Weekend update

COVID-19 testing

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM–
Photo by Michele Orallo on Unsplash

The House of Representatives and the Senate will be engaged in Committee business and floor voting this coming week. The Senate’s Executive Calendar states that

Ordered, That at 5 p.m. on Monday, June 14, 2021, the Senate proceed to executive session to resume consideration of the nomination of Ketanji Brown Jackson, of the District of Columbia, to be United States Circuit Judge for the District of Columbia Circuit.

Ordered further, That at 5:30 p.m., all post-cloture time expire.

Ordered further, That following disposition of the Jackson nomination the cloture motions with respect to the nominations of Lina M. Khan, of New York, to be a Federal Trade Commissioner for the unexpired term of seven years from September 26, 2017 and Kiran Arjandas Ahuja, of Massachusetts, to be Director of the Office of Personnel Management for a term of four years, ripen.

Ordered further, That with respect to the motions to invoke cloture on Kahn and Ahuja nominations, the mandatory quorum calls required under Rule XXII be waived.

Ordered further, That if any of the nominations are confirmed, the motions to reconsider be considered made and laid upon the table and the President be immediately notified of the Senate’s actions. (Jun. 10, 2021.)

The FEHBlog will continue to keep an eye on Ms. Ahuja’s nomination.

Here’s a link to the Blue Cross FEP website for its COVID-19 vaccination incentive. FedSmith has a complete report on his experience with the new program.

Fierce Healthcare reports that

More than 96% of U.S. physicians have been fully vaccinated for COVID-19, with no significant difference in vaccination rates across regions, according to a new survey from the American Medical Association (AMA).

Of the physicians who are not yet vaccinated, an additional 45% do plan to get vaccinated, the AMA survey data (PDF) shows. The most common reason for not receiving the vaccine was that it was too new and has unknown long-term effects, according to physician responses.

The national AMA survey polled 300 physicians, including primary care doctors and specialists, between June 3-8. It’s the first survey to specifically collect data on practicing physicians’ COVID-19 vaccination rates, according to the AMA.

The survey results show an increase of more than 20% for physicians who have been fully vaccinated for COVID-19 compared to a May 2021 Medscape poll, AMA said.

“Practicing physicians across the country are leading by example, with an amazing uptake of the COVID-19 vaccines,” said AMA President Susan R. Bailey, M.D. in a statement.

In other encouraging news, the Wall Street Journal reports

The proportion of Covid-19 laboratory tests that are coming back positive is at the lowest recorded point since the pandemic took hold in the U.S., a sign of progress as the country moves ahead with reopening. * * *

The proportion of tests coming back positive has been consistently falling since April this year and is now at the lowest point since March 2020, the furthest back the Johns Hopkins data are available.

The low positivity rate [2%] is a signal that the drop in infections is really due to less disease in the country rather than because the U.S. is testing less for the virus, according to epidemiologists. It is another indication of how the U.S. is gaining ground against the Covid-19 pandemic, along with declining case counts, hospitalizations and deaths. 

“It’s a true reflection of a decrease in overall circulation in the U.S.,” said Anne Rimoin, an infectious-disease epidemiologist at the UCLA Fielding School of Public Health. “But we still do have pockets where we’re seeing transmission of the virus, and we need to be careful.”

NBC News adds that “There are only three Covid-19 patients at Sandra Atlas Bass Heart Hospital at North Shore University Hospital, on Long Island, New York — a far cry from when the hospital, which is part of Northwell Health, had as many as 600 patients during the peak of the pandemic. All three patients, who are in the intensive care unit, have one thing in common, said Dr. Hugh Cassiere, director of the hospital’s critical care services: They’re unvaccinated. The trend appears to be occurring at hospitals nationwide. “I haven’t had anyone that’s been fully vaccinated become critically ill,” said Dr. Josh Denson, a pulmonary medicine and critical care physician at Tulane University Medical Center in New Orleans.”

As the FEHBlog mentioned in Friday’s post, the federal government’s semi-annual regulatory agenda was posted on June 11. Over the course of this week, the FEHBlog will highlight the FEHB rule makings. Of note

OPM proposes to amend the Federal Employees Health Benefits Acquisition Regulation (FEHBAR) to update reporting requirements for health insurance carriers providing benefits through the Federal Employees Health Benefits (FEHB) Program. In the course of business, FEHB carriers collect pharmacy, enrollment, provider, person-specific medical and pharmacy claims, or in the case of managed care plans, encounter data related to enrollees and family members in order to provide healthcare coverage to those individuals. Under this proposed regulation, FEHB carriers would be required to submit this information to OPM, related to all benefits and services provided under the Program, on no less than an annual basis. This rule clarifies the requirements for FEHB carriers to furnish such reasonable reports, pursuant to 5 U.S.C. 8910, to better enable OPM, as a health oversight agency, to obtain the information necessary for proper administration of the FEHB Program.

View Rule (reginfo.gov) OPM first proposed to create an FEHB identifiable claims data warehouse in 2010. In 2015 OPM reported a massive data breach. Logically OPM should have backed off the idea of an FEHB identifiable claims data warehouse because that would be such an attractive target for hackers. It didn’t; OPM proposed an FEHB rule to create the identifiable claims data warehouse in September, 2019, and the rule making died at the Office of Management and Budget review stage three months later. OPM now has decided to take another bite at the apple; this time with an acquisition regulation.

OPM also has its own No Surprises Act rule making which includes the independent dispute resolution processes. 

This interim final rule with comment would implement additional protections against surprise medical bills under the No Surprises Act, including provisions related to the independent dispute resolution processes. 

New Section 8902(p) of the FEHB Act requires OPM to implement certain No Surprises Act provisions in the FEHB carrier contracts and to extend corollary obligations on healthcare providers by rule making. OPM states that this rule has a statutory deadline of October 1, 2021. HHS also is scheduled to release Part II of its No Surprises Act interim final rule making by the same date. The FEHBlog noted last week that Part I of that HHS rule making which has a statutory deadline of July 1, 2021, is pending OMB review.

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.

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.”

Monday Roundup

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, Patient safety, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the COVID-19 front:

  • Beckers Hospital Review reports that

Of the more than 123 million people fully vaccinated as of May 17, just 1,949 breakthrough cases involving hospitalizations or death had been reported to the CDC. 

Three more [CDC] findings:

  • Ninety-three percent of cases involved hospitalizations. Of these, 25 percent involved people who were asymptomatic and hospitalized for reasons not related to COVID-19.
  • Eighteen percent of all reported cases were fatal. Of these deaths, 18 percent involved people who were asymptomatic and died for reasons unrelated to the virus. 
  • In total, 79 percent of all reported cases involved people aged 65 or older.

The new data comes after the CDC changed how it tracks breakthrough COVID-19 cases among fully vaccinated Americans. As of early May, the agency only monitors the most severe cases.

  • The New York Times’ Upshot column discusses opinions on how vaccinated parents can do in terms of socializing activities with children under 12 years of age, the minimum age threshold for COVID-19 vaccination,

As vaccinated Americans return to many parts of their prepandemic lives this summer, one group will be left out: children under 12, who cannot yet be vaccinated. So what should families with young children do when everyone else starts socializing again?

We asked experts as part of an informal New York Times survey. The group of 828 who responded included epidemiologists, who study public health, and pediatric infectious disease physicians, who research and treat children sick with diseases like Covid-19.

They noted that this phase was temporary. Pfizer has said vaccines for children ages 2 and up could come as soon as September. Of the survey respondents with young children, 92 percent said they would vaccinate their own children as soon as a shot was approved. (Only five said no; some were undecided.) In the meantime, families with young children may need to retain more precautions, like masking and distancing, than their childless friends do. But they said some minimally risky activities could help counteract the mental health effects of pandemic living.

  • David Leonhardt also in the New York Times believes that vaccination hesitancy is affecting the working class.

Public health experts believe that there are specific strategies that can narrow the vaccination divide [between classes].

One is information. About 25 percent of unvaccinated people remain unsure whether somebody who previously had Covid should still get the vaccine, according to Kaiser. The answer is yes: Almost everybody 12 and older should.

Another promising strategy is making shots even more convenient. Employers can help by hosting on-site vaccinations and giving workers paid time off — including the day after the shot for people who experience side effects. Drugstores and supermarkets can accept walk-ins, as some already do. Government officials can send mobile, walk-in clinics into more communities. (Text your ZIP code to 438829 — or text “VACUNA” for Spanish — and you’ll find your local options.)

“We’ve just got to remove all the barriers,” Brodie said.

Finally, friends and relatives can turn a vaccination into something more than just a shot. “Say, ‘Let’s do this together. Let’s do something, so if you get vaccinated, let’s grab dinner after. Let’s celebrate together,’” Dr. Edith Bracho-Sanchez, a New York pediatrician, told CNN.

  • A friend of the FEHBlog called attention to this American Psychology Association “Stress in America survey conducted in late February 2021 found 42% of U.S. adults reported undesired weight gain since the start of the pandemic, with an average gain of 29 pounds.” Whoa Nelly!
  • The FEHBlog’s dogs pointed out this American Hospital Association report that “a new study from researchers at the London School of Hygiene & Tropical Medicine and others suggests that people infected with COVID-19 have a distinct body odor that specially trained dogs can rapidly detect with up to 94.3% sensitivity and up to 92% specificity. The study found dogs could detect the odor on clothing samples from individuals, including those who were asymptomatic, had low viral loads and two different strains. The study has yet to be peer reviewed and replicated in real-world settings, but shows promise as a way to screen individuals for COVID-19 testing at airports and other public places, the authors said.” Man’s best friend indeed.

In a Monday mishmosh of other healthcare news

  • A Wall Street Journal reporter discusses her own postpartum illness that nearly resulted in another maternal death.

The U.S. has a maternal mortality rate double that of most other high-income countries, including Britain, Canada and Australia, according to the New York City-based Commonwealth Fund, a healthcare research foundation. The CDC says that about two-thirds of pregnancy-related deaths are preventable; factors include lack of access to care, delayed diagnoses and missed warning signs. Black women and those on Medicaid are disproportionately affected.

To help address this, the American College of Obstetricians and Gynecologists recommended in 2018 that women have contact with their providers much sooner than six weeks—within three weeks after birth for low-risk women and sooner for women at higher risk of complications. (The roughly 30% of women who have cesarean sections sometimes already have a follow-up appointment after two weeks.)

The doctors who authored the 2018 recommendations said such a major change is challenging. “It is old habits. This is a huge culture shift,” said Tamika Auguste, chairwoman of Women’s and Infants’ services at MedStar Washington Hospital Center, who co-wrote the recommendations. My midwife said that in her two decades of practice, she has seen most women after about six weeks and found it effective.

Wouldn’t telehealth provide a Goldilocks solution here?

The American College of Obstetricians and Gynecologists also supports in-home visits by a nurse in the days after birth, which is a standard practice in other high-income countries but isn’t always covered by insurance in the U.S. * * * Even doctors who support adding more care say it’s hard to find the right balance. “We don’t know how much contact or care that we need that would be beneficial,” said Mark Clapp, a maternal-fetal medicine specialist at Massachusetts General Hospital.

See above telehealth suggestion.

  • UPMC’s Health Plan has a created a virtual concierge for its members using Amazon’s Alexa and the Google Home Assistant.
  • The Pew Charitable Trust has released an interesting report on the impact of state No Surprise billing laws on healthcare costs.

Eighteen states have passed surprise billing laws since 2014, most of them in the past three years. Last year, former President Donald Trump signed a federal version that covers self-funded health plans, including those offered by many employers, as opposed to the individual and commercial health plans regulated by states.

The concerns stem from guidelines states have established to help impartial arbitrators resolve disputes between providers and insurance carriers over how much should be paid for surprise, out-of-network bills.

“An upward trend in payments for out-of-network care could push rates higher in in-network contracts,” health policy researchers at Georgetown University wrote in a blog post last month. “These costs, in turn, could push premium costs higher for employers and consumers.”

A healthy lifestyle can lower dementia risk, even among those with a family history of cognitive decline, according to a study presented Thursday during an American Heart Association conference held virtually because of the COVID-19 pandemic.

This includes eating a healthy diet, exercising regularly, not smoking or drinking alcohol to excess and maintaining good sleep habits and a healthy body weight, the researchers said during the Epidemiology, Prevention, Lifestyle and Cardiometabolic Health Conference.

Adults ages 50 to 73 who embrace at least three of the behaviors can reduce their dementia risk by 30%, the data showed.

Those with a family history of dementia who followed at least three of the behaviors had a 25% to 35% reduced risk for the condition compared to those who followed two or fewer.

  • The National Committee for Quality Assurance issued an illuminating blog post describing the digital changes taking place with its HEDIS healthcare quality measures which play an important role in OPM’s FEHB Plan Performance Assessment system.

Midweek Update

David Ermer–CDC, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Medicare, U.S. Healthcare–
Photo by Mark Tegethoff on Unsplash

Govexec reports that at the Senate Homeland Security and Governmental Affairs Committee’s business meeting today, the Committee advanced to the Senate floor the nominations of Kiran Ahuja to be OPM Director along party lines and the three nominations of Postal Service Governors with bipartisan margins. The FEHBlog expects these nominations to be brought to the Senate floor next month.

From the COVID-19 front:

  • The Wall Street Journal informs us that “Vaccines appear to be starting to curb new Covid-19 infections in the U.S., a breakthrough that could help people return to more normal activities as infection worries fade, public-health officials say. By Tuesday, 37.3% of U.S. adults were fully vaccinated against Covid-19, with about 2.7 million shots each day. * * * With the U.S. recently averaging at least 50,000 new daily cases, the pandemic is far from over. But the U.S. is nearing a nationwide benchmark of having 40% of adults fully vaccinated, which many public-health experts call an important threshold where vaccinations gain an upper hand over the coronavirus, based on the experience from further-along nations such as Israel.”
  • Today the Centers for Disease Control released a report on the mRNA vaccines. Here are the highlights which support the Journal’s report particularly as over 2/3s of Americans over age 65 are fully vaccinated.

Clinical trials suggest high efficacy for COVID-19 vaccines, but evaluation of vaccine effectiveness against severe outcomes in real-world settings and in populations at high risk, including older adults, is needed.

What is added by this report?

In a multistate network of U.S. hospitals during January–March 2021, receipt of Pfizer-BioNTech or Moderna COVID-19 vaccines was 94% effective against COVID-19 hospitalization among fully vaccinated adults and 64% effective among partially vaccinated adults aged ≥65 years.

What are the implications for public health practice?

SARS-CoV-2 vaccines significantly reduce the risk for COVID-19–associated hospitalization in older adults and, in turn, might lead to commensurate reductions in post-COVID conditions and deaths.

  • The Wall Street Journal also reports that “Covid-19 tests for people to use to get quick results at home are finally becoming available to buy at pharmacies and retailers. Yet an obstacle might stand in the way of regular use: cost. * * * The U.S. Food and Drug Administration recently cleared over-the-counter sales of two of these rapid at-home screening tests, one from Abbott Laboratories and another from Quidel Corp. 

Major pharmacies recently said they plan to sell a two-pack of Abbott’s test for nearly $24, while Walmart says it will charge just under $20. The price for Quidel’s test hasn’t been released, though Quidel has indicated it will be less than $30 for a pair.

“Twenty-five dollars for a Covid test, I think most people would pay that once. But would they pay it every week or every two weeks?” says Zoe McLaren, a health economist and an associate professor in the School of Public Policy at the University of Maryland, Baltimore County. “It’s not designed to be a one-time cost.”

Dr. McLaren and medical-testing experts expressed hope that prices would drop if more companies get clearance to sell paper-strip tests. * * * Public-health authorities say they are glad to see the tests in stores, and the tests will be valuable tools for checking symptoms or for specific occasions, such as traveling or visiting relatives.

From the Medicare front

  • The Centers for Medicare and Medicaid Services released yesterday a proposed fiscal year 2022 Medicare Part A inpatient prospective payment system rule. “The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record (EHR) users is approximately 2.8 percent. This reflects the projected hospital market basket update of 2.5 percent reduced by a 0.2 percentage point productivity adjustment and increased by a 0.5 percentage point adjustment required by legislation.”
  • Healthcare Dive provides its perspective on the proposal which evidently was well received by the hospital industry. “[T]he American Hospital Association applaud[ed] the provision that removes the requirement that hospitals report privately negotiated rates with Medicare Advantage payers on Medicare cost reports and another that repeals market-based weight methodology for determining payments.”

On the FEHB front

  • FedSmith advises that “Federal employees facing a future with children aging out of TRICARE should consider enrolling in an FEHB policy. This is because FEHB plans provide coverage for children in the family option up to age 26. Additionally, the family FEHB premium for the employee, spouse, and children may be less than the cost of the TYA option for one individual. FEHB employees who are eligible for TRICARE and interested in having their children covered in an FEHB plan have to enroll during Open Season. Federal employees with TRICARE also need to enroll in a plan at least a year ahead of retirement for the FEHB plan to be continue in retirement.” Interesting.

On the artificial intelligence front, Forbes lists its top 50 AI companies to watch. Enjoy.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, HSA, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

Mondays have tended to be good news days for COVID-19 vaccines. As of today, over 50% of Americans over age 18 have received at least one dose of a COVID-19 vaccine.

Fierce Healthcare reports that

“CVS Pharmacy has begun stocking its virtual and in-store shelves nationwide with rapid tests for COVID-19—which can be purchased without a prescription and used by anyone regardless of whether or not they are showing symptoms—including three FDA-authorized diagnostics and sample collection kits produced by LabCorp, Ellume and Abbott.”

“Even as vaccines become more widely available, COVID-19 testing remains a critical tool to keep our communities safe,” Walgreens President John Standley said in a statement. Walgreens currently offers on-site testing at more than 5,500 of its pharmacies and plans to expand to 6,000 drive-thru sites by May, using Abbott’s ID NOW portable testing machines.

In addition, earlier this month CVS began offering COVID-19 antibody testing for $38 at 1,100 in-house clinics, using fingerstick blood samples to determine previous infections.

The U.S. Office of Personnel Management announced today that the agency

will allow [FSAFEDS] flexibilities permitted under the Consolidated Appropriations Act 2021 and the American Rescue Plan Act including allowing full carryover for a health care flexible spending account (HCFSA) and Limited Expense FSA (LEX FSA); extending the grace period for a dependent care flexible spending account (DCFSA); and permitting care for dependents through age 14 for 2020 and 2021 under a DCFSA. In addition, OPM is working with our FSAFEDS contractor, Health Equity, to offer a Special Enrollment/Election Period (SEP) in the near future.  This SEP will allow participants to increase or decrease their current elections for their DCFSA and/or their HCFSA.  In addition, the SEP will allow those who did not re-enroll for 2021 during Open Season in the Fall, the opportunity to enroll in a DCFSA and/or HCFSA for 2021.  Finally, OPM will allow DCFSA participants to increase their election during the Special Election Period to the new IRS maximum of $10,500 for 2021. 

All good news.

What’s more, the Wall Street Journal reported in its Saturday essay about the U.S. airline safety revolution.

Over the past 12 years, U.S. airlines have accomplished an astonishing feat: carrying more than eight billion passengers without a fatal crash.

Such numbers were once unimaginable, even among the most optimistic safety experts. But now, pilots for domestic carriers can expect to go through an entire career without experiencing a single engine malfunction or failure. Official statistics show that in recent years, the riskiest part of any airline trip in the U.S. is when aircraft wheels are on the ground, on runways or taxiways.

The achievements stem from a sweeping safety reassessment—a virtual revolution in thinking—sparked by a small band of senior federal regulators, top industry executives and pilots-union leaders after a series of high-profile fatal crashes in the mid-1990s. To combat common industry hazards, they teamed up to launch voluntary incident reporting programs with carriers sharing data and no punishment for airlines or aviators when mistakes were uncovered.

One wonders whether this successful strategy may be transferable to other pressing safety issues, such as patient safety. In this regard, a friend of the FEHBlog suggested check this Washington Post opinion piece written by a group of psychologists titled “We instinctively add on new features and fixes. Why don’t we subtract instead?
‘Less is more’ is a hard insight to act on, it turns out.” How true.

In other healthcare news —

  • The Kaiser Family Foundation informs us that

a relatively small number and share of drugs accounted for a disproportionate share of Medicare Part B and Part D prescription drug spending in 2019 (Figure 1).

— The 250 top-selling drugs in Medicare Part D with one manufacturer and no generic or biosimilar competition (7% of all Part D covered drugs) accounted for 60% of net total Part D spending.

— The top 50 drugs covered under Medicare Part B (8.5% of all Part B covered drugs) accounted for 80% of total Part B drug spending.

Some recent proposals to lower prescription drug prices have limited the number of drugs subject to price negotiation and international reference pricing. This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors. Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources . . . .

  • Employee Benefits News tells us

New research from Voya shows employees have a bias against HDHPs and the reason for that is as simple as marketing.

“One of the really interesting findings that we saw from the research about why there is that bias comes down to branding, pure and simple,” says Nate Black, vice president of consumer driven health for Voya Financial. “When we replaced the high deductible health plan name and called it something more generic, the share of people choosing high deductible health plans doubled. So just the name itself can have a really significant impact on how people think about what plan they should choose.”

Sixty-three percent of the people surveyed by Voya said they would choose the plan with the lowest deductible. As part of the study Voya designed an experiment asking participants to choose between a PPO and an HDHP. The experiment was set up in a way that the HDHP was always the optimal financial choice, despite this, 65% of those surveyed still chose the PPO plan.

Communicating the long term value of plans connected with health savings accounts is quite important.

  • Here’s a link to the CDC’s website on the Johnson & Johnson vaccine pause which explains

If you received the vaccine more than three weeks ago, the risk of developing a blood clot is likely very low at this time.

If you received the vaccine within the last three weeks, your risk of developing a blood clot is also very low and that risk will decrease over time.

Contact your healthcare provider and seek medical treatment urgently if you develop any of the following symptoms: severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin (petechiae), or new or easy bruising.

If you experience any adverse events after vaccination, report them to v-safe and the Vaccine Adverse Event Reporting System

The FEHBlog enrolled in v-safe after his first Pfizer vaccination and the CDC has continued to inobtrusively check in weekly. The FEHBlog is happy to help out.

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Employee Wellness Programs, Federal employment benefits, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Bloomberg reports that “President Joe Biden said [today] he wants all American adults eligible for a coronavirus vaccine by April 19, two weeks earlier than his previous goal. All but two states are already set to meet that goal, with Oregon and Hawaii having planned to open up vaccines to all non-minors on May 1.”

Yesterday, the Centers for Disease Control (“CDC”) released a report finding that “The principal mode by which people are infected with SARS-CoV-2 (the virus that causes COVID-19) is through exposure to respiratory droplets carrying infectious virus. It is possible for people to be infected through contact with contaminated surfaces or objects (fomites), but the risk is generally considered to be low.” As this BBC News article illustrates, last Spring we were quite worried about contracting COVID-19 from contaminated surfaces. In any event, thank heavens that we have the vaccines.

Federal News Network reports that front line federal employee access to the COVID-19 vaccine depends upon their employing agency.

If you are a federal employee working in the field, like Food and Drug Administration inspectors, Forest Service rangers or Custom and Border Protection officers, getting a COVID-19 vaccine from your agency isn’t a sure thing.

The Department of Homeland Security is making an all-out effort to vaccinate all 300,000 employees.

Other agencies like the Agriculture Department or the IRS are asking employees to take a path through their state and local governments.

This inconsistent application of agency support for “frontline” workers to receive one of the three inoculations has the potential to create a have and have nots among agencies.

Hopefully as the COVID-19 vaccine supply continues to expand and access restrictions are removed, these unfortunate quirks in the process will be ironed out quickly.

In other healthcare related tidbits

  • On April 12, the CDC will be sponsoring its decennial meeting on healthcare associated infections.
  • The Food and Drug Administration released a COVID-19 update today. The FEHBlog wonders when the FDA will take up granting full marketing approval for the Pfizer and Moderna vaccines and when AstraZeneca will file an emergency use authorization with the FDA for its COVID-19 vaccine. Those steps take us closer to ironing out the process quirks.
  • MedPage Today reports that

A personalized, hands-on care strategy for patients struggling with addiction was effective at reducing hospital readmission, a randomized trial found. In a comparison of hospitalized adults with substance use disorder involving opioids, cocaine, or alcohol, those who received Navigation Services to Avoid Rehospitalization (NavSTAR) care saw far better outcomes than those who simply received treatment as usual, according to Jan Gryczynski, PhD, of the Friends Research Institute in Baltimore, and colleagues.

  • Health Payer Intelligence informs us that

A digital therapeutic weight loss program led to major medical cost savings, according to a Rally Health Inc. study that points to wellness programs as cost-effective strategies to tackle the obesity epidemic. The study published in Obesity examined program data over a three-year period to analyze medical cost trends for those participating in Rally Health’s Real Appeal weight loss intervention program.

Researchers compared medical costs for a group of participants in the digital therapeutic wellness program with costs for a control group of non-participants. The control group was selected to match the intervention group in terms of health risk, baseline medical costs, age, gender, geographic region, and chronic conditions.

The study found that the wellness programming resulted in significant weight loss. There was an average weight loss of 3 percent for 4,790 program participants who attended at least one session over a 52-week period. In addition to providing positive member outcomes, the wellness program lowered medical expenditures significantly. Costs for the intervention cohort were 12 percent less than costs for the control group. What’s more, the savings of the wellness program cohort were 2.3 times more than program costs, marking significant return on investment.

  • Adam Fein reports in his Drug Channels blog that

The drug channel is consolidating, both vertically and horizontally. For evidence, look no further than Drug Channels Institute’s estimates of pharmacy benefit manager (PBM) market share, which are shown in the chart below. For 2020, DCI estimates that the three biggest PBMs [CVS Health (including Caremark and Aetna), the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group] accounted for more than three-quarters of total equivalent prescription claims. * * * This concentration helps plan sponsors and payers, which can maximize their negotiating leverage by combining their prescription volumes within a small number of PBMs. 

Weekend update

David Ermer–ACA, CDC, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM–
Photo by Michele Orallo on Unsplash

Happy Easter!

Congress remains on State/district work breaks for the coming week.

As of the beginning of this week, according the CDC’s website, 75.4% of the U.S population over age 65 and 40.2% of the U.S. population over age 18 has received at least one dose of the COVID-19 vaccine. 54.5% of the over age 65 population and 23.2% of the over 18 age population have been fully vaccinated.

That’s progress. Here are a couple of interesting angles on the vaccine distribution process:

  • The Wall Street Journal reports that “Johnson & Johnson’s Covid-19 vaccine has found a niche among organizations that work with the homeless, who say the one-dose shot is better-suited for a population that can be difficult to reach twice.”

[H]ealthcare workers say they have been surprised to find many homeless people specifically requesting the J&J vaccine, which is branded as Janssen, a unit of J&J. Some of them point out that the shot was still effective even though it was tested after Covid-19 variants entered the mix. Others say they are worried about getting a vaccine once, let alone twice, given the potential side effects.

“If you’re in a shelter, or don’t have a home, those side effects are different than if you can stay at home,” said Bobby Watts, chief executive of the National Health Care for the Homeless Council, which supports hundreds of providers that cater to the homeless.

  • Health Payer Intelligence informs us that “To ensure COVID-19 vaccine access for homebound individuals, the Commonwealth of Massachusetts has partnered with the Commonwealth Care Alliance (CCA), a health plan that says it has proven best practices for vaccinating this population.” “The Commonwealth defines a “homebound” individual as anyone who needs assistance from two or more people to leave home. In Massachusetts, there are about 20,000 individuals who meet this definition.”

As one of the first healthcare organizations in the country to vaccinate homebound individuals, CCA has also been part of the national discussion around strategies to ensure COVID-19 vaccine access for this population. Last month, CCA joined AHIP in briefing the White House, promoting the prioritization of homebound individuals in COVID-19 vaccine delivery efforts and underlining CCA’s best practices in this endeavor.

Speaking of AHIP, the organization on Friday announced

AHIP’s new SEP landing page also features other important resources to help guide consumers through the SEP, including fast facts, an educational blog, a link to a Get Covered Connector tool offered by Young Invincibles, and a link to a Health Insurance Marketplace Calculator provided by the Kaiser Family Foundation.

“Health insurance coverage is an important way to protect your health and financial stability, especially during the COVID-19 pandemic,” said Matt Eyles, president and CEO of AHIP.  “Health insurance available through the individual marketplaces cover products and services such as COVID-19 care and vaccines, mental health care and support, $0 copay preventive care, regular doctor visits and prescription medications to keep you healthy, and much more.”

In other COVID-19 news, Kaiser Health News provides details on over-the-counter COVID-19 testing kits.

Even with vaccines, epidemiologists say, rapid tests are desperately needed because more testing, along with mask-wearing and physical distancing, will get people back in offices and classrooms and help catch cases that go undetected. * * *

[M]any experts support the widespread distribution of cheap, rapid tests, even if they aren’t as sensitive as lab-run alternatives, and see a demand. In Germany, the supermarket chain Aldi began selling rapid tests in early March, roughly $30 for a five-pack, and sold out within hours. One recent study found that if a pack of tests was mailed to every household in the U.S. — even assuming that up to 75% would go into the garbage — they would save thousands of lives and avert millions of infections. “Don’t let perfect be the enemy of good,” said study co-author and Yale University professor A. David Paltiel. “This doesn’t have to work perfectly to make a huge difference.”

The Federal News Network shares opinions that it obtained from former OPM officials on the recent National Academy of Public Administration report on the agency.

Janice Lachance, the Clinton-era OPM director, sees the budget as a good starting point for the Biden administration and the new director. The president nominated Kiran Ahuja, a former chief of staff for the agency, for the role.

“The new director has a tremendous opportunity to go in there, do a very effective assessment of the situation and make a reasonable request that covers all of the things that need to be done — and that we want to do,” said Lachance, who currently serves as an executive vice president for the American Geophysical Union. “The NAPA report is very aspirational. What is it going to take to get OPM from where it is today to this desired state that’s articulated in the NAPA report over how many years?”

The new director, Lachance added, will need to make the case why an empowered OPM will help resolve the federal government’s talent problems.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, OPM–
Photo by Juliane Liebermann on Unsplash

In FEHB News

  • OPM is finalizing without change its proposed rule to remedy some federal employee benefit problems that cropped up during the last, particularly lengthy government shutdown.
  • CVS Health announced yesterday that

CVS Caremark, the Pharmacy Benefit Manager (PBM) of CVS Health, is continuing its long-standing agreement to serve the Government-wide Service Benefit Plan.  Since 1993, CVS Caremark has provided high-quality pharmacy care to the Service Benefit Plan to help federal employees, retirees and their families achieve prescription drug savings and better health outcomes, while being a responsible steward of taxpayer dollars.

The expanded contract will go into effect January 1, 2022 and now includes specialty pharmacy in addition to existing retail, mail and clinical pharmacy services in the current contract.

From the COVID-19 front

  • The Wall Street Journal reports that

The FDA late Wednesday gave the green light to three tests that are meant to be used frequently or multiple times over a few days—called serial tests. Consumers will be able to buy two of them over the counter without a prescription; the other, for use in such places as schools and doctors’ offices, requires a prescription. The FDA had previously authorized them for use among people with symptoms. * * *

Wednesday’s authorizations, awarded to companies [Quidel Corp., Abbott Laboratories and Becton, Dickinson & Co.] with bulk manufacturing power, add to the tests that can be purchased over the counter among people without symptoms if they are used repeatedly, potentially enabling rapid, at-home testing to become more widely accessible and affordable.

  • Today, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted. Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly. Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.”

Midweek Update

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

The FEHBlog noticed today that OPM has posted the agenda for its annual FEHB Carrier Conference which AHIP co-hosts. While the agenda includes many hot topics, the FEHBlog is surprised that new FEHB Act Section 8902(p) / the No Surprises Act is not highlighted on the agenda.

From the COVID-19 front —

  • The Centers for Disease Control’s daily report on COVID-19 vaccinations in the U.S. reports that that over 150 million doses have been delivered.
  • Pfizer and BioNTech announced that “in [study] participants aged 12-15 years old, [their two dose COVID-19 vaccine] BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated. The companies plan to submit these data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as soon as possible to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2.” This is good news for the next school year. Testing on younger children continues.
  • The Wall Street Journal reports that “Pregnant women who get the coronavirus vaccine pass their antibodies on to their newborns, recent studies suggest, a promising sign that babies can acquire from their mothers some protection against Covid-19. At least three studies have found that women who received either the Pfizer Inc. –BioNTech SE vaccine or the Moderna Inc. shots during pregnancy had coronavirus antibodies in their umbilical-cord blood. That indicates the women’s babies got the antibodies, too. * * * Pregnant women are at higher risk of a severe case of Covid-19 and of preterm delivery if they are infected. The studies’ findings, though preliminary, suggest women could safely protect themselves and their newborns by getting vaccinated.
  • Health Payer Intelligence explains “How Payers Are Involved in Boosting COVID-19 Vaccine Confidence — Payers are targeting coronavirus vaccine confidence through collaborations, marketing tools, and incentive programs.”
  • The National Institutes of Health announced that “The Centers for Disease Control and Prevention (CDC), in collaboration with NIH, has launched an innovative community health initiative called “Say Yes! COVID Test” starting in Pitt County, North Carolina, and coming soon to Chattanooga/Hamilton County, Tennessee. As many as 160,000 residents across the two communities will have access to free, rapid antigen tests that they can administer themselves to use three times a week for one month. NIH will provide the tests (also called a home-test or at-home test) and evaluate the effectiveness of the initiative, which aims to determine if frequent self-administered COVID-19 testing helps residents reduce community transmission of SARS-CoV-2, the virus that causes COVID-19 disease.”

And from the survey front —

  • The International Foundation of Employee Benefit Plans released its “2020 Employee Benefits Survey [which] provides benchmarking data on their health care offerings, covered dependents, plan funding, dental and orthodontia benefits, prescription drug offerings and other benefits.”
  • Becker’s Hospital Review identifies two dozen health care facilities that offer care to long haul COVID-19 patients.