Weekend Update / Cybersecurity Saturday

No Surprises Act

Weekend Update / Cybersecurity Saturday

David Ermer–Congress, Cybersecurity, FDA, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare–
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

David Ermer–Congress, COVID-19, Federal employment benefits, Medicare, No Surprises Act, OPM–

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, cases, deaths, and hospitalizations have all been decreasing steadily. Much of the U.S. population has some form of immunity, either through vaccination or previous infection. In addition, CDC’s 2023 Child and Adolescent Immunization Schedule now includes COVID-19 primary vaccine series and links to the latest guidance on booster dose vaccination in all populations.

The Wall Street Journal offers former CDC Director Tom Frieden view on the past three pandemic years.

The CDC’s Fluview continues to report “Seasonal influenza activity remains low nationally.”

The New York Times highlights a recent breakthrough in stroke treatment. The article reports that this breakthrough allowed John Fetterman to be a U.S. Senator from Pennsylvania. Here’s the catch.

There’s a number that floats around in medicine: It takes, on average, 17 years for a new treatment or technique, or some other form of research breakthrough, to filter down into widespread clinical practice. But the actual timeline varies widely from case to case. “What everybody’s trying to do is speed up that process,” says Dr. Sharon Straus, the director of the Knowledge Translation Program at St. Michael’s Hospital in Toronto. (“Knowledge translation” is one of several terms for a young, multidisciplinary field that aims to better understand and improve the medical research-to-practice pipeline.) “Some things do take off more quickly.”

That number of years is sobering. Good luck, Dr. Straus.

In FSAFeds news, the Internal Revenue Service issued FAQs addressing “whether certain costs related to nutrition, wellness, and general health are medical expenses under section 213 of the Internal Revenue Code (Code) that may be paid or reimbursed under a health savings account (HSA), health flexible spending arrangement (FSA), Archer medical savings account (Archer MSA), or health reimbursement arrangement (HRA).”

Thursday Miscellany

David Ermer–ACA, CDC, CMS, COVID treatment, COVID-19, COVID-19 testing, FDA, Federal employment benefits, Medicare, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare–
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.

Happy International Women’s Day

David Ermer–CDC, FDA, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Hannah Busing on Unsplash

The Wall Street Journal reports

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 late 2019, 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.
  • STAT News reports
    • 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.)
  • MedTech Dive informs us
    • “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.
    • “Advocates also want the federal government to bar nonprofit hospitals from selling patient debt or denying medical care to people with past-due bills, practices that remain widespread across the U.S., KHN found.
    • “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.”

FEHBlog message to Congress

  • FEDWeek reports
    • 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.

Tuesday’s Tidbits

David Ermer–Congress, FDA, Mental health care, NIH, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

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.

Healthcare Dive tells us

  • 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.”

  • Beckers Hospital Review informs us,

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.

Covis Pharma Group said it will stop selling its drug to prevent preterm births, after a study couldn’t confirm the medicine worked and U.S. health regulators were taking steps that could have it pulled.

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.

From the U.S. Healthcare business front —

  • Beckers Hospital Review tells us,
    • “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.”
  • Healthcare Dive informs us
    • “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 —

  • The Wall Street Journal relates
    • “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.
  • Securian Financial announced
    • “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.”
  • BioPharma Dive points out
    • “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.
    • “Data from the trial were presented at a medical conference and published in The New England Journal of Medicine. They have been highly anticipated since October when Merck said the study, dubbed STELLAR, was a success.”
  • The National Institutes of Health (NIH) announced
    • “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.

Friday Factoids

David Ermer–CDC, COVID-19, Electronic health records, FDA, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

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. 

In other public health news

  • Healio informs us
    • 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.”
  • The Washington Post reports
    • 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 body may be triggering or exacerbating depression in the brains of some 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.”

From the miscellany department

  • Beckers Hospital Review relies on the Harvard Business Review to identify “four measures needed to create shoppable healthcare beyond price transparency.”

Strap Yourself In

David Ermer–FDA, Federal employment benefits, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

In the 1980s and 1990s, the Washington Post had a television critic named John Carmody who would warn readers at the beginning of his column to “strap yourselves into your breakfast nook” when he had big news. So strap yourselves in, and here goes. (The photo to the right is a rough approximation of a breakfast nook, a concept which has fallen out of style evidently.

Over the next 18 to 24 months, according to the Wall Street Journal, Humana will withdraw from the employer health benefits market to focus on the government health programs market.

Humana, which currently offers many FEHB HMO plans, placed the FEHB Program in the “bye-bye” employer health benefits market even though the employer is the federal government. The FEHBlog, and Congress for that matter, prefer to view the FEHB Program as part of the employer market.

In short, Humana could have justified staying in FEHB but chose not to do so. The decision is worth pondering, particularly if you have a long-term perspective.

In other U.S. healthcare business news —

  • Healthcare Dive reports on earnings announcements from telehealth vendors Teladoc and Amwell.
    • In related telehealth news, Forbes informs us about a “new survey out from Rock Health.”
      • “While 80% of respondents said they had used telemedicine, there were only two categories where a majority of people preferred telemedicine over in-person care: prescription refills and minor illnesses. More than 60% of people surveyed preferred in-person visits for mental health and chronic condition care, while more than 70% wanted an in-person annual wellness visit. The starkest divide was on physical therapy: 80% of people preferred in-person visits, while only 20% preferred telemedicine.”
  • Biopharma Dive reports on Moderna’s earnings announcement.
    • In other vaccine news, CNN tells us
      • “The independent vaccine advisers to the US Centers for Disease Control and Prevention voted unanimously Wednesday in favor of the two-dose Jynneos mpox vaccine for adults at risk of catching the disease during an outbreak.”
      • “If the CDC agrees with the committee’s recommendation, there will be a recommendation in place to give the vaccine to people who are at risk for mpox during future outbreaks.”
      • “Even as mpox cases continue to fall, the CDC is encouraging people who are at risk to get vaccinated.”

From the preventive services front —

  • The U.S. Preventive Services Task Force issued for public comment a draft research plan regarding preventive interventions for perinatal depression. The public comment deadline is March 22, 2023.
  • The Mercer consulting firm offers useful observations on how employers and health plans can optimize their investments in preventive care.

From the Rx coverage front, Beckers Hospital Review tells us that the Centers for Medicare and Medicaid Services will not change its Medicare coverage policy on Aduhelm, an Alzheimer’s Disease treatment, based on the recent FDA approval of Leqembi.

CMS said in April 2022 that it would limit Aduhelm coverage to clinical trials only, which partly blocked the drugmaker’s efforts to sell the drug it once deemed a blockbuster. Leqembi will be subject to the same coverage plan. 

“We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable,” CMS said in a Feb. 22 statement. “After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration.”

If “any new evidence” becomes available or an amyloid-targeting Alzheimer’s drug receives traditional approval, CMS said it may reconsider its coverage decision.  

As readers know, CMS’s Medicare coverage decision on these drugs effectively controls the market for these drugs.

From the miscellany department

  • Affordable Care Act FAQ 57 was issued yesterday. This FAQ concerns implementation guidance for the No Surprise Act’s anti-gag clause provision.
  • FedSmith identifies five milestones toward federal retirement.
  • Kaiser Family Foundation has created federal and state litigation trackers regarding reproductive rights.

Midweek Update

David Ermer–CMS, COVID treatment, FDA, Medicare, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Affordable Care Act front, the WTW consulting firm informs us

Group health plans and health insurance issuers will not be required to submit certain information on air ambulance services by March 31, 2023 (the deadline included in an example in the proposed regulations). The Centers for Medicare & Medicaid Services has informally confirmed that since final regulations have not yet been issued, no reporting is required in 2023.

Also following up on recent posts, Healthcare Dive tells us that

Amazon completed its $3.9 billion acquisition of primary care chain One Medical on Wednesday, significantly increasing its healthcare offerings with the addition of physical medical clinics.

and

UnitedHealth has closed its $5.4 billion acquisition of home health business LHC Group, continuing a trend of payers elbowing into direct care delivery.

In other U.S. healthcare business news, Forbes points out that

Aledade, a startup that helps primary care doctors enter into value-based contracts with insurers, has acquired artificial intelligence software company Curia. The acquisition follows a pilot program, where Aledade used Curia’s predictive algorithms to identify 8,000 patients to get them enrolled in a special end-of-life care program. 

In a bit of good regulatory news for the FEHB Program, the CMS has delayed for up to one year final rulemaking on a civil monetary penalty rule for Medicare secondary payer violations. The proposed rule issued in Feburary 2020 treated FEHB plans and other group health plans inequitably as compared to non-group health plans, including trial lawyers. The FEHBlog is glad that CMS is trying to create a fair rule.

In other regulatory news, the Food and Drug Administration announced filing civil monetary penalty complaints against four e-cigarette manufacturers.

From the medical research front, MedPage Today reports

Patients with mild to moderate COVID-19 treated with the oral antiviral ensitrelvir within 5 days of symptom onset saw their symptoms resolve a day earlier, according to data from a phase II/III randomized trial.

Median time to symptom resolution was 24.3 hours earlier for patients treated with 125-mg ensitrelvir compared with those receiving placebo (P=0.04), reported Takeki Uehara, PhD, senior vice president of drug development and regulatory science at Shionogi and Co. in Osaka, Japan, during the Conference on Retroviruses and Opportunistic Infections. * * *

Ensitrelvir is a novel 3C-like protease inhibitor that targets the SARS-CoV-2 virus. “Because of its mode of action, ensitrelvir maintains antiviral activities across various different types of variants, including recently circulating Omicron variants,” Uehara said.

Of note, follow-up of patients continued out to 3 months and 6 months to evaluate the drug’s effectiveness on long COVID.

and

An important new study came out last week in the New England Journal of Medicine (NEJM), which found that a candidate vaccine against RSV was highly effective in preventing lower respiratory tract (read: lung) disease [in adults]. The study also found the vaccine prevented severe disease.

The study has many of the features you want to see from a well-conducted study: the vaccine was compared to placebo and the study was blinded, meaning that participants and the scientists carrying out the analysis were not aware of who got what. The study had nearly 25,000 participants and was carried out across 17 nations.

The vaccine was found to be over 80% effective against lower respiratory tract disease (the main outcome the study was designed to measure) and 94% effective against severe disease. This is great news.

.From the Rx coverage front —

  • Bloomberg relates “Eli Lilly & Co said on Tuesday that all doses of its new diabetes drug Mounjaro are now available after social-media enthusiasm about the drug’s weight-loss benefits sparked a two-month-long shortage.”

while

  • The Wall Street Journal reports
    • Drugs like Ozempic have become so popular among people seeking to lose weight that they are now in short supply for patients with diabetes who depend on the medicines.
    • Diabetes patients said they are spending hours trying to find nearby pharmacies that have their prescriptions in stock. If they don’t, some patients have had to reduce dosing of Ozempic and similar drugs to stretch out their supplies, or switch to alternative drugs.
    • The shortfalls are making it harder for people with diabetes to keep their blood-sugar levels low and limit their risk of complications like kidney disease and damage to blood vessels, doctors said.  * * *
    • Novo Nordisk A/S, which sells Ozempic, has been moving to expand production capacity. People may still experience periodic shortages, however, Chief Executive Lars Fruergaard Jorgensen said, because the work hasn’t been finished while demand may remain high. 
  • Biopharma Dive tells us
    • By and large, doctors appear to be comfortable prescribing biosimilar drugs, the copycat version of biologic medicines like inflammatory disease drug Humira or eye treatment Lucentis. But they aren’t yet sure the discounts offered are enough to justify switching patients who are stable on the brand-name products, according to an annual report from healthcare distributor Cardinal Health released Wednesday. * * *
    • [A] majority of physicians from the three Humira-prescribing specialties [rheumatology, gastroenterology and dermatology] said they were “very” or “somewhat” comfortable prescribing biosimilars, including 100% of gastroenterologists. Among the ophthalmologists, 48% said they were “uncomfortable from a clinical standpoint” among their primary concerns prescribing biosimilars.
    • When asked which patients they are most likely to prescribe a biosimilar, the most common response among the Humira-prescribing specialists was “existing patients for whom payers have mandated a biosimilar,” suggesting that insurers’ policies will drive uptake. However, 40% of rheumatologists said “new patients” would be the most likely people to get a biosimilar prescription.
  • Drug Channels offers its annual update on copay assistance accumulator and maximizer programs.

From the miscellany department –

  • The Milbank Memorial Fund issued a Baseline Scorecard Tracking Support for High Quality Primary Care. The baseline leaves a lot of room for improvement.
  • Fierce Healthcare informs us that CMS recently has issued price transparency warnings to hospitals, 300 of which have been satisfactorily resolved.
  • Health Payer Intelligence reports
    • While Medicare Advantage enrollment has increased by 1.5 million beneficiaries in 2023, this marks a slower growth compared to the last three years, according to data from Chartis.
    • The analysis reflects Medicare Advantage enrollment, plan, and pricing data from January 2019 to January 2023.
    • Between 2019 and 2023, Medicare Advantage enrollment has grown by 2.1 percent. As of January 2023, 46 percent of all Medicare beneficiaries are enrolled in Medicare Advantage, translating to 29.5 million people. * * *

Friday Factoids

David Ermer–COVID-19, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

    From the Omicron and siblings front —

    The CDC’s Covid Data Tracker shows all news cases, hospitalizations and deaths statistics trending down.

    Health Day informs us, “Natural immunity from a COVID infection confers protection on par with that from mRNA vaccines, but patients run the risk of hospitalization and death during their initial infection.”

    “The vaccines and boosters are still the safest way to acquire immunity, mainly for those who are in high-risk populations,” said study co-author Caroline Stein, a postdoctoral researcher at the University of Washington’s Institute for Health Metrics and Evaluation.

    In fact, the best protection now appears to come from “hybrid immunity,” the combination of an actual infection and vaccination, said Dr. William Schaffner, medical director of the Bethesda, Md.-based National Foundation for Infectious Diseases.

    From the public health front —

    • The CDC’s weekly Fluview reports, “Seasonal influenza activity is low nationally.”
    • The Fluview also discusses the risk that avian flu H5N1 poses to humans.
      • “The current public health threat to people from the H5N1 virus is low. The current H5N1 outbreak in poultry and birds continues to be mostly an animal health issue. However, people should avoid direct and close contact with sick or dead wild birds, poultry, and wild animals. People should not consume uncooked or undercooked poultry or poultry products, including raw eggs. Consuming properly cooked poultry, poultry products, and eggs is safe. Other preventive measures are available at Bird Flu: Current Situation Summary “
    • Health Day tells us, based on a recent CDC study, that “Far too many young kids aren’t eating enough fruits and vegetables, even as they consume plenty of sugary sodas.” No bueno.
    • The Wall Street Journal considers “How Common is Depression After a Stroke? Sen. John Fetterman’s Treatment Prompts Question. Depression can often follow a major medical issue or chronic illness. Here’s what to know.”
      • “Overall, between 20% and 30% of people with a chronic illness experience depression, says Karina Davidson, a clinical psychologist and dean of academic affairs at Northwell Health’s Feinstein Institutes for Medical Research.”
    • The Mercer consulting firm explains how new approaches are filling gaps created by obstetric unit closings.
      • “As the access to obstetrics care dwindles, employers can and should be looking for additional solutions to help keep their pregnant members and their newborns healthy. Whether that’s exploring new digital tools [such as Pregnascan and HeraMED] coming to market or just expanding coverage on their health plans to include doulas, community doulas, midwives, and birthing centers, any effort will be an important step forward in the fight to reduce maternal mortality and poor health outcomes in the US.”

    From the No Surprises Act front, a colleague reminded the FEHBlog today that the deadline for health plans and air ambulance providers to submit their first NSA air ambulance report, March 31, 2023, is closing in. While the federal government has made available draft information on preparing this report, no sign of an official submission portal has appeared online. The clock continues clicking.

    From the Miscellany Department —

    • Medscape offers an excellent article on the cost of gene therapies. Remember to click pages.
    • Mercer also delves into the abortion pill coverage quandary. (While FEHB plans must cover contraceptive pills, including the Plan B pill, abortion pills are excluded from coverage unless the mother’s life would be endangered if the fetus were carried to term or when the pregnancy is the result of an act of rape or incest.”
    • The American Hospital Association puts a favorable spin on a recent CMS report on health system compliance with the federal government’s hospital pricing transparency rule.
    • CMS is pleased “to provide you with the recording (password: 4%2M!3c?) and slides of the February 9, 2023, virtual education session hosted by the CMS Office of Burden Reduction and Health Informatics on the Advancing Interoperability and Improving Prior Authorization Processes proposed rule.
      • As a reminder, we welcome your feedback on the proposed policies introduced in the CMS Advancing Interoperability and Improving Prior Authorization Processes proposed rule (CMS-0057-P). Comments must be received within the 90-day comment period, which closes on March 13, 2023. When commenting, please refer to file code: CMS-0057-P.”
    • Beckers Hospital Review reports, “The Federal Trade Commission has welcomed the State University of New York Upstate Medical University and Crouse Health System’s decision to abandon their proposed merger, which it said would have left Syracuse with just two hospital systems — Upstate and St. Joseph’s Health — and given the combined entity a 67 percent share of commercially insured inpatient services in Onondaga County.”

    Midweek Update

    David Ermer–Congress, COVID-19 vaccine, No Surprises Act, U.S. Healthcare–

    From Washington D.C., Roll Call tells us

    The federal government will run out of cash to pay all its bills sometime between July and September unless the statutory debt limit is lifted, the Congressional Budget Office [CBO] warned Wednesday.

    The report by the nonpartisan budget scorekeeper could put pressure on a divided Congress to reach a deal to increase, or at least suspend, the debt limit before adjourning for the annual August recess.

    [A] separate CBO report issued Wednesday underscores the challenges for both parties in making the math add up. Deficits over the next decade are now projected to grow by $3.1 trillion, or 20 percent, during the next decade from the agency’s forecast last May. 

    STAT News “sat down with AMA President Jack Resneck on the sidelines of the [AMA’s Washington., D.C.] conference to talk about legislative reforms, physician burnout, and where the doctors’ lobby goes from here.” The Q&A made the FEHBlog crack up

    What is the AMA stance on implementation of the law to end surprise medical bills for patients?

    There’s a lot about the way those [HHS] rules were first written that went way outside of congressional intent. They put major thumbs on the scale of basically moving towards the insurers’ notion of what that value should be.

    There’s so many things about those rules that basically would encourage insurers to either just say “Oh, I can pay so much less through this arbitration system that I’m just going to purposely not contract with any physicians” … or just unilaterally, dramatically lower payment rates in a way that threatens practices.

    What nonsense!

    Medical Economics shares a letter to Congress from a group of medical associations on the topic of value-based care.

    The National Academies issued a report on “Achieving Whole Health.”

    Whole health is physical, behavioral, spiritual, and socioeconomic well-being as defined by individuals, families, and communities. Whole health care is an interprofessional, team-based approach anchored in trusted relationships to promote well-being, prevent disease, and restore health. It aligns with a person’s life mission, aspiration, and purpose. It shifts the focus from a reactive disease-oriented medical care system to one that prioritizes disease prevention, health, and well-being. It changes the health care conversation from “What’s wrong with you?” to “What matters to you?”

    The Office of Personnel Management released

    its inaugural report: Government-wide DEIA: Our Progress and Path Forward to Building a Better Workforce for the American People. This report highlights accomplishments aligned with the Government-wide Strategic Plan to Advance DEIA in the Federal Workforce and preview priorities for 2023 consistent with Executive Order (EO) 14035.

    “Whether you want to cure diseases, protect and preserve our national parks, combat climate change, or embark on missions to discover new galaxies, the Federal government is full of opportunity for the best and brightest to serve our country,” said OPM Director Kiran Ahuja. “In order to recruit and sustain the best talent, we must ensure every service-minded individual feels welcome and supported in contributing their talents to the Federal workforce. This inaugural report highlights progress made to advance diversity, equity, inclusion, and accessibility in the workplace, and we look forward to continuing the work to break down barriers to serve and help build a Federal government that draws from the strength and diversity of its people.”

    Tomorrow, February 16, at 10 am ET, the Senate Commerce, Science, and Transportation Committee will hold a hearing titled “Bringing Transparency and Accountability to Pharmacy Benefit  Managers.”

    This hearing will address how the “Pharmacy Benefit Manager Transparency Act” will bring transparency into PBM business practices and prohibit unfair or deceptive PBM conduct that drives up costs for consumers. The bipartisan S. 127, Pharmacy Benefit Manager Transparency Act of 2023, was introduced by Chair Cantwell and Sen. Chuck Grassley (R-Iowa), on January 27, 2023.

    From the Omicron and siblings front —

    STAT News reports

    In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution.

    The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage. For those lacking sufficient insurance, the company will tap a patient assistance program. “Everyone in the U.S. will have access to Moderna’s Covid-19 vaccine regardless of their ability to pay,” the company said.

    The about-face came on the same day that Sen. Bernie Sanders (I-Vt.), who chairs the Senate Committee on Health, Education, Labor, and Pensions, accused the company of “corporate greed” and scheduled a hearing next month to examine the initial decision to charge Americans for its Covid-19 shot. Moderna Chief Executive Officer Stéphane Bancel is among those expected to testify. * * *

    A spokesman for America’s Health Insurance Plans, an industry trade group, suggested that health insurers will still get a bill. He sent a note saying the Advisory Committee on Immunization Practices (which advises the CDC) recently updated its list of recommended Covid vaccines and that, while beneficiaries pay nothing in cost sharing after commercialization, health plans are picking up the full cost.

    No doubt about the validity of AHIP’s point.

    Medscape notes, “The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.”

    From the public health front —

    • The White House announced
      • “the Consumer Financial Protection Bureau (CFPB) released a new report that shows that the number of Americans with medical debt on their credit reports fell by 8.2 million from the first quarter of 2020 to the first quarter of 2022. Today’s report is consistent with a recent report from the Centers for Disease Control and Prevention (CDC) that found that the number of Americans who are part of families having trouble paying their medical bills declined by 5.5 million between 2020 and 2021. One driver of these declines is the significant increase in the number of insured Americans over this period, a result of the President’s strategy of protecting and strengthening the Affordable Care Act (ACA) and lowering health care costs. The decline also reflects continued actions by the CFPB to highlight problems with inaccurate reporting of debt in collections and put the industry on notice to correct their behavior.”
    • The Wall Street Journal reports “More older women with low-risk breast cancer could forgo radiation after surgery to avoid further side effects and costs, research showed, as some doctors work to limit tough treatments without hurting survival.” STAT News also offers an article on this topic.
    • The National Cancer Institute posts on a variety of cancer topics. For example
      • “The Food and Drug Administration (FDA) approved tucatinib (Tukysa) with trastuzumab (Herceptin) to treat HER2-positive advanced colorectal cancer. The approval was based on the MOUNTAINEER trial, in which nearly 40% of participants’ tumors shrank after receiving the drugs.”

    In other health care cost news —

    Beckers Payer Issues relates

    Employer-sponsored plans pay much higher rates for physician-administered drugs than Medicare, a research letter published Feb. 10 in JAMA Health Forum found. 

    Researchers at the Healthcare Cost Institute compared per-unit prices for the 10 most expensive and 10 most common physician-administered drugs from 2016 to 2020. 

    For the most commonly used drugs, employer-sponsored plans paid prices up to 3,350 percent higher than Medicare. For midazolam, employer-sponsored plans paid 30 times more than Medicare for the same drug, and they paid 20 times more for ondansetron. 

    For the most expensive drugs, employer-sponsored plans did not pay as extreme markups, the researchers found. Markups were  54 percent more than Medicare at the high end, and employer-sponsored plans paid similar prices to Medicare rates for some drugs. 

    Read the full study here. 

    Thank heavens OPM is allowing FEHB plans to offer Medicare Part D EGWPs for the Medicare prime members next year.

    Health Payer Intelligence informs us “Out-of-pocket costs for buprenorphine prescriptions for opioid use disorder treatment decreased between 2015 and 2020, but costs varied by payer, according to a study published in JAMA Network Open.”

    From the U.S. healthcare business front

    Beckers Payers Issues advises

    The nation’s largest payers have filed their fourth quarter earnings reports, revealing which have the most U.S. commercial members.
    Commercial includes fully- and self-insured members

    Commercial enrollment rankings in 2022:

    1. Elevance Health: 31.4 million
    2. UnitedHealth Group: 26.7 million
    3. Cigna: 22 million
    4. CVS Health (Aetna): 17 million
    5. Centene: 2.5 million
    6. Humana: 986,000

    Healthcare Dive reports

    • After more than two decades together, CommonSpirit Health and AdventHealth are dissolving their joint venturemanaging hospital operations in Colorado and western Kansas. 
    • The management company, Centura, operates one of the largest hospital networks in the region, with 20 hospitals and a network of outpatient practices.
    • In a release on Tuesday, the systems said the partnership had reached its “natural maturity.” CommonSpirit and AdventHealth didn’t lay out a timeline for the transition.

    and

    Elevance has closed its deal to acquire specialty pharmacy BioPlus, the insurer announced Wednesday, after first announcing the buy in November 2022.

    The acquisition builds off the Indianapolis-based insurer’s promise to acquire companies around its health services business, with Elevance CEO Gail Boudreaux announcing at a November industry conference that the insurer planned to grow “very aggressively” into adjacent care services.

    Beckers Hospital Review tells us

    Walgreens has agreed to buy the assets of defunct digital pharmacy Medly for $19.35 million, according to a bankruptcy court filing.

    Medly declared bankruptcy in December, months after its founder stepped down and it laid off more than half its staff. A judge approved the acquisition of Medly’s assets, including its files, inventory and intellectual property, Feb. 7 in U.S. Bankruptcy Court for the District of Delaware.

    Medly raised $100 million in 2020, positioning itself as a digital competitor to retail pharmacies such as Walgreens and CVS.