Roll Call reports on the state of the debt ceiling negotiations and Senator Bernie Sanders’s encounter today with the Moderna CEO Stéphane Bancel at a Senate hearing that Senate Sanders chaired. The FEHBlog can’t understand why Senator Sanders and his majority colleagues are flipping their lids over a $100 price per vial increase on a low-cost vaccine.
The Medicare Payment Advisory Commission’s recent breakdown of the hospital sector’s financial viability largely struck a different tone from the doom and gloom industry groups have voiced as of late.
The independent commission advises Congress on year-to-year Medicare policy adjustments, which are largely based on data from 2020 and 2021, preliminary data for 2022 and trend projections for upcoming years. It released its annual report to Congress last week.
With the exception of additional support for safety-net providers—which industry group America’s Essential Hospitals (AEH) has already criticizedfor “overlooking” uncompensated care delivered to non-Medicare patients—the group largely told Congress that most hospitals will manage their finances and recommended that lawmakers stay the course with 2024’s inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) rules.
“The Commission anticipates that a 2024 update to hospital payment rates of current law plus 1% would generally be adequate to maintain FFS beneficiaries’ access to hospital inpatient and outpatient care and keep IPPS and OPPS payment rates close to the cost of delivering high-quality care efficiently,” the group wrote in its report (PDF).
This decision must have the American Hospital Association flipping its lid.
The Department of Health and Human Services announced an organ procurement and transplantation network modernization initiative that “includes the release of new organ donor and transplant data; prioritization of modernization of the OPTN IT system; and call for Congress to make specific reforms in the National Organ Transplant Act.” More background on his announcement is available at Roll Call.
An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients.
By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 3-5 vote (with one abstention) the same experts concluded that the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval.
The FDA is not required to follow the recommendation of its outside advisors, but often does. The mixed votes suggest the FDA will likely grant Biogen accelerated approval for tofersen based on preliminary evidence. This would allow the company to market the drug while it collects additional data to confirm its benefit.
Benefits Pro offers guidance on employer-sponsored health plan coverage of the new weight loss drugs, Mounjaro, Saxenda, and Wegovy. OPM has already decided that FEHB carriers will oprovidecoverage of one or more of these drugs in their 2024 formularies. Currently, carriers are developing their 2024 benefit and rate proposals.
The FEHBlog has flipped his lid because he discovered that OPM hhadrefreshed its FEHB carrier website. This merits further investigation.
Federal health regulators are nearing a decision on whether to authorize a second round of the Omicron-targeted booster shots for the elderly and other people at high-risk of severe Covid-19, people familiar with the agency’s deliberations said.
Food and Drug Administration officials could make the decision within a few weeks, the people said.
The officials are moving toward authorizing the second jabs of the Omicron-targeted shots for people who are 65 years and older or who have weakened immune systems, though the officials haven’t reached a final decision and could change their mind, one of the people said.
The Centers for Disease Control and Prevention would then have to recommend the shots for them to become widely available.
From the primary care front, Healthcare Finance informs us
People are shifting away from traditional primary care providers, with about three in 10 foregoing primary care altogether between 2016 and 2022, according to FAIR Health’s new analysis of private claims data.
That number, though, ranged from a high of 43% in Tennessee to a low of 16% in Massachusetts, suggesting significant regional variations. Of the providers who performed primary care services in that time, 56% were physicians, while 44% were nonphysicians. * * *
The analysis pointed to evidence showing that primary care improves health regardless of age, sex, race, ethnicity, education, employment, income, health insurance and smoking status. It has also been reported that a gain of 10 additional primary care physicians per 100,000 people is associated with an increase in life expectancy by 51.5 days.
Guiding members to primary care providers is a vital health plan task, in the FEHBlog’s opinion.
From the miscellany department —
Health IT Analytics highlights, “Researchers from Utica University recently leveraged socioeconomic data to gain insights into generational poverty and other health equity barriers that impact patients’ ability to prioritize their health to improve clinical outcomes.”Hela
Health Payer Intelligence relates, “The National Alliance of Healthcare Purchaser Coalitions (National Alliance) has announced the publication of its playbook which aims to encourage biosimilar adoption among employers.”
EHR Intelligence informs us, “Nuance Communications, a Microsoft company, has announced Dragon Ambient eXperience (DAX) Express, the first clinical documentation application to combine conversational and ambient artificial intelligence (AI) with OpenAI’s newest model, ChatGPT-4.:
The FEHBlog’s Friday Insights did not publish as scheduled on Saturday morning. To get the email distribution back on schedule the FEHBlog is combining the Weekend Update and the Cybersecurity Saturday posts below.
Recently, the Centers for Medicare and Medicaid Services confirmed that the No Surprises Act air ambulance reporting will not occur in 2023.
Under section 106 of the No Surprises Act, air ambulance providers, insurance companies, and employer-based health plans must submit to federal regulators information about air ambulance services provided to consumers. The Centers for Medicare & Medicaid Services (CMS) in the Department of Health & Human Services (HHS) is conducting this Air Ambulance data collection (AADC), which will be used to develop a public report on air ambulance services. The proposed rules describing the proposed form and manner of the data collection can be found at this link. The final rules will specify the final reporting requirements, including the data elements and the deadlines for the data collection. The data collection will not begin until after the final rules are published. This page will be updated when the rules are finalized and more information on data collection is available.
From the value added care front, Behavioral Health Business discusses how Aetna and Optum are collaborating with a large mental health provider, Universal Health Services, to develop reliable outcome measurements for mental health services.
When the FDA approved bempedoic acid, marketed under the brand name Nexletol, back in 2020, it was clear that the drug helped lower LDL — “bad”cholesterol. The drug was intended for people who can’t tolerate statin medications due to muscle pain, which is a side effect reported by up to 29% of people who take statins.
What was unknown until now, is whether bempedoic acid also reduced the risk of cardiovascular events. Now, the results of a randomized, controlled trial published in TheNew England Journal of Medicine point to significant benefit. The study included about 14,000 people, all of whom were statin intolerant.
“The big effect was on heart attacks,” says study author Dr. Steven Nissen of Cleveland Clinic.
People who took daily doses of bempedoic acid for more than three years had about a 23% lower risk of having a heart attack, in that period, compared to those taking a placebo.There was also a 19% reduction in coronary revascularizations, which are procedures that restore blood flow to the heart, such as a bypass operation or stenting to open arteries.
A common chemical that is used in correction fluid, paint removers, gun cleaners, aerosol cleaning products, and dry cleaning may be the key culprit behind the dramatic increase in Parkinson’s disease (PD), researchers say.
An international team of researchers reviewed previous research and cited data that suggest the chemical trichloroethylene (TCE) is associated with as much as a 500% increased risk for Parkinson’s disease (PD).
Lead investigator Ray Dorsey, MD, professor of neurology, University of Rochester, New York, called PD “the world’s fastest-growing brain disease,” and told Medscape Medical News that it “may be largely preventable.”
“Countless people have died over generations from cancer and other disease linked to TCE [and] Parkinson’s may be the latest,” he said. “Banning these chemicals, containing contaminated sites, and protecting homes, schools, and buildings at risk may all create a world where Parkinson’s is increasingly rare, not common.”
The paper was published online March 14 in the Journal of Parkinson’s Disease.
The FEHBlog has several friends with Parkinson’s Disease.
From the Medicare front, Health Payer Intelligence relates
Beneficiaries with end-stage renal disease (ESRD) are increasingly shifting from Medicare fee-for-service (FFS) to Medicare Advantage, leading more Medicare Advantage plans to form value-based arrangements with kidney care management companies, according to Avalere.
Beneficiaries with ESRD have typically received coverage through Medicare FFS because only those already enrolled in a Medicare Advantage plan before initiating dialysis were eligible for the private program through 2020.
A provision under the 21st Century Cures Act that went into effect on January 1, 2021, made all Medicare beneficiaries with ESRD eligible to enroll in Medicare Advantage plans.
Although patient safety awareness week is over, the Wall Street Journal makes us aware that
Black boxes on airplanes record detailed information about flights. Now, a technology that goes by the same name and captures just about everything that goes on in an operating room during a surgery is making its way into hospitals.
The OR Black Box, a system of sensors and software, is being used in operating rooms in 24 hospitals in the U.S., Canada and Western Europe. Video, audio, patient vital signs and data from surgical devices are among the information being captured.
The technology is being used primarily to analyze operating-room practices in hopes of reducing medical errors, improving patient safety and making operating rooms more efficient. It can also help hospitals figure out what happened if an operation goes wrong. * * *
Duke University Hospital, where two operating rooms are equipped with black boxes, is using the technology to study and improve on patient positioning for surgery to reduce the possibility of skin-tissue and nerve injuries. It is also studying and using the technology to improve communication among nursing personnel throughout a surgical procedure to ensure that key tasks—such as confirming that surgical instruments and medical devices are available for a procedure—are being completed promptly, effectively and efficiently.
Cybersecurity Saturday
From the cybersecurity policy front, the American Hospital Association informs us that
The Senate Homeland Security and Governmental Affairs Committee held a full Committee hearing examining cybersecurity risks to the healthcare sector on March 16. Witnesses included Scott Dresen, chief information security officer for Corewell Health, a large integrated health system in Michigan.
“The increasing frequency of attack from nation state actors and organized crime has created a sense of urgency within the healthcare sector and we need help from the United States government to respond to these threats more effectively,” Dresen said.
Specifically, he called for enhancing existing partnerships with and between federal agencies, expanding the sharing of actionable threat intelligence, incentivizing access to affordable technology to defend against advanced threats, ensuring there is an adequate cyber workforce, and reforming legislation to encourage the adoption of best practices while not penalizing the victims of cyberattacks.
STAT News reveals why an HHS rule amending the HIPAA Privacy Rule will wreak financial havoc on health systems. The proposed rule was issued in January 2021, so the final rule has been pending for a long time.
The Cybersecurity and Infrastructure Security Agency (CISA) is looking to position a new “Cyber Analytics and Data System” at the center of national cyber defenses, as the agency’s post-EINSTEIN plans come into focus in its fiscal 2024 budget request.
CISA is seeking $424.9 million in the 2024 budget for “CADS.” The program is envisioned as a “system of systems,” budget documents explain, that provides “a robust and scalable analytic environment capable of integrating mission visibility data sets and providing visualization tools and advanced analytic capabilities to CISA cyber operators.”
The new program is part of the “restructuring” of the National Cybersecurity Protection System, according to the documents. More commonly known as “EINSTEIN,” the NCPS has been in place to defend federal agency networks since the Department of Homeland Security’s inception in 2003.
From the cyber breaches front, Tech Target brings us up to date on the DC Health Link breach.
An additional wrinkle to the breach came Monday [March 13] when another user on the same dark web forum using the alias Denfur, who had previously published sample data from the breach, created a thread supposedly aiming to clear up misinformation surrounding the breach.
Claiming to be a friend of IntelBroker, Denfur said the attack vector for the breach was an exposed, insecure database belonging to DC Health Link. Moreover, the poster said the database was likely exposed “for over a year and a half” before the breach occurred. TechTarget Editorial contacted DC Health Link in order to verify Denfur’s claims, but a spokesperson declined to comment.
At least two hacking groups were able to gain access to at least one federal agency’s servers through an old vulnerability in a software development and design product, according to a cybersecurity advisory issued Wednesday.
According to an alert issued by the Cybersecurity and Infrastructure Security Agency, or CISA, hackers were able to gain access to and run unauthorized code on a federal agency’s server, though they were not able to gain privileged access or move deeper into the network. The malicious activity was observed between November 2022 and early January, though the initial compromise goes as far back as August 2021.
Hackers used a vulnerability in old versions of Telerik UI, a software developer kit for designing apps, which, when exploited, allows hackers with access to execute code. The vulnerability was discovered in 2019 and builds on previous vulnerabilities discovered in 2017 that allow bad actors to gain privileged access and “successfully execute remote code on the vulnerable web server.”
The National Vulnerability Database—managed by the National Institute of Standards and Technology—rates this a critical vulnerability, with a score of 9.8 out of 10.
From the cyber vulnerabilities front, HHS’s Healthcare Cybersecurity Coordination Center (HC3) released its February 2023 list of vulnerabilities of interest to the health sector.
In February 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for this month are from Microsoft, Google/Android, Apple, Mozilla, SAP, Citrix, Intel, Cisco, VMWare, Fortinet, and Adobe. A vulnerability is given the classification as a zero-day if it is actively exploited with no fix available or is publicly disclosed. HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.
Researchers are warning that state-linked and financially motivated threat actors may try to exploit a critical zero-day vulnerability in Microsoft Outlook to launch new attacks against unpatched systems.
Microsoft urged customers to patch their systems against CVE-2023-23397 to address the critical escalation of privilege vulnerability in Microsoft Outlook for Windows, the company said Tuesday. Microsoft Threat Intelligence warned that a Russia-based threat actor launched attacks against targeted victims in several European countries.
Mandiant researchers warned that other criminal and cyber-espionage actors will race to find new victims vulnerable to the zero day before organizations can apply patches.
CISA added three and then one more known exploited vulnerability to its catalog this week.
Security Week highlights that “Deepfakes are becoming increasingly popular with cybercriminals, and as these technologies become even easier to use, organizations must become even more vigilant.”
Deepfakes are part of the ongoing trend of weaponized AI. They’re extremely effective in the context of social engineering because they use AI to mimic human communications so well. With tools like these, malicious actors can easily hoodwink people into giving them credentials or other sensitive information, or even transfer money for instant financial gain. Deepfakes represent the next generation of fraud, by enabling bad actors to impersonate people more accurately and thus trick employees, friends, customers, etc., into doing things like turning over sensitive credentials or wiring money.
Here’s one real-world example: Bad actors used deepfake voice technology to defraud a company by using AI to mimic the voice of a CEO to persuade an employee to transfer nearly $250,000 to a Hungarian supplier. Earlier this year, the FBI also warned of an uptick in the use of deepfakes and stolen PII to apply for remote work jobs – especially for positions with access to a lot of sensitive customer data.
The Security Week article also discusses defenses to deepfake tactics.
From the ransomware date infiltration front –
The Federal Bureau of Investigation (FBI), CISA, and the Multi-State Information Sharing and Analysis Center (MS-ISAC) has released a joint cybersecurity advisory (CSA), #StopRansomware: LockBit 3.0. This joint advisory details known indicators of compromise (IOCs) and tactics, techniques, and procedures (TTPs) that FBI investigations correlatedwith LockBit 3.0 ransomware as recently as March 2023. LockBit 3.0 functions as an affiliate-based ransomware variant and is a continuation of LockBit 2.0 and LockBit. CISA encourages network defenders to review and apply the recommendations in the Mitigations section of this CSA.
“Black Basta was initially spotted in early 2022, known for its double extortion attack, the Russian-speaking group not only executes ransomware but also exfiltrates sensitive data, operating a cybercrime marketplace to publicly release it, should a victim fail to pay a ransom. The threat group’s prolific targeting of at least 20 victims in its first two weeks of operation indicates that it is experienced in ransomware and has a steady source of initial access. The level of sophistication by its proficient ransomware operators, and reluctance to recruit or advertise on Dark Web forums, supports why many suspect the nascent Black Basta may even be a rebrand of the Russian-speaking RaaS threat group Conti, or also linked to other Russian-speaking cyber threat groups. Previous HC3 Analyst Notes on Conti and BlackMatter even reinforce the similar tactics, techniques, and procedures (TTPs) shared with Black Basta. Nevertheless, as ransomware attacks continue to increase, this Threat Profile highlights the emerging group and its seasoned cybercriminals and provides best practices to lower risks of being victimized.”
Here is a link to the always interesting Bleeping Computer Week in Ransomware.
the creation of the Ransomware Vulnerability Warning Pilot (RVWP). Through the RVWP, CISA:
Proactively identifies information systems—belonging to critical infrastructure entities—that contain vulnerabilities commonly associated with ransomware intrusions.
Notifies the owners of the affected information systems, which enables the owners to mitigate the vulnerabilities before damaging intrusions occur.
Review the RVWP webpage for details, including information on the authorities and services CISA leverages to enable RVWP notifications.
HelpNetSecurity tells us how to use ChatGPT to improve cyber defenses.
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.
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.
From our Nation’s Capital, Roll Call fills us in on the debt ceiling negotiations. Significantly,
Economists at Moody’s Analytics estimate that the Treasury Department will run out of borrowing room by mid-August if Congress doesn’t act to raise or suspend the statutory debt limit by then.
The “x date” after which Treasury may not be able to pay all of the federal government’s bills appears to be Aug. 18, specifically, according to Moody’s economists Mark Zandi, Christian deRitis and Bernard Yaros.
The trio laid out various scenarios and potential consequences of failure to lift the $31.4 trillion debt ceiling in a new paper this week, on a topic that was examined more closely Tuesday afternoon in a Senate Banking subcommittee hearing led by Sen. Elizabeth Warren, D-Mass. Zandi is among those slated to testify.
The propspect of a mid-August explosion may encourage Congress to suspend the debt ceiling suspension until the end of the federal fiscal year, September 30, and focus on negotiating the interrelated 2024 appropriations and the debt ceiling topics.
The President provided highlights of the Medicare proposals in his 2024 fiscal year budget. The American Hospital Association explains
The president’s fiscal year 2024 budget will propose policies to keep Medicare’s Hospital Insurance Trust Fund solvent for at least an additional 25 years by directing additional Medicare taxes and savings from prescription drug reforms to the HI Trust Fund, the White House announced today. According to the latest annual report by the Medicare Trustees, the fund currently has sufficient funds to pay full benefits until 2028.
Among other Medicare provisions, the president’s budget will propose to eliminate cost-sharing for three behavioral health visits per year; require parity between physical health and mental health coverage; lower out-of-pocket costs for drugs subject to price negotiation; and cap Part D cost-sharing for certain generic drugs, the White House said.
The president’s FY 2024 budget is expected to be publicly released on March 9, with additional detail on March 13. AHA members will receive additional information on the president’s budget as those details are released.
Congress shared the budget with the Congressional Budget Office to analyze whether this plan will work.
Federal News Network reports on a recent GAO report about OPM.
The Office of Personnel Management is at “significant risk” of being unable to help agencies address governmentwide skills gaps, if it can’t first do a better job of addressing its internal skills gaps, GAO said in a report published last week.
Persistent internal skills gaps “could compromise OPM’s ability to implement its strategic objectives related to closing governmentwide skills gaps,” GAO said in the Feb. 27 report.
Although OPM has made progress in some areas of workforce management, such as creating an internal committee to hire and train new staff members, the agency is struggling to clearly identify and address several skills gaps within its own staff. * * *
Ron Sanders, former chairman of the Federal Salary Council and former associate director for HR policy at OPM, said the results of the GAO report were “unsurprising,” but that the reason behind the challenges may be difficult to measure.
“I think the skills gaps and have more to do with intangibles than they do with specific functional specializations,” Sanders, current president and CEO of Publica Virtu LLC, said in an interview with Federal News Network.
Hang in there, OPM, which has a lot on its plate, as we all do.
The Federal Trade Commission will give the public an additional 30 days to comment on a sweeping proposal to ban employers from imposing noncompete contracts on their workers.
The agency said interested parties have requested an extension, though acknowledged others oppose the delay. The public now has until April 19 to comment on the proposed rule, the FTC said on Monday.
FTC Commissioner Christine Wilson said in a separate statement that she would have supported an even longer extension since the proposal is “a departure from hundreds of years of precedent.”
MedCity News writes about the state of No Surprises Act rulemaking. Of note,
What the industry really needs from the government agencies at this point is a road map, or, as the Workgroup for Electronic Data and Interchange (WEDI) said in a recent letter to the secretary of HHS, a “glide path” that explains how the industry and the government will develop standards and operating rules together. In the letter, WEDI asked for the government’s expectations on vetting and testing standards and an estimate on timelines for implementing NSA regulations.
The FEHBlog heartily agrees with WEDI. Congress should consider amending certain provisions, particularly the good faith estimate and advance explanation of benefit provisions which should be amendments to the HIPAA electronic transaction standards and narrowed in scope.
From the Food and Drug Administration front —
STAT News provides an interview with Food and Drug Commissioner Dr. Robert Califf. For example
FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools. But he also said he saw it as an example of a drug company filling the void left by health systems that aren’t teaching doctors and trainees how to use new medicines.
“I think it’s a shame that you would need to depend on a pharmaceutical company for an educational program about something that’s affecting half of Americans,” Califf said during a meeting with STAT reporters and editors.
But, he said, “we also live in a practical real world. You might argue that if health systems did their jobs, you would have no need for educational programs from drug companies. But talk to people who practice medicine who are part of these big health systems and ask them how much help they get and guidance on what to do from the health systems they work for. I say this being a card-carrying lover of academic health systems, but that’s not where the money goes in academic health systems.”
The FDA is set to decide whether to fully approve Leqembi, Eisai and Biogen’s Alzheimer’s treatment by July 6, CNBC reported March 6.
Leqembi is an antibody treatment that targets brain plaque associated with Alzheimer’s. The drug is administered intravenously twice a month and in clinical trials has shown it can slow early Alzheimer’s disease by 27 percent; however, the deaths of three trial participants may be tied to brain swelling caused by the drug.
The FDA approved the drug on an expedited basis in January, but CMS has made it accessible to patients only in clinical trials. CMS plans to provide broader coverage if Leqembi is fully approved, according to CNBC.
Makena was the only drug approved by the Food and Drug Administration to reduce the risk of preterm birth in women with a history of early deliveries.
Covis said Tuesday it wants to work with the FDA to set a wind-down period for the drug so that patients aren’t abruptly taken off of it. The company said it was acting after experts advising the agency recommended it pursue Makena’s withdrawal from the market.
Eli Lilly and Company (NYSE: LLY) today [March 3] announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio® (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence. High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3).1 This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.
“The first hospitals seeking CMS’ new rural emergency hospital designation have submitted their applications, Kaiser Health News reported March 6.
“Hospitals that convert receive a 5 percent increase in Medicare payments as well an average annual facility fee payment of about $3.2 million, according to the report. In return, the hospitals must close their inpatient beds and focus solely on outpatient and emergency care.”
“Regional health system Atrium Health [headquartered in Charlotte, NC] is partnering with tech retailer Best Buy to co-design hospital-at-home programming, bolster Atrium’s existing hospital-at-home program and sell to other hospital clients down the line.
The partnership, announced Tuesday, aims to combine Atrium’s hospital-at-home program and existing telemedicine infrastructure with Best Buy Health, the retailer’s healthcare vertical that includes care-at-home business Current Health, along with its home installation and supply chain capabilities.
“The Atrium and Best Buy partnership seeks to improve some aspects of hospital-at-home programs that can be particularly tricky for operators, like patient education and technology installation in the home.
Beckers Hospital Review tells us, “Mark Cuban Cost Plus Drug Co. has entered into an agreement with IBSA Pharma to sell Tirosint, a medication for hypothyroidism. It will be the first brand-name drug offered by Mr. Cuban’s pharmacy.”
From the medical and pharmaceutical research and studies front —
“Some doctors are urging patients to cut back their consumption of sugar substitutes as questions mount about their health effects.
“In the latest study, published February in the journal Nature Medicine, Cleveland Clinic researchers found that the commonly used zero-calorie sweetener erythritol was associated with an increased risk of heart attacks, strokes and death within three years.
“Erythritol, a sugar alcohol produced naturally in the body, is used as a sugar substitute in low-calorie and low-carb products, often in those marketed as keto-friendly, such as ice cream, baked goods and condiments. It is also often mixed with other sweeteners.
“As low-carb and ketogenic diets have grown popular, people have turned to nonsugar-sweetened products for a hit of sweetness with less sugar and carbs. Yet, researchers are warning that sugar substitutes might pose their own health concerns.”
Medscape considers whether Vitamin D is a viable prevention strategy for dementia.
The NIH Director’s Blog discusses the importance of dental/oral health care to overall health and well-being.
“Fully 73% of Generation Z employees and 74% of Millennial employees have utilized mental health benefits offered by their employers, while 58% of Generation X employees and 49% of Baby Boomer employees have used the benefits.
Additionally, while 65% of Generation Z and 60% of Millennial workers say it’s “very important” for their employers to provide mental wellness benefits, just 49% of Generation X and 45% of Baby Boomer workers say the same.”
“An experimental medicine for a rare blood vessel disorder [pulmonary arterial hypertension, or PAH, which is caused by a thickening of the blood vessels around the lungs] improved patients’ exercise capacity and potentially slowed the disease’s progression, according to detailed results from a late-stage clinical trial that were revealed on Monday.
“The drug, called sotatercept and owned by Merck & Co., was the principal prize of an $11.5 billion acquisition the pharmaceutical company negotiated more than a year ago.
“Researchers at the National Institutes of Health show the benefits of screening adult patients in remission from acute myeloid leukemia (AML) for the residual disease before receiving a bone marrow transplant. The findings, published in JAMA(link is external), support ongoing research aimed at developing precision medicine and personalized post-transplant care for these patients.
About 20,000 adults in the United States are diagnosed each year with AML, a deadly blood cancer, and about one in three live past five years. A bone marrow transplant, which replaces unhealthy blood-forming cells with healthy cells from a donor, often improves these chances. However, research has shown that lingering traces of leukemia can make a transplant less effective.
“Researchers in the current study wanted to show that screening patients in remission for evidence of low levels of leukemia using standardized genetic testing could better predict their three-year risks for relapse and survival. To do that, they used ultra-deep DNA sequencing technology to screen blood samples from 1,075 adults in remission from AML. All were preparing to have a bone marrow transplant. The study samples were provided through donations to the Center for International Blood and Marrow Transplant Research.
As we close out Black History Month, let’s join the Trust for American Health in celebrating notable African American in public health.
From the Covid front, the Wall Street Journal reports
The U.S. Energy Department has concluded that the Covid pandemic most likely arose from a laboratory leak, according to a classified intelligence report recently provided to the White House and key members of Congress.
The shift by the Energy Department, which previously was undecided on how the virus emerged, is noted in an update to a 2021 document by Director of National Intelligence Avril Haines’s office.
The new report highlights how different parts of the intelligence community have arrived at disparate judgments about the pandemic’s origin. The Energy Department now joins the Federal Bureau of Investigation in saying the virus likely spread via a mishap at a Chinese laboratory. Four other agencies, along with a national intelligence panel, still judge that it was likely the result of a natural transmission, and two are undecided.
From the miscellany department —
Fortune Well provides us with insights on how to manage a life-threatening diagnosis.
Health Payer Intelligence tells us what payers can expect to find in the proposed CMS electronic prior authorization rule. The public comment deadline on the rule is March 13, 2023
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.”
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