Midweek Update

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

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. * * *

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, FDA, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the U.S. healthcare business front, the Wall Street Journal reports

Amazon.com Inc. will be able to close its purchase of 1Life Healthcare Inc., the operator of the One Medical line of primary-care clinics, without a legal challenge by antitrust enforcers.

The Federal Trade Commission won’t sue in time to block the $3.9 billion deal, including debt, but will continue its investigation of the merger, an agency spokesman said. The decision clears a path for Amazon to substantially expand its healthcare offerings and operate physical medical clinics. Amazon has invested in the healthcare space for years, including with an online pharmacy and other health ventures.

“The FTC’s investigation of Amazon’s acquisition of One Medical continues,” FTC spokesman Douglas Farrar said. “The commission will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.”

Becker’s Hospital Review offers two articles on Mark Cuban’s Cost Plus Drug Co.

  • In one article, BHR observes
    • As news outlets, celebrities, swingers on Reddit and people on Twitter praise Cost Plus Drug for its low prices on hundreds of generics, some of its products are more expensive than options at local pharmacies, KHN reported using GoodRx data. 
    • For example, one presentation of amoxicillin-clavulanate, an antibiotic currently in shortage, is $267.60 at Cost Plus Drug Co. and $109.44 at the average community pharmacy. 
    • Mr. Cuban told the outlet that its analysis was not comprehensive because of the company’s pricing model, which is a 15 percent markup, $3 for labor per drug and $5 for shipping. Because the shipping cost is overall and not for each medication, Mr. Cuban said his pharmacy can still offer a cheaper sale. 
  • In the other article, BHR informs us that the Cost Plus Drug Co., which already has business arrangements with three prescription drug managers, is contacting independent pharmacies for business.

From the public health front, February is Low Vision Awareness Month.

  • The BrightFocus Foundation proclaimed
    • Global vision and brain research non-profit BrightFocus Foundation celebrates the U.S. Food and Drug Administration’s (FDA) approval of Syfovre (pegcetacoplan injection), the first-ever treatment to slow the progression of vision loss from geographic atrophy, an advanced form of dry age-related macular degeneration and a leading cause of blindness. 
    • “Today’s FDA approval of Syfovre provides hope to the more than five million people worldwide who are at risk of permanent vision loss from geographic atrophy,” said BrightFocus President and CEO Stacy Pagos Haller. “This first-of-its-kind treatment is a momentous step forward in vision research and will make a meaningful difference in the lives of millions of people.” 
    • An estimated one million people in the U.S. have geographic atrophy, an advanced and severe form of age-related macular degeneration in which regions of cells in the retina waste away and die (atrophy). This progressive and irreversible disease can lead to permanent vision loss. Nearly 20 million adults in the U.S. have some form of age-related macular degeneration (AMD), almost double the previous estimate of 11 million people, according to a new report.    
    • People living with geographic atrophy often experience emotional hardships including anxiety, feeling powerless, and frustration. Approximately one in three have recently withdrawn from their social lives because of their disease, and BrightFocus offers a free AMD community group and educational audio chats for affected individuals.
    • Syfovre is expected to be available by the beginning of March through select specialty distributors and specialty pharmacies nationwide.

The New York Times Morning column criticizes the public health system for undertreating people with opioid use disorder, obesity and mental health issues, among other problems.

Similarly, HHS’s Agency for Healthcare Research and Quality calls attention to the underuse of cardiac rehabilitation in our country.

From the Rx coverage front —

  • BioPharma Dive explains that while the last decade’s lapse of patents impacted blockbuster small-molecule drugs, this decade’s lapse impacts specialty drugs such as Humira and Keytruda. Time will tell whether patients will convert to biosimilar drugs as quickly as they converted to generic drugs when patents lapse.
  • STAT News reports on “A battle between Vertex and insurers [over copay assistance accumulators] is leaving cystic fibrosis patients with crushing drug costs. Copay assistance accumulators prevent co-pay assistance from accumulating toward the plan’s out-of-pocket payments maximum required by the Affordable Care Act.
  • The Institute for Clinical and Economic Research related a final evidence report on treatments for multiple sclerosis.

From the medical research front, STAT News reports

An experimental antibody that delivers lethal radiation directly to the bone marrow improved the outcomes of stem cell transplants for older patients with relapsed leukemia — and may change the way transplant medicine is practiced.

The antibody-radiation treatment, called Iomab-B, is being developed by Actinium Pharmaceuticals, a small drugmaker based in New York.

In the results of a Phase 3 clinical trial presented Saturday, 22% of patients with acute myeloid leukemia who were administered Iomab-B to prepare their bone marrow for transplants had durable remissions lasting six months or more. None of the patients in the study who received conventional care prior to transplant achieved durable remissions.

Amazing.

From the miscellany / tidbits department

  • The U.S. Preventive Services Task Force proposes to renew the following Grade A recommendation:
    • The USPSTF recommends that all persons planning to or who could become pregnant take a daily supplement containing 0.4 to 0.8 mg (400 to 800 μg) of folic acid.
    • The public comment period on this renewal is open until March 20, 2023/
  • Beckers Payer Issues reports
    • Anthem BCBS Colorado, Indiana, Missouri and Nevada are rolling out virtual primary care to more members.
    • Eligible commercial members will gain access to a virtual care team that conducts an initial health screening, creates a personalized care plan, and then provides care services, according to a Feb. 7 news release.
    • The virtual care services will take place through Anthem’s app, Sydney Health. The app offers 24/7 medical text chat, preventive wellness visits, support services, including new prescriptions and refills, and in-network referrals.
    • Virtual primary care is now available to eligible individuals enrolled in Anthem’s fully insured plans and certain large group administrative services clients.

Happy Presidents’ Day

David Ermer–Congress, COVID treatment, COVID-19, OPM, Rx coverage, U.S. Healthcare–
Mount Rushmore

The House of Representatives and the Senate are on District/State work breaks this week.

Govexec alerts us, “Labor Secretary Marty Walsh will be leaving the Biden administration in mid-March to become executive director of the National Hockey League Players’ Association.” 

Federal News Network offers an update on implementing the Postal Service Health Benefits Program that takes effect on January 1, 2025. The article expresses concern about a tight timeline for implementation. The article does not consider OPM’s January 2023 decision to allow FEHB plans to offer Medicare Part D EGWPs in 2024. That welcome decision puts the new PSHBP and the existing FEHB on a similar footing.

While the new PSHBP will be more tightly integrated with Medicare Part B., the benefits of that phased in change will develop over time. For example, although the Postal Services will offer a one-time, penalty-free Part B Special Open Enrollment Period next year for annuitants over 65 who did not elect Part B, early retirees under 65 and active employees over age 64 on January 1, 2025, will be exempt from the PSHBP’s mandatory Part B election requirement.

In other FEHB news, AHIP has made available a topic overview for the March 29 – 30 OPM AHIP FEHB Carrier Conference.

In OPM news, Meritalk breaks down last week’s inaugural DEIA Annual Report from OPM’s Office of Diversity, Equity, Inclusion, and Accessibility (ODEIA).

From the Omicron and siblings front, the Wall Street Journal and Fierce Healthcare report on the Covid death rate. The Journal points out, “Deaths caused by Covid are heavily concentrated among the elderly, an analysis of CDC data shows. In recent weeks people 75 years and older have represented about seven of every 10 Covid-19 deaths.” Fierce Healthcare provides this perspective:

The JAMA Network Open study concluded that “COVID-19 due to the Omicron variant was associated with a higher risk of in-hospital mortality compared with patients with influenza. This indicates that the SARS-CoV-2 Omicron variant should still be taken seriously, and improved prevention and treatment strategies are still highly relevant, although overburdening of the health care system has become less likely over time.”

Fortune Well tells us about the importance of cardiac care following even a mild case of Covid.

In a bid to determine why and how COVID can affect the heart, Dr. Andrew Marks, a cardiologist and biophysics professor at Columbia University, and Steven Reiken, a research scientist in his lab, studied heart tissue from people who died of COVID, in addition to the hearts of mice that had been infected with COVID.

Among their findings, which they’ll present Monday at the 67th Annual Biophysical Society Meeting in San Diego:

  • Heart tissue from humans shows increased levels of oxidative stress and inflammation, and changes in calcium levels due to damage to the system that regulates them in the heart. Such alterations can lead to arrhythmia or heart failure, according to the researchers.
  • Chest pain and tachycardia, or an unusually fast heartbeat, are common long-term among COVID survivors.
  • Heart tissue from mice shows an increased percentage of fibrosis and dilation of fibers—a common signal of early cardiomyopathy, which makes it more difficult for the heart to pump blood and can result in heart failure.
  • The death of heart cells and blood clots in the hearts of mice who had been infected with COVID-19 were also observed.

“Doctors should be aware of heart changes related to COVID-19 infections and should be looking for them,” Marks says. He hopes his research leads to increased awareness among medical providers of the virus’s potentially stealthy cardiac fallout—and, eventually, treatments for those whose hearts have been damaged by the pathogen.

MedPage Today adds

People who took the antiviral Paxlovid to treat COVID-19 infections were not more likely to get back-to-back bouts of the virus, a new study shows.

The findings offer clarity amid concerns that the use of Paxlovid, which works by stopping the spread of the virus in the body, increased the risk of COVID-19 rebound.

“Rebound is a re-emergence of symptoms and an uptick in viral load after a period of recovery,” the Center for Infectious Disease Research and Policy explained in a summary of the study.

Researchers found that patients who received Paxlovid, another antiviral called Lagevrio, or no antiviral medication had rebounds at similar rates, ranging from 4.5% to 6.6%.

From the medical research front, the Wall Street Journal reports

A fist that opened and shut. A once-limp arm that moved from her side. Two women whose strokes left them with partial paralysis for years saw life trickle back to their limbs when electric pulses were delivered to the back of their spinal cord as part of a pilot study. 

Neurologists said the approach, reported Monday in the journal Nature Medicine, could be transformative for stroke survivors, many of whom have some arm impairment after the event.

“I think it is amazing,” said Helmi Lutsep, a neurologist at Oregon Health & Science University, who wasn’t involved with the study. “I think patients will be thrilled if this comes to fruition.” 

The pilot study was convincing but it would take much larger studies and a decade or more to know if stroke patients generally could benefit, according to Nick Ward, a neurologist at the University College London who wasn’t involved with the study.  

From the U.S. healthcare business front, the Wall Street Journal informs us why “Walgreens CEO Bets on Doctors Over Drugstores in Search for Growth; Rosalind Brewer is shifting the chain’s focus to medical clinics,” like Village MD.

The strategy is guided by Ms. Brewer’s belief that the nation’s second-largest drugstore chain is in a business that she says no longer works. Industry growth is chronically slow, she said. Meanwhile, a shortage of workers is further cutting into revenue because the chain has had to reduce pharmacy hours.  

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front —

Federal News Network tells us

Federal cybersecurity leaders are looking forward to a major update for the National Institute of Standards and Technology’s Cybersecurity Framework, as NIST aims to add new details on governance, supply chain risks and more to a document that guides the cybersecurity practices of many organizations.

NIST released the original framework in 2014 and last updated the document in 2018. It began gathering feedback on the shift to “CSF 2.0” through a request for information last February, and hosted an initial workshop on the new framework in June.

Last month, NIST published a concept paper laying out some of the initial planned changes. Comments on the paper are due March 3. NIST plans to have a draft of CSF 2.0 ready by this summer, before releasing a final version in early 2024.

During a Wednesday workshop hosted by the standards agency, CISA Director Jen Easterly applauded NIST’s work to update the framework. She reiterated a recent push from CISA for the technology community to focus on “product safety and “the idea that software and hardware must be secure by design and secure by default,” adding that NIST’s work on the framework is an important element in that endeavor.

Federal News Network adds

The Social Security Administration is getting $23.3 million from the Technology Modernization Fund to implement multifactor authentication across its internal systems, part of a trio of recent TMF awards focused on cybersecurity and reliability.

The TMF announced three new investments today for SSA, the Treasury Department and the U.S. Agency for Global Media (USAGM).

USAGM is getting $6.2 million from the TMF to implement a zero trust architecture across its global network. * * * Other agencies to receive zero trust architecture funding from the TMF, include USAID, the Office of Personnel Management, the Education Department, and the General Services Administration.

Cyberscoop informs us

The U.S. government is stepping up its effort to combat threats from foreign technology investments, data acquisition and cyberattacks with a new collaboration between the Departments of Justice and Commerce, Deputy Attorney General Lisa Monaco said Thursday.

Speaking at the Chatham House in London as part of a conversation on disruptive technologies by nation states and malign actors, Monaco announced the “Disruptive Technology Strike Force,” to fight the ability of autocrats seeking “tactical advantage through the acquisition, use, and abuse of disruptive technology, innovations that are fueling the next generation of military and national security capabilities.”

Venture Beat identifies five cybersecurity trends for 2023:

  • Cyber insurance coverage requirements grow;
  • AI’s role in threat protection matures, and
  • Cybersecurity must be flexible to meet threats.

Speaking of cyber insurance, the Advisory Council of Employee Welfare and Pension Plans issued a report on Cybersecurity Insurance and Employee Benefit Plans.

From the cyber threats front —

  • The Health and Human Services Office for Civil Rights shared “two Reports to Congress for 2021, on 
  • These reports, delivered to Congress today, may benefit regulated entities to assist in their HIPAA compliance efforts. The reports also share steps OCR took to investigate complaints, breach reports, and compliance reviews regarding potential HIPAA rule violations.  The reports include important data on the numbers of HIPAA cases investigated, areas of noncompliance, and insights into trends such as cybersecurity readiness.”  
  • The Cybersecurity and Infrastructure Security Agency added four known exploited vulnerabilities to its catalog on February 14, 2023, and one more on February 16, 2023. Bleeping Computer discusses February 14, 2023, additions.
  • The Healthcare Sector Cybersecurity Coordination Center produced a Healthcare Sector DDoS Guide:
  • “Distributed Denial of Service (DDoS) attacks have the potential to deny healthcare organizations and providers access to vital resources that can have a detrimental impact on the ability to provide care. In healthcare, disruptions due to a cyber-attack may interrupt business continuity by keeping patients or healthcare personnel from accessing critical healthcare assets such as electronic health records, software-based medical equipment, and websites to coordinate critical tasks. (See HC3 Analyst Note titled: Pro- Russian Hacktivist Group ‘Killnet’ Threat to HPH Sector). Link can be found here.
  • “Threat actors utilize DDoS attacks due to the cost-effectiveness and relatively low resources and technical skills needed to deploy this type of attack as a hacker doesn’t have to install any code on a victim’s server. Moreover, DDoS attacks are getting more sophisticated and complex while getting easier and cheaper to perpetrate as cyber criminals take advantage of the sheer number of insecure internet-connected devices. (Analyst Comment: It is strongly recommended by cybersecurity institutions, like the National Institute of Standards and Technology, that organizations effectively manage the cybersecurity and privacy risks associated with Internet-of-Things (IoT)). (See NIST Report (NISTIR) – 8228). Link can be found here.”

Health IT Security discusses this guide here.

One of the biggest hospital chains in the US said hackers obtained protected health information for 1 million patients after exploiting a vulnerability in an enterprise software product called GoAnywhere.

Community Health Systems of Franklin, Tennessee, said in a filing with the Securities and Exchange Commission on Monday that the attack targeted GoAnywhere MFT, a managed file transfer product Fortra licenses to large organizations. The filing said that an ongoing investigation has so far revealed that the hack likely affected 1 million individuals. The compromised data included protected health information as defined by the Health Insurance Portability and Accountability Act, as well as patients’ personal information.

From the cybersecurity defenses front —

  • Cyberscoop fills us in on the benefits of proactive cyber threat protection.
  • Venture Beat explains how to use blockchain to prevent data breaches.
  • The Wall Street Journal discusses “How Companies Can Minimize the Cybersecurity Risk From Their Tech Vendors.”
    • Set up a rigorous review process when hiring vendors; 
    • Spell out expectations in vendor agreements, including how data will be shared;
    • Hire internal assessors to regularly brief directors on vendor cybersecurity programs and vulnerabilities;
    • Carefully guard access to company data from the vendors, and 
    • Empower the chief information security officer and bring security expertise to boards.

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.”

    Thursday Miscellany

    David Ermer–CMS, Congress, COVID-19, Electronic health records, FDA, Mental health care, OPM, Rx coverage, SDOH, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From our Nation’s capital

    • Govexec informs us that the President “doubled down Thursday on his administration’s commitment to using the federal government’s power to support underserved communities and advance racial equity.  A new executive order issued by the president builds on one he signed his first day in office as well as other executive and legislative actions.”
    • “The U.S. Office of Personnel Management (OPM), Department of Labor, and Office of Management and Budget (OMB) have developed and launched a new portal on USAJOBS for prospective Federal interns. Located at intern.usajobs.gov, the Federal Internship Portal is a one-stop shop for prospective interns to find opportunities and apply for internships in the Federal government.”
    • The Senate Commerce, Science and Transportation Committee held a hearing on PBM transparency and accountability, which Fierce Healthcare describes as the hearing as “heated.”
    • The Senate Health, Education, Labor and Pensions Committee held a hearing on healthcare workforce shortages, which Fierce Healthcare describes as the beginning of “a major effort to shore up the healthcare workforce after lingering shortages have roiled the industry.”
    • The U.S. Commissioner of Food and Drugs updated the public on his agency’s efforts prevent drug overdoses and reduce deaths.
      • In related news from MedPage Today, “Advisors to the FDA unanimously recommended the agency approve the first over-the-counter (OTC) naloxone (Narcan) product, though many committee members expressed continued concern about user instructions for the opioid overdose reversal drug. * * *While the FDA is not required to follow the recommendations of its advisory committees, it typically does.”

    From the medical research front

    • STAT News tells us, “A team of researchers from Stanford and University of California San Francisco have built a predictive model that uses electronic health records to calculate the risk of sepsis, cerebral palsy, and other serious conditions in newborns. The team trained a deep learning model on health records from more than 30,000 mother-newborn pairs treated in the Stanford health system, building a neural network that could predict 24 different health outcomes. The researchres, who also published an interactive website for readers to explore the network’s data. said the predictions outperformed currently-used risk scores.” 
    • Nature explains “How a pioneering diabetes drug teplizumab offers hope for preventing autoimmune disorders. Approving an antibody therapy that pauses the progression of type 1 diabetes is a first in the field, and some say, a model for other drug developers.
    • The National Institutes of Health disclosed that “Black and Hispanic Americans appear to experience more symptoms and health problems related to long COVID, a lay term that captures an array of symptoms and health problems, than white people, but are not as likely to be diagnosed with the condition, according to new research funded by the National Institutes of Health. The findings – from two different studies by NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative – add to a growing body of research aimed to better understand the complex symptoms and other issues associated with long COVID that millions have experienced.”
    • The All of Us program shared its research roundup, focusing on heart disease this month.
    • The Robert Wood Johnson Foundation offers an award-winning scholar’s “Lessons From the Intersection of Race, Inequality, and Health.”
    • The Institute for Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH). This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“

    From the U.S. healthcare business front —

    • Beckers Payer Issues identified over thirty payers who made Forbes rankings of top U.S. employers.
    • Beckers also reports, “A federal judge granted Cigna a temporary restraining order in its lawsuit alleging former executive Amy Bricker’s departure for rival CVS Health violated a noncompete agreement, Bloomberg Law reported Feb. 15.”  A TRO is a short duration order that allows the court time to consider awarding a preliminary injunction.
    • According to Healthcare Dive
      • CommonSpirit Health announced Wednesday that it will acquire regional health system Steward Health Care in Utah for $685 million.
      • The deal marks CommonSpirit’s entry into Utah, expanding the hospital operator’s footprint to a total of 22 states.
      • CommonSpirit will acquire five hospitals from Steward, along with more than 40 clinics and other ambulatory services, the system said. The deal is expected to close later this year. CommonSpirit’s Centura Health will manage the Utah sites.
    • Also from Healthcare Dive
      • Wednesday is the last day that LHC Group will trade on the Nasdaq, suggesting UnitedHealth will complete its acquisition of the home health business prior to market open on Thursday.
      • LHC’s stock will be halted aftermarket on Wednesday, according to a Nasdaq notice. As a result, the merger is tentatively scheduled to close the next morning, subject to pending regulatory approvals.
      • Speculation that the Federal Trade Commission will move to block the $5.4 billion deal has been rampant, but reports late last month suggest that regulators are unlikely to challenge the transaction. 
      • Louisiana-based LHC is a major player in the home health space, with more than 960 locations in 37 states and $2.2 billion in revenue last year
    • The Baton Rouge Business Report discusses a foundation that would be created in the wake of the Blue Cross and Blue Shield of Louisiana sale would have more than $3 billion in assets. The Accelerate Louisiana Initiative, as the foundation would be called, would be one of the largest private foundations in the nation, says Cindy Wakefield with BCBSLA. 
    • Fierce Healthcare reports, “EHR provider Elation Health announced its acquisition of medical billing company Lightning MD. The growth adds a piece to the Elation puzzle as it seeks to become the sector’s first all-in-one technology solution for primary care practices, the company said.”

    From the miscellany department —

    • Health Payer Intelligence reports, “AHIP Asks CMS to Reconsider Proposed Medicare Advantage Policy Changes. The extensive policy changes included in the proposed rule will negatively impact Medicare Advantage beneficiaries and plans, AHIP said.” It’s easier to write up orders than to implement them.
    • CMS announced that “a new chart titled Top 10 Section 111 Group Health Plan Reporting Errors, covering the July 1 – December 31, 2022, is now available in the Download section below.  Descriptions of these and all reporting errors are available for review in the GHP User Guide.”
    • WTW explains “What the end of the COVID-19 emergencies will mean for group health plans.”

    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.

    Tuesday Tidbits

    David Ermer–CDC, CMS, COVID treatment, Electronic health records, FDA, Medicare, Mental health care, NCQA, Rx coverage, Telehealth–
    Photo by Laura Ockel on Unsplash

    From the Omicron and siblings front, HealthDay tells us

    Paxlovid remains a powerful weapon against the Omicron variants BA.4 and BA.5, new research shows

    The antiviral continued to protect against hospitalization and death in patients [including the immunocompromised] who took it

    Research is ongoing to see if Paxlovid also guards against newer Omicron variants such as XBB.1.5 and BQ.1

    From the public health front —

    • Medscape reports that the five-year survival rate in pancreatic cancer is increasing.
    • MedPage Today explains that while there’s no ‘Recipe’ to reduce dementia risk, here’s how to discuss it with patients until more evidence emerges.
    • The U.S. Preventive Services Task Force reaffirmed a Grade D recommendation against routine serologic screening for genital herpes simplex virus infection in asymptomatic adolescents and adults, including pregnant persons.

    From the healthcare quality front

    • Beckers Hospital Review shares Healthgrades’ 2023 list of top hospitals for joint replacement by state.
    • The National Committee for Quality Assurance opened its 2023 HEDIS public comment period yesterday. The comment period closes on March 13.

    From the Medicare front —

    • The Department of Health and Human Services unveiled three models for reducing prescription drug costs charged to Medicare beneficiaries, including two-dollar generic drug prescriptions for Medicare Part D.
      • “Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans participating in the Model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug”.
    • Beckers Payer Issues reports, “Medicare beneficiaries who enroll in a Medicare Advantage plan may need less retirement savings to cover their healthcare costs, an analysis published Feb. 9 by the Employee Benefits Research Institute found.”
    • Fierce Healthcare informs us
      • “Health insurers and the Biden administration are at loggerheads over whether Medicare Advantage (MA) plans will see a pay cut next year, the ramifications of which come amid increased regulatory scrutiny for the popular program.
      • “Insurer groups and some politicians charge that the latest 2024 payment rule will wind up being a 2.27% cut to MA plans after considering risk adjustment changes and other factors. The Centers for Medicare & Medicaid Services (CMS) has pushed back, arguing that isn’t true.”
    • STAT News relates, “Medicare advisers on Tuesday recommended that the program alter its requirements for drugs, diagnostics, and medical devices that face coverage restrictions [such as the Biogen Eisai Alzheimers Disease drugs] to make the process more transparent and better incorporate diversity data.”
      • Speaking of which, USA Today reports
        • One in 10 new drugs was cleared by federal drug regulators in recent years based on studies that didn’t achieve their main goals, a new study shows.
        • The study by Harvard and Yale researchers found that of 210 new therapies approved by the Food and Drug Administration from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or endpoints, that wasn’t achieved. Those 21 drugs were approved to treat cancer, Alzheimer’s and other diseases.
        • Researchers said the findings raise questions about whether the federal agency’s drug approvals lack transparency about some products’ safety and effectiveness. 

    In hospital pricing transparency news —

    • Healthcare Dive discusses a JAMA-published study of available hospital pricing data, which produced head-scratching results.
    • Beckers Hospital Review explains four ways CMS is trying to improve hospital price transparency in 2023. Good luck with that.

    From the HR department

    • The Society for Human Resource Management tells us
      • “Employers need to understand that the timeline for submitting their demographic data to the U.S. Equal Employment Opportunity Commission (EEOC) is somewhat different this year. The agency recently confirmed that EEO-1 reporting for 2022 data is scheduled to begin in mid-July. In recent years, the starting points and deadlines for data collection have varied.”
      • “All private employers with 100 or more employees and federal contractors with 50 or more employees must file EEO-1 reports each year that summarize employee headcount by sex, race/ethnicity, and job category. This component of data collection, called Component 1, does not include pay data.
    • HR Dive explores how the Pregnant Workers Fairness Act protects pregnant workers beginning this June and how do those accommodations stack up to the federal Family and Medical Leave Act? 
    • HR Dive also notes, “Short breaks of fewer than 20 minutes taken by hourly, non-exempt employees who telework or must be counted as compensable time under the Fair Labor Standards Act — as is the case for employers working from an employer’s own location — Jessica Looman, principal deputy administrator of the U.S. Department of Labor’s Wage and Hour Administration, wrote in a Field Assistance Bulletin published Thursday.”

    From the tidbits department

    • Healio advises “Adolescents and young adults with type 1 diabetes who primarily attend diabetes clinic visits via telehealth have better overall attendance and less diabetes distress compared with those who attend in person, according to study data.”
    • MedCity News states, “Since the start of the Covid-19 pandemic, there has been a 23% increase in alcohol abuse and a 16% increase in drug abuse, and people in self-isolation reported a 26% higher consumption than usual, according to the National Library of Medicine. Some apps are trying to meet this need, including Sober Sidekick and SoberBuddy.”

    Monday Roundup

    David Ermer–CDC, COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    From our Nation’s capital, Federal News Network informs us

    The Office of Management and Budget filled a key personnel and performance leadership role with a familiar name.

    Federal News Networks has confirmed that Loren DeJonge Schulman is starting as the new associate director for performance and personnel management today.

    She replaces Pam Coleman, who left in August after 20 months in that role.

    DeJonge Schulman joins OMB from the Partnership for Public Service where she was vice president of research, evaluation and modernizing government for the last two-plus years. In that role, she helped lead the Best Places to Work in Government rankings and focused on issues around improving federal workforce management.

    The U.S. Office of Personnel Management announced

    The U.S. Office of Personnel Management (OPM) has announced the Finalists for this year’s Presidential Management Fellows (PMF) Program. Of the more than 10,000 individuals from around the world who applied for the program, 850 Finalists were chosen. The large number of applications to this competitive program marks a record number of applications over the past ten years.  

    “Presidential Management Fellows are the next generation of government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2023 PMF finalists. We cannot wait to see what you will accomplish in public service.”  * * *

    PMFs are appointed to a two-year, full-time Federal position with salary and benefits, where they apply their skills while engaging in leadership development training that includes experiential learning, cohort-based interactive training, and optional rotational experiences. 

    In Omicron and siblings news, BioPharma Dive informs us

    The U.S. has agreed to buy 1.5 million additional doses of Novavax’s COVID-19 vaccine as part of preparations for the government’s planned transition from bulk purchases to private market sales.

    The agreement, announced Monday by Novavax, will support development of an updated version of the company’s shot in line with the Food and Drug Administration’s plan to annually match COVID vaccines to the most prevalent virus variants. It will also aid the company in developing smaller dose vials, which are less logistically challenging.

    Novavax did not disclose the cost of the purchases, which are funded under an existing $1.6 billion contract with the government. Its shot uses a vaccine technology that has long been a mainstay and that the company claims remains an important option for those who cannot or will not take the messenger RNA-based shots from Pfizer and Moderna.

    From the public health front —

    • The Washington Post discusses a horrifying CDC report on the mental health of high school students.
      • “Teen girls across the United States are ‘engulfed in a growing wave of violence and trauma,’ according to federal researchers who released data Monday showing increases in rape and sexual violence, as well as record levels of feeling sad or hopeless.”
      • In its report, the CDC steered attention to the nation’s schools, saying activities there can make a profound difference in the lives of teens. It recommended improved access to mental health services, more classroom management training for teachers, school clubs that foster gay-straight alliances, high-quality health education and enforcement of anti-harassment policies. Ideally, schools would take on multiple initiatives.”
    • NBC News reports “A handful of factors, such as education, income and job type, may increase the likelihood that people in their mid-50s will still be mentally sharp, a new study finds.”

    From the No Surprises Act front, Healthcare Dive adds

    One in five Americans still report receiving surprise bills, despite the ban. That’s in part because the law has notable exceptions — for example, ground ambulances were excluded from the ban, though they’re a frequent source of the bills.

    In January, the HHS said it’s received significantly more requests to resolve payment disputes than the department expected.

    STAT News delves into the ground ambulance billing issue today. It’s worth noting at the risk of belaboring the obvious that air ambulances are considerably more expensive than ground ambulances.

    The FEHBlog was surprised to read about the number of arbitration requests in January given the Texas Medical Association’s contention that the new $350 per party arbitration fee would suppress the numbers of arbitrations. In the FEHBlog’s view, providers should place more focus on the open negotiation phase of the process.

    From the electronic health records front, HealthITBuzz alerts us

    A little over a year ago, we announced the completion of a critical 21st Century Cures Act requirement by publishing the Trusted Exchange Framework and Common Agreement (TEFCA). This milestone established a clear infrastructure model and governing approach for nationwide health information exchange.

    Today, we marked the next major milestone during an event at the U.S. Department of Health and Human Services (HHS) headquarters, which recognized the first set of networks to be approved to implement TEFCA as prospective Qualified Health Information Networks (QHINs). Once fully onboarded, the organizations will officially be “designated” as QHINs. At this event, HHS Secretary Becerra recognized and congratulated CommonWell Health Alliance, eHealth Exchange, Epic TEFCA Interoperability Services, Health Gorilla, Kno2, and KONZA for their willingness to voluntarily step up and meet the rigorous TEFCA eligibility requirements, terms and conditions of TEFCA participation, and commitment to a 12-month go-live timeline. Collectively, the QHIN applicants have networks that cover most U.S. hospitals, tens of thousands of providers, and process billions of annual transactions across all fifty states.

    Bravissimo.

    From the U.S. healthcare business front —

    Cigna announced a rebranding of its businesses: The Cigna Group, the global health company; Cigna Healthcare, the health benefits provider; and Evernorth Health Services, the pharmacy, care and benefits solutions provider.

    Politico, upon examining whether a new CMS policy can save rural hospitals, offers us a mixed bag:

    The Rural Emergency Hospital designation, aimed at sustaining emergency rooms, outpatient care and clinics, will be a major consideration for a significant number of hospitals, according to a new report from Chartis, a health care consulting group.

    The policy changes are among the largest made to the rural health system in years. Through Medicare, hospitals that agree to the program requirements are guaranteed a set amount of money for facilities and a boosted Medicare reimbursement rate.

    About 400 hospitals are “most likely” to consider conversion, according to the analysis, with about 80 of those “ideal” candidates for the change — often facilities on the brink of closing without growing revenues.

    Several dozen hospitals are expected to move toward the new designation in the next 12 to 18 months “because they’re right on the ropes,” Michael Topchik, national leader of the Chartis Center for Rural Health, told Pulse.

    Another group will wait and see how the first group does under the new rules, he said.

    Still, most of the nearly 1,600 rural hospitals aren’t interested. The designation requires giving up inpatient care, a key part of many hospitals’ business and a handful of financial incentives offered through other rural health programs.

    That doesn’t mean rural hospitals are thriving, though. Closures slowed significantly during the pandemic, likely because of the government’s infusion of resources through the pandemic, but are again ticking up.

    Fierce Healthcare reports

    Sanford Health and Fairview Health Services have agreed to push back their planned megamerger by two months.

    The health systems said in a statement that they jointly determined they should “voluntarily” move the expected closure date for the deal to May 31, according to a report in MPR News. The merger was originally set to close March 31, but Minnesota Attorney General Keith Ellison asked the two providers to delay.

    The deal includes 58 hospitals, and, if the two systems are joined, they would employ more than 80,000 people.

    Happy Lincoln’s Birthday

    David Ermer–Uncategorized–

      The Washington Post shows how one of its staff photographers found enduring traces of the sixteenth President across our country.

      The House of Representatives is on a District work break for the next weeks while the Senate is engaged in Committee business and floor voting on Capitol Hill.

      On Wednesday, February 15, the Senate Foreign Relations Committee will hold a hearing “to examine countering illicit fentanyl trafficking.” The Wall Street Journal adds

      A veterinary tranquilizer that can cause serious wounds for regular users is spreading menace within the illicit drug supply. 

      Xylazine, authorized only for animals, is one ingredient in an increasingly toxic brew of illicit drugs that killed a record of nearly 107,000 people in the U.S. in 2021. It is typically mixed with fentanyl, a synthetic opioid that itself has broadly infiltrated U.S. drug supply, including in supplies of cocaine and methamphetamine. Taken together, the volatile mixing means drug users often don’t know what’s in the substances they take. 

      Dealers may mix xylazine into fentanyl to save money, federal law-enforcement authorities said. The drug—known as “tranq” among some users—can be purchased at low prices from Chinese suppliers and offset some of the opioid in the mix. Its presence in the drug supply is part of the arms race between criminals seeking to enhance their products and authorities trying to disrupt the market. Public-health authorities are working on ways to monitor the constantly changing drug market.

      For users, xylazine can also lengthen a high—with serious risks. The overdose-reversal drug naloxone that can be critical to saving fentanyl users doesn’t work against xylazine. And users can become physically dependent on xylazine in addition to fentanyl, complicating treatment. 

      No bueno.

      From the Omicron and siblings front, NPR Shots tells us

      In another sign of the changing state of the pandemic, an invaluable source of information about the virus over the last three years is shutting down, NPR has learned.

      The Johns Hopkins Coronavirus Resource Center plans to cease operations March 10, officials told NPR.

      “It’s bittersweet,” says Lauren Gardner, an engineering professor who launched the project with one of her students on March 3, 2020. “But it’s an appropriate time to move on.

      Agreed.

      From the No Surprises Act front, the American Hospital Association has removed from its reports on Judge Kernodle’s February 6 opinion the erroneous statement the Judge had struck down the entire rule. The FEHBlog has redlined the Judge’s edits to the Public Health Service Act provisions in the NSA’s August 26 Independent Dispute Resolution Rule for your edification. As of Friday, February 10, the Justice Department has not noticed an appeal from this final judgment. The government has sixty days to notice an appeal.

      From the public health front, the New York Times reports

      In the United States, the richest mothers and their newborns are the most likely to survive the year after childbirth — except when the family is Black, according to a groundbreaking new study of two million California births. The richest Black mothers and their babies are twice as likely to die as the richest white mothers and their babies. * * *

      The study, published last month by the National Bureau of Economic Research, includes nearly all the infants born to first-time mothers from 2007 to 2016 in California, the state with the most annual births. For the first time, it combines income tax data with birth, death and hospitalization records and demographic data from the Census Bureau and the Social Security Administration, while protecting identities. * * *

      Rich and poor mothers were equally likely to have high-risk pregnancies, but the poor mothers were three times as likely to die — even within the same hospitals. Rich women’s pregnancies “are not only the riskiest, but also the most protected,” the paper’s authors wrote.

      This finding suggests that the American medical system has the ability to save many of the lives of babies with early health risks, but that those benefits can be out of reach for low-income families.

      * * *

      There is clear evidence that Black patients experience racism in health care settings. In childbirth, mothers are treated differently and given different access to interventions. Black infants are more likely to survive if their doctors are Black. 

      the richest white Californians in this study still gave birth to less healthy babies than the richest Swedish women. Their newborns were more likely to be premature or underweight. The two groups had roughly equal maternal death rates.

      “That finding really does strongly suggest that it’s something about the care model,” said Dr. Neel Shah, chief medical officer of Maven Clinic for women’s and family health and a visiting scientist at Harvard Medical School. “We have the technology, but the model of prenatal care in the United States hasn’t really gotten an update in the last century.”

      What is a new model of prenatal care? The Mayo Clinic and the ACOG, among others, have ideas.