FEHBlog

Midweek Update

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, OPM, U.S. Healthcare–

From the Delta variant front, MedPage Today reports on a recent study supporting the FDA/CDC conclusion that all immunocompromised folks over the vaccine eligibility age should receive a COVID vaccine booster.

Kaiser Health News surveys the U.S. market for convenience COVID testing.

FedWeek reminds us that

Just days remaining before the deadline for federal employees to receive a Coronavirus vaccination under the mandate and disciplinary actions could soon follow, although indications are that such actions will not necessarily be immediate nor fast-moving.

Taking into account the two-week waiting period afterward that required to be considered fully vaccinated by the deadline of November 22, employees would need to receive either the single Johnson and Johnson vaccine or the second dose of the two-dose Pfizer or Moderna vaccines no later than next Monday (November 8).

In the third quarter financial results department, we find

Healthcare Dive reporting that

  • “CVS Health’s payer business Aetna reported higher-than-expected costs for COVID-19 treatment and testing in the third quarter as the highly infectious delta variant spread and deferred care returned.
  • “However, a greater volume of vaccinations and COVID-19 tests (along with pharmacy services growth) fueled a sharp jump in profit, leading the Woonsocket, Rhode Island-based company to boost its full-year outlook.
  • “CVS beat Wall Street expectations on both earnings and revenue for the quarter, with a topline of $73.8 billion, up 10% year over year, contributing to net income of $1.6 billion, up 30% year over year.”

Fierce Healthcare reporting

  • “Humana expects its individual Medicare Advantage membership to grow by 8% in 2022 as part of a more conservative financial outlook. 
  • “The insurer gave hints to its outlook for next year as part of its earnings report released Wednesday that saw Humana post a $1.5 billion profit in the third quarter but cut its financial outlook for 2021 due in part to higher-than-expected COVID-19 costs.
  • “The insurer’s third-quarter earnings report, though, released Wednesday, pointed to strong growth in its Medicare Advantage offerings and lower-than-expected healthcare use among MA beneficiaries.
  • “Humana also generated $20.7 billion in revenue for the third quarter, which fell short of Wall Street expectations.”

BioSpace reporting

  • “Pfizer reported its third-quarter 2021 financials, citing $24.1 billion in quarterly revenues, a stunning 130% operational growth. If you exclude the sales of its COVID-19 vaccine with BioNTech, revenues grew 7% operationally to $11.1 billion. The company raised its full-year guidance to range from $81 to $82 billion.
  • “’While we are proud of our third quarter financial performance, we are even more proud of what these financial results represent in terms of the positive impact we are having on human lives around the world,’ said Albert Bourla, Pfizer’s chairman and chief executive officer. ‘For example, more than 75% of the revenues we have recorded up through third-quarter 2021 for Comirnaty have come from supplying countries outside the U.S., and we remain on track to achieve our goal of delivering at least two billion doses to low- and middle-income countries by the end of 2022 — at least one billion to be delivered this year and one billion near year, with the possibility to increase those deliveries if more are placed by these countries for 2022.’”

The FEHBlog also ran across this STAT News article discussing Moderna’s unexpected approach to breaking into the CRISPR gene editing market.

Moderna, flush with cash thanks to its blockbuster Covid-19 vaccine, made waves back in August when CEO Stéphane Bancel declared the company’s next frontier to be genome editing, the nascent science of rewriting DNA to treat disease. Three months later, Moderna has picked a partner for its foray into CRISPR, and it’s not one of the field’s multibillion-dollar players.

Metagenomi, a three-year-old startup out of the University of California, Berkeley, signed a deal to help Moderna discover and develop genome-editing therapies, the companies said Tuesday. The agreement includes an up-front cash payment to Metagenomi, bonuses for meeting development milestones, and royalties on any products that arise from the collaboration. Moderna will also make an equity investment in the company. Neither side disclosed financial details.

The idea behind Metagenomi is mining nature’s infinite complexity in search of new ways to edit DNA. That means scouring the natural world for soils, sediments, and microbiomes, putting the samples through intensive genome sequencing, and sifting the results for better genome-editing mousetraps. It’s a process called metagenomics, according to company co-founder and CEO Brian Thomas, and it has already produced results.

Many genome-editing efforts rely on pairing CRISPR with an enzyme called Cas9, which functions as the molecular pair of scissors that makes cuts to DNA. By studying nature, Metagenomi has discovered newer and potentially more potent enzymes that might broaden CRISPR’s medicinal promise.

Cool.

From the Open Season front, Health Payer Intelligence directed the FEHBlog to this fascinating ValuePenguin study of consumer attitudes toward health benefit open seasons. For example, eagerness to consider changing plans steadily decreases with age which may explain the relatively low turnover rate that typically occurs in FEHB Open Seasons.

Who is planning to change their health insurance?
From the ValuePenguin study

EHR Intelligence reports that the federal government is putting its weight behind the adoption of The HL7 Gender Harmony Logical Model in U.S. electronic health record systems:

  • “Gender identity (GI): an individual’s personal sense of being a man, woman, boy, girl, or something else.
  • “Sex for clinical use: a summary sex classification element based on clinical observations like organ survey, hormone levels, and/or chromosomal analysis.
  • “Recorded sex or gender (RSG): sex values or gender values that are specified administrative documents such as identity cards or insurance cards.
  • “Name to use (NtU): the name that the patient wishes to use in healthcare interactions.
  • “Pronouns: the English language third-person personal pronoun determined by the patient for use in healthcare interactions, clinical notes, and written instructions to caregivers.”

Assuming the model works with EHR system, it would be a logical next step to extended this model to health plan claim and customer service systems.

Tuesday Tidbits

David Ermer–CDC, COVID-19, COVID-19 vaccine, Medicare, Telehealth, U.S. Healthcare–

From the Delta variant vaccination front, AHIP informs us that

Photo by Patrick Fore on Unsplash

Today, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met to discuss the safety, efficacy and clinical considerations for the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years. The committee unanimously voted (14-0) to recommend the vaccine with the following statement:

“The Pfizer-BioNTech COVID-19 vaccine is recommended for children 5-11 years of age in the U.S. population under the FDA’s Emergency Use Authorization (EUA).”

During the meeting, representatives from Pfizer and the CDC presented data that showed the vaccine to be immunogenic and safe, with majority of adverse events documented as injection site pain. Data from Pfizer showed no correlation of the vaccine with incidence of multisystem inflammatory syndrome MIS-C, and the CDC will continue to monitor the long-term effects of myocarditis in this population. The CDC also noted the disparities in COVID-19 disease epidemiology, that Black, Hispanic, and American Indian/Native Alaskan children are at greater risk for hospitalization and disease severity.  * * *

Additionally, the American Academy of Pediatrics, American Academy of Family Physicians, National Association of Pediatric Nurse Practitioners, and the Pediatrics Infection Disease Society endorsed the COVID-19 vaccine’s administration in all eligible children as authorized by the FDA.

The Wall Street Journal adds that the CDC Director Dr. Rochelle Walensky has ratified the ACIP’s recommendation.

The endorsement * * * on Tuesday, was the last step before doctors, nurses and pharmacists could start giving the shots. Some sites could start administering the vaccine as early as Wednesday, though federal officials don’t expect vaccinations in the age group to be in full swing across the U.S. until next week.

Over 2/3rds of the vaccine eligible U.S. population (12 years and older) are fully vaccinated and a quarter of Americans over age 65 have received a booster according to today’s CDC update.

From the also busy Medicare front, the American Hospital Association tells us about three final Calendar Year 2022 rules released today:

— Hospital Outpatient Services (Part A): The Centers for Medicare & Medicaid Services late today issued a final rule that increases Medicare hospital outpatient prospective payment system rates by a net 2.0% in calendar year 2022 compared to 2021.  In addition, as urged by AHA, CMS finalized its proposals to reverse two policies finalized in CY 2021. The first policy halts the elimination of the inpatient only list and adds back to the IPO list almost all of the services removed in 2021. The second reinstates several patient safety criteria for adding a procedure to the ambulatory surgical center covered procedures list that were in place in CY 2020 and prior. The rule also removes 255 of the 258 surgical procedures that had been added to the ASC CPL in 2021.

— Hospital Price Transparency: CMS also finalizes as proposed a number of modifications to the hospital price transparency rule, including significant increases to the civil monetary penalty for noncompliance. * * * Currently, the CMP is set at a maximum amount of $300/day. CMS will scale up the CMP based on a hospital’s bed count, with a minimum of $300/day for small hospitals (30 or fewer beds) and an additional $10/bed/day for larger hospitals with a daily cap of $5,500. CMS also will prohibit specific barriers to accessing the machine-readable files, including through automated searches and direct downloads. CMS provides updated clarifications on the price estimator tools for those hospitals that choose to use them to fulfill the shoppable service requirement, including allowing patients to manually input their insurance information and permitting broad disclaimers, as appropriate.

— Home Healthcare Services (Part A): The Centers for Medicare & Medicaid Services today released its calendar year 2022 final rule for the home health prospective payment system. The rule finalized a net update of 3.2% relative to CY 2021. This includes a 2.6% market basket increase ($465 million), a 0.7% increase for high-cost outlier cases ($125 million), and 0.1% decrease to rural payments as required by law (-$20 million).

— Physician Services (Part B): The Centers for Medicare & Medicaid Services late today released its calendar year 2022 final rule for the physician fee schedule. The rule cuts the conversion factor to $33.59 in CY 2022, as compared to $34.89 in CY 2021, which reflects the expiration of the CY 2021 3.75% payment increase, a 0.00% conversion factor update, and a budget neutrality adjustment. The rule also finalizes several policies to expand access to telehealth for mental health services, including, in certain instances, covering audio-only services. In addition, as urged by the AHA, CMS finalized a delayed implementation of the payment penalty phase of the Appropriate Use Criteria program to the later of Jan. 1, 2023, or the Jan. 1 that follows the end of the COVID-19 public health emergency. Currently, the penalty phase is set to begin Jan. 1, 2022.   “The AHA applauds today’s ruling by CMS to delay the proposed enforcement of the Appropriate Use Criteria (AUC) program as well as to expand access to telehealth for behavioral health services,” said AHA Executive Vice President Stacey Hughes. 

Speaking of telehealth, Healthcare Dive calls attention to its finding that ‘While women are more likely than men to visit doctors and consume healthcare services in general, telehealth seems to be uniquely attractive to women.” Moreover, [t]he data also suggests female physicians offer virtual care services at higher rates than their male counterparts.”

In the tidbits department, we find

  • Healthcare Dive reports that “The median change in operating margins for hospitals fell 18.2% in September compared to August, according to the latest monthly report from Kaufman Hall, a hospital consultant group. Patient volumes declined in almost every key category, including emergency room visits and operating room minutes, potentially signaling that the rise in the delta variant caused some to once again defer care out of concern over contracting the coronavirus. Outpatient revenues declined, too, further underscoring this potential trend. Although fewer patients were admitted, patients were sicker and stayed longer. The average length of stay is also trending above pre-pandemic levels.”
  • MedPage Today offers an interesting story on Chicago’s Rush Medical Center “journey to health equity” using social determinants of health data, among other tools.
  • Federal Times reports that “The Partnership for Public Service held its annual Samuel J. Heyman Service to America awards Nov. 1, honoring nine federal employees and their associated teams out of 29 nominees for making a significant impact through their public service.” Congratulations to all of the nominees and thanks for your service to our country.

Monday Roundup

David Ermer–ACA, CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Government Contracting, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Delta variant front, Medscape informs us that

“Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published Friday in the CDC’s Morbidity and Mortality Weekly Report.”

and

People who already have had COVID-19 may have more reason to get vaccinated, with new findings suggesting that vaccination after infection can boost protection. Under viral threat, the body first uses B cells to make antibodies against the invader, a process that can take up to 2 weeks. The immune system simultaneously creates memory B cells that can recognize the virus if it reappears and rapidly mounts a powerful secondary response.

In a series of  shots, the first dose triggers the primary response. The follow-up doses activate the memory B cells, strengthening defenses against the pathogen.

These new results, published in Cell Reports , show that a SARS-CoV-2 infection, like a first vaccine dose, will elicit the primary response, as expected.

Fierce Biotech tells us that

COVID-19 testing newcomer Detect aims to reset expectations for regular screening against the pandemic coronavirus—and it’s now received an FDA green light to move forward with its rapid, lab-quality test for repeated use in the home.

The company’s molecular diagnostic received an emergency authorization allowing it to be sold at retail stores over-the-counter. Equipped with a reusable analyzer and $50 cartridge-based tests, the system aims to produce results with PCR-level accuracy within one hour.

From the Delta variant mandate front, the Society for Human Resource Management reports that

​The White House issued guidance on Nov. 1 that its Dec. 8 deadline for federal contractors to be vaccinated against COVID-19 isn’t set in stone, providing companies with the opportunity to educate workers past that date rather than fire workers who haven’t been vaccinated by then.

“A covered contractor should determine the appropriate means of enforcement with respect to its employee at a covered contractor workplace who refuses to be vaccinated and has not been provided, or does not have a pending request for, an accommodation,” according to the guidelines.

As federal contractors prepare to implement the vaccine mandate, many questions have arisen on timing, costs and related issues, which prompted the White House to release the new guidance.  

Also today, OMB’s Office of Information and Regulatory Affairs concluded its review of the OSHA vaccination screening rule for private sector employers with 100 or more employees. This means that the rule should be released this week. Heavens only knows when the FAR Council will release its vaccine mandate rule for federal contractors.

Federal News Network offers an update on the federal employee vaccine mandate.

From the recognition department, Fierce Healthcare names ten women of influence in healthcare while Healthcare Dive points out that “Healthcare employees bore the brunt of the pandemic in the workforce. Women bore the brunt of the pandemic at home. Most nurses are both.”

In Affordable Care Act new, the IFEBP reports that “The Internal Revenue Service (IRS) issued the final 1094-B, 1095-B, 1094-C, and 1095-C forms that employers, plan sponsors and group health insurers will use to report health coverage to plan members and the IRS as required by the Affordable Care Act (ACA). IRS hasn’t released final instructions.” Links to the final forms are available at this link.

Weekend update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Telehealth, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

Happy Halloween!

The U.S. House of Representatives and the Senate will be engaged in floor voting and Committee business this coming week. The Hill brings us up to date on Democrat Congressional leadership negotiations over the social spending budget reconciliation bill. Bloomberg adds

While the $500 billion infrastructure bill has already passed the Senate, the larger economic package will have to return there for another vote. Some Democratic Senators are signaling they may seek changes to what is passed in the House, possibly adding further delays. 

From the Open Season front, the ACA marketplace open season resumes tomorrow. The Federal Employee Benefits Open Season begins a week from tomorrow. OPM’s 2022 online FEHB Plan Comparison Tool is now available.

From the Delta variant front, the Wall Street Journal tells us that

The Food and Drug Administration is delaying a decision on Moderna Inc.’s application to authorize use of its Covid-19 vaccine in adolescents to assess whether the shot leads to a heightened risk of myocarditis, the company said.

The FDA notified Moderna on Friday evening that an analysis may not be completed until January of next year while the agency reviews recent international data on the risk of myocarditis after vaccination, the company said Sunday.

The Wall Street Journal reported earlier this month that the FDA was delaying a decision on Moderna’s application for authorization in 12- to 17-year-olds after several Nordic countries limited use due to myocarditis reports. 

Moderna also said it would delay asking the FDA to authorize use of a lower dose of its shot in even younger children, ages 6 to 11, while the agency continues to review its request to clear the shots in adolescents.

From the CMS front, Medicare offers coverage for those under age 65 who are afflicted with End Stage Renal Disease (“ESRD”). On Friday, CMS finalized its ESRD prospective payment rule for calendar year 2022. In its announcement CMS explained that

Through the ESRD Prospective Payment System (PPS) annual rulemaking, CMS is making changes to the ESRD Quality Incentive Program (QIP) and the ESRD Treatment Choices (ETC) Model, and updating ESRD PPS payment rates. The changes to the ETC Model policies aim to encourage dialysis facilities and health care providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status, making the model one of the agency’s first CMS Innovation Center models to directly address health equity.

“Today’s final rule is a decisive step to ensure people with Medicare with chronic kidney disease have easy access to quality care and convenient treatment options,” said CMS Administrator Chiquita Brooks-LaSure. “Enabling dialysis providers to offer more dialysis treatment options for Medicare patients will catalyze better health outcomes, greater autonomy and better quality of life for all patients with kidney disease.”

That makes sense to the FEHBlog.

From the healthcare network front, the Yale School of Public Health (YSPH”) informs use that “a new survey analysis from a researcher at the YSPH suggests that privately insured adults are significantly more likely to rate their mental health provider network as inadequate compared to their medical provider network.” With due respect to Yale, this finding is hardly surprising given the fact that relative few mental health therapists join a health plan network because they don’t need patient referrals. That’s why it so important for the hub and spoke telehealth services to offer ongoing mental health care over their networks.

From the OPM front, Federal News Network reports that

As agencies contemplate and continue to plan for the future of work, the Office of Personnel Management is trying to let agencies know they have some help — and some new resources — to guide them through the unknown.

The agency is preparing to release more guidance on telework and remote work “very soon,” OPM Director Kiran Ahuja said in an interview with Federal News Network.

It’s all part of an effort to help agencies establish themselves as model employers that can meet the moment — and part of OPM’s own plans to reestablish itself as a human capital resource for the rest of government. They’re priorities Ahuja set in the early days since becoming OPM director, and they’ll continue well into 2022 and beyond, she said.

The guide will offer, in some detail, advice for agencies on making the shift to remote and hybrid work.

“We want to support what’s involved in our lives around flexibilities and child care but also knowing that we can be really productive,” Ahuja said. “We have this guide coming out. We’re also pulling together trainings and information around how to manage in a hybrid work environment and how to operate well in a work environment, as well as a new website focused on future of work.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

The Wall Street Journal reported on Monday that

The Russia-linked hackers behind last year’s compromise of a wide swath of the U.S. government and scores of private companies, including SolarWinds Corp. SWI -3.19% , have stepped up their attacks in recent months, breaking into technology companies in an effort to steal sensitive information, cybersecurity experts said.

In a campaign that dates back to May of this year, the hackers have targeted more than 140 technology companies including those that manage or resell cloud-computing services, according to new research from Microsoft Corp. The attack, which was successful with as many as 14 of these technology companies, involved unsophisticated techniques like phishing or simply guessing user passwords in hopes of gaining access to systems [a/k/a “password spraying”], Microsoft said.

“This recent activity is another indicator that Russia is trying to gain long-term, systematic access to a variety of points in the technology supply chain,” said Tom Burt, Microsoft’s corporate vice president for customer security and trust, according to a blog post provided ahead of the announcement by Microsoft on Monday.

Security Week adds that

Microsoft has also made available technical guidance that can help organizations detect attacks launched by Nobelium.

Last month, Microsoft published a blog post detailing a piece of malware used by the threat group to exfiltrate data from compromised servers.

ZDNet delves into the password spraying approach to hacking.

Microsoft’s Detection and Response Team (DART) has outlined two main password spray techniques, the first of which it calls ‘low and slow’. Here, a determined attacker deploys a sophisticated password spray using “several individual IP address to attack multiple accounts at the same time with a limited number of curated password guesses.” 

The other technique, ‘availability and reuse’, exploits previously compromised credentials that are posted and sold on the dark web. “Attackers can utilize this tactic, also called ‘credential stuffing,’ to easily gain entry because it relies on people reusing passwords and usernames across sites,” Microsoft explains.

From our Nation’s capital, Cyberscoop informs us that

The Cybersecurity and Infrastructure Security Agency [(CISA)] has begun working to map out the U.S. critical infrastructure that, if hacked, could result in serious consequences for national security and economic interests, CISA Director Jen Easterly said Friday.

Labeling such infrastructure is the subject of a proposal of the Cyberspace Solarium Commission, a congressional committee, which recommended identifying “systemically important critical infrastructure,” or SICI. Lawmakers have introduced SICI legislation in recent months, but Easterly said her Department of Homeland Security agency is proceeding ahead with or without a bill.

Moreover, per Cyberscoop

Federal Chief Information Security Officer Chris DeRusha, who has played an integral part in responding to the SolarWinds hack, is getting a second gig as deputy national cyber director for federal cybersecurity.

National Cyber Director Chris Inglis hailed DeRusha’s appointment on Twitter Thursday. * * *

DeRusha steps into his additional role at a time when questions persist on Capitol Hill about the breakdown of cyber roles within the federal bureaucracy. The national cyber director’s office is the newest addition to that bureaucracy, established only this year. The office is coming into being as the Department of Homeland Security’s Cybersecurity Infrastructure and Security Agency is increasingly focused on incident response and information sharing in the federal government, and as Deputy National Security Adviser Anne Neuberger probes ways for the U.S. to combat ransomware.

In an interview with The Washington Post that published Thursday, Inglis said the coordination with DeRusha should benefit federal agency cyber officials. “Particularly if you’re a chief information security officer, you’ll see us speaking complementary ways and using our resources in a collaborative manner,” he said.

Also HHS’s Office for Civil Rights, which enforces the HIPAA Privacy and Security Rules, issued its Fall 2021 Cybersecurity Newsletter. This newsletter’s topic is securing legacy systems.

Health IT Security explores the value of applying the zero trust model to health data.

Under the watchful eye of a zero trust security model, no device or user is automatically trusted before being vetted by strict authentication processes. Zero trust is not a single technology or tactic, but a set of cyber defenses that collectively look for threats outside and within a network perimeter.

Implementing a zero trust architecture could make a life-or-death difference in how healthcare organizations operate and respond to cybersecurity incidents. * * *

HC3 recommended that organizations begin zero trust implementation by employing a software-defined perimeter (SDP). SDP is a computer security approach that effectively hides internet-connected infrastructure, such as servers and routers, so that unauthorized third parties cannot see it. With this approach, the network perimeter is based in software rather than hardware and is less vulnerable to hackers.

Organizations should also consider Mesh VPNs, which use a peer-to-peer (P2P) architecture so that every device in the network can connect directly to a peer without going through a central gateway. Mesh VPNs are typically less expensive and easier to scale, HC3 noted.

Healthcare organizations may also benefit from a modern network access control (NAC) platform that can enforce access control and identify every device and user on the network before granting access. This approach provides continuous monitoring and ensures that every device and user is authenticated and trusted.

And as alway here’s a link to Bleeping Computers weekly report on ransomware.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Government Contracting, U.S. Healthcare–

Based on the Centers for Disease Control’s COVID Data Tracker, here’s the FEHBlog weekly chart of new COVID cases in 2021, which uses Thursday as the first day of the week:

Encouraging, n’est-ce pas?

The CDC’s chart of new COVID hospitalizations points in the same hopeful direction.

Here’s the FEHBlog’s weekly chart of new COVID deaths which while a lagging indicator is now heading in the right direction too.

Here is the FEHBlog’s weekly chart of newly distributed and administered COVID vaccines, which includes boosters.

For the each of the past three days over 1 million COVID vaccines have been administered in our country. 67.7% of Americans over age 12 (the current minimum age to receive the vaccination) are fully vaccinated. 85% of the 65 and older U.S. population is fully vaccinated and 22% of that cadre has received the booster.

Here is a link to the CDC’s weekly interpretation of these COVID statistics which was released today. The CDC’s most recent Fluview report is that “Seasonal influenza activity in the United States remains low.”

In related Delta variant news, the Washington Post reports that the acting Food and Drug Commissioner Dr. Janet Woodcock today ratified the FDA vaccinations panel’s recommendation to award emergency use authorization to administering the Pfizer vaccine to children ages 5 to 11. The Post explains that

the process of getting vaccines cleared for younger school-age children has been fraught, with members of the FDA’s outside advisory committee expressing some angst and disagreements during a vociferous public debate this week. In the end, the panel voted 17 to 0, with one abstention, to recommend the vaccine, agreeing with the FDA that the shot’s known and potential benefits outweighed the known and potential risks — the criteria for an emergency authorization.

The discussion about the shot is expected to resume Tuesday when the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention, is scheduled to meet to recommend how to use the vaccine. After CDC Director Rochelle Walensky signs off, probably on the same day, providers, including pediatricians and pharmacists, will be able to begin administering the vaccine.

The Wall Street Journal adds that

Covid-19 was over five times more common among hospitalized people who were unvaccinated and had a previous infection, compared with those who were fully vaccinated and hadn’t had Covid-19 before, a study published by the Centers for Disease Control and Prevention found.

The report, released Friday and written by scientists from the federal agency as well as hospitals across the U.S., adds to the body of research suggesting that vaccines provide stronger protection against the coronavirus than prior-infection immunity.

In No Surprises Act news, the Texas Medical Association has filed a lawsuit against the federal agencies implementing this law, including OPM, alleging that the recently issued interim final rule on the independent dispute resolution process conflicts with Congressional intent by giving health plans an unfair advantage in NSA arbitrations. The FEHBlog views this as an exercise in futility, but we shall see if the Court share the FEHBlog’s viewpoint.

Also from the litigation front, Govexec reports that

Eleven states with Republican governors are challenging the Biden administration’s vaccine mandate for federal contractors between two lawsuits filed on Thursday and Friday. 

The state of Florida filed a lawsuit in the U.S. District Court for the Middle District of Florida in the Tampa Division seeking an injunction on the mandate that has a December 8 deadline for millions of employees of federal contractors to get vaccinated against COVID-19. Then on Friday, Missouri, Nebraska, Alaska, Arkansas, Iowa, Montana, New Hampshire, North Dakota, South Dakota and Wyoming filed a similar lawsuit in the U.S. District Court for the Eastern District of Missouri also seeking an injunction. 

The FEHBlog will be keeping an eye on these cases too.

Thursday Miscellany

David Ermer–ACA, Congress, Federal employment benefits, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The FEHBlog was particularly struck by an in-depth article in the Wall Street Journal about a lower income man in his sixties who emptied his retirement plan to pay for hospital bills for his wife who was stricken with cervical cancer. How does this happen in the Affordable Care Act world. The FEHBlog is not blaming the law. Rather the FEHBlog believes that people from the hospital, the insurance company, etc. dropped the ball when they had a chance to help this now broken man. The woman’s adult daughter, presumably the man’s step daughter, created a Go Fund Me page. Isn’t that a red flag?

The Journal also reports from Capitol Hill that the President’s Hail Mary pass to score a legislative victory with the billion dollar infrastructure bill fell short.

The Mercer consulting company is offering a report on furious state legislative efforts this year to regulate prescription benefit managers in the wake of last December’s U.S. Supreme Court decision on ERISA preemption and such laws, which was favorable to the state legislatures. The laws in the FEHBlog’s view while well intentioned mainly raise administrative costs.

Govexec in an Open Season related article discusses the No Surprises Act provisions that take effect on January 1, 2022, for enrollees with primary FEHB coverage in the United States. The FEHBlog does expect that this law will achieve its objective of getting patients out of the middle of billing disputes between out of network providers and health plans in emergency care, ancillary care at hospitals and surgicenters and air ambulances. The article notes that “The new rules don’t apply to people with coverage through programs such as Medicare, Medicaid, the Indian Health Service, the Veterans Affairs health system or TRICARE, because these programs already have other protections against high medical bills.”

From the third quarter financial reporting front / telehealth front, Healthcare Dive tells us that

  • “Teladoc plans to take on financial risk for its offerings in the future, including its virtual-first primary service, in a bid to expand revenue per member, the CEO of the New York-based virtual care giant said Wednesday.
  • The telehealth vendor made that program, called Primary360, available nationwide earlier this month, and it will be available through CVS Health-owned payer Aetna and Centene’s marketplace plans in Michigan, Mississippi, South Caroline and Texas early next year. And Teladoc is also beginning to talk with health systems about using Primary360 as a white-labeled digital front door to care for their populations, CFO Mala Murphy told investors on a call.
  • In its third quarter financial results also released Wednesday, Teladoc beat Wall Street expectations on earnings and revenue, with a topline of $522 million, up 81% year over year due to strength in multi-product sales and behavioral health, management said. The 19-year-old vendor saw 3.9 million visits in the quarter, representing 37% year-over-year growth.”

From the Affordable Care Act front, Kaiser Health News reports that

The federal government’s effort to penalize hospitals for excessive patient readmissions is ending its first decade with Medicare cutting payments to nearly half the nation’s hospitals.

In its 10th annual round of penalties, Medicare is reducing its payments to 2,499 hospitals, or 47% of all facilities. The average penalty is a 0.64% reduction in payment for each Medicare patient stay from the start of this month through September 2022. The fines can be heavy, averaging $217,000 for a hospital in 2018, according to Congress’ Medicare Payment Advisory Commission, or MedPAC. Medicare estimates the penalties over the next fiscal year will save the government $521 million. Thirty-nine hospitals received the maximum 3% reduction, and 547 hospitals had so few returning patients that they escaped any penalty.

Here is a link to KHN’s online tool to look up hospitals to find out whether the hospital was assessed a 2022 penalty.

From the reports and studies department —

  • The Kaiser Family Foundation released its COVID vaccine monitor for October 2021.
  • The American Medical Association discusses a study concluding that, notwithstanding a tremendous amount of consolidation between health systems and providers, private practices continue to play a “big part” in primary care, which the FEHBlog finds reassuring.
  • Health Payer Intelligence informs us

From the beginning, it was clear that seniors’ lives would be turned upside down as a result of the coronavirus pandemic, but Humana’s survey of over 1,000 seniors reveal the severe toll the pandemic has taken on senior mental health and social health.

“Health plans should take particular notice, since it is critical to understand all the evolving needs of seniors – health, social and behavioral – as the industry increasingly moves toward models of ‘whole health’ senior care and coverage,” said Kathy Driscoll, senior vice president and chief nursing officer at Humana.

The survey reached 1,003 Americans ages 64 and older, nationwide. Kelton Global fielded the survey from September 14 to September 21, 2021.

One of the most striking results of the survey was that, despite the rise in mental and behavioral healthcare needs and the expanded access to telemental and telebehavioral services that the pandemic brought, only three percent of seniors had accessed mental healthcare.

The results run parallel with a separate Anthem study which found that mental healthcare claims dropped even though mental healthcare demand rose during the coronavirus pandemic.

However, the low rate of telehealth utilization for these specific demands does not mean that seniors were as hesitant to use telehealth for other health-related purposes. Seniors were far more likely to use telehealth in order to access wellness programming (84 percent) and a third of seniors used telehealth to connect with their providers.

Midweek Update

David Ermer–COVID treatment, COVID-19, Telehealth, U.S. Healthcare–

From the Delta variant front —

STAT News offers an in-depth report on the Delta plus (AY.4.2) variant that has shown up in the United Kingdon. The article concludes

It’s possible that whatever transmission advantage AY.4.2 has over Delta is so narrow that it will take a while for it to start to gain on its parent strain in places beyond the United Kingdom. Also, there’s a lot of randomness when a new form of a pathogen gets introduced into an area — many imported cases simply die out without setting off a transmission chain. If AY.4.2 has just a small edge over Delta, then probability dictates it would require more imported cases for some to take off than if something much more transmissible arrived.

Some variants also don’t circulate everywhere — a lot depends on what other versions of the virus are out there, and what the local environment looks like. The Alpha and Delta variants were so much more transmissible than the other iterations of the virus that were present when they emerged and encountered so many susceptible people that they became dominant. The Beta and Gamma variants, however, only caused issues in the regions where they emerged; there were cases detected elsewhere, but they never drove outbreaks globally.

At this point, it’s too early to say what impact, if any, AY.4.2 will have in the United States. It takes higher levels of population immunity to slow more transmissible pathogens, but between vaccinations and past infections, the country has a big wall of protection out there, with vulnerable pockets interspersed. For now, U.S. modeling still indicates a continued ebbing of the epidemic.

In other encouraging news, the Wall Street Journal informs us that

A widely available antidepressant holds promise as a treatment for Covid-19, according to a new study. Covid-19 patients who received fluvoxamine were significantly less likely to require hospitalization than those who didn’t, in the largest clinical trial evaluating the antidepressant’s effect on Covid-19 to date.

Fluvoxamine belongs to a class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. It is commonly used to treat obsessive compulsive disorder and is also prescribed for depression. In use for decades, fluvoxamine has been shown to be safe and costs about $4 for a 10-day course, said Edward Mills, one of the study’s lead researchers and a professor of health sciences at McMaster University in Hamilton, Ontario. He said fluvoxamine’s low cost and wide availability make it a compelling alternative to other Covid-19 therapies including monoclonal antibody treatments, which are costly and require an infusion. Another treatment, Merck & Co. and Ridgeback Biotherapeutics LP’s experimental molnupiravir pill, will cost the U.S. government around $700 per course in the U.S.

“For both poor countries and even wealthy countries, it’s a great option,” Dr. Mills said of fluvoxamine. * * *

“This is exciting data,” said Daniel Griffin, chief of infectious disease at healthcare-provider network ProHealth New York, who wasn’t involved in the study. “There are several other trials that are in progress and if they confirm this finding, this may end up being standard of care.”

In related good treatment news, STAT News tells us that “In a notable bid to widen access to Covid-19 remedies, Merck has agreed to license its widely anticipated antiviral pill to the Medicines Patent Pool, which in turn can now strike deals with other manufacturers to provide versions of the drug to 105 low and middle-income countries.”

From the gene therapy front, the National Institutes of Health (NIH) announced that the “U.S. Food and Drug Administration, [NIH], 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease. While there are approximately 7,000 rare diseases, only two heritable diseases currently have FDA-approved gene therapies. The newly launched Bespoke Gene Therapy Consortium (BGTC), part of the NIH Accelerating Medicines Partnership (AMP) program and project-managed by the Foundation for the National Institutes of Health (FNIH), aims to optimize and streamline the gene therapy development process to help fill the unmet medical needs of people with rare diseases.

In a more practical development,

Aetna®, a CVS Health® company, announced the launch of its designated Gene-based, Cellular, and Other Innovative Therapies™ (GCIT) network. This network is designed to enable members’ access to new therapies that treat and potentially cure rare genetic diseases, while helping to manage the high cost of these therapies. Aetna’s national GCIT network includes access to more than 75 designated GCIT service providers that have demonstrated quality and value in the delivery of GCIT services.

Beginning January 1, 2022, Aetna’s designated GCIT network will provide three gene therapy services, including Luxturna, Spinraza and Zolgensma for the treatment of inherited retinal disease and spinal muscular atrophy. The GCIT network is included as a standard medical benefit in all Aetna fully insured plans and is also available to self-insured plans.  

From the reports and studies front

NIH released

Part two of the latest Annual Report to the Nation on the Status of Cancer [which] finds that cancer patients in the United States shoulder a large amount of cancer care costs. In 2019, the national patient economic burden associated with cancer care was $21.09 billion, made up of patient out-of-pocket costs of $16.22 billion and patient time costs of $4.87 billion. Patient time costs reflect the value of time that patients spend traveling to and from health care, waiting for care, and receiving care, according to the report.

The report, appearing October 26, 2021, in JNCI: The Journal of the National Cancer Institute, is the most comprehensive examination of patient economic burden for cancer care to date and includes information on patient out-of-pocket spending by cancer site, stage of disease at diagnosis, and phase of care. While this analysis is about the costs that are directly incurred by patients, which are critical to patient finances, the total overall costs of cancer care and lost productivity in the United States are much larger.

The Patient Centered Outcomes Research Institute (PCORI) announced its adoption of “five National Priorities for Health, which serve as ambitious long-term goals to guide PCORI’s funding of patient-centered comparative clinical effectiveness research (CER) and other engagement, dissemination and implementation, and research infrastructure initiatives. The adopted National Priorities for Health are:

  • Increase Evidence for Existing Interventions and Emerging Innovations in Health 
  • Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research 
  • Advance the Science of Dissemination, Implementation, and Health Communication 
  • Achieve Health Equity, and
  • Accelerate Progress Toward an Integrated Learning Health System”

From the substance use front, “Health and Human Services Secretary Xavier Becerra today announced the release of the new HHS Overdose Prevention Strategy, designed to increase access to the full range of care and services for individuals who use substances that cause overdose, and their families.  This new strategy focuses on the multiple substances involved in overdose and the diverse treatment approaches for substance use disorder. * * * For more information on the new Overdose Prevention Strategy, visit: www.hhs.gov/overdose-prevention/.  Read the full issue brief here: https://aspe.hhs.gov/reports/overdose-prevention-strategy“

From the teleheath front, Healthcare Dive takes “a look at Teladoc’s primary care strategy from its head of US group health. Kelly Bliss teased upcoming clients for a new virtual-first primary care product and parsed out Teladoc’s growth strategies for 2022 and beyond.” Enjoy.

Tuesday’s Tidbits

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

From the Delta variant front —

AHIP Informs us that

Today, the Food & Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) met in open session to discuss a request to amend Pfizer-BioNTech’s Emergency Use Authorization (EUA) to include administration of their COVID-19 mRNA vaccine for children 5 through 11 years of age.

The Committee voted 17-0, with 1 member abstaining, to authorize the amendment, based on the evidence available that the benefits of including children in the recommendation for the Pfizer vaccine outweigh the risks when the vaccine is administered as a 2-dose series of 10ug vaccines, given three weeks apart.

Members of the Committee expressed concerns over the lack of data on myocarditis incidence, and the possibility of vaccine mandates being implemented without sufficient data on the effects of the vaccine in this population.  Ultimately, they determined that the vaccinations should be available for parents who want to protect their children from COVID-19 upon discussion with their pediatrician, so that children who need the vaccine can get it, particularly those with comorbidities.

Data presented by Pfizer showed two doses of vaccine to be effective, durable, and safe, with only mild to moderate adverse reactions. Pfizer also presented data that protection against infection and severe disease appears more durable in younger people.

The American Medical Association (AMA) already updated the Current Procedural Terminology (CPT®) code set to include vaccine and administration codes for pediatric doses. The code set is effective upon receiving EUA from the FDA. Short, medium, and long descriptors for all vaccine-specific CPT codes can be accessed on the AMA website.

The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet November 2-3 to discuss and vote on vaccines for this population.

The American Medical Association reminds us that the Biden administration is relying heavily on pediatricians to promote the younger children’s vaccine, once approved by the FDA and the CDC.

“The fact is, physicians are the single most trusted source of vaccine information, and their offices are the most preferred location to get vaccinated,” said White House Vaccinations Coordinator Bechara Choucair, MD. “Pediatricians, family doctors and those in the Vaccines For Children (VFC) program will be an essential part of our strategy to vaccinate 5–11-year-olds, and we strongly encourage those who are not already enrolled to enroll to administer the COVID-19 vaccine. We stand ready to support them in any way we can.”

Good decision. It’s worth noting that

The U.S. Food and Drug Administration approved the first COVID-19 vaccine [on August 23, 2021]. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

The ages 5 to 11 vaccine will be an expansion of the existing ages 12 to 15 emergency use authorization.

David Leonhardt reports in this morning’s New York Times that “The number of new daily Covid-19 cases has plunged 57 percent since peaking on Sept. 1. Almost as encouraging as the magnitude of the decline is its breadth: Cases have been declining in every region.” * * * The C.D.C. tracks a range of Covid forecasting models. On average, the models predict that new daily cases in the U.S. will fall roughly another 20 percent over the next three weeks.The bottom line: There is no reason to expect another Covid surge anytime soon, but surges don’t always announce themselves in advance.”

From the tidbits department

  • The Hill offers an interesting story about internal Democrat leadership negotiations over timing of House votes on the infrastructure and social spending bills.
  • Healthcare Dive reports that health insurer and FEHB plan carrier “Centene is looking to divest “non-core assets” as it embarks on a long-term plan to improve its profit margin. Executives said they also plan to consolidate the company’s pharmacy benefit management business down to one platform and plan to send out a request for proposal in 2022 for a PBM to manage its more than $30 billion in pharmacy spend across its business.”
  • Fedweek discusses new, but not earth shaking, Safer Federal Workforce task force guidance on vaccines that meet the cut for the President’s vaccine mandate for federal employees.
  • Healthcare Dive informs us that “Cigna on Tuesday announced a significant expansion of virtual care benefits to millions of its customers receiving coverage through their employer, as payers increasingly turn to digital channels to cut costs without sacrificing access. The payer, which acquired telemedicine vendor MDLive earlier this year, is integrating MDLive physicians into digital-first primary, dermatology, behavioral and urgent care. Starting in January, Cigna customers insured through their job will have access to MDLive’s network for virtual primary care providers for routine care, sick visits, prescription refills or any needed follow-up care after a wellness visit, the Connecticut-based payer said.”
  • Medpage Today tells us about the “results of the SAMHSA annual National Survey on Drug Use and Health for 2020.” “More than 40 million Americans were living with a substance use disorder in 2020, Capt. Michael King, PhD, MSW, of the Substance Abuse and Mental Health Services Administration (SAMHSA) said Monday.”

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From the Delta variant front —

  • The Wall Street Journal reports “Federal officials said they would do more to get over-the-counter Covid-19 tests to consumers, after some manufacturers have struggled to meet demand after the Delta surge drove increased demand from individuals, schools and businesses.” Better late, etc. Here’s a link to the HHS press release.
  • The Journal also reports that “Moderna Inc.’s MRNA 7.05% Covid-19 vaccine was generally safe and induced the desired immune responses in children ages 6 to 11 in a clinical trial, according to the company. The Cambridge, Mass., company said Monday that it would submit the results to health regulators in the U.S., Europe and elsewhere in seeking authorization to widen the use of its shots to include this younger age group. The company announced the interim data in a press release, and results haven’t yet been published in a peer-reviewed medical journal. * * * An FDA decision on the Pfizer vaccine in children [ages 5 to 11] could come soon, following an advisory panel meeting scheduled for Tuesday. 
  • The Centers for Disease Control informs us in a newly issued study on Delta variant cases

What is already known about this topic?

The SARS-CoV-2 B.1.617.2 (Delta) variant is highly transmissible; however, whether it causes more severe disease in adults has been uncertain.

What is added by this report?

Analysis of COVID-NET data from 14 states found no significant increases in the proportion of hospitalized COVID-19 patients with severe outcomes during the Delta period. The proportion of hospitalized unvaccinated COVID-19 patients aged 18–49 years significantly increased during the Delta period.

What are the implications for public health practice?

Lower vaccination coverage in adults aged 18–49 years likely contributed to the increase in hospitalized patients during the Delta period. COVID-19 vaccination is critical for all eligible adults, including adults aged <50 years who have relatively low vaccination rates compared with older adults.

From the COVID vaccine mandate front

  • The Equal Employment Opportunity Commission released new FAQ guidance on “Vaccinations – Title VII and Religious Objections to COVID-19 Vaccine Mandates.”
  • The Senate today confirmed the President’s nominee, Douglas Parker as Assistant Secretary of Labor in charge of the Occupational Health and Safety Administration by a 50 to 41 vote. Govexec adds that “Douglas Parker, most recently chief of California’s Division of Occupational Safety and Health, [will lead] the workplace safety agency that has about 1,800 employees. Parker previously served as deputy assistant secretary for policy in the Labor Department’s Mine Safety and Health Administration under the Obama administration and was part of the Biden transition team on worker health and safety issues.” OSHA is responsible for the pending vaccination screening program rule applicable to private sector employers with 100 or more employees.

On a related note, Federal News Network tell us that

The federal workforce used just slightly more than half of the funds Congress set aside earlier this year for a special emergency leave program.

The American Rescue Plan Act, which Congress passed into law in March, created a $570 million emergency paid leave fund that allowed federal employees to take time off for a variety of pandemic-related reasons.

Employees were each eligible for 600 hours, or 15 weeks, of paid leave to quarantine, recover from a personal infection or care for a family member sick with COVID-19. They could also use the emergency paid leave to recover from adverse symptoms after receiving the COVID-19 vaccine.

The Office of Personnel Management was responsible for administering the fund on behalf of the executive branch and U.S. Postal Service. OPM formally launched the program at the end of April.

Eligible federal employees had until Sept. 30 to request emergency paid leave, per the sunset date in the American Rescue Plan, or earlier if the funds were exhausted before that date.

From the cost and frequency of healthcare front —

  • The American Hospital Association issued a report about the cost of healthcare over the past decade / the first decade of the Affordable Care Act, particularly the cost of hospital care versus health insurance premiums.
  • Fierce Healthcare reports that “Common elective surgeries are starting to recover volume lost during COVID-19 lockdown measures, according to a new study by Epic Health Research Network. No common elective surgery is back at pre-pandemic volumes, though some are nearing it, the study found.”

From the Rx coverage front —

  • Healthcare Dive informs us that “National employer group the Purchaser Business Group on Health is starting a new company to develop healthcare products for large employers, frustrated by unmet need and rising costs. The venture, called Emsana Health, launched on Monday with its first business unit, a pharmacy benefit manager called EmsanaRx. Emsana will develop products designed with and for PBGH member organizations, which include Walmart, Costco, Microsoft, Intel and Tesla, among others, but products will be available to outside companies as well, a PBGH spokesperson confirmed.”
  • Fierce Healthcare adds that “The Mark Cuban Cost Plus Drug Company PBC also launched its own PBM this week, The Wall Street Journal reported. Cuban’s company aims to sell generic drugs at a transparent, fixed rate, and to achieve this united manufacturing, distribution and pharmacy services under one roof, according to the article. Cuban, a billionaire investor, told the WSJ he agreed to back the venture after receiving a pitch via email from its now-CEO, Alex Oshmyansky M.D., Ph.D. The PBM will begin to bid for clients next year and aims to be fully up and running by 2023, Oshmyansky told WSJ. “The supply chain for distributing pharmaceuticals to patients is so cumbersome and broken,” he told the outlet. “We decided the only way to get our drugs to the people who need them is to build a parallel supply chain where we have control of all the intermediary players and ensure the same level of transparency at every level.”
  • Health Payer Intelligence reports that “Prescription digital therapeutics (PDTs) coverage remains nascent, as the adoption rate is only at 40 percent among the minority of payers who have familiarity with PDTs, according to a survey that Avalere conducted for Pear Therapeutics. A post from the Institute for Patient Access defined PDTs most succinctly. ‘Prescription digital therapeutics are software programs that physicians prescribe as a form of treatment,’ the post explained. ‘The software captures patients’ information about symptoms or progress that can then be shared or remotely accessed by their providers. The technology has been found to help patients adhere to their treatment plans.’”

From the FEHB Open Season front, OPM today released a spreadsheet identifying those FEHB plans for which the 2022 employee contribution for self and one coverage will be more than the 2022 employee contribution for self and family coverage. In all cases the total premium for self and family coverage is more the total premium for self plus one coverage. The employee contributions become upside down due to the vagaries of the government contribution formula. It was a Congressional mistake to add the self plus one tier to FEHB given the relatively small family size in FEHB plans.