FEHBlog

Monday Roundup

Photo by Sven Read on Unsplash

    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 12 suffering 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.

    Weekend Update / Cybersecurity Saturday

    Blue Bonnets — The Texas State Flower

    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.

    Weekend Update

    The House of Representatives and the Senate will be in session for Committee business and floor voting on Wednesday, Thursday and Friday this week.

    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.

    From the healthcare developments front —

    NPR tells us

    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 The New 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.

    Medscape highlights a “revolutionary” treatment for suicidal depression, the Stanford neuromodulation therapy (SNT) protocol.

    From the medical research front, Medscape reports

    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.

    Federal News Network reports

    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.

    Nextgov reports

    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.

    Cybersecurity Dive informs us.

    • 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 correlated with 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.
    • HC3 posted a threat profile on Black Basta.
      • “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.

    From the cyber defenses front —

    CISA announced

    the creation of the Ransomware Vulnerability Warning Pilot (RVWP). Through the RVWP, CISA:     

    1. Proactively identifies information systems—belonging to critical infrastructure entities—that contain vulnerabilities commonly associated with ransomware intrusions.
    2. 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.

    Friday Insights

    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.

    Also at the AHIP conference per MedCity News

    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 statistics tells us

    As we mark three years of the COVID-19 pandemic, casesdeaths, 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).”

    Thursday Miscellany

    Photo by Josh Mills on Unsplash

    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. 

    From the Medicare front, Healthcare Dive tells us

    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.

    Midweek update

    From the federal employment front, Govexec tells us

    The Biden administration is looking to add 82,000 employees in fiscal 2024, a 3.6% increase that would bring civilian federal rolls to their highest levels since World War II. 

    Nearly every federal agency would receive a funding boost in President Biden’s fiscal 2024 budget, and all but one major agency is anticipating adding staff as a result. Some of the hiring is still aimed at making up for losses sustained during Obama-era budget caps and Trump-era targeted reductions, though much of it is for implementing major new initiatives Biden has ushered into law like the Inflation Reduction Act and the bipartisan infrastructure measure Congress approved in 2021.

    “As we release the President’s FY 2024 Budget, we are proud of the mission-driven investments it makes in the federal government’s most important asset—our people,” Office of Management and Budget Deputy Director for Management Jason Miller and Office of Personnel Management Director Kiran Ahuja said in a [Performance.gov] blog post Monday. 

    From the end of the public health emergency front, Health Payer Intelligence reports

    In most states, beneficiaries who lose Medicaid coverage when the public health emergency ends are likely to transition into employer-sponsored health plans, according to a study funded by AHIP from NORC at the University of Chicago (NORC).

    NORC used the Urban Institute’s public health emergency Medicaid coverage loss estimates and historic data from the Current Population Survey (CPS) Annual Social and Economic Supplement (ASEC).

    The researchers recategorized the data, taking into account respondents’ coverage type in year one and year two of the transition, supplementing data for smaller states, and applying a hierarchy of coverage types to distribute respondents with multiple coverage sources. When respondents had multiple coverage types, the researchers prioritized first employer-sponsored coverage, then uninsurance, CHIP, nongroup coverage, and other public coverage, respectively.

    When the researchers blended these two data sources, the study found that individuals who lose their Medicaid coverage after the end of the public health emergency will transition into employer-sponsored health plans in most states.

    More than half of the beneficiaries who lose Medicaid coverage will transition to employer-sponsored health plan coverage in every state except for Georgia (48.9 percent), according to the dashboard associated with the report. The state with the highest share of beneficiaries going into employer-sponsored health plans after the public health emergency was Delaware (57.1 percent).

    Because FEHB-eligible annuitants and family members must be on Medicaid, OPM may want to consider sharing information with federal agencies about how this cohort can shift from Medicaid to FEHB and when to apply.

    From the Medicare front —

    • CMS today trumpeted that Medicare Part D members can receive vaccinations without cost sharing. CMS doesn’t mention that commercial plans, including FEHB plans, have offered this opportunity under the Affordable Care Act since 2011. For example, the FEHBlog received a shingles vaccination with no-sharing (in-network) before he went on Medicare (because his company has under 20 employees). He got hit with a $400 Medicare Part D copay when he received the updated shingles shots in 2019. Better late than never because the FEHBlog needs a TDap booster next year.
      • While Congress emptied this bowl of wrong, Medicare beneficiaries still face a pre-existing condition limitation (except in certain states) if they try to enroll in a Medicare supplement plan after the first opportunity.
    • CMS announced “27 prescription drugs for which Part B beneficiary coinsurances may be lower from April 1 – June 30, 2023. Thanks to President Biden’s new law to lower prescription drug costs, some people with Medicare who take these drugs may save between $2 and $390 per average dose starting April 1, depending on their individual coverage.” One CMS fact sheet explains how this program works, and another CMS fact sheet lists the 27 drugs, which include Humira. This will reduce FEHB Program spending as a secondary payer for annuitant and eligible family members with primary Part B. In the FEHBlog’s opinion, this program will not generate a dollar-for-dollar cost shift from Medicare to the FEHB cohort without primary Part B due to how the new program is structured.
    • Looking forward, CMS released its “Initial Guidance for Historic Medicare Drug Price Negotiation Program for Price Applicability Year 2026.” Thanks to OPM’s decision to allow FEHB plans to offer Part D EGWPs in 2024, the FEHB will be advantaged by the Part D savings.

    From the public health front, the Alzheimers Association issued

    Alzheimer’s Disease Facts and Figures, an annual report released by the Alzheimer’s Association, reveals the burden of Alzheimer’s and dementia on individuals, caregivers, government and the nation’s health care system.

    The accompanying special report, The Patient Journey in an Era of New Treatments, examines the importance of conversations about memory at the earliest point of concern, as well as a knowledgeable, accessible care team to diagnose, monitor disease progression and treat when appropriate. This is especially true now, in an era when treatments that change the underlying biology of Alzheimer’s are available.

    From the miscellany department –

    • Forbes informs us that “the U.S. government is suing Rite Aid — accusing the drugstore chain of “knowingly” filling unlawful prescriptions for controlled substances — only adds to the financial and operational woes of the embattled drugstore chain.”
    • AHIP has added details to the March 29-30 OPM AHIP FEHB Carrier Conference agenda.
    • The Wall Street Journal reports on yesterday’s abortion pill hearing before a federal judge in Amarillo, Texas. “A federal judge on Wednesday questioned the government about its approval of a medication used in more than half of the abortions in the U.S. but also asked whether there was any precedent for a court blocking sales of a drug long after it had been allowed on the market.” The FEHBlog expects the Court to rule in the federal government’s favor because no such precedent exists.  
    • Beckers Hospital Review tells us

    A ChatGPT update released March 14 has been stunning physicians with its ability to deliver sound medical advice, The New York Times reported.

    Anil Gehi, MD, a cardiologist and associate professor of medicine at Chapel Hill, N.C.-based UNC Health, described the health history of a patient, using advanced medical terminology, to the artificial intelligence chatbot and asked it how he should treat the person, according to the March 14 story.

    “That is exactly how we treated the patient,” he said of ChatGPT’s answer.

    Experts told the newspaper the new GPT-4 technology is more precise, accurate and descriptive than its predecessor, which OpenAI released in November. However, the chatbot is still prone to “hallucination” and making things up.

    Tuesday’s Tidbits

    Happy Pi Day!

    Photo by Patrick Fore on Unsplash

    From the Omicron and siblings front —

    • The Wall Street Journal reports
      • 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 Institute of MIT and Harvard, a biomedical research center 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.
    • The Wall Street Journal reports,
      • Novo Nordisk A/S is set to cut the U.S. list prices for several insulin drugs by up to 75%, the latest big drugmaker to make steep price reductions amid pressure to curb diabetes treatment costs.

      • 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.

    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 NIH DIrectors in his blog, explains
      • “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.

    Monday Roundup

    Photo by Sven Read on Unsplash

    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.”

    From the Rx coverage front —

    The Wall Street Street Journal reports

    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

    From the Rx business front —

    BioPharma Dive informs us

    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.

    STAT News relates

    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.
    • Beckers Hospital Review reports
      • 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 launch of a series of online dialogues to gather ideas and other public input on how health policies can support workers’ mental health most effectively.
      • 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.

    Weekend update

    Bluebonnets — The Texas State Flower

    The House of Representatives and the Senate will be in session this week for Committee business and floor voting.

    HHS’s Agency for Healthcare Quality and Research reminds us that we observe Patient Safety Awareness Week from March 12 through March 18.

    HR Dive reminds us that March 2023 marks the thirtieth anniversary of Congress enacting the Family and Medical Leave Act.

    From the public health front —

    • The American Medicare Association explains what doctors wish patients knew about falling U.S. health expectancy and identifies steps patients can take to lower high blood pressure.
    • Fortune Well informs us, “Researchers have found long-term evidence that actively monitoring localized prostate cancer is a safe alternative to immediate surgery or radiation.”
    • A Fortune Well reporter shares lessons learned from wearing a continuous glucose monitor for a decade.

    From the Rx coverage front, STAT News reports

    The emergence of highly effective obesity drugs has spurred renewed efforts to get Medicare to pay for weight loss medications, but a group of health policy experts is sounding caution.

    Even a small amount of uptake would create significant costs for Medicare, likely leading the federal insurer to raise premiums in the long run, the researchers said in a perspective piece Saturday in the New England Journal of Medicine.

    The chronic medications may also have fewer benefits and more risks for older people — the population that Medicare serves, they wrote.

    OPM advised FEHB carriers in a January 2023 carrier letter

    FEHB Carriers must have adequate coverage of FDA approved anti-obesity medications on the formulary to meet patient needs and must make available their exception process to members. Carriers must cover at least one anti-obesity drug from the GLP-1 class for weight loss and cover at least 2 additional oral anti-obesity drug options. As new anti-obesity drugs are approved by the FDA, OPM expects Carriers to evaluate and update their coverage of anti-obesity drugs. Carriers should provide access to a range of obesity drugs on the formulary in order to satisfy OPM’s requirement in Carrier Letter 2022-02 that Carriers must ensure non-discriminatory access to safe, clinically appropriate drug therapy for members with chronic conditions. This includes drug therapies indicated for adolescents age 12 years and older.

    In cases where utilization management edits are applied, the process and evidence-based criteria for coverage must be transparent, readily accessible, and follow OPM required turnaround timelines for standard and expedited reviews. We recognize the progress made in covering anti-obesity medications; our goal is to have all Carriers offer adequate coverage.

    From the medicare practice front —

    • RevCycle Intelligence relates, “Providers are Increasingly Billing Outpatient Visits at Higher Levels; The share of outpatient visits billed at the two highest complexity levels increased from 24 percent in 2004 to 43 percent in 2021,” and “A study finds that outpatient surgery rates for 4 common procedures rose significantly during the pandemic, while barriers prevent greater uptake for other surgical operations.
    • In an intriguing contrast of news —
      • RevCycle Intelligence highlights, “New data shows that 46% of patients rely on online provider reviews for provider selection. With loyalty on the back burner, a poor patient experience could prompt consumers to look elsewhere.”
      • Meanwhile, the Wall Street Journal reports
        • “Doctor-rating websites regularly fail to mention such black marks on physicians’ records, according to research published in November in the Journal of Empirical Legal Studies. 
        • “The researchers compared two groups of online reviews. One group consisted of ratings for 221 doctors in Illinois and Indiana who had paid medical-malpractice claims and had disciplinary actions against them. The other group had ratings for 221 doctors in the same two states with clean records. Based on their findings across five online rating services—Healthgrades.com, RateMDs.com, Vitals.com, WebMD and Yelp.com—the researchers reported no significant difference in the two groups’ ratings. 
        • “If you have a physician with both discipline and medical-malpractice claims, you should probably be looking for someone else, but that information is not easy to find,” says David Hyman, an author of the study and a health-law and policy professor at Georgetown University Law Center. 
        • “Of the five websites in the study, only Healthgrades reports medical-malpractice claims and disciplinary actions, but it misses 90% of those claims and actions, according to the study authors.”

    Cybersecurity Saturday

    From Capitol Hill, the Senate Homeland Security and Governmental Affairs Committee will hold a full Committee hearing to examine cybersecurity risks to the healthcare sector. The hearing will occur on Thursday, March 16, 2023, at 10 am.

    Among the topics at the hearing will be a serious cybersecurity breach at DC Health Link which runs the DC health marketplace under the Affordable Care Act (“Act”). In the Affordable Care Act (“ACA”) Congress shifted its health benefits coverage for its members and senior staffers from FEHB to the ACA marketplace. Of note, Congress was directly hit in the OPM breach and this new one.

    Axios explains

    A hacker who uses the pseudonym “Denfur” is selling a database they claim includes stolen sensitive data from at least 55,000 customers of D.C.’s health insurance marketplace, including members of Congress and their staffs.

    Driving the news: Congressional leaders started warning lawmakers on Wednesday about the breach at DC Health Link and suggested they freeze their credit while an investigation continues.

    • DC Health Link, which confirmed the breach and dark web leaks in a statement, helps all city residents purchase health insurance, not just members of Congress.

    What’s happening: Researchers at Check Point Research told Axios Thursday that a malicious hacker had posted the database for sale on the “biggest English-speaking dark web hacking forum.” The member claims the database includes sensitive data from thousands of customers, including Social Security numbers, birthdates and home addresses.

    • Denfur is now selling the stolen database for just “a few dollars,” researchers noted. Denfur signed off the post with “Glory to Russia!”
    • CyberScoop reports that a sample of the stolen data includes information about former defense officials and lobbyists, and the Associated Press reported it was able to authenticate data belonging to two victims in the set.
    • Axios has seen the dark web post, which was still live as of Friday morning.

    Cyberscoop adds,

    A person using the moniker “IntelBroker” first posted the stolen data on March 6 to an online forum, where data breaches are publicized and data is either published for download or offered for sale. That post was subsequently pulled down, and “IntelBroker” is now listed permanently banned. 

    Three days later, on March 9, a second user going by the name “Denfur” — whose signature on the site reads “Glory to Russia!” — posted what they claimed was the full database, along with a sample that includes 200 entries. The full dataset includes 67,565 unique entries and about 55,000 “unique people,” Denfur claimed. 

    At about midday Thursday Denfur also claimed that “the intended target WAS U.S. Politicians and members of U.S. Government.” The quote appeared alongside a link to a news story about the incident quoting House of Representatives Chief Administrative Officer Catherine Szpindor as saying that the members of Congress were not the specific target of the attack.

    From the cybersecurity risks / vulnerabilities front —

    Tech Republic tells us,

    CrowdStrike, a cybersecurity firm that tracks the activities of global threat actors, reported the largest increase in adversaries it has ever observed in one year —  identifying 33 new threat actors and a 95% increase in attacks on cloud architectures. Cases involving “cloud-conscious” actors nearly tripled from 2021.

    “This growth indicates a larger trend of e-crime and nation-state actors adopting knowledge and tradecraft to increasingly exploit cloud environments,” said CrowdStrike in its 2023 Global Threat Report.

    Besides the raft of new threat actors in the wilds that it pinpointed, CrowdStrike’s report also identified a surge in identity-based threats, cloud exploitations, nation-state espionage and attacks that re-weaponized previously patched vulnerabilities. * * *

    Last week’s revelation of an attack on password manager LastPass, with 25 million users, says a lot about the difficulty of defending against data thieves entering either by social engineering or vulnerabilities not usually targeted by malware. The insurgency, the second attack against LastPass by the same actor, was possible because the attack targeted a vulnerability in media software on an employee’s home computer, releasing to the attackers a trove of unencrypted customer data.

    The Cybersecurity and Infrastructure Security Agency (CISA) added three known exploited vulnerabilities to its catalog on March 7, 2023, and two more on March 10. Bleeping Computer provides its perspective here.

    Tech Republic also highlights a cybersecurity report from the World Econonic Forum that is worth a gander.

    From the ransomware front

    Tech Republic informs us based on the CrowdStrike report that cybercriminals are shifting tactics from ransomware to data exfiltration and extortion like what happened at DC Health Link. “There was a 20% increase in the number of adversaries conducting data theft and extortion last year, by CrowdStrike’s reckoning.”

    HHS’s Healthcare Sector Cybersecurity issued a threat alert on data exfiltration trends in the healthcare sector on March 9.

    Here’s a link to Bleeping Computer’s The Week in Ransomware.

    From the cybersecurity defenses front —

    Health IT Security reports

    HHS, through the Administration for Strategic Preparedness and Response (ASPR), and the Health Sector Coordinating Council (HSCC) Cybersecurity Working Group released the Cybersecurity Framework Implementation Guide to help the healthcare sector manage cybersecurity risks amid an increasingly sophisticated threat landscape.

    The guide aims to help healthcare organizations align their cyber programs with the National Institute for Standards and Technology (NIST) Cybersecurity Framework (CSF). * * *

    The publication is not intended to replace other cybersecurity programs or provide a roadmap to compliance, the guide states. Rather, the voluntary guidance can help healthcare organizations bolster their existing programs and ideally reduce risk by aligning the healthcare sector with NIST’s robust framework.  

    Bank Info Security points out that “In addition to the new joint NIST cybersecurity framework toolkit, the Health Sector Coordinating Council and HHS are also close to completing an update of a joint 2019 publication, Health Industry Cybersecurity Practices.”

    Director Ahuja appears before Congress

    Photo by Michele Orallo on Unsplash

    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.