FEHBlog

Cybersecurity Saturday

David Ermer–Cybersecurity–

From Capitol Hill, Roll Call informs us

The Senate voted overwhelmingly Thursday to pass the final defense authorization bill for fiscal 2023, clearing the sweeping measure for President Joe Biden’s signature.

If Biden signs the NDAA into law, as he is expected to do, it would be the 62nd straight fiscal year that the defense policy measure has been enacted.

The Senate’s final NDAA passage vote was 83-11, and 60 votes were required. The House passed the bicameral compromise on Dec. 8.

Of note to FEHB carriers in the bill, as noted last week, is the Chinese-made semiconductor provision. The law requires a FAR rule to implement the provision within three years, and the FAR rule cannot take effect until December 2027, five years after enactment, which will occur when the President signs the bill.

The New York Times adds

The Biden administration on Thursday stepped up its efforts to impede China’s development of advanced semiconductors, restricting another 36 companies and organizations from getting access to American technology.

The action, announced by the Commerce Department, is the latest step in the administration’s campaign to clamp down on China’s access to technologies that could be used for military purposes and underscored how limiting the flow of technology to global rivals has become a prominent element of United States foreign policy. * * *

Among the most notable companies added to the list is Yangtze Memory Technologies Corporation, a company that was said to be in talks with Apple to potentially supply components for the iPhone 14.

On Thursday, Congress passed a military bill including a provision that will prevent the U.S. government from purchasing or using semiconductors made by Y.M.T.C. and two other Chinese chip makers, Semiconductor Manufacturing International Corporation and ChangXin Memory Technologies, because of their reported links to Chinese state security and intelligence organizations.

The Wiley law firm helpfully offers details on this important provision.

From the cyber vulnerabilities front —

The Cybersecurity Infrastructure and Security Agency (CISA) added five known exploited vulnerabilities and then one more to its catalog.

Healthcare Dive reports

The HHS’ Office of Information Security has released a report looking at the implications of automation for healthcare cybersecurity and how criminals are using artificial intelligence in their hacking activities.

Cyberattackers are using AI to build better malware, the office said. The technology includes machine learning-enabled penetration testing tools, AI-supported password guessing and data to enable impersonation on social networking platforms.

Hackers are also using automated software to identify valuable information such as emails, passwords, credit cards and personal data, according to the report.

The Healthcare Sector Cybersecurity Coordination Center issued this sector alert:

Citrix released patches for a vulnerability that impacts both their Application Delivery Controller and Gateway platforms. This vulnerability allows a remote attacker to completely compromise a target system. These vulnerabilities are known to be actively exploited by a highly capable state-sponsored adversary. Furthermore, the Department of Health and Human Services is aware of U.S. healthcare entities that have already been compromised by the exploitation of this vulnerability. HC3 strongly urges all healthcare and public health organizations to review their inventory for these systems and prioritize the implementation of these patches.

Forbes explains “Why Employee-Targeted Digital Risks Are The Next Frontier Of Enterprise Cybersecurity.”

From the ransomware front —

Bleeping Computer’s The Week in Ransomware has a long introduction which begins

To evade detection by security software, malware developers and threat actors increasingly use compromised code-signing certificates to sign their malware.

This trend was illustrated this week when Microsoft disclosed during the December Patch Tuesday that developer accounts were compromised to sign malicious, kernel-mode hardware drivers in the Windows Hardware Developer Program.

Health IT Security reports

The HHS Health Sector Cybersecurity Coordination Center (HC3) issued two new analyst notes detailing the tactics and indicators of compromise for LockBit 3.0 and BlackCat. The LockBit ransomware family and the BlackCat ransomware variant have been observed targeting the healthcare sector.

Healthcare organizations should remain vigilant and apply recommended mitigations to reduce risk.

CISA released an update to its Cuba ransomware advisory.

From the cybersecurity defenses front

  • Health IT Security tells us

Organization executives are doubling down on investments toward cybersecurity reliance as an uptick in data security breaches jeopardizes business operations and overwhelms industries, including the healthcare sector, according to a recent Cisco report.

The “Security Outcomes Report, Volume 3: Achieving Security Resilience” revealed that 96 percent of executives consider security resilience crucial, with 62 percent of organizations surveyed reporting a data security event that impacted business in the past two years.

When asked to elaborate on the types of resilience-impacting incidents, over half the respondents reported data breaches and system outages. Further, ransomware events and distributed denial of service (DDoS) attacks impacted more than 46 percent of surveyed organizations.

The report also indicated that the state of security resilience among organizations is mixed less than 40 percent confident their organization would fare well during a cybersecurity event.

  • Forbes identifies ten qualities of a good security program and delves into “Tackling Mental Health And Burnout In Cybersecurity.”

Friday Stats and More

David Ermer–CDC, COVID-19, HIPAA Privacy and Security Rules, Patient safety–

From the Centers for Disease Control’s Covid data tracker and its weekly interpretative summary of its Covid statistics:

  • New Cases totaled 455.556 this week, down 2.7% from last week.
  • Variants BQ.1.1 and BQ.1 are estimated to represent 78% of Covid / Omicron cases
  • New Hospitalizations averaged 5,010 this week, up 2.3% from last week.
  • New Deaths totaled 2,703, down 13.2% from last week.
  • “As of December 14, 2022, 660.4 million vaccine doses have been administered in the United States. About 228.8 million people, or 68.9% of the U.S. population, have completed a primary series.* More than 44.2 million people, or 14.1% of the U.S. population ages 5 years and older, have received an updated (bivalent) booster dose.”

The CDC reports good news about the efficacy of the bivalent booster here and here.

Pfizer announced the sale $2 billion worth of Paxlovid pills (3.7 million courses) to the federal government and its ongoing research on developing combined mRNA Covid and flu vaccine.

From CDC’s Fluview — “Seasonal influenza activity remains high but appears to be declining in some areas.”

Health Affairs brings us up to date on mpox.

Looking forward, Healthcare Dive reports

  • Leaders at hospitals and health systems across the country are anticipating a potentially turbulent operating environment in the coming year, according to a survey from Deloitte.
  • Among health system leaders, 85% said staffing challenges would have a major impact on their 2023 strategy and 76% said inflation is a significant factor. Other expected headwinds include affordability issues for patients, shrinking margins and continual supply chain disruptions.
  • Deloitte also polled health plan executives and found they face challenges related to inflation and a tight labor market, though are generally in a better financial position than hospitals and health systems.

Speaking of hospitals, Fierce Healthcare informs us

The care given in emergency departments came under fire yesterday with the release of a government study saying that 250,000 Americans die every year due to misdiagnoses.

The findings spurred an immediate response from the president of the American College of Emergency Physicians (ACEP), who questions the study’s veracity and methodology.

Christopher S. Kang, M.D., president of the ACEP, said in a statement that “in addition to making misleading, incomplete and erroneous conclusions from the literature reviewed, the report conveys a tone that inaccurately characterizes and unnecessarily disparages the practice of emergency medicine in the United States.”

One of the authors of the study—David Newman-Toker, M.D., Ph.D., a neurologist at Johns Hopkins University—vehemently defends the methodology and told Fierce Healthcare that “high levels of variation in care (across conditions, across hospitals, across demographic groups) tells us that these errors do not need to be thought of as ‘the price of doing business.’ It tells us that there are already probably ways to get it right.”

The study, conducted by Johns Hopkins for the Agency for Healthcare Research and Quality, states that among 130 million ED visits in the U.S. per year, 7.4 million patients are misdiagnosed. In addition, 2.6 million suffer an adverse event, and about 370,000 suffer serious harm from diagnostic errors.

The teenage daughter of CNN reporter Jake Tapper writes in CNN about her frightening ER experience. The FEHBlog joined his wife at a Dripping Springs TX knitting store holiday event. He mentioned the Alice Tapper story to two nurses who were horrified. In the FEHBlog experience, nurses are the best judge of hospital care across facilities.

In HIPAA news, the American Hospital Association tells us

The Department of Health and Human Services yesterday proposed a standard format for attachments to support electronic health care claims and prior authorization transactions under the Health Insurance Portability and Accountability Act. The standard would apply to all health plans, health care clearinghouses, and providers, who currently lack an efficient and uniform method of sending attachments, which can lead to provider burnout, slow down processing and delay payments or patient care.

“The AHA supports establishing a standard for attachments to reduce the administrative burdens facing clinicians, and we look forward to providing robust commentary after analyzing the rule’s specifics,” said Terrence Cunningham, AHA’s director of administrative simplification policy.

Comments on the rule are due March 21. 

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 testing, FDA, NIH, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports

The Senate passed an $858 billion defense-policy bill [National Defense Authorization Act] on Thursday that authorizes U.S. military leaders to purchase new weapons and would increase pay for service members, checking a major item off Congress’s year-end to-do list.

The House passed the legislation last week with 350 votes in favor and 80 votes against. It now goes to President Biden’s desk for his signature.

The Journal also provides information on the NDAA’s key provisions.

The Washington Post adds,

The Senate late Thursday approved a measure to fund the government through Dec. 23, securing a one-week deadline extension that gives Democrats and Republicans one final opportunity to work out a longer-term spending deal.

The 71-19 vote — coming a day after the House adopted it — sends the stopgap to President Biden and staves off a federal government shutdown that otherwise would have occurred after midnight this Friday.

From the Omicron and siblings front, the American Hospital Association informs us,

The Department of Health and Human Services today recommended governors take certain actions to prepare for a potential further increase in COVID-19 cases and hospitalizations this winter, and has pre-positioned N-95 masks, gloves, gowns and ventilators at strategic locations should states need them, the Biden Administration announced.

The Administration also announced that all U.S. households can now order four more free at-home COVID-19 tests, which will begin shipping the week of Dec. 19.

From the public health front, AP reports

The number of U.S. deaths dropped this year, but there are still more than there were before the coronavirus hit.

Preliminary data — through the first 11 months of the year — indicates 2022 will see fewer deaths than the previous two COVID-19 pandemic years. Current reports suggest deaths may be down about 3% from 2020 and about 7% vs. 2021.

The National Institutes of Health announced

The percentage of adolescents reporting substance use in 2022 largely held steady after significantly declining in 2021, according to the latest results(link is external) from the Monitoring the Future survey(link is external) of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States. Reported use for almost all substances decreased dramatically from 2020 to 2021 after the onset of the COVID-19 pandemic and related changes like school closures and social distancing. In 2022, reported use of any illicit drug within the past year remained at or significantly below pre-pandemic levels for all grades, with 11% of eighth graders, 21.5% of 10th graders, and 32.6% of 12th graders reporting any illicit drug use in the past year.

The Monitoring the Future survey is conducted each year by researchers at the University of Michigan, Ann Arbor, and funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

From the Rx coverage front –

BioPharma Dive takes a “deep dive” reporting on a recently approved drug called to treat ALS or Lou Gehrig’s disease. “Amylyx Pharmaceuticals’ Relyvrio is in high demand in clinics across the U.S. Though some patients are already getting it, insurance and out-of-pocket costs remain a source of anxiety. * * * In the clinical trial that led to its approval, Relyvrio appeared to slow the functional decline associated with ALS. The trial also found patients treated with the drug lived a median of five months longer than those given a placebo. While Relyvrio’s benefits have been called modest, the drug has become a vital source of hope for many ALS patients.”

BioPharma Dive also lets us know that

  • Yet another competitor for the top-selling inflammatory disease drug Humira will be waiting in the wings after Fresenius Kabi won U.S. approval of its copycat version called Idacio.
  • The Food and Drug Administration cleared the medicine for all the eligible indications of Humira, Fresenius Kabi said Wednesday. Due to a previous patent settlement with AbbVie, the company won’t launch Idacio in the U.S. until July.
  • Idacio, developed by Fresenius Kabi SwissBioSim, is currently available in 37 countries after initially launching in 2019. Fresenius Kabi said it has made selling biosimilars worldwide a priority.

Health Affairs Forefront offers Parts 1 and 2 of its insights on drug pricing reform enacted this past summer’s federal budget reconciliation act.

From the regulatory front

  • The FEHBlog noticed that the HHS press release concerning the 2024 Medicare Part D proposed rule (posted yesterday) lacked links to the proposed rule and the fact sheets. So here are the missing links:

The proposed rule can be accessed at the Federal Register at https://www.federalregister.gov/public-inspection/2022-26956/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program. Comments on the proposed rule are due by February 13, 2023.

View the fact sheet on the proposed rule here.

  • Health Affair’s Forefront’s second article on Monday’s proposed 2024 ACA benefit and payments parameter rule is here. This article concerns risk adjustment.

From the telehealth front, Health Payer Intelligence relates that

  • Most patients who had a telehealth visit didn’t need an in-person follow-up appointment in the next three months, according to new research from Epic. The trend was reflected in almost every specialty included in the study.
  • For specialties that required follow-ups, the additional visits were likely due to patients needing additional, not duplicative, care, Epic researchers said. That’s because high follow-up rates were only present in specialties that require regular hands-on care, such as obstetrics and surgery.
  • The study is the latest addressing whether telehealth results in duplicative care, instead of replacing an in-person encounter. The question is being debated by lawmakers as they consider how much telehealth flexibility should be allowed once the COVID-19 public health emergency expires.

In innovation news, Fierce Healthcare discusses

ElliQ, [which is] a voice-operated care companion for the elderly, is getting an update with 2.0 hardware and software including a companion app for family members and caregivers.

The robot, called the first proactive AI care companion and a Time Best Invention of 2022, was developed to address the loneliness epidemic in older adults and has shown the ability to decrease loneliness by 80%, according to the company. * * *

Interventions like the ones ElliQ performs are shown to improve the quality of life for seniors living alone by 80% through increasing fitness and facilitating social connections, according to a recent McKinsey report.

The first ElliQ impact studies have shown that 80% of users report a reduction in loneliness, 82% experienced better mental health and 90% feel overall better since using the robot.

Midweek Update

David Ermer–ACA, AHRQ, CDC, CMS, Congress, COVID-19, OPM–

From Capitol Hill, the Wall Street Journal reports

The House on Wednesday passed a one-week government funding measure to give congressional negotiators time to complete and pass a full-year omnibus spending bill, overcoming opposition from Republicans who urged postponing any deal until next year, when the GOP will take control of the chamber. * * *

The Senate is expected to next approve the one-week extension [on Thursday December 15]. 

The vote on a one-week continuing resolution, which keeps the government funded at fiscal 2022 spending levels, follows the announcement Tuesday that Democratic and Republican negotiators had reached agreement on a framework and would turn to completing the details. 

From the public health front, Healthcare Dive tells us

  • National health spending grew almost 3% in 2021, reaching $4.3 trillion as big increases in healthcare use and insurance coverage were offset by lower government spending on COVID-19.
  • The year’s growth rate was smaller than the 10% notched in 2020. CMS actuaries chalked the deceleration up to lower federal health spending, which fell 3.5% in 2021 compared to a 37% increase in 2020 as funding to combat the pandemic skyrocketed.
  • Health spending grew at a much slower clip than the nation’s gross domestic product, which increased 11% in 2021 — the largest growth rate since 1984.

Here’s the report which is posted on Health Affairs.

Medscape relates

New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes — 2023.

The document, long considered the gold standard for care of the more than 100 million Americans living with diabetes and prediabetes, was published December 12 as a supplement in Diabetes Care. The guidelines are also accessible to doctors via an app; last year’s standards were accessed more than 4 million times.

The Agency for Healthcare Quality and Research’s Director is posting a series of four reports concerning the agency’s effort to rethink healthcare quality in view of the fact

In seven years, the United States is expected to reach a demographic tipping point that will redraw the picture of healthcare delivery in America.  

In 2030, all baby boomers [birth dates from 1946 to 1964] will be older than 65, according to the U.S. Census Bureau. Just four years later—in 2034—older adults will outnumber children for the first time in history. The scope of this and future demographic shifts—including our population’s growing racial and ethnic diversity—will profoundly impact how healthcare is accessed, delivered, paid for, and evaluated.

The National Institutes of Health reports “Two randomized, placebo-controlled trials evaluating three Ebola vaccine administration strategies in adults and children found that all the regimens were safe in both age groups, according to results published today in the New England Journal of Medicine.”

Health Payer Intelligence informs us

Privately-insured Americans experienced higher rates of heat-related illness diagnoses in 2021 compared to 2016, in some cases a more than 37 percent increase, according to a report from FAIR Health.

“The Centers for Disease Control and Prevention has identified projected increases in extreme summer heat as one source of adverse health impacts from climate change. However, systematic, national data on trends in heat-related illnesses in the United States have been lacking,” the report began.

From the omicron and siblings front, a subset of public health —

  • The New York Times explores the question — who are the never Coviders? Even if you have never had Covid, you certainly have been impacted mightily by Covid. Nevertheless, it is an interesting article.
  • MedPage Today notes “Long COVID played a role in more than 3,500 deaths in the U.S. since the start of the pandemic, according to data from the CDC’s National Center for Health Statistics (NCHS).” The NCHS report may be overestimating because the first death occurred in April 2020 just after Covid got rolling and the most commonly mentioned term on death certificates with long COVID was “post COVID,” which was mentioned in 89.6% of long COVID-related deaths.” This may be a rare case in which the “retrospectoscope” is cloudy. See Dr. Martin Markary’s opinion piece on long Covid in yesterday’s Wall Street Journal.

From the regulatory front —

  • CMS issued a proposed rule on Medicare Part D changes for 2024.
  • Health Affairs began a series of three informative articles on the proposed 2024 notice of benefit payments and parameters released on Monday.
  • STAT News discusses a feature of the parameters notice that is drawing industry attention. To wit, “The Biden administration signaled Monday that it will require health plans on federal exchanges to cover more of the costs of generic drugs, a small tweak that nevertheless has industry groups divided on how best to manage drug costs.”
  • Health Leaders Media examines the gap that must be bridged to achieve a recent HHS proposed rule’s goal of implementing electronic prior authorization.

In agency event news —

  • OPM issued a press release about its “first government-wide summit for diversity, equity, inclusion, and accessibility (DEIA) on December 6-8, 2022.”
Biden administration outlines how agencies can measure progress toward PMA goals

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, No Surprises Act, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Politico reports tonight

Top appropriators struck a deal Tuesday night on a government funding framework critical to finalizing a mammoth year-end spending package.

In a statement, retiring Senate Appropriations Chair Patrick Leahy (D-Vt.) said appropriators have “reached a bipartisan, bicameral framework that should allow us to finish an omnibus appropriations bill that can pass the House and Senate and be signed into law by the President.”

Leading negotiators didn’t release those government funding totals in announcing the deal, but appropriators have largely settled on an $858 billion defense budget in recent weeks.

That’s good news. Presumably, Congress still plans to extend the continuing resolution from December 16 to December 23 this week in order to allow time to write and pass the omnibus bill.

From the Omicron and siblings front, Healthcare Dive reports that

In the two years since the COVID-19 vaccine became available for U.S. patients, the country’s vaccination program prevented more than 18.5 million hospitalizations and 3.2 million deaths, according to new research from the Commonwealth Fund and Yale School of Public Health.

Many millions of infections were prevented, preserving hospital resources for patients who otherwise would not have received timely care, the researchers said. The vaccine also saved the country $1.15 trillion in medical costs, kept children in school and allowed businesses to reopen, the study said. 

To arrive at its findings, the study used a computer model of disease transmission, comparing the pandemic trajectory to a simulated scenario without a vaccination program. The results can be used to inform future evidence-based decisions on vaccine use to reduce disease burden, the researchers said.

The FEHBlog has no doubt that the rapidly developed mRNA vaccines pulled us out of a jam in winter 2020 while Paxlovid and other anti-virals saved us from the monstrous Omicron surge in winter 2021.

From the CMS front —

  • CMS has activated the Ground Ambulance and Patient Billing Advisory Committee required by the No Surprises Act. The Committee’s report likely will be released in the second quarter of 2023.
  • CMS released a readout from “We Can Do Better: Advancing Maternity Care Together – the first CMS convening on maternal health since the agency launched its Maternity Care Action plan in July 2022 as part of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. Attendees discussed key actions to improve the health of pregnant and postpartum individuals – including the need for a robust and diverse maternity care workforce and the ability for consumers to easily identify health systems engaged in improving maternal care.”
  • CMS also called attention to the “recently released proposed rule that, if finalized, would modify the current National Council for Prescription Drug Programs (NCPDP) retail pharmacy standards for electronic transactions and expand the applicability of the Medicaid pharmacy subrogation transaction to all health plans.”
  • In related news, EHR Intelligence tells us, “In a recent letter, Health Level Seven International (HL7) called on the National Committee on Vital and Health Statistics (NCVHS) to include FHIR as a data standard for electronic clinical attachments. NSG encourages the public to submit comments on the proposed rule by January 9th, 2023.” The original version of HIPAA enacted over 25 years ago called for this attachments standard, which has been a thorn in CMS’s side.

In other HHS news —

  • HHS’s Agency for Healthcare Quality and Research informs us that the U.S. Preventive Services Task Force has proposed to keep in place the grade A recommendation “that clinicians prescribe pre-exposure prophylaxis with effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV infection.” The original PREP recommendation was made in 2018.
  • The American Hospital Association relates “The Substance Abuse and Mental Health Services Administration today proposed updating opioid treatment program standards and admission criteria to expand access to treatment. According to the agency, the rule would expand the definition of OTP practitioner to include any provider appropriately licensed to dispense and/or prescribe approved medications; no longer require one year of opioid addiction for admission; add evidence-based delivery models such as telehealth; expand patient access to take-home methadone doses, and no longer require annual reports from practitioners with a waiver to prescribe buprenorphine to up to 275 patients. The agency will accept comments on the proposed rule through Feb. 14.” That makes sense to the FEHBlog.

From the drug development front —

The Wall Street Journal reports

A customized Moderna Inc. MRNA 19.63%increase; green up pointing triangle vaccine helped ward off the recurrence of melanoma in a mid-stage trial, a milestone in long-running efforts to use the shots as treatments and a big step in the biotech’s ascent.

The combination of Moderna’s personalized cancer vaccine and MerckMRK 1.78%increase; green up pointing triangle & Co.’s Keytruda cancer immunotherapy reduced patients’ risk of relapse or death by about 44%, versus Keytruda alone, in the 150-volunteer study, the companies said Tuesday.

The results, which the companies said were statistically significant but haven’t been reviewed by independent scientists, suggest promise for an emerging but unproven class of vaccines that aim to treat diseases rather than prevent infections like typical shots.

MedCity News reports

Multiple myeloma can be treated by several drugs but relapse in this type of blood cancer is common and when that happens, patients need other treatment options. Johnson & Johnson is looking to fill that need with a drug that addresses a novel target. The pharmaceutical company is seeking regulatory approval for this molecule and the most up to date clinical data supporting the application were presented during the annual meeting of the American Society of Hematology (ASH).

Patients in the Phase 1/2 clinical trial had some of the toughest cases that progressed after treatment with at least three different therapies, according to Ajai Chari, director of clinical research in the multiple myeloma program at Mount Sinai and an investigator in the study. Despite that, treatment with the J&J drug, talquetamab, led to response rates of up to 74%.

From the healthcare business front, Fierce Healthcare tells us

Operating margins for the three largest for-profit hospital chains exceeded pre-pandemic levels in the third quarter, according to a new analysis that comes as hospital lobbies are pushing for financial relief from Congress. 

The analysis, released Monday by the Kaiser Family Foundation, looked at the latest financial performance for large hospital chains HCA Healthcare, Tenet Healthcare and Community Health Systems. * * *

Kaiser’s analysis comes a day after The Wall Street Journal published a report that showed hospitals received billions of dollars in aid, with some going to profitable systems that didn’t need it. Part of the problem was a mismatch in the federal government’s allocation of the $175 billion Provider Relief Fund passed by Congress at the onset of the pandemic in early 2020, the report said. 

From the tidbits department, the FEHBlog learned at the ABA Washington Health Law Summit today

  • The third Texas Medical Association case filed November 30 and pending before District Judge Kernodle concerns the manner in which the qualifying payment amount is calculated – a new issue which nevertheless could have been joined to the second lawsuit. Go figure.
  • In 2018, Congress passed a law called the Eliminating Kickbacks in Recovery Act (“EKRA”), 18 U.S.C. § 220. The Epstein, Becker and Green law firm explains, “EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.”

Monday Roundup

David Ermer–ACA, Congress, COVID-19, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Govexec reports

Congress will vote this week on a seven-day stopgap funding bill to avoid a shutdown Friday evening and buy negotiators more time to reach a deal on full-year appropriations. 

Top lawmakers voiced optimism on Monday for the first time in weeks as they inched toward an agreement on setting line-by-line funding levels across the government. The current continuing resolution is set to expire late Friday, while the new measure would push that back by one week and set the new deadline just two days before Christmas.

“Over the weekend, appropriators held positive and productive conversations, enough that both sides are moving forward in good faith to reach a deal,” Senate Majority Leader Chuck Schumer, D-N.Y., said Monday. He advised his colleagues to prepare to take “quick action” on a one-week CR “so we can give appropriators more time to finish a full funding bill before the holidays.” * * *

“We’re trading serious suggestions back and forth,” said Sen. Richard Shelby, R-Ala., who serves as ranking member on the Senate Appropriations Committee. “The main thing is, fund the government. Don’t shut it down.” 

WisPolitics tells us

On Monday, U.S. Sen. Ron Johnson (R-Wis.) and U.S. Sen. Rick Scott (R-Fla.) sent a letter to Gene Dodaro, Comptroller General of the Government Accountability Office (GAO), requesting an audit of health care providers under the Federal Employees Health Benefits (FEHB) Program. Following reports on similar programs, GAO uncovered potential fraud through improper payments causing an increase in the cost of the FEHB Program.

“GAO’s previous work on similar issues in the Medicare program and the Veterans Community Care program has uncovered a number of potentially ineligible providers, flagged weaknesses in provider vetting controls, and made valuable recommendations for improving program integrity and managing the potential risk to the care of Medicare enrollees and veterans, respectively, from ineligible providers,” explained the senators.

FEHB is an employer-sponsored health benefits program with strong controls. The FEHBlog does not expect the GAO to find similar problems in FEHB.

Govexec reports that the incoming Republican Chair of the House Oversight and Reform Committee says that his Committee will return “to its primary duty to root out waste, fraud, abuse, and mismanagement in the federal government.”

From the regulatory front —

  • The Department of Health and Human Services issued its proposed 2024 Notice of Benefit and Payment Parameters as the Affordable Care Act (ACA) requires. Here’s the Fact Sheet.
  • The Internal Revenue Service finalized the rule that it first issued in December 2021 to modify Form 1095-B and 1095-C following the Tax Cuts and Jobs Act sunsetting the ACA’s individual penalty for failure to maintain essential coverage during the tax year. The final rule makes some helpful tweaks to the 2021 modifications.

Today the FEHBlog attended the first day of the American Bar Association’s Washington Health Law Summit. Of note, there was a talk about the looming end of the Covid public health emergency, which, according to Politico reporters, is likely to occur in the first half of 2023. A “soft landing” is predicted, which is the outcome the FEHBlog also expects.

Others spoke about healthcare worker burnout / the workforce problem. Two speakers noted that a noticeable increase in hospital code calls for security assistance compounds the problem. The FEHBlog had not heard of that factor.

Following up on yesterday’s healthcare business post, Healthcare Dive tells us

Amgen on Monday said it has agreed to acquire Ireland-based drugmaker Horizon Therapeutics, outlasting rival suitors Sanofi and Johnson & Johnson in takeover negotiations that were first disclosed last month.

The deal values Horizon at $27.8 billion on a fully diluted basis. In dollar terms, it’s the largest in Amgen’s four-decade history, eclipsing a 2002 acquisition of Immunex that gave the California biotechnology company rights to Enbrel, its top-selling drug and for years one of the most lucrative pharmaceutical products.

While buying Horizon is not likely to give Amgen its next Enbrel, it does hand the company a portfolio of rare and immune disease drugs that are projected to bring in sales of $3.6 billion this year.

Enbrel will lose market exclusivity at the end of this decade and Amgen, like other pharmas facing looming patent cliffs, has turned to dealmaking to hunt for new products. In August, it spent $4 billion to acquire ChemoCentryx and its inflammatory disease drug Tavneos.

Per terms of the acquisition, Amgen will pay $116.50 per Horizon share, a roughly 20% premium to their closing price Friday and 48% higher than what they were worth before Horizon disclosed it was in deal talks. 

Weekend update

David Ermer–Congress, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

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

The Wall Street Journal adds

Congressional leaders are set to return to the Capitol on Monday under pressure to negotiate a spending bill that would fund the federal government’s operations beyond Friday.

Negotiators have days to reach a deal on a full-year spending bill or pass a short-term measure delaying the deadline to avoid a partial government shutdown. To reach a longer-term deal, they will have to break the partisan deadlock between Republicans and Democrats, who are split over $26 billion in nondefense spending in talks to craft an omnibus bill. * * *

Senate lawmakers are expected this week to pass a defense policy bill that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. 

Tomorrow is the last day of the Federal Employee Benefits Open Season. According to OPM, the official end is 11:59 pm “in the location of your electronic enrollment system”

The FEHBlog noticed on Linked In that OPM Director Kiran Ahuja spoke last week at the Milken Institute’s Future of Health Summit.

Director Ahuja spoke about eradicating stigmas surrounding mental health treatment and creating a welcoming work environment for all. 

As the largest employer in the nation, the Federal government must continue to invest in policies, tools, and resources that gives every employee the high quality and accessible mental health supports they need

Hey OPM, why don’t you post the Director’s remarks on opm.gov?

From the infectious disease front, the Secretary of the Treasury has written a letter to the state governors on resources available to combat the tripledemic. The FEHBlog has read articles recommending that we must return to masking and social distancing. The FEHBlog, who is a lawyer, not a health professional, thinks that if we accept this mistaken guidance, we will be tied to masking and social distancing in the winter forever. N.B. This is not a criticism of people who choose to mask social distance. The FEHBlog’s point is that the tripledemic was unavoidable.

From the No Surprises Act (NSA) front, the FEHBlog checked out the docket sheet for the second Texas Medical Association versus the federal NSA regulators challenging the revised final rule implementing the NSA’s independent dispute resolution process without giving the revised rule a chance.

The case is at the cross-summary judgment stage. A summary judgment motion asks the Court to decide the case without a trial because the issues presented are entirely legal.

The federal government filed its motion in early November. The FEHBlog knew the AHIP and employee benefit associations subsequently had filed friends of the court/amici briefs supporting the NSA regulators. The FEHBlog was delighted to read that a group of patient/consumer organizations, including “ALS Association, CancerCare, Epilepsy Foundation, Families USA Action, Hemophilia Federation of America, Leukemia & Lymphoma Society, National Multiple Sclerosis Society, United States Public Interest Research Group, Inc., and Cancer Support Community” also filed an amicus brief supporting the NSA regulators. That is an uplifting amici lineup.

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

Amgen Inc. is in advanced talks to buy drug company Horizon Therapeutics PLC. according to people familiar with the matter, in a takeover likely to be valued at well over $20 billion and mark the largest healthcare merger of the year.

The U.S. biotechnology company was the last of three suitors standing in an auction for Horizon, the people said, after French drugmaker Sanofi SA said Sunday it was out of the running.

A deal could be finalized by Monday assuming the talks with Amgen don’t fall apart, the people said.

Horizon develops medicines to treat rare autoimmune and severe inflammatory diseases that are currently sold mostly in the U.S. Its biggest drug, Tepezza, is used to treat thyroid eye disease, an affliction characterized by progressive inflammation and damage to tissues around the eyes.

The company is Nasdaq-listed, but based in Ireland and has operations in Dublin, Deerfield, Ill., and a new facility in Rockville, Md.

Wow-wee.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front, Cyberscoop reports on the highlights of the cybersecurity provisions of the bipartisan National Defense Authorization Act that the House of Representatives passed this week and the Senate is expected to pass next week.

The December 7 FEHBlog quote included the following Roll Call quote:

Also of note, the bill would ban contractors across the government from using Chinese-made semiconductors, after a lengthy phase-in period, an aide with knowledge of the provision said Tuesday. Many federal contractors and other businesses say they are unclear how they will comply.

The Cyberscoop article does not treat this provision as a highlight of the bill. The FEHBlog turned to ComputerWorld, which provides more details on this provision —

While the draft legislation still provides for [Chinese made semiconductor] restrictions to be enacted, contractors now have five years to comply with them, rather than the two years stipulated in an earlier version of the proposal, and the language of the new draft leaves room for waivers to the restrictions under certain circumstances.

Cyberscoop adds

There are a few major exclusions in the combined House and Senate versions, too.

[For example,] FedScoop’s John Hewitt Jones reports that the NDAA left out an amendment to codify a software bill of materials, or SBOM, in the federal procurement process. Lawmakers removed it following strong criticism from industry.

That piece of the legislation would have required “all holders of existing covered contracts and those responding to requests for proposals from the U.S. Department of Homeland Security to provide a bill of materials and to certify that items in the bill of materials are free of vulnerabilities or defects,” Hewitt Jones reported.

Health IT Security tells us

Experts gathered in Boston on December 5 and 6 for the HIMSS Healthcare Cybersecurity Forum to explore topics such as risk quantification, clinical perspectives on cybersecurity, and medical device security.

Speakers included leaders from the Health Sector Coordination Council (HSCC), Northwell Health, Forrester, the Federal Bureau of Investigation, the National Institute for Standards and Technology (NIST), and more.

The presentations collectively showed that healthcare cybersecurity experts are well aware of the risks facing the sector. However, more collaboration, communication, and balance are needed to effectively tackle those risks and emerge stronger as an industry.

The Cybersecurity Infrastructure and Security Agency (CISA) offers a readout from the December 6 meeting of its Cybersecurity Advisory Committee:

[CISA] Director [Jen] Easterly led a discussion with committee members on the CSAC’s strategic focus for 2023.   

“I truly appreciate the caliber of experts who have taken the time to participate in this committee and, moreover, for their continuous work in helping CISA become the Cyber Defense Agency our nation needs and deserves,” said CISA Director Jen Easterly. “I look forward to working with the Committee in the new year to ensure we are continuing to build a more cyber resilient nation to confront the challenges we face in cyber space.”   

“In a time of critical cybersecurity threats, CISA is in a unique position to make a meaningful impact on our Nation’s security,” said the CSAC Chair and Chairman, President & CEO of Southern Company, Tom Fanning. “The Committee members and I look forward to providing strategic recommendations to CISA’s Director Jen Easterly in the coming year to advance CISA’s mission, as they continue to strengthen the cybersecurity posture of the United States.” 

From the cyber vulnerabilities front —

HHS’s Health Sector Cybersecurity Coordinating Center (HC3) released the following documents on this topic:

CISA added one more known exploited vulnerability to its catalog.

Cybersecurity Dive looks back at the log4shell cybersecurity crisis that first gained widespread public attention in December 2021.

One year after the disclosure of a critical vulnerability in the Apache Log4j logging utility, the nation’s software supply chain remains under considerable threat as federal authorities and the information security community struggle to transform how it develops, maintains and consumes applications in a more secure fashion. 

The vulnerability, dubbed Log4Shell, allowed unauthenticated and untrained threat actors to gain control over applications using a single line of code. 

Thus far, many of the initial fears of catastrophic cyberattacks have failed to materialize, but federal authorities warn this constitutes a long-term threat that must be carefully monitored and fully remediated to prevent a major security crisis. 

From the ransomware front —

Cybersecurity Dive reports, “Ransomware attacks shift beyond US borders; U.S.-based organizations remain the top target for ransomware gangs, but the scale of that misfortune is waning, according to Moody’s.” Here’s the Moody report on 2023 Global Cyber Risk.

HC3 released an analyst report on Royal ransomware. “Royal is a human-operated ransomware that was first observed in 2022 and has increased in appearance. It has demanded ransoms up to millions of dollars. Since its appearance, HC3 is aware of attacks against the Healthcare and Public Healthcare (HPH) sector. Due to the historical nature of ransomware victimizing the healthcare community, Royal should be considered a threat to the HPH sector.”

The Bleeping Computer’s Week in Ransomware informs us

This week has been filled with research reports and news of significant attacks having a wide impact on many organizations.

Last week, Rackspace suffered a massive outage on their hosted Microsoft Exchange environment, preventing customers from accessing their email. On Tuesday, Rackspace finally confirmed everyone’s fears that a ransomware attack caused the outage.

However, today [December 9] they began warning customers to be on the lookout for targeted phishing emails and to monitor their credit reports and banking account statements for suspicious activity. This warning could indicate that the ransomware operation likely stole data in the attack.

From the cyber defenses front —

CISA provides us with

a Phishing Infographic to help protect both organizations and individuals from successful phishing operations. This infographic provides a visual summary of how threat actors execute successful phishing operations. Details include metrics that compare the likelihood of certain types of “bait” and how commonly each bait type succeeds in tricking the targeted individual. The infographic also provides detailed actions organizations and individuals can take to prevent successful phishing operations—from blocking phishing attempts to teaching individuals how to report successful phishing operations.

ZDNet also discusses how people can identify and deter phishing attacks.

The National Institute of Standards and Technology issued Special Publication (SP) 1800-34, which offers organizations guidance on verifying that the internal components of the computing devices they acquire are genuine and have not been tampered with.

Friday Stats and More

David Ermer–CDC, COVID-19, Mental health care, OPM, Patient safety, Telehealth–
Photo by Sincerely Media on Unsplash

Based on the Centers for Disease Control’s Covid Data Tracker, the CDC’s weekly interpretation of those new cases, hospitalizations and death statistics shows across-the-board increases. Welcome winter.

New Cases

As of December 7, 2022, the current 7-day average of weekly new cases (65,569) increased 49.6% compared with the previous 7-day average (43,825). A total of 99,241,649 COVID-19 cases have been reported in the United States as of December 7, 2022.

Variant Proportions

CDC Nowcast projections* for the week ending December 10, 2022, estimate the proportion of lineages designated as Omicron with estimates above 1%: BA.5—and four of its sublineages (BQ.1, BQ.1.1, BF.7, and BA.5.2.6)—BA.4.6, and XBB. XBB is a recombinant of two BA.2 sublineages.

The two predominant Omicron lineages and the two that are increasing this week are BQ.1.1, projected to be 36.8% (95% PI 34.1-39.6%) and BQ.1, projected to be 31.1% (95% PI 29.0-33.4%) nationally. All other lineages (BA.5, BF.7, XBB, BN.1, BA.5.2.6, and BA.4.6) are decreasing in proportion this week compared to last.

New Hospitalizations

The current 7-day daily average for November 30–December 6, 2022, was 4,844. This is a 13.8% increase from the prior 7-day average (4,256) from November 23–29, 2022.

New Deaths

The current 7-day average of new deaths (426) increased 61.7% compared with the previous 7-day average (263). As of December 7, 2022, a total of 1,080,472 COVID-19 deaths have been reported in the United States.

CNN adds,

Hospitals are more full than they’ve been throughout the Covid-19 pandemic, according to a CNN analysis of data from the US Department of Health and Human Services. But as respiratory virus season surges across the US, it’s much more than Covid that’s filling beds this year.

More than 80% of hospital beds are in use nationwide, jumping 8 percentage points in the past two weeks.

Hospitals have been more than 70% full for the vast majority of that time. But they’ve been 80% full at only one other point: in January, during the height of the Omicron surge in the US. Back in January, about a quarter of hospital beds were in use for Covid-19 patients. But now, only about 6% of beds are in use for Covid-19 patients, according to the HHS data.

From the Omicron countermeasures front, the weekly interpretation tells us

As of December 7, 2022, 657.9 million vaccine doses have been administered in the United States. Overall, about 228.6 million people, or 68.9% of the total U.S. population, have completed a primary series.* More than 42.0 million people, or 13.5% of the U.S. population ages 5 years and older, have received an updated (bivalent) booster dose.

Medscape adds, “Getting at least one dose of a COVID-19 vaccine decreases the chances of having symptoms beyond 3 weeks or developing long COVID, a new analysis shows.”

The weekly interpretation usually encourages more Covid vaccinations. This week, the interpretation opens by touting the use of Paxlovid, to wit —

As we enter the holiday season, it’s important to take steps to protect yourself and others from serious illness with COVID-19, including staying up to date on COVID-19 vaccines and promptly talking to your healthcare provider about treatment options if you test positive for COVID-19.

If you have COVID-19 symptoms:

Test : Use a self-test, locate a test site, or find a Test to Treat location.

Talk: If you test positive, talk to a healthcare professional to determine if you are eligible for treatment, even if your symptoms are mild right now.

Treat: Start treatment within five days of developing symptoms.

Note to Readers: Paxlovid is not a replacement for COVID-19 vaccination. COVID-19 vaccination makes you much less likely to get very sick. Still, some vaccinated people, especially those ages 65 years or older or who have other risk factors for severe disease, may benefit from treatment if they get COVID-19. A healthcare provider will help decide which treatment, if any, is right for you.

That’s the full picture for most folks. Here’s the “real-world data” link if you are interested. Thank you CDC.

Here are the key points from this week’s CDC FluView:

  • Seasonal influenza activity is high across the country.
  • Of the influenza A viruses detected and subtyped during week 48, 76% have been influenza A(H3N2), and 24% have been influenza A (H1N1).
  • Seven influenza-associated pediatric deaths were reported this week, for a total of 21 pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 13 million illnesses, 120,000 hospitalizations, and 7,300 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 48 during every previous season since 2010-2011.
  • The number of flu hospital admissions reported in the HHS Protect system increased during week 48 compared to week 47.
  • The majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.
  • All viruses collected and evaluated this season have been susceptible to influenza antivirals.
  • An annual flu vaccine is the best way to protect against the flu. Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with the flu.
  • CDC recommends that everyone ages 6 months and older get a flu vaccine annually. Now is a good time to get vaccinated if you haven’t already.
  • There are also prescription flu antiviral drugs that can be used to treat flu illnesses. It’s very important that flu antiviral drugs are started as soon as possible to treat patients who are hospitalized with flu, people who are very sick with flu but who do not need to be hospitalized, and people with flu who are at higher risk of serious flu complications based on their age or health.
  • Multiple respiratory viruses are currently co-circulating with influenza.  Testing is important to determine the appropriate treatment.

From the FEHB front, the FEHBlog was bowled over to discover on reginfo.gov that on November 29, the Office of Personnel Management took a major step forward in implementing the Postal Service Health Benefits Program by submitting a draft interim final rule to OMB’s Office of Information and Regulatory Affairs for its review. This is the final step before the rule is published in the Federal Register. The statutory deadline for so promulgating this rule is April 8, 2023.

From the miscellany department

  • HR Dive discusses a Mercer report on how employers can impact the maternal mortality problem.
    • EBRI offers a useful analysis of telemedicine and its relationship with other healthcare services, enrollee health, and costs.
    • Chain Drug News reports that PCMA, the prescription drug manager trade association, has issued policy recommendations to accelerate patient biosimilar drug use.
    • The Wall Street Journal offers encouraging news about prison programs to resolve inmate addiction issues.

    Two-thirds of people entering prisons and jails have what the Department of Health and Human Services diagnoses as substance-use disorder. For years, the only treatment in all but a handful of detention centers was to detox.

    Some 630 of the roughly 5,000 jails and prisons nationwide now provide medication treatment for opioid use, according to the nonprofit Jail and Prison Opioid Project, up from about 20 in 2015. The drugs include buprenorphine, which tamps cravings for opioids, naloxone, which reverses their effects, and methadone, which eases withdrawal symptoms. Some are taken daily, others can be taken once a month in extended-release versions. The Biden administration said it wants medication available for every drug user in federal custody and at half of state prisons and jails by 2025.

    Thursday Miscellany

    David Ermer–Congress, COVID-19 vaccine, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From Capitol Hill, the Wall Street Journal reports

    A top Senate Democrat said that his party planned to introduce an omnibus spending bill Monday, aiming to pressure Republicans to accept a deal or risk an alternative that would freeze government spending at current levels for the full year and cut off the ability to reallocate money in military and other programs.

    Senate Appropriations Committee Chairman Patrick Leahy (D., Vt.) said that the measure would provide military funding at the level Congress is authorizing in its separate defense policy bill—some $858 billion, or roughly a 10% increase—while also paying for what he called a needed increase to nondefense programs.

    “This is a reasonable path forward, and I suggest my Republican friends take it,” Mr. Leahy said. * * *

    If no deal is reached as the end of the year approaches, lawmakers have said they might need to fall back to a so-called continuing resolution, which funds the government at current levels. Various lawmakers have floated stretching funding into early 2023 or for the full fiscal year, which ends in September. 

    The path forward was unclear, as neither House Speaker Nancy Pelosi (D., Calif.) nor Senate Majority Leader Chuck Schumer (D., N.Y.) announced votes on an omnibus bill for next week.

    The Journal adds,

    House lawmakers on Thursday passed a defense policy bill [discussed in yesterday’s FEHBlog post] that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. * * * The legislation is expected to pass the Senate by the end of next week before heading to President Biden’s desk for his signature.

    STAT News tells us

    Key decision makers in Congress are closer than they’ve been in years to revamping the way the government regulates some of the diagnostic tests that patients use to make crucial decisions about their health care [due to the Theranos fiasco].

    If the VALID act passes, the FDA wouldn’t regulate every single clinical test, but only tests considered “high risk” to patients, where the risk to patients of an inaccurate result could cause serious or irreversible harm.

    One example would be a test for breast cancer that could lead a patient to have a mastectomy, Boiani said. Another would be a genetic test that could determine which cancer treatment patients receive, said Jeff Allen, the president and CEO of Friends of Cancer Research.

    From the Federal Employee Benefits Open Season front, Tammy Flanagan writing in Govexec and Drew Friedman writing in Federal News Network offer last minute decision-making tips.

    Investment News provides advice on income adjusted Medicare premium issues.

    Most Medicare beneficiaries will pay the standard Part B premium of $164.90 per month in 2023, down slightly from this year’s monthly premium of $170.10. Medicare Part B covers doctors’ fees and out-patient services. Coupled with a huge 8.7% cost-of-living adjustment in Social Security benefits next year, most retirees will enjoy larger monthly net Social Security benefits after automatic deductions for their Part B premiums in 2023.

    But about 8%, or about 5 million, of the nearly 63 million Medicare beneficiaries will pay more than the standard monthly premium for both Part B and Part D prescription drug plans based on their income. My husband and I are among them.

    For 2023, single beneficiaries with incomes of $97,000 or more and married couples with joint incomes of $194,000 or more pay a Medicare premium surcharge, officially known as an income-related monthly adjustment amount, or IRMAA. The thresholds increased from $91,000 and $182,000, respectively, in 2022, meaning some beneficiaries may avoid IRMAA surcharges altogether in 2023 or pay less than this year due to the inflation adjustments of the income tiers that trigger those surcharges.

    In other health benefits news, Insurance News Net informs us

    The average per-employee cost of employer-sponsored health insurance rose by 3.2% in 2022, according to Mercer’s 2022 National Survey of Employer-Sponsored Health Plans, released today.

    US employers expect a sharper increase of 5.4% in 2023 — and faster cost growth in the years ahead seems likely

     For now, most employers are prioritizing enhancing benefits to attract and retain workers over cost-cutting; enhancements range from adding perks to improving healthcare affordability

     Mental health remains a top concern of employers and employees – and virtual mental healthcare is proving key to improving access to services

    From the Rx development and coverage front, we have three reports from STAT News —

    • Well, this government action didn’t take long. STAT News relates “The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.”
    • Also according to STAT News, “A year ago, the [Purchaser Business Group on Health] coalition created Emsana Health that, in turn, hatched the EmsanaRx pharmacy benefit manager. [Beginning March 1, 2023,] EmsanaRx will run the technology to ensure prescriptions handled by Cuban Cost Plus Drugs are paid and fulfilled, and report all this information back to the [self-funded] employer. In exchange, EmsanaRx will take a flat 1.5% fee for legal, administrative, and data sharing services, but not charge more than $3 for each insurance claim and will pass along any rebates collected.”
    • Finally from STAT News, “Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, according to the official who oversees the program. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, administrator for the Centers for Medicare and Medicaid Services, said Thursday at the Milken Institute Future of Health Summit when asked about how the agency will approach lecanemab. “We will look at it as new data comes.”

    From the public health front —

    An outside group [the Reagan Udall Foundation] that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. * * *

    In a statement, FDA Commissioner Robert M. Califf said he will review the report and make decisions about the future of the agency with input from experts inside and outside the FDA.

    • The Congressional Research Service issued an “In Focus” report on “Regulating Reproductive Health Services After Dobbs v. Jackson Women’s Health Organization.”
    • Health Payer Intelligence tells us

    Overall, major health outcomes measures are trending in a negative direction, according to America’s Health Rankings Annual Report for 2022.

    The Annual Report examines 23 measures to assess health outcomes trends nationwide, including measures for eight chronic conditions. The data for these measures primarily represented 2021 outcomes, but some measures drew from 2018, 2019, 2020, and 2022.

    A Morning Consult online survey conducted in October 2022 informed the results as well as racial and ethnic subpopulation data and a total of 80 national and state measures to assess the state of healthcare in the US.

    Based on the findings, the coronavirus pandemic has continued to have ripple effects on healthcare. The top three major trends in health outcomes are:

    • Increased drug deaths
    • Increased non-medical drug use
    • Increased premature death