reducing maternal mortality and high-risk pregnancies including C-section births, and improving our understanding of social determinants of health in pregnant and postpartum women.
The future of Alzheimer’s treatments and coverage hung heavily over lawmakers’ Wednesday [March 22 Senate Finance Committee] hearing with Health and Human Services Secretary Xavier Becerra.
Dotted throughout the hearing room for Becerra’s testimony on the president’s proposed health care budget for 2024 were purple-clad advocates for Alzheimer’s disease treatments, who Democrats and Republicans alike acknowledged repeatedly throughout the hearing. But while senators from both parties pushed for speedy approvals and Medicare coverage of new drugs for the disease, they unsurprisingly diverged on how to manage the costs.
At the center of discussions was a controversial Medicare decision, last year, not to cover Biogen’s Aduhelm except through clinical trials, a decision later extended to Eisai’s Leqembi. The Food and Drug Administration approved both via the accelerated pathway, with limited data on either drug’s effectiveness. The drugmakers are required to follow up with more extensive data proving each medicine’s benefit.
CMS expects to revisit this Medicare decision publicly this summer.
For about an hour and a half on March 22, four pharmaceutical supply experts outlined ideas to lawmakers to reform the nation’s slippery access to critical drugs.
The FDA reports 130 drugs are currently in shortage; the American Society of Health-System Pharmacists says there are 302. Recently, the availability of vital drugs for cancer patients and emergencies has shrunk, and the closure of a U.S. drugmaker could put more out of stock.
The hearing waded through causes of shortages — including manufacturing delays and opaque supply data. Some members on the Senate Committee on Homeland Security and Governmental Affairs pushed back on some pitched solutions, such as changing FDA practices and working to control drug prices.
In 2022, the number of new drug shortages increased by 30 percent, according to a report released by the Senate Committee on Homeland Security and Governmental Affairs hours before the hearing began.
“Colleagues and other hospitals have asked me to respond to the never-ending game of drug shortage Whac-A-Mole,” Andrew Shuman, MD, chief of the clinical ethics service center for bioethics and social sciences in medicine for the University of Michigan Medical School in Ann Arbor, said during the hearing.
The House Ways and Means Committee’s Health subcommittee held a hearing yesterday on healthcare costs. The American Hospital Association submitted a letter to the subcommittee that “shared how rising labor and other costs for hospitals and health systems are exacerbating workforce shortages and delaying patient access to care.”
Looking forward, Mercer Consulting identifies innovation in cancer treatment and prevention as the next frontier and McKinsey and Co. explores the pharmacy of the future.
“Use of nirmatrelvir-ritonavir (Paxlovid) in older adults with risk factors for severe disease was associated with a roughly 25% lower risk of a post-COVID condition (PCC), a retrospective study of Veterans Affairs data showed.
“In the cohort of over 280,000 patients with a confirmed COVID case, 13% of those prescribed nirmatrelvir-ritonavir went on to develop a PCC over the following 6 months compared with 18% of those who were not prescribed the antiviral (relative risk [RR] 0.74, 95% CI 0.72-0.77), Ziyad Al-Aly, MD, of the VA St. Louis Health Care System in St. Louis, and colleagues reported.” Fehblog observation: Go Paxlovid!
42% of adults in the U.S. are living with obesity, meaning they have a body mass index of 30 or higher, according to an analysis from NORC at the University of Chicago.
Researchers used 2013 to 2021 data from the CDC’s Behavioral Risk Factor Surveillance System to estimate obesity rates at the national and state level. To account for any reporting biases in the BMI measure, NORC adjusted BMI distribution to that of the National Health and Nutrition Examination Survey for corresponding time periods. NORC also created an interactive map to present its findings.
The article lists estimated state obesity rates for 2019 to 2021, ranked from highest (Mississippi – 51%) to lowest (Colorado 34%). FEHBlog observation At least one-third of every state’s population is morbidly obese, and yet we wonder why the life expectancy of Americans is dropping.
For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large US trial.
The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.
The study was published by JAMA Network Open on March 22.
“These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in US health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington. (FEHBlog observation: Good idea.)
Roll Call reports on the state of the debt ceiling negotiations and Senator Bernie Sanders’s encounter today with the Moderna CEO Stéphane Bancel at a Senate hearing that Senate Sanders chaired. The FEHBlog can’t understand why Senator Sanders and his majority colleagues are flipping their lids over a $100 price per vial increase on a low-cost vaccine.
The Medicare Payment Advisory Commission’s recent breakdown of the hospital sector’s financial viability largely struck a different tone from the doom and gloom industry groups have voiced as of late.
The independent commission advises Congress on year-to-year Medicare policy adjustments, which are largely based on data from 2020 and 2021, preliminary data for 2022 and trend projections for upcoming years. It released its annual report to Congress last week.
With the exception of additional support for safety-net providers—which industry group America’s Essential Hospitals (AEH) has already criticizedfor “overlooking” uncompensated care delivered to non-Medicare patients—the group largely told Congress that most hospitals will manage their finances and recommended that lawmakers stay the course with 2024’s inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) rules.
“The Commission anticipates that a 2024 update to hospital payment rates of current law plus 1% would generally be adequate to maintain FFS beneficiaries’ access to hospital inpatient and outpatient care and keep IPPS and OPPS payment rates close to the cost of delivering high-quality care efficiently,” the group wrote in its report (PDF).
This decision must have the American Hospital Association flipping its lid.
The Department of Health and Human Services announced an organ procurement and transplantation network modernization initiative that “includes the release of new organ donor and transplant data; prioritization of modernization of the OPTN IT system; and call for Congress to make specific reforms in the National Organ Transplant Act.” More background on his announcement is available at Roll Call.
An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients.
By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 3-5 vote (with one abstention) the same experts concluded that the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval.
The FDA is not required to follow the recommendation of its outside advisors, but often does. The mixed votes suggest the FDA will likely grant Biogen accelerated approval for tofersen based on preliminary evidence. This would allow the company to market the drug while it collects additional data to confirm its benefit.
Benefits Pro offers guidance on employer-sponsored health plan coverage of the new weight loss drugs, Mounjaro, Saxenda, and Wegovy. OPM has already decided that FEHB carriers will oprovidecoverage of one or more of these drugs in their 2024 formularies. Currently, carriers are developing their 2024 benefit and rate proposals.
The FEHBlog has flipped his lid because he discovered that OPM hhadrefreshed its FEHB carrier website. This merits further investigation.
Federal health regulators are nearing a decision on whether to authorize a second round of the Omicron-targeted booster shots for the elderly and other people at high-risk of severe Covid-19, people familiar with the agency’s deliberations said.
Food and Drug Administration officials could make the decision within a few weeks, the people said.
The officials are moving toward authorizing the second jabs of the Omicron-targeted shots for people who are 65 years and older or who have weakened immune systems, though the officials haven’t reached a final decision and could change their mind, one of the people said.
The Centers for Disease Control and Prevention would then have to recommend the shots for them to become widely available.
From the primary care front, Healthcare Finance informs us
People are shifting away from traditional primary care providers, with about three in 10 foregoing primary care altogether between 2016 and 2022, according to FAIR Health’s new analysis of private claims data.
That number, though, ranged from a high of 43% in Tennessee to a low of 16% in Massachusetts, suggesting significant regional variations. Of the providers who performed primary care services in that time, 56% were physicians, while 44% were nonphysicians. * * *
The analysis pointed to evidence showing that primary care improves health regardless of age, sex, race, ethnicity, education, employment, income, health insurance and smoking status. It has also been reported that a gain of 10 additional primary care physicians per 100,000 people is associated with an increase in life expectancy by 51.5 days.
Guiding members to primary care providers is a vital health plan task, in the FEHBlog’s opinion.
From the miscellany department —
Health IT Analytics highlights, “Researchers from Utica University recently leveraged socioeconomic data to gain insights into generational poverty and other health equity barriers that impact patients’ ability to prioritize their health to improve clinical outcomes.”Hela
Health Payer Intelligence relates, “The National Alliance of Healthcare Purchaser Coalitions (National Alliance) has announced the publication of its playbook which aims to encourage biosimilar adoption among employers.”
EHR Intelligence informs us, “Nuance Communications, a Microsoft company, has announced Dragon Ambient eXperience (DAX) Express, the first clinical documentation application to combine conversational and ambient artificial intelligence (AI) with OpenAI’s newest model, ChatGPT-4.:
The FEHBlog’s Friday Insights did not publish as scheduled on Saturday morning. To get the email distribution back on schedule the FEHBlog is combining the Weekend Update and the Cybersecurity Saturday posts below.
Recently, the Centers for Medicare and Medicaid Services confirmed that the No Surprises Act air ambulance reporting will not occur in 2023.
Under section 106 of the No Surprises Act, air ambulance providers, insurance companies, and employer-based health plans must submit to federal regulators information about air ambulance services provided to consumers. The Centers for Medicare & Medicaid Services (CMS) in the Department of Health & Human Services (HHS) is conducting this Air Ambulance data collection (AADC), which will be used to develop a public report on air ambulance services. The proposed rules describing the proposed form and manner of the data collection can be found at this link. The final rules will specify the final reporting requirements, including the data elements and the deadlines for the data collection. The data collection will not begin until after the final rules are published. This page will be updated when the rules are finalized and more information on data collection is available.
From the value added care front, Behavioral Health Business discusses how Aetna and Optum are collaborating with a large mental health provider, Universal Health Services, to develop reliable outcome measurements for mental health services.
When the FDA approved bempedoic acid, marketed under the brand name Nexletol, back in 2020, it was clear that the drug helped lower LDL — “bad”cholesterol. The drug was intended for people who can’t tolerate statin medications due to muscle pain, which is a side effect reported by up to 29% of people who take statins.
What was unknown until now, is whether bempedoic acid also reduced the risk of cardiovascular events. Now, the results of a randomized, controlled trial published in TheNew England Journal of Medicine point to significant benefit. The study included about 14,000 people, all of whom were statin intolerant.
“The big effect was on heart attacks,” says study author Dr. Steven Nissen of Cleveland Clinic.
People who took daily doses of bempedoic acid for more than three years had about a 23% lower risk of having a heart attack, in that period, compared to those taking a placebo.There was also a 19% reduction in coronary revascularizations, which are procedures that restore blood flow to the heart, such as a bypass operation or stenting to open arteries.
A common chemical that is used in correction fluid, paint removers, gun cleaners, aerosol cleaning products, and dry cleaning may be the key culprit behind the dramatic increase in Parkinson’s disease (PD), researchers say.
An international team of researchers reviewed previous research and cited data that suggest the chemical trichloroethylene (TCE) is associated with as much as a 500% increased risk for Parkinson’s disease (PD).
Lead investigator Ray Dorsey, MD, professor of neurology, University of Rochester, New York, called PD “the world’s fastest-growing brain disease,” and told Medscape Medical News that it “may be largely preventable.”
“Countless people have died over generations from cancer and other disease linked to TCE [and] Parkinson’s may be the latest,” he said. “Banning these chemicals, containing contaminated sites, and protecting homes, schools, and buildings at risk may all create a world where Parkinson’s is increasingly rare, not common.”
The paper was published online March 14 in the Journal of Parkinson’s Disease.
The FEHBlog has several friends with Parkinson’s Disease.
From the Medicare front, Health Payer Intelligence relates
Beneficiaries with end-stage renal disease (ESRD) are increasingly shifting from Medicare fee-for-service (FFS) to Medicare Advantage, leading more Medicare Advantage plans to form value-based arrangements with kidney care management companies, according to Avalere.
Beneficiaries with ESRD have typically received coverage through Medicare FFS because only those already enrolled in a Medicare Advantage plan before initiating dialysis were eligible for the private program through 2020.
A provision under the 21st Century Cures Act that went into effect on January 1, 2021, made all Medicare beneficiaries with ESRD eligible to enroll in Medicare Advantage plans.
Although patient safety awareness week is over, the Wall Street Journal makes us aware that
Black boxes on airplanes record detailed information about flights. Now, a technology that goes by the same name and captures just about everything that goes on in an operating room during a surgery is making its way into hospitals.
The OR Black Box, a system of sensors and software, is being used in operating rooms in 24 hospitals in the U.S., Canada and Western Europe. Video, audio, patient vital signs and data from surgical devices are among the information being captured.
The technology is being used primarily to analyze operating-room practices in hopes of reducing medical errors, improving patient safety and making operating rooms more efficient. It can also help hospitals figure out what happened if an operation goes wrong. * * *
Duke University Hospital, where two operating rooms are equipped with black boxes, is using the technology to study and improve on patient positioning for surgery to reduce the possibility of skin-tissue and nerve injuries. It is also studying and using the technology to improve communication among nursing personnel throughout a surgical procedure to ensure that key tasks—such as confirming that surgical instruments and medical devices are available for a procedure—are being completed promptly, effectively and efficiently.
Cybersecurity Saturday
From the cybersecurity policy front, the American Hospital Association informs us that
The Senate Homeland Security and Governmental Affairs Committee held a full Committee hearing examining cybersecurity risks to the healthcare sector on March 16. Witnesses included Scott Dresen, chief information security officer for Corewell Health, a large integrated health system in Michigan.
“The increasing frequency of attack from nation state actors and organized crime has created a sense of urgency within the healthcare sector and we need help from the United States government to respond to these threats more effectively,” Dresen said.
Specifically, he called for enhancing existing partnerships with and between federal agencies, expanding the sharing of actionable threat intelligence, incentivizing access to affordable technology to defend against advanced threats, ensuring there is an adequate cyber workforce, and reforming legislation to encourage the adoption of best practices while not penalizing the victims of cyberattacks.
STAT News reveals why an HHS rule amending the HIPAA Privacy Rule will wreak financial havoc on health systems. The proposed rule was issued in January 2021, so the final rule has been pending for a long time.
The Cybersecurity and Infrastructure Security Agency (CISA) is looking to position a new “Cyber Analytics and Data System” at the center of national cyber defenses, as the agency’s post-EINSTEIN plans come into focus in its fiscal 2024 budget request.
CISA is seeking $424.9 million in the 2024 budget for “CADS.” The program is envisioned as a “system of systems,” budget documents explain, that provides “a robust and scalable analytic environment capable of integrating mission visibility data sets and providing visualization tools and advanced analytic capabilities to CISA cyber operators.”
The new program is part of the “restructuring” of the National Cybersecurity Protection System, according to the documents. More commonly known as “EINSTEIN,” the NCPS has been in place to defend federal agency networks since the Department of Homeland Security’s inception in 2003.
From the cyber breaches front, Tech Target brings us up to date on the DC Health Link breach.
An additional wrinkle to the breach came Monday [March 13] when another user on the same dark web forum using the alias Denfur, who had previously published sample data from the breach, created a thread supposedly aiming to clear up misinformation surrounding the breach.
Claiming to be a friend of IntelBroker, Denfur said the attack vector for the breach was an exposed, insecure database belonging to DC Health Link. Moreover, the poster said the database was likely exposed “for over a year and a half” before the breach occurred. TechTarget Editorial contacted DC Health Link in order to verify Denfur’s claims, but a spokesperson declined to comment.
At least two hacking groups were able to gain access to at least one federal agency’s servers through an old vulnerability in a software development and design product, according to a cybersecurity advisory issued Wednesday.
According to an alert issued by the Cybersecurity and Infrastructure Security Agency, or CISA, hackers were able to gain access to and run unauthorized code on a federal agency’s server, though they were not able to gain privileged access or move deeper into the network. The malicious activity was observed between November 2022 and early January, though the initial compromise goes as far back as August 2021.
Hackers used a vulnerability in old versions of Telerik UI, a software developer kit for designing apps, which, when exploited, allows hackers with access to execute code. The vulnerability was discovered in 2019 and builds on previous vulnerabilities discovered in 2017 that allow bad actors to gain privileged access and “successfully execute remote code on the vulnerable web server.”
The National Vulnerability Database—managed by the National Institute of Standards and Technology—rates this a critical vulnerability, with a score of 9.8 out of 10.
From the cyber vulnerabilities front, HHS’s Healthcare Cybersecurity Coordination Center (HC3) released its February 2023 list of vulnerabilities of interest to the health sector.
In February 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for this month are from Microsoft, Google/Android, Apple, Mozilla, SAP, Citrix, Intel, Cisco, VMWare, Fortinet, and Adobe. A vulnerability is given the classification as a zero-day if it is actively exploited with no fix available or is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.
Researchers are warning that state-linked and financially motivated threat actors may try to exploit a critical zero-day vulnerability in Microsoft Outlook to launch new attacks against unpatched systems.
Microsoft urged customers to patch their systems against CVE-2023-23397 to address the critical escalation of privilege vulnerability in Microsoft Outlook for Windows, the company said Tuesday. Microsoft Threat Intelligence warned that a Russia-based threat actor launched attacks against targeted victims in several European countries.
Mandiant researchers warned that other criminal and cyber-espionage actors will race to find new victims vulnerable to the zero day before organizations can apply patches.
CISA added three and then one more known exploited vulnerability to its catalog this week.
Security Week highlights that “Deepfakes are becoming increasingly popular with cybercriminals, and as these technologies become even easier to use, organizations must become even more vigilant.”
Deepfakes are part of the ongoing trend of weaponized AI. They’re extremely effective in the context of social engineering because they use AI to mimic human communications so well. With tools like these, malicious actors can easily hoodwink people into giving them credentials or other sensitive information, or even transfer money for instant financial gain. Deepfakes represent the next generation of fraud, by enabling bad actors to impersonate people more accurately and thus trick employees, friends, customers, etc., into doing things like turning over sensitive credentials or wiring money.
Here’s one real-world example: Bad actors used deepfake voice technology to defraud a company by using AI to mimic the voice of a CEO to persuade an employee to transfer nearly $250,000 to a Hungarian supplier. Earlier this year, the FBI also warned of an uptick in the use of deepfakes and stolen PII to apply for remote work jobs – especially for positions with access to a lot of sensitive customer data.
The Security Week article also discusses defenses to deepfake tactics.
From the ransomware date infiltration front –
The Federal Bureau of Investigation (FBI), CISA, and the Multi-State Information Sharing and Analysis Center (MS-ISAC) has released a joint cybersecurity advisory (CSA), #StopRansomware: LockBit 3.0. This joint advisory details known indicators of compromise (IOCs) and tactics, techniques, and procedures (TTPs) that FBI investigations correlatedwith LockBit 3.0 ransomware as recently as March 2023. LockBit 3.0 functions as an affiliate-based ransomware variant and is a continuation of LockBit 2.0 and LockBit. CISA encourages network defenders to review and apply the recommendations in the Mitigations section of this CSA.
“Black Basta was initially spotted in early 2022, known for its double extortion attack, the Russian-speaking group not only executes ransomware but also exfiltrates sensitive data, operating a cybercrime marketplace to publicly release it, should a victim fail to pay a ransom. The threat group’s prolific targeting of at least 20 victims in its first two weeks of operation indicates that it is experienced in ransomware and has a steady source of initial access. The level of sophistication by its proficient ransomware operators, and reluctance to recruit or advertise on Dark Web forums, supports why many suspect the nascent Black Basta may even be a rebrand of the Russian-speaking RaaS threat group Conti, or also linked to other Russian-speaking cyber threat groups. Previous HC3 Analyst Notes on Conti and BlackMatter even reinforce the similar tactics, techniques, and procedures (TTPs) shared with Black Basta. Nevertheless, as ransomware attacks continue to increase, this Threat Profile highlights the emerging group and its seasoned cybercriminals and provides best practices to lower risks of being victimized.”
Here is a link to the always interesting Bleeping Computer Week in Ransomware.
the creation of the Ransomware Vulnerability Warning Pilot (RVWP). Through the RVWP, CISA:
Proactively identifies information systems—belonging to critical infrastructure entities—that contain vulnerabilities commonly associated with ransomware intrusions.
Notifies the owners of the affected information systems, which enables the owners to mitigate the vulnerabilities before damaging intrusions occur.
Review the RVWP webpage for details, including information on the authorities and services CISA leverages to enable RVWP notifications.
HelpNetSecurity tells us how to use ChatGPT to improve cyber defenses.
From the OPM front, Federal News Efforts lays out the OPM issues raised by the House Oversight Accountability Committee, including an FEHB improper payments issue.
The Federal Employees Health Benefits (FEHB) Program came under scrutiny during the committee hearing. Several members pointed to a report from the Government Accountability Office showing that OPM spends about $1 billion annually on ineligible FEHB members.
Without a monitoring mechanism to identify and remove ineligible members from FEHB, GAO said these costs will keep accruing.
“GAO’s report suggests OPM has been aware of this problem for years but has consistently failed to address it effectively. As GAO recounts, OPM acknowledged the possibility of a problem when it issued regulations in 2018 allowing agencies and participating insurers to request proof of eligibility for federal employees’ family members. OPM did not, however, actually require proof of eligibility,” Chairman James Comer (R-Ky.) said in a Jan. 23 letter to Ahuja.
In response to the concerns, Ahuja said during the hearing that OPM is working on creating a master enrollment index (MEI) — essentially a roster of FEHB subscribers and family members. The creation of an MEI has been in the works in OPM’s FEHB department for at least the last couple of years.
“We have been focused on this issue,” Ahuja said. “It’s a very decentralized health benefits program. We’ve been working with agencies and carriers to be able to ensure that we manage any ineligibility.”
Ahuja said the index will help clear up discrepancies in FEHB enrollment between both agencies and health carriers.
“That’s going to be a way forward,” she said.
With all due respect to the Director, the key problem is that OPM has never provided FEHB carriers with an enrollment roster that ties individuals to premiums paid for (and by) them. Until carriers can reconcile premiums with enrollment, the Master Enrollment Index remains flawed
HIPAA offers a widely used “820” electronic transaction standard for this purpose. In a perfect world, OPM would have rolled out the use of the 820 transactions to allow carriers to clean their enrollment records. It’s not too late, and doing so should be prioritized over the family member issue and centralization.
Family member eligibility is a secondary issue because 48% of FEHB enrollment is self-only, and the FEHB Program family member size averages under three people. The family member eligibility issue can be addressed with surveys based on statistical sampling rather than the entire enrollment of eligible family members.
The private sector uses the HIPAA 820, and randomized family member eligibility audits to keep enrollment records accurate.
From the CMS front, the American Hospital Association tells us that following up on U.S. District Judge Jeremy Kernodle’s February 6, 2023, revisions to the No Surprises Act’s (NSA) independent dispute resolution/arbitration rule:
The Centers for Medicare & Medicaid Services today instructed certified independent dispute resolution entities to resume making payment determinations for disputes involving items or services furnished on or after Oct. 25, 2022. Updated guidance to disputing parties regarding disputes involving items and services furnished on or after Oct. 25, 2022 is posted here. CMS also announced that starting March 17, disputing parties will begin receiving a majority of their payment determination notices from the IDR portal, specifically from auto-reply-federalidrquestions@cms.hhs.gov. Disputing parties are advised to make note of this email address.
The FEHBlog finds it mysterious that this guidance is coming from CMS when Medicare and Medicaid are exempt from the NSA.
In other CMS news
The Centers for Medicare & Medicaid Services will make whole health care providers impacted by lowered coinsurance on 27 Medicare Part B prescription drugs. The reduced coinsurance rates, which are required by the Inflation Reduction Act, take effect April 1 and will remain in effect through June 30. CMS in a fact sheet says it will pay impacted health care providers the difference between the full and reduced adjusted beneficiary coinsurance (in addition to their usual payment), after applying the Part B deductible and prior to sequestration, if applicable.
That’s good news because other FEHB and other plans providing secondary coverage would be picking up that cost.
In conference news, Fierce Healthcare discusses policy presentations from HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-Lasure at an AHIP conference and health and medtech presentations from the South by Southwest conference in Austin.
Improving the mental health workforce shortage is one of the Substance Abuse and Mental Health Services Administration’s top priorities right now, said Miriam Delphin-Rittmon, assistant secretary for mental health and substance use at HHS and the administrator of SAMHSA. To tackle this, the organization has several resources and grant programs in place to recruit more providers and support primary care physicians in treating mental health.
Each of these conferences was held this week.
From the public health front, CMS’s biweekly review of its Covid statisticstells us
As we mark three years of the COVID-19 pandemic, cases, deaths, and hospitalizations have all been decreasing steadily. Much of the U.S. population has some form of immunity, either through vaccination or previous infection. In addition, CDC’s 2023 Child and Adolescent Immunization Schedule now includes COVID-19 primary vaccine series and links to the latest guidance on booster dose vaccination in all populations.
The Wall Street Journal offers former CDC Director Tom Frieden view on the past three pandemic years.
The CDC’s Fluview continues to report “Seasonal influenza activity remains low nationally.”
The New York Times highlights a recent breakthrough in stroke treatment. The article reports that this breakthrough allowed John Fetterman to be a U.S. Senator from Pennsylvania. Here’s the catch.
There’s a number that floats around in medicine: It takes, on average, 17 years for a new treatment or technique, or some other form of research breakthrough, to filter down into widespread clinical practice. But the actual timeline varies widely from case to case. “What everybody’s trying to do is speed up that process,” says Dr. Sharon Straus, the director of the Knowledge Translation Program at St. Michael’s Hospital in Toronto. (“Knowledge translation” is one of several terms for a young, multidisciplinary field that aims to better understand and improve the medical research-to-practice pipeline.) “Some things do take off more quickly.”
That number of years is sobering. Good luck, Dr. Straus.
In FSAFeds news, the Internal Revenue Service issued FAQs addressing “whether certain costs related to nutrition, wellness, and general health are medical expenses under section 213 of the Internal Revenue Code (Code) that may be paid or reimbursed under a health savings account (HSA), health flexible spending arrangement (FSA), Archer medical savings account (Archer MSA), or health reimbursement arrangement (HRA).”
In the three years since Covid-19 surfaced in the U.S., most Americans have been infected and are largely back to their prepandemic routines and workaday lives.
Scientists, still in the dark about what the virus will do in the long term, warn it is too early to sound the all clear. Despite the success of a global effort to decode the SARS-CoV-2 virus and create vaccines and treatments to combat it, there remains uncertainty about how the virus will behave, the path of its mutations and Covid-19’s long-term effects.
Covid-19 vaccines are widely available, but researchers don’t yet know enough about how the virus might change or how long immunity lasts to be certain who should get future boosters or how often. The unknowns could have public-health consequences in the years ahead, virus experts said.
“A big question is how will that play out over time?” Bronwyn MacInnis said of the virus’s mutations. She is director of pathogen genomic surveillance at the Broad Instituteof MIT and Harvard, a biomedical researchcenter in Cambridge, Mass. “Are there other tricks we have yet to see?” she said. * * *
“Any time someone talks about Covid, I think it’s good to start with a lot of humility,” Moderna Chief Executive Officer Stéphane Bancel said. “It’s still a new virus. So we don’t know everything.”
The Food and Drug Administration (FDA) announced amending “the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.”
Yesterday, The FDA took the following steps concerning the Johnson and Johnson (Jannsen) vaccine.
The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The Fact Sheet for Recipients and Caregivers was also revised to include information about myocarditis and pericarditis following the administration of the Janssen COVID‑19 Vaccine. An additional revision to the Fact Sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use. Also, the scope of authorization for a booster dose of the Janssen COVID-19 Vaccine has been revised to reflect that the vaccine may be administered as a first booster dose at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. The FDA reissued the letter of authorization for the Janssen COVID-19 Vaccine to revise the scope of authorization related to the administration of a booster dose and the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Janssen Biotech, Inc. to include myocarditis and pericarditis.
The Janssen COVID-19 Vaccine is authorized for emergency use for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The letter of authorization and revised fact sheets are available on the FDA’s website.
From the Rx coverage front —
Fierce Healthcare offers its insights into why the Veterans Administration decided to offer the new Alzheimer’s Disease drug Leqembi to its patients who are eligible for the drug under the FDA’s guidance. Fierce Healthcare does not expect to CMS to follow this approach later this year. Currently, Medicare covers the drug when offered in a clinical trial, while the FDA’s approach is much broader.
Novo, one of the biggest sellers of insulin in the U.S. and around the world, said Tuesday it would cut the list price of its NovoLog insulin by 75% and the prices for Novolin and Levemir by 65% starting in January 2024.
In addition, Novo plans to cut prices for its unbranded insulin products to match the reduced price of Novo’s corresponding brands.
The Centers for Disease Control issued a Vital Signs report titled “Progress Toward Eliminating HIV as a Global Public Health Threat Through Scale-Up of Antiretroviral Therapy and Health System” over the period 2004 through 2022.
What is already known about this topic?
The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) began providing HIV antiretroviral therapy (ART) worldwide in 2004. [At that time, George W. Bush was President.} Through viral load suppression, effective ART improves health outcomes and prevents transmission.
What is added by this report?
By 2022, approximately 20 million persons with HIV infection in 54 countries received PEPFAR-supported ART (62% CDC-supported); this number represents an increase of 300-fold from 66,6550 in 2004. During 2015–2022, viral load suppression rates increased from 80% to 95% among those who received testing.
What are the implications for public health practice?
To eliminate HIV as a global public health threat, achievements must be sustained and expanded to reach all subpopulations. PEPFAR remains committed to tackling HIV while strengthening public health systems and global health security.
Beckers Hospital Review tells us that drug shortages in U.S. emergency departments are increasing. “Standard antibiotics such as amoxicillin continue to be in short supply, as do dextrose 50, dextrose 25, dexamethasone and betamethasone. Even over-the-counter medications such as Tylenol and Motrin are short in some areas due to increased demand, according to Southern Standard.”
In recognition of Patient Safety Awareness Week, Beckers Hospital Review highlights
Healthgrades recognized 864 hospitals with its 2023 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 83 of those hospitals received both awards.
The dual recipients spanned 28 states. Texas had the most dual recipients with 12 honorees — including three Baylor Scott and White Health hospitals.
From the medical research front,
NIH researchers compared a new genetic animal model of Down syndrome to the standard model and found the updated version to be more similar to the changes seen in humans. The new mouse model shows milder cognitive traits compared to a previously studied Down syndrome mouse model. The results of this study, published in Biological Psychiatry, may help researchers develop more precise treatments to improve learning and memory in people with Down syndrome.
“The human brain is profoundly complex, consisting of tens of billions of neurons that form trillions of interconnections. This complex neural wiring that allows us to think, feel, move, and act is surrounded by the blood-brain barrier (BBB), a dense sheet of cells and blood vessels. The BBB blocks dangerous toxins and infectious agents from entering the brain, while allowing nutrients and other essential small molecules to pass right through.
“This gatekeeping function helps to keep the brain healthy, but not when the barrier prevents potentially life-saving drugs from reaching aggressive, inoperable brain tumors. Now, an NIH-funded team reporting in the journal Nature Materials describes a promising new way to ferry cancer drugs across the BBB and reach disease sites [1]. While the researchers have not yet tried this new approach in people, they have some encouraging evidence from studies in mouse models of medulloblastoma, an aggressive brain cancer that’s diagnosed in hundreds of children each year.”
Thanks, research mice.
From the healthcare costs front, the New York Times reports, “Most older cancer patients received invasive care in the last month of their lives, a new study finds. That may not be what they wanted.”
The health care system could improve end-of-life care. When palliative care is introduced soon after a diagnosis, patients have a better quality of life and less depression, a study of people with metastatic lung cancer found. Though they were less likely to undergo aggressive treatment, they survived longer.
Palliative care doctors, skilled in discussions of serious illness, are scarce in some parts of the country, however, and in outpatient practices.
Nomi Health announced today that “Diabetes costs U.S. employers approximately $245 billion a year — more than double what the entire American automotive industry is worth. * * *Employers spend more than $175 billion annually on direct medical and pharmacy costs for diabetic members, in addition to nearly $70 billion on indirect costs from employee absenteeism, reduced productivity and diabetes-related disability, the research showed.”
Additional findings from Nomi Health’s Trends in Spend Tracker research include:
Cost of care for diabetics is increasing twice as fast as for non-diabetics, and it’s growing at a staggering clip of nearly 20% year over year, reaching more than $20,000 average per member per year (PMPY) for employers in 2020-21.
A diabetes diagnosis means higher costs for patients, too, who spend about 240% more annually on medical bills and nearly 450% more on pharmacy expenses than non-diabetics.
The high cost of diabetes extends to the chronic conditions associated with the disease, which often cost more than the diabetes itself. Care for diabetics with ketoacidosis or kidney disease in 2020-21 cost employers 252% above the average, or $68,325 average PMPY.
This retrospective cohort analysis was conducted by Artemis — a leading benefits analytics platform acquired by Nomi Health last year
From the post-Dobbs front, Healthcare Dive relates
Senate Democrats are urging the largest retail pharmacies in the U.S. to ensure access to the abortion pill mifepristone amid ongoing confusion over legal access to the pill.
On Monday, 18 Democrats sent letters to seven of the biggest pharmacy chains in the country requesting more information about their plans to provide customers access to mifepristone — currently an open question for some chains as pressure from anti-abortion lawmakers and lawsuits target the legality of medication abortion.
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