Happy New Year 2023

David Ermer

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

Happy New Year 2023

David Ermer–ACA, Congress, COVID-19, OPM–

NPR shares its favorite articles with “actionable, evidence-based strategies for cultivating a healthy body and mind.”

Fortune Well identifies “six foods and drinks to choose in the New Year to improve mood, energy, and longevity” and discusses the differences between dry January and damp January.

The American Medical Associations tells us about what doctors wish their patients knew about effective New Years resolutions.

From Capitol Hill, the Wall Street Journal reports

A new era of divided government dawns this week as the 118th Congress begins, with Republicans looking to deploy their power with a fragile majority in the House and Democrats doing the same in the Senate.

The House of Representatives will convene on Tuesday, a date designated by the 20th Amendment of the U.S. Constitution that stipulates Congress should begin each new session at noon on Jan. 3.

The first order of business will be electing a new Speaker. The last time that the election went beyond one ballot was one hundred years ago, but the streak could be broken tomorrow as Roll Call explains.

The Senate whose leadership is not changing will hold a routine opening day tomorrow.

No Congressional Committee hearings will be held this week.

From the Omicron and siblings front, NBC News and Forbes each offer detailed looks at the latest dominant Omicron variant XBB and XBB 1.5. NBC News states

“It’s clear that there’s immune evasive properties of XBB,” said Dr. Isaach Bogoch, an infectious disease physician and epidemiologist at the University of Toronto. “That’s been demonstrated both in laboratory studies and seen clinically in cases and hospitalizations.” 

Given the high level of population immunity in the U.S. — either through infection, vaccination or both — Bogoch and others hope that, even if cases start to rise significantly, there won’t be a dramatic spike in hospitalizations or deaths as seen in previous waves. 

Antibody studies don’t tell the whole story. Other parts of the immune system can protect against the virus and the Covid vaccines should remain effective at preventing severe illness and death from the virus, evidence suggests.

From the FEHB front, the Postal Service’s Inspector General released a “primer” on the 2022 Postal Reform Act, which requires a new Postal Service Health Benefits Program to be launched in two years.

From the Affordable Care Act marketplace, Health Payer Intelligence informs us

Affordable Care Act (ACA) marketplace enrollment has grown 18 percent from last year, with 11.5 million people signing up for coverage as of December 15, 2022, HHS announced.

“Unprecedented investments lead to unprecedented results. Under President Biden’s leadership, we have strengthened the Affordable Care Act Marketplace with continued record affordability, robust competition, and historic outreach efforts – and today’s enrollment numbers reflect that,” HHS Secretary Xavier Becerra said in the press release. * * *

“Thanks to the Inflation Reduction Act, four out of five customers will be able to find a plan for $10 or less. As we head into the new year, there is no greater gift than the peace of mind that comes with having high-quality, affordable health care. There is still time to sign up until January 15 – visit HealthCare.gov today,” Becerra added.

Cybersecurity Saturday

David Ermer–Cybersecurity–

The Wall Street Journal reports on Chief Information Officer cybersecurity priorities for 2023:

At Cisco Systems Inc., CIO Fletcher Previn said the company is focusing on addressing cyber threats for a remote and in-office workforce, where “we might have video games and smart thermostats on the same network segment as an employee’s remote workplace.”

That means the networking-equipment maker is adopting a zero-trust architecture, as well as practices like two-factor authentication, investing in network automation, and application scanning, Mr. Previn said.

“The threat landscape has become more challenging and our networks more porous,” Mr. Previn said. “All it takes is one slip-up or letting your guard down for a minute for an adversary to get in.”

The Journal also lists CIO favorite reads in 2022.

Health IT Security “spoke with a variety of industry leaders who shared their healthcare cybersecurity and privacy predictions for the upcoming year.”

The experts suggested that in order to maintain cybersecurity and patient privacy, organizations will have to continue to adapt and enhance existing security practices to combat ongoing cyber threats.

However, positive regulatory changes may be on the horizon, and the lasting effects of the pandemic have shown that the sector is more than willing to pivot its strategies and remain resilient amid constant challenges.

The Cybersecurity Infrastructure Security Agency added two more known exploited vulnerabilities to its catalog.

Health IT Security also reminds us

Improper disposal of protected health information (PHI) can result in HIPAA violations, Office for Civil Rights (OCR) investigations, and hefty fines. * * *

Fortunately, HHS maintains a great deal of guidance on the proper and improper ways to dispose of physical records and electronic PHI as required under the HIPAA Privacy and Security Rules.

Happy New Year!

Friday Stats and More

David Ermer–CDC, COVID-19, FDA, No Surprises Act, OPM, Rx coverage–
Photo by Sincerely Media on Unsplash

The CDC’s Covid Data Tracker for the week ended December 29, 2022, informs us:

  • New Covid cases totaled 402,525, down 84,000 cases from the previous week.
  • The daily average of new Covid hospital admissions was 5,,668 up 3.7% from the previous week.
  • New Covid deaths totaled 2,530, down 400 deaths from the previous week.
  • 17.3% of the U.S. population aged 18 and older and 37.5% of the U.S. population aged 65 and older have received the bivalent booster.

The CDC’s weekly Fluview tells us

  • Seasonal influenza activity remains high but continues to decline in most areas.
  • Of influenza A viruses detected and subtyped during week 51, 83% were influenza A(H3N2) and 17% were influenza A(H1N1).
  • Fourteen influenza-associated pediatric deaths were reported this week, for a total of 61 pediatric flu deaths reported so far this season.
  • CDC estimates that, so far this season, there have been at least 20 million illnesses, 210,000 hospitalizations, and 13,000 deaths from flu.
  • The cumulative hospitalization rate in the FluSurv-NET system was more than 4 times higher than the highest cumulative in-season hospitalization rate observed for week 51 during previous seasons going back to 2010-2011. However, this in-season rate is still lower than end-of-season hospitalization rates for all but 4 pre-COVID-19-pandemic seasons going back to 2010-2011.
  • The number of flu hospital admissions reported in the HHS Protect system decreased nationally from the week prior for the third week in a row.

From the No Surprises Act front, STAT News reports

Health care providers are swamping the government with billing disputes under the new law that bans surprise medical bills. So far, just 4% have ended in payment. 

That’s according to the Biden administration’s progress report on the No Surprises Act’s so-called independent dispute resolution (IDR) process, in which mediators help out-of-network providers and insurers decide appropriate payment amounts for services. So far, the government is fielding a much higher volume of requests than expected, mostly related to emergency services. Health care providers, air ambulance providers, and companies working for them submitted about 90,000 out-of-network payment disputes between April 15 and Sept. 30, far more than the roughly 17,000 anticipated in a full year. 

Also exceeding expectations is the complexity of the cases and the time it’s taking to reach resolutions, which has led to a severe backlog of disputes awaiting resolution. Of the roughly 23,000 cases closed so far, mediators made payment determinations in about 3,600 — 4% of the 90,000 submissions.

In the FEHBlog’s opinion, providers and payers should focus on resolving cases at the initial open negotiation phase. Last week, the NSA regulators announced that the administration cost for one arbitration would increase from $50 to $350 per party, which should encourage payers and providers to reach the FEHBlog’s conclusion.

From the public health front, the Hill relates according to a new CDC report

  • About 526,000 young Americans could have both Type 1 and Type 2 diabetes by 2060, up from 213,000 in 2017 
  • The expected surge is alarming health officials, who say the increase will disproportionately affect minority populations.
  • A potential factor behind the trend could be an increase in childhood obesity.

These statistics place in context this STAT News story titled “Wegovy [Novo Nordisk’s latest obesity drug] may help teens with obesity lose weight but isn’t a magic bullet.”

“I’m concerned that doctors are going to rush to judgment and employ a medication that is very expensive and has its own side effects without giving proper consideration of what the actual cause of the problem is,” said Robert Lustig, professor emeritus of pediatrics at the University of California, San Francisco. Wegovy costs more than $1,300 per month and can cause nausea, vomiting, and rare cases of pancreatitis.

Lustig said each teen’s obesity is caused by different genetic, environmental, and behavioral factors and requires tailored treatment. He worries that widespread use of Wegovy could lead physicians to overlook the root causes of an individual’s condition.

“Treating the downstream symptoms of the problem is only putting a Band-Aid on the problem, it’s not fixing the problem,” Lustig said. “I’m worried that Wegovy is a Band-Aid.”

Since Wegovy, Saxenda, and other drugs are meant to be taken over the long term to maintain weight loss — potentially the rest of an individual’s life — teenagers would be on the medication for an especially long time, and there isn’t yet information on the effects of the drug over that time span, Lustig added.

The FEHBlog did not realize that these are long-term drugs.

In other Rx coverage news, the Food and Drug Administration on Wednesday

approved Briumvi (ublituximab-xiiy) injection for treating patients with relapsing forms of multiple sclerosis (RMS) in adults. Researchers demonstrated Briumvi’s efficacy in two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either Briumvi or teriflunomide, the active comparator. The primary outcome of both studies was the annualized relapse rate (ARR) over the treatment period. In both studies, Briumvi significantly lowered the ARR compared to teriflunomide. The most common adverse reactions were infusion reactions, including fever, chills, headache, influenza-like illness, elevated heart rate, nausea, throat irritation, reddening of the skin (erythema) and an anaphylactic (allergic) reaction; infections including serious and fatal bacterial, fungal, and new or reactivated viral infections and reduction in immunoglobulins.

From the miscellany department

  • Govexec reports on the Postmaster General’s plans for next year.
  • Milliman suggests “how to understand and impact health plan administrative expenses.”
  • The New York Times Morning column provides good year-end news: After spiking in 2020 and 2021, murders in large U.S. cities had decreased more than 5% this year and gun deaths, injuries, and mass shootings are also down this year. The Times attributes the drop to Covid’s transition to endemic status.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, FDA, Rx coverage, Uncategorized–
Photo by Josh Mills on Unsplash

The Washington Examiner reports that “President Joe Biden signed the nearly $2 trillion omnibus spending bill into law Thursday night while vacationing in St. Croix.”

The New York Times relates,

The Food and Drug Administration’s process for approving the Alzheimer’s drug Aduhelm, despite great uncertainty about whether it worked, was “rife with irregularities,” according to a congressional investigation released on Thursday. The agency’s actions “raise serious concerns about F.D.A.’s lapses in protocol,” the report concluded.

The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documentsshowed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found.

STAT News seconds the Times report:

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

STAT News also presents eight key takeaway‘s from the Congressional report on Aduhelm’s approval and reports

Pfizer said Thursday that its experimental gene therapy for hemophilia B significantly reduced the number of bleeds patients experienced over a year. 

Data from the 45-patient trial could set the stage for a second gene therapy to be approved for patients with the rare and serious bleeding disorder in as many years. In November, UniQure won approval for Hemgenix, the first hemophilia B gene therapy. 

“The results from this long-awaited study are great news for hemophilia B patients that soon may have access to a second durable treatment option,” Luk Vandenberghe, a gene therapy expert at Harvard, said in a text message, after reviewing the results. 

Looking toward next year, STAT News discusses “three things to watch in chronic disease in 2023: obesity drugs, long Covid and health care costs.”

Consider the already-astronomical cost of chronic disease care in the United States: trillions of dollars devoted to diabetes, heart disease, kidney disease, cancer and other conditions, and still so many people unable to access necessary care and treatments. Consider the strain of Covid on the health care system, the decimation of public health staffing, and the scarcity of health care workers — and how all these costs make their way to patients. What bold moves can be made in 2023 to help reduce the cost of care? We’ll see.

Also, from the healthcare cost front, Beckers Hospital Review looks into “Questions about hospitals’ culture, leadership, survival and opportunity come with a trillion-dollar price tag given the importance of hospitals and health systems in the $4.3 trillion U.S. healthcare industry.” 

From the public health front, the Wall Street Journal reports

A measles outbreak among mostly unvaccinated children in Ohio that local health officials feared could take months to control has slowed in the past week, giving hope that what was expected to be a lengthy battle could be cut short.

The total number of cases since the outbreak began in November reached 82 on Thursday, but new cases have fallen off significantly in the last seven days or so, said Mysheika Roberts, Health Commissioner for the city of Columbus.

“It could be much worse,” Dr. Roberts said Thursday. “I’m hoping due to our outreach in the community, and the community’s willingness to roll up their sleeves and get vaccinated, that we might be starting to see the end of this. But obviously, it’ll take several weeks and days before we’ll know if this is actually over.”

From the Rx coverage front, Medscape tells us

Merck & Co Inc’s COVID antiviral molnupiravir speeds up recovery but does not reduce the hospitalisation or death rate in higher-risk vaccinated adults, detailed data from a large study showed on Thursday. * * *

When Merck originally tested molnupiravir, it was found 30% effective in reducing hospitalisations, but that was in unvaccinated patients.

In the latest study, led by University of Oxford researchers, nearly all of the more than 25,000 patients in the study had received at least three vaccine doses.

These results demonstrate that vaccine protection is so strong that there is no obvious benefit from the drug in terms of further reducing hospitalisation and deaths, said study co-author Jonathan Van-Tam from the University of Nottingham.

The drug was, however, effective in reducing viral load and can help hasten patient recovery by roughly four days, researchers estimated based on study data. 

In interesting social news,

About 2.6 million couples are saying “I do” this year [2022] — roughly 600,000 more than in prepandemic years, according to The Knot, a company that offers wedding-planning tools, a vendor marketplace and a gift-registry platform. 

The wedding boom is the byproduct of two years of the pandemic, when many ceremonies were postponed or pared down, says Lauren Kay, executive editor of The Knot. And ceremonies this year have a whole new vibe. Now, “people feel empowered to personalize, push the envelope—rules are out the window,” Mrs. Kay says. * * *

This year, “weddings are back, and people are excited to celebrate,” Mrs. Kay says. In 2023, weddings in the U.S. will likely return to prepandemic levels at 2.1 million, according to internal research from The Knot.

  • The Washington Post looks into “Why do people like being tipsy? Here’s how alcohol affects the brain. The buzz produced by alcohol comes from a cocktail of pharmacology and social ingredients, research shows.” The article also discusses how to enjoy alcoholic beverages responsibly.

Finally, the Department of Health and Human Services announced

a Notice of Proposed Rulemaking (NPRM), entitled Safeguarding the Rights of Conscience as Protected by Federal Statutes, which proposes to restore the longstanding process for the handling of conscience complaints and provide additional safeguards to protect against conscience and religious discrimination. * * *

Public comments on the NPRM are due 60 days after publication of the NPRM in the Federal Register.

The NPRM may be viewed here: https://www.hhs.gov/sites/default/files/conscience-rule-nprm.pdf – PDF

Midweek update

David Ermer–ACA, CDC, NIH, Telehealth–
Photo by JOSHUA COLEMAN on Unsplash

Mercer Marsh Benefits presents the top five trends from its 2023 employer-sponsored health plan survey of 225 insurers located in 56 countries:

  1. Per-person medical cost increases are back to pre-pandemic levels. 68% of insurers expect plan sponsors to prioritize improvements. This is even though double-digit medical cost increases are forecast for some markets.
  2. COVID-19 continues to impact the claims experience. 55% of insurers report an increase in the later-stage illness diagnosis due to deferred care.
  3. Plan modernization has begun. To make coverage more inclusive for those who identify as LGBTQ+, one in two insurers have changed or expect to change eligibility requirements and eligible expenses.
  4. The mental health gaps persist. 16% of insurers report not providing plans that cover mental health services (versus 26% in 2022).
  5. Plan management requires greater rigor. More than one in five insurers in Asia are adjusting their medical plan premiums based on an individual’s COVID-19 vaccination status.

All five main points ring true, but the prime examples for the fourth and fifth points don’t fit the FEHB market.

The American Medical Association points out six often overlooked steps to better health while Rebecca G. Baker, Ph.D., the director of the NIH HEAL Initiative® looks back at a virtual stakeholder briefing to visit the initiative’s progress in resolving chronic pain and opioid misuse issues and to describe future plans. 

From the public health front, the New York Times reports about

a large study published on Tuesday found a surprising trend among adolescents who repeatedly visited the hospital. The patients most likely to reappear in emergency rooms were not patients who harmed themselves, but rather those whose agitation and aggressive behavior proved too much for their caregivers to manage.

In many cases, repeat visitors had previously received sedatives or other drugs to restrain them when their behavior became disruptive. * * *

The results suggest that researchers should focus more attention on families whose children have cognitive and behavioral problems, and who may turn to emergency rooms for respite, Dr. [Anna] Cushing [an author of the study] said.

“I’m not sure we’ve been spending as much time talking about these agitated and behaviorally disregulated patients, at least on a national scale,” she said.

The JAMA study found that overall visits to pediatric emergency rooms for mental health crises increased 43 percent from 2015 to 2020, rising by 8 percent per year on average, with an increase in emergency visits for every category of mental illness. By comparison, emergency room visits for all medical causes rose by 1.5 percent annually.

Nearly one-third of visits were related to suicidal ideation or self-harm, and around one-quarter of patients presented with mood disorders, followed by anxiety disorders and impulse control disorders. Around 13 percent of patients made a repeat visit within six months.

From the telehealth front, Axio informs us

There are few things more stressful than getting a serious medical diagnosis, but pandemic-era changes in virtual care are prompting more patients to obtain a second opinion without leaving home.

Why it matters: The telehealth explosion made it easier to get advice from top doctors across the country — and for health systems to grow business beyond their physical footprints and even treat some of the people seeking consultations.

Case in point: The Clinic, a joint venture between Cleveland Clinic and telehealth giant Amwell, launched in 2020 just before the pandemic began.

The idea was to pair the Cleveland Clinic brand with Amwell’s virtual tools and its existing connections with private insurers to make it easier for patients to get their records reviewed, said Frank McGillin, CEO of The Clinic.

In litigation news, Health Payer Intelligence relates

A United States district court has ruled against Blue Cross Blue Shield of Illinois (BCBSIL), stating that the payer cannot exclude coverage for medically necessary gender-affirming care in its employer-sponsored ERISA health plans.

Lambda Legal and Sirianni Youtz Spoonemore Hamburger PLLC filed a class action lawsuit against BCBSIL on behalf of a 17-year-old transgender man, CP, and his parents. According to the lawsuit, the payer administered discriminatory exclusions of gender-affirming care, violating the anti-discrimination of the Affordable Care Act (ACA), known as Section 1557. * * *

The court determined that BCBSIL is a “health program or activity” that receives federal funds and thus cannot discriminate based on race, national origin, sex, age, or disability in its role in administering ERISA health plans.

From inside the Beltway, Govexec reports

The White House released a plan on Wednesday for how the Biden administration seeks to foster a more open and accountable government.

Transparency is something for which many presidential administrations strive, but success can be elusive, as shown during the Obama and Trump presidencies. Nevertheless, the almost-two year old Biden administration unveiled its first and the fifth overall U.S. Open Government National Action Plan, shared exclusively with Government Executive ahead of its release. This builds on many of the Biden administration’s efforts, including the president’s management agenda. 

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, the National Rural Healthcare Association trumpets the “big rural health advocacy wins in FY23 appropriations bill” that the President will be signing this week. Notably —

Given the devastating outcome of COVID-19 in rural areas, NRHA has been committed to working with Capitol Hill to see an Office of Rural Health created at the Centers for Disease Control and Prevention (CDC). Included in the FY 2023 appropriations bill was $5 million to establish an Office of Rural Health at CDC. The text dictates that the ORH will enhance implementation of CDC’s rural health portfolio, coordinate efforts across CDC programs, and develop a strategic plan for rural health that maps the way forward both administratively and programmatically. This is a massive victory for rural health, and NRHA is looking forward to working with CDC to see this stood up quickly, to ensure rural representation in America’s public health infrastructure.

$3.45 billion for the Rural Community Facilities Program and $2 million for the Rural Hospital Technical Assistance Program through the United States Department of Agriculture Rural Development (RD) programs. 

From the public health front –

  • Beckers Hospital Review tells us

Omicron subvariant XBB is encroaching on BQ.1 and BQ.1.1’s dominance, CDC data shows, as it accounts for 18.3 percent of U.S. cases and makes up more than 1 in 2 infections in the Northeast. 

Subvariants BQ.1 and BQ.1.1, which became the nation’s most pervasive strains in November, are on the decline. 

The FDA began tracking XBB on Nov. 28. The subvariant is a fusion of two other omicron subvariants, BA.2.10.1 and BA.2.75, and it caused a wave of cases in Singapore. Eric Topol, MD, founder and director of Scripps Research Translational Institute in San Diego, wrote Dec. 23 that XBB mutation XBB.1.5 “has the most growth advantage vs. BA.5,” which was causing most COVID-19 cases for months. 

  • Beckers also reports, “The CDC issued a health advisory on Dec. 22 to alert the medical community of a rise in severe strep A infections among children. * * * Read the full advisory and provider recommendations here.”

From the U.S. healthcare business front, the Wall Street Journal challenges non-profit hospital business practices which fail to help the needy.

Many of the nation’s largest nonprofit hospital systems, which give aid to poorer communities to earn tax breaks, have been leaving those areas and moving into wealthier ones as they have added and shed hospitals in the last two decades. 

As nonprofits, these regional and national giants reap $8.8 billion from tax breaks annually, by one Johns Hopkins University researcher’s estimate. Among their obligations, they are expected to provide free medical care to those least able to afford it.

Many top nonprofits, however, avoid communities where more people are likely to need that aid, according to a Wall Street Journal analysis of nearly 470 transactions. As these systems grew, many were more likely to divest or close hospitals in low-income communities than to add them. * * *

Ascension was the most active deal maker in the Journal’s review. Through deals involving 93 hospitals over the past 20 years, Ascension has grown into one of the largest U.S. systems, with $28 billion in revenue and $19.5 billion in cash reserves in its most recent fiscal year, ended June 30.

Among the hospitals Ascension pruned as it grew were those serving some of the poorest neighborhoods of Washington, D.C., and Chicago.

Local elected officials said that when a system exits a market, it can be difficult for remaining facilities to serve the community.

The Journal also questions online advertising for prescription drugs by certain telehealth companies.

In an advertisement on Facebook and Instagram, a middle-aged man holding a dumbbell says testosterone “literally changed my life,” restoring his energy and happiness.

What the October ad from telehealth startup Hone Health doesn’t say is that the unidentified man is an actor who has never used the prescription drug. It doesn’t mention that testosterone is approved by the Food and Drug Administration only for men with specific disorders and that among its risks are heart attacks and stroke.

Similar telehealth companies are flooding TikTok, Instagram and other platforms with ads that don’t conform to longtime standards governing the marketing of prescription drugs and healthcare treatments. They feature actors posing as customers, tout benefits of drugs with no mention of side effects and promote medications for uses not approved by the FDA.

In the two years since the government expanded the scope of medical services allowed via video calls, telehealth companies have been operating largely outside advertising rules that govern drugmakers, a gray area subject to little government oversight or guidance. Instead, the main gatekeepers exercising the power to review or remove telehealth advertising are the social-media giants paid to run the ads.

Boxing Day Update

David Ermer–Congress, FDA, OPM, Rx coverage–

Congress is on a State / District work break until January 3, 2023, when the 118th Congress convenes.

Govexec informs us

President Biden on Friday issued an executive order implementing his plan to provide federal civilian employees with an average 4.6% pay raise in January.

As proposed in his fiscal 2023 budget plan last March, the raise provides federal workers with a 4.1% across-the-board raise to basic pay, as well as an average 0.5% increase in locality pay. * * *

The Office of Personnel Management now must publish pay tables outlining the pay raise across all General Schedule pay grades and locality pay areas. Once updated, they will be available on the OPM website. The pay raise will go into effect for the first full pay period of 2023.

From the public health front —

  • The Wall Street Journal spoke with ear, nose, and throat specialists about they treat their own flu and colds.
  • McKinsey Consulting suggests the secret to great health is escaping the healthcare matrix. “The blueprint for achieving a lifetime of great health is increasingly clear and within our control. But unlocking it requires challenging the orthodoxies currently guiding individuals and institutions.”

From the Rx coverage front —

  • The Wall Street Journal delves into health plan strategies for covering million-dollar-plus gene therapies.

A pharmaceutical nonprofit was granted priority review from the Food and Drug Administration to make an inexpensive overdose-reversal drug for use without a prescription. 

Harm Reduction Therapeutics Inc. said its 3 milligram nasal spray naloxone formulation, called Rivive, had three times higher concentration in the blood of 36 participants than naloxone delivered as a shot. The company said Monday that the FDA gave it a target approval date of April 28. The FDA declined to comment.

HRT said it would give away one-tenth of its product and sell the rest to pharmacies, public-sector employees and groups that work with drug users at-cost, about $18 a dose. HRT said it plans to produce 2 million doses a year.  * * *

Emergent BioSolutions Inc., maker of the Narcan brand of naloxone nasal spray, said earlier this month that its application for over-the-counter status had received an expected approval date of March 29. The company’s two-dose prescription-only nasal spray was selling at pharmacies recently at a cash price of more than $100 without insurance.

Pocket Naloxone Corp. is applying for a nasal-swab version of the drug it said would be cheaper than nasal-spray versions. The startup said earlier this month that it submitted results to the FDA showing that its drug works more quickly than prescription versions. * * *

Other nonprofits are also working to lower drug prices. Civica Rx, a nonprofit founded in 2018, introduced a cancer drug this year with a recommended price of $171 a month versus more than $3,000 a month without discounts for an older version charged to patients on Medicare Part D. Medicines360, a women’s health group, developed a hormonal intrauterine birth-control device it said it sells to safety-net clinics for $100, about a 90% discount.

Cybersecurity Saturday

David Ermer–Cybersecurity–

The American Hospital Association informs us

The Healthcare Cyber Communications Center, FBI, Cybersecurity & Infrastructure Security Agency and National Security Agency in December warned of new ransomware strains and other cyber threats targeting health care.

  • The FBI and CISA warned of the “Cuba” Ransomware threat.
  • HC3 warned of the Royal ransomware threat.
  • HC3 warned that a new ransomware strain known as Blackcat was also targeting health care and appeared to be the successor of the notorious Russian speaking REvil ransomware gang.
  • HC3 also warned of the latest version of the LockBit ransomware, known as LockBit 3.0. The LockBit “ransomware as service” in its various forms has targeted health care since 2019.
  • The NSA advised of an advanced persistent threat known as APT5, which may be affiliated with the Chinese government, targeting the Citrix Application Delivery Controller which then provides the adversary broad network access.

“Our cyber adversaries believe we may pause for the holidays, which may result in their increased targeting of hospitals and health systems as we have seen around past holidays,” said John Riggi, AHA national advisor for cybersecurity and risk. “But our hospitals never close and our network defenders never cease their vigilance.

Cybersecurity Dive provides guidance on the same topic.

Health IT Security reports

HITRUST plans to release version 11 of its cybersecurity framework (CSF) in January with new and improved features for managing emerging cybersecurity threats and reducing certification efforts, the organization announced.

As previously reported, HITRUST can help healthcare organizations improve their security postures and manage third-party risk. The HITRUST CSF is a risk and compliance-based framework that aims to provide structure and guidance across a variety of data privacy and security regulations and standards, helping organizations reduce burden and complexity.

Specifically, CSF v11 offers improved control mappings and precision in order to reduce certification efforts by 45 percent. In addition, the new version “enables the entire HITRUST assessment portfolio to leverage cyber threat-adaptive controls that are appropriate for each level of assurance.”

CSF v11 also includes expanded authoritative sources, including the National Institute of Standards and Technology (NIST) SP 800-53, Rev 5, and the Health Industry Cybersecurity Practices (HICP) standards.  

HITRUST also developed artificial intelligence-based standards development capabilities to assist its assurance experts in mapping and maintaining authoritative sources. HITRUST said that this AI-based toolkit will reduce maintenance and mapping efforts by up to 70 percent.

In event news, CMS announced

The National Standards Group (NSG), on behalf of the Department of Health and Human Services (HHS), issued a Notice of Proposed Rulemaking (NPRM) CMS-0053-P. The proposed rule, if finalized, would make a regulatory change that would implement requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Patient Protection and Affordable Care Act (Pub. L. 111-148).

This webinar will provide a public forum for CMS to hear feedback on the proposed rule. The call will cover the following topics:

• Background on the current standards
• What the proposed rule would do
• How to submit comments on the proposed rule

Note: Feedback received during this call is not a substitute for formal comments on the rule. See the proposed rule for information on submitting comments.

This free webinar will be held on January 25, 2023, at 2 pm ET. You can register here.

From the vulnerabilities front, the Healthcare Sector Cybersecurity Coordination Center issued an Analyst Note last Thursday. According to the Executive Summary:

HC3 is closely tracking hacktivist groups which have previously affected a wide range of countries and industries, including the United States Healthcare and Public Health (HPH) sector. One of these hacktivist groups—dubbed ‘KillNet’—recently targeted a U.S. organization in the healthcare industry. The group is known to launch DDoS attacks primarily targeting European countries perceived to be hostile to Russia, and operates multiple public channels aimed at recruitment and garnering attention from these attacks.

From the ransomware front, Cybersecurity Dive reports

  • CrowdStrike researchers discovered a new exploit method by Play ransomware actors that can bypass URL rewrite mitigations released by Microsoft in October, according to a Tuesday blog post from the incident response firm. Microsoft’s updates were designed to mitigate ProxyNotShell vulnerabilities.
  • Crowdstrike researchers discovered the new method while investigating Play ransomware activity. The entry vector was suspected to be zero-day vulnerabilities CVE-2022-41080 and CVE-2022-41082, according to the blog. 
  • While investigating the attacks, researchers found threat actors entered through Outlook Web Access (OWA) and leveraged Plink and AnyDesk in order to maintain access.

Bleeping Computer’s The Week in Ransomware is available here. After sharing its thoughts on the Microsoft issue, Bleeping Computer adds

TrendMicro also confirmed this week our September report that a Conti cell known as Zeon rebranded to Royal Ransomware.

Other reports this week shed light on various ransomware operations:

From the cybersecurity defenses front

  • Healthcare IT News offers a roundup of strategies and next steps for improving cybersecurity in 2023.
  • The Wall Street Journal reports that Chief Information Officers and Chief Information Security Officers are working together to better align their respective positions.

Omnibus bill passes

David Ermer–ACA, Congress, COVID-19, No Surprises Act, Uncategorized–

Per Roll Call, the House of Representatives followed the Senate by passing the Consolidated Apppropriations Act 2023 and the one week further extension of the continuing resolution to December 30, 2023. The 117th Congress has completed its work.

The Centers for Disease Control will not be published its weekly interpretation of Covid statistics until next year as today and next Friday precede three day weekends.

The CDC did update its Covid data tracker and Fluview which happens on Thursdays. The new daily Covid cases and deaths for the week ending December 22 averaged approximately 69,600 cases and 420 deaths. “Seasonal influenza activity remains high but is declining in most areas.” As noted in yesterday post, RSV cases appear to have peaked.

In No Surprises Act news, the Labor Department’s Employee Benefit Administration announced this afternoon

  • Effective January 1, 2023, the administrative cost for holding an arbitration under an independent dispute resolution process will increase from $50 per party to $350 per party. That should tamp down the number of NSA arbitrations.
  • ACA FAQs 56 concerning the NSA prescription drug reporting that health plans, including FEHB plans, are scheduled to submit next Tuesday, December 27, for the 2020 and 2021 plan years. Significantly,

For the 2020 and 2021 data submissions that are due by December 27, 2022, the Departments will not take enforcement action with respect to any plan or issuer that uses a good faith, reasonable interpretation of the regulations and the Prescription Drug Data Collection (RxDC) Reporting Instructions in making its submission. The Departments are also providing a submission grace period through January 31, 2023, and will not consider a plan or issuer to be out of compliance with these requirements provided that a good faith submission of 2020 and 2021 data is made on or before that date.

  • Initial Report on the Independent Dispute Resolution Process: April 15 – September 30, 2022.

The FEHBlog will release Cybersecurity Saturday on December 24 and the Holiday weekend update on December 26. Merry Christmas and of course Jingle Bells.

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, COVID treatment, COVID-19, COVID-19 testing, FDA, HSA, NIH, OPM, Rx coverage–

From Capitol Hill, the American Hospital Association tells us

The Senate today passed (68-29) an amended version of the $1.7 trillion omnibus appropriations bill that funds the federal government through the end of the current fiscal year. The legislation also includes many provisions affecting hospitals and health systems.

The Senate also passed another short-term continuing resolution through Dec. 30 to allow time for the more than 4,000-page legislation to be enrolled and for President Biden to sign it. This ensures there will be no interruption of services or federal shutdown.

The omnibus spending bill, which includes relief from Medicare cuts and extensions of rural and telehealth programs, as well as the Dec. 30 continuing resolution, now go to the House, which is expected to consider them today . The president is expected to sign the short-term continuing resolution before current funding for the government expires at 11:59 p.m. ET on Dec. 23, and to sign the omnibus later next week.

The Wall Street Journal adds, “House Majority Leader Steny Hoyer (D., Md.) said the House would vote on the bill Friday.”

In other 2023 Consolidated Appropriations Act or omnibus news

  • The Hill reports on “last minute” changes to the omnibus, including provisions assisting nursing and pregnant workers.
  • Mercer Consulting alerts us to a two-year-long extension of telehealth flexibilities available to high deductible plans with health savings accounts.
  • Think Advisor and the Wall Street Journal provide an overview of the Secure 2.0 Act provisions in the omnibus. The Secure 2.0 Act affects 401(k) plans offered to employees and IRAs. The key provision that takes effect for 2023 is an increase in the required minimum distribution age from 72 to 73.
  • The Wall Street Journal reviews the other omnibus provisions affecting businesses.

From the public health front —

Beckers Hospital Review informs us

While the respiratory “tripledemic” continues to slam emergency rooms and children’s hospitals, there are two glimmers of hope on the horizon, according to a Dec. 22 report in The New York Times. 

COVID-19, the flu and respiratory syncytial virus attack the body in different ways, and there are varying levels of disease severity across the U.S. Today, some scientists say RSV has peaked in most parts of the country.

“I think it’s likely that the RSV season has peaked in most parts of the country,” said Virginia Pitzer, ScD, an infectious disease epidemiologist at New Haven, Conn.-based Yale School of Public Health. “I think that there is a light at the end of the tunnel.”

Additionally, there’s reason to believe next winter won’t be as burdensome for the American population and healthcare organizations.

Ironically, the safety precautions used to help stem the pandemic in the past couple of years have also kept adults and children from being exposed to the viruses that typically circulate this time of year, said Dr. Pitzer.

“There was a bit of a buildup of susceptibility at the population level,” she added. “It’s a worse than normal winter, but one that hopefully will not be repeated next year.”STS

The American Hospital Association tells us

The Society for Healthcare Epidemiology of America today recommended hospitals and health systems no longer routinely screen symptom-free patients for COVID-19 upon admission or before procedures and rely instead on enhanced layers of infection prevention interventions.

“The small benefits that could come from asymptomatic testing at this stage in the pandemic are overridden by potential harms from delays in procedures, delays in patient transfers, and strains on laboratory capacity and personnel,” said Thomas R. Talbot, M.D., MPH, the chief hospital epidemiologist at Vanderbilt University Medical Center, and a member of the SHEA Board of Directors. “Since some tests can detect residual virus for a long period, patients who test positive may not be contagious.”

STAT News reports

[According to a CDC report, a] baby born in the U.S. in 2021 has a life expectancy of 76.4 years, down from 77 years in 2020 and the lowest level the CDC has recorded since 1996. The age-adjusted death rate for Covid rose by 22.5% between 2020 and 2021, while death rates from unintentional injuries — one-third of which come from overdoses — rose by 12.3%.

HHS’s Agency for Healthcare Quality and Researched refreshed its Healthcare Cost and Utilization Project Fast Stats website. The site provides “summary statistics on inpatient stays, emergency department visits, and priority topics, by select characteristics.”

From the OPM front, OPM’s medical director, Dr. Ron Kline announced today on Linked In that he is leaving OPM to take a new position beginning January 17, 2023 as

the Chief Medical Officer of the Quality Measurement and Value-Based Incentives Group (QMVIG) at the Center for Clinical Standards and Quality (CCSQ) at the Centers for Medicare & Medicaid Services (CMS).

QMVIG is responsible for developing, evaluating and supporting the implementation of quality measurement programs across the entire federally-supported health care continuum. This includes Medicare’s Quality Payment Program and the Inpatient (i.e. Hospital) Quality Reporting Program. These measures and policies guide these innovative programs to improve healthcare quality for all Americans.

Best wishes, Dr. Kline, and thanks for your work with the FEHB over the past 3 1/2 years.

From the Rx coverage and medical research fronts –

MPR reports

The Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for intravenous (IV) use to treat COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

ICER released evidence reports on Alzheimer’s Disease treatments (draft) and hemophilia A and B (final) STAT News explains

The latest Alzheimer’s disease treatment from Eisai and Biogen needs to be cheaper than $20,000 a year to be cost-effective, according to a draft analysis from an influential nonprofit organization published Thursday.

The Institute for Clinical and Economic Review, or ICER, dug into the evidence for lecanemab and concluded that the drug’s demonstrated benefits, a modest but statistically significant delay in the advance of Alzheimer’s, are worth between $8,500 and $20,600 per year. ICER’s calculations, which could change in response to public comment over the next month, are based on metrics meant to quantify the value of improvements to quality of life.

Eisai, which is leading the effort to commercialize lecanemab, has not disclosed how much it will charge for the medicine, saying only that it will prize affordability and access. That will soon change, as the drug, a twice-monthly infusion, is expected to win a preliminary Food and Drug Administration approval by Jan. 6. * * *

Lecanemab’s safety has come into sharp focus over the past two months after three patients died of major brain bleeds.

Regarding hemophilia therapies, ICER observes

The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of etranacogene dezaparvovec (Hemgenix, CSL Behring,) for hemophilia B. ICER also updated the previous Hemophilia A assessment on valoctocogene roxaparvovec (Roctavian™, BioMarin).  

Key recommendations stemming from the roundtable discussion include:

  • The value of high-impact single and short-term therapies should not be determined exclusively by estimates of long-term cost offsets, particularly when the existing standard of care is acknowledged to be priced significantly higher than reasonable cost-effective levels.
  • Payers should work with manufacturers to develop and implement outcomes-based agreements to address the uncertainty and the high cost of gene therapies for hemophilia.
  • At least one national payer has suggested to patient representatives that step therapy with emicizumab is being considered prior to provision of coverage for Roctavian. Clinical experts and patient experts view this approach as lacking any clinical justification and appears to be only a method for trying to avoid the high one-time fee for gene therapy while assuming that patients may switch insurers before the cost-saving potential of gene therapy is fully realized. In short, step therapy does not appear to be a reasonable consideration for this treatment.

ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

NIH announced

Scientists used patient stem cells and 3D bioprinting to produce eye tissue that will advance understanding of the mechanisms of blinding diseases. The research team from the National Eye Institute (NEI), part of the National Institutes of Health, printed a combination of cells that form the outer blood-retina barrier—eye tissue that supports the retina’s light-sensing photoreceptors. The technique provides a theoretically unlimited supply of patient-derived tissue to study degenerative retinal diseases such as age-related macular degeneration (AMD). 

Amazing.

From the miscellany department, the Wall Street Journal and MedPage Today explore the new AI text tool known as ChatGPT. From the Journal article

If you haven’t yet tried ChatGPT, OpenAI’s new artificial-intelligence chatbot, it will blow your mind. Tell the bot to write you anything—an email apologizing to your boss, an article about the world’s richest hamster, a “Seinfeld” script set in 2022—and it spits out text you’d think was written by a human. Knowledge of the topic, proper punctuation, varied sentence structure, clear organization. It’s all there.