Monday Roundup

OPM

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, OPM, Rx coverage–
Thanks to Aaron Burden for sharing their work on Unsplash.

Happy Flag Day!

According to the U.S. Senate Press Gallery, sometime after 11:30 am tomorrow morning, the Senate will hold a cloture vote on Kiran Ahuja’s nomination to be OPM Director. If the cloture vote receives majority approval (assuming a quorum exists), then the Senate will vote to confirm Ms. Ahuja’s nomination sometime after 2:30 pm tomorrow.

From the COVID-19 front

  • MedPage Today reports that “While experience so far with COVID vaccines shows that some are associated with very rare, early side effects, experts say they have confidence about the long-term safety of these vaccines. That’s because past experience shows that severe side effects from vaccines most often appear within a time frame of about 6 weeks after vaccination, according to Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).”
  • Bloomberg reports that “Covid-19 vaccines from Pfizer Inc. and AstraZeneca Plc are highly effective after two doses at preventing hospitalization of those infected with the delta variant, underscoring the urgency in getting people fully protected, according to health authorities in England.” David Leonhardt adds in the New York Times that

The news about Covid-19 has been mostly positive in the U.S. over recent months. The vaccines continue to work well against every variant, and the number of Americans who have gotten a shot continues to rise.

But the U.S. still faces two problems. First, the pace of vaccinations has slowed, and a substantial share of Americans — close to one third — remains hesitant about getting a shot. These unvaccinated Americans will remain vulnerable to Covid outbreaks and to serious symptoms, or even death.

Second, the Delta variant — which appears to be both more contagious and more severe than earlier versions of the virus — is spreading rapidly within the U.S., after having first been identified in India. It now accounts for about 10 percent of cases, according to Dr. Scott Gottlieb, a former F.D.A. commissioner. * * *

“The Delta variant is by far the most contagious variant of this virus we have seen in the entire pandemic,” Dr. Ashish Jha saidyesterday. “The good news is the data suggests that, if you’ve been fully vaccinated, you remain protected, that the vaccines hold up.”

The clearest place to see this pattern is Britain, where the Delta variant has spread widely and where the vaccination rate is high. In Britain, there is “still no sign of increase in deaths, well after the strain has become dominant,” as Dr. Eric Topol of the Scripps Research Translational Institute noted.

Vaccine maker Novavax said Monday its shot was highly effective against COVID-19 and also protected against variants in a large, late-stage study in the US and Mexico.

The vaccine was about 90 percent effective overall and preliminary data showed it was safe, the company said.

While demand for COVID-19 shots in the US has dropped off dramatically, the need for more vaccines around the world remains critical. The Novavax vaccine, which is easy to store and transport, is expected to play an important role in boosting vaccine supplies in the developing world.

That help is still months away, however. The company says it plans to seek authorization for the shots in the US, Europe and elsewhere by the end of September and be able to produce up to 100 million doses a month by then.

  • The Department Health and Human Services announced that it has “awarded $125 million to support 14 nonprofit private or public organizations to reach underserved communities in all 50 states plus the District of Columbia, Puerto Rico, Guam and the Freely Associated States to develop and support a community-based workforce that will engage in locally tailored efforts to build vaccine confidence and bolster COVID-19 vaccinations in underserved communities.”

Fierce Healthcare reports that

Following its acquisition of MDLive and the approval of new drugs in the market, Cigna’s Evernorth is expanding its care management program for weight loss.

The Weight Management Care Value program initially launched under Express Scripts as part of its slate of SafeGuardRx programs. Now, the company is harnessing the capabilities of other assets under its umbrella to broaden the program.

Members who enroll in the program will have access to new therapies like Novo Nordisk’s Wegovy, when clinically appropriate and prescribed by their doctor, as well as virtual care options provided by MDLive.

Here are two more OPM rule makings that were listed in OPM’s semi annual regulatory agenda that was released last Friday June 11

  • OPM has in store for us a new proposed rule on FEHB Enrollment and Changes in Enrollment “The Office of Personnel Management (OPM) proposes to amend title 5 part 890 of the Code of Federal Regulations governing the Federal Employees Health Benefits (FEHB) Program to allow OPM to make improvements and clarifications to the FEHB Program’s enrollment rules and processes, including centralizing certain health benefits enrollment functions. Currently, enrollment is administered by an enrollee’s employing agency or retirement system. This rule would allow OPM to leverage necessary IT functionality in order to conduct certain enrollment functions and collect information necessary to administer FEHB enrollments with greater efficiency and in alignment with the best practices of employer-sponsored insurance programs. In addition, OPM is proposing a process that would allow an employing office or OPM to decrease an individual’s enrollment type from self plus one or self and family to self only when there is only an enrollee and no family member.”
  • OPM plans to issue an interim final rule extending FEHB coverage to Tribal employees at 297 grant schools in accordance with the Consolidated Appropriations Act. This action suggests that the extension will take effect for the next Federal Benefits Open Season

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.

Tuesday’s Tidbits

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

The Blue Cross Blue Shield Association announced today that

the Blue Cross and Blue Shield (BCBS) Government-wide Service Benefit Plan, also known as the Federal Employee Program® (FEP®) announced it will launch a COVID-19 Vaccination Incentive Program starting Friday, June 11, 2021, to encourage members to get vaccinated against COVID-19 and help meet President Biden’s goal of having at least 70% of the U.S. adult population receive one or more vaccinations for COVID-19 by July 4, 2021.

Eligible members – those over the age of 18 with an FEP MyBlue® account – will receive $50 on their MyBlue Wellness Card when they provide official documentation of their COVID-19 vaccination record. Members can use these incentive funds to purchase qualified medical expenses. FEP is the first Federal Employees Health Benefit program to offer a vaccination incentive like this to its members.

In other COVID-19 news —

  • The Wall Street Journal reports that

Pfizer and partner BioNTech SE said Tuesday that they have begun testing their vaccine in children under 12 years old in a pivotal study. If the results prove positive, Pfizer said it would ask U.S. health regulators in September to expand use to some of the younger children.

Meantime, Moderna Chief Executive Stephane Bancel said results of testing Moderna’s vaccine in children as young as five years could become available by the fall, which if positive could lead to regulatory authorization of its use in the younger age group.

  • Dr. Marty Makary writes in a Journal op-ed that “The news about the U.S. Covid pandemic is even better than you’ve heard. Some 80% to 85% of American adults are immune to the virus: More than 64% have received at least one vaccine dose and, of those who haven’t, roughly half have natural immunity from prior infection. There’s ample scientific evidence that natural immunity is effective and durable, and public-health leaders should pay it heed.”

Hospitals, state health departments and the federal government are racing to decide how to use up millions of Johnson & Johnson’s vaccine doses that are set to expire this month.

The prospect of so many doses going to waste in the U.S. when developing nations are desperate for shots would add pressure on the Biden administration to share stockpiled vaccines. But there are few practical solutions to administering them quickly in the U.S. or distributing them in time to foreign countries, according to those involved in the vaccination drive.

The stockpile is, in part, an unintended consequence of the U.S.’s decision in April to temporarily suspend administration of J&J doses to assess a rare blood-clot risk. The pause forced states and providers to cancel large blocks of appointmentsthat were never rescheduled, leaving a surplus of supply, and in some areas increasing hesitancy over the J&J vaccine’s safety, according to industry officials. * * *

The issue of expiring doses is the latest setback for J&J’s Covid-19 vaccine effort. An accident at a contract manufacturer’s plant led to the contamination of material that could have yielded up to 15 million doses and led to a halt in production of the J&J vaccine there.

This serious Johnson & Johnson one dose COVID-19 vaccine distribution problem impairs efforts to vaccinate people like the unhoused who are unlikely to return for a second dose of the mRNA vaccine.

Following up on yesterday’s news about Food and Drug Administration of an Alzheimer’s Disease drug, the Wall Street Journal offers a medical specialist’s observations on this terrible disease. Also Fierce Healthcare informs us that Biogen has “unveiled collaborations with CVS Health, Cigna to boost access to its Alzheimer’s drug.”

The Washington Post informs us that

Senate Republicans are blocking a quick confirmation for President Biden’s nominee to lead the federal personnel agency, targeting her past emphasis on the concept of systemic racism known as “critical race theory” that has become a lightning rod for conservatives.

Republicans also are pushing back on Kiran Ahuja’s support for abortion rights at a time when a long-standing ban on federal funding for the procedure — known as the Hyde Amendment — has emerged as a renewed flash point for the right because of Biden’s support for overturning it.

The delay on Ahuja’s nomination is being led by Sen. Josh Hawley (R-Mo.), although several Republicans objected to a quick confirmation vote for her, according to senior Democratic and GOP officials. The move will force Senate Majority Leader Charles E. Schumer (D-N.Y.) to go through procedural hurdles on the Senate floor, rather than move quickly with a pro forma vote that is more common for nominees to lower-profile posts.

In the tidbits department —

The majority of the average healthcare premium dollar goes toward prescription drugs and outpatient and inpatient hospital costs, according to AHIP’s most recent research.

AHIP looked at 30 commercial health insurance providers’ financial statements between 2016 and 2018 to get the breakdown of how payers were spending members’ premiums. The data included spending by employer-provided coverage and coverage that individuals can purchase on the healthcare market.

The biggest chunk of the healthcare dollar went towards prescription drugs, with 21.5 cents dedicated to payments for outpatient prescription medications and prescription medications administered in a physician’s office or clinic.

Prescription drugs are closely followed by spending on outpatient hospital and inpatient hospital services, both around 19 cents while medical services come in at 12 cents.

  • Healthcare Dive informs us that yesterday “Apple unveiled new health features aimed at patient-doctor data exchange.” Moreover, “Apple is launching new mobility capabilities for its iPhone. Using information from its motion sensors, the phone can now collect data on someone’s balance, stability and coordination by measuring stride length and timing, and warn them they might be at risk for a harmful fall if they’re walking unsteadily. Usually, fall risk is assessed by a provider using a questionnaire and in-person exam.” The new features will be available on Apple devices in the fall of this year.
  • According to a Department of Health and Human Services press release, “The White House, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the U.S. Food and Drug Administration (FDA) today released a series of policy recommendations to address the vulnerabilities in U.S. pharmaceutical supply chains. Led by FDA and ASPR, the White House report – PDF and its recommendations have been accepted by President Biden.”

“To secure the supply chain, the report’s recommendations center on four pillars:

  1. Boosting local production and fostering international cooperation;
  2. Promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience;
  3. Creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance, and
  4. Leveraging data to improve supply chain resilience.”

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

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 Weekend update

David Ermer–CDC, Congress, Congress, COVID-19, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Thanks to Justin Casey for sharing their work on Unsplash.

Congress is on a State / district work break this coming week. The Supreme Court has over thirty cases to decide, including the latest Affordable Care Act constitutionality case, before adjourning for the summer in late June / early July.

The federal employee news organizations have highlighted portions of the President’s fiscal year 2022 budget proposal which was released last Friday.

  • The Federal Times reports that “President Joe Biden’s fiscal year 2022 budget anticipates a more than 50,000 full-time-equivalent employee increase to the federal payrolls next year, as part of concerted efforts to attract young and expert workers to federal service. * * * ‘The Federal workforce continues to become older on average. Almost 30 percent (635,397) of employees are older than 55, while 8.1 percent (176,805) of employees are younger than 30. By comparison, in the private sector, 23 percent of the workforce is younger than 30. Every single agency has fewer employees younger than 30 today than they had in 2010,’ the budget proposal’s analytical perspectives state.
  • Govexec informs us that “President Biden on Friday formally proposed an average 2.7% pay increase for federal civilian employees in 2022 as part of his fiscal 2022 budget proposal. * * * It was unclear Friday how Biden’s proposal would be divvied up between an across-the-board boost to basic pay and increases in locality pay. In recent years, pay raise provisions have included a 0.5% average increase in locality pay, although it was frozen at 2020 levels this year. * * * The proposal also marks a return to the principle of pay parity between the civilian and military workforce, as service members would also receive a 2.7% pay raise in 2022. 

Federal News Network offers three brief stories on the U.S. Postal Service

The Postal Service sent its first reduction in force notices to non-union management employees Friday [no indication of how many notices were sent out], and is planning to set higher prices on its mail products well above the rate of inflation [first class stamp would increase by 5% from 55 cents to 58 cents].

The Senate, meanwhile, voted [by unanimous consent] to confirm [Anton Hajjar] President Joe Biden’s third nominee to serve on the USPS Board of Governors. The board is now fully staffed for the first time since 2010, and will help the agency get its 10-year reform plan off the ground.

Thus the Senate has confirmed all three of the President’s Postal Governor nominees who shared a confirmation hearing with OPM Director Kiran Ahuja while Ms. Ahuja waits for a confirmation vote.

In healthcare news —

  • Bloomberg tells us that “The U.S. reported the lowest level of infection since the early days of the pandemic and welcomed back sports fans to stadiums. The Indianapolis 500 was run before 135,000 fans, the largest crowd for a sporting event since the pandemic began [but 1/3 of capacity].  * * * The world needs the cooperation of the Chinese government to trace the origins of Covid-19 and prevent future pandemic threats, two leading U.S. disease experts said Sunday.
  • NPR reports that “For children in particular, the risk of serious consequences from COVID-19 is the same magnitude as the risk they face from the flu, she says. But many parents seem more worried about the new and less familiar disease. * * * [E]xperts urge parents to try not to worry too much.
  • Because many FEHB plans provide hypertensive members with at home blood pressure monitor, the FEHBlog wants to share the American Medical Association’s views on what doctors wish their patients knew about home blood pressure measurement.

Finally, the FEHBlog’s eyes were drawn to the weekend Wall Street Journal’s Heard on the Street column which discusses the efforts of Walmart and Amazon to enter the healthcare business.

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.”