Voice of America’s Asian American Changemakers series premiered its final episode recently, featuring the work of the U.S. Office of Personnel Management and the leadership of Director Kiran Ahuja. Asian American Changemakers is a character-driven docuseries highlighting the lives and experiences of Asian Americans in the political and public arena. * * *
Watch the full Asian American Changemakers episode here and learn more about opportunities to serve at opm.gov.
OPM also informed FEHB carriers that “The recent opinion in Braidwood Management, Inc. v. Becerra, — F. Supp. 3d —, 2023 WL 2703229 (N.D. Tex.), in the U.S. District Court for the Northern District of Texas, pertains to the preventive services requirement under the Affordable Care Act; it does not impact the preventive services requirements for FEHB Carriers.” Regardless, and as the FEHBlog anticipated, writers in Health Affairs suggest sensible administrative law approaches to repairing the Braidwood management problem. For example, “the HHS Secretary could authorize the director of the Agency for Health Care Research and Quality or the CDC director to review and adopt the Task Force’s recommendations, which the CDC director now does before ACIP’s immunization recommendations become effective.” No wonder HHS appealed Braidwood Management to the Fifth Circuit without requesting a stay of the district court’s decision.
In other judicial news, the Washington Post reports
“A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.
“The highly anticipated ruling puts on hold the Food and Drug Administration’s approval of mifepristone, a medication first cleared for use in the United States in 2000. The ruling will not go into effect for seven days to give the government time to appeal.”
Later today, per the AP, “A federal judge in Washington state on Friday ordered U.S. authorities not to make any changes that would restrict access to the abortion medication mifepristone in 17 Democratic-led states that sued over the issue, countering a ruling by a judge in Texas on the same day that ordered a hold on federal approval of the drug.”
From the healthcare of the near future front —
Medscape relates
“US regulators may soon clear blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.
“Most recently, Guardant Health, Inc., announced the completion of its US premarket approval application for its Shield blood test to screen for CRC. Approval by the US Food and Drug Administration (FDA) would position Guardant to later secure Medicare coverage for its test.
“Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.
I”f these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.”
A Wall Street Journal essay digs into why “doctors are turning to artificial intelligence to help them make the best decisions for patients.
From the public health front –
Fierce Healthcare informs us “Black mothers living in the least vulnerable areas of the U.S. are more likely to die or have worse birth outcomes compared to white mothers living in the most vulnerable areas, a sweeping new study has found.”
Fierce Healthcare tells us “Reports of serious patient safety events among healthcare facilities in 2022 rose 19% from 2021 with falls, the most common such event, rising nearly 27%, according to data reported to The Joint Commission and released Tuesday.”
From the Omicron and siblings front, Kaiser Family News reports
More than three years into the COVID-19 pandemic, about half (53%) the public says they would likely get an annual COVID-19 vaccine if offered similar to an annual flu shot, the latest KFF COVID-19 Vaccine Monitor finds. This includes about a third (32%) who would be “very likely” to do so. The findings provide a window into the potential uptake of an annual COVID-19 vaccine, which the Food and Drug Administration has raised as a potential option to provide future protection from the virus.
* * *
Nearly a quarter (23%) of adults say they’ve gotten the latest bivalent COVID-19 booster, which has been available since September. Similar shares say they have received an earlier booster shot (25%) or have gotten their initial course of vaccinations but no booster (25%). That leaves slightly more than a quarter (27%) who say that they are either partially vaccinated or not vaccinated at all.
Half (49%) of adults say they’ve heard at least something about the Biden administration’s plan to end the COVID-19 public health emergency on May 11.
* * *
Nearly a third (32%) of all adults nationally say they have never tested positive for COVID-19 or never thought they’ve had the virus, and the new survey examines their experiences. This never-had-it group includes nearly half (46%) of adults ages 65 and older, who generally had earlier access to the vaccines due to their high risks.
In other public health news
“The U.S. Department of Health and Human Services (HHS) released a National Cancer Plan, developed by the National Institutes of Health’s (NIH) National Cancer Institute (NCI). The plan provides a framework for everyone—across the federal government and all of society—to collaborate in ending cancer as we know it, and to realize the vision laid out by President Joe Biden and First Lady Jill Biden’s Cancer Moonshot.”
“The U.S. National Institute on Aging (NIA) is funding a 6-year, up to $300 million project to build a massive Alzheimer’s research database that can track the health of Americans for decades and enable researchers to gain new insights on the brain-wasting disease.
“The NIA, part of the government’s National Institutes of Health (NIH), aims to build a data platform capable of housing long-term health information on 70% to 90% of the U.S. population, officials told Reuters of the grant, which had not been previously reported.”
Bloomberg Prognosis looks back at the perfect storm of serious ailments that afflicted children worldwide last year. The culprit was socially distancing the kids.
In FDA and drug development news
BioPharma Dive points out five FDA drug decisions to watch for in this quarter. “By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy, two vaccines for RSV and a closely watched ALS drug.”
“The U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”
The Wall Street Journal offers a fascinating look at how Lilly reengineered its drug development business. The article explained that in the last decade, Lilly focused on non-interference with the patent status of existing blockbuster drugs, e.g., squeezing the last egg out of the golden goose. Late last decade, Lilly redirected its focus to bringing new drugs to market regardless of patent concerns. As a result, Lilly is close to receiving FDA market approval for the “King Kong” of obesity drugs Mounjaro.
The drug Mounjaro helped a typical person with obesity who weighed 230 pounds lose up to 50 pounds during a test period of nearly 17 months.
No anti-obesity drug has ever safely made such a difference. In the coming months, it is widely expected to get the go-ahead from U.S. health regulators to be prescribed for losing weight and keeping it off, and some patients are already using it unapproved for that purpose.
The advance of Mounjaro, which is already on the market to treat Type 2 diabetes, has excited doctors and patients who have been waiting decades for effective treatments, while helping turn its maker, Eli Lilly & Co., into themost valuable standalone pharmaceutical company in the U.S. with a market value of more than $300 billion.
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.
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 Wall Street Journal reported this morning that maternal mortality cases in the U.S. spiked in 2021, rising from around 850 to 1200 nationwide. From examining Journal reader comments, the FEHBlog ran across a helpful breakdown of maternal deaths per U.S. state. The lowest maternal death rate is in California, and the highest maternal death rate is in Louisiana. The breakdown points out what the States with the lowest rates are doing right and what the States with the highest rates are doing to remedy the problem. Healthcare is local.
The FEHBlog also was directed to this article from the T.H. Chan public health school at Harvard:
October 21, 2022 – Women in the U.S. who are pregnant or who have recently given birth are more likely to be murdered than to die from obstetric causes—and these homicides are linked to a deadly mix of intimate partner violence and firearms, according to researchers from Harvard T.H. Chan School of Public Health.
Homicide deaths among pregnant women are more prevalent than deaths from hypertensive disorders, hemorrhage, or sepsis, wrote Rebecca Lawn, postdoctoral research fellow, and Karestan Koenen, professor of psychiatric epidemiology, in an October 19 editorial in the journal BMJ.
The U.S. has a higher prevalence of intimate partner violence than comparable countries, such violence is often fatal, and it frequently involves guns, Lawn and Koenen noted. They cited one study that found that, from 2009–2019, 68% of pregnancy-related homicides involved firearms. That study also found that Black women face substantially higher risk of being killed than white or Hispanic women.
I also located the CDC’s website on keeping new mothers alive.
This evening the Journal discussed why our country’s maternal mortality rate is so high.
Finally, STAT News reports that this afternoon the Centers for Disease Control announced preliminary 2022 maternal mortality figures.
Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests.
More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.
Officials say the 2022 maternal death rate is on track to get close to pre-pandemic levels. But that’s not great: The rate before Covid-19 was the highest it had been in decades.
The CDC counts women who die while pregnant, during childbirth, and up to 42 days after birth. Excessive bleeding, blood vessel blockages, and infections are leading causes.
Covid-19 can be particularly dangerous to pregnant women, and experts believe it was the main reason for the 2021 spike. Burned out physicians may have added to the risk by ignoring pregnant women’s worries, some advocates said.
In 2021, there were about 33 maternal deaths for every 100,000 live births. The last time the government recorded a rate that high was 1964.
What happened “isn’t that hard to explain,” said Eugene Declercq, a long-time maternal mortality researcher at Boston University. “The surge was Covid-related.”
The FEHBlog’s goal is to provide perspective on this vital issue.
From the Omicron and siblings front, MedPage Today informs us
An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19.
By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to reduce the risk of hospitalization or death in outpatients at risk for severe outcomes.
“Besides oxygen, Paxlovid has probably been the single most important treatment tool in this epidemic, and it continues to be,” said Richard Murphy, MD, MPH, of the White River Junction VA Medical Center in Hartford, Vermont.
The Mercer consulting firm considers employer approaches to coverage of Covid tests following the end of the public health emergency.
Employers have some important decisions to make over the next two months before the COVID Public Health Emergency (PHE) comes to an end on May 11. One is how to handle cost-sharing for PCR and other COVID tests and related services provided by a licensed healthcare or otherwise authorized provider. Under the PHE, group health plans had to cover testing received either in- or out-of-network at no cost to participants.
We recently polled recipients of our New Shape of Work newsletter to ask whether they planned to impose cost-sharing requirements once allowed. Of the more than 1,000 readers who responded, about half indicated that their organization will not make any change when the PHE ends: 22% will continue to cover PCR testing at 100% both in- and out-of-network, and 29% say that they require COVID testing at their worksites and provide it at no cost. Only about a fourth (26%) will now require cost-sharing from participants even when they use an in-network facility for testing; about another fourth (23%) will add a cost-sharing requirement only for out-of-network services.
Personally, the FEHBlog would opt for restoring a cost-sharing requirement only for out-of-network services.
From the Rx coverage front
STAT News tells us, “Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024.”
The Mercer consulting firm offers its perspective on coverage of the new era of weight loss drugs, e.g., Ozempic.
For plans covering weight-loss medications, adding prior authorization criteria can help manage cost growth. These include requirements such as a certain body mass index (BMI), co-morbid conditions, enrollment in a behavior modification program, and/or reduced calorie diet. Upon initiation of therapy, patients and clinicians should partner to create a comprehensive plan to achieve goals and use the medication purposefully alongside a targeted and managed lifestyle program. The plan should include a discussion regarding medication discontinuation when/if goals are met to prevent relapse and weight regain/ weight cycling. Medical nutrition therapy (MNT) with a registered dietitian should be covered; ideally 14 in-person or telenutrition sessions.
Cognitive-behavioral therapy, self-monitoring, motivational interviewing, structured meal plans, portion control and goal setting are recommended interventions. Ideally, patients would progress from dietary intervention (covered MNT or weight management solution), to weight loss medications, and then, potentially, to bariatric surgery.
In recognition of Patient Safety Awareness Week, the Partnership to Fight Infectious Disease announced, making March 18 a day of action to raise awareness of the need to #squashsuperbugs so that we can all do our part to prepare and perhaps even prevent a future pandemic due to antibiotic resistance.
From the No Surprises Act front, Fierce Healthcare reports
An “astronomical” number of surprise billing arbitration dispute cases is impacting the Centers for Medicare & Medicaid Services (CMS), a top agency official said.
Education and communication are integral to an “orderly transition” in the handling of independent dispute resolutions for out-of-pocket charges, the official said. The agency has grappled with legal issues and implementation hiccups surrounding a controversial process for settling feuds between payers and providers on out-of-network charges.
“We are seeing more than expected number of disputes getting to that last stopgap part, which is the independent dispute resolution part,” said Ellen Montz, director of CMS’ Center for Consumer Information and Insurance Oversight. Montz spoke during a session Wednesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C.
The agency is also seeing a lot of ineligible cases that don’t qualify for the dispute resolution process, which requires a third party to choose between out-of-network charges submitted by the payer and provider.
These ineligible cases require “a lot of casework, phone calls and back and forth to determine eligibility,” Montz said.
The group that advises Congress on Medicare policy is recommending updating base physician payment rates by 1.45% for 2024, according to its annual March report out Wednesday.
The Medicare Advisory Payment Commission, or MedPAC, did not make recommendations for ambulatory surgery center payment updates or for Medicare Advantage plans.
The commission did note concern with MA plan coding intensity, and said Medicare now spends more on MA enrollees than it would have spent had those enrollees remained in fee-for-service plans.
The FEHBlog doubts that this MedPAC report made anyone happy.
From the federal employee benefits front, FedWeek reminds folks that while the dependent care flexible spending accounts available to federal employees typically are used for child care, they also can be used for senior care in certain circumstances.
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.
From our Nation’s capital, the President presented his Fiscal Year 2024 budget to Congress today. Roll Call informs us
While spending would increase by $1.9 trillion over a decade, revenue would increase by $4.7 trillion, for over $2.8 trillion in a 10-year deficit reduction. But according to the Office of Management and Budget’s numbers, the budget shortfall would still total more than $17 trillion over the next decade even if Biden’s plans were fully implemented, which seems unlikely.
The Wall Street Journal adds, “Biden’s budget shows the rising cost of leaving Medicare and Social Security untouched. In the President’s blueprint, the two programs plus interest consume a sharply growing share of economic output.
The President’s proposed spending and tax increases will face an unfriendly reception among Republicans in Congress, as lawmakers gear up for a fight over the debt ceiling that could come before the Sept. 30 end of the fiscal year. GOP leaders in the House have called for unspecified spending cuts as a condition of raising the federal debt limit. But the president has said he won’t negotiate over raising the debt ceiling.
Republicans plan to release their own budget proposal in the coming months, though they haven’t agreed on a plan.
The President will make public more budget details over the next few days. Until then, it’s worth noting that the budget includes the following healthcare proposal
The budget proposes $11 billion for a five-year effort the White House hopes will eliminate hepatitis C in the U.S., said Dr. Francis Collins, the former National Institutes of Health director who is spearheading the initiative. Drugs to treat the disease have been on the market since 2013, but normally retail for about $24,000 per patient.
In related news, the American Hospital Association tells us,
“The Centers for Disease Control and Prevention [CDC] today recommended screening all U.S. adults at least once in their lifetime for hepatitis B using three laboratory tests. It also expanded risk-based testing recommendations to certain populations and activities with increased risk for the hepatitis B virus.”
The FEHBlog is unsure how this meshes with the ACA’s preventive services mandate because the current US Preventive Services Task Force recommendation is Grade B for “screening for hepatitis B virus (HBV) infection in adolescents and adults at increased risk for infection.” The CDC’s new recommendation is significantly broader.
The Office of Personnel Management released on March 7 “a new memorandum today detailing a vision for the future of the workforce: a Federal government with a workforce that is inclusive, agile and engaged, with the right skills to enable mission delivery.”
From the public health front —
The Kaiser Family Foundation notes ten numbers to mark the third anniversary of the Covid pandemic
The Dana Farber Cancer Institute highlights a comprehensive article about colon cancer in young adults.
The Food and Drug Administration “published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.
The New York Times reports, “A review of poisonings among children 5 and younger found that opioids contributed to nearly half of the deaths from 2005 to 2018, largely from accidental overdoses, according to new research. * * * The study, published on Wednesday in the journal Pediatrics, analyzed 731 poisoning-related deaths that occurred from 2005 to 2018 across 40 states.”
From weight loss drugs front —
STAT News continues its reporting on obesity drugs. The latest article concerns “‘Emotional hunger’ vs. ‘hungry gut’: The attempt to subtype obesity and tailor treatments.”
Medscape provides the account of a physician who took the new obesity drugs, specifically Ozempic. This article is particularly worth a gander.
From the SDOH front, Mercer Consulting lays out its latest “Must-Do Strategy: Lean in on Benefits Strategy to Support DEI Goals.”
From the miscellany department
Cigna offers its insights on how to choose among virtual care, urgent care centers, and emergency rooms.
“In a March 8 Twitter thread, the FDA acknowledged it’s aware of a potential drug supply disruption after Gurnee, Ill.-based Akorn Operating Co. closed in late February.
“The FDA clarified that the ongoing shortage is of a specific albuterol inhalation solution used in nebulizers, typically in hospitals, for patients having trouble breathing, not in inhalers at the consumer level. The agency said it is working with manufacturers to ease the shortage and “reiterated that outsourcing facilities may compound the specific product.”
Finally, following up on the FEHBlog’s message to Congress about FEHB prescription drug costs, OPM stated its position against carving out prescription drug coverage from FEHB carrier responsibilities in the agency’s FY 2018 annual financial report on page 123:
OPM does not concur with OIG’s suggestion that OPM continue to pursue efforts towards a prescription carve-out program. The Federal Employees Health Benefits (FEHB) Program is a market-based program that provides complete health benefits within each FEHB plan. The FEHB Program is not a self-funded plan and its statutory framework does not contemplate it to be the direct payer of benefits. Each FEHB Program plan offers comprehensive medical services including services provided by physicians and other health care professionals, hospital services, surgical services, prescription medications, medical supplies and devices, and mental health services. FEHB Program plans compete to offer all of these benefits in a high quality manner at the most competitive price possible.
Carving out pharmacy benefits or any of the other services normally covered under an FEHB Program contract and administering the benefit as a separate contract or program, could undermine the fundamental market-based nature ofthe FEHB Program. It would be disruptive and could lead to a reduction in plan participation, and limit the ability of FEHB carriers to focus on comprehensively improving the health of the population. There would likely be less effective
coordination of medical and pharmacy claims, and potentially less effective, one-size-fits-all pharmacy utilization and disease management programs. OPM is now assessing carrier performance on the basis of clinical quality measures that require tight coordination between medical and pharmacy benefits. A carved out pharmacy benefit is not consistent with or supportive of plan performance assessment, and may impair achievement of OPM’s long-term population health goals. As an example, carriers being held accountable for controlling diabetes and hypertension in the population they serve cannot do so readily if they do not have control over pharmacy benefit design and real time access to adherence data.
To control the cost of prescription drugs, OPM works with carriers to better manage pharmacy networks, focus on drug utilization techniques, coordinate coverage of specialty drugs between the medical and pharmacy benefit, optimize the prescription drug benefit via formulary design, and implement effective cost comparison tools for members and prospective enrollees. Additionally, OPM notes that the most recent drug trend reported by FEHB carriers showed a significantly slower rate of growth compared with previous years, in line with industry trends.
This statement continues to warm the FEHBlog’s heart.
American women are staging a return to the workforce that is helping propel the economy in the face of high inflation and rising interest rates.
Women have gained more jobs than men for four straight months, including in January’s hiring surge, pushing them to hold more than 49.8% of all nonfarm jobs. Female workers last edged higher than men on U.S. payrolls in late2019, before the pandemic sent nearly 12 million women out of jobs, compared with 10 million men.
The Society for Human Resource Management offers five ways employers can reduce gender disparities at work.
Following up on recent posts —
The Wall Street Journal brings us up to date on Lilly’s decision to offer its insulin products on the commercial market with a $35 copayment.
“Lilly comes out the winner of this saga, for now. It dealt PBMs a blow, avoided paying Medicaid rebates that were going to rise next year if its insulin products remained highly-priced, and received plaudits from President Biden. The move also complicates matters for upstarts such as Civica. But Allan Coukell, Civica’s senior vice president of public policy, says plans to introduce low-cost insulin as soon as next year are unchanged.”
Bloomberg offers an article on biological age testing that mentions Elysium Health, whose CEO spoke at the WSJ Health Forum on Monday.
Beckers Hospital Review tells us that the Amoxicillin shortage is continuing. Because Amoxicillin is one of several drug shortages, Pharma News Intelligence offers short-term and long-term management strategies to deal with them.
Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems.
“Now the FDA has released a rare comment clarifying what happened during its authorization process. The new details are raising hopes among other home-test manufacturers that the FDA is becoming more flexible about its requirements for approving at-home flu test kits.”
Beckers Payer Issues informs us,” Providers join payers in urging CMS to halt proposed 2024 Medicare Advantage rates.” Good news for AHIP. Healthcare Dive reviews insurer and trade association comments to CMS on this topic.
The Wall Street Journal highlights the growing backlog of No Surprises Act arbitrations. The silver lining in this cloud is that the litigation-related backup does not impact the law’s Open Negotiation Process. Providers and payers should work to resolve qualifying payment disputes through that effective process.
In other news
JAMA points out a recent CDC report documenting disparities in mental health-related emergency department care.
The Drug Channels blog lists the 15 largest U.S. pharmacies. (Trigger warning the link is principally a sales pitch for Drug Channels, but the information is useful.)
“Abbott received U.S. Food and Drug Administration clearance for what it said will be the first commercially available laboratory blood test to help evaluate traumatic brain injury (TBI), also known as concussion.
“The test offers a result in 18 minutes, allowing clinicians to quickly assess patients with concussion and triage them, the company said Tuesday. A negative test result can rule out the need for a CT scan, eliminating wait time at the hospital.
“The test runs on Abbott’s Alinity i laboratory instrument, making it widely available to U.S. hospitals, the Chicago area-based company said.”
NPR discusses efforts to right various healthcare debt collection wrongs:
“Dozens of advocates for patients and consumers, citing widespread harm caused by medical debt, are pushing the Biden administration to take more aggressive steps to protect Americans from medical bills and debt collectors.
“In letters to the IRS and the Consumer Financial Protection Bureau, the groups call for new federal rules that, among other things, would prohibit debt for medically necessary care from appearing on consumer credit reports.
“And the groups are pressing the IRS to crack down on nonprofit hospital systems that withhold financial assistance from low-income patients or make getting aid cumbersome, another common obstacle KHN documented.”
The House Oversight and Accountability Committee has started an investigation into the role of “pharmacy benefit managers” (PBMs), which act as a middleman between insurance carriers and pharmaceutical companies in healthcare programs, including the FEHB.
“Greater transparency in the PBM industry is vital to determine the impact PBM tactics are having on patients and the pharmaceutical market,” chairman Rep. James Comer, R-Ky., wrote to OPM. He asked for copies of the PBM contracts in the program and information on how they are carried out, as well as for information on the rebates, fees, or other similar charges received by PBMs and any efforts the agency has made to recoup overpayments to them.”
“The use of pharmacy benefit managers has been a long-running issue in the FEHB, with prior proposals—mainly sponsored by Democrats, unsuccessfully—to limit their role or even have OPM negotiate with pharmaceutical companies directly on a program-wide basis.
“The inspector general’s office at OPM also has raised that issue, in a recent report saying that “the discounts and other financial terms differed significantly among carriers, with those that have higher enrollments receiving the best deals, reducing the likelihood that the FEHB is maximizing prescription drug savings.”
“That report recommended that OPM conduct a study on options to hold down prescription drug costs, which account for a quarter of all spending in the FEHB. OPM agreed in principle, although it said it does not have the needed funds to conduct such a study.”
OPM should inform Rep. Comer that
The FEHB Program’s experience-rated carriers, who cover 80% of the FEHB enrollment, are subject to the country’s strictest PBM price transparency arrangement, as far as the FEHBlog knows. Congress should evaluate that system to help the legislative body decide whether transparency should be expanded to ERISA and ACA marketplace plans.
In the late 2010s, OPM announced in a management report that the agency agreed with carriers that the FEHB Program saves money by allowing carriers to manage medical and pharmacy benefits under OPM’s oversight. FEHB plan carrier HealthPartners offers a useful examination of carve-in vs. carve-out Rx program management topics.
OPM has authorized FEHB carriers to offer prescription drug plans integrated with Medicare Part D beginning in 2024. This change will rapidly reduce the FEHB Program’s prescription drug spend to commercial plan levels. It’s not magic.
In sum, the FEHB Program remains a model employer-sponsored health program.
Errata — In Thursday’s post, the FEHBlog’s item on the CDC action concerning Alzheimer’s Drug coverage in Medicare should say that the CDC was NOT changing its position that such coverage is limited to clinical trials.
From the No Surprises Act front, U.S. District Judge Jeremy Kernodle modified the NSA’s independent dispute resolution (IDR) arbitration rule on February 6 so it does not skew in favor of the statutory qualifying payment amount. The FEHBlog personally marked up the relevant portion of the IDR rule to show the edits. The FEHBlog, who represents health plans, does not find the edits earthshaking.
The NSA regulators sensibly told the NSA arbitration community to stop issuing arbitration awards while considering the next steps. This afternoon, the American Hospital Association tells us that an interim step was announced.
Effective Feb. 27, certified independent dispute resolution entities will resume issuing payment determinations for payment disputes involving out-of-network services and items furnished before Oct. 25, 2022, the Centers for Medicare & Medicaid Services announced. CMS has posted guidance for certified IDRs issuing payment determinations for items and services furnished before Oct. 25, 2022.
“The standards governing a certified IDR entity’s consideration of information when making payment determinations in these disputes are provided in the October 2021 interim final rules, as revised by the [February 2022] opinions and orders of the U.S. District Court for the Eastern District of Texas ” CMS said. [This refers to the FEHBlog’s edited portion of the IDR rule without the Judge’s Feburary 6, 2023 edits.]
The agency said IDRs will hold issuance of payment determinations for items or services furnished on or after Oct. 25, 2022 until the departments of Health and Human Services, Labor,The and the Treasury issue further guidance.
There you go.
From the public health front, the CDC’s Covid Data Tracker new cases, hospitalizations, and deaths continue their downward trend, while the CDC’s weekly interpretative review of its Covid data notes that “As of February 23, 2023, there are 67 (2.1%) counties, districts, or territories with a high COVID-19 Community Level, 655 (20.3%) with a medium Community Level, and 2,498 (77.6%) with a low Community Level [of the disease].
Sign of the times — the CDC Weekly Review is moving to a bi-weekly schedule.
The CDC’s FluView, which will shut down at the traditional end of the flu season, reports, “Seasonal flu activity is low nationally.”
Meanwhile, the Food and Drug Administration announced issuing
an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
People with many low-risk sleep factors had reduced all-cause, CV and cancer mortality risk vs. those with one or no low-risk sleep factors, according to data slated for presentation at the American College of Cardiology Scientific Session.
“We saw a clear dose-response relationship, so the more beneficial factors someone has in terms of having higher quality of sleep, they also have a stepwise lowering of all cause and cardiovascular mortality,” Frank Qian, MD, an internal medicine resident physician at Beth Israel Deaconess Medical Center and a clinical fellow in medicine at Harvard Medical School, said in a press release. “These findings emphasize that just getting enough hours of sleep isn’t sufficient. You really have to have restful sleep and not have much trouble falling and staying asleep.”
One in five Americans will experience major depressive disorder in their lifetime, and many will not find relief from current therapies. But now researchers have identified an unexpected source of the problem: inflammation.
Inflammation in the bodymay be triggering or exacerbating depression in the brains ofsome patients. And clinical trial data suggests that targeting and treating the inflammation may be a way to provide more-precise care.
The findings have the potential to revolutionize medical care for depression, an often intractable illness that doesn’t always respond to conventional drug treatments.While current drug treatments target certain neurotransmitters, the new research suggests that in some patients, depressive behaviors may be fueled by the inflammatory process.
The Powerline Blog shares eye-catching charts on the U.S. population’s gray wave.
From the wearables front —
mHealth Intelligence relates
In 2023, about 40 percent of U.S. adults are using healthcare-related applications, and 35 percent are using wearable healthcare devices, a new survey shows.
Released by Morning Consult, the survey polled 2,201 adults between Jan. 23 and Jan. 25. The results were compared to a previous Morning Consult poll conducted in December 2018 among 2,201 adults.
The 2023 survey shows gains in health app and wearables use. While health app use jumped 6 percentage points from 2018, wearables use increased by 8 percentage points.
Health app and wearables use varied across age groups, according to the survey. Forty-seven percent and 40 percent of respondents aged 18 to 34 used health apps and wearables, respectively, compared to 30 percent and 25 percent of adults over 65.
Of those who said they used health apps and wearables, most use them daily.
Bloomberg adds that “Apple Makes Major Progress on No-Prick Blood Glucose Tracking for Its Watch.” Completion of the moonshot project remains “years away.”
Beckers Hospital Review relies on the Harvard Business Review to identify “four measures needed to create shoppable healthcare beyond price transparency.”
From the U.S. healthcare business front, the Wall Street Journal reports
Amazon.com Inc. will be able to close its purchase of 1Life Healthcare Inc., the operator of the One Medical line of primary-care clinics, without a legal challenge by antitrust enforcers.
The Federal Trade Commission won’t sue in time to block the $3.9 billion deal, including debt, but will continue its investigation of the merger, an agency spokesman said. The decision clears a path for Amazon to substantially expand its healthcare offerings and operate physical medical clinics. Amazon has invested in the healthcare space for years, including with an online pharmacy and other health ventures.
“The FTC’s investigation of Amazon’s acquisition of One Medical continues,” FTC spokesman Douglas Farrar said. “The commission will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.”
Becker’s Hospital Review offers two articles on Mark Cuban’s Cost Plus Drug Co.
As news outlets, celebrities, swingers on Reddit and people on Twitter praise Cost Plus Drug for its low prices on hundreds of generics, some of its products are more expensive than options at local pharmacies, KHNreported using GoodRx data.
For example, one presentation of amoxicillin-clavulanate, an antibiotic currently in shortage, is $267.60 at Cost Plus Drug Co. and $109.44 at the average community pharmacy.
Mr. Cuban told the outlet that its analysis was not comprehensive because of the company’s pricing model, which is a 15 percent markup, $3 for labor per drug and $5 for shipping. Because the shipping cost is overall and not for each medication, Mr. Cuban said his pharmacy can still offer a cheaper sale.
In the other article, BHR informs us that the Cost Plus Drug Co., which already has business arrangements with three prescription drug managers, is contacting independent pharmacies for business.
Global vision and brain research non-profit BrightFocus Foundation celebrates the U.S. Food and Drug Administration’s (FDA) approval of Syfovre (pegcetacoplan injection), the first-ever treatment to slow the progression of vision loss from geographic atrophy, an advanced form of dry age-related macular degeneration and a leading cause of blindness.
“Today’s FDA approval of Syfovre provides hope to the more than five million people worldwide who are at risk of permanent vision loss from geographic atrophy,” said BrightFocus President and CEO Stacy Pagos Haller. “This first-of-its-kind treatment is a momentous step forward in vision research and will make a meaningful difference in the lives of millions of people.”
An estimated one million people in the U.S. have geographic atrophy, an advanced and severe form of age-related macular degeneration in which regions of cells in the retina waste away and die (atrophy). This progressive and irreversible disease can lead to permanent vision loss. Nearly 20 million adults in the U.S. have some form of age-related macular degeneration (AMD), almost double the previous estimate of 11 million people, according to a new report.
People living with geographic atrophy often experience emotional hardships including anxiety, feeling powerless, and frustration. Approximately one in three have recently withdrawn from their social lives because of their disease, and BrightFocus offers a free AMD community group and educational audio chats for affected individuals.
Syfovre is expected to be available by the beginning of March through select specialty distributors and specialty pharmacies nationwide.
The New York Times Morning column criticizes the public health system for undertreating people with opioid use disorder, obesity and mental health issues, among other problems.
Similarly, HHS’s Agency for Healthcare Research and Quality calls attention to the underuse of cardiac rehabilitation in our country.
From the Rx coverage front —
BioPharma Dive explains that while the last decade’s lapse of patents impacted blockbuster small-molecule drugs, this decade’s lapse impacts specialty drugs such as Humira and Keytruda. Time will tell whether patients will convert to biosimilar drugs as quickly as they converted to generic drugs when patents lapse.
STAT News reports on “A battle between Vertex and insurers [over copay assistance accumulators] is leaving cystic fibrosis patients with crushing drug costs. Copay assistance accumulators prevent co-pay assistance from accumulating toward the plan’s out-of-pocket payments maximum required by the Affordable Care Act.
The Institute for Clinical and Economic Research related a final evidence report on treatments for multiple sclerosis.
From the medical research front, STAT News reports
An experimental antibody that delivers lethal radiation directly to the bone marrow improved the outcomes of stem cell transplants for older patients with relapsed leukemia — and may change the way transplant medicine is practiced.
The antibody-radiation treatment, called Iomab-B, is being developed by Actinium Pharmaceuticals, a small drugmaker based in New York.
In the results of a Phase 3 clinical trial presented Saturday, 22% of patients with acute myeloid leukemia who were administered Iomab-B to prepare their bone marrow for transplants had durable remissions lasting six months or more. None of the patients in the study who received conventional care prior to transplant achieved durable remissions.
Amazing.
From the miscellany / tidbits department
The U.S. Preventive Services Task Force proposes to renew the following Grade A recommendation:
The USPSTF recommends that all persons planning to or who could become pregnant take a daily supplement containing 0.4 to 0.8 mg (400 to 800 μg) of folic acid.
The public comment period on this renewal is open until March 20, 2023/
Eligible commercial members will gain access to a virtual care team that conducts an initial health screening, creates a personalized care plan, and then provides care services, according to a Feb. 7 news release.
The virtual care services will take place through Anthem’s app, Sydney Health. The app offers 24/7 medical text chat, preventive wellness visits, support services, including new prescriptions and refills, and in-network referrals.
Virtual primary care is now available to eligible individuals enrolled in Anthem’s fully insured plans and certain large group administrative services clients.
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