Happy Veterans’ Day

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Happy Veterans’ Day

David Ermer–COVID-19, HSA, OPM, Telehealth–
Thanks to Justin Casey for sharing their work on Unsplash.

Happy Veterans’ Day! Here’s a link to the OPM Director’s thoughts on this day as posted in OPM’s Medium channel.

Roughly 30 percent of the federal workforce has served our nation in uniform, and at OPM, we are working hard to welcome more. We are the guardians of the competitive hiring process, which includes ensuring that agencies are properly applying the Veterans’ preference rules. Much like in our recently expanded Military Spouse Hiring Authority, we recognize the unique leadership qualities on display in military households. We are eager to honor their contributions and match their skills with the needs of the American people.

From the Open Season advice front, Tammy Flanagan writes about FEHB high deductible health plans (“HDHP”), enrollment in which allows a federal or postal employee to contribute to a health savings account (“HSA”).

In 2022, for each month you are eligible for an HSA, you will receive a premium pass through, which is portion of your monthly health plan premium that is deposited to your HSA each month. You can make additional tax-free contributions to your HSA, as long as total contributions do not exceed $3,650 for an individual and $7,300 for a family.

In many of the FEHB HDHP plans, the premium pass through amount ranges from $75 to $100 per person per month, which can go a long way toward offsetting the high deductibles that are inherent to this kind of plan. There’s no time limit for withdrawing money from an HSA to pay for [healthcare ]expenses.

HSA contributions and related income are never federally taxed as long as the money is used for healthcare expenses. The trick is to grow the funding in an HSA before you hit high out of pocket medical spending for raising a family or in retirement.

It’s also worth noting that the alway informative Reg Jones has been writing about Open Season in FedWeek for the past three weeks.

In related news, Health Payer Intelligence discusses the Medicare Advantage open season also now underway.

Medicare Advantage has seen a lot of growth in recent years and that trend is set to continue into 2022, as evident in the number of plan offerings for the Medicare Advantage 2022 open enrollment season, according to a Kaiser Family Foundation (KFF) issue brief.

“As Medicare Advantage enrollment continues to grow, insurers seem to be responding by offering more plans and choices to the people on Medicare,” the researchers explained. Payers are offering a total of more than 3,800 Medicare Advantage plans in 2022. Nearly nine out of ten of these health plans are Medicare Advantage-prescription drug plans. 

In FSAFeds news, the Internal Revenue Service announced its 2022 inflation adjustments to various and sundry tax matters. Rev. Proc. 2021-45. Of note,

For taxable years beginning in 2022, the dollar limitation under § 125(i) on voluntary employee salary reductions for contributions to health flexible spending arrangements is $2,850. If the cafeteria plan permits the carryover of unused amounts, the maximum carryover amount is $570.

These increases are not automatic, but rather are triggered by employer action to amend the underlying plan.

From the COVID vaccine mandate front —

  • The Safer Federal Workforce Task Force has updated its guidance and FAQs for federal contractors. The best guidance currently available to contractors is the Task Force’s guidance document supplemented by the FAQs.
  • Federal News Network brings us up to date on the federal employee lawsuits challenging the vaccine mandate imposed on them. The Courts have turned away the plaintiffs’ requests for stays / preliminary injunctions on the employee mandate based on failure to meet the high standards for that extraordinary relief.

From the telehealth front, Healthcare Dive tells us that

As the delta variant surged in the third quarter, virtual care giant Amwell saw its urgent care volumes spike, while specialty care and behavioral health visits came in below expectations. That’s a sharp turnaround from the first half of the year, when urgent care volumes, specialty care and behavioral health visits grew together, analysts noted.

Urgent care visits are cheaper, however, so the higher urgent care mix had an unfavorable impact on total revenue per visit. Amwell’s revenue was down less than 1% year over year to $62.2 million, lower than Wall Street expectations though the Boston-based telehealth vendor’s earnings squeaked in slightly above forecasts.

To account for expected decreases in visit volume and the shift in visit-type mix toward urgent care versus specialty due to delta, Amwell lowered its full-year revenue guidance.

Friday Stats and More

David Ermer–AHRQ, COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, OPM, Telehealth–

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the wee, here is the FEHBlog’s weekly chart of new COVID cases this year:

New cases plateaued this week. Weekly new COVID hospitalizations continue their down trend. For the latest week, the number of new admissions was 5,025 compared to a peak of 16,478 in the first week of 2021.

The number of COVID-related deaths continues it decline according the FEHBlog’s chart:

Distribution and administration of COVID vaccines was up sharply the past two weeks. At least one million doses were administered daily last week.

Here’s a link to the CDC’s weekly interpretation of its COVID statistics. Notably,

As of November 4, 2021, 426.7 million vaccine doses have been administered. Overall, about 222.6 million people, or 67% of the total U.S. population, have received at least one dose of vaccine. About 193.2 million people, or 58.2% of the total U.S. population, have been fully vaccinated.* About 21.5 million additional/booster doses in fully vaccinated people have been reported. As of November 4, 2021, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 1,510,524, a 55.8% increase from the previous week.

The best news is Pfizer’s announcement of a successful trial of antiviral pill to tame early COVID.

  • PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
  • In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
  • Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible

The Merck pill that Great Britain approved this week and the FDA will consider this month had the following reporting efficacy in its trial —

  • At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died

The FEHBlog points this out to illustrate the strength of the Pfizer pill not to downplay the Merck pill.

The public health strategy for defeating COVID always has been a combination of testing, drugs, and vaccines. Nobody expected the vaccines to lead the pack, but the FEHBlog is grateful that testing and drugs finally are catching up to the wonderous vaccines. You combine these new drugs with rapid at home tests like the recently FDA approved FlowFlex on top of the vaccines, and you are left with endemic COVID in the FEHBlog’s view. As the FEHBlog is not a medical expert, let’s close this section with a squib from STAT News:

The development of oral medicines that can be used to treat Covid early on could blunt the impact of the pandemic.

Nahid Bhadelia, the founding director of the Center for Emerging Infectious Diseases Policy & Research at Boston University, called oral antiviral pills “incredibly important” because existing treatments such as monoclonal antibodies must be given intravenously or as shots.

“With an oral antiviral, patients have more time and greater access to a treatment that will keep them out of the hospital,” Bhadelia said. “But the promise of oral antivirals will only be recognized if they’re available at your local pharmacy, and you can afford it, and you can get the test that tells you that you’re positive for Covid, so you can actually take advantage of this drug. So, the promise is there, but the rest of the pieces need to come together.”

From the tidbits department —

Morning Consult reports that

  • 72% of U.S. adults who have used telehealth said they’ve accessed virtual care through their regular provider or health plan, while another 17% have gotten care through a direct-to-consumer platform and 11% have used both types of services.
  • 53% of U.S. adults said they’d rather use in-person health care than telehealth moving forward, but that share fell to 45% among those who have used telehealth in the past.
  • Among the challenges for on-demand telehealth is getting coverage for the services, as traditional payers and providers roll out their own virtual care options.

The HHS Agency for Healthcare Quality and Research reports that

The Lehigh Valley Health Network (LVHN) used an AHRQ initiative to expand treatment for opioid use disorders in Pennsylvania. As a result, primary care physicians are now using medication-assisted treatment to care for their patients with opioid use disorders.  This new practice has been a success; as of fall 2021, 75 percent of patients who initiated treatment have returned in the following calendar month to continue treatment. With addiction treatment, this number of returning patients represents a major improvement, as most patients traditionally end treatment quickly.

With eight hospitals and numerous health centers, physician practices, rehabilitation locations, and other outpatient locations, LVHN serves patients in seven eastern Pennsylvania counties. LVHN used AHRQ resources to integrate treatment for opioid use disorder into primary care practice.

“In one visit, a patient can get his diabetes and blood pressure medications, plus his medication for opioid use disorder, without feeling the judgement of going to an addiction specialist,” noted Gillian A. Beauchamp, M.D., LVHN emergency physician. “When you’re sitting in a primary care waiting room, nobody knows why you’re there, so you don’t feel the stigma you might in another setting of care.”

Bloomberg tells us that

Even though the [COVID pandemic] upheaval increased risk factors for suicide like financial stress, the number of Americans who took their own lives decreased by 3% in 2020, the Centers for Disease Control’s statistical group reported this week

Suicides had increased steadily this century before peaking in 2018 with 48,000 annual deaths. That number declined slightly in 2019 and continued to drop in 2020, to less than 46,000, according to the CDC’s provisional data. In April, when shutdowns were most severe, the U.S. saw the lowest number of suicides in any month of 2020, 14% below the previous year’s total that month.

Federal News Network reports

In an ongoing effort to inject more young talent into the federal workforce, the Office of Personnel Management is out with yet another new hiring policy.

The latest policy, which OPM will publish as an interim rule Friday, is designed to help agencies more easily recruit and hire recent college graduates into administrative and professional positions in the federal government.

The new hiring policy means agencies can noncompetitively appoint qualified and eligible college graduates to permanent career positions at or below the General Schedule 11 level, OPM said. In a blog post on the new policy, OPM Director Kiran Ahuja said recent gradates have a chance to earn up to $72,000 a year under this new authority.

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.

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.”

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.”

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Telehealth, U.S. Healthcare–

The U.S. House of Representatives and the Senate again will be engaged in Committee business and floor voting this week. According to the Hill, the House leadership is aiming to vote on the massive social spending / budget reconciliation bill next Sunday October 31. “We have 90 percent of the bill agreed to and written. We just have some of the last decisions to be made,” [Speaker Nancy] Pelosi said on CNN’s “State of the Union.”

From the Delta variant front —

  • Bloomberg reports that “Top U.S. health officials signaled confidence that children ages 5 to 11 will begin getting Covid-19 vaccines by early November. The Pfizer vaccines will likely be given at pediatricians’ offices rather than at pharmacies or large sites.”
  • Medpage Today informs us that “The CDC has begun to provide weekly data on COVID-19 cases and deaths by vaccination status, illustrating the stark differences between those who have received the shots and those who haven’t — and even revealing some differences [among] vaccines.”
  • Precision Vaccinations discusses the likely evolution of the fully vaccinated against COVID definition in our country.

From the healthcare business front —

  • Healthcare Dive tells us that Lyft named Buck Poropatich as its new head of healthcare, according to an email statement sent Friday. Poropatich joined the company in 2019 and previously served as the director of healthcare strategy. * * * The ride-hailing giant wants to continue capitalizing on non-emergency medical transportation, and Poropatich has been instrumental in that expansion, along with finding new use cases in the sector, Lyft said.”
  • Fierce Healthcare reports that “Consumer genetic testing company 23andMe plans to buy Lemonaid Health, a virtual care and pharmacy provider, to integrate its personalized genetics service more deeply into primary care. 23andMe, which went public in June via a merger with Richard Branson’s blank check company, will pay $400 million for Lemonaid Health, with 25% of the purchase price in cash and the rest in shares of 23andMe. The acquisition is expected to close by the end of 2021. The acquisition adds Lemonaid Health’s telemedicine and prescription drug delivery services to 23andMe’s consumer business.”
  • Health Dive also lets us know that “Oak Street Health, a value-based primary care network for seniors, has acquired virtual specialty provider RubiconMD for $130 million, integrating specialty care into its existing care model. New-York based RubiconMD offers a platform providing access to medical specialists across 230 specialties, including cardiology, nephrology and pulmonology. The deal, announced Thursday, comes as major U.S. clinical networks increasingly build out their suite of services to jockey for employer and payer clients in the increasingly competitive space.”
  • Mobihealth News reports that “Virtual addiction treatment Workit Health raised $118 million in Series C funding led by Insight Partners. Other investors participating in the round include CVS Health Ventures, FirstMark Capital, BCBS Venture Fund, and 3L Capital. ‘Workit is at the forefront of massive acceleration in telemedicine adoption, which is key to solving the overdose crisis that was exacerbated by COVID-19. The risk factors associated with substance use have dramatically increased,’ Lisa McLaughlin, Workit Health’s co-CEO, said in a statement.  ‘This latest funding round helps us grow our relationship-based, telehealth-first, value-based approach into new regions that are in desperate need of simple and trusted solutions like Workit.’

Last Friday, the FEHBlog spoke with a group of federal annuitants at a client’s membership conference. Suffice it to say the FEHBlog thinks it is important for plans to promote OPM’s FEHB Fast Facts on FEHB and Medicare on their websites.

Last Thursday, the FEHBlog post about an OPM edit to Section 3 of the 2022 FEHB Significant Events Changes benefit administration letter. The FEHBlog noticed that he unintentionally cut off the copy of the edited section of the BAL. For that reason, here is a link to a complete copy of the revised BAL. Lo siento readers.

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Delta variant front, Health Magazine informs us that “Former FDA Chief Scott Gottlieb, MD, calls for research into UK Surge of New Delta Plus Variant, AY.4.2 While not yet singled out as a concern in the US, the new Delta subtype prompted a reminder that the world needs ‘robust systems’ to identify up-and-coming threats.” Ruh roh?

The Wall Street Journal reports that

The Food and Drug Administration [FDA] is moving to soon allow people to receive booster shots that are different from their first Covid-19 vaccine doses, people familiar with the matter said. 

The FDA won’t recommend any booster over the others but will permit people to get a booster shot that is different from the shot they first received, one of the people familiar with the matter said.

The FDA is seeking to authorize mixing and matching as soon as this week, the people familiar with the matter said. The FDA is also expected to approve Moderna Inc. and Johnson & Johnson boosters this week, according to a person familiar with the matter.

If you find the last sentence somewhat confusing, at this point, only the FDA’s vaccine advisory committee has approved the Moderna and Johnson & Johnson boosters. The acting FDA commissioner Janet Woodcock has to act on that guidance. Once Dr. Woodcock acts then her decision moves to the Centers for Disease Control for its decision.

The FEHBlog noticed today that the Office of Management and Budget’s Office of Information and Regulatory Affairs has held twenty five stakeholder listening sessions so far on the OSHA vaccination screening program rule that will apply to businesses with 100 or more employees. The rule arrived at OIRA last Tuesday October 12. The large number of listening sessions suggests to the FEHBlog that OIRA wants to wrap up its work expeditiously. The OIRA approved rule will be published in the Federal Register.

From the federal employee benefits front, Federal News Network informs us that

The Office of Personnel Management has proposed expanding eligibility for the Federal Employees Dental and Vision Insurance Program (FEDVIP) to include certain temporary and seasonal workers, among others.

OPM will publish a draft rule Tuesday in the Federal Register, which will describe several recommended FEDVIP changes, including new clarifications and provisions designed to make it easier for certain employees to alter their enrollment with the program outside of the traditional open season window.

Federal employees on temporary, seasonal or intermittent schedules — specifically those who work 130 hours a month for at least 90 days — [plus seasonal firefighters] would become eligible to enroll in FEDVIP under OPM’s draft policy.

OPM expanded eligibility for the Federal Employees Health Benefits Program (FEHBP) to this group back in 2014, and the agency’s proposed rule would simply allow temporary and seasonal workers to enroll in FEDVIP as well.

[T]o give [the 86,000] federal and USPS workers on temporary, seasonal and intermittent schedules a chance to enroll for the first time in FEDVIP, OPM envisions giving newly eligible employees a 60-day window after the date that it finalizes this new policy.

The preamble to the proposed rule notes that “As of August 3, 2021, FEDVIP has 5.4 million enrollees with approximately 7.3 million covered individuals.” The FEHB Program’s enrollment is evenly split between 2 million employed enrollees and 2 million retired enrollees plus 4 million eligible family members for a grand total of eight million. The FEHBlog understands why they are more enrollees in FEDVIP because Congress recently added certain TRICARE eligible folks to the FEDVIP program. But why does FEDVIP have the only half the number of eligible family members found in the FEHB Program? Does the FEHB Program offer adequate dental coverage for children? The FEHBlog has never explored that angle.

OPM has bulked up the family member status information and documentation found on its FEHB eligibility website.

From the Rx coverage front, the FDA today approved for marketing “the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for),  its reference product Humira (adalimumab) for Cyltezo’s approved uses.” Humira is a blockbuster drug which suggests big health system savings from this action. However, STAT News adds that those savings will not be realizable until June 2023 due to a Humira patent settlement. Furthermore

The FDA approved a biosimilar version that will only be available in low-dose concentrations. But three years ago, AbbVie began shifting patients to high-dose concentrations of Humira, which contain fewer excipients that often cause burning and discomfort when the medicine is injected. In fact, high-dose concentrations now account for 80% of the market, according to Bernstein analyst Ronny Gal.

The situation “is not so straightforward,” Evercore ISI analyst Josh Schimmer wrote in an investor note.

In its view, however, Boehringer Ingelheim believes Cyltezo should be considered to have the same “strength” as the corresponding original concentration and high-concentration versions of Humira, because they contain the same total drug content per container.

Nothing is simple when it comes to specialty drugs.

From the benefit design front, STAT News tells us that

The pandemic prompted a mad dash to figure out how to deliver health care virtually. As the dust settles, UnitedHealthcare, the country’s largest insurer, is laying the foundation for the future with a health plan built primarily around telemedicine services designed to be more affordable and accessible.

Called NavigateNOW, the new virtual-first plan will offer care for common services without a copay, including both in-person and virtual primary and behavioral health care, virtual urgent care, and most generic medications. UnitedHealthcare said plan premiums will be about 15% cheaper. The new offering, announced Monday, comes as both legacy insurers and startups are beginning to offer new flavors of health plans that combine conventional and digital services to offer a hybrid kind of care.

NavigateNOW enrollees will have 24-hour access to a virtual health team that includes primary, behavioral, and urgent care through UnitedHealth Group subsidiary Optum, which will also provide in-person care when necessary. Unlike some competitors, United will use its homegrown technology infrastructure to deliver the virtual care.

On a related note Healthcare Dive reports that

Seven months after announcing plans to merge, virtual care company Doctor on Demand and clinical navigator Grand Rounds are launching a new brand for their combined company: Included Health.

The name is meant to stress how the entity offers mental and behavioral healthcare, primary care, chronic care, specialty care, care for LGBTQ individuals and patient navigation tools all under the same roof, Included President Robin Glass and Chief Medical Officer Ian Tong told Healthcare Dive.

The inspiration for the rebrand came from Included Health, a care navigation platform for the LGBTQ community, which Doctor on Demand and Grand Rounds acquired in May in a bid to strengthen their offerings for the underserved population. Included, which covers just under 100 million members, declined to share how much it is investing in the rebrand.

Weekend update

David Ermer–Congress, Rx coverage, Telehealth, U.S. Healthcare–

Both the U.S. House of Representatives and the Senate will be engaged in Committee business and floor voting this coming week.

From the telehealth front —

Fierce Healthcare discusses the state of the telehealth marketplace.

“Ten years ago, Doctor On Demand, MDLive and Amwell had the market onto themselves. Largely, in part, due to pandemic, but also with reimbursement policy changes and innovation and an emerging tech side of the market, this has all driven new entrants to what you think of as the classic telehealth space,” Jeff Becker, principal healthcare analyst at CB Insights, told Fierce Healthcare.

The competition is “coming from everywhere,” Becker said, noting that the incumbent telehealth players traditionally generated revenue from one-off urgent care, low-acuity care and primary care visits handled virtually.

“Now you have Heal and DispatchHealth sending clinicians to your house or workplace to compete for that same urgent care book of business. You have Forward and One Medical with direct primary care and they, with a lot of venture backing, are competing for that one-off primary care, urgent care telehealth book of business,” he said.

There are also startups providing remote patient monitoring and virtual chronic disease management with a focus on specialty conditions, such as Monogram Health for chronic kidney disease patients and Hinge Health, which focuses on musculoskeletal pain. And there are digital health companies like Hims & Hers and Ro that offer prescription drug delivery and telehealth visits.

  • What’s more, on Friday October 15, Walmart, which also is engaged in the telehealth market, and Transcarent, which sells in the digital marketplace,

announced they would be working together as go-to-market partners for self-insured employers across the country. The agreement allows Transcarent, which offers employees and their dependents a new, different, and better health and care experience, to share Walmart’s everyday low-cost on pharmaceuticals and other services with self-insured employers and their employees for the first time.

The collaboration makes it easier for millions of employees and the families of self-insured employers to access high-value care – no matter where they live – at affordable prices. This new offering will allow employers of all sizes to leverage Walmart’s healthcare size and scale to more easily provide their employees convenient care and cost-effective health and wellness options.

  • mHealth Intelligence further informs us that

Several large health systems have formed a coalition to support strategies that use telehealth and remote patient monitoring to provide acute care for patients at home.

The Advanced Care at Home Coalition builds on both the surge in remote patient monitoring [RPM] programs during the pandemic and the Acute Hospital at Home Program, launched in late 2020 by the Centers for Medicare & Medicaid Services. That program, which now involves more than 100 hospitals and health systems across the country, offers CMS waivers for a home-based care management plan to treat patients who would otherwise require hospitalizations for a broad range of acute conditions, including asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease (COPD). Treatment plans combine RPM and telehealth with in-person care.

The coalition was launched by the Mayo Clinic, Medically Home and Kaiser Permanente, and includes Adventist Health, ChristianaCare, Geisinger Health, Integris, Johns Hopkins Medicine, Michigan Medicine (the University of Michigan), Novant Health, ProMedica, the Sharp Rees-Stealy Medical Group, UNC Health and UnityPoint Health.

From the Rx coverage front, this coming Saturday October 23 is the latest Drug Enforcement Administration National Rx Take Back Day allowing consumers to conveniently and safely dispose of unused prescription and over the counter drugs.

From the medical research front, Health Payer Intelligence tells us that

Using predictive analytics, University of Chicago researchers have developed a method to determine an eventual diagnosis of autism spectrum disorder (ASD) in young children. The new computational approach gathers data using diagnostic codes from previous doctor’s visits, eliminating the need for blood work or procedures to make a diagnosis.

According to researchers, this method reportedly reduced the number of false-positive ASD diagnoses produced by traditional screening methods by half. ASD can be diagnosed as early as two years old. However, false positives flagged by the initial screens commonly used today can delay confirming a true diagnosis.

With the importance of early intervention and the limited number of trained professionals, tools that can potentially reduce the number of patients required to undergo the lengthy, multistep process to receive an official positive diagnosis can significantly impact patient care.