Tuesday’s Tidbits

Congress

Tuesday’s Tidbits

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

From the Open Season advice front, here are recent articles from FedSmith and Govexec .

From Capitol Hill, FedWeek reports that last Wednesday Nov. 3

The Senate Homeland Security and Governmental Affairs Committee has approved:

HR-2662, to give agency IGs authority to subpoena former federal employees; require an administration to provide a “substantive rationale, including detailed and case-specific reasons” prior to removing an IG; limit the use of administrative leave for IGs, including during the 30 days following the removal announcement; require acting IGs to be selected from among senior-level employees within the watchdog community; and require regular training to IG employees on their whistleblower rights.

The House already has passed the HR 2662. The Senate Committee amended the House bill before voting to sending the “favorable” substitute bill to the Senate floor for a vote.

From the Delta variant front Medscape informs us that

Pfizer and its European partner BioNTech have asked the US Food and Drug Administration (FDA) to expand emergency authorization of its COVID vaccine to allow everybody 18 and older to get a booster dose.

If it goes through, the broader use of Pfizer boosters would be a step toward President Joe Biden’s goal of boosters for all adults. He announced the goal last August but backed off to let the regulatory process by the FDA and the Centers for Disease Control and Prevention (CDC) play out.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to a company news release.

This would be Pfizer’s second bite at the FDA apple for this approach to its booster.

Govexec informs us from the Delta variant vaccine mandate front that

VA Secretary Denis McDonough spoke at the National Press Club in Washington, D.C. on Tuesday afternoon, which came after the October 8 deadline for health care employees to get vaccinated but before the November 22 deadline for the rest of the federal workforce. 

“We’re still getting all of our data together,” he said. As of this morning, about 91% of the health care professionals at VA “have uploaded their data,” which could be proof of vaccination or requests for one of the exemptions. This is up from about 70% about two and a half weeks ago. 

“We’re not going to question the legitimacy of anyone’s individual declaration of a religious exception,” McDonough said. However, “we may find ourselves in a situation where, for example, in an oncology department or in a spinal cord injury facility or in an intensive care unit…or community living center[s], we may have so many people who have claimed a religious exemption that we can’t safely provide care to our veterans in those vulnerable situations, in which case we reserve the right to deny religious exemptions.” 

Fedweek cautions that “Both supporters and opponents of the Coronavirus vaccine mandate expect it to increase turnover among federal employees, although it is hard to say how large that increase will be and how much of it will be involuntary versus voluntary.”

From the No Surprises Act (NSA) front, the FEHBlog noticed that the Centers for Medicare and Medicaid Services has created a public NSA website. Posted on the site is an October 25, 2021, CMS letter announcing required federal government website and contact information to be included in the consumer notice about the NSA and other NSA related documents.

Website: https://www.cms.gov/nosurprises/consumers. Note, consumer and provider functionality for complaints inquiry and triage will not be operational until January 2022.

Phone number for information and complaints: 1-800-985-3059.

We ask regulated entities not to include the above phone number in any plan documents for any plan or policy years that begin before January 1, 2022.

In other healthcare news

Per Fierce Healthcare, here are the 10 most cost-efficient hospitals in the U.S., according to the Lown Institute: 

  1. Pinnacle Hospital (Crown Point, Indiana)
  2. Saint Mary’s Regional Medical Center (Reno, Nevada)
  3. Mercy Medical Center Dubuque (Dubuque, Iowa)
  4. Encino Hospital Medical Center (Encino, California)
  5. Park Ridge Health (Hendersonville, North Carolina)
  6. Oroville Hospital (Oroville, California)
  7. Saint Michael’s Medical Center (Newark, New Jersey)
  8. UnityPoint Health – Meriter (Madison, Wisconsin)
  9. East Liverpool City Hospital (East Liverpool, Ohio)
  10. Maple Grove Hospital (Maple Grove, Minnesota)

“Overall, if all hospitals performed as well as the most cost-efficient hospitals, Medicare would save $8 billion each year.”

Healthcare Dive informs us that

Nonprofit health giant Kaiser Permanente’s operating margin continued to shrink in the third quarter as expenses grew faster than revenue, spurred by labor unrest and surging COVID-19 patients, the Oakland, California-based integrated health system said.

Kaiser reported $38 million in operating income in the quarter, on $23.2 billion in revenue. That’s a 0.2% operating margin — exceedingly low compared to a margin of 2.1% same time last year. 

The 39-hospital system’s expenses in the third quarter grew 7.5% year over year to $23.1 billion, while revenue only increased 5.5%. Kaiser said the expense growth was due to higher costs from COVID-19 patients and workforce requirements, as — like other hospital operators — Kaiser has had to pay more for travel nurses and other contract labor to meet rising patient levels during the pandemic.

Weekend update

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, U.S. Healthcare, Uncategorized–
Lincoln Memorial in the Fall

The Senate is on a State work break this week which includes the Veterans’ Day holiday on Thursday. The House of Representatives is not holding votes this week but a handful or so of Committee hearings are scheduled for Tuesday and Wednesday.

Roll Call tells us that

Buoyed, finally, by forward movement on a larger package of President Joe Biden’s domestic priorities, the House late Friday cleared a Senate-passed bipartisan infrastructure bill that pours billions of dollars into roads, bridges, water systems, transit and broadband.

The long-awaited House vote sends the bill, which passed the Senate in August, to Biden for his signature. 

The House vote was 228-206, with 13 Republicans backing it despite GOP leadership whipping against the bill. All but six Democrats voted for the measure, despite the House not voting in tandem on the larger budget reconciliation package as progressives had demanded for months. 

Instead, Democrats were forced to accept a vote to adopt the rule that sets debate parameters on the reconciliation bill as a sign of progress on that measure. 

Under that rule, the House is expected to vote on the social spending / climate budget reconciliation bill during the week of November 15. The additional week is expected to allow the Congressional Budget Office to release its report on this massive spending bill

With respect to the infrastructure bill the Wall Street Journal explains that ‘

The $1 trillion package would invest in refurbishing aging roads, bridges and ports; easing transportation bottlenecks; replacing harmful lead pipes; expanding internet access; upgrading the nation’s power grid; and boosting infrastructure resilience amid growing concerns over climate change. The spending is to be paid for with a variety of revenue streams, including more than $200 billion in repurposed funds originally intended for coronavirus relief but left unused; about $50 billion from delaying a Trump-era rule on Medicare rebates; and $50 billion from certain states returning unused unemployment insurance supplemental funds.

From the COVID vaccine mandate front, the Wall Street Journal reports that the U.S. Court of Appeals temporarily stated the OSHA vaccination screening program rule applicable to private sector employers with 100 or more employees plus the Postal Service.

A three-judge panel on the New Orleans-based Fifth U.S. Circuit Court of Appeals granted an emergency stay prohibiting enforcement of the rules for now, saying they raise “grave statutory and constitutional issues.” The Fifth Circuit said it would quickly consider whether to issue an injunction against the vaccine and testing requirements, ordering the Biden administration to file initial legal papers by late Monday afternoon.

OSHA issued this emergency rule under a law providing that challenges to such rules should be brought in the U.S. Court of Appeals rather than the lower District Courts. That’s a quicker path to Supreme Court review.

Roll Call discusses federal government contractor concerns about legal risks arising from the unclear federal vaccine mandate. The Federal Acquisition Regulation implementing the President’s executive order is still weeks away. In the meantime, contractors have to rely on the Safer Federal Workforce Task Force’s subregulatory FAQs. The Task Force typically issues new FAQs on a weekly basis.

From the Delta variant front, the American Medical Association discusses the available evidence on the utility of COVID booster mixing and matching which the Food and Drug Administration recently authorized.

In other vaccine news, Precision Vaccines reports on a Lancet study on the high value of HPV vaccine:

The Lancet published a review of the UK’s national human papillomavirus (HPV) vaccination program and its positive impact on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence.

Published on November 3, 2021, this observational study shows the use of HPV vaccines dramatically reduces cervical cancer rates by almost 90% in women in their 20s who were offered the vaccine beginning at age 12.

These researchers estimated that the HPV vaccination program prevented around 450 cervical cancers and about 17,200 cases of precancerous conditions over 11 years.

HPV vaccination was most effective when given between the ages of 11 and 13 when someone is less likely to have been exposed to HPV.

“It’s a historic moment to see the first study showing that the HPV vaccine has and will continue to protect thousands of women from developing cervical cancer,” stated Michelle Mitchell, Cancer Research UK’s chief executive, in a related press statement.

The HPV vaccine when administered to boys protects against male cancers according to the CDC’s website. “The U.S. FDA has approved different types of HPV vaccines listed on this Precision Vaccinations webpage.”

Last but not least tomorrow is the opening day for the Federal Employees Benefits Open Season for 2022. Here’s a link to today’s FedWeek report on the big day. “There will be 275 [FEHB] plan choices—down by one after a few dropouts and additions—including 18 nationwide plan choices open to all, four available only to certain groups, and the rest available regionally.” December 13 is the closing day of this Open Season.

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.

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.

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Delta variant front, AHIP informs us that

Today, the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) convened its final day of a scheduled meeting to discuss and vote on recommendations for booster doses of the Moderna and Janssen (Johnson & Johnson) COVID-19 vaccines, and to review data from the National Institutes of Health on mix-and-match booster doses.

The Committee unanimously voted (15-0) to approve the use of a single COVID-19 vaccine booster dose as follows:

1. Single booster dose of Moderna COVID-19 vaccine to be administered at least 6 months after completion of the primary series for individuals:

2. Single booster dose of the Janssen COVID-19 vaccine to be administered at least 2 months after completion of the primary regimen to individuals 18 years and older

3. Use of each of the available COVID-19 vaccines can be used as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine

Data presented by Moderna showed a slow decline in neutralizing antibodies generated from the primary series over time.  Data from Janssen showed lower overall vaccine effectiveness compared to those who received an mRNA vaccine, and that evidence is not sufficient to determine if vaccine effectiveness is waning.

ACIP evaluated the benefits and risks of a booster dose for both the Moderna mRNA vaccine and for the Janssen vaccine.  The booster dose for the Moderna vaccine is half the dosage of the primary series shots, while those receiving a Janssen booster will receive the same dosage as the primary series.  CDC recommends that people receiving a booster dose receive the same vaccine as the primary series unless unavailable or another product is preferred.  Today’s vote created the pathway for heterologous booster doses for all vaccines, following FDA authorization yesterday.

The Committee also reviewed updates on the safety of all approved COVID-19 vaccines regarding incidences of myocarditis, pericarditis, and thrombocytopenia (TTS) and found no increased rates of these serious adverse events following additional booster doses of the vaccines. The data indicated that serious side effects for all vaccines are extremely rare. More research needs to be done on the safety of heterologous vaccine administration.

The final stop for these recommendations is the CDC Director Rochelle Walensky. The Wall Street Journal reports that Dr. Walensky approved the Committee’s recommendations this evening.

STAT News points out

When the [COVID] shots arrived late last year, the message from health officials was simple: Get vaccinated when you become eligible, and get whichever jab is offered to you. But with boosters becoming available for select groups of people, and a lower-dose shot for young children expected shortly, the campaign is moving from a simple set of instructions to more of a messy flow chart for people organizing and delivering the jabs. * * *

Sorting all this out will fall to pharmacies, immunization programs, pediatricians, and vaccine administrators, many already stretched thin, who will also have to track inventory and try to minimize waste. It will be a quick turnaround, as well: As soon as the CDC checks the final box for boosters with its recommendations, people will start demanding them.

Under ACA FAQ 50 issued October 4, 2021, health plans must immediately begin to cover administration of these boosters without member cost-sharing.

From the vaccine mandate front, Federal News Network reports that

A memo released by the Defense Department states that civilian [employees] will ultimately be fired from their jobs if they are not fully vaccinated. DoD wants all of its civilians to get the shot and go through the required waiting period for antibodies to flourish by Nov. 22.

DoD civilians who refuse to get the shot will go through “progressive enforcement actions,” the first of which is a five-day counseling and education period.

If an employee is still recalcitrant, they will be suspended without pay for less than 14 days. If the refusal continues, DoD will then terminate the employee for “failing to follow a direct order.”

The memo states that DoD will designate officials to handle the disciplinary process and “ensure consistent application of disciplinary measures.”

There are some exceptions to the rule. DoD will provide waivers to those who cannot get the vaccine due to medical conditions or for religious reasons. Further guidance will be available soon on the exceptions and DoD is currently not taking any action on exemption requests.

From the FEHB Open Season front, OPM made the following edit to its FEHB 2022 Significant Events chart:

StateFEHB CarrierPlan NameTerminatingOptions (endof 2021)TerminatingCodes (end of2021)Automatic EnrollmentOption and Codes for2022
IndianaHumana Health Plan,Inc.Humana Health Plan,Inc.HighLouisvilleMetropolitan areaMH1, MH3, MH2StandardLouisville Metropolitanarea – MH4, MH6, MH5
IndianaHumana Health Plan of Ohio, Inc.Humana Health Plan of Ohio, IncHighA61, A63, A62BasicW61,W63,W62
KentuckyHumana Health Plan of Ohio, Inc.Humana Health Plan of Ohio, Inc.HighA61, A63, A62Basic W61,W63,W62

From the federal employment benefits front, Reg Jones in Fedweek discusses death benefits available to surviving beneficiaries following a federal annuitant’s post-retirement death.

From the HLTH2.0 conference, Healthcare Dive provides more Amazon Health news and Fierce Healthcare discusses how to attract younger health plan members.

From the the Capitol Hill front, Healthcare IT News explains that why this may be the year that Congress finally restores funding for a HIPAA patient identification number. Fingers crossed.

Tuesday’s Tidbits

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

From the Delta variant front —

  • The Centers for Disease Control reported today on a study finding that “Among hospitalized U.S. patients aged 12–18 years, vaccine effectiveness of 2 doses of Pfizer-BioNTech vaccine against COVID-19 hospitalization during June–September 2021, was 93% (95% confidence interval = 83%–97%).”
  • The Wall Street Journal tells us that General Electric Co., Union Pacific Corp. and other large U.S. employers are imposing Covid-19 vaccine mandates for their workers to comply with a Dec. 8 deadline set by the Biden administration for companies that are federal contractors. The FEHBlog expects that these companies understandably are taking this approach without prodding from the government contracting officers in order to avoid the OSHA vaccination screening program.
  • David Leonhardt in this morning’s New York Times, wrote about the death of General Colin Powell, who was a great American leader. He points out that

Colin Powell’s death at 84 underscores the continuing risk that Covid-19 presents to older people — even if they are fully vaccinated, as Powell was. For vaccinated Americans in their 70s and 80s, Covid remains more dangerous on average than many other everyday risks, including falls, choking, gunshot wounds or vehicle accidents. * * *

If cases return to their low levels of the spring and early summer, deaths among older adults will probably plummet as well. 

He also encourage older folks to get the COVID booster, which is happening, and the country to expand rapid COVID tests. He concludes

For most Americans, vaccination makes the risk of a serious form of Covid extremely rare. And for children, Covid tends to be mild even without vaccination. But until caseloads decline more, the situation remains frightening for many older people.

From Capitol Hill, the Federal New Network discusses the Senate Budget Committee’s release of the majority’s appropriations bills yesterday.

For federal employees, the draft bills from Senate Democrats are noticeably silent on a pay raise for civilian workers next year.

In their silence, Senate appropriators have essentially deferred to the plan President Joe Biden presented to Congressearlier this year. That plan called for a 2.2% across-the-board pay increase for federal employees, with an additional 0.5% in locality adjustments to total, on average, a 2.7% raise for 2022.

Neither the House nor Senate appears interested in legislating their own federal pay raise for civilian employees next year, making Biden’s planned 2.7% increase all the more likely.

From the waste front, UPI reports that

Medicare spent nearly $600 million over a three-year period to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease for which the Food and Drug Administration approved them, an analysis published Monday by JAMA Internal Medicine found.

More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer, including breast and lung as well as liver and urinary tract cancers, the data showed.

From the over the counter front, Healthcare Dive reports that

  • “FDA proposed a rule creating a new category of over-the-counter hearing aids, allowing the products to be sold directly to consumers in stores and online without a medical exam or being fitted by an audiologist.
  • “The agency’s proposal is meant to increase competition in the lucrative hearing aid market and improve access to the high-cost technology for millions of Americans through a safe, effective and more affordable OTC alternative. While the rule, if finalized, would more clearly define prescription hearing aids, FDA said it would not change the classification of existing device types.
  • “A Cowen analyst said in a Tuesday note the FDA’s proposed rule would effectively allow consumer electronics manufacturers to get into the hearing aid space that has been dominated by companies such as ReSound, Sonova and William Demant. The Wall Street Journal reported last week that Apple is studying ways to make its AirPods into a health device, including for enhancing hearing.”

Competition is good.

It’s worth noting that in contrast to FEHB and employer sponsored coverage generally, Medicare Part B rarely requires prior authorization for any prescribed course of treatment.

From the tidbits department, Fierce Healthcare is offering a series of articles from the ongoing HLTH 2.0 conference

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.

Tuesday’s Tidbits

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

From the Capitol Hill front, Roll Call reports that “The House [of Representatives] cleared a temporary debt limit bill Tuesday that will buy lawmakers a little more time [at least until December 3] to negotiate a longer-term solution * * * . The House voted 219-206 to adopt a rule for floor debate on unrelated legislation that “deemed” the Senate-passed debt limit bill as having cleared that chamber. That maneuver sent the bill, which would increase the Treasury Department’s borrowing authority by $480 billion to nearly $28.9 trillion, to President Joe Biden’s desk where he’s expected to sign it this week.”

Here are a few COVID vaccination mandate tidbits for your consideration —

  • Fedweek discusses the status of the President’s mandate that federal employees receive the COVID vaccine.
  • CNBC lets us know that Boeing, which holds large defense contracts, is rolling out a COVID vaccination mandate for its 125,000 U.S. employees.
  • The Wall Street Journal reports that

The Labor Department signaled Tuesday evening that it is close to acting on President Biden’s plan to require private-sector workers get Covid-19 vaccinations or be regularly tested, a move that has drawn a mixed reaction from larger and smaller companies.

The proposed mandate, according to an earlier announcement by the Biden administration, would apply to businesses with 100 or more employees. It would be implemented under a federal rule making known as an emergency temporary standard and affect roughly 80 million workers nationwide, according to Biden administration estimates, or more than half the total U.S. workforce.

The Labor Department said its Occupational Safety and Health Administration submitted the initial text of the proposed standard to the White House for approval, signaling its final release could soon follow. The details could change during the White House review.

Also from the Delta variant front, STAT News tells us that “Food and Drug Administration scientists did not take a clear position as to whether the agency should authorize booster doses of the Moderna Covid-19 vaccine in documents released Tuesday. * * * The FDA has not made available its briefing document on the Johnson & Johnson vaccine. * * * [The briefing documents relate to the FDA vaccine advisory committee meetings scheduled for Thursday and Friday this week.] One of the most interesting topics for the meeting comes at the end of day two: the discussion of a National Institutes of Health study that examines what happens when people get a booster dose of a different vaccine than the one they originally received. Allowing such mix-and-match boosterscould make it much simpler to give people the shots in the future. It would also open the Covid-19 vaccine market up to many more players, instead of giving Pfizer and Moderna an effective lock on the market.”

In miscellaneous tidbits

  • The National Institutes of Health yesterday 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. The study, funded by the National Institute on Aging (NIA), part of the National Institutes of Health, advances a precision medicine approach for individuals at greater risk of the disease because of their genetic makeup.

The research team analyzed information in databases of brain tissue samples and FDA-approved drugs, performed mouse and human cell experiments, and explored human population studies to identify bumetanide as a leading drug candidate that may potentially be repurposed to treat Alzheimer’s.

“Though further tests and clinical trials are needed, this research underscores the value of big data-driven tactics combined with more traditional scientific approaches to identify existing FDA-approved drugs as candidates for drug repurposing to treat Alzheimer’s disease,” said NIA Director Richard J. Hodes, M.D.

  • FEHB plans that offer plan brochures in Spanish may be interested to know that AHRQ has translated its medical visit question builder tool for patients into Spanish.
  • In an interesting business move, Best Buy, according to Healthcare Dive, is expanding its home healthcare business.

Best Buy is acquiring United Kingdom-based at-home care platform Current Health for an undisclosed amount, expanding its push into the health industry.

The massive consumer electronics retailer already owns two healthcare companies, and is now snapping up Current, which has a platform combining remote patient monitoring, telehealth and patient engagement. The move comes as an increasing amount of care is delivered in the home, accelerating consumers’ use of health tech.

The acquisition should allow Best Buy to play a bigger role in virtual care delivery, the company said in a blog post Tuesday. Best Buy expects the deal, which will be financed with cash, to close by the end of the fourth quarter of its 2022 fiscal year, per a filing with the U.S. Securities and Exchange Commission.