Weekend update

Weekend update

The Senate has left town for a two week long State work break while the House of Representatives will continue Committee business and floor voting through Thursday July 1. The House Appropriations Committee will mark up that fiscal year 2022 financial services and general government appropriations bill on Tuesday morning, June 29. The Federal Times reports on that process here.

The U.S. Supreme Court is expected to wrap up its October 2020 term this week.

Last Friday, President Biden issued an executive order on “Diversity, Equity, Inclusion, and Accessibility in the Federal Workforce.” Here’s a link to the accompanying fact sheet. The new OPM Director will play a key role in implementing this executive order which makes one specific mention of the FEHB Program:

Sec. 11 (c) To ensure that LGBTQ+ employees (including their beneficiaries and their eligible dependents), as well as LGBTQ+ beneficiaries and LGBTQ+ eligible dependents of all Federal employees, have equitable access to healthcare and health insurance coverage:
(i) the Director of OPM shall take actions to promote equitable healthcare coverage and services for enrolled LGBTQ+ employees (including their beneficiaries and their eligible dependents), LGBTQ+ beneficiaries, and LGBTQ+ eligible dependents, including coverage of comprehensive gender-affirming care, through the Federal Employees Health Benefits Program; * * *

The 2022 OPM technical guidance for benefit and rate proposals clearly anticipated this directive.

On the COVID-19 front

  • The Hill informs us that public health experts are wondering when the Food and Drug Administration will give full approval to the mRNA COVID-19 vaccines, given the fact that a sizable cadre of unvaccinated folks have expressed concern about emergency use authorization status of those vaccine.
  • The Wall Street Journal reports that “In the coronavirus pandemic, a wave of mental-health crises has grown into a tsunami, flooding an already taxed system of care. As the country appears to be emerging from the worst of the Covid-19 crisis, emergency departments say they are overwhelmed by patients who deferred or couldn’t access outpatient treatment, or whose symptoms intensified or went undiagnosed during the lockdowns.”

On the new Alzheimer’s drug / Aduhelm front, STAT News offers

  • a calculator to estimate the cost of Aduhelm to Medicare depending upon utilization. “Estimates of how many seniors on Medicare will actually take Aduhelm, which has a list price of $56,000 [annually], vary wildly. Some experts have guessed at relatively low patient interest, around 500,000 people. Biogen, the company behind the drug, has put its target population far higher, around 1 million to 2 million people. But technically, since the FDA approved the drug for every Alzheimer’s patient, not just those with early-onset disease, the number could skyrocket toward 5.8 million, the number of adults over 65 with Alzheimer’s.”
  • a report that “The top House Democrats on two powerful committees on Friday announced an investigation into the approval and pricing of Biogen’s controversial Alzheimer’s drug, Aduhelm. Both Biogen and the Food and Drug Administration will be under the microscope, House Committee on Oversight and Reform Chair Carolyn Maloney (D-N.Y.) and Energy and Commerce Chair Frank Pallone (D-N.J.) said. “We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit,” the chairs said in a joint statement.

Midweek Update

Photo by Manasvita S on Unsplash

In anticipation of tomorrow morning’s markup session, the House Appropriations Committee today released the draft Fiscal Year 2022 financial services and general government appropriations bill. Of note,

  • Office of Personnel Management (OPM) – The bill includes $372 million, an increase of $42 million above the FY 2021 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
  • [The bill] eliminates provisions preventing the FEHBP from covering abortion services [subject to limited exceptions, e.g. life of the mother is endangered by continuing the pregnancy].

Govexec.com adds that “the bill makes no mention of a pay raise for federal employees, effectively endorsing [President] Biden’s plan to give feds an average 2.7% pay raise next year. It remains unclear how the White House would divvy up the 2.7% between an across-the-board increase to basic pay and an average increase in locality pay, although traditionally 0.5% has been reserved for locality pay increases.

From the COVID-19 front, the American Hospital Association informs us

The AHA today joined the Department of Health and Human Services, Centers for Disease Control and Prevention, and other national health care and public health organizations in encouraging COVID-19 vaccination for everyone age 12 and older who is eligible. “Today, the CDC Advisory Committee on Immunization Practices (ACIP) met to discuss the latest data on reports of mild cases of inflammation of the heart muscle and surrounding tissue called myocarditis and pericarditis following COVID-19 vaccination among younger people,” the statement notes. “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.” 

Separately, the Food and Drug Administration today told ACIP that it was moving quickly to adjust the language on its emergency use authorization fact sheets for the Pfizer and Moderna COVID-19 vaccines to note a likely association in rare cases of myocarditis and pericarditis in vaccine recipients.

Bloomberg reports in this regard that

CDC Director Rochelle Walensky said Wednesday that mRNA vaccines have been successful in preventing severe illness and death among young people. For every million second doses of an mRNA vaccine administered to those 18-to-24-year-olds, the CDC projects 26,000 cases of Covid and 1,657 hospitalizations are prevented, while only 49 to 61 cases of myocarditis may develop. Speaking at the Milken Institute Future of Health Summit, Walensky added that the data presented at the advisory committee meeting still “overwhelmingly demonstrate that the benefits of vaccination far outweigh the risks.”

The Society for Human Resource Management offers advice on confronting COVID-19 vaccination misinformation in the workplace.

From the prescription drug front, Fierce Healthcare reports that employer groups are asking Congress to look into Biogen’s pricing of its new Alzheimer’s drug at $56,000 per course of treatment and the CVS Health continues to remove hyperinflationary drugs from its formularies in order to control drug spending.

Posaconazole, an antifungal medication, is priced at $4,500 for a 30-day supply—while an alternative, fluconazole, costs less than $14. This is an example of a growing trend: medications, including many generics, with “hyperinflated” prices, experts at CVS Caremark say. The pharmacy benefit manager giant culled 72 such drugs from its formulary in 2020 alone, leading to savings of $1.2 billion compared to 2018.

From the price transparency world, RevCycle Intelligence tells us that “The majority of the top 100 hospitals by gross revenue are using a price estimator tool to comply with a landmark hospital price transparency rule from HHS, according to a recent study.”

Finally, CIGNA has added a telemental service called Brightside to its behavioral health network. According to the provider’s press release,

Brightside, a mental health telemedicine platform that offers access to high-quality anxiety and depression care from anywhere, today announced that it has joined the national behavioral health network for Cigna Corporation, a global health service company. Cigna’s 14 million behavioral health customers can now access Brightside’s evidence-based and data-driven approach to treating anxiety and depression through their commercial health care plans.” * * * “The pandemic has shined a light on the need for broader, more convenient access to mental health care. Cigna is committed to providing our customers with the behavioral health care they need, when and where they need it – and that is what Brightside will help us offer,” said Dr. Doug Nemecek, Cigna’s chief medical officer for behavioral health. “By increasing access through virtual care, customers can talk to a psychiatrist or therapist from the comfort and privacy of their homes. This is another demonstration of our commitment to provide timely and convenient access to depression and anxiety care for Cigna members.

The FEHBlog appreciates such services because in contrast to in person care where the mental health providers are typically out of network, telemental providers in a spoke and hub arrangement like this one are always in-network, thereby creating savings for the plan and the member.

Monday Roundup

Photo by Sven Read on Unsplash

The International Foundation of Employee Benefit Plans informs us that

The Department of Labor’s (DOL) Employee Benefits Security Administration along with the Office of Personnel Management, Internal Revenue Service, Department of the Treasury, Centers for Medicare & Medicaid Services, and Department of Health and Human Services (collectively, The Departments) issued an information collection related to certain reporting requirements under section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 (CAA) that are applicable to group health plans and health insurance issuers offering group or individual health insurance coverage.​

In addition, the Departments and OPM are also seeking input about whether the requirements apply to Federal Employees Health Benefits carriers, including whether or not they are also health insurance issuers.

Here’s the FEHBlog’s input on that last point. Congress extended specific provisions of Division BB of the Consolidated Appropriations Act, 2021 to the FEHB Program when it created a new Section 8902(p) of the FEHB Act. Today’s notice concedes that Section 204 was not among those provisions in Section 8902(p). Regulations are intended to implement and interpret statutory law, and in the case of the FEHBP there is no statute to implement here. What’s more carriers already are obligated to report aggregated prescription benefit data to OPM. In other words, the regulatory field is occupied as far as the FEHB Program is concerned. The public comment deadline on this information collection notice is July 23, 2021.

The American Hospital Association gleefully reports

Nearly 100 bipartisan House members led by Reps. Thomas Suozzi, D-N.Y., and Brad Wenstrup, R-Ohio, urge the departments of Health and Human Services, Labor and the Treasury [in a June 17, 2021 letter] to ensure their rulemaking for the No Surprises Act reflects congressional intent for a balanced process to settle payment disputes between health plans and providers. The lawmakers also emphasized the need to provide sufficient time for public comments and evaluation through proposed notice and comment rulemaking. 

The FEHBlog wonders what caused Congress to fire this shot across the regulator’s bow. The statutory deadline for these rules is October 1, 2021, thereby creating an all too brief three month long implementation period for providers, payers, lawyers and arbitrators. This should be interesting.

To show that the FEHBlog is not entirely cranky as he writes this post, CVS Health announced today

Over the last year, Aetna, a CVS Health® company, has been implementing a comprehensive strategy to reduce suicide attempts 20 percent among Aetna members by the year 2025. With the right intervention and support, resources and management of suicidal thoughts, suicide is known to be preventable. In fact, 90 percent of people who die by suicide have a potentially treatable mental health condition.

This month, Aetna is launching its latest initiative — the development of a specialty provider network with a sole focus on suicide prevention in collaboration with Psych Hub, the world’s most comprehensive platform for mental health education. The joint effort will further arm Aetna practitioners with no-cost, evidence-based instruction, tools, and resources to identify and treat those at risk of suicide.

Well done and best of luck.

Also from the COVID-19 front Bloomberg informs us

After more than a year of obsessively tracking Covid-19 case numbers, epidemiologists are starting to shift focus to other measures as the next stage of the pandemic emerges.

With rich countries vaccinating growing proportions of their vulnerable populations, the link between infection numbers and deaths appears to be diminishing. Now, in some places the focus is on learning to live with the virus — and on the data that matter most to avoid fresh lockdowns.

“It’s possible we’ll get to a stage of only monitoring hospitalizations,” said Jennifer Nuzzo, an epidemiologist at Johns Hopkins University’s Coronavirus Resource Center, which has built one of the most comprehensive platforms to track the virus and its impact.

The Wall Street Journal provides an overview of the COVID-19 variant called Delta.

The latest data from The Centers for Disease Control and Prevention estimates the Delta variant makes up 9.9% of reported U.S. Covid-19 cases, while Alpha stands at 65.5%. * * *

Scientists are still studying the virus and their early conclusions aren’t definitive. But British scientists, who have probably done the most work on the variant, estimate it is from 40% to as much as 80% more infectious than the so-called Alpha variant, or B.1.1.7, which was first identified in England last year, is now prevalent in the U.S. and is itself more contagious than the version of the virus that emerged in China in 2019.

An analysis of more than 14,000 Delta cases by England’s public-health agency found a double dose of the shot developed by Pfizer Inc. and BioNTech SE reduces the risk of hospitalization after infection with Delta by 96%. Two doses of the vaccine developed by the University of Oxford and AstraZeneca reduce the risk by 92%, Public Health England said.

Very few of those hospitalized in the U.K. have been fully vaccinated, with the new cases mostly among younger people who aren’t yet vaccinated. There is no evidence that young adults and children are more at risk proportionately from this variant than other age groups, and the increased transmission mostly reflects the fact that they haven’t been immunized, scientists say.

In other news that caught the FEHBlog’s eye this Monday —

  • The FEHBlog enjoys following the healthcare efforts of business giants like Amazon, Apple, and Walmart. ZdNet reports on Microsoft’s new healthcare strategy.
  • Louisville KY television station WDRB tells us

Brentwood, Tenn.-based LifePoint Health [a large regional health system that owns over 80 hospitals] will acquire Louisville-based Kindred Healthcare LLC, a specialty hospital company, for undisclosed terms, according to a news release Monday. The deal is scheduled to close by the end of the year. The announcement comes weeks after Louisville-based Humana Inc. said it would absorb the remainder of the former Kindred’s home health and hospice business. In the news release, LifePoint said it plans to continue Kindred’s strategy of growing by establishing joint ventures and partnerships with hospitals. * * * LifePoint said it plans to invest $1.5 billion in its business following the deal.

At the time of wrapping up this post on Monday evening, the Senate had not yet taken up Kiran Ahuja’s nomination to be OPM Director. The FEHBlog will keep an eye on this matter. [Tuesday morning supplement — The Senate Press Gallery Calendar informs us that

The Senate on Tuesday morning at 11:45 am will hold two votes:

  1. Confirmation of the Fonzone nomination.
  2. Motion to invoke cloture on Kiran Ahuja to be Director of the Office of Personnel Management.

The Senate will recess following the cloture vote on the Ahuja nomination until 2:15 p.m. 

At 2:30 p.m. vote:

  1. Confirmation of the Ahuja nomination.

Midweek Update

Photo by Dane Deaner on Unsplash

The Senate took no action on Kiran Ahuja’s nomination to be OPM Director today as Senators Booker and Peters remain out of pocket due to family illnesses.

On the hospital front —

  • The Advisory Board informs us about U.S. News and World Reports most recent rankings of children’s hospitals.
  • Axios reports that “Some of the hospitals with the highest revenue in the country also have some of the highest prices, charging an average of 10 times more than the actual cost of the care they deliver, according to new research by Johns Hopkins University provided exclusively to Axios.”

On the mental healthcare front, we have two articles on start- up companies from Katie Jennings in Forbes. One concerns Burlingame, Calif.-based Lyra Health and the other concerns “Lifestance Health Group, one of the nation’s largest outpatient mental health providers.” Check them out.

On the prescription drug front —

  • Healthcare Dive reports that “Anthem, one of the biggest U.S. payers, has joined an initiative to create low-cost generic drugs for hospital and retail pharmacies. The initiative CivicaScript, a subsidiary of hospital-owned nonprofit drugmaker Civica Rx, plans to initially develop and manufacture six to 10 common but pricey generic medicines that don’t have enough market competition to drive down cost, officials said Wednesday. The first generics could be available as early as 2022.”
  • Fierce Pharma informs us that “Antibody treatments have shown little success in helping COVID-19 patients with  severe disease. But a large [UK] study of hospitalized patients reveals that Regeneron’s antibody cocktail can reduce the chance of death in patients who haven’t produced their own antibody responses to the disease.”
  • STAT News interviews the Alzheimer Association’s CEO about the newly approved drug Aduhelm.

In miscellaneous news

  • The Wall Street Journal reportsApple Inc. Chief Executive Tim Cook has said the company’s greatest contribution to mankind will be in health. So far, some Apple initiatives aimed at broadly disrupting the healthcare sector have struggled to gain traction, according to people familiar with them and documents reviewed by The Wall Street Journal.”
  • Healthcare Dive tells us that “A University of Pennsylvania study that tracked Medicare claims for about 1.35 million beneficiaries who had joint replacement surgery found that hospitals participating in bundled payment programs spent less on the hip and knee joint procedures than hospitals receiving traditional fee-for-service payments. Spending, however, did not differ between hospitals that voluntarily joined bundling programs and those whose involvement was mandatory, according to the findings, which were published in a JAMA research letter. The results failed to validate assumptions that voluntary participants tend to achieve greater savings because they choose programs for the opportunity to reduce spending. The findings come as the head of the Center for Medicare and Medicaid Innovation, Elizabeth Fowler, suggested the agency would look to shift away from voluntary arrangements in favor of more mandatory models.”
  • Fierce Healthcare informs us that “The Centers for Disease Control and Prevention (CDC) released new interim guidance late Monday for healthcare providers treating patients with post-COVID conditions—an umbrella term the agency is using to capture a wide range of physical and mental health issues that sometimes persist four or more weeks after an individual’s COVID-19 infection. Sometimes referred to as “long COVID,” the conditions can present among COVID-19 patients regardless of whether they were symptomatic during their acute infection, the agency wrote in the guidance.”

Midweek Update

Mark Gongloff in Bloomberg opinion lays out the global COVID-19 situation quite clearly

Former FDA chief Scott Gottlieb, a sensible observer throughout this disaster, tells Michael R. Strain he sees Covid-19 becoming like the flu, both in its seasonality and fatality rate. He figures Americans will be fully back to work and school by the fall and then face a new Covid wave in the winter. But with widespread vaccinations, it shouldn’t be worse than a bad flu season. Sounds kind of nice. 

But in the developing world, vaccinations are lagging badly, giving the disease too many chances to evolve. The scariness of India’s “delta” variant may be overhyped, but it seems both more transmissible and severe than others, writes Sam Fazeli. Vaccines are effective against it. But it could make Covid more tiger-like again for unvaccinated Americans and Brits, including young people.

So developed countries must get far more serious about vaccinating the rest of the world to stem further deaths, mutations and economic damage. President Joe Biden promising to give the world 500 million Pfizer doses is a great start, but it’s only a start. 

Former U.K. Prime Minister Gordon Brown writes this Friday’s G-7 meeting is a chance for countries to commit to more such concrete action and spending. The world’s biggest countries must pony up to the best of their ability, as they have with other emergencies. 

Also from the COVID-19 front

  • The Centers for Medicare and Medicaid Services announced today that

While many Medicare beneficiaries can receive a COVID-19 vaccine at a retail pharmacy, their physician’s office, or a mass vaccination site, some beneficiaries have great difficulty leaving their homes or face a taxing effort getting around their communities easily to access vaccination in these settings. To better serve this group, Medicare is incentivizing providers and will pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home, increasing the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose. For a two-dose vaccine, this results in a total payment of approximately $150 for the administration of both doses, or approximately $70 more than the current rate.

  • The Department of Health and Human Services announced that

The U.S. government will procure approximately 1.7 million courses of an investigational antiviral treatment, molnupiravir (MK-4482), for COVID-19 from Merck, pending emergency use authorization (EUA) or approval from the U.S. Food and Drug Administration (FDA).

Molnupiravir (MK-4482) is designed to induce viral genome copying errors to prevent the virus from replicating in the human body, and evidence to date from clinical trials in patients with COVID-19 suggests that molnupiravir may reduce replication of the SAR-CoV-2 virus.

This treatment is being evaluated in an ongoing Phase 3 trial for its potential to reduce the risk of hospitalization or death in non-hospitalized patients who have symptoms for five days or less and are at high risk for severe illness. The trial plans to enroll a total of 1,850 patients globally with final data expected in the fall of 2021.

  • FedSmith offers more details on Blue Cross Federal Employee Program (FEP)’s announcement that it will offer a $50 wellness incentive to FEP members over age 18 who are fully vaccinated against COVID-19. Notably, “FedSmith has been advised that eligible members who have already been vaccinated for COVID-19 can also take advantage of this program and receive the $50 on their MyBlue Wellness Card. These individuals will also have to submit evidence of their COVID-19 vaccination record.”

From the general healthcare front

  • PriceWaterhouseCoopers (PwC) released its Health Research Institute’s 2022 projection of medical cost trend.

PwC’s Health Research Institute (HRI) is projecting a 6.5% medical cost trend in 2022, slightly lower than the 7% medical cost trend in 2021 and slightly higher than it was between 2016 and 2020. Healthcare spending is expected to return to pre-pandemic baselines with some adjustments to account for the pandemic’s persistent effects.

HRI defines medical cost trend as the projected percentage increase in the cost to treat patients from one year to the next, assuming benefits remain the same. Typically, spending data from the prior year is used as an input in the projection. For 2021 and 2022, the medical cost trend is the projected percentage increase over the prior year’s spending, with the effects of the pandemic removed from the prior year’s spending.

  • Not surprisingly, the American Hospital Association sent a letter to UnitedHealthcare stating in pertinent part that

America’s hospitals and health systems are deeply concerned by UnitedHealthcare’s (UHC) recent policy announcement [recently mentioned in the FEHBlog] to allow for the retroactive denial of coverage for emergency-level care in facilities. This policy would put patients’ health and wellbeing in jeopardy, and we urge you to reverse the policy immediately.

The AHA contends that UHC’s policy violates the Affordable Care Act’s requirement that heath plans adjudicate emergency care claims using a prudent layperson standards. The FEHBlog expects that UHC has taken this legal requirement into account. The FEHBlog will continue to follow this matter.

  • mHealth Intelligence reports that “New research out of the University of California Davis finds that telehealth treatments for people with non-urgent mental health needs can be delivered via an asynchronous (store-and-forward) platform just as well as through an audio-visual platform.” This approach could make the delivery of mental healthcare more efficient.
  • According to a company press release, “Datavant, the leader in helping healthcare organizations securely connect their data, and Ciox Health, the leader in clinical data exchange, today announced that they have signed a definitive agreement to merge the two companies in a transaction valued at $7.0 billion. The combined entity, to be named Datavant, will be the nation’s largest health data ecosystem, enabling patients, providers, payers, health data analytics companies, patient-facing applications, government agencies, and life science companies to securely exchange their patient-level data. “The fragmentation of health data is one of the single greatest challenges facing the healthcare system today,” said Pete McCabe, CEO of Ciox Health. “Each of us has many dozens of interactions with the healthcare system over the course of our lives, and that information is retained in siloed databases across disparate institutions. Every informed patient decision and every major analytical question in healthcare requires the ability to pull that information from across the health data ecosystem while protecting patient privacy. We are thrilled to join forces with the Datavant team to connect health data to improve patient outcomes. Together we are well positioned to navigate the technical, operational, legal, and regulatory challenges to doing so, and are committed to acting as a neutral connectivity solution for our many customers and partners.”
  • The National Committee for Quality Assurance answers questions about the use of electronic clinical data in HEDIS reporting. For example,

Q: How does administrative reporting relate to ECDS reporting?

A: Administrative claims are considered a key data source for ECDS reporting if the data can also be made available to a member’s care team. It is one of the four major data categories for ECDS reporting. The ECDS reporting method expands the types of data permitted for HEDIS® reporting by allowing the use of structured data from electronic health records, health information exchanges and clinical registries, and case management systems in addition to administrative claims.

Q: Is NCQA going to phase out the hybrid method of data collection from HEDIS?

A: NCQA is actively assessing the appropriateness of removing the hybrid reporting method from select HEDIS measures as other data sources improve.

Midweek Update

President Biden announced today that June will be a month of action to encourage COVID-19 vaccinations in the U.S. The President has set a goal of 70% of adult Americans having received at least one dose of a COVID-19 vaccine by Independence Day. As of today we are 62.9% according to the CDC. The fact sheet on the announcement lists many private-public efforts underway to provide convenient access to and incentivize people receive the COVID-19 vaccine.

The FEHBlog ran across today a CDC COVID-19 vaccine hesitancy map of our country. The New York Times adds that

A recent Kaiser Family Foundation poll found that about a third of unvaccinated adults were unsure whether insurance covered the new vaccine and were concerned they might need to pay for the shot. The concern was especially pronounced among Hispanic and Black survey respondents.

“The conversations we have are like: ‘Yes, I know it’s good. Yes, I want it, but I don’t have insurance,’” said Ilan Shapiro, medical director of AltaMed, a community health network in Southern California that serves a large Hispanic population. “We’re trying to make sure everyone knows it’s free.”

The confusion may represent a lack of information, or skepticism that a bill won’t follow a visit to the doctor. Liz Hamel, director of survey research at Kaiser, said it could reflect people’s experience with the health system: “People may have heard it’s available for free, but not believe it.”

The FEHBlog is concerned that, notwithstanding encouraging press accounts last week, the Food and Drug Administration and Emergent Biosolutions have not yet reached an agreement allowing Emergent to resume manufacturing the one dose Johnson & Johnson vaccine at its Baltimore, MD plant. Kaiser Health News projects no shipments of the one dose vaccine next week (June 7). It seems to the FEHBlog that the one dose vaccine is best suited for pop-up vaccination sites. Hopefully, distribution will resume soon.

Yesterday the FDA issued

safety communication to warn the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) because the FDA has serious concerns about the performance of the tests and believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA. The FDA has identified this issue as a class I recall, which is the most serious type of recall. The FDA is aware that these unauthorized tests were distributed to pharmacies to be sold for at-home testing by consumers, as well as offered for sale directly to consumers.

Importantly, HealthDay reports that COVID-19 does not pose a threat to the safety of the United States’ blood supply under existing donor screening guidelines, researchers report.

In FEHB news, the National Federation for the Blind announced on May 19 that

Under a consent decree entered in federal court in the Northern District of Illinois last week [May 13], the federal Office of Personnel Management (OPM) has agreed to take steps to ensure that health benefit information is accessible to blind federal employees, retirees, and other plan participants.

The consent decree resolves a lawsuit brought in 2019 by Jamal Mazrui, a retired blind federal employee, and the National Federation of the Blind, America’s civil rights organization of the blind.

Among other steps, OPM will ensure that health-benefit information on opm.gov is accessible and will notify all providers of federal employee health benefits that they must make their own federal employee benefits websites and mobile apps accessible or face potential consequences to their contracts.

For more details, here’s a link to consent decree which advises FEHB plan carriers to expect an OPM carrier letter on the settlement this month. With regard to timing the consent decree states (pp. 8 – 9) that

The carrier letter will utilize a phased-in approach, instructing carriers to either submit a certification that the Carrier FEHB Electronic Content on their websites and mobile applications is conformant with WCAG 2.0 AA or submit work plans pursuant to which (in the absence of any relevant legal exception(s)), logins, secure messaging, Explanations of Benefits, and ID cards would be conformant with WCAG Requirements by January 1, 2023, with a requirement of full conformance of the carrier’s Carrier FEHB Electronic Content with WCAG 2.0 AA on their mobile applications and their websites by January 1, 2024.

America’s Health Insurance Plans (AHIP) has “announced a refreshed brand and updated mission that better aligns with its work, goals, and commitments. Moving forward, the industry trade association will go simply by AHIP. The organization has also unveiled a new logo, conveying a more modern, more inclusive and even more active AHIP, along with a new tagline: Guiding Greater Health. AHIP believes that health insurance providers play a critical role in making health care better and coverage more affordable and accessible for everyone. Its new mission and brand reflect AHIP’s commitment to innovation, solutions, equity and delivering results for every patient in every community.” Good luck.

In an encouraging medical test development, MedPage Today reports that

A simple blood test, coupled with brief memory tests, showed who will develop Alzheimer’s disease in the future with a high degree of accuracy.

Combining plasma phosphorylated tau (p-tau), APOE genotype, and scores from 10-minute executive function and memory tests predicted Alzheimer’s disease onset within 2 to 6 years among people with memory complaints with 90% certainty, reported Oskar Hansson, MD, PhD, and Sebastian Palmqvist, MD, PhD, both at Lund University in Sweden, and colleagues.

When dementia experts examined the same patients, they were about 71% accurate, the researchers noted in Nature Medicine. * * *

As of now, it’s been tested only on patients who have been examined in memory clinics, he added. “Our hope is that it will also be validated for use in primary healthcare as well as in developing countries with limited resources.”

The Society for Human Resource Management points out four take aways from last week’s EEOC guidance to employers about COVID-19 vaccination inquiries and incentives.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

Over 275 million doses of the COVID-19 vaccines have been administered in the United States and 47.5% of the U.S population has received at least one dose of COVID-19 vaccine ,and 37.5% of the total U.S. population has been fully vaccinated. The Wall Street Journal reports today that

Covid-19 vaccines are showing up in unlikely places—on public transportation, at churches and in factories. Shots are also being offered in restaurants, casinos and ballparks. These pop-up locations represent a bid by health advocates and community leaders to reach a group of unvaccinated individuals less likely to make headlines: the ambivalent.

From the American Medical Association front

  • The AMA continues to rail against health insurer requests for prior authorizations.
  • In contrast the AMA is now a fan of telehealth as long as health insurers pay adequately for it.

“Here are the top five services physicians surveyed say they want to offer after the COVID-19 pandemic has ended, along with the percentage who said they wanted to continue each service:

  • Chronic disease management—73%.
  • Medical management—64%.
  • Care coordination—60%.
  • Preventative care—53%.
  • Hospital or emergency department follow-up—48%.

“Physicians also identified what they anticipate to be the barriers to maintaining telehealth after the public health emergency. No. 1 on that list? About 73% of physicians worry there will be low—or no—payment.”

STAT News reports that the House Oversight and Reform Committee bludgeoned prescription drug manufacturer Abbvie’s CEO over its pricing practices particularly for its blockbuster drug Humira during a hearing held today.

Three powerful Democrats wrote to the Federal Trade Commission Tuesday urging them to investigate whether drug maker AbbVie violated the law in trying to keep cheaper versions of its blockbuster drug Humira off the market.

The surprise announcement came in the first minutes of a Tuesday hearing held by the House Oversight Committee investigating the company’s pricing practices. AbbVie’s CEO Richard Gonzalez is testifying.

“I sent a letter to the FTC today … asking for a formal inquiry into whether AbbVie’s anticompetitive practices violated the law,” said the committee’s chair, Rep. Carolyn Maloney (D-N.Y.). The letter was also signed by the chair of the House Judiciary Committee, Rep. Jerrold Nadler (D-N.Y), and the chair of that committee’s antitrust subcommittee, Rep. David Cicilline (D-R.I.).

From the tidbit front

  • The Internal Revenue Service released guidance for employers on the American Rescue Plan’s subsidization of COBRA continuation coverage for employees who lose their health coverage due to an involuntary termination or reduction in hours.
  • The Department of Health and Human Services announced that its “Substance Abuse and Mental Health Services Administration (SAMHSA) is distributing $3 billion in American Rescue Plan funding — the largest aggregate amount of funding to date for its mental health and substance use block grant programs. The Community Mental Health Services Block Grant (MHBG) Program and Substance Abuse Prevention and Treatment Block Grant Program (SABG) will disperse $1.5 billion each to states and territories (with the latter also awarding money to a tribe). This follows the March announcement of supplemental funding of nearly $2.5 billion for these programs.”
  • The U.S. Preventive Services Task Force released a new final recommendation that persons aged 45 through 49 should receive screening for colorectal cancer. This supplements USPSTF’s current recommendation that persons aged 50 to 75 received this testing. The new recommendation will become a mandate on FEHB carriers and other group health plans to provide in-network coverage with no member cost sharing for this service for the lower aged cadre beginning January 1, 2023.
  • In 2019 the FEHBlog heard a hospital system executive vociferously object to Medicare’s new site neutrality policy under which Medicare pays the same rate whether the service is rendered inpatient or outpatient. It occurred to the FEHBlog that this site neutrality rule may lower healthcare costs. Needless to say, a trade association lawsuit challenged the rule, and the government won before the U.S. Court of Appeals for the D.C. Circuit. Healthcare Dive reports that Justice Department is opposing the American Hospital Association’s petition for U.S. Supreme Court review of the D.C. Circuit ruling.

Weekend update

FEHBlog opening note — The FEHBlog goofed by posting this May 7 COVID-19 charts in the May 14 Friday Stats and More post. The FEHBlog corrected his error on Saturday after the Friday post email went out. You can check out the website if you want to see the May 14 charts which are encouraging. In contrast, check out the Wall Street Journal’s charts on the COVID-19 situation in India which is still struggling with virus. Whereas 37% of the U.S. population is fully vaccinated, less than 5% of the much larger and younger Indian population has reached that status. In this regard, the Rome (N.Y.) Sentinel offers an Excellus Blue Cross consulting pharmacist’s valuable guidance on why people in the age 18 to 34 bracket should received the COVID vaccination.

Q: Katie [Abbott, Pharm.D.], you are in that age group. Why did you choose to get vaccinated? 

I trust the science behind the vaccines and believe they will help bring us back to how life was before the pandemic.

Q: Some, or most cases of COVID-19 in younger people are not severe. Why would a younger person get vaccinated if younger people aren’t really dying from COVID-19?

The younger population may not be seeing as many severe cases or deaths, but they are still at high risk of long COVID. Long COVID is when those who have recovered from COVID-19 experience lasting effects, including a range of symptoms such as fatigue, brain fog, chest pain, shortness of breath, cough, joint or muscle pain, depression, anxiety, and so much more. Long COVID can develop weeks or months after infection. It can happen to anyone who has had COVID, even if they had mild or no symptoms. Getting the vaccine remains a safe way to protect yourself, along with your community, family members, and those who cannot be vaccinated.

Returning to the regular weekend update, both Congress will be in session this week for Committee work and House and Senate floor votes. The House Oversight and Reform Committee will hold its third recent hearing on prescription drug costs on Tuesday morning. It’s worth noting that although the House Oversight and Reform Committee approved the Postal Reform bill (HR 3076) last week, the House Energy and Commerce and Ways and Means Committees also have jurisdiction over the bill. So we don’t know right now, when the bill may reach the House floor.

In OPM news, the Federal Times reports that

In anticipation of more employees returning to the office and in the spirit of May’s Mental Health Awareness Month, the Office of Personnel Management issued a tip sheet for agency human resource staff to better support employees at a vulnerable time. * * * In addition to communicating with employees about the usual resources available to them – such as the Employee Assistance Program and mental health treatments offered through Federal Employee Health Benefit plans – OPM encouraged agency work-life coordinators and HR professionals to be as communicative as possible about office safety procedures and available work schedule adjustments to ease any potential employee anxiety.

In other healthcare news,

  • mHealth Intelligence discusses the work of University of West Virginia researchers who are seeking to determine the best mix of in-person and virtual care. “With telehealth use skyrocketing over the past year and a half due to the coronavirus pandemic, some have wondered if there’s a limit to its effectiveness. Is there a certain number of virtual visits that a patient – especially one with a chronic condition – should get, after which the technology outlasts its value? The answer, according the researchers at the University of West Virginia, is … uncertain.” While that outcome is surprising to the FEHBlog, the researchers have gone back to the drawing board.
  • Fierce Healthcare reports that “GoodRx, a telehealth and drug-pricing comparison software company, acquired competitor RxSaver for $50 million in cash. The company closed the deal in late April, GoodRx reported during its first-quarter 2021 earnings call Thursday. RxSaver, which was owned by Vericast Corp., the payment and marketing company controlled by billionaire Ronald Perelman, operates a price comparison platform to provide discount offerings through partnerships with pharmacy benefit managers (PBMs). The acquisition will expand GoodRx’s business capabilities and consumer reach, particularly with respect to its prescription offering, the company said in its first-quarter 2021 earnings report.”
  • Health Payer Intelligence informs us that ” To help combat racial care disparities in communities of color, Blue Shield of California (Blue Shield) provided $300,000 to 12 different nonprofit organizations in California that promote the mental health and well-being of youths in their communities.   This act supports the health equity strategy of Blue Cross Blue Shield Association (BCBSA), Blue Shield’s parent company, as it seeks to improve racial care disparities by collaborating with local community leaders. By contributing $25,000 to each organization, Blue Shield is providing opportunities for youths of color that can improve their mental health.”
  •  Healthcare Dive reports that “Piedmont Healthcare signed a non-binding letter of intent to acquire Augusta, Georgia-based University Health Care System, which operates three hospitals as well as skilled nursing facilities and urgent care clinics along Georgia’s eastern border with South Carolina. * * * Just last week, the 11-hospital system announced plans to buy four additional hospitals from HCA Healthcare for $950 million. The sale is expected to close in the third quarter of this year. The hospitals in the HCA deal circle the outskirts of the Atlanta region. * * * Altogether, the two most recent deals would give Piedmont a total of 18 hospitals in Georgia, in addition to more ancillary services.” Healthcare Dive adds that the two deals are likely to face regulatory scrutiny.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

The FEHBlog had been wondering what was going on with the Postal Reform bill that includes a new Postal Service Health Benefits Program. It turns out that the House Oversight and Reform Committee plans to mark up the latest draft of that bill on Thursday morning. The FEHBlog plans to tune in for this meeting.

In health equity developments —

  • The Wall Street Journal reports that “Ride-sharing companies Uber Technologies Inc. and Lyft Inc. will make all rides to and from vaccination sites free until July 4 under a new partnership with the White House. * * * While the companies were already providing free or discounted rides in some circumstances, the rides will now be free to anyone in the U.S. who is going to a vaccination site to get the shot, and Lyft and Uber will promote the rides to and from tens of thousands of vaccination sites through their apps. The feature will launch in the next two weeks and run until July 4.”
  • Health Leaders Media informs us about Horizon Blue Cross’s ongoing efforts to advance health equity in New Jersey in cooperation with healthcare and community organizations as well as solid data.
  • The American Medical Association released a “strategic plan to embed racial justice and advance health equity.” “With the input of many both inside and outside of AMA, this strategic plan serves as a three-year roadmap to plant the initial seeds for action and accountability to embed racial justice and advance health equity for years to come.”

In regulatory developments –

  • Professor Katie Keith in the Health Affairs blog provides background on yesterday HHS decision to “interpret Section 1557 and Title IX, which prohibit discrimination on the basis of sex, to include discrimination on the basis of sexual orientation and gender identity.”
  • Fierce Healthcare reports that “The Centers for Medicare & Medicaid Services has sent its first wave of warning letters out to hospitals breaking federal rules requiring them to disclose payer-negotiated prices, a spokesperson for the agency confirmed.”
  • Healthcare Dives discusses healthcare organization comments to HHS’s Office for Civil Rights on its proposed rule that would make generally helpful adjustments to the HIPAA Privacy Rule, in the FEHBlog’s opinion.

Miscellaneous tidbits —

  • Reg Jones discusses the Federal Employees Group Life Insurance Program in FedWeek.
  • The Society for Human Resources Management writes about “Supporting Mental Health in the Post-Pandemic Workplace.”
  • Health Payer Intelligence discusses Blue Cross of North Carolina’s successful effort to consolidate member experience data from across the company to boost member satisfaction.

Midweek Update

Photo by Thought Catalog on Unsplash

OPM has released the 2020 highlights of its FEHB Plan Performance Assessment System. With this system, the 2020 plan scores which are based on 2019 data are used to determine the 2021 service charge for experience rated plans and the 2021 performance adjustment for community rated plans. 2020 was a tricky scoring year because the data was being gathered and analyzed just as the great hunkering down began in March 2020.

Reg Jones provide FEHB background for federal employees in Fedweek.

On the COVID-19 front, Bloomberg discusses the work of the federal government’s recently created COVID-19 Community Corps. The article discusses a Maine dairy farmer who set up a COVID-19 vaccination clinic for her employees and community members. “Organized in small teams that run the gamut from veterans and religious groups to progressive youth organizations and a Black LGBTQ group, the corps has been in the forefront of reaching the reluctant. The idea is that this wide demographic outreach will radiate, so that the friends and neighbors of the vaccinated follow suit.” Bravo.

WTOP, a local news radio station here in Washington DC reports that Pfizer “will seek [emergency] approval for use [of its COVID-19 vaccine] in children between 2 and 11 years old as early as September.

In other healthcare news

  • Mobihealth News reports that “On-demand behavioral health platform Ginger is now available as a health benefit for Cigna’s 14 million members, the companies announced [on April 28]. Members with Cigna’s employer-sponsored or individual and family insurance plans can now access Ginger’s behavioral health coaching, therapy and psychiatry services as an in-network benefit.” Smart move.
  • Healthcare Dive reports that “Telehealth utilization among the commercially insured fell 16% from January to February, the first month-to-month drop since September, according to a tracker from nonprofit Fair Health. The data suggests a potential slowdown in demand for virtual care services that spiked last year in the early months of COVID-19. Historically high levels of telehealth utilization spurred an unprecedented influx of cash into the digital health sector, but the sustainability of that boom depends in part on continued demand from consumers that could be waning as vaccinations increase and the pandemic wanes. Mental health conditions continued to top the list of diagnoses. However, COVID-19, which joined the top five diagnoses list in December, dropped from the list, likely reflecting the national decline in cases in February.”
  • Since Monday the FEHBlog has been looking at the Health Affairs blog to post here Katie Keith’s follow up post on the 457 page long second final ACA notice of benefit and payment parameters. It turns out that he had posted Prof. Keith’s follow up post on Monday and that the lead entry was made last Saturday May 1. Here are the links to Prof. Keith’s lead and follow up posts on that important ACA rule making. Considering it’s Cinqo de Maio, lo siento lectors.

The FEHBlog hasn’t mentioned the Econtalk podcast in a while but he does listen every week. This week the host Russ Roberts spoke with behavioral scientist Katy Milkman of the Wharton School at the University of Pennsylvania talks about her new book How to Change: The Science of Getting from Where You Are to Where You Want to Be.” Professor Milkman talks about soft commitment strategies [to achieve goals] and hard commitment strategies. An example of a soft commitment strategy involved a doctor posting a letter visible to patients committing to specific Choosing Wisely recommendations such as proper prescribing of antibiotics. As for hard commitments she notes this example, which was news to the FEHBlog, “websites like StikK and Beeminder that let you fine yourself if you’re not achieving your goals.” She also discusses the carrot strategy .”The carrot is, let’s actually figure out ways to make it more enjoyable in the moment, and that way your willpower won’t be needed to do the thing that’s good for you.” An example is binging junk TV while using the treadmill. Their discussion on self control is fascinating. Check it out.