Monday Roundup

David Ermer

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

Monday Roundup

David Ermer–AHRQ, Congress, FDA, Federal employment benefits, HSA, Rx coverage, SDOH–
Photo by Sven Read on Unsplash

From Washington DC —

  • The Wall Street Journal reports,
    • “Time isn’t on Washington’s side.
    • “With the U.S. facing a potentially economy-shaking default as soon as next month, logistical hurdles, disagreements on the scope of any talks, a tight legislative calendar and a late start are complicating negotiations over raising the debt ceiling.
    • “President Biden said Monday that the next meeting with congressional leaders will come Tuesday, while responding “no” when asked if there were updates regarding the talks with Republicans. House Speaker Kevin McCarthy (R., Calif.) said that the two sides remain “far apart” and that he would like a deal to be done by this weekend.” * * *
    • “A second meeting with the president and congressional leaders that was originally set to take place on Friday was postponed until early this week. The House and Senate are scheduled to be in session simultaneously for just one more week this month, and Mr. Biden is set to travel overseas for a Group of Seven meeting. Moreover, Republican leaders have so far rejected any short-term debt deal to buy more time.”
  • According to the White House’s briefing room,
    • “President Biden announced his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH), the world’s preeminent biomedical research organization. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader who has the vision and leadership needed to deliver on NIH’s mission to seek fundamental knowledge and promote human health.”  

From the litigation front, the American Hospital Association informs us

“The U.S. Court of Appeals for the 5th Circuit today temporarily restored an Affordable Care Act requirement that most health plans cover certain preventive services without cost sharing. The 5th Circuit ordered that this requirement remain in effect for everyone (except the few health plans challenging the requirement) until it issues a final decision in the case, which is expected later this year. A federal judge in Texas recently vacated the requirement nationwide, prompting the Department of Health and Human Services and plaintiff to appeal the decision and seek this temporary stay.”

From the public health front —

  • HealthDay tells us,
    • “Older Americans are dying of falls at more than double the rate of 20 years ago — with women, men and all racial groups showing increases, according to a new study.
    • “In 2020, the study found, just over 36,500 Americans age 65 and up died of a fall-related injury. That was up from roughly 10,100 deaths in 1999.
    • “Adjusted for age, those numbers translated into a more than twofold increase in the rate of fall-related deaths among older Americans: from 29 per 100,000 in 1999, to 69 per 100,000 in 2020.” * * *
    • The National Council on Aging has a tool for older adults to check their risk of falls.

From the Rx coverage front —

  • MPR relates
    • “The Food and Drug Administration’s (FDA) Pulmonary-Allergy Drug Advisory Committee voted 16:6 in favor for adults, and 17:5 in favor for children (<18 years of age and ≥30kg), that available data support a favorable benefit-risk assessment for neffy® in the treatment of severe allergic reaction (Type 1), including anaphylaxis, for adults and children who weigh more than 30kg. * * *
    • “While not bound to the committee’s recommendations, the FDA does take them into consideration when making final decisions on approval. If approved, neffy would be the first needle-free epinephrine product to treat severe allergic reaction. A decision is expected by mid-2023.”
  • The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension.
  • The Wall Street Journal delves into “How to Get Your Health Insurance to Cover Ozempic and Other Drugs Used for Weight Loss; Tips for checking whether your health plan will pay for a prescription and then getting authorization.”
  • Per Hub International,
    • “CMS recently released its updated Medicare Part D guidelines that can be used by group health plan sponsors to determine whether their plans’ prescription drug coverage is creditable for 2024 and to update the information needed for required Part D disclosures to eligible individuals and to CMS.
    • “To help determine whether prescription drug coverage is creditable, CMS has released the following 2024 parameters for the standard Medicare Part D prescription drug benefit:
      • Deductible: $545 (up from $505 in 2023);
      • Initial coverage limit: $5,030 (up from $4,660);
      • Out-of-pocket threshold: $8,000 (up from $7,400);
      • Total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are not eligible for the coverage gap discount program: $11,477.39 (up from $10,516.25 in 2023); and
      • Estimated total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are eligible for the coverage gap discount program: $12,447.11 (up from $11,206.28).”

From the artificial intelligence front —

  • This week’s episode of the Econtalk podcast features an artificial intelligence discussion between host Russ Roberts and his guest Tyler Cowen. Russ Roberts suggests using ChatGPT to formulate questions for your doctor or your parents’ or your kids’ doctors.
  • Bloomberg examines the use of AI by drug manufacturers.
  • Medcity News looks into the use of AI by pharmacists and PBMs.

From the miscellany department —

  • Fierce Healthcare points out, “Million-dollar claims per million covered employees rose 15% in the past year and 45% from 2019 to 2022, according to a report by Sun Life, a life and disability insurance company.”
  • EHR Intelligence reports,
    • “The Health IT End-Users Alliance has released a consensus statement regarding collecting and using social determinants of health (SDOH) data to support health equity.
    • “The Alliance brings together health information professionals, physicians, hospitals, and other front-line healthcare providers to advance end-user perspectives in health IT policy and standards development.
    • “The statement calls for additional efforts to standardize and increase the uniform collection and reporting of SDOH. The group also calls for more training on collecting this data, better use of appropriate tools and processes to manage and share SDOH, and ongoing research to support these efforts.”
  • Employee Benefit News notes, “Thirteen FSA and HSA-eligible expenses that may surprise you.”

Weekend update

David Ermer–Congress, OPM, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

Happy Mothers’ Day! Here’s a reminder that on June 27, 2023, two new federal employment laws will take effect — the Pregnant Workers Fairness Act and the PUMP Act (fairness for nursing mothers).  

OPM shares excerpts from OPM Director Kiran Ahuja’s commencement address to the graduating class of the University of Georgia’s School of Public and International Affairs.

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

The Wall Street Journal reports

  • The Biden administration and congressional Republicans are making progress in their negotiations over federal spending and raising the debt limit, Treasury Secretary Janet Yellen said, adding that she believes the talks could result in an agreement.
  • “I’m hopeful. I think the negotiations are very active. I’m told they have found some areas of agreement,” Ms. Yellen said in an interview Saturday at the end of a gathering of finance ministers from the Group of Seven advanced democracies in Japan.
  • Republicans and Democrats are racing to find a compromise for raising the nation’s roughly $31.4 trillion debt limit. Republicans say lifting the debt ceiling should be paired with cuts to federal spending, while Democrats say raising the cap shouldn’t be contingent on broader budget negotiations.

Axios tells us that “The Biden administration is pouring billions of dollars into the development of future coronavirus vaccines, trying to develop a sequel to Operation Warp Speed even as the public health emergency ends.”

Also, from the research front, Biopharma Dive informs us

  • Sanofi and AstraZeneca released new study results on Friday [May 11] that showed their antibody drug for respiratory syncytial virus reduced hospitalizations for infection-related respiratory disease by 83% in infants.
  • The drug, sold as Beyfortus, won approval in Europe in November as a preventive treatment for babies in their first RSV season and is due a decision by U.S. regulators in the third quarter. The results released Friday add to earlier data that showed the drug to be 75% effective in reducing RSV-related hospitalizations over a placebo.
  • RSV is a leading cause of hospitalization in infants, often overlapping with seasonal patterns for influenza and now COVID-19, too. It is estimated that more than 25,000 children under 5 years old die from RSV infections globally each year, with millions hospitalized.

and MedTech Dive points out,

  • Guardant Health on Tuesday presented the results of a pivotal study of Shield, its blood-based test for colorectal cancer, demonstrating an overall sensitivity of 83% and specificity of 90%.
  • Looking at the results by stage, the test only detected 55% of stage I cancers. Its detection of later-stage cancers was 100%.
  • The test should meet the criteria to gain FDA approval and Medicare reimbursement, but its early-stage performance will likely make Shield less competitive against Exact Sciences’ stool-based test, Cologuard, to start, analysts with Craig Hallum wrote in a research note on Wednesday. 

From the SDOH front, Healthcare Finance relates,

  • CVS Health said this week it’s adding mental health screenings to Project Health, the company’s free, community-based health screening program. 
  • It will kick-start its mental health screenings in Greensboro, North Carolina and Petersburg, Virginia. Over the course of the year it will also add nearly 100 organizations to host its mobile units in under-resourced communities.
  • CVS Health plans to host nearly 2,000 Project Health screening events across the U.S. in 2023. The company hosts these events at CVS Pharmacy locations and community organizations, offering free biometric screenings, including blood pressure, cholesterol, glucose level and body mass index, to detect early risks of chronic conditions such as diabetes, hypertension and heart disease.
  • The screenings will now also offer PHQ-2 assessments – screenings to help identify people who require additional evaluation for depression. Following these screenings, participants have the opportunity to meet with a nurse practitioner who can provide referrals for treatment and advice on follow-up care.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front —

  • On May 10, 2023, the National Institute of Standards and Technology posted “revised draft guidelines, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations (NIST Special Publication [SP] 800-171 Revision 3).”
    • “Notable updates in the draft include: 
      • “Changes to reflect the state-of-practice cybersecurity controls;
      • “Revised criteria used by NIST to develop security requirements;
      • “Increased specificity and alignment of the security requirements in SP 800-171 Rev. 3 with SP 800-53 Rev. 5, to aid in implementation and assessment; and
      • “Additional resources to help implementers understand and analyze the proposed updates.”
    • “NIST is requesting public comments on the draft guidelines by July 14, 2023.”
    • “NIST anticipates releasing at least one more draft version of SP 800-171 Rev. 3 before publishing the final in early 2024. Following the publication of the final version, the authors plan to revise the set of supporting NIST publications on protecting controlled unclassified information, including SPs 800-171A (security requirement assessment), SP 800-172 (enhanced security requirements) and SP 800-172A (enhanced security requirement assessment).” 
    • “NIST is planning a webinar for June 6, 2023, to introduce the changes made to SP 800-171. Registration information will be posted next week on the Protecting CUI project site.” 
  • Cybersecurity Dive reports, “White House considers ban on ransom payments, with caveats. Experts suggest the effort, a reversal from the administration’s previous stance, is fraught with complications that could cause unintended consequences.”
    • Cybersecurity Dive adds,
      • “As the White House floats the possibility of a ban on ransom payments, the number of organizations hit by ransomware that ultimately pay a ransom remains high. 
      • “Nearly half, 46%, of organizations hit by ransomware during the past year paid a ransom to recover data, according to research Sophos released Wednesday [May 10].”
      • “The survey also found that cybersecurity insurance plays a direct role in the likelihood of an organization making a ransom payment. Nearly 3 in 5 organizations with a standalone cyber insurance policy paid the ransom, compared to the 15% of uninsured organizations that paid the ransom.”
    • Cybersecurity Dive points out,
      • “The number of ransomware claims filed by U.S. clients of insurance broker Marsh spiked 77% in the first quarter of the year compared with the prior three-month period, the company told CFO Dive.
      • “Marsh saw 55 ransomware claims from U.S. clients in the first quarter of the year versus 31 claims in the fourth quarter. The figures, which are expected to be published in an upcoming report, follow a downward trend in 2022 that had been credited with helping to moderate skyrocketing premiums in the cyber insurance market.
      • “I do think that we can still continue to see a deceleration of rate increases for those companies that have an optimal cyber risk maturity profile and have not suffered significant events that have caused the carriers to make claim payments,” Meredith Schnur, Marsh’s U.S. and Canada cyber brokerage leader, said in an interview.”
  • Cybersecurity Dive reports,
    • “Acting National Cyber Director Kemba Walden said the national cybersecurity strategy has been well received, however, acknowledged there were areas of disagreement. 
    • “Walden speaking Tuesday [May 9, 2023] at a forum hosted by The Software Alliance, also known as BSA, said there are two major areas of common ground that form the basis of the policy. Individual technology users, small businesses, local governments and small infrastructure providers like schools and hospitals are currently bearing the brunt of the cybersecurity risk — and that needs to change. 
    • “Cybersecurity risk is in the wrong place,” Walden said. “I think that’s an area of common ground.”
    • “Secondly, the U.S. is currently engaged in a game of Whac-A-Mole with malicious actors and the country needs to work together to make sure systems can be properly defended.
    • “Walden said her main concern regarding the national cyber strategy is to make sure the U.S. can build a more resilient digital ecosystem.”

From the cyber vulnerabilities front —

  • Health IT Security informs us,
    • “The Health Sector Cybersecurity Coordination Center’s (HC3) latest alert [dated May 10, 2023] details the growing trend of threat actors targeting a known vulnerability in Veeam Backup & Replication (VBR) software. VBR is a popular software product that can be used to back up, replicate, and restore data on virtual machines (VMs).
    • The vulnerability, known as CVE-2023-27532, is a high-severity vulnerability with a CVSS score of 7.5 that exposes encrypted credentials stored in the VBR configuration to unauthenticated users. If successfully exploited, threat actors may be able to gain access to the backup infrastructure hosts and could steal data or deploy ransomware.”
  • Health IT Security further tells us,
    • “The internet has a bot problem, cybersecurity company Imperva suggested in its 2023 Bad Bot Report. Nearly half of all internet traffic came from bots in 2022, while human traffic dipped to its lowest level in eight years.
    • “Bots are not inherently bad – they can help automate select tasks, measure customer engagement, or simulate conversations. However, malicious bots can help threat actors launch denial-of-service attacks, distribute malware, or crack passwords. Imperva observed an uptick in bad bot traffic volume for the fourth consecutive year, growing to 30.2 percent in 2022, compared to 27.7 percent in 2021.
    • “Bad bots interact with applications like legitimate users would, making them harder to detect and block. They abuse business logic by exploiting the way a business operates, rather than exploiting technical vulnerabilities,” the report stated. * * *
    • “Imperva suggested that businesses begin mitigating risk by protecting exposed APIs and mobile apps, monitor traffic, and remain aware of data breaches and leaks occurring across the industry.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) added one and then seven more known exploited vulnerabilities to its catalog.

From the ransomware front —

  • Cyberscoop calls our attention to “The Ransomware Malicious Quadrant, published Wednesday by ransomware-focused cybersecurity firm Halcyon and first shared with CyberScoop, takes a range of the most consequential and effective ransomware groups over the past year and gathers the most critical datapoints on each, and categorizes them.”
  • Silicon Angle tells us,
    • “A new ransomware group targeting vulnerabilities in virtual private network appliances has been found that has a unique twist: The ransomware encrypts itself to avoid detection by security software.
    • “Discovered by security researchers at Kroll LLC, the ransomware, dubbed “Cactus,” is believed to have first been deployed in March. The ransomware targets known vulnerabilities in Fortinet Inc. VPN appliances to gain access to major organizations before getting to work.”
  • “CISA and FBI have released [on May 11, 2023] a joint Cybersecurity Advisory (CSA), Malicious Actors Exploit CVE-2023-27350 in PaperCut MF and NG. This joint advisory provides details related to an exploitation of PaperCut MF/NG vulnerability (CVE-2023-27350). FBI observed malicious actors exploit CVE-2023-27350 beginning in mid-April 2023 and continuing through the present. In early May 2023, the FBI observed a group self-identifying as the Bl00dy Ransomware Gang attempting to exploit vulnerable PaperCut servers against the Education Facilities Subsector. The advisory further provides detection methods for exploitation and details known indicators of compromise (IOCs) related to the group’s activity. CISA encourages network defenders to review and apply the recommendations in the Detection Methods and Mitigations sections of this CSA.”
  • Here’s the latest’s Bleeping Computer Week in Ransomware report.

From the cyberdefenses front —

  • The Washington Post reports,
    • “The Justice Department announced on Tuesday [May 9] that it disrupted Russian government cyberespionage malware that has infected targets in at least 50 countries. The U.S. government had been investigating it for more than 20 years.
    • “On the same day, a coalition of U.S. and U.S.-allied cyber agencies released technical details on the malware, known as Snake, to help industry and governments to shut it down.”
  • The Washington Post also discusses the growing use of artificial intelligence as a hacking tool, adding,
    • AI will help defenders as well, scanning reams of network traffic logs for anomalies, making routine programming tasks much faster, and seeking out known and unknown vulnerabilities that need to be patched, experts said in interviews.
    • Some companies have added AI tools to their defensive products or released them for others to use freely. Microsoft, which was the first big company to release a chat-based AI for the public, announced Microsoft Security Copilot in March. It said users could ask questions of the service about attacks picked up by Microsoft’s collection of trillions of daily signals as well as outside threat intelligence.
    • [However, b]y multiplying the powers of both sides, AI will give far more juice to the attackers for the foreseeable future, defenders said at the RSA conference.”

Friday Factoids

David Ermer–CDC, COVID-19, End of the PHE, NE, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Today marks the final issue of the CDC’s weekly interpretative review of its Covid statistics. The final issue advises

“The latest updates to CDC’s COVID Data Tracker reflect these changes. The homepage has a new look, and there are also new landing pages for hospitalizations, emergency department (ED) visits, and death data, as well as visualizations of trends and maps. Several pages have also been retired, but COVID Data Tracker has a page with links to archived data and visualizations.

“These are the most notable changes to COVID Data Tracker:

  • Hospital admission rates and the percentage of COVID-19 deaths among all deaths are now the primary surveillance metrics.
  • COVID-19 hospital admission levels replace COVID-19 Community Levels (CCLs) as the main indicator of county trends. COVID-19 hospital admission levels are comparable with CCLs.
  • Provisional death certificate data from the National Vital Statistics System (NVSS) will become the primary source for mortality surveillance, replacing aggregate death counts.
  • Aggregate case and death count reporting has been discontinued.
  • ED visit data will serve as an early indicator of COVID-19 activity.”

The Wall Street Journal reports on the ongoing struggles of people afflicted with long Covid.

From the public health front –

  • In recognition of Mothers’ Day this weekend, the CDC encourages pregnant women to get a flu shot (not the nasal flu vaccine spray).
  • MedPage Today tells us that “The CDC reported that the nation’s first-ever cases of treatment-resistant ringworm were identified in New York City. (Morbidity and Mortality Weekly Report)
  • The Department of Health and Human Services celebrated “the first anniversary of the National Maternal Mental Health Hotline. Since being launched on Mother’s Day 2022 by the Health Resources and Services Administration (HRSA), the hotline’s professional counselors have provided emotional support, resources, and referrals to almost 12,000 pregnant and postpartum individuals struggling with mental health concerns, and their loved ones.  Additionally, HRSA is introducing an updated, more user-friendly toll-free number for the Hotline: 1-833-TLC-MAMA (1-833-852-6262).”

From the Rx coverage front —

  • The Food and Drug Administration announced “approving Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.”
  • Mercer Consulting offers advice to employers and health plans on how to help employees and members address drug shortages.
  • Biopharma Dive reports
    • “A group of Food and Drug Administration advisers narrowly supported approving what could be the first gene therapy for Duchenne muscular dystrophy in a meeting Friday, clearing the way for the agency to make a closely watched decision later this month.
    • “By an 8-6 vote, the panel recommended that the treatment, developed by biotechnology company Sarepta Therapeutics, be granted an “accelerated” approval. The close vote reflected a daylong back-and-forth over the treatment, and whether the protein it’s designed to produce in the body — called microdystrophin — is reasonably likely to benefit people with Duchenne who can still walk. * * *
    • “The FDA usually follows the advice of its advisory committees, but isn’t required to do so. The agency is set to make its decision by May 29.
    • “While far from unanimous, the panel’s recommendation could make that decision easier, and marks an important moment for a Duchenne patient community that has long advocated for gene therapy.”

From the federal employee benefits front, NARFE informs us that.

  • “Effective May 1, 2023, the US Office of Personnel Management (OPM) extended its contract with John Hancock to provide insurance coverage to all Federal Long Term Care Insurance Program (FLTCIP) enrollees. Although OPM solicited multiple bids, John Hancock remained the sole bidder. The program administrator, Long Term Care Partners LLC, has mailed notice of this action to enrollees.  
  • “Per the extended contract, most enrollees should expect to face a premium increase effective January 1, 2024. In September 2023, each enrollee will be offered personalized options that will include accepting the premium rate increase to maintain current coverage or to reduce coverage to reduce the impact of any increase. OPM indicated that premium increases would be phased in over three years for some options.  
  • No additional information on the premium increases or personalized options is available currently.” 

From the bravery department, Govexec points out that the National Association of Letter Carriers named two dozen letter carriers were named as heroes of the year for taking life-saving actions on the job. Bravo!

From the healthcare spending front, Fierce Healthcare informs us

  • “The anti-dementia medication lecanemab will come with an extraordinarily high price tag if the Centers for Medicare & Medicaid Services (CMS) decides to cover it, according to a research letter in JAMA Internal Medicine.
  • “Researchers at RAND estimate that covering the drug and other associated services could add between $2 billion and $5 billion in annual Medicare costs. This could also lead to “substantial out-of-pocket costs for beneficiaries lacking supplemental coverage,” the researchers said.
  • :Those out-of-pocket costs could be as much as one-fifth of the annual income for a Medicare beneficiary, according to the study. The medication, developed by Eisai and Biogen, costs $26,500 a year, including treatment add-ons such as imaging.”

Whoa, Nelly. Thank heavens OPM is allowing FEHB carrier to offer Medicare Part D EGWPs next year.

Thursday Miscellany

David Ermer–Congress, COVID-19, End of the PHE, NE, FDA, Medical / Rx research, Rx coverage–

From Washington DC —

Photo by Josh Mills on Unsplash
  • The Secretary of Health and Human Services issued a statement on the end of the Covid health emergency which occurred today.
    • Govexec and the Society for Human Resource Management respectively discuss the impact of this event on federal agencies and employers generally.
      • SHRM notes, “President Biden in April ended the pandemic national emergency weeks earlier than expected—but the premature ending won’t shift the deadlines spelled out in the administration’s guidance from March, including the extended deadline for special enrollment in health plans. * * * July 10 will also mark the end of some COBRA-related relief, under which employees were allowed extra time to pay their COBRA premiums or to decide whether they wanted to use the coverage.”
  • The Wall Street Journal reports
    • “A highly anticipated meeting scheduled for Friday between President Biden and congressional leaders to chart a path forward on lifting the debt ceiling was postponed until next week, officials said.
    • “The delay will give White House and congressional staff more time to make progress in their closed-door spending talks, the officials said, adding that one of the lawmakers was unable to attend the meeting Friday because of a scheduling conflict.
  • STAT News informs us
    • “The Senate health committee on Thursday passed a package of bills aimed at speeding generic drug competition and reining in drug middlemen business practices. But they failed to pass an ambitious reform to the pharmacy benefit manager sector, despite strong bipartisan support for it.
    • “Chairman Bernie Sanders (I-Vt.) is pursuing the drug pricing reforms at the behest of Senate Majority Leader Chuck Schumer (D-N.Y.), who wants to hold a floor vote on an even bigger package of health bills later this year. The markup came just a day after the same panel held a major hearing on PBM and drugmakers’ role in high insulin prices.
    • “It’s not clear when the Senate would take up that package, and while the package is bipartisan, it’s not clear whether it has enough support among House Republicans to pass in that chamber. There are a few, tamer PBM bills that the House Energy and Commerce Committee is expected to mark up on May 17, but there is no indication that Senate and House lawmakers are coordinating on PBM legislation.
    • “The committee passed 18 to 3 a bill that would ban PBMs from using so-called spread pricing. It would also require that the middlemen disclose rebates, fees, and other payments they receive and to pass them on to the insurers for whom they negotiate those concessions. * * * The committee included an amendment from Sen. Tina Smith (D-Minn.), that would let patients appeal insurer decisions to make them try cheaper drugs before getting more expensive drugs.”

From the public health front, Healio tells us that “Overweight and obese BMI during adulthood appeared associated with increased risk for colorectal cancer and non colorectal gastrointestinal cancers, according to study results published in JAMA Network Open.” The FEHBlog does not think that the new generation of obesity-reduction drugs needs publicity, but there you go.

From the Rx coverage and more front, the FDA announced

  • “the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.”
    • Medpage Today adds, “Brexpiprazole’s labelopens in a new tab or window will continue to carry a boxed warning about the risk of increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs. The warning further stipulates that the drug is not approved for patients with dementia-related psychosis who are not experiencing agitation associated with Alzheimer’s dementia.”
  • and “finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.”
  • Beckers Hospital Review points out “The Biden administration has been taking action to address the prescription drug supply shortage, which has caused upheaval both for patients and providers, according to a May 10 Bloomberg report.”

From the medical research front —

  • STAT News reports
    • “Home to billions of cells that form trillions of connections, the human brain isn’t just the body’s most important organ; it’s also the hardest to study. But an international team of scientists using cutting-edge stem cell technology has devised a new way to better understand the brain’s cellular cleanup crew — and its connection to neurological disease.
    • “Researchers coaxed stem cells to grow into microglia, immune cells that roam the brain searching for signs of damage and that monitor and maintain neuronal connections. They then added microglia to brain organoids, tiny 3D structures of neurons that mimic some aspects of brain function, and transplanted these microglia-containing “mini-brains” into mice. Doing so caused microglia to look and behave much more like they would in a human brain compared to previous lab experiments conducted in a dish.
    • “The authors also found early hints that they could use these transplanted organoids to study disease, including the role that microglia might play in autism. Microglia in brain organoids derived from people with autism had larger cell bodies than cells from controls and had an overabundance of small cellular extensions associated with an active, inflammatory state researchers believe may contribute to the disorder.”
    • “The findings, published on Thursday in the journal Cell, are the result of a collaboration between scientists from San Diego to Germany to Israel. The study raises the possibility of using transplanted organoids to understand the complex crosstalk between neurons and immune cells across a range of diseases, and to perhaps one day use this system to test potential treatments.”
  • The Washington Post adds
    • “A skin patch being developed by a French pharmaceutical company to treat peanut allergy is showing promise in toddlers, according to a peer-reviewed study published Wednesday.
    • “The “peanut patch” outperformed a placebo in “desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms,” said the study, which was funded by the company DBV Technologies and published in the New England Journal of Medicine.”

Midweek Update

David Ermer–Congress, End of the PHE, NE, NCQA, NIH, OPM, Rx coverage, Telehealth, Uncategorized–
Photo by Michele Orallo on Unsplash

From Capitol Hill —

Roll Call reports

  • “The White House and congressional leaders are discussing the duration of appropriations caps and a debt limit raise as staff talks get underway in advance of the next principals meeting on Friday.
  • “A two-year appropriations deal is under consideration, according to sources familiar with the talks, along the lines of three separate laws since 2015 that were paired with suspensions of the debt limit. 
  • “The White House and top Democrats are pushing for two years of debt limit breathing room, as in the 2019 deal cut with former President Donald Trump. That law contained two years of spending caps, which Speaker Kevin McCarthy pointed out as far back as January.
  • “Such an arrangement would, in theory, remove the threat of fiscal cliffs facing lawmakers and the economy until after the 2024 elections.”

Fierce Healthcare tells us,

  • “The Senate Health, Education, Labor and Pensions (HELP) Committee convened the heads of three big pharmas—Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jørgensen and Sanofi CEO Paul Hudson—as well as the top brass at the three largest PBMs—CVS Health Executive Vice President and President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.
  • “The legislation on the docket for the HELP Committee aims to inject transparency into the pharmaceutical supply chain as well as increase access to generics. PBM reforms on the table include eliminating spread pricing models as well as clawbacks from pharmacies. * * *
  • “The HELP Committee will convene Thursday to mark up four bills that target drug pricing. Sanders said that while these measures are a priority, there’s more work to be done in addressing this issue. He added that issues with affording drugs are a broader part of the ongoing challenges around affordability in healthcare.”

Tomorrow is the last day of the Covid public health emergency, and today the Department of Health and Human Services posted a fact sheet on how the end of the PHE affects telehealth.

From the Rx coverage front, the Wall Street Journal points out

  • “Advisers to the Food and Drug Administration recommended making an oral contraceptive available without a prescription for the first time, potentially widening access to birth control for women across the country. 
  • “The panel of FDA advisers voted 17 to 0 on Wednesday that there was enough evidence for the agency to approve the medication’s sale over-the-counter. The FDA, which is expected to make a final decision this summer, doesn’t have to follow the expert panel’s advice, though it often does.
  • “The FDA approved the pill, called Opill, for prescription use in 1973. HRA Pharma, owned by Perrigo, a Dublin-based generic drugmaker, submitted its application to make Opill available over-the-counter last July. 
  • “The advisory panel said the benefits of making oral contraceptives available over-the-counter outweighed the risks.”

The cost curve is pointing down.

From the medical research front, the National Institutes of Health updates us on multiple mRNA vaccines that show promise for treating HPV-Related cancers.

From the healthcare quality front, NCQA informs us

  • “We launched our Race and Ethnicity Stratification Learning Network.
  • “The network is a free, interactive, online tool that offers data and best practices to help health plans improve how they collect race and ethnicity data on enrollees.
  • Improving data collection of race and ethnicity data is vital to improving health equity.
  • “The data available in this new resource summarize the care of 20 million people enrolled in 14 health plans that reported results on 5 HEDIS measures, stratified by race and ethnicity.
  • “Best practices we identify come from NCQA’s qualitative interviews of key staff at plans in the learning network.
  • “A report groups our findings in three areas.”

Check it out.

From the federal employment front, the Office of Personnel Management announced

  • released proposed regulations that would prohibit the use of previous salary history in setting pay for federal employment offers. Under the new proposed regulations, federal agencies would not be able to consider an applicant’s salary history when setting pay for new federal employees in the General Schedule pay system, Prevailing Rate pay system, Administrative Appeals Judge pay system, and Administrative Law Judge pay system.  
  • “These proposed regulations are a major step forward that will help make the federal government a national leader in pay equity,” said OPM Director Kiran Ahuja. “Relying on a candidate’s previous salary history can exacerbate preexisting inequality and disproportionally impact women and workers of color. With these proposed regulations, the Biden-Harris Administration is setting the standard and demonstrating to the nation that we mean business when it comes to equality, fairness, and attracting the best talent.” 

Tuesday’s Tidbits

David Ermer–ACA, COVID-19, End of the PHE, NE, FDA, Federal employment benefits, OPM, Telehealth–
Photo by Patrick Fore on Unsplash

From Washington DC, the Wall Street Journal reports

  • “President Biden and House Speaker Kevin McCarthy remained at loggerheads after a meeting Tuesday at the White House, appearing to make little progress in averting the first-ever default by the federal government as soon as next month.
  • “House Republicans have demanded deep spending cuts in exchange for raising the debt ceiling and criticized Mr. Biden for not starting talks earlier. But Mr. Biden and Democrats in Congress maintain that the federal borrowing limit should be raised without preconditions and have called the GOP stance irresponsible. Neither side has presented a path forward that could win enough support to pass both chambers of Congress.
  • ”I didn’t see any new movement,” Mr. McCarthy said after leaving the meeting. He said he thought negotiators only had about two weeks to reach an agreement. He said there were staff-level meetings planned and the key leaders would meet again on Friday.”

From the end of the public health emergency front —

  • The Department of Health and Human Services released a fact sheet on the end of the Covid public health emergency, which ends on Thursday, May 11.
  • The Washington Post tells us,
    • “The federal government will allow doctors to keep using telemedicine to prescribe certain medications for anxiety, pain and opioid addiction, extending for six months emergency flexibilities established during the coronavirus pandemic.
    • “The Drug Enforcement Administration and Substance Abuse and Mental Health Services Administration made the announcement Tuesday, two days before the telemedicine flexibilities were set to expire along with the coronavirus public health emergency.
    • “The ability to prescribe controlled medications remotely will run through Nov. 11, 2023. And that deadline will be longer still if doctors have already established a telemedicine relationship with patients. In that circumstance, physicians can keep prescribing the medications virtually through Nov. 11, 2024.”
  • Govexec informs us
    • “President Biden on Tuesday officially revoked the COVID-19 vaccine mandates for federal employees and contractors that had already been mired in lawsuits that prevented them from being enforced. 
    • “The mandates–issued in September 2021–will end on May 12, Biden said in an executive order. The move had been expected following an announcement from the White House earlier this month, and will coincide with the end of the COVID public health emergency on May 11.”
  • STAT News adds
    • “The White House isn’t quite ready to launch its new pandemic response office for a neat handoff at the end of the Covid-19 public health emergency, White House Covid-19 Response Coordinator Ashish Jha told reporters Tuesday.
    • “Jha said White House officials are in the middle of setting up an Office of Pandemic Preparedness and Response Policy that Congress mandated them to create in December, but it won’t be ready in time for a clean transfer at the end of the public health emergency on May 11.
    • “He deflected questions about whether he will stay on after the transition.

From the substance abuse disorder front, Google tells us that this is National Fentanyl Awareness Day, and Shatterproof addresses four myths about fentanyl.

From the preventive services front, the U.S. Preventive Services Task Force posted

  • “a draft recommendation statement on screening for breast cancer. The Task Force now recommends that all women get screened for breast cancer every other year starting at age 40. This is a B grade. More research is needed on whether or not women with dense breasts should have additional screening with breast ultrasound or MRI, and on the benefits and harms of screening in women older than 75. These are I statements.”
  • The public comment period ends on June 5, 2023.

From the litigation front, STAT News reports

  • “A federal jury handed a major win to Gilead Sciences on Tuesday in a closely watched battle with the U.S. government over the rights to groundbreaking HIV prevention pills.
  • “The jury decided Gilead did not infringe on patents held by the Centers for Disease Control and Prevention and, in fact, that the agency’s patents were invalid. The CDC helped fund academic research into HIV prevention that later formed the basis for the pills. The Department of Health and Human Services contended that Gilead refused to reach a licensing agreement despite several attempts to reach a deal.
  • “For its part, the company argued that it invented the pills — an older one called Truvada and a newer, upgraded version called Descovy — and that the concept of using Truvada to prevent HIV was well-known by the time the government tried to obtain its patents. Moreover, Gilead maintained that it acted in good faith during its negotiations with the government.”

From the tidbits front —

  • Federal News Network relates
    • “The Postal Service is falling short of its goal to start turning around its financial losses this year, but Postmaster General Louis DeJoy says the agency is taking “aggressive actions” to get the agency back on track to break even by the end of the decade.
    • “USPS reported a $2.5 billion net loss for the second quarter of fiscal 2023, and is expected to see a net loss for the entire fiscal year.
    • The agency saw more than an 8% decline in first-class mail volume and a 5% decline in package volume, compared to the same period last year.”
  • OPM announced
    • “U.S. Office of Personnel Management (OPM) Director Kiran Ahuja will deliver the commencement address to the 2023 graduating class of the University of Georgia’s (UGA) School of Public and International Affairs at the Ramsey Auditorium on the UGA campus.  
    • “Director Ahuja, an alumna of the University of Georgia School of Law, will speak to the Class of 2023 on the opportunities that a career in federal service offers. As federal agencies seek to fill the positions necessary to implement legislation such as the 2021 Bipartisan Infrastructure Law, OPM is leading the federal government’s recruitment efforts. Director Ahuja’s message to graduates will be simple: if you want a career with impact, the federal government is hiring.”
  • HUB International points out that
    • “The IRS recently released a Chief Counsel Memo confirming its long-standing position that all flexible spending account (“FSA”) expenses must be substantiated. This means that, no matter how small, each expense must have some kind of third-party verification. While Chief Counsel Memos are not official, binding IRS guidance, they are informative of the IRS’s views in a particular area.”
  • Last Wednesday, “the FDA published a new web page with details about over-the-counter (OTC) Hearing Aids: What You Should Know before and after buying an OTC hearing aid.”

 

  

Monday roundup

David Ermer–Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the public health front

  • The Washington Post reports
    • “In 2022, 8,300 cases of tuberculosis were identified in the United States, marking a 5 percent increase from the year before, according to a report from the Centers for Disease Control and Prevention.
    • “The 2022 rebound in TB cases included a 26 percent increase in TB diagnoses in children 4 or younger — from 160 cases in 2021 to 202 last year. That increase is concerning, CDC officials said in a news release, because cases in that age group are usually the result of recent transmission rather than reactivation of a long-standing latent infection.
    • “Still, the overall 2022 tally did not reach the pre-pandemic count of 8,895 TB cases in 2019. That number fell by 20 percent in 2020, which health officials generally attributed to delayed or missed diagnoses during the pandemic, as well as changes in people’s travel and movement that limited their potential exposure to the disease.”
  • STAT News informs us
    • “Only about one in 5,000 people in the United States is a centenarian. (About 1,900 centenarians live in Massachusetts, according to 2021 federal records.) And the odds of reaching 110 are rarer still: just one in 5 million.
    • “But it’s not just longevity that makes [centerarian Heldra] Senhouse exceptional. Her clear memory and sharp thinking are hallmarks of super agers, as these ancients are known; so is her generally good health. Major age-related illnesses hit most centenarians about 20 to 30 years later than everyone else. And few ever develop Alzheimer’s disease.
    • “Increasingly, scientists believe that genes, and not necessarily good habits, determine who lives past 100. Many people who exercise regularly, eat healthy diets, and refrain from smoking will make it to 90. Beyond that is when researchers say genetics plays a much larger role.
    • FEHBlog note — the researchers are trying to identify the super ager genes.
  • JAMA Online offers a discussion of the role of pediatricians in resolving the maternal mortality problem.

From the substance use disorder front —

  • The Washington Post discusses community efforts to create “overdose prevention centers [that] allow people to take illegal drugs like fentanyl under the watch of staff trained to reverse overdoses.”
  • STAT News tells us
    • “Ever since fentanyl came to dominate the U.S. illicit drug supply, doctors and patients have found buprenorphine, a key addiction-treatment medication, increasingly difficult to use.
    • “All too often, fentanyl’s potency has meant that patients transitioning to buprenorphine, a far weaker drug, experience excruciating symptoms known as “precipitated withdrawal.” Often, the discomfort is so severe that patients give up on buprenorphine altogether.
    • “But a trio of West Coast doctors is reporting a buprenorphine breakthrough thanks to an unlikely-seeming medication: ketamine, an anesthetic used both medicinally and recreationally and that has hallucinogenic effects at high doses. Giving tiny doses of ketamine as patients begin buprenorphine treatment, they say, has all but eliminated their withdrawal symptoms.”

From the U.S. healthcare business front, Healthcare Dive reports, “Nonprofit Kaiser Permanente posted net income of $1.2 billion for the first quarter this year, as higher care volumes and a more generous financial market boosted quarterly profit. The operator reported a $961 net loss in the first quarter of last year.”

From the telehealth front, Healthcare IT News shares a sneak peek at a new Ernst & Young survey. “The firm’s global health leader speaks with Healthcare IT News about hybrid care, digital transformation, big data, generative AI and smart technology.”

Weekend update

David Ermer–Congress, FDA, Telehealth, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

The Senate will be on a State work period this week, while the House of Representatives will hold a DC work week. This means that Committee business will occur.

The Wall Street Journal reports

“Top Democrats and Republicans are racing to try to find a politically acceptable way to raise the nation’s borrowing limit in the coming weeks, diving into talks that President Biden has avoided during months of impasse. 

“Mr. Biden will host House Speaker Kevin McCarthy (R., Calif.) and other congressional leaders at the White House on Tuesday, the first direct contact in months as officials grapple with the prospect of the first-ever U.S. default as soon as June 1. 

“While the two parties are publicly standing by their negotiating stances, officials on both sides of the aisle have started to quietly search for a way out of a potential crisis.”

From the Rx coverage front —

  • Fortune Well tells us,
    • “U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.
    • “Advisers to the Food and Drug Administration meet [this] week to review drugmaker Perrigo’s application to sell a decades-old pill over the counter. The two-day public meeting is one of the last steps before an FDA decision.
    • “If the FDA grants the company’s request, Opill would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves or online.
    • “In an initial review posted Friday, the FDA raised several concerns about studies of Opill, citing problems with the reliability of some of the company’s data and raising questions about whether women with certain other medical conditions would correctly opt out of taking it. It also noted signs that study participants had trouble understanding the labeling instructions.
    • “The agency will ask the panel to consider whether younger teenagers will be able to understand and follow the instructions.
    • “At the end of the meeting, the FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks. However, the panel vote is not binding, and the FDA is expected to make its final decision this summer.
  • Healthcare Dive reports,
    • “U.S. supply of Novo Nordisk’s weight loss drug Wegovy will be “reduced temporarily,” the company said Thursday, revealing the latest setback to a launch that’s been slowed by manufacturing issues over the last year and a half. 
    • “Availability of the lower three of Wegovy’s five doses, used as weekly starter shots to gradually increase patients’ tolerance to the drug, will be limited to ensure people who now get maintenance treatment can maintain “continuity of care,” the company said. Novo indicated the problem will be eased once it gets a new contract manufacturer up and running. * * *
    • “Despite the production hurdles, Wegovy sales continued to grow. Sales rose to 4.6 billion Danish kroner, or about $676 million, in the first quarter, up from 2.4 billion kroner the previous quarter and 1.4 billion over the first three months of 2022.”

From the health plan design front, Fierce Healthcare points out

“The first step to living healthier is choosing that lifestyle, and CareFirst BlueCross BlueShield has tapped Noom for Work to help many of its approximately 3.2 million members make that decision.

“The partnership, announced this week, will focus on CareFirst members who struggle with obesity as well as those with prediabetes, according to an announcement.

“In what Noom called a “mind-first approach,” the program will include a curriculum for those struggling with weight control that will focus on the “why” behind the behaviors that have led to problems, and then get to work on changing those behaviors.

“Included are daily lessons tailored to each person’s weight-loss goals, such as continuous education, food intake tracking and advice on how to connect to devices, such as scales and wearables, that offer not only immediate feedback but also encouragement.

From the U.S. healthcare business front, NPR Shots notes

“The Biden administration on Thursday cautioned Americans about the growing risks of medical credit cards and other loans for medical bills, warning in a new report that high-interest rates can deepen patients’ debts and threaten their financial security.

“In its new report, the Consumer Financial Protection Bureau estimated that people in the U.S. paid $1 billion in deferred interest on medical credit cards and other medical financing in just three years, from 2018 to 2020.

“The interest payments can inflate medical bills by almost 25%, the agency found by analyzing financial data that lenders submitted to regulators.”

From the fraud, waste, and abuse front, Fierce Healthcare reports

“Just as the long off-ramp from the COVID-19 public health emergency (PHE) ends and telepsychiatry providers breathe a sigh of relief with a temporary extension of virtual prescribing flexibilities, a report dropped showing an estimated $348 million in telehealth psychotherapy Medicare payments were noncompliant.

“This week, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the findings of an audit (PDF) of Medicare payments from March 2020 through February 2021. During the audit period, Medicare Part B paid $1 billion for more than 13.5 million psychotherapy services, including telehealth services.

“Of the $1 billion in Medicare Part B payments, approximately $591 million was for psychotherapy services that were billed as telehealth services, and approximately $439 million was in payments for in-person psychotherapy services, according to the report.

“The federal watchdog estimates $580 million in improper payments for services that did not comply with Medicare requirements during the audit period, including $348 million for telehealth services, or about 60% of the payments, and $232 million for non-telehealth services.”

 

Cybersecurity Saturday

David Ermer–Cybersecurity, Uncategorized–

From the cyber breaches front, Health IT Security reports on the latest healthcare breaches.

From the cybersecurity justice front —

The Washington Post informs us,

  • “Former Uber chief security officer Joe Sullivan avoided prison Thursday as he was sentenced for covering up the 2016 theft of company data on 50 million Uber customers while the company was being investigated by the Federal Trade Commission over a previous breach.
  • “Sullivan had been convicted in October of obstruction of justice and hiding a felony, making him the first corporate executive to be found guilty of crimes related to a data breach by outsiders.
  • “U.S. District Judge William Orrick sentenced Sullivan to three years of probation, noting his significant past work in protecting people from the sort of crime he later concealed. He also said that Sullivan’s steps had succeeded in keeping the stolen data from being exposed.
  • “Orrick said he felt former Uber chief executive Travis Kalanick was equally responsible for what he considered a serious offense, and he wondered aloud why Kalanick had not been charged. The judge also said he was influenced by the unprecedented nature of the case, warning that future offenders would be jailed, even if they were the pope.”

Cybersecurity Dive tells us,

  • “A New Jersey appellate court upheld a prior ruling in favor of Merck, a major pharmaceutical company embroiled in a closely watched case involving $1.4 billion in claims stemming from the 2017 NotPetyacyberattack.
  • “The court agreed Monday that insurers could not deny coverage under war exclusion language contained in the policies, saying the circumstances didn’t apply in the Merck case. 
  • “The decision is considered a major victory for companies seeking claims for cyberattacks at a time when hackers linked to rogue nation-states have stepped up threat activity through supply chain attacks, ransomware and other malicious threats.”

From the cyber vulnerabilities front, the Cybersecurity and Infrastructure Security Administration added three more known exploited vulnerabilities to its catalog.

Cybersecurity Dive points out “three areas of generative AI the NSA is watching in cybersecurity.
Generative AI is a “technological explosion,” NSA Cybersecurity Director Rob Joyce said. While it is a game-changing technology, it hasn’t delivered quite yet.”

From the ransomware front —

Cyberscoop relates that “Victims’ reluctance to report ransomware stymies efforts to curb cyberattacks, say federal officials. Federal officials say they need more victims to report when they’ve been hit by ransomware in order to better defend against the problem.”

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

  • “This week’s ransomware news has been dominated by a Royal ransomware attack on the City of Dallas that took down part of the IT infrastructure.
  • “The attack occurred early Monday, affecting the Dallas Police dispatch system and the public library’s computer network. Additional systems, including the City’s website, were shut down as time passed.
  • “On Wednesday, the City’s network printers began printing ransom notes from the attack. BleepingComputer obtained a screenshot of this note, allowing us to identify that the Royal ransomware operation was behind the attack.”

From the cyber defenses front, Cybersecurity Dive notes

  • “Google rolled out a feature Wednesday that allows account holders to create passkeys, part of a wider move to phase out passwords across the industry.
  • “Passkeys are stored on local computers or mobile devices, reducing the risk of credentials being hacked through a phishing attack. Passkeys allow users to sign into apps and sites the same way as they would access their devices, such as a face scan or fingerprint. 
  • “Dashlane separately announced a feature called passwordless login on Wednesday, which means users of the password manager will no longer need to create a master password to access the service.”