From the Omicron and siblings front, the Washington Post reports
Americans infected with the coronavirus’s omicron variant are less likely to develop symptoms typical of long covid than those who had covid-19 earlier in the pandemic, according to the largest-ever study of who is most vulnerable to being sickened — or debilitated — by the virus’s lingering effects.
The analysis of nearly 5 million U.S. patients who had covid, a study based on a collaboration between The Washington Post and research partners, shows that 1 in 16 people with omicron received medical care for symptoms associated with long covid within several months of being infected. Patients exposed to the coronavirus during the first wave of pandemic illness — from early 2020 to late spring 2021 — were most prone to develop long covid, with 1 in 12suffering persistent symptoms.
In other public health news, the Wall Street Journal reports
A rare and often deadly fungus is spreading rapidly across the U.S., federal researchers said, raising pressure to find new treatments for severe fungal disease.
Candida auris, a fungus discovered about 15 years ago in Japan, infected at least 2,377 people in the U.S. in 2022, up from 53 in 2016, the Centers for Disease Control and Prevention said. Its swift spread into most states and more than 40 countries has prompted the CDC and World Health Organization to label it a growing threat to public health. Candida auris has a mortality rate of up to 60% and is particularly risky for people who are older or have compromised immune systems, the CDC said.
“To see a new species arrive on the scene and then suddenly emerge as a global pathogen less than 15 years later—that’s really remarkable,” said Dr. Peter Pappas, an infectious-disease specialist at the University of Alabama at Birmingham.
From the obesity treatment front
NBC News informs us that Americans are turning to local compounding pharmacies for lower-cost versions of Ozempic and Wegovy, the new wave of semaglutide-base obesity drugs, which is a patient safety issue.
STAT News, as part of its continuing series on these new drugs, tells us
When, in January 2023, the American Academy of Pediatrics released its first formal clinical practice guidelines centered on the screening and treatment of young patients with obesity, many eyes turned to the document.
Unlike earlier, more general guidance that recommended a progression of treatment through various stages, the new guidelines say there shouldn’t be “watchful waiting.” They call for early diagnosis, intense counseling, and two new aggressive options for children with obesity: weight loss drugs for children as young as 12 who are in the 95th weight percentile, and consultation for weight loss surgery for teenagers who have severe obesity (120% of the 95th percentile or a body mass index of 35 or more).
Now that experts have had a couple of months to comb through the 100-page document, from executive summary to supporting material, one thing is clear: There is still no consensus on how best to approach obesity in children.
Beckers Hospital Review identifies the ten most overweight cities in the country. All of them are located in the southeast. McAllen, Texas, is number one.
In other relevant survey/study news —
Per Kaiser Family Foundation News, “Young adults in the United States continue to be more likely than their older counterparts to be experiencing symptoms of anxiety or depression, according to the latest federal data analyzed by KFF researchers.”
The Kaiser Family Foundation / Peterson Health System Tracker evaluates preventive services utilization.
The AP reports “A Pentagon study has found high rates of cancer among military pilots and for the first time has shown that ground crews who fuel, maintain and launch those aircraft are also getting sick.”
Health Affairs offers plan design guidance intended to help resolve the maternal health crisis.
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).”
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, OPM released its Fiscal Year 2024 Congressional Budget Justification document, which is part of the federal budget process. Of interest to the FEHBlog is this OPM goal:
Improve customer experience by making it easier for Federal employees, annuitants, and other eligible persons to make a more informed health insurance plan selection.
By September 30, 2023, complete user-centered design and develop a minimum viable product for a new, state-of-the-art Decision Support Tool that will give eligible individuals the necessary information to compare plan benefits, provider networks, prescription costs, and other health information important to them and their families.
Federal News Network tells us about a related Office of Management and Budget analytical perspective on federal workforce issues.
The Office of Management and Budget, in one of its analytical perspectives supplementing the Biden administration’s 2024 budget request, said federal workers’ pay is “increasingly hamstrung” by statutory requirements “that curb the ability of agencies to reward talent, including for specialized occupations, in a national competitive job environment.”
Eisai Co.’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year.
Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.
An estimated 167,954 veterans receiving care through the VA have Alzheimer’s dementia, according to government estimates. To qualify for Leqembi, patients must be over 65, have early-stage symptoms and elevated brain amyloid, sticky protein fragments, which the drug is designed to remove.
STAT News describes the VA’s step as “unexpected,” which is an understatement because CMS does not plan to issue a Medicare national coverage decision until mid-year. STAT News adds
The [VA] published a guide on its formulary saying coverage will extend to any veteran who meets specified criteria, including an MRI scan within the previous year, amyloid PET imaging consistent with Alzheimer’s and a staging test indicating mild Alzheimer’s dementia. There is also a long list of criteria that would exclude veterans.
The agency can negotiate prices for drugs, but the price it will pay for Leqembi was not listed and the Eisai spokesperson did not offer a cost. Leqembi has an annual wholesale price of $26,500, although the Institute for Clinical and Economic Review recently said the treatment should cost between $8,900 and $21,500 per year to be considered cost effective.
Under federal law, the VA can bill other health plans (including FEHB but not Medicare) for non-service related care such as this drug. For this reason, this VA action opens the back door to FEHB coverage of Leqembi.
From the end of the public health emergency front —
The Society for Human Resource Management offers its take on how employers should prepare for the end of the PHE, now less than two months away.
The American Hospital Association points out
The Food and Drug Administration will end 22 COVID-19-related policies when the public health emergency ends May 11 and allow 22 to continue for 180 days, including temporary policies for outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective equipment practices for sterile compounders not registered as outsourcing facilities, the agency announced. FDA plans to retain 24 COVID-19-related policies with “appropriate changes” and four whose duration is not tied to the PHE, including its recently revised policy for COVID-19 tests.
Pfizer has agreed to buy Seattle-based Seagen for $43 billion in a blockbuster deal that would unite the pharmaceutical giant with a biotechnology company that pioneered a new type of tumor-killing medicine.
The acquisition is the largest Pfizer has attempted since its 2009 purchase of Wyeth, and is the most sizable in the drug industry by value since AbbVie’s $63 billion buyout of Allergan in 2019.
Acquiring Seagen gives Pfizer control of the top-selling lymphoma medicine Adcetris as well as a pipeline of cancer treatments that’s yielded three new drug approvals in the past three years. Seagen specializes in a type of cancer therapy known as an antibody-drug conjugate, and has steadily improved on the technology since its founding in 1997.
Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion.
The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.
The French pharma giant will now own TZield outright, paying $25 per share to acquire Provention — a 273% premium over Friday’s closing stock price.
In recognition of Patient Safety Awareness Week
The HHS Agency for Healthcare Quality and Research’s Director Robert O. Valdez, Ph.D., M.H.S.A. explains how AHRQ is sharpening its focus on diagnostic safety.
The pediatric mental health crisis is the most pressing patient safety concern in 2023, the Emergency Care Research Institute said on March 13.
The ECRI, which conducts independent medical device evaluations, annually compiles scientific literature and patient safety events, concerns reported to or investigated by the organization, and other data sources to create its top 10 list.
Here are the 10 patient safety concerns for 2023, according to the report:
1. The pediatric mental health crisis
2. Physical and verbal violence against healthcare staff
3. Clinician needs in times of uncertainty surrounding maternal-fetal medicine
4. Impact on clinicians expected to work outside their scope of practice and competencies
5. Delayed identification and treatment of sepsis
6. Consequences of poor care coordination for patients with complex medical conditions
7. Risks of not looking beyond the “five rights” to achieve medication safety
8. Medication errors resulting from inaccurate patient medication lists
9. Accidental administration of neuromuscular blocking agents
10. Preventable harm due to omitted care or treatment
The U.S. Department of Labor announced on March 10
The crowdsourcing will focus on four areas of concern for people with mental health conditions, including benefits policies that meet their needs, access to workplace care and supports, the reduction of related social stigmas, disparities faced by people in underserved communities, shortages of behavioral health professionals, and the establishment of state resource systems.
Part of the department’s ePolicyWorks initiative, the dialogues will remain open until April 3. Input received will inform the next meeting of the Mental Health Matters: National Task Force on Workforce Mental Health Policy
Healthexec calls attention to FDA recalls of certain eyedrops.
From the value-based care front, Health Payer Intelligence notes
CareFirst BlueCross BlueShield (CareFirst) has formed a strategic alliance with Aledade, Inc. (Aledade), offering independent primary care physicians tools and resources to improve healthcare affordability and effectiveness, supporting CareFirst member physicians in achieving value-based care goals.
Through this value-based relationship, CareFirst member physicians can leverage specialists, including onsite business support for physician practices, a technology platform that works with more than 100 different EHRs, and healthcare regulatory and policy expertise.
From the medical debt front, Healthcare Dive reports
Hospitals are a prime source of medical debt in America that hits underserved populations hardest, despite charity care programs and financial assistance policies, according to a new analysis from the Robert Wood Johnson Foundation.
Of the 15% of U.S. adults with past-due medical debt, almost two-thirds owe some or all of that debt to hospitals, according to research from the Urban Institute. That medical debt disproportionately affects underserved populations, such as low-income individuals and people with disabilities, researchers found.
While medical debt remains a persistent financial burden in the U.S., a new analysis from the Urban Institute highlights how targeting hospital billing could ameliorate the problem.
On Thursday, OPM Director Kiran Ahuja appeared at a hearing before the House Oversight and Accountability Committee for around three hours of questioning. Federal News Network tells us
This week, the Oversight and Accountability Committee held seven hearings in the span of just two days. Members are probing fraudulent payments of pandemic relief programs, advances in artificial intelligence (AI) and inflation, to name just a handful.
The FEHBlog listened to the hearing. Much of the questioning at the hearing stems from OPM’s struggles with federal retirement program administration. OPM must deal with an unnecessarily complicated retirement system that Congress created. Congress could solve OPM’s administration/customer service problem by simplifying federal employee retirement laws.
In FEHB news, Ms. Ahuja announced
OPM will issue the Postal Service Health Benefits Program (“PSHBP”) interim final implementation rule in April 2023. Bear in mind that the statutory deadline is April 6, 2023.
OPM expects to solve its FEHB eligibility issues by ending the current decentralized approach to FEHB enrollment under which federal agencies hold primary responsibility. Remember that half of the enrollment, the annuitants, already are centralized in the OPM annuitant payroll office. Nevertheless, OPM plans to roll out its new 100% centralized approach with the PSHBP for 2025 and subsequently extend it to legacy FEHB.
OPM works “hand in glove” with the Postal Service to implement the PSHBP.
Like FedWeek (as discussed in FEHBlog posts earlier this week), Congress does not understand the FEHB’s hardcore transparent prescription drug pricing program for experience-rated carriers. Director Ahuja did not trumpet OPM’s game-changing decision to allow integrated Medicare Part D EGWPs for 2024.
It’s worth adding that the Federal Times has recognized that OPM has improved FEHB infertility treatment benefits for 2024 and that Govexec.com includes an article about the OPM call letter for 2024 benefit and rate proposals, which includes a misunderstanding of Medicare programs being integrated into FEHB for greater savings.
OPM is encouraging FEHB carriers to offer Medicare Advantage Prescription Drug Employer Group Waiver Plans, which are designed to maximize value to enrolled individuals under FEHB and Medicare. These are special plans more generous than standard Medicare Advantage plans.
In recent years, a growing number of FEHB carriers have offered such plans. They must provide benefits that are at least the same as those offered by other Medicare plans.
Over the past decade, FEHB plans have been integrating Medicare Advantage / Prescription Drug Plans. These are known as MAPDs. Annuitants with Medicare Part A and B coverage can opt into these MAPD plans and receive a Part B premium subsidy, among other benefits.
In a January 2023 carrier letter and the February 2023 call letter, OPM informed carriers of a new opportunity to offer Medicare Part D EGWPs. These “new to FEHB” Part D prescription drug plans, which can be integrated with FEHB Rx benefits, are open to all Medicare prime annuitants, including Medicare Part A only members.
With the current integrated MAPD plans, opting-in annuitant members must pay the Medicare Part B premium adjusted for the Plan subsidy. With the Part D PDPs / EGWPs, the Plan covers the Part D premiums for the participating members.
In regular Friday post news, here are links to the CDC’s Covid Data Tracker, which continues to show downward trends in new cases, hospitalizations and deaths, and the CDC’s weekly Fluview, which indicates, as folks know, that the flu epidemic is over.
The FEHBlog also suggests that readers listen to the 15-minute long, eye-opening Wall Street Journal podcast on fentanyl test strips.
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.
Here are links to the CDC’s Covid Data Tracker and its last weekly interpretative review of those statistics. From now until the interpretative review ends, the interpretative review will be offered every other week, except when that Friday is the beginning of a federal three-day weekend. Good timing for this change because we just started the three-day weekend drought, which ends with Memorial Day.
The summary notes, “At this point in the pandemic, COVID-19 cases, hospitalizations, and deaths have been decreasing for several weeks, and much of the country has protection against circulating strains either through vaccination, previous infection, or a combination of both.” Nevertheless, the CDC urges folks to be vaccinated or stay current on vaccinations because the virus can change.
The CDC’s Fluview says, “Seasonal influenza activity remains low nationally.”
From the Rx coverage, Ed Silverman writing in STAT News comments
Now that Eli Lilly slashed the price for some of its insulin products, the moves raised questions about what will happen to other efforts to provide low-cost insulin, Kaiser Health News explains. Civica, a nonprofit, plans to begin selling biosimilar insulin for roughly $30 per vial by 2024 — $5 more than the new price of Lilly’s generic insulin. And the Mark Cuban Cost Plus Drug Co. plans to sell low-cost insulin. But drug pricing experts predict Lilly’s moves will not undercut those efforts. And these other initiatives to bring lower-cost insulin to market, in turn, would put pressure on Lilly to keep its prices down.
The FEHBlog agrees with these comments. Cost curve down.
From the U.S. healthcare business front, Healthcare Dive informs us
VillageMD, the clinical network majority owned by Walgreens, has acquired a medical group in Connecticut that operates more than 30 locations across the state.
On Friday, VillageMD said it snapped up Starling Physicians, which operates primary care and multi-specialty practices, for an undisclosed sum.
The acquisition expands VillageMD to more than 700 medical centers, as Walgreens continues to invest in expanding its clinical footprint.
Tammy Flanagan, writing in Govexec, points out irrevocable benefits decisions, e.g., FEHBP, that a federal or postal employee must make at the time they decide to take a CSRS or FERS retirement
From our Nation’s capital, the Wall Street Journal reports
President Biden said Tuesday he would nominate Julie Su, the No. 2 official at the Labor Department, to lead the agency, maintaining continuity within a department that played a prominent role in averting a rail strike last year.
Ms. Su, the current deputy secretary, was widely seen as the leading candidate to succeed departing Secretary Marty Walsh. Asian-American lawmakers and advocacy groups threw their support behind her, lobbying Mr. Biden to tap his first Asian-American cabinet secretary. Ms. Su, age 54, is Chinese-American.
The nomination now heads over to the Senate for its approval. The Secretary of Labor, the HHS Secretary, and the Treasury Secretary / IRS form the agencies responsible for the overseeing the Affordable Care Act.
From the Food and Drug Administration (FDA) front —
Pfizer and BioNTech are seeking full [FDA marketing] approval for their Omicron-targeted bivalent Covid shot, and they’re following an FDA advisory committee’s advice on “harmonizing” vaccine compositions.
The partners have filed a supplemental BLA for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as both a primary dose or a booster for patients over the age of 12. That means unvaccinated children and adults could skip the original primary series and receive a bivalent shot first.
The move is in response to an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) vote last month, intended to clear up confusion around varying primary and booster dose formulations and utilize vaccines that better target currently circulating strains of Covid.
In two somewhat close votes, an FDA panel of outside experts recommended the agency approve Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, despite concerns over the potential risk for Guillain Barré syndrome.
By a tally of 7-4 for safety and efficacy (with one abstention in each case), the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said the evidence favors the RSV prefusion F protein vaccine (RSVPreF) — which carries a proposed trade name of Abrysvo — for reducing RSV-related lower respiratory tract infections in adults 60 and up.
However, VRBPAC members showed reservations ranging from the largely health study population, rather than the more vulnerable group of older adults who need the vaccine most, to the limited number of events for the main outcomes.
Federal regulatorsapproved a drug to treat a debilitating disease usingdata collected about patients over decades, creating an opening for researchers of other rare conditions who often struggle to prove their treatments work.
The Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc.’s drug Skyclarys, or omaveloxolone, for treating the neurological disorder Friedreich’s ataxia in adults and adolescents age 16 and older.
The FDA last year said results from a single clinical trial didn’t sufficiently demonstrate the drug slows the progression of a disease thatcauses progressive damage to the spinal cord, muscle weakness, and movement problems and often kills people by age 35. Instead of running another trial, Reata submitted additional data including an analysis from a so-called natural history study that has continued to collect information about patients for more than two decades.
“Data created by patient communities can be regulatory grade,” said Annie Kennedy, chief of policy, advocacy and patient engagement at the EveryLife Foundation for Rare Diseases, a nonprofit advocacy group. “This approval is proof of that principle.”
The FDA issued an import alert Tuesday to clamp down on the illegal importation of xylazine, an animal tranquilizer showing up more and more in illicit drugs.
“This action aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals,” the agency said in a press release.
Veterinarians legitimately use drug products containing xylazine to sedate large animals such as horses and deer, but it is not safe for use in people and may cause serious and life-threatening side effects, the FDA noted. However, “it has been identified as a contaminant found in combination with opioids such as illicit fentanyl, and in combination with other illicit products that contain stimulants such as methamphetamine and cocaine. People who use illicit drugs may not be aware of the presence of xylazine.”
Hospitals continue to experience the same challenges that made 2022 the worst financial year since the start of the COVID-19 pandemic, including higher labor expenses and lower patient volumes, according to the latest report on hospital finances from Kaufman Hall. Hospital operating margins fell from -0.7% in December 2022 to -1% in January 2023, following persistent negative margins throughout last year. Notably, drug expenses have increased 12% compared to YTD 2020.
“While we have seen a stabilization in operating margins over the past several months, the trendline continues to show that hospitals will be in a tough spot financially for the foreseeable future,” said Erik Swanson, senior vice president of data and analytics for Kaufman Hall. “With future COVID surges possible and challenging financial months ahead for hospitals, managing cash on hand will be critical to weathering the storm.”
The Wall Street Journal explains how doctors are diagnosing patients with artificial intelligence.
From the mental health care front —
The Kaiser Family Foundation provides good news about the rapidly growing use of the 988 National Suicide Prevention and Crisis Hotline. “Since the launch of 988, Lifeline has received over 2.1 million contacts—consisting of over 1.43 million calls, over 416,000 chats, and more than 281,000 texts.” But, of course, the KKF study also notes some problems.
MedCity News tells us about a newly formed collaboration consisting of Bicycle Health, Wellpath and the Federal Bureau of Prisons that will provide virtual opioid use disorder services to those living in the Bureau’s residential reentry centers in 42 states.
STAT New discusses the downfall of Mindstrong, a mental health care tech / app company.
The Washington Post offers an intriguing look at how the human brain ages.
From the end of the public health emergency front –
CMS issued a comprehensive fact sheet titled “CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency.” Notwithstanding the title, the fact sheet includes sections on how the end of the PHE impacts
Private Health Insurance
Vaccines: Most forms of private health insurance must continue to cover COVID-19 vaccines furnished by an in-network health care provider without cost sharing. People with private health insurance may need to pay part of the cost if an out-of-network provider vaccinates them.
Testing: After the expected end of the PHE on May 11, 2023, mandatory coverage for over-the- counter and laboratory-based COVID-19 PCR and antigen tests will end, though coverage will vary depending on the health plan. If private insurance chooses to cover these items or services, there may be cost sharing, prior authorization, or other forms of medical management may be required.
Treatments: The transition forward from the PHE will not change how treatments are covered, and in cases where cost sharing and deductibles apply now, they will continue to apply.
Private Health Insurance and Telehealth
As is currently the case during the PHE, coverage for telehealth and other remote care services will vary by private insurance plan after the end of the PHE. When covered, private insurance may impose cost-sharing, prior authorization, or other forms of medical management on telehealth and other remote care services.
For additional information on your insurer’s approach to telehealth, contact your insurer’s customer service number located on the back of your insurance card.
Telehealth providers and advocates are balking at proposed telemedicine rules released by the Drug Enforcement Administration (DEA) late Friday. If made permanent, the rules would be a marked change from the suspension of the Ryan Haight Online Pharmacy Consumer Protection Act, which propelled a telepsychiatry boom during the COVID-19 pandemic.
Under the proposed rule released by the DEA, developed in concert with the U.S. Department of Health and Human Services (HHS) and in coordination with the U.S. Department of Veterans Affairs, some medications would require an in-person doctor’s visit. Controlled substances including stimulants like Adderall and opioids such as oxycodone and buprenorphine used to treat opioid use disorder (OUD) would require at least one in-person visit.
The DEA created a 30 day public comment period for this proposed rule.
From the U.S. healthcare business front, STAT News tells us about this surprising twist
On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles. * * *
The company’s lawyers indicated in the bankruptcy hearing that Lucira was not able to find anyone willing to buy the company prior to the Chapter 11 filing. With the only authorized at-home flu test on the American market, it’s an open question whether the company’s continued operations will allow the company to survive or will entice another party to buy Lucira.
The FEHBlog’s guess is that drug manufacturers will be lined up at the bankruptcy courthouse door to place a bid on the company if allowed.
“Cancer drug developer Seagen is in early talks to be acquired by Pfizer, according to The Wall Street Journal, which cited people familiar with the situation. A deal still may not be reached, the Journal said.
“Last summer, the Journal reported Seagen, a Washington-based company currently worth more than $30 billion, was considering selling to Merck & Co. for upwards of $40 billion. But as Bloomberg would later report, the deal stalled out because of disagreements over price. Since then, Seagen has brought on a new CEO, the longtime Novartis executive David Epstein, who played an integral role in ramping up the Swiss pharmaceutical giant’s cancer drug division.
“Should Pfizer acquire Seagen, it would gain access to a slate of experimental medicines as well as four marketed products that, together, generated $2 billion in revenue last year. Pfizer recorded $100 billion in product revenue in 2022, but estimates sales from its COVID-19 vaccine and Paxlovid therapy will fall significantly in the coming months. It also expects to lose around $17 billion in annual revenue between 2025 and 2030 due to the expiration of key patents.”
From the Rx coverage front —
The Wall Street Journal fills us in on the side effects of the new semaglutide weight loss drugs. For example, “Semaglutide spurs weight loss by stimulating the release of insulin and lowering blood sugar. It also delays stomach emptying, which causes people to feel full quickly and stay sated for longer stretches. When a patient comes off the drug, their normal appetite returns. * * * “People who stopped taking semaglutide gained back, on average, two-thirds of the weight they lost within a year, according to a study published in August 2022 in the journal Diabetes, Obesity, and Metabolism.”
The Journal also reports that “Amyloid Gains Converts in Debate Over Alzheimer’s Treatments; Dispute has far-reaching consequences, including whether Medicare will pay for new anti-amyloid drugs [e.g., Aduhelm and Leqembi].” Nevertheless, “Dr. [David] Knopman [,a Mayo Clinic neurologist,] said that Leqembi’s success is only a partial vindication of the amyloid hypothesis, which in the minds of many doctors promised to stop Alzheimer’s in its tracks or even reverse certain symptoms.”
From the mental health care front, David Leonhardt, the New York Times Morning columnist, “examines the raging debate about smartphones and teenage mental health.”
I called Lisa Damour last week and asked what advice she would give to parents. Damour is a psychologist who has written two best-selling books about girls and just published a new book, “The Emotional Lives of Teenagers.” She is no anti-technology zealot. She thinks social media can have benefits for teenagers, including connections with peers. But she also sees reason for concern.
Her first piece of advice is not to blame teenagers. They didn’t invent smartphones, and earlier generations would have used those phones in the same ways that today’s teens are.
Her second piece of advice might be summarized as: less. She believes teenagers should rarely have their phones in their bedrooms, especially not at night. A phone is too disruptive to sleep, and sleep is too important to mental health.
Parents can also introduce digital technology in stages, recognizing that a 13-year-old brain is different from a 17-year-old brain. For younger teens, Damour suggests a phone that can send and receive texts but does not have social media apps.
From the miscellany department –
Beckers Hospital Review provides details on the business model of One Medical, which became part of Amazon last week.
The company employs primary care providers across more than 125 clinics in 19 markets, according to its website. One Medical then partners with local hosptials and health systems to provide specialty care.
One Medical offers a subscription-based membership — for $199 a year (though Amazon is now offering a promotion for $144 annually) — that gives patients access to its digital health platform, with 24-7 access to virtual care and online appointment booking and prescription renewals. The company still bills those patients’ insurance for the visits.
Govexec reports “The federal employees appeals board is setting new precedents restricting when agencies can fire employees who were injured on the job, issuing new rulings on cases that languished for years while the agency was rendered partially incapacitated.”
The Wall Street Journal tells us “The White House said there is no consensus within the Biden administration over the origins of the Covid-19 virus, a day after the disclosure of an Energy Department assessment that the pandemic likely originated with a leak from a Chinese lab.”
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie
Duration
Description
cookielawinfo-checbox-analytics
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
