Weekend update

Telehealth

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.

Midweek update

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

From the COLA front, FedWeek informs us that

  • A federal retirement COLA of 5.9 percent will be paid in January to those retired under CSRS and 4.9 percent to those retired under FERS who are eligible for COLAs, increases that have been neared in recent decades only twice.
  • The announcement follows completion of the count toward that adjustment with release of the September inflation figure on Wednesday (October 13), which was up 0.4 percent. * * *
  • A 5.9 increase also will be paid on Social Security benefits. That’s primarily of interest to FERS retirees, for whom Social Security is a basic part of the retirement benefit, but also of interest to CSRS Offset retirees who have Social Security coverage as part of their benefit. Also, some “pure” CSRS retirees qualify for Social Security through from military service or earnings covered under that system before, after—and in some cases from outside earnings during—their CSRS working years. In many cases those benefits are reduced by the “windfall elimination provision” however. * * *
  • Congress appears to be on track to accept a raise payout by default of President Biden’s recommendation for a 2.7 percent average raise, with 2.2 percentage points to be paid across the board and the funds for the remainder divided up as locality pay.

From the Delta variant front, MedPage Today offers an interesting article on the efforts of primary care providers to convince their reluctant patients to receive a COVID vaccine.

[Australian social psychologist Matthew] Hornsey [observed] that in a world where the institutional memory of pandemics has been lost, only the perception of vaccine risk remains. With adverse effects making headlines daily, even in mainstream outlets, it’s hard to promote a message of safety.

David M. Oshinsky, PhD, a Pulitzer Prize-winning author and professor of medicine at NYU Grossman School of Medicine in New York City, noted the sense of euphoria with the polio vaccine, dubbed at the time as “the peoples’ vaccine.”

Well put.

Also, the Food and Drug Administration (FDA) staff today released their vaccination advisory committee briefing book on the one dose Johnson & Johnson vaccine. According to the Wall Street Journal’s report

A booster of Johnson & Johnson’s Covid-19 vaccine showed signs of significantly bolstering the immune defenses of study subjects, federal health regulators said Wednesday.  The regulators cautioned, however, that data was limited and that they had to rely on J&J’s own analysis for some of the study findings, rather than conducting their own.

The committee will take up the Modern booster tomorrow and the Johnson & Johnson vaccine as well as the topic of mixing and matching different COVID boosters on Friday.

From the telehealth front, Employee Benefit News reports that

Telehealth providers have found that their platforms are uniquely suited to address gaps in pediatric behavioral healthcare and are expanding their services to adolescents. Brightline, launched just before the pandemic, offers an “on-ramp” to behavioral health services, Allen says. The platform does an intake assessment and then provides education and 30-minute coaching services for parents and their children.

“Kids are actually more resilient using technology than we expected, and now there’s a strong preference for virtual first behavioral healthcare, because of the privacy and the comfort of delivering care in your home,” Allen says. “If Brightline hired every single pediatric therapist in the entire United States, we would still have a national shortage, so we instead use these tools to figure out what’s an appropriate care pathway and measure whether they’re working.”

From the Rx coverage front, STAT News informs us that Pfizer is backing up one of its expensive lung cancer drugs Xalkori with a insurance company backed warranty.

“In reality, this is for Medicare patients,” said Susan Raiola, president of Real Endpoints, an advisory and analytics firm that tracks reimbursement issues. Why? Medicare co-pays are used toward the so-called donut hole, the term used to describe a temporary limit on what Medicare will pay to cover a drug. The co-pays can add up, though, making refunds more desirable. * * *

To what extent warranties may become commonplace remains to be seen. But the concept may find takers among drug makers marketing high-priced treatments that cost $1 million or more, because winning reimbursement is challenging, according to Emad Samad, president of Octaviant Financial, a firm that is promoting the use of warranties in the pharmaceutical industry.

“So far, no one else has done this,” Samad said of the Pfizer program. “But where warranties will really come into play will be with high-cost treatments, such as gene and cell therapies. These companies will have to change commercial paths with these $1 million to $3 million drugs. They need tools – such as even more innovative warranty structures – so that payers can get comfortable with the varied outcomes potentially transformative therapies could have.”

From the medical devices front, Healthcare Dive informs us that the “FDA has awarded the latest crop of breakthrough device designations, granting regulatory privileges to investigational products including liquid biopsy tests for Alzheimer’s disease and bladder cancer. Check out the list.

From the medical research front, the National Institutes of Health announced that “A commonly available oral diuretic pill approved by the U.S. Food and Drug Administration may be a potential candidate for an Alzheimer’s disease treatment for those who are at genetic risk, according to findings published in Nature Aging. The research included analysis showing that those who took bumetanide — a commonly used and potent diuretic(link is external) — had a significantly lower prevalence of Alzheimer’s disease compared to those not taking the drug.” Fingers crossed.

Weekend Update

David Ermer–Congress, Federal employment benefits, Mental health care, Telehealth–

The U.S. House of Representatives is engaged in Committee business this week following Columbus Day and the Senate is on State work break / recess. The House also is expected to vote this week on the temporary debt limit increase.

The Medicare Open Season begins on Friday October 15.

From the Federal Benefits Open Season front, Federal News Network discusses the No Surprises Act (“NSA”) which takes effect on January 1, 2022. The NSA addresses three types of surprising billing — out of network emergency care; out of network care at in-network facilities and out-of-network air ambulance services. It does not address situations where the patient chooses out of network medical or mental health care or ground ambulance services. The article appropriately concludes

Of course, these [NSA] changes shouldn’t mean federal employees toss the basic rules of choosing an appropriate health insurance plan.

[Walt] Francis suggests FEHB participants check with their doctors each year to ensure they’re planning to stay within their preferred network — and then do some research about what new benefits are coming to your current plan and the others.

The plans change every year, and nearly all insurance providers add new benefits or perks to compete with others and respond to OPM’s priorities for the FEHBP.

From the mental healthcare front, the Wall Street Journal reported last week that “Finding a therapist who takes insurance was tough before the pandemic. Now, therapists and patients say, an increase in the need for mental-health care is making the search even harder.”

Especially in big cities such as Los Angeles, New York and Washington, D.C., demand for mental-health care is so strong that many experienced therapists don’t accept any insurance plans, they say. They can easily fill their practices with patients who would pay out of pocket, they add. Therapists who do take insurance are often booked up. And in many smaller towns and rural areas, there are few mental-health professionals at all. Finding a provider who takes insurance, or lowering your rates in other ways, is possible but often takes legwork that can be draining when you are already grappling with mental-health issues.

[Among other approaches] Telehealth can provide access to a broader pool of providers, including therapists who are farther away from you. [Health plan sponsored telehealth providers are always in network.]

Insurance companies say they are trying to increase access to therapists. Anthem Inc. says it added about 2,000 additional providers to its telehealth platform during the early days of the pandemic to handle increased demand. UnitedHealth Group Inc. says it has grown its network of mental-health-care providers by 50% in the past five years to more than 260,000 nationwide.

As for therapists’ complaints of low reimbursement rates, Anthem health plans “routinely review reimbursements to ensure that providers receive market rates,” the company said in a statement. Margaret-Mary Wilson, UnitedHealth Group’s associate chief medical officer, says the company uses data on how patients are improving to financially “reward providers for delivering care with better outcomes.”

Fortune offers a fascinating article about Aetna’s preventive approach to mental health care. Among other tools the authors point out

Employee Assistance Programs (EAPs) are also valuable modes of preventing escalated mental health concerns, as they provide 24/7 life assistance across a wide range of issues that can lower risks of feeling overwhelmed, anxious or depressed. In fact, one study found that companies with EAPs see a 24% improvement in life satisfaction and a 10% reduction in workplace distress among their workers. But we need to better inform people that EAPs are more than a workplace productivity tool. Aetna’s Resources for Living, which provides EAP services,is one example of a resource that supports those facing stress and anxiety, family conflict, legal and financial issues, grief and loss and even loneliness among our Medicare members.

Federal agencies and the Postal Service offer robust employee assistance programs to their employees independent of the FEHB Program and the FEHBlog’s view OPM should put more emphasis on coordinating such related services.

Thursday Miscellany

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

From Capitol Hill, Roll Call reports that

The Senate passed a temporary debt limit increase along party lines Thursday evening, a move that would give the Treasury Department at least a couple of months before it once again bumps up against its legal borrowing cap.

The 50-48 vote sent the bill to the House, where that chamber will need to clear the measure before it heads to President Joe Biden. That vote, likely next week, could be tricky given GOP opposition to the short-term patch and Democrats in that chamber barely backing a longer suspension of the debt limit late last month.

Karine Jean-Pierre, the White House’s principal deputy press secretary, said Biden “looks forward to signing” the debt limit measure after it clears.

The Senate amended the House bill, which passed 219-212, replacing a longer debt ceiling suspension with a $480 billion increase in Treasury’s borrowing cap designed to last into early December, though it may go a little longer.

The current continuing appropriations resolution is set to expire relatively contemporaneously on December 3, 2021.

From the Federal Benefits Open Season front, federal benefits consultant Tammy Flanagan has posted her first GovExec column on this year’s Open Season while GEHA, the second largest plan in the FEHB, has posted information on its 2022 benefits.

From the Delta variant front, Healthcare Dive informs us that

Pfizer and BioNTech have officially asked U.S. regulators for emergency clearance of their coronavirus vaccine in children between 5 and 11 years old, making the developers the first to seek authorization for younger kids.

Thursday’s announcement, which Pfizer made on Twitter, comes nine days after the companies said they had started submitting data to the Food and Drug Administration in support of their application, which, if authorized, could make more than 28 million children in the U.S. eligible for vaccination.

The FDA has already scheduled an Oct. 26 advisory panel to discuss the vaccine’s potential authorization in children, more and more of whom have been infected and hospitalized as the delta variant spread and the school year began. Clearance is reportedly expected in November, though the evaluation could be complicated by turnover within the agency’s vaccine review office.

From the healthcare business front —

Healthcare Dive tells us that

Total revenue of hospital M&A so far this year dipped only slightly from last year despite the number of deals being nearly cut in half, according to a Wednesday report from Kaufman Hall.

The average seller size of $659 million was well above year-to-date average going back to 2015, the earliest year featured in the report. This year’s third quarter included the Intermountain Health merger with SCL Health to create an $11 billion system and HCA’s buy of five Steward Health hospitals in Utah.

Hospitals are increasing looking outside traditional care delivery methods to diversify business models by pursuing stakes in home health, virtual care and post-acute services. They are also identifying strategic partnership with payers, physicians groups and other adjacent sectors, Kaufman Hall said.

United Healthcare’s subsidiary Optum announced a collaboration with SSM Health, a Catholic health system in the Midwest.

Together, the organizations will work to improve the overall well-being of individuals and communities – while addressing the complex social and economic factors affecting each person’s health.

SSM Health and Optum will partner across certain functions – including inpatient care management, digital transformation and revenue cycle management – to improve health outcomes and patients’ health care experiences. The organizations also will collaborate to redefine the consumer health care journey through the design and development of a seamless digital experience to simplify patient access to the care and services they need.

“Creating a new ecosystem of care requires bringing together the best and the brightest to collaborate for the common good,” said Laura S. Kaiser, FACHE, president and chief executive officer, SSM Health. “The commitment of UnitedHealth Group and Optum to improving health care experiences and outcomes for everyone aligns well with SSM Health’s Mission to ensure all people have access to high-quality, compassionate and affordable care. We are excited to partner with them to achieve our vision of transforming health care in America – and address the health equity gap for the most vulnerable in society.”

To help advance health equity, UnitedHealth Group and SSM Health will jointly invest in vital community health programs to ensure the disadvantaged and vulnerable have equal access to quality health care services. These efforts will focus on closing the health equity gap and critical health priorities in the communities SSM Health serves throughout the Midwest.

Medcity News reports that

Primary and urgent care provider Carbon Health is expanding its service offerings with a new acquisition.

The San Francisco-based company has bought Alertive Healthcare, a remote patient monitoring provider, for an undisclosed sum. Alertive Healthcare provides a suite of RPM tools across a range of specialties, including primary care, cardiology, neurology and nephrology. * * *

Carbon Health launched in 2015 and has raised upwards of $522 million in funding, according to Crunchbase. Its goal is to become the “Starbucks of healthcare.”

As of August, Carbon Health operated 83 clinics across 12 states following its acquisition of Tucson, Arizona-based Southern Arizona Urgent Care and Sacramento, California-based Med7 Urgent Care.

From the telehealth front, Healthcare Dive reports that

Teladoc Health on Wednesday announced it is making its virtual primary care pilot broadly available to commercial health plans, employers and other benefits sponsors nationwide.

The Primary360 service, which the New York-based telemedicine giant has been piloting for the past few years, is currently being used by several large companies, and will be available through CVS Health-owned payer Aetna early next year, Teladoc said in a release.

The vendor hopes Primary360 will serve as an access point to the primary care system while enticing patients to its other services like specialty care and mental health to boost business.

From the miscellany department, Healthcare Dive interviewed the CEO of Morgan Health.

The mission of J.P. Morgan’s new healthcare venture is to innovate employer-sponsored healthcare, not just for the investment bank’s massive employee base but eventually for all 150 million Americans receiving coverage through their job. But it’s a lofty goal for the small business unit, called Morgan Health, launched late May, and there are many skeptics of efforts from major employers looking to disrupt the deep-rooted and complex healthcare industry.

Check it out.