Monday Roundup

COVID-19 vaccine

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Electronic health records, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

The Food and Drug Administration (“FDA”) announced today that the agency has “approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit. 

“Under the accelerated approval provisions, which provide patients suffering from the disease earlier access to the treatment, the FDA is requiring the company, Biogen, to conduct a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.”

The Wall Street Journal adds

Biogen priced the newly approved drug higher than analysts expected. The company said it would charge about $56,000 a year per patient.

A preliminary analysis conducted by the Institute for Clinical and Economic Review, a nonprofit research and advisory group, said the drug could be cost-effective at a per-patient price of $2,500 to $8,300 a year.

Alzheimer’s is a progressive degenerative disease that slowly robs people of their memory and the ability to care for themselves.

About six million people suffer from Alzheimer’s in the U.S. Of those, as many as 1.4 million could be eligible to take Aduhelm, according to estimates by Cigna.

What’s more, according to the Journal,

Cigna will likely cover the drug for people who match the patients studied in Biogen’s clinical trials—those with early-stage Alzheimer’s and amyloid buildup in their brains—said Steve Miller, Cigna’s chief clinical officer.

Most Alzheimer’s patients are covered by Medicare, and their out-of-pocket costs could be significant, depending on their coverage, because of so-called coinsurance payments that require patients to cover a percentage of certain health costs, Dr. Miller said.

“The out-of-pocket testing costs could be a real barrier for those patients who lack the financial means,” said Dr. Miller.

Cigna estimates that patients with traditional Medicare insurance could be on the hook for more than $10,000 a year in coinsurance and copayments for the drug and amyloid testing, Dr. Miller said. Additional costs for people with supplemental Medigap insurance or commercial coverage through Medicare Advantage could reach up to $4,000 annually.

Dr. Miller said patients may be eligible for financial assistance to cover the extra costs through nonprofit foundations, which are often funded by drugmakers.

Healthcare Dive offers a comprehensive article about the new drug that is not behind a paywall.

From the COVID-19 front

  • David Leonhardt in the New York Times reports on his takeaways from Britain’s recent, modest rise in new COVID-19 cases:

One, vaccines are still the most effective way, by far, to defeat this terrible pandemic. Nothing matters more than the speed at which shots go into arms — in Britain, in the U.S. and especially in poorer countries, where vaccination rates are still low.

Two, behavior restrictions can still play a role in the interim. If hospitalizations or deaths in Britain rise over the next two weeks, there will be a strong argument for pushing back the full reopening of activities. And that has obvious implications for the U.S., too. Restricting indoor activities for unvaccinated people is particularly important.

Three, caseloads are no longer as important a measure as they used to be. Before the vaccines were available, more cases inevitably meant more hospitalizations and deaths. Now, the connection is more uncertain. As a recent Times story put it, paraphrasing British scientists, “upticks in new infections are tolerable so long as the vast majority do not lead to serious illness or death.”

  • The Society for Human Resource Management discusses stepped-up employer efforts to encourage COVID-19 vaccinations and reduce employee tensions over COVID-19 masks and vaccination in the workplace.
  • Medscape offers suggestions for healthcare providers and possible health plans on how to target COVID-19 vaccine hesitancy.
  • The Massachusetts Institute of Technology’s Pandemic Technology Project reports on best community practices in closing COVID-19 vaccination gaps.

From the OPM front

  • Govexec informs us that OPM “on Monday moved to finalize new regulations making it easier for federal agencies to bring back former employees at a higher salary than when they left government. Currently, federal agencies have the authority to rehire former federal workers outside the competitive hiring process, but they can only offer them positions at the same pay grade they held before they left federal service. Under a final rule set to be published in the Federal Register Tuesday, effective July 8, agencies will be able to use that process to rehire former federal workers at higher salaries than when they left government, accounting for the experience and skills they gained through education and the private sector.”
  • Federal News Network informs us that “Federal retirement activity slowed across the board last month, from new claims to backlogged cases and even the time it takes to process them. The latest numbers from the Office of Personnel Management showed that 7,684 new claims were filed in May compared to 9,414 in April — an 18.4% decrease month over month but a 15.6% increase from the same time a year ago. The number of claims processed also dropped to 8,451 in May versus 11,396. That’s a 25.8% decline month other month, although April was unusually high for processed claims when compared to historical monthly totals. May’s processed claims were about even year over year. The retirement backlog decreased from 25,386 claims in April to 24,619 claims in May, but that represented a 35.4% increase from May 2020. In January of this year, the backlog, which has not met it’s goal of 13,000 claims for more than a year and a half, peaked at 26,968 claims and has slowly inched back down.” It’s the FEHBlog’s understanding that OPM’s issues stem from an unnecessarily complex federal retirement system that only Congress can fix.

In other news

  • Beckers Hospital Review reports that “Walmart Health’s primary care medical group has filed paperwork to expand virtual care in 16 more states, Insider reported June 7.”
  • Healthcare Dive informs us that even before the new information blocking rule’s effective date, “the majority of hospitals have allowed patients to view and download their health information via their own patient portal [in recent year] . However, hospitals allowing patients to use third-party apps to see their data increased sharply from 2018 to 2019, according to a new report from the federal agency that regulates U.S. health IT.”

Weekend update

David Ermer–ACA, COVID-19, COVID-19 vaccine, OPM, Rx coverage–

The Senate will resume Committee work and floor voting this coming week while the House of Representatives will be limited to Committee business.

From the COVID-19 front

  • Bloomberg reports that “U.S. hospitalizations continue to fall, with 3.17% of beds occupied by Covid-19 patients on June 4, according to the U.S. Department of Health and Human Services. That percentage dropped from 3.67% on May 28 and is the lowest since March 14, 2020.”
  • The Advisory Board informs us its June 4, 2021, COVID-19 Roundup that “The World Health Organization (WHO) on Monday announced variants of the coronavirus will now be named after letters of the Greek alphabet, to simplify the variants’ names and avoid names that can be stigmatizing to a country. According to the new naming system, the variant B.1.1.7, which was first discovered in the United Kingdom, will now be called Alpha; the B.1.351 variant first discovered in South Africa will be called Beta; and the B.1.617.2 variant first discovered in India will be called Delta. Once all 24 letters of the Greek alphabet have been used, WHO said it will announce another naming system.”

Kaiser Health News tells us that

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process.

The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.

Some FDA scientists in November joined with the company to present a document praising the intravenous drug. But other FDA officials and many outside experts say the evidence for the drug is shaky at best and that another large clinical trial is needed. A consumer advocacy group has called for a federal investigation into the FDA’s handling of the approval process for the product.

A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company.

The Department of Health and Human Services, last Friday, released

a new report that shows 31 million Americans have health coverage through the Affordable Care Act – a record.  The report also shows that there have been reductions in uninsurance rates in every state in the country since the law’s coverage expansions took effect. People served by the health Marketplaces and Medicaid expansion have reached record highs.  

The data shows those individuals currently enrolled in health coverage through the Health Insurance Marketplaces and Medicaid expansion under the ACA, including 11.3 million people enrolled in the ACA Marketplace plans as of February 2021 and 14.8 million newly-eligible people enrolled in Medicaid through the ACA’s expansion of eligibility to adults as of December 2020. 

In addition, there are one million people enrolled in the ACA’s Basic Health Program, and nearly four million previously-eligible adult Medicaid enrollees who gained coverage under expansion due to the ACA’s enhanced outreach, streamlined applications, and increased federal funding under the ACA. Today’s report shows the important role the ACA has played in providing coverage to millions of Americans nationwide.

The report also shows that between 2010 and 2016, the number of nonelderly uninsured adults decreased by 41 percent, falling from 48.2 million to 28.2 million. All 50 states and the District of Columbia have experienced reductions in their uninsured rates since the implementation of the ACA, with states that expanded Medicaid experiencing the largest reduction in their uninsured rate. California, Kentucky, New York, Oregon, Rhode Island, Washington, and West Virginia have reduced their uninsured rate by at least half from 2013 to 2019 through enrollment in Marketplace coverage and expansion of Medicaid to adult populations. To date, 37 states and the District of Columbia have expanded Medicaid to cover adults under the ACA. 

Healthcare Dive reports that

  • The nation’s largest commercial insurer is taking a closer look at whether visits to the emergency room by some of its members are necessary. Starting July 1, UnitedHealthcare will evaluate ER claims using a number of factors to determine if the visit was truly an emergency for its fully insured commercial members across many states, according to a provider bulletin. 
  • If UnitedHealthcare finds the visit was a non-emergency, the visit will be “subject to no coverage or limited coverage,” the provider alert states.
  • However, a statement provided to Healthcare Dive said the insurer will reimburse for non-emergency care according to the member’s benefit plan. In other words, the amount paid by UnitedHealthcare may be less if deemed a non-emergency.    

For what it’s worth, this plan designed to control healthcare resources makes sense to the FEHBlog.

Last week, the FEHBlog noted that OPM had a settled a lawsuit in the National Federation for the Blind alleged that the agency’s website was not adequately accessible to visually impaired FEHB members. To place the settlement in context, the FEHB calls attention to this NextGov article reporting that

Federal websites are not as accessible for those with disabilities as the law mandates they should be, according to a report released Thursday by the Information Technology and Innovation Foundation.

The report tested the 72 most popular federal websites and used a combination of automated tests and qualitative assessments to assess their compliance with Section 508 of the Rehabilitation Act. The law requires the General Services Administration to ensure federal websites are accessible to people with disabilities, including federal employees and the public.

According to the report, 30% of the most popular federal websites did not follow modern web accessibility standards on their homepages, and 48% failed a standard test on at least one of their three most popular web pages.

The report finds that

Overall, our assessments reveal a large amount of variation in how agencies are meeting Section 508 requirements. Some agencies that have a large footprint—such as the Internal Revenue Service, the Census Bureau, the Department of Defense, and the Department of Education’s office of Federal Student Aid—scored low in our accessibility test of their websites, indicating that people with disabilities may have difficulty accessing essential government services or information about these services online. * * *

Notably, the White House and the Centers for Disease Control and Prevention earned a perfect score in our accessibility test of all three of their pages, and also performed well in our qualitative assessment. The Biden administration has committed to adhering to WCAG 2.1 Level AA criteria on the White House website—a step above Section 508’s requirements, which use WCAG 2.0.19

Friday Stats and More

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

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 22nd week of this year (beginning April 2, 2020, and ending June 2, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through June 2, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through June 2, 2021 which also uses Thursday as the first day of the week:

In this week’s COVID-19 update, the CDC advises

With summer upon us, many adolescents are looking forward to returning to activities they may have missed last summer, including travel, hanging out with friends, work, and summer camp. Vaccinating adolescents is an important step toward stopping the spread of COVID-19. As of June 3, 2021, more than 5.9 million adolescents ages 12-17 years have received at least one dose of a COVID-19 vaccine. Fully vaccinated adolescents are at low risk of symptomatic or severe infection and are less likely to transmit COVID-19 to others. If you or someone you know is considering adolescent vaccination, talk with your pediatrician or healthcare provider about the benefits of vaccination. To find a vaccine provider near you, visit vaccines.gov.

In other new

  • The tri-agencies which administer the Affordable Care Act issued FAQ 46 today which reminds interested that the Biden Administration lowered the in-network out-of-pocket maximum limit for 2022 that the Trump Administration had proposed. As the FEHBlog reported in early May 2021, the maximum annual limitation on [in-network] cost sharing for the 2022 plan year will be $8,700 for self- only coverage, and $17,400 for other than self-only coverage.”
  • Fierce Pharma reports that “Friday brought news that the FDA has made Regeneron’s monoclonal antibody cocktail [to treat COVID-19] more user friendly, allowing it to be administered by subcutaneous injection in addition to its original administration form of intravenous infusion. The agency also approved a lower dose of the Regeneron drug, 1200 mg, allowing the company and officials to stretch available supply.”
  • The American Medical Association informs us about “Ochsner’s Connected MOM (Maternity Online Monitoring) initiative, which uses digital health tools to offer expectant mothers a convenient way to safely manage their pregnancy in collaboration with their physicians.” Oschner, of course, is a major health system serving New Orleans, LA, and environs.
  • HR Dive tells us about the types of incentives that employers are offering to encourage employees to get COVID-19 vaccinations. “Adam Sencenbaugh, partner at Haynes and Boone, said he has seen several creative forms of incentives from clients, ranging from paid time off to raffles. That mirrors reports of what other employers have done to incentivize vaccination, with ideas including direct payments and transportation provided to those receiving a vaccine. “We have yet to have a client ask us about a program that would be coercive in that respect,” Sencenbaugh added. “It’s been something that, if done appropriately, can even boost morale.”

Thursday Miscellany

David Ermer–CDC, COVID-19, COVID-19 vaccine, Medicare, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

President Biden today announced a strategy for sharing “at least 80 million U.S. [COVID 19] vaccine doses globally by the end of June.

On the U.S. COVID-19 vaccination front

  • David Leonhardt reports in the New York Times that

When the C.D.C. reversed its Covid-19 guidelines last month and said that vaccinated Americans rarely needed to wear masks, it caused both anxiety and uncertainty.

Many people worried that the change would cause unvaccinated people to shed their masks and create a surge of new cases. On the flip side, a more optimistic outcome also seemed possible: that the potential to live mostly mask-free would inspire some vaccine-hesitant Americans to get their shots.

Almost three weeks after the change, we can begin to get some answers by looking at the data. So far, it suggests that the optimists were better prognosticators than the pessimists.

  • HR Dive informs us that “Vaccine mandates are not a consideration for 83% of employers responding to law firm Fisher Phillips’ recent pulse survey. That figure is up from January, when the firm recorded 64% of respondents saying they would not impose a vaccine requirement. At that time, 27% of employers said they had yet to decide if they would mandate vaccinations. “Most employers — 75% — said they are encouraging workers to get their vaccines, the May 25 survey results revealed.”

Fortune Magazine released its Fortune 500 and sitting in the top 10 are four healthcare companies (CVS Health (4), United Health Group (5), McKesson (7) and AmerisourceBergen (8). For the second year in a row the top two companies are Walmart and Amazon, both of which are attempting to break into the healthcare market.

In his latest FedWeek column, Reg Jones discusses continuing FEHB coverage of unmarried children of enrollees beyond age 26 provided the child is incapable of self-support. “The term “incapable of self support” generally means that the child earns less than the equivalent of GS-5, step 1 [$30,414 in 2021]. However, this is not a hard and fast rule. In making a decision, consideration is given to the child’s earnings and condition or prognosis.”

From the Centers for Medicare and Medicaid Services front:

  • Kaiser Health News reports that expanding health insurance coverage is the top priority of the newly installed CMS Administrator, Chiquita Brooks-Lasure.
  • Healthcare Dive tells us that Elizabeth Fowler, head of the Center for Medicare and Medicaid Innovation, said that CMMI’s ongoing strategy review has resulted in more conscious choices in where it should invest, which includes pivoting away from voluntary models. “Voluntary models are subject to risk selection, which has a negative impact on the ability to generate system-level savings. Providers that aren’t generating the extra revenue tend to exit the program, and those that are tend to stay,” Fowler, now on her third month at the job, said at a Health Affairs briefing. “So we are exploring more mandatory models.”
  • Fierce Healthcare informs us that Congress wants CMMI to be more transparent in its spending. A bipartisan letter “said CMMI’s authorizing statute, which was part of the Affordable Care Act, calls for the center to gather input from interested parties. However, this requirement has often been shunted aside by the center and rarely observed.”

Medcity News reports that the Labor Department’s top health benefits law enforcement priority is compliance with the federal mental health parity law.

To uphold the law and ensure parity in coverage, the labor department has two strategies in place, [Secretary of Labor] Walsh said.

The department’s Employee Benefits Security Administration agency has created a task force that focuses on enforcement of the act, he said. The task force is reviewing its inventory of case files, looking to identify potential violations and send out requests to payers for data on parity analyses, which they are required to maintain to show their compliance with the law.

Further, the Department of Labor, along with other government agencies involved in this work such as the Department of Health and Human Services and Internal Revenue Service, is providing regular reports to Congress on their findings and enforcement actions, Walsh said. This can help inform legislation on insurance coverage moving forward.

Govexec provides the latest Postal Service news, including a confirmed report that the FBI is investigating Postmaster General DeJoy “for allegations that he illegally pressured employees at his former company to donate to Republican candidates while promising to later reimburse them through bonuses.”

The Wall Street Journal reports today that

A drug sold by AstraZeneca PLC and Merck & Co. reduced the recurrence of breast cancer in women with an early but aggressive form of the disease, a long-running [blinded] international study found. The finding, which on Thursday was published online by the New England Journal of Medicine and released at a major cancer-research meeting, marked the latest advance in cancer treatments targeting the genetic traits of tumors. It could expand the arsenal of weapons against a hereditary form of breast cancer. The result also helps validate the pharmaceutical industry’s investment in a pricey new class of drugs that target cancer cells, known as PARP inhibitors.  * * *

PARP inhibitors work by blocking cancer cells from relying on a survival tactic: the ability to repair their own DNA after their DNA is damaged naturally or by other drug treatments. This, in turn, contributes to cancer-cell death.

Health regulators have approved these types of drugs in recent years to treat ovarian, breast, prostate and pancreatic cancers. The drugs have been found to be particularly useful against cancers associated with harmful mutations in genes known as BRCA1 and BRCA2. Women with these hereditary mutations have a higher risk of developing breast cancer, and often at a younger age than is typical. The BRCA mutations account for about 5% of the estimated 281,000 cases of breast cancer diagnosed annually in the U.S.

Midweek Update

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, OPM, U.S. Healthcare–

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

a 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

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Today is the deadline for submission of 2022 FEHB benefit and rate proposals to OPM. Also on the federal employment front, Federal News Network reports that

Agencies have until July 19 to submit employee and contractor reentry plans to the Office of Management and Budget, the Biden administration said Tuesday.

Agencies must finalize their plans for both reopening offices and setting post-reentry procedures and policies by that date, the Safer Federal Workforce Task Force, in collaboration with OMB, the Office of Personnel Management and the General Services Administration, said in an email.

Those final plans will build on draft reentry plans, which agencies are supposed to submit to OMB by June 18.

Agencies can, in phases, bring more employees and contractors back to their work sites after completing their final reentry plans, satisfying collective bargaining obligations and giving the workforce advanced notice, the task force said.

According to the CDC, over 50% of the total U.S. population has received at least one dose of a COVID-19 vaccine.

Also from the COVID-19 vaccination front

  • Moderna announced today that “it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older.” Pfizer took the same FDA approval step with its mRNA COVID-19 vaccine a few weeks ago. This FDA approval process likely will take several months.
  • The Centers for Medicare and Medicaid Services released an informational bulletin on COVID-19 vaccinations for adolescents. While directed at the Medicaid program, the bulletin is filled with useful information for everyone. What’s more, the American Medical Association offers its view on what doctors wish parents knew about these vaccines.
  • The National Institutes of Health Director, Dr. Francis Collins, explains on this blog that “Studies confirm COVID-19 mRNA vaccines [are] safe, effective for pregnant women.” “Overall, both studies show that COVID-19 mRNA vaccines are safe and effective in pregnancy, with the potential to benefit both mother and baby. Pregnant women also are more likely than women who aren’t pregnant to become severely ill should they become infected with this devastating coronavirus. While pregnant women are urged to consult with their obstetrician about vaccination, growing evidence suggests that the best way for women during pregnancy or while breastfeeding to protect themselves and their families against COVID-19 is to roll up their sleeves and get either one of the mRNA vaccines now authorized for emergency use.”

MedPage Today in an op-ed adds that “policymakers should include natural immunity as determined by an accurate and reliable antibody test or the documentation of prior infection (previous positive PCR or antigen test), as evidence of immunity equal to that of vaccination. That immunity should be given the same societal status as vaccine-inducted immunity.” (FEHBlog supplement — At least at this early stage when it’s not clear whether a booster is required.) The CDC should give more attention to this cadre.

From the flu vaccine front, the National Institutes for Health announced that “A first-in-human, Phase 1 trial assessing the safety and immunogenicity of an investigational nanoparticle influenza vaccine designed to provide long-lasting protection against multiple flu virus strains has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland.” Wild.

In other good news, Health Payer Intelligence reports that “Member satisfaction has improved significantly among commercial health plans, JD Power’s 2021 commercial member health plan study found. “The past year has proven without a doubt that effective use of digital channels has the power to increase customer engagement, build trust and promote brand advocacy,” said James Beem, managing director of global healthcare intelligence at J.D. Power.“While many plans are showing tremendous progress by delivering for their members during a highly volatile and stressful period, they still have a long way to go when it comes to delivering consistently strong levels of customer engagement across all segments of their member populations.”

Regarding the President’s Fiscal Year 2022 Budget proposal

  • Govexec informs us that “President Biden ends trend of [federal employee] benefit-cutting budgets, but new Federal Workforce Initiatives are still being developed. Most of the workforce provisions outlined in the president’s first budget submission are vague references to policies that will be part of the forthcoming president’s management agenda.”
  • Becker’s Hospital Review offers seven takeaways on the budget proposal for healthcare executives.
  • Forbes Magazine predicts that President “Biden’s answer to the [looming] Medicare Trust Fund Insolvency is hidden In his Budget Proposal.” The answer, by the way, is to pay Medicare Part A from the general treasury like the other parts.

In other crystal ball articles

  • The Journal of AHIMA discusses how this health informatics organization is preparing for the post-pandemic world.
  • Healio predicts how primary care providers will use telehealth in the new normal. The answer is quite a bit. “Thirty-five percent of adults in the United States who were surveyed said they would consider leaving their primary care physician for qualified physicians providing on-demand telehealth services. This percentage was even higher — 50% — among Generation Z and millennials, according to the data. Older adults also expressed interest in telehealth services, with 48% of respondents aged 65 years and older reporting that they will likely continue to use telehealth after the COVID-19 pandemic.”

Memorial Day Update

David Ermer–CMS, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Thanks to Justin Casey for sharing their work on Unsplash.

On this second (and hopefully last) Memorial Day of the COVID-19 pandemic, let’s take a look at recent reports on the nation’s COVID-19 vaccination campaign —

  • The Wall Street Journal reports that while vaccination rates in the Southeastern states have been relatively low, COVID-19 transmission has been slowed in those states by a combination of vaccinations supplemented by people engaging in open air activities.

Health officials in warm-weather states have launched public-information campaigns to encourage residents to spend as much time outside as possible and are pushing for more vaccinations at outdoor sites such as state parks and minor league baseball parks, as a way of heading off another potential summer surge this year.

“Vaccination and people spending time outdoors are the two biggest factors” in why cases have been relatively low this spring, said Brannon Traxler, an epidemiologist who heads South Carolina’s public-health division.

Encouraging people to spend time outside is a high priority, but the even bigger priority is the focus on vaccination, Dr. Traxler said: “If we can get folks vaccinated, then the weather and where and how people congregate becomes less of a problem.”

  • The Centers for Disease Control reports on Patterns in COVID-19 Vaccination Coverage, by Social Vulnerability and Urbanicity from December 2020 through April 2021:

What is already known about this topic?

Counties with higher levels of social vulnerability have been disproportionately affected by COVID-19.

What is added by this report?

Disparities in county-level vaccination coverage by social vulnerability have increased as vaccine eligibility has expanded, especially in large fringe metropolitan (areas surrounding large cities, e.g., suburban) and nonmetropolitan counties. By May 1, 2021, vaccination coverage among adults was lower among those living in counties with lower socioeconomic status and with higher percentages of households with children, single parents, and persons with disabilities.

What are the implications for public health practice?

Outreach efforts, including expanding public health messaging tailored to local populations and increasing vaccination access, could help increase vaccination coverage in counties with high social vulnerability.

  • The San Francisco Chronicle reports that “Hope builds that COVID vaccine boosters won’t be needed for a year – or much long.” “’I expect we will have to be revaccinated eventually, but I don’t think it’s going to be in a year-or-two time frame,’ said Dr. Joel Ernst, an infectious disease expert at UCSF. ‘Obviously we don’t have a long period of observation, because we haven’t had the vaccines that long. But so far I’m reassured that the vaccine-induced immunity seems to be pretty durable.’”

In other news

  • Healthcare Dive informs us that “The Mayo Clinic reported turning a profit in the first quarter of the year, although its expenses rose significantly compared to the first quarter of 2020, which was mostly completed before the COVID-19 pandemic became a significant issue. * * * [M]ost patient volumes returned to pre-pandemic levels. Outpatient visits for the quarter matched 2019 numbers, while surgical volumes exceeded those of 2019, although inpatient days were down.”
  • Kaiser Health News tells us that “The Biden administration said Friday it has no timeline on whether it will allow states to import drugs from Canada, an effort that was approved under President Donald Trump as a key strategy to control costs.  Six states have passed laws to start such programs, and Florida, Colorado and New Mexico are the furthest along in plans to get federal approval.  The Biden administration said states still have several hurdles to get through, including a review by the Food and Drug Administration, and such efforts may face pressures from the Canadian government, which has warned its drug industry not to do anything that could cause drug shortages in that country.” Smart move by the Administration. Our country’s population dwarfs Canada’s.
  • The Wall Street Journal reports that “Genetically altered mosquitoes target deadly Dengue fever and ZikaIn pioneering test, insects with a gene primed to interrupt breeding are flying in the Florida Keys. Go get em. One pandemic is enough.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 21st week of this year (beginning April 2, 2020, and ending May 26, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceeds new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through May 26, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through May 26, 2021 (five months) which also uses Thursday as the first day of the week:

The Centers for Disease Control observes that “COVID-19 cases and deaths in the United States have dropped to their lowest levels in nearly a year, and the number of people vaccinated continues to grow. As of May 27, 2021, nearly 133 million people in the U.S. are fully vaccinated, and the national percentage of COVID-19 tests that came back positive over the last 7 days was less than 3%”

Also on the COVID-19 vaccine front, Healthcare Dive reports that

Federal equal employment opportunity laws do not prohibit policies requiring that all employees who physically enter a workplace receive a COVID-19 vaccination, so long as such policies comply with the reasonable accommodation provisions of the Americans with Disabilities Act and Title VII of the Civil Rights Act as well as other applicable laws, according to technical assistance from the U.S. Equal Employment Opportunity Commission updated May 28.

Title VII and the ADA require employers to provide reasonable accommodations for employees who, because of a disability or a sincerely held religious belief, practice, or observance, do not get vaccinated for COVID-19, unless providing an accommodation would pose an undue hardship on the operation of the employer’s business, EEOC said. Employers with such a requirement also may need to respond to allegations that the requirement has a disparate impact on, or disproportionately excludes, an employee based on protected characteristics including age, race, color, religion, sex and national origin.

Employers also may offer incentives to employees to voluntarily show documentation or confirmation that they have received a COVID-19 vaccine, but the agency outlined some limits in the event that employers are incentivizing employees to voluntarily receive a vaccine administered by an employer or its agent. An employer may offer an incentive to employees to provide documentation or other confirmation from a third party not acting on the employer’s behalf, such as a pharmacy or health department, that employees or their family members have been vaccinated.

In other news —

  • Today, the President released his Fiscal Year 2022 U.S. budget. Here is a link to the Office and Management and Budget’s fact sheet. OPM’s budget information may be found beginning on page 1211 of the Appendix.
  • Yesterday, the Milliman consulting firm released its 2021 Medical Index. Peering into its crystal ball, Milliman states that “We project healthcare costs will grow by approximately 8.4% for the MMI family from 2020 to 2021. This rate, driven by a forecasted rebound in healthcare utilization, is higher than historical healthcare cost increases and gross domestic product (GDP) growth over the past five years.”
  • Healthcare Dive informs us that “Despite the financial turmoil COVID-19 wrought on U.S. medical practices over the past year, physician income has remained relatively steady, according to a new survey by the Medical Group Management Association. The survey — which included 185,000 providers among more than 6,700 physician-owned and hospital-owned practices — concluded they experienced flat or modest income growth in 2020. While compensation for primary care physicians — traditionally one of the lowest-paid specialties — grew, most specialist physicians either experienced small bumps or decreases in their income. Many medical specialties also experienced a decrease in patient encounters last year — a nearly inevitable outcome after many elective procedures were postponed in order to keep hospital capacity low enough to treat COVID-19 patients. However, the MGMA survey concluded that most practices saw patient volumes return to normal by mid-summer of 2020. Analysts predict the trend will continue to grow in 2021.” Agreed.
  • Recycle Intelligence informs us that “Hospital revenue, volumes, and margins increased in April 2021 both year-to-date and year-over-year, but have a long way to go in terms of COVID-19 recovery, according to a report by health care consulting firm Kaufman Hall. Despite the increases, hospital financial performance is down compared to last month.”
  • Last but not least, the Wall Street Journal reports that “A pathbreaking pill for lung cancer from Amgen Inc. was approved by the U.S. Food and Drug Administration, adding a new potential blockbuster to the biotech giant’s aging stable of drugs. The drug, called Lumakras, was approved Friday to treat a portion of lung cancer patients with a particular genetic mutation who have already tried other therapies. The mutation, known as KRAS, is among the most common found in cancers, but researchers struggled for so many years to find a medicine that can treat it that the mutation came to be considered ‘undruggable.’” Bravo. The Journal adds that “The company will charge $17,900 a month for the drug in the U.S., an Amgen spokeswoman said. Analysts project the drug could eventually ring up more than $1 billion in annual sales.”

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, OPM, Rx coverage–
OPM Headquarters a/k/a the Theodore Roosevelt Building

Federal News Network reports

The Office of Personnel Management is reshuffling current senior leadership and reorganizing a few of its offices as it waits for the arrival of its new director.

“OPM is making staff and organizational updates in order to better serve the agency’s mission,” the agency told Federal News Network. “These staff and organizations updates will help us to increase efficiency, better leverage our incredible internal talent and build back the agency for the future.”

Dennis Coleman, the agency’s current chief financial officer, will be the new chief management officer, OPM announced Thursday.

Margaret Pearson, OPM’s deputy chief financial officer, will be the acting CFO until the agency fills the job permanently. It will conduct a national search to find a new permanent CFO, OPM said.

From the COVID-19 vaccine front

  • The Wall Street Journal informs us that “The Food and Drug Administration and vaccine maker Johnson & Johnson expect to announce as early as Friday that contamination problems at a Covid-19 vaccine plant in Baltimore are resolved, clearing the way for millions more doses to become available.”
  • The New York Times tells us that “Immunity to the coronavirus lasts at least a year, possibly a lifetime, improving over time especially after vaccination, according to two new studies. The findings may help put to rest lingering fears that protection against the virus will be short-lived. Together, the studies suggest that most people who have recovered from Covid-19 and who were later immunized will not need boosters. Vaccinated people who were never infected most likely will need the shots, however, as will a minority who were infected but did not produce a robust immune response.”
  • A Bloomberg op-ed write opines (accurately in the FEHBlog’s opinion) that “The news that some employers have started handing out cash rewards to workers who are vaccinated against Covid-19 warms my libertarian heart. Yes, the idea is controversial; yes, there are legal implications. But providing incentives to get people to do what others think they should is almost always superior to punishing them for defying those wishes.” To that end, CVS Health announced that “beginning June 1, eligible customers who received or plan to receive a COVID-19 vaccination through CVS Health may choose to enter the #OneStepCloser sweepstakes for an opportunity to win one of over a thousand fun and exciting prizes through weekly drawings and grand prizes over a six-week period.” (Regrettably the FEHBlog got his vaccinations at a Maryland mass vaccination flight.)
  • Fierce Biotech reports that “Sanofi, GlaxoSmithKline kick-start phase 3 COVID-19 vax test as the pair targets variants, Q4 approval.”

From the prescription drug front —

  • Fierce Pharma informs us that “Within hours of granting emergency use approval to a COVID-19 antibody drug by GlaxoSmithKline and Vir, the United States has restricted the use of another COVID antibody treatment, this one from Eli Lilly. The FDA has halted the distribution of Lilly’s combination of bamlanivimab and etesevimab in Arizona, California, Florida, Indiana, Oregon and Washington––all states where coronavirus variants from Brazil and South Africa account for more than 10% of those with the disease. The antibody combo had previously been paused in Illinois and Massachusetts.  Providers in those states should use Regeneron’s antibody treatment of casirivimab and imdevimab, the FDA says. Lab studies have shown that option is more effective against the Brazilian (P.1) and South African (B.1.351) strains, according to the agency.’
  • Fierce Healthcare reports that CMS delays for six months [until July 1, 2022] a [complex] requirement for drugmakers to offer multiple best prices for Medicaid value-based deals. Also “The Pharmaceutical Research and Manufacturers of America, a top drug lobbying group, sued CMS in federal court on May 21 over another section of the Dec. 31, 2020, final rule. The drug industry wants a federal judge to ditch a requirement for manufacturers to factor in copay assistance into the Medicaid best price.”
  • Business Insider tells us that “Amazon is considering options for creating a physical retail-pharmacy presence in the US, three people familiar with the matter told Insider. It’s part of a plan to win over a larger slice of the prescription-drug industry. There is not a concrete plan to do so, and the talks are mostly exploratory, the people said. They were not authorized to speak to the press. Any meaningful rollout of stores could take more than a year, one of them said.” The FEHBlog watched a Bloomberg TV interview of Amazon’s CEO Jeff Bezos. The interview asked Mr. Bezos how he fills his workdays. He responded that he and his direct reports think about the future so this makes sense.
  • Virta Health, which offers diabetic treatments, announced a free webinar on Thursday June 17 at 2 pm to discuss a new potentially blockbuster Novo Nordisk anti-obesity drug. Here’s the skinny so to speak —

Obesity rates continue to soar, but earlier this year we were met with intriguing news. Early 2021, Novo Nordisk released phase 3 data for their diabetes drug, Semaglutide, in which the outcomes which were described as “breakthrough” and “game-changing” Patients on average lost 33.7 pounds after 68 weeks, more than 1.5 higher than the next best obesity drug. Experts predict the record-breaking efficacy rates could unleash the obesity drug market, which has historically lingered at a low <1% penetration rate. 

Despite what looks like a promising turn of events at the surface, there is growing concern that we’re at a tipping point for a healthcare cost crisis. With an estimated list price per patient of $13,000, semaglutide could take a huge hit on employers and payers who are already struggling to control growing medication and healthcare costs. 

Tuesday’s Tidbits

David Ermer–ACA, CDC, CMS, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Federal News Network provides the latest on the controversy over the Postal Service Health Benefits Program provisions in the Postal Reform Act (H.R. 3076 which has a Senate companion bill).

The new legislation requires current postal workers to enroll in Medicare Part A and B when they reach age 65. It gives current retirees the option of enrolling in Medicare, waiving the usual late enrollment penalties. Medicare will pick up initial hospital and prescription costs, and the Postal Service will become the secondary payer.

But current retirees who choose not to opt into Medicare will stay in the FEHBP.

While this arrangement is designed to save the Postal Service billions over the next decade, NARFE [ a prominent federal employee organization] worries it could raise premiums for federal employees and retirees still enrolled in the FEHBP. Those who are Medicare-eligible but choose not to enroll are some of the most expensive participants to insure.

The FEHBlog has a different outlook. First off, all federal annuitants, with exception of a naturally diminishing cadre of members who retired before 1984, have no cost Medicare Part A coverage. Most federal annuitants do join Part B. Income adjusted Part B premiums likely are the cause of newer annuitants tending to decline Part B coverage. In any event, Part A hospital expenses are weightier than Part B expenses. If a federal annuitant over 65 has declined Part B coverage and is enrolled in an FEHB fee for service plan, that Plan covers the annuitant’s expenses at Medicare rates which the FEHB Act, 5 U.S.C. Sec. 8904(b), obligates the provider to accept. That law has been in effect for nearly 30 years.

As the FEHBlog has mentioned on occasion, the enormous new savings opportunity that Postal reform will unleash lies in Part D prescription drug integration, not in Part B integration. In the 2003 Medicare Modernization Act that created Part D, Congress expressly permitted FEHB plans to integrate their benefits with Medicare Part D for annuitants over 65 (see 42 USC 1395w–132(b),(c)(3)). Integrated Part D programs known as EGWPs pay the Part D premium while reaping tremendous savings over going it alone. If OPM simply allowed all FEHB plans to exercise this option, FEHB premiums would be lower, and the Postal Service would not be militating for a separate program, in the FEHBlog’s considered opinion.

Healthcare Dive reports the Senate today confirmed the President’s nomination of Chiquita Brooks-LaSure to be Administrator of the Centers for Medicare and Medicaid Services by a 55-45 vote.

Brooks-LaSure has a long career in public policy, working in the Office of Management and Budget as a Medicaid analyst before moving on to serve as deputy director for policy at the Center for Consumer Information and Insurance Oversight during the Obama administration. She was also a director of coverage policy at HHS before transitioning to the private sector, working as a Medicare and Medicaid policy consultant for Manatt Health. With Tuesdays vote, Brooks-LaSure becomes the first Black woman to lead CMS.

The Senate has turned to considering an Assistant Attorney General nomination, and the FEHBlog hopes that Kiran Ahuja’s nomination to be OPM Director reaches the Senate floor soon thereafter for a confirmation vote.

From the COVID-19 front, Fierce Pharma informs us that

Teens across the U.S. started getting COVID-19 vaccines this month after Pfizer’s shot. With new data released Tuesday, Moderna’s shot could soon be available to kids, too.

In a phase 3 trial in kids ages 12 to 18, Moderna’s vaccine posted 100% efficacy after two doses. Investigators enrolled 3,700 participants and randomly assigned two-thirds to receive two doses of the Moderna vaccine. The remaining third received two doses of placebo.

Investigators recorded zero COVID-19 cases in the vaccinated group 14 days after the second dose, and four in the placebo group. They didn’t identify any new safety concerns.

The results set Moderna up for an FDA filing in the age group next month. Under that timeline, the vaccine could score an authorization in teens sometime this summer and play a role in a back-to-school vaccination push. * * *

Even younger children could be on their way to eligibility, too; Pfizer and Moderna are both running studies testing their vaccines in children as young as six months.

As of today, 50% of the U.S. population over age 18 is fully vaccinated against COVID-19, and public health experts opine in Medscape on why the jury is out on COVID-19 vaccination boosters.

And here are Tuesday’s Tidbits —

  • Medscape reports on how the COVID-19 pandemic has lead doctors to rethink low value care.
  • The Annals of Internal Medicine discusses on a study finding that “In clinician-owned practices, implementing a workflow to routinely screen, counsel, and connect patients to smoking cessation resources, or implementing a documentation change or a referral to a resource alone led to an improvement of at least 10 points in the smoking outcome with a moderate level of facilitation support. These patterns did not manifest in health- or hospital system–owned practices or in Federally Qualified Health Centers, however. The [blood pressure] BP outcome improved by at least 10 points among solo practices after medical assistants were trained to take an accurate BP. Among larger, clinician-owned practices, BP outcomes improved when practices implemented a second BP measurement when the first was elevated, and when staff learned where to document this information in the electronic health record. With 50 hours or more of facilitation, BP outcomes improved among larger and health- and hospital system–owned practices that implemented these operational changes.” Little things.
  • OPM released today a corrected version of Benefits Administration Letter No. 21-802, dated May 20, 2021, “which provides guidance on the OPM implementation of FSAFEDS Program flexibilities offered under the Consolidated Appropriations Act 2021 and accompanying law and guidance.”
  • MedPage Today posts a transcript of an interesting podcast in which “Vinay Prasad, MD, MPH, breaks down a new study that examined differences in breast cancer screenings before and during the COVID-19 pandemic overall, and among sociodemographic population groups.“
  • The Internal Revenue Service released draft 2021 Forms 1095-B and 1095-C which health plans and employers respectively use to report individual health coverage information to the Service.
  • Healthcare Dive reports that “The finances of U.S. hospitals continue to improve as the coronavirus pandemic wanes, following months of steep losses last year, according to a new report from Kaufman Hall. In April, hospital margins, volumes and revenues were up across most performance metrics year to date and year over year, though they were down compared to March, the consultancy found. Researchers called the results ‘encouraging,’ but noted they were more indicative of a recovering industry following the record-low performance seen in the first two months of COVID-19 in 2020, rather than strong performance overall this year.”