Midweek Update

Telehealth

Midweek Update

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, OPM, Telehealth, U.S. Healthcare–

From the Delta variant front –

  • In a joint statement, a group of high ranking HHS public health experts explained today that

“We have developed a plan to begin offering [COVID-19 vaccination] booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster. We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.

“We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

The FEHBlog will be in line for his third dose of the Pfizer vaccine when the time comes.

  • The Wall Street Journal reports that “Early data from Israel suggests a booster shot of Pfizer Inc.’s Covid-19 vaccine can significantly improve immunity in those aged 60 and above, as the U.S. and other countries plan additional doses to increase protection against the highly infectious Delta variant.”
  • Health Affairs reports on a study suggest”[ing] that the early COVID-19 vaccination campaign was associated with reductions in COVID-19 deaths. As of May 9, 2021, reductions in COVID-19 deaths associated with vaccines had translated to value of statistical life benefit ranging between $625 billion and $1.4 trillion.” The smartest move that the government made was to prioritize the elderly who suffered the most deaths during the pre-vaccination era of COVID-19.

From the federal employee vaccination screening program front, the Safer Federal Workforce task force issued a set of FAQs on COVID-19 testing employees, contractors and visitors who cannot attest to receiving a COVID-19 vaccination. The FEHBlog was pleased to read that the FAQs impose the testing cost on the agencies, not on the FEHB Program, which is the proper legal outcome under the federal CARES Act (unnumbered FAQ 3). Federal News Network makes its own observations on the Testing FAQs here.

In healthcare utilization news, Healthcare Dive reports that

  • More than one in 10 adults ages 16 to 64 said they delayed or went without needed healthcare services due to virus fears in the past 30 days, an April survey from the Urban Institute funded by the Robert Wood Johnson Foundation found. 
  • One in 10 parents delayed seeking care for their children for that reason, according to the report published Wednesday.
  • Hispanic and Black adults, along with adults with lower incomes, reported delaying care at higher rates than other groups. Adults with chronic health problems were also more likely than those without such conditions to say they went without needed care.

It’s worth noting that this survey was conducted during the month that vaccinations became widely available and before the Delta variant broke out.

In other healthcare news

  • Govexec reports that “Officials at the Centers for Disease Control and Prevention announced on Wednesday that the agency is launching a new organization to focus on disease forecasting.  The Center for Forecasting and Outbreak Analytics will be a hub for research and innovation aimed at mitigating the effects of future disease threats. Its launch comes as the federal government continues to fight the coronavirus pandemic and now the rapidly spreading Delta variant. It will build on current modeling efforts at the agency. * * * The center’s initial funding will come from the $1.9 trillion American Rescue Plan enacted in March for coronavirus relief.”
  • The NCQA Blog discusses the hospital at home movement in the U.S. “Humana Home Solutions​ Vice President Dr. Amal Agarwal estimated that up to 35% of Medicare Advantage spending might be addressable at home. As Mayo Clinic Platform President John Halamka explained, hospital at home also “brings the family back into wellness.” This matters because family involvement affects patient satisfaction.” Interestingly the experts explained that hospital at home care is best suited for mid-level acuity patients, not folks who need the ICU or folks who don’t require hospitalization.

Dr. Halamka used an accessible and memorable analogy to outline the long-term possibilities for hospital at home.

He explained that the tractor manufacturing company John Deere transformed itself into a data company by covering its tractors with sensors. The sensors report back information about the weight and volume of crops that customers harvest—soybeans, for example. The predictive value of the information reported to John Deere is so high that the data are now used to forecast soybean prices.

Likewise, Americans are filling their homes and strapping to their bodies millions of behavioral and biometric sensors.

“We are instrumenting homes with sensors to gather patient data that we can use to understand not only that patient’s progression, but aggregating and analyzing that data [to] understand the progression of similar patients,” said Halamka.

Well put, Doctor.

  • In support of extending initiatives like this to rural areas of the country, the Department of Health and Human Services announced today “key investments that will strengthen telehealth services in rural and underserved communities and expand telehealth innovation and quality nationwide. These investments—totaling over $19 million—are being distributed to 36 award recipients,” such as “Telehealth Centers of Excellence (COE) program: $6.5 million is being awarded to 2 organizations to assess telehealth strategies and services to improve health care in rural medically underserved areas that have high chronic disease prevalence and high poverty rates. The Telehealth COEs will be located in academic medical centers and will serve as telehealth incubators to pilot new telehealth services, track outcomes, and publish telehealth research. The COEs will establish an evidence-base for telehealth programs and a framework for future telehealth programs.’

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Delta variant front —

  • Govexec tells us that last Friday August 13, the Department of Justice issued its internal guidance on employee, on-site contractor, and visitor COVID-19 vaccine attestation program required by the White House. ‘Federal employees, regardless if they are working in person or teleworking, must complete a Certification of Vaccination Form and update it if there is a change in their vaccination status. ‘Employees who are not fully vaccinated will be required to obtain and provide to their supervisor (or component designee) a negative COVID-19 test result, from a test taken within the past three days, each time they enter a department facility or participate in an official meeting or function in another location other than the telework location,’ said the memo. ‘The department is developing a program to facilitate testing for employees.’”
  • The American Medical Association informs us about the reasons why moderately and severely immuno-compromised Americans who compose 2.7% of the population should get an mRNA vaccine booster. “[Food and Drug Administration] Approval of a third dose comes amid growing evidence that people with weakened immune systems do not get adequate protection from the normal two-dose regimen of Pfizer and Moderna COVID-19 vaccines. This makes immunocompromised people especially susceptible to breakthrough COVID-19 infections.”
  • The Wall Street Journal reports that Pfizer and BioNTech are starting to share clinical evidence of the value of a third booster vaccination for a broader swath of the U.S. population administered six months to a year following the first two doses. “Pfizer and BioNTech are also conducting a larger late-stage study evaluating whether a third dose safely provides more protection. The companies said they expect those results shortly and will then submit the data to the FDA. The FDA is considering a broader booster strategy, which the agency could issue in the next few weeks.”

With regard to the other public health emergency, the American Hospital Association points us to it web resources for the addressing opioid epidemic.

In healthcare business news

  • Labcorp has announced the acquisition of “Ovia Health, a digital health platform used by millions of women seeking information and support with family planning, pregnancy and parenting.”
  • CareMax, a “technology-enabled provider of value-based care to seniors, announced [on August 13] it has signed a collaboration agreement with Anthem, a national health benefits company. Through this collaboration, CareMax plans to build medical centers in areas where Anthem will offer a value-based care model to improve patient outcomes. * * * Through this collaboration agreement, CareMax plans to open approximately 50 medical centers with a focus on Indiana, Texas, Kentucky, Wisconsin, Georgia, Connecticut, and Virginia, among others.”

From the studies front

  • The University of Michigan’s Institute for Healthcare Policy and Innovation has released an eye opening study on telehealth. The FEHBlog commends it to his readership.
  • Benefits Pro tells us that “Interest in health savings accounts is on the rise, but there is still a gap in understanding about how HSAs work and how they can be used as a retirement savings tool. According to the Plan Sponsor Council of America’s (PSCA) 2021 HSA Survey, education about HSAs remains a key goal for plan sponsors. * * * The study pointed to a potential missed opportunity for employers to solicit HSA rollovers for newly hired employees, with less than 20 percent indicating they do so.”
  • The National Institutes of Health informs us that “A single two-hour session of a pain management skills class could offer as much benefit as eight sessions of cognitive behavioral therapy (CBT) for patients experiencing chronic low-back pain (CLBP), suggests a study published in JAMA Network Open(link is external). Supported by the National Center for Complementary and Integrative Health (NCCIH) and the National Institute on Drug Abuse, both part of the National Institutes of Health, the study explored whether a compressed intervention could lead to the same benefits as a longer-course of CBT.”
  • STAT News reports that the National Institute for Mental Health’s “Director Joshua Gordon told STAT the agency recognizes that new treatments for depression are needed and that it is funding research to explore the underlying biology beyond the monoamine hypothesis. When it comes to understanding depression, “there are fewer and fewer questions of importance with regard to the monoamine systems,” he said. He noted that in addition to federal funding, many startups and small companies are pursuing new treatments for depression. Currently, almost all patients with depression are first treated with medications called selective serotonin reuptake inhibitors, a class of drugs that includes both Zoloft and Prozac. They increase the amount of the neurotransmitter serotonin in the brain, which controls mood, emotions, and cognition. Serotonin and two other neurotransmitters targeted by some antidepressants, norepinephrine and dopamine, are called monoamines because they contain one chemical group called an amine.” The article also discusses those new treatments, including .

Friday Stats and More

David Ermer–Congress, COVID-19, COVID-19 vaccine, Government Contracting, Telehealth, 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 32nd week of this year (beginning April 2, 2020, and ending August 11, 2021); using Thursday as the first day of the week in order to facilitate this weekly update):

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

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the same period (April 2, 2020, through August 11, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 11, 2021, which also uses Thursday as the first day of the week:

Here is a link to the Centers for Disease Control’s (“CDC”) latest weekly review for the COVID data tracker upon which the FEHBlog relies. The review is aptly titled: “Put on Your Masks and Thinking Caps.”

The American Hospital Association has released on You Tube a two minute long presentation on the value of COVID-19 vaccines. It’s called Eight Things to Know About the COVID-19 Vaccine. Its message should be widely distributed.

The Federal Times reports that Kaiser Permanente which is the third largest carrier in the FEHB Program announced a COVID-19 vaccine incentive for its FEHB plan membership today.

The CDC also issued 2021-22 Flu Season FAQs today. Among thing the FEHBlog learned that “All flu vaccines will be quadrivalent (four component), meaning designed to protect against four different flu viruses. For more information: Quadrivalent Influenza Vaccine | CDC.”

In an ironic twist, check out this quote from Fierce Healthcare

“The recent emergence of the delta variant has introduced some uncertainty to our second half visits outlook,” said Ido Schoenberg, M.D., chairman and CEO of Amwell, during the call.

“With mask mandates quickly returning and also acknowledging other trends we are observing within visit mix and volumes, we need to account for these other dynamics and a likely weaker cold and flu season due to these variant-related protective measures,” he said, also noting the company does not expect extra COVID-related demand.

“Consequently, we are adjusting down our visit forecast for the remainder of the year to account for these factors,” he said.

As the French say, “quelle domage”.

But seriously folks, Revcycle Intelligence informs us that

The percentage of telehealth claim lines has stabilized at about 5 percent of medical claim lines, indicating a new balance of virtual and in-person care.

The analysis conducted by FAIR Health as part of its Monthly Telehealth Regional Tracker included data representing the privately insured population, including Medicare Advantage, and excluded Medicare fee-for-service and Medicaid claims data.

The data revealed that the percentage telehealth claim lines increased slightly to 5 percent in May 2021, from 4.9 percent the previous month. The slight increase suggests a stabilization of telehealth utilization since telehealth claim lines had declined each month from February to April of this year.

And what’s more —

  • Healthcare Dive has a helpful wrap up article on the HIMSS conference. Take a look.
  • Federal News Network reports that the General Services Administration released federal employee travel per diems for the fiscal year beginning October 1, 2021. The combined per diems provide a cap of the federal contractor travel expenses that can be charged against an experience rated FEHB contract.
  • From Capitol Hill, Roll Call reports that nine centrist House Democrats have told Speaker Pelosi in writing that “We will not consider voting for a budget resolution until the bipartisan Infrastructure Investment and Jobs Act passes the House and is signed into law.” Roll Call adds that “Together, they’ve got more than enough support to stall the budget in the narrowly divided House where Democrats can lose no more than three members on party-line votes. No Republicans are expected to vote for the budget resolution, which is needed to begin the process on a $3.5 trillion reconciliation package chock full of Democratic priorities.”

Thursday Miscellany

David Ermer–COVID-19, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Govexec reports that

The Veterans Affairs Department will more than triple the number of employees who must receive the vaccine, bringing the total to 360,000. VA originally required just its frontline health care staff—those hired under Title 38 of the U.S. Code—to be inoculated, which amounted to about 115,000 workers. 

The mandate will now include Title Five employees within the Veterans Health Administration—such as housekeepers, engineers and administrative staff—and health care providers such as psychologists, pharmacists, physical therapists, nursing assistants and others in “Hybrid Title 38” positions. 

“We’re now including most VHA employees and volunteers and contractors in the vaccine mandate because it remains the best way to keep veterans safe, especially as the Delta variant spreads across the country,” Secretary Denis McDonough said. “This pandemic is not over and VA must do everything in our power to protect veterans from COVID-19. With this expanded mandate, we can once again make—and keep—that fundamental promise.”

Employees impacted by the new mandate will have eight weeks to get the vaccine or prove they already have.

In the same vein, the Department of Health and Human Services (“HHS”) announced today that

[HHS] will require more than 25,000 members of its health care workforce to be vaccinated against COVID-19.

Staff at the Indian Health Service (IHS) and National Institutes of Health (NIH) who serve in federally-operated health care and clinical research facilities and interact with, or have the potential to come into contact with, patients will be required to receive the COVID-19 vaccine. This includes employees, contractors, trainees, and volunteers whose duties put them in contact or potential contact with patients at an HHS medical or clinical research facility.

Additionally, U.S. Surgeon General Dr. Vivek Murthy will immediately require members of the U.S. Public Health Service Commissioned Corps to be vaccinated against COVID-19 as part of medical readiness procedures to prepare for any potential deployment need as emergency responders

Those two mandates apply to about 20% of the federal workforce. In contrast, the general approach is a vaccine screening requirement — either attest to receiving the vaccine or wear a facemask and receive regular COVID-19 testing.

Furthermore, the Wall Street Journal reports that

The U.S. Food and Drug Administration authorized booster shots for certain people with weakened immune systems, likely the launch of broader efforts to better protect against evasive variants like Delta.

The agency on Thursday cleared giving a third dose of a messenger RNA Covid-19 vaccine from Pfizer Inc. PFE 2.01% and its partner BioNTech SE BNTX 4.13% or from Moderna Inc. MRNA 1.58% to immunocompromised people who had received a solid organ transplant or individuals who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

From the health equity front, the National Institutes of Health released a disturbing study on maternal mortality:

Racial and ethnic disparities in maternal mortality — deaths related to pregnancy or childbirth — in the United States may be larger than previously reported, suggests a study funded by the National Institutes of Health. By re-examining information on death certificates from 2016 and 2017, researchers found that the maternal mortality rate among non-Hispanic Black women was 3.5 times higher than among non-Hispanic white women. Previously, standard analyses had indicated a 2.5-times-higher death rate for Black women.

The new analysis also revealed that these disparities were concentrated among a few causes of death. Postpartum cardiomyopathy (disease of the heart muscle) and the blood pressure disorders preeclampsia and eclampsia were leading causes of maternal death for Black women, with mortality rates five times higher than those for white women. Pregnant and postpartum Black women were two to three times more likely than white women to die of hemorrhage (severe bleeding) or embolisms (blood vessel blockages).

The study was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and led by Marian MacDorman, Ph.D., of the Maryland Population Research Center at the University of Maryland. It appears in the American Journal of Public Health.

Healthcare Dive reports on HIMSS conference presentations on this important topic of achieving health equity.

Healthcare executives do say equity is a top priority for their organizations, with half of the CEOs surveyed by Deliotte early this year saying its among their top three organizational priorities this year, according to a recent report from the consultancy.

However, companies are at different stages of actually implementing equity and inclusion programs, with some reporting they’ve been focused on addressing disparities for years, and others just beginning to define what it means to their organization.

Of the 20 chief executives surveyed by Deliotte, 17 said they had a dedicated team or budget for health equity initiatives.

That top-level buy-in is important, but addressing health inequities needs to be a whole-enterprise mission, [Ronald] Copeland[, the chief equity, inclusion and diversity officer for integrated health giant Kaiser Permanente] said, integrated into every facet of payer and provider goals. One strategy to achieve this could be to make health equity a formal dimension of quality improvement, a policy that’s even recently been considered in federal payer programs under the Biden administration.

In other HIMSS conference news —

  • Fierce Healthcare informs about HIMSS conference discussion on rationalizing patient and provider experiences with multiple front end apps.
  • Healthcare Dive interviews Teladoc’s president of hospitals and health systems, Joe DeVivo about the state of the telehealth market and the company’s ambitions.

STAT News informed us today that 19,000 people attended the HIMSS conference in person and 5,000 attended virtually. 700 exhibitors attended. Both of those totals are about half of the normal in person attendance at HIMSS.

From the drug costs front, the White House released the President’s ideas on how to reduce prescription drug costs. The President leads off with encouraging Congress to allow CMS to negotiate Medicare Part D drug contracts. That change may save money for the federal government but it shift those savings to the commercial sector including the FEHB.

Also the HHS Inspector General released a report on opioid use among Medicare beneficiaries in 2020. “More than 43,000 Medicare Part D beneficiaries suffered an opioid overdose—from prescription opioids, illicit opioids, or both—in 2020.” The Inspector General also noticed a drop in prescriptions for opioid treatments which the OIG found concerning. “A May 2020 OIG data brief recommended that CMS educate Part D beneficiaries and providers about access to MAT drugs and naloxone. We continue to encourage CMS to take these steps. It is also critical for CMS to closely monitor the number of beneficiaries receiving MAT drugs and naloxone and take action, if needed. OIG is also committed to continuing our work on opioid use and access to treatment.”

In litigation news, the prescription benefit manager trade association, PCMA, has filed a lawsuit against HHS in the District of Columbia’s federal court challenging the legality of certain aspects of the payer transparency rule scheduled to start phasing in on January 1, 2022.

PCMA is not challenging the portions of the rule that direct plans to provide useful information directly to patients. But we are challenging the portions of the rule that do not meet those important objectives and will not produce information that patients and physicians can use.

These parts of the Trump administration’s transparency rule will drive prescription drug costs higher. By requiring disclosure of “historical” net prices, which are essentially current year net prescription drug prices, the rule will directly provide drug manufacturers access to their competitors’ negotiated rebates, discounts, and price concessions. This in turn will allow drug manufacturers to discount less deeply as they realize their price concessions went beyond those of competitors.

In addition, outside entities will not be able to develop reported information into a useful and understandable format for patients. Unlike health plans and PBMs, third-party application developers will not know patients’ existing insurance enrollment and eligibility or their current benefits and whether they have met a deductible or reached an out-of-pocket limit, and so the third-party applications are likely to cause widespread confusion among patients. Net prices are generally not useful information to patients because their deductible and coinsurance payments are calculated based on negotiated rates, not net prices.

PBMs and health plans already have real-time benefits tools for patients and prescribers, which they can use at the point of prescribing to check on cost-sharing for every patient based on their individual situation and health plan.

Coincidentally, the U.S. Chamber of Commerce has filed a substantially similar lawsuit in the federal court for the Eastern District of Texas. That case challenges the legality of the “historical net prices” provision and the “three machine readable tapes” provision of the HHS rule on the ground that they have no utility to consumers. Good luck.

Finally, the Census Bureau released a lot more 2020 census data today. The Wall Street Journal observes that “The nation’s population grew just 7.4% during the decade, the second slowest on record for a decennial census. Only the 1930s—the era of the Great Depression—saw slower growth.”

Midweek Update

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Medicare, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The American Hospital Association informs us that

The Senate early this morning approved on a party line vote a $3.5 trillion budget resolution, which included reconciliation instructions which will provide the majority party with the means to pass a comprehensive reconciliation package with just 51 votes in the Senate, rather than the usual 60-vote hurdle. The House will reconvene on Aug. 23 to consider the budget resolution. Once the resolution has passed both chambers, the House and Senate majorities can proceed with the reconciliation process, a resolution to which is expected in the fall. 

Bloomberg adds

Translating the budget framework into law will require Biden and Democratic congressional leaders keeping their party’s moderate and progressive wings marching together.

Just hours after passage of the budget blueprint, Senator Joe Manchin, a Democrat from West Virginia, said he couldn’t support a social spending bill with a $3.5 trillion price tag. Senator Kyrsten Sinema, an Arizona Democrat, has said the same. One Democratic objection is all it would take to scuttle the package in the Senate.

Time will tell but we are talking about $3.5 trillion on top of the $1 trillion infrastructure bill and multi-trillion COVID-19 relief bills that Congress has passed in the last 18 months. It appears that Congress is trying to disprove the adage that money can’t solve all problems.

One of the initiatives in the budget reconciliation package is to add dental, vision, and hearing coverage to Medicare. Kaiser Health News discusses the issue here.

From the Delta variant front

  • The Centers for Disease Control’s Advisory Committee on Immunization Practice released a helpful report on COVID-19 adverse side effects which it summarized as follows

What is already known about this topic?

Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome (GBS) and thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination.

What is added by this report?

On July 22, 2021, the Advisory Committee on Immunization Practices reviewed updated benefit-risk analyses after Janssen and mRNA COVID-19 vaccination and concluded that the benefits outweigh the risks for rare serious adverse events after COVID-19 vaccination.

What are the implications for public health practice?

Continued COVID-19 vaccination will prevent COVID-19 morbidity and mortality far exceeding GBS, TTS, and myocarditis cases expected. Information about rare adverse events should be disseminated to providers, vaccine recipients, and the public.

  • Forbes tells us that today “The Centers for Disease Control and Prevention encouraged anyone pregnant and breastfeeding to get vaccinated against coronavirus Wednesday, pointing to a growing amount of evidence that vaccines are safe and effective as new cases and hospitalizations linked to the virus surge across the country.” The Washington Post adds “Just 23 percent of pregnant women have received at least one shot of vaccine.”
  • Also from Forbes as schools begin to reopen “Vaccine rates among teenagers have remained lower than the U.S. population overall, with only 43% of 12- to 15-year-olds and 52.8% of 16- and 17-year-olds receiving at least a first dose as compared with 58.9% of the total population and 71.2% of adults.”
  • The Boston Globe discusses this teenage hesitancy issue — “The top reservation among parents of unvaccinated teens was the lack of information about the long-term effects of the shot, followed by concerns about side effects and fertility — despite conclusive evidence that the vaccine has no negative impacts on reproduction. Dr. Jill Kasper, a pediatrician at Cambridge Health Alliance, said she typically encounters ‘very little hesitancy’ from parents about routine adolescent vaccinations. That hasn’t been the case with COVID-19.”

The HHS Agency for Healthcare Quality and Research issued two noteworthy studies today. Here are the topline findings

  • #1 Overuse or low-value procedures may result in patient physical, psychological, or emotional harm. This study explored the association between eight low-value care procedures and length of stay (LOS) and cost. All eight procedures were associated with increased LOS and cost, particularly spinal fusion. Patients receiving low-value care may be exposed to increased risk of adverse events and hospital-acquired conditions.
  • #2 Medication administration errors made by parent or caregivers can result in medication errors at home. This systematic review found that 30% to 80% of pediatric patients experience a medication error at home, and that the risk increases based on characteristics of the caregiver and if a prescription contains more than two drugs.

Healthcare Dive informs us that

  • CVS Health said its Aetna unit will offer virtual primary care to self-funded employers nationwide in a move that underscores the growing popularity of telehealth services fueled by the COVID-19 public health emergency.
  • Using Teladoc Health’s physician-led care team model, the Aetna Virtual Primary Care service is intended to help strengthen the patient-doctor relationship and improve access to care, the vertically integrated company announced Tuesday. Members can receive health services remotely and in person.

Such support for primary care should be applauded.

In other healthcare news

  • STAT News reports that The Department of Veterans Affairs has decided not to cover a new Alzheimer’s drug from Biogen [Adulhelm], citing insufficient evidence of “a robust and meaningful clinical benefit” and concerns about safety. In a notice issued by the agency, the VA said it will make exceptions for “highly selected patients” and listed several hurdles that must be cleared before the medicine will be covered, such as requiring it to be prescribed by providers who specialize in treating dementia and ensuring patients had recently received MRI brain scans. * * * ‘Its bad news for Biogen,’ said Ira Loss of Washington Analysis, which tracks legislative and regulatory issues affecting the pharmaceutical industry for investors, who noted several private insurers have either declined or delayed coverage for the drug. ‘The VA is a big buyer of medicines. And you don’t like this kind of publicity, that’s for sure.’”
  • Fierce Healthcare continues to report from the HIMSS conference in Las Vegas. “Health IT giant Epic launched a new customer story-sharing website that lets Epic users share insights, tips and creative ideas around using health IT to improve their organizations and patient care. The site, EpicShare.org, combines insights from industry leaders, quick tips on improving outcomes and performance, in-depth case studies as well as a “Hey Judy” column from Epic founder and CEO Judy Faulkner.”

Weekend update

David Ermer–Congress, COVID-19, Electronic health records, OPM, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The Senate remains in session for Committee and floor business while the House of Representatives remains on its District work break. Politico reports from the Senate floor that

The bipartisan infrastructure deal embraced by President Joe Biden and shaped by a gang of 10 senators is inching closer to clearing the chamber, with one more filibuster to clear on Sunday before the bill can pass later this week and land in the the House. * * *

[House Speaker] Pelosi and Senate Majority Leader] Schumer have devised a two-track process to enact as much of Biden’s domestic agenda as possible, pledging that the bipartisan infrastructure bill will only advance if it is married to the party-line legislation that will spend as much as $3.5 trillion on climate change action, paid leave policies and health care expansion. 

The Senate will immediately proceed to a budget setting up that massive bill on filibuster-proof ground after it completes its work on the bipartisan infrastructure bill. Schumer is also considering forcing votes on more elections legislation after Democrats’ sweeping overhaul plan failed in June.

From the Delta variant front

  • The CDC’s COVID Data Tracker informs us today that just over two thirds of Americans over age 12 and 90% of Americans over 65 have received at least one dose of a COVID-19 vaccine. The data tracker consistently has shown a 10% difference between one dose and fully vaccinated Americans which indicates to the FEHBlog that people follow through a get the second dose.
  • However, the Wall Street Journal reports about how neighbor deaths from unvaccinated neighbors has caused an Arkansas town to reconsider their reluctance to receive the COVID-19 vaccine. Another Journal article adds that “Top U.S. public-health officials on Sunday [August 8] voiced support for Covid-19 vaccination mandates imposed at the local level, while the head of a national teachers union also backed such a move in schools.”
  • Speaking of mandates, the FEHBlog found a link to the Safer Federal Workers Task Force FAQs on the Biden Administration’s vaccine screening program for federal employees, federal office visitors and on-site contractors that were released last Friday August 6. Interestingly, an FAQ indicates that

Q: Do agencies need to ask employees on maximum telework or remote workers about their vaccination status?

A: Yes, agencies should provide the Certification of Vaccination form to all employees, including employees on maximum telework and remote workers.

Healthcare Dive informs us about

  • Five intriguing panels at this week’s in-person HIMSS conference in Las Vegas.
  • A new survey conducted by Social Sciences Research Solutions for the Bipartisan Policy Center [that] concludes that telehealth is likely an ongoing viable option for consumers even after the COVID-19 pandemic winds down.
  • An overview of second quarter financial reports from health insurers.

The Biden Administration to its credit has proposed a rule rescinding the Trump Administration’s rule to establish a most favored nation pricing approach for Medicare Part B covered drugs.

Govexec reports on a recent Postal Service Board of Governors meeting attended by the three recently confirmed members whom President Biden had nominated. “The tenure of the U.S. Postal Service’s newest board members got off to a tense start on Friday as President Biden’s appointees voiced their displeasure with the agency’s direction and USPS’ leader stated he will still move forward with reforms.”

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, Rx coverage, Telehealth, 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 31st week of this year (beginning April 2, 2020, and ending August 4, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

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

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through August 4, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 24, 2021, which also uses Thursday as the first day of the week:

While COVID-19 cases are soaring, the number of deaths remains stable thanks to the high vaccination rates for Americans over age 65. It is also encouraging that the number of administered vaccinations also is increasing.

In other Delta variant news:

  • Surprisingly, according to STAT News, “with nearly 20% of all U.S. Covid cases last week recorded in children, the American Academy of Pediatrics and 11 other organizations put out a consensus statement this week calling on providers conducting sports physicals to ask about children’s Covid vaccination status and to use it as an opportunity to administer a vaccine, if possible.”
  • Fierce Pharma tells us that “In a trial of nearly 480,000 healthcare workers in South Africa, Johnson & Johnson‘s one-dose vaccine helped prevent severe disease from the Delta variant, Bloomberg reports. The trial is the first piece of large-scale evidence that shows the shot works against the variant, the news service stated. In fact, Glenda Gray, one of the leaders of the work, said the vaccine may provide better protection against Delta than the Beta variant.”
  • MedPage Today reports that “Unvaccinated adults who were previously infected with COVID-19 were twice as likely to be reinfected as those previously infected but also fully vaccinated, researchers found. A case-control study in Kentucky found a more than two times higher risk of COVID-19 cases among unvaccinated adults with prior infection compared with their fully vaccinated counterparts (OR 2.34, 95% CI 1.58-3.47), reported Alyson Cavanaugh, PhD, of the CDC, and colleagues, writing in an early edition of the Morbidity and Mortality Weekly Report.“
  • In related news Precision Vaccines tells us that “The World Health Organization (WHO) issued Influenza Update N° 399 on August 2, 2021, saying, ‘Globally, despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year.'”

From the No Surprises Act (“NSA”) front, the FEHBlog discovered today that last Tuesday the tri-agencies and OPM submitted their second NSA interim final rule, which concerns the independent dispute resolution process, to OMB’s Office of Information and Regulatory Affairs for final review. OIRA already has two listening sessions concerning this rule making on its calendar. This indicates that the second interim final rule will be made public in early September, rather than on its October 1, 2021, due date.

From the federal employee front

  • Govexec brings us up to date on the development of the President’s mandatory vaccination program for federal employees. “The Safer Federal Workforce Task Force—a group President Biden created by executive order that is led by the White House, General Services Administration and Office of Management and Budget—confirmed in new guidance agencies would not initially ask for proof of vaccination, but they could follow up for documentation if they receive “a good faith allegation that strongly suggests” an employee lied on their attestation form. Those “certification of vaccination” forms will soon go out via email to all federal employees, with an Office of Management and Budget official saying that process will begin next week.  While agencies will initially rely on the honor system as it begins asking employees for their vaccination status, the administration made clear there could be consequences for lying.”
  • Govexec also discusses how Medicare Advantage plans are being integrated into FEHB plans. The trend started with HMOs and the APWU Health Plan picked it up for this year. Expect more plans to follow suit for 2022.  

In more news

  • Earlier this week, the FEHBlog noted a Reuters report that the Justice Department is preparing to file suit to block Optum’s acquisition of Change Healthcare. Fierce Healthcare reports today au contraire that “Change Healthcare President and CEO Neil de Crescenzo said Thursday he’s pleased with the company’s progress on regulatory review of its pending deal with Optum and is moving forward with plans for a successful integration. ‘We look forward to continuing to work diligently in coordination with UHG (UnitedHealth Group) to provide the necessary information requested by the DOJ (Department of Justice) and completing the transaction.'” Time will tell.
  • Medcity News informs us that “GoodRx struck a partnership with medication data giant Surescripts that would let healthcare providers access cash price information on medications. Arlington, Virginia-based Surescripts dominates the e-prescribing market, offering technology that routes clinicians’ electronic prescriptions directly to pharmacies. It’s owned by CVS Health and Express Scripts, and nearly 2 billion prescriptions were delivered through its software last year.”
  • mHealth Intelligence tells us that “While the pandemic prompted an unprecedented surge in telehealth to address healthcare needs, it also highlighted the gap between those who can access care and those who can’t. Now health systems, community health organizations, non-profits and philanthropic groups are moving to address those gaps with programs that use telehealth to extend care to those who can’t access or afford it. They’re fueling a surge in connected health charities and projects targeting the social determinants of health. Among those groups is Beam Up, an organization launched by telehealth company Beam Healthcare to address gaps in access to health food, quality education and healthcare services. Executives see a need for these services not only in other countries – a partnership with Tyto Care is equipping a handful of orphanages in Mexico with telemedicine technology – but in cities and rural regions across the United States.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Rx coverage, Telehealth–

From the Delta Variant front

  • As explained in this White House fact sheet, President Biden announced, among other things, that “to help protect workers and their communities, every federal government employee and onsite contractor will be asked to attest to their vaccination status. Anyone who does not attest to being fully vaccinated will be required to wear a mask on the job no matter their geographic location, physically distance from all other employees and visitors, comply with a weekly or twice weekly screening testing requirement, and be subject to restrictions on official travel. * * * These rules should not only apply to federal workers and onsite contractors. President Biden is directing his team to take steps to apply similar standards to all federal contractors. The Administration will encourage employers across the private sector to follow this strong model.”
  • The FEHBlog was struck by the fact that President intends to apply the mandate to federal contractors which group includes all of the FEHB carriers. If President were to flow down the mandate to federal subcontractors, he would pick up a large chunk of the American economy. This mandate whatever its scope would be accomplished by an amendment to the Federal Acquisition Regulation or perhaps regulator interpretations of the FAR which already includes a lot of provisions on worker safety. Time will tell.
  • Govexec reports on federal employee union and organization responses to the vaccine mandate which has been mixed. The Wall Street Journal adds that “Two prominent business groups, the U.S. Chamber of Commerce and Business Roundtable, said they welcomed Mr. Biden’s actions.”
  • The Wall Street Journal reports on private sector employers that have implemented a vaccine mandate, including Morgan Stanley, Google and Facebook. These mandates have been tied to office reopenings.

In telehealth business news —

Healthcare Dive reports that

Teladoc Health saw its year-over-year total revenue more than double in the second quarter of this year, coming in above Wall Street expectations and hiking its full-year guidance for the second time this year after offering mild expectations in February.

Analysts noted, however, that membership numbers were stale and the hospital business was slower than expected for the quarter. Shares were down 6% in morning trading Wednesday.

In a call with investors Tuesday, executives tried to steer the conversation toward per-member revenue metrics and touted new contracts, including with major Blues payer HCSC and a primary care platform agreement in the works with an unnamed national payer.

Fierce Healthcare reports that “Amwell is acquiring two digital health companies for $320 million to expand its services beyond telehealth visits. The virtual care company is scooping up SilverCloud Health, a digital mental health platform, and Conversa Health, which offers automated virtual healthcare. The addition of the two companies’ technology will help to differentiate Amwell from other telehealth players, company executives said.”

In prescription drug news, STAT News tells us more about the interchangeable insulin biosimilar that the Food and Drug Administration approved for marketing yesterday. Of note

The agency endorsed Semglee, a copy of long-acting Lantus (insulin glargine), that it first approved last year. * * * But Lantus, which is sold by Sanofi (SNY), already faces competition from several other long-acting insulins. And the company that sells Semglee – Viatris (VTRS), which was created last year when Mylan merged with Pfizer’s Upjohn unit – faces the same challenges winning coverage from health insurers. * * *

The real impact rests with patients whose out-of-pocket costs are more closely tied to the wholesale price for Semglee, according to Sonia Oskouei, vice president of biosimilars at Cardinal Health, a large pharmaceutical wholesaler. Those who pay cash or have high deductible health insurance typically pay more than others, which is where the “market opportunity” exists, she explained.

Depending on the pharmacy, Semglee injector pens cost about $150 to $180 without insurance for a typical month’s supply, compared to $340 or more for the same supply of Lantus, according to the GoodRx web site.

Also STAT News informs us that “Emergent BioSolutions (EBS) plans to resume Covid-19 vaccine production at its Baltimore plant after getting the green light from the FDA, according to The Wall Street Journal. The Baltimore plant had been shut down after FDA inspectors determined there was severe contamination at the plant, which makes the Johnson & Johnson (JNJ) vaccine. While domestic demand for the J&J shot has dwindled in recent months, the Biden administration is seeking to export the vaccine to countries needing protection against Covid-19.” The loss of the Johnson & Johnson to the U.S vaccination campaign will be noted in histories as the one dose is effective with socially vulnerable communities.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

Both Houses of Congress are in session this week for Committee business and floor voting. Roll Call reports that the House of Representatives is expected to hold a floor vote on a minibus appropriations bill including OPM appropriations during the week of July 26.

On the COVID-19 front —

  • Fierce Healthcare reports that “This is becoming a pandemic of the unvaccinated,” said Rochelle Walensky, M.D., director of the Centers for Disease Control and Prevention, during a briefing Friday [July 16]. “We are seeing outbreaks of cases in parts of the country that have low vaccination coverage because unvaccinated people are at risk. Communities that are fully vaccinated are generally faring well.” On the brighter side, “States with the highest cases are starting to see their vaccination rates go up, [Jeff] Zients {the White House coronavirus response coordinator] said [at the same briefing]. ‘In the past week, the five states with the highest case rates had a higher rate of people getting newly vaccinated compared to the national average,’ he added.”
  • In Friday’s post the FEHBlog noted that the Food and Drug Administration has fast tracked the Pfizer – Biotech application for full FDA approval of its COVID-19 vaccine. Precision Vaccinations tells us that “The Prescription Drug User Fee Act goal date for a decision by the U.S. FDA is in January 2022.”
  • Looking ahead, the JAMA Network offers an interesting article on the search for a single vaccine against coronaviruses yet to come.

On the telehealth front, Becker’s Hospital Review discusses how Amazon, Walmart and seven others have been expanding their respective telehealth businesses in 2021.

On the fraud waste and abuse front, Kaiser Health News reports that

Tens of thousands of times a year, hospitals charge enormously expensive trauma alert fees for injuries so minor the patient is never admitted.

In Florida alone, where the number of trauma centers has exploded, hospitals charged such fees more than 13,000 times in 2019 even though the patient went home the same day, according to a KHN analysis of state data provided by Etienne Pracht, an economist at the University of South Florida. Those cases accounted for more than a quarter of all the state’s trauma team activations that year and were more than double the number of similar cases in 2014, according to an all-payer database of hospital claims kept by Florida’s Agency for Health Care Administration.

While false alarms are to be expected, such frequent charges for little if any treatment suggest some hospitals see the alerts as much as a money spigot as a clinical emergency tool, claims consultants say.

“Some hospitals are using it as a revenue generator,” Tami Rockholt, a registered nurse and medical claims consultant who appeared as an expert witness in the Sutter Health car-accident trial, said in an interview. “It’s being taken advantage of” and such cases are “way more numerous” than a few years ago, she said.

Finally, the American Medical Association offers common sense views on what doctors wish their patients knew about healthy eating.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth–

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 28th week of this year (beginning April 2, 2020, and ending July 14, 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 materially exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through July 14, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through July 14, 2021 which also uses Thursday as the first day of the week:

As of today, according to the Centers for Disease Control, 160.7 million Americans are fully vaccinated against COVID-19, which figure represents 59.6% of the population eligible to be vaccinated (age 12 and up). 79.3% of the population over age 65 is fully vaccinated. That’s a key fact.

The American Hospital Association informs us that “Pfizer today said its COVID-19 vaccine will receive a priority review from the Food and Drug Administration, indicating that Pfizer has completed its rolling submission of its application for the vaccine’s full authorization. The company’s Biologics License Application, which is intended for individuals age 16 and older, is supported by clinical date from its phase 3 clinical trial.” That’s good news.

The Washington Post reports that “A federal advisory panel [the CDC’s Advisory Committee on Immunization Practices] is expected next week to consider whether health-care workers should be allowed to give additional coronavirus shots to patients with fragile immune systems, even as top U.S. health officials have said an additional dose of vaccine is not widely needed. * * * The advisory panel[on July 22] plans to focus on the 2 to 4 percent of U.S. adults who have suppressed immunity, a population that includes organ transplant recipients, people on cancer treatments and people living with rheumatologic conditions, HIV and leukemia.”

From the prescription drug front —

  • STAT News reports that “A prominent panel of medical experts [convened by the Institute of Clinical and Economic Review] unanimously voted that there is no evidence to suggest the recently approved Alzheimer’s drug offers patients any health benefits beyond the usual care. * * * After the voting, a roundtable discussion was held during which Mark McClellan, a former Centers for Medicare & Medicaid Administrator, said that access to Aduhelm “is going to be pretty limited at least until the nine-month period is over” and that we are “not going to see very big numbers in the near term.” This is likely because many payers will want to wait for Medicare to make its coverage decision in early 2022.”
  • Bloomberg reports that ” When a new obesity medication from the Danish drugmaker Novo Nordisk A/S began selling in the U.S. in June, it became the most effective weight loss drug on the market. Wegovyhelps patients lose an average of about 15% of their body weight, almost double the rates demonstrated by other prescription treatments, according to study results. That translates to a loss of about 20 to 70 pounds for eligible patients. Only costly and invasive bariatric surgery has shown the ability to eliminate more pounds. With more than 100 million people categorized as obese, the U.S. is a potentially huge market for Wegovy, which costs $1,350 for four weekly injections and is being pitched as a long-term therapy. * * * Insurance companies, pharmacy benefit managers, and employers determine whether health plans cover weight loss drugs, and which ones. Today only about half the clients of Cigna Corp.’s Express Scripts unit and Prime Therapeutics LLC, two major pharmacy benefit managers, reimburse for weight loss drugs. Express Scripts recently added Wegovy to its largest formulary, covering about 24 million people. Insurers Anthem Inc. and CVS Health Corp.’s Aetna don’t typically cover weight loss drugs, but both have indicated Wegovy will likely get some coverage. Others have yet to decide. Although “it’s not for everyone,” Wegovy has a role to play in treating obesity, says Amy Bricker, president of Express Scripts. She says she’s optimistic that treating obesity will lower costs for Express Scripts’ health plans.”

HealthTech Magazine offers a useful article on integrating virtual care into a healthcare organization’s overall delivery strategy. During the NCQA / HL7 Digital Quality Measure conference this week more than one doctor remarked that no one has found the Goldilocks level for virtual care, but at least study appears underway.