Midweek Update

Midweek Update

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

Reg Jones provide FEHB background for federal employees in Fedweek.

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

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

In other healthcare news

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

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

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

The Wall Street Journal reports

The Biden administration said it would begin reallocating some Covid-19 vaccine doses to states with higher demand for shots and direct pharmacies to offer walk-in vaccinations, as the president aims to get 70% of the adult population at least one dose by July 4.

President Biden said Tuesday he also wants 160 million U.S. adults to have the full course of the vaccine by that point, which he said would mean administering about 100 million shots over the next 60 days. The U.S. administered about 220 million shots in Mr. Biden’s first 100 days, but the pace of vaccinations has fallen in recent weeks, according to the Centers for Disease Control and Prevention. Roughly 56% of U.S. adults had received at least one dose as of Monday, according to the CDC.

Also from the COVID-19 front, the NIH Director Dr. Francis Collins offers a real world look at COVID-19 vaccines versus variants.

Healthcare Dive reports

  • CVS Health beat Wall Street expectations for earnings and revenue in the first quarter, reporting a topline of $69.1 billion, up 3.5% year over year due to growth across all major businesses.
  • The diversified healthcare behemoth brought in net income of $2.2 billion, compared to $2 billion at the same time last year in financial results released premarket Tuesday. 
  • Following the quarter, which saw a strong financial showing from all major U.S. payers, CVS raised its full-year earnings guidance, noting it expects normal utilization throughout 2021 and minimal effects from the COVID-19 pandemic. However, management did warn vaccine hesitancy could slightly hamper expected earnings growth.

In related CVS news —

  • NPR Shots informs us about how CVS Health is adding mental health therapists to its Minute Clinics and Health Hubs.
  • Drug Channels places CVS Specialty at the top of its list of top 15 specialty pharmacies.

In other healthcare business news

  • STAT News informs us that “Although the pharmaceutical industry argues that wholesale prices do not accurately reflect prescription drug costs, a new study finds that rising wholesale prices have, in fact, led to higher out-of-pocket expenses for roughly half of insured patients.” Shocking.
  • The Wall Street Journal reports that “Pfizer Inc. raised this year’s sales forecast for its Covid-19 vaccine to about $26 billion, a 73% increase that reflects the shot’s growing role in a long-term global vaccination campaign.” Thanks Pfizer.
  • Health Payer Intelligence reports

Gross margins and medical loss ratios from 2020 may confirm that payer profitability increased during the coronavirus pandemic, according to a brief from Kaiser Family Foundation.

The researchers leveraged data from the National Association of Insurance Commissioners (NAIC) to observe the pandemic’s effects on the profitability of four health insurance markets: Medicare Advantage, Medicaid managed care, the individual health insurance marketplace, and the fully-insured group health insurance marketplace.

“By the end of 2020, gross margins per member per month across these four markets remained relatively high and medical loss ratios were relatively low or flat compared to recent years,” the researchers discerned. “These findings suggest that many insurers remained profitable through 2020.”

Here are some additional healthcare tidbits —

  • The Lown Institute announced that “Every 80 seconds, a hospital in the U.S. delivers a low-value test or procedure to an older adult, putting hundreds of thousands at risk of harm, according to a new analysis from the Lown Institute, a health care think tank. The Institute today released a ranking of over 3,100 U.S. hospitals that examines success at avoiding the use of tests and procedures that offer little to no clinical benefit.”
  • The Congressional News Service released a helpful report titled “A Comparison of Tax-Advantaged Accounts for Health Care Expenses.”
  • The Department of Health and Human Services announced “the availability of nearly $1 billion to strengthen COVID-19 response efforts and increase vaccinations in rural communities. As part of the Biden Administration’s commitment to expanding access to vaccines and ensuring equity in the COVID-19 response, the Health Resources and Services Administration, a part of HHS, will increase the number of vaccines sent to rural communities, expand testing and other COVID-19 prevention services, and work to increase vaccine confidence by empowering trusted local voices with additional funding for outreach efforts in underserved communities.”

Last but not least here are some federal employment tidbits —

  • The Office of Personnel Management reminds us that “Each year Federal Executive Boards (FEBs) across the nation recognize federal employees who have made exceptional contributions in their community or the advancement of their agency’s mission. This year, OPM and the Partnership for Public Service are highlighting more than 300 awards winners from FY2020 and FY2021. To learn more about these recipients and their exemplary accomplishments, visit the FEB awards site.  
  • Federal News Network reports that “Union leaders say staffing shortages are stretching their agencies thin.”
  • Govexec reports that “Some U.S. Postal Service employees will receive layoff notifications later this month, the mailing agency told workers in a memorandum this week. * * * USPS declined to specify how many positions would be eliminated, but said it aims to offer impacted workers opportunities for reassignment.”

Weekend update

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Both of Houses of Congress are engaged in Committee business this week. The Senate Homeland Security and Governmental Affairs Committee will meet Wednesday morning to consider moving Kiran Ahuja’s OPM Director nomination to the Senate floor. The Senate will be engaged in floor business this week. Among other business items, the Senate will consider confirming Jason Miller to be OMB Deputy Director for Management. The President will address a joint session of Congress on Wednesday night.

From the COVID-19 front —

According to the CDC, over 1/3 of Americans over age 18 and over 2/3s of Americans over 65 are fully vaccinated against COVID-19. Bloomberg reports that “in the next few weeks, what the vaccine campaign is going to look like is going to change dramatically. The Biden administration is pursuing a strategy of abundance, which the White House has referred to as an “overwhelm the problem” approach. That means that there will likely still be widespread shipping of vaccines to pharmacies and health centers, inoculation clinics and mobile vaccine resources. But what’s likely to disappear are lines and scarcity.”

The FEHBlog has been looking for news that Pfizer and Moderna have applied for full Food and Drug Administration marketing approval for their vaccines. A San Diego television station reports on the implications of full marketing approval for these vaccines.

Companies want full approval for several reasons. Once the pandemic is no longer officially designated as an emergency, only fully approved products can remain on the market. And the stamp of approval from the FDA carries valuable credibility, [Dr. Sidney] Wolfe [co-founder of Public Citizen’s Health Research Group] said. “Aside from what benefit for marketing it does in this country, it will clearly have an international benefit,” he said.

The FEHBlog also understands that full marketing approval would allows the companies to distribute the vaccines directly to physicians’ offices.

Typically it takes the FDA about six months to review a licensure application for a high-priority drug. Pfizer said it expects to apply in the first half of 2021, and it expects a decision from the FDA in the second half of the year.

Another news source indicates that Moderna recently filed its licensure application with the FDA.

Good Housekeeping offers a timeline for when children will receive COVID-19 vaccines. Pfizer has applied to extend its COVID-19 vaccine’s emergency use authorization to people aged 12 to 15. However, the FEHBlog sees no FDA advisory committee scheduled to consider this request as yet.

From the artificial intelligence and telehealth fronts, the Wall Street Journal reports that

  • A journalist writes on her experience with telehealth over the past year.

For me, both in-person conversations and remote conversations have their unique advantages and disadvantages. Sometimes, eye contact or hands-on care is just what I need to feel confident in my doctor’s diagnosis or advice. But other times, there’s nothing like leveling the playing field with video or phone chat to make everything feel a bit more intimate and safer. One of the lessons we’ve learned from a year of remote everything is that in-person interactions have strengths that virtual conversations can’t quite match, and vice versa. Healthcare may be one more area where the future is hybrid.

It’s a reminder that health plans should focus their telehealth efforts on mental health services because people are comfortable with it and it extends the plan’s network.

  • In the other article three experts weigh in on whether artificial intelligence can replace human mental health therapists. Of course, the answer to that question is no. Nevertheless the experts’ responses on exciting uses of artificial intelligence in the mental health field is interesting, e.g., “In the near term, I am most excited about using AI to augment or guide therapists, such as giving feedback after the session or even providing tools to support self-reflection.” and

We can generate a vast amount of data about the brain from genetics, neuroimaging, cognitive assessments and now even smartphone signals. We can utilize AI to find patterns that may help us unlock why people develop mental illness, who responds best to certain treatments and who may need help immediately. Using new data combined with AI will likely help us unlock the potential of creating new personalized and even preventive treatments.

Encouraging.

From the federal employment front, the Federal Times informs us that “Even during the worst global pandemic of the century, increased demands on public jobs and a radical shift to predominantly remote work, federal employees are confident in their agencies’ ability to keep them safe and recognize their hard work, according to results of the [OPM] 2020 Federal Employee Viewpoint Survey.” Bravo.

Weekend update

Congress returns to committee work and floor voting this week. On Wednesday, the Senate Homeland Security and Governmental Affairs Committee will hold a business meeting concerning the nomination of Jason S. Miller, of Maryland, to be Deputy Director for Management, Office of Management and Budget. On Thursday, the Senate Finance Committee with hold a confirmation hearing for Andrea J. Palm, of Wisconsin, to be Deputy Secretary, and Chiquita Brooks-LaSure, of Virginia, to be Administrator of the Centers for Medicare and Medicaid Service, both of the Department of Health and Human Services.

On the COVID-19 front —

  • The Center for Disease Control announced that 4.6 million COVID-19 vaccinations were administered on April 10. As of Saturday, 46% of the U.S. population over age 18 has received at least one dose of the COVID-19 vaccine and 28% of that population are fully vaccination. 78.5% of the U.S. population over age 65 have received at least one dose and 61% of that population are fully vaccinated. A Bloomberg columnist adds that

Consider one of the most at-risk populations, people over 65. As of March, they accounted for most Covid-19 deaths — about 430,000, compared with just 104,000 for people under 65. Now, though, about 55% of older folks are vaccinated, and 75% have received at least one dose — which suggests that about 65% are probably protected from death by Covid. So if the past year of cases were replayed, the U.S. would see 65% — or 280,000 — fewer deaths among the elderly, and the total death count would be cut by more than half.

New cases will probably be even less deadly. For one, the vaccination campaign has targeted the most vulnerable among the elderly — people in nursing homes and other group living arrangements — so the distribution of those who get sick will also be skewed younger and healthier now. Also, younger people — and particularly those with underlying health conditions — have been taking up the vaccine more and more. Given these trends, the mortality rate per confirmed case is likely to be a lot less than half of what it used to be.

Bravo.

There’s a late entrant into the COVID-19 vaccine race: The United States Army. And it hopes its own variety of COVID shot can protect against emerging variant strains of coronavirus, a threat which may loom large going forward and is feeding a resurgence of cases in certain regions.

On Tuesday, Army doctors began human clinical trials of the somewhat complicatedly dubbed the spike ferritin nanoparticle (SpFN) COVID vaccine candidate at the Walter Reed Army Institute of Research (WRAIR), which is housed under the Army’s medical research arm. 

Officials said that the technology behind this particular vaccine could be more effective at protecting against new strains of coronavirus, although existing COVID vaccines such as Pfizer/BioNTech’s have demonstrated efficacy against certain newer strains.

Fingers crossed.

What’s wrong with offering more good news? The AP reports that

The number of U.S. suicides fell nearly 6% last year amid the coronavirus pandemic — the largest annual decline in at least four decades, according to preliminary government data. Death certificates are still coming in and the count could rise. But officials expect a substantial decline will endure, despite worries that COVID-19 could lead to more suicides.

The number of suicides dropped by 1% in 2019 so this will be the second year in a row. The FEHBlog hope this drop is attributable to greater acceptance of mental illness, e.g., no more stigmatizing, and the major uptick in virtual mental healthcare stemming from the pandemic. Nevertheless, health plans and healthcare providers should promote the national suicide prevention lifeline. tel:1-800-273-8255.

If you have access to STAT News check out this article by Bryan Vartabedian, MD, about the portrait in the header of this post.

I couldn’t escape the painting’s draw, though I couldn’t put my finger on what I found so compelling about the image this time around.

Then it hit me. It was the intensity of the doctor’s gaze and his posture. What caught me this time was his presence. This doctor was all in.

Presence is the mindfulness that one individual brings to an encounter with another. It’s a defining element of human connection. In medicine, it’s what happens when a clinician’s connection is untrammeled by a screen or other competing inputs. It’s the focus of mind, spirit, and intent around a moment in time that’s about another person and his or her most pressing problem. Presence, be it in a clinic exam room or with a friend over coffee, is a uniquely human gift.

The good doctor suggests that the use of artificial intelligence will enable doctors to return to applying this human gift to patients. Hope springs eternally.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

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

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

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

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

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

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

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

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

In other healthcare related tidbits

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

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

  • Health Payer Intelligence informs us that

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

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

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

  • Adam Fein reports in his Drug Channels blog that

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

Friday Stats and More

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 13th week of this year (beginning April 2, 2020, and ending March 31, 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 greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the one year period (April 2, 2020 through March 31, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through March 31, 2021, which also uses Thursday as the first day of the week:

Bloomberg reported this afternoon that

More than 101 million people in the U.S. have received a first dose of a Covid-19 vaccine, or about 31% of the population.

Less than four months into the U.S. vaccination effort, coverage is best in people 65 years or older, with 74% of the group getting at least one dose and 54% completing vaccination, according to figures published by the Centers for Disease Control and Prevention and compiled by the Bloomberg Vaccine Tracker.

On Friday, the U.S. set a one-day record for vaccine doses reported administered, adding almost 4 million. On average, the U.S. is administering close to 3 million shots a day as of Friday’s update, also a record.

In other COVID-19 vaccination news

  • Fierce Pharm reports that Johnson & Johnson which offers a one dose vaccine has joined the two dose vaccine manufacturers Pfizer and Moderna in its vaccine on adolescents aged 12-17.
  • The Society for Human Resource Management informs us that

The following measures may increase vaccine acceptance in the workforce, according to the CDC:

1. Train interested staff to become COVID-19 vaccination ambassadors who will speak confidently and honestly, relaying personal stories about the vaccine to fellow co-workers and addressing any of their concerns.

2. Employ all available communication tools when promoting the COVID-19 vaccine to staff, including social media, internal communication channels, and posters or signs around the workplace.

3. Hold a virtual town hall where leadership, respected local medical experts and staff share their COVID-19 vaccine experiences and other vaccine facts and answer audience questions. Use experts to communicate to staff when talking about the COVID-19 vaccine. Ensure the experts present facts about the vaccine, including the risks.

4. Consider giving employees paid time off to get the vaccine and offering paid sick leave for employees who have adverse reactions.

5. Have workplace leadership take the COVID-19 vaccine, capture their experience using video or photo, and share the experience with staff.

  • In this regard, Govexec.com reports that

Next week, the Health and Human Services Department plans to open a vaccination site for federal employees in the National Capital Region.

A source familiar with the plans told Government Executive on Friday that the site will be in Gaithersburg, Maryland. “The site will provide COVID vaccinations to federal, essential, critical infrastructure workers,” said the source. Federal agencies will determine eligibility based on “job duties and [the Cybersecurity and Infrastructure Security Agency’s] guidance on the essential, critical infrastructure workforce,” which includes 24 agencies.  

The source was unsure at the moment on how many vaccine doses will be available or how many employees will be able to receive them. Employees will be notified starting Friday, April 2, the source said.

In health benefits news —

  • The Labor Department’s Employee Benefits Security Administration released ACA FAQ 45 today. FAQ 45 provides compliance guidance on Section 203 of Division BB of the Consolidated Appropriates Act 2021. Section 203 requires health plans, including FEHB plans, to prepare and keep current written analyses demonstrating compliance with the non-quantitative treatment limitations requirements of the federal mental health parity law and implementing regulations.
  • Fierce Healthcare explains how Optumcare successfully expanded the use of at home colon cancer screenings during the pandemic.

OptumCare used data analytics to flag the patients at risk for colon cancer and then reached out to them about the home test kits. While the kits included an information letter to describe the process, the clinical team also followed up four times by phone to check in with them.

If the testing results were positive or abnormal, the patient’s physician or care team would reach out directly to explain what the results meant and schedule them for future appointments to ensure care was coordinated throughout the process.

Frank said OptumCare saw a 5% higher return rate under the expanded program than in previous years, and the increased engagement drove interest in expanding other home health options such as home testing for blood glucose among diabetic patients.

  • Fierce Healthcare also informs us that

The American Medical Association innovation subsidiary Health2047 has spun off a company that uses personalized medicine to fight obesity. Phenomix Sciences is a phenotype testing company that carries out the AMA’s mission to confront chronic diseases such as obesity.

Phenomix uses a blood test called MyPhenome that it has licensed from the Mayo Clinic to allow doctors to prescribe individualized therapies. MyPhenome measures DNA as well as a person’s metabolites and hormones. These biomarkers make up a person’s phenotype, according to Phenomix.

The company’s blood-based test uses phenotype-driven multi-omics technology to predict responses to obesity interventions that the Food and Drug Administration (FDA) has approved. A multi-omics test is important because testing for obesity involves multiple factors, including genetics, metabolomics and environmental aspects, according to Phenomix CEO Mark Bagnall.

Because patients respond differently to obesity treatment, the Phenomix founders turned to AI to personalize this treatment. AI can personalize a multi-omics obesity test and analyze single-nucleotide polymorphisms, metabolites and hormones that correspond with a certain obesity phenotype, according to Bagnall.

AI can help identify a specific obesity phenotype so patients can receive the right treatment.

“[We] demonstrated in several clinical studies that knowing a patient’s phenotype doubles the likelihood of weight loss and doubles the amount of weight lost,” Bagnall said.  

Monday Roundup

Photo by Sven Read on Unsplash

The big news today is Astra Zeneca’s announcement that its two dose COVID-19 vaccine “demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation.

This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.

Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.

The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.

Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization [EUA”].”

Typically these trial result announcements have been made a week or two submission of the EUA application to the FDA and then the FDA takes two to three weeks to approve the application. Consequently, it appears that a fourth COVID-19 vaccine will be online in mid-to-late April.

CAVEAT: Bloomberg reports Tuesday morning that

AstraZeneca Plc may have released outdated information about its Covid-19 vaccine trial, giving an “incomplete” view of the efficacy of the shot, said the leading U.S. agency on infectious diseases.

The Data and Safety Monitoring Board, charged with ensuring the safety and accuracy of AstraZeneca’s vaccine trial, has expressed concerns to the National Institute for Allergy and Infectious Diseases that the information released about the testing results included outdated information.

This “may have provided an incomplete view of the efficacy data,” the agency said in a statement early Tuesday, without elaborating.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” said the group headed by Anthony Fauci, the top U.S. infectious disease official.

Astra Zeneca needs this news like it needed a hole in the head as one of the FEHBlog’s grandmothers would say.

The Centers for Disease Control offers guidance on how to talk about COVID-19 vaccines with friends and family. The FEHBlog’s general advice is simply get it. The key consideration is that all three available vaccines as well as the Astra Zeneca vaccine have 100% efficacy on preventing severe hospitalization or death from COVID-19.

The Hill reports that the Senate confirmed by a 68-29 vote the President’s nomination of Boston Mayor Marty Walsh to be Secretary of Labor. This is an important position with respect to the Affordable Care Act and ERISA as well as labor affairs.

EHR Intelligence discusses the growing role of state run health information exchanges in achieving health information interoperability.

The CMS interoperability rule addresses admission, discharge, and transfer (ADT) notifications. Providers need to fulfill a CMS condition of participation that will require all healthcare facilities to send outbound event notifications by May 2021.

All healthcare facilities must send direct electronic notifications to a patient’s provider once the patient is admitted, discharged, or transferred from another facility.

Health information exchanges are in a prime position to help prepare their clients accordingly.

This is a nifty idea, but why not give electronic notice to the health plan too?

In its latest call letter for FEHB carrier benefit and rate proposals, OPM encouraged carriers to pay attention to controlling low value care. Health Payer Intelligence discusses a relevant JAMA Open Network study finding that “there are at least 13 areas of low-value care in which Medicare Advantage and Medicare alike are not reducing healthcare spending,” among them, “antibiotics for acute upper respiratory infection, antibiotics for influenza, anxiolytic, sedative, or hypnotic medication, benzodiazepine for depression, an opioid for headache, an opioid for back pain, nonsteroidal anti-inflammatory drug (NSAID) for hypertension, heart failure, or kidney disease, radiograph for back pain, and MRI or CT for back pain or for headaches.”

From the healthcare innovation front —

  • Health IT Analytics informs us that “Statistical suicide risk prediction models could be implemented cost-effectively in healthcare organizations and may help save many lives each year, according to a study published in JAMA Psychiatry.”
  • mHealth Intelligence reports that “Researchers at the University of Cincinnati are developing a small drone, that, equipped with telehealth tools, can enter a house to facilitate virtual visits, drop off or pick up supplies, even survey living conditions.”

From the “Big Bowl of Wrong” front, the Wall Street Journal reports that “Hospitals that have published their previously confidential prices to comply with a new federal rule have also blocked that information from web searches with special coding embedded on their websites, according to a Wall Street Journal examination.” Yet, nn the bright side “After the Journal approached hospitals about its findings, the search-blocking code was removed from sites including those of HCA, Penn Medicine and Beaumont, and of South Dakota-based Avera Health, Tennessee-based Ballad Health, Maine’s Northern Light Health and Gundersen Health System in Wisconsin.” Good job Journal.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

Surprise! The FEHBlog mentioned the other day that he considered the Trump Administration’s proposed HIPAA Privacy Rule amendments to be a dead letter because they had not been scheduled to be published in the Federal Register today, the last day of the Trump Administration’s Federal Register. Well, as it turns out, that proposed rule showed up in the Federal Register public inspection list today with a Federal Register publication date of Thursday January 21. In any event. as the FEHBlog mentioned, the Biden Administration will be decide the fate of this rule making, which for what it’s worth the FEHBlog considers to be a helpful improvement.

Also today, OPM released a preview of the 2020 Federal Employee Viewpoint Survey results. “A preview of the governmentwide results are heartening,” said Acting Director Michael Rigas. “Through the toughest times, employees have been resilient and motivated while supervisors and senior leaders alike have served employees well by embracing their roles to keep employees safe and informed.”  Well done, OPM and federal agency employers and employes.

The FEHBlog is a fan of new health plan designs. Fierce Healthcare reports that

UnitedHealthcare is launching a new, virtual primary care option as part of an effort to expand access to local clinicians in its employer-sponsored plans.

Virtual primary care will be available to members in certain employer plans across 11 states, UnitedHealthcare said in an announcement. The insurer expects to expand the offering to additional states over the course of the year.

The goal, UnitedHealth said, is to make it easier for patients to establish and maintain an ongoing relationship with a primary care provider.

“The UnitedHealthcare Virtual Primary Care service and updated policy help expand the use of virtual care from delivering care to people who are sick, to now also focusing on preventing and detecting disease before it starts and, if needed, helping people more conveniently manage certain chronic conditions,” said Anne Docimo, M.D., chief medical officer at UnitedHealthcare,” in a statement.

Creative.

In another creative move, Fierce Healthcare calls our attention to the following:

As healthcare continues to evolve, legacy players are aiming to be the first to gain access to the latest innovations.

At Anthem, that effort has meant launching its own Digital Incubator, which pairs financial backing with mentorship and opportunities for partnerships with universities and corporations.

“Essentially, we are looking to get access to cutting-edge healthcare products,” said Kate Merton, staff vice president and head of Anthem Digital Incubator, in an interview with Fierce Healthcare. “We work with our entrepreneurs early in the cycle to make sure they’re developed with the mindset of the payer, of the consumer and the provider all in one.”

ADI offers a number of pathways for innovators to take and operates in both digital and physical platforms, with its first incubation space opening in Palo Alto, California.

On the mental healthcare front —

  • IFEBP informs us that the Department of Labor’s Employees Benefit Security Administration, which enforces ERISA, “released the Fiscal Year (FY) 2020 Mental Health Parity and Addiction Equity Act (MHPAEA) fact sheet on investigations.”
  • “The U.S. Department of Health and Human Services (HHS) and the Office of the Surgeon General (OSG)—in collaboration with the National Action Alliance for Suicide Prevention (Action Alliance)—released The Surgeon General’s Call to Action to Implement the National Strategy for Suicide Prevention. This new report outlines the actions that communities and individuals can take to reduce the rates of suicide and help improve resilience.”

Friday Stats and More

Based on the CDC’s Cases in the U.S. website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 1st week of this year (beginning April 2, 2020, and ending January 6, 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 noted that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period April 2, 2020 through January 6, 2021.

Because this week the CDC began to update its COVID-19 vaccinations data on a daily basis the FEHBlog was able to create this vaccines distributed and initially administered over the 51st week of 2020 through the first week of 2021 (December 23, 2020 through January 6, 2021):

Over the past four daily reports, the number of initial COVID vaccines administered increased steadily from 273,209 doses on January 4 to 748,313 doses yesterday. Per the AMA’s Morning Rounds

USA Today (1/6, Weintraub) reports HHS Secretary Alex Azar told governors to vaccinate as many people against SARS-CoV-2 as possible and warned to not let “perfection be the enemy of the good,” referring to priority plans. Azar said that with up to 70% of distributed vaccines still on shelves, states should focus on vaccinating the most people rather than prioritizing certain groups.

Today’s Fluview continues to report that “Seasonal influenza activity in the United States remains lower than usual for this time of year.”

UPI reports today that

At least half of COVID-19 transmission globally may have been caused by symptom-free infected people unknowingly spreading the virus to others, a study published Thursday by JAMA Network Open found.

In addition, nearly one in four cases of virus spread involves infected people who remain asymptomatic, the researchers estimated.

The findings highlight the importance of public health measures such as social distancing, mask-wearing and hand-washing — even for people who don’t feel sick — in preventing the spread of the virus, they said.

Mercer writes about the most pressing requirement of the Consolidated Appropriations Act – preparing and document comparative analyses to document compliance with the non-quantitative treatment limitations requirements under the federal mental health parity law. Mercer notes that

In case plan sponsors need more motivation to step up compliance efforts, we’re also seeing more litigation against plan sponsors and insurers alleging MHPAEA violations and breach of fiduciary duties under ERISA. In late 2020, in Wit v United Behavioral Health (UBH), a class action lawsuit ended with a decision by a federal court granting the plaintiffs the full extent of relief they requested and requiring UBH to reprocess nearly 67,000 mental health and substance use disorder (MH/SUD) benefit claims that were denied between 2011 and 2017. The federal court held that UBH breached its fiduciary duty to plan participants based on its use of overly restrictive medical necessity guidelines that resulted in the improper denial of more than 67,000 MH/SUD claims. This is just one example of the more than 100 lawsuits filed in the past several years alleging various MHPAEA and ERISA claims review violations relating to exclusions for ABA therapy, coverage for residential and other treatment facilities, medical necessity standards, and other items.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

The Wall Street Journal reports tonight that

The Trump administration made a $916 billion coronavirus relief offer to Democrats, opening yet another front in the multi-track effort to reach an agreement in talks that rank-and-file lawmakers have been leading in the final weeks of the year. The proposal, announced in a brief statement by Treasury Secretary Steven Mnuchin, came after Democrats rejected an effort by Senate Majority Leader Mitch McConnell (R., Ky.) to narrow the scope of a coronavirus relief bill by excluding aid for hard-hit state and local governments prioritized by Democrats and liability protections sought by Republicans. 

The President’s proposal reportedly includes $600 per person direct payments. The FEHBlog will be surprised if the COVID-19 relief bill negotiations are unsuccessful, but it would be hardly be the first time that Congress surprises the FEHBlog.

Also according the Wall Street Journal, the House of Representatives tonight passed the FY 2021 National Defense Authorization Act by a veto proof 335-78 margin. As the FEHBlog noted last week this bill includes goodies for federal employees. Federal News Network identifies policy winners and losers in this must pass bill which now goes over to the Senate.

Federal News Network columnist Mike Causey touts the FEHBlog’s personal favorite health plan design the high deductible health plan with health savings account (“HSA”). Mr. Causey aptly describes the HSA as a “Roth IRA on steroids” because and HSA is triple tax favored — tax exempt on the way in and out and grows tax free while in the account. The Federal Benefits Open Season ends on Monday December 14.

Fierce Healthcare informs us that

The FDA has released its internal review documents ahead of the closely watched COVID-19 vaccine advisory committee meeting scheduled for Thursday [December 10] —and they bode well for Pfizer and partner BioNTech’s prospects for securing a quick emergency use authorization (EUA). The FDA meeting briefing, published (PDF) on Tuesday, confirmed the efficacy and safety profile of Pfizer and BioNTech’s BNT162b2, reiterating that the shot was 95% effective at preventing COVID-19 after two doses with no serious safety concerns.

The Moderna vaccines turn before this panel occurs one week later on December 17.

Healthcare Dive reminds us that

Hospitals are readying for Jan. 1, [2021] when they expect they will have to publicly disclose the negotiated prices they reach with insurers for services performed inside their facilities — barring any intervention from a federal appeals court. [Such intervention in the FEHBlog’s humble opinion, is highly unlikely.]

The policy requires hospitals to share two streams of information. First, hospitals will have to share a machine-readable format of its negotiated prices with every insurer and every insurance product — a sizable pool of information. 

Then they will also have to prepare a list of 300 “shoppable services.” A total knee replacement would be a good example. It’s a procedure a consumer likely has time to plan and prepare for, unlike an emergency surgery due to an accident or failing health. The idea is to provide the price information so consumers can shop around for the best deal. 

The FEHBlog attended the second day of the American Bar Association’s Washington Health Law Summit (“WLS”). It’s worth noting that every panelist (six or seven in total) who has opined on the outcome of the Supreme Court’s California v. Texas case on the ACA’s constitutionality shares the FEHBlog’s opinion that the Supreme Court will preserve the ACA expect perhaps for the individual mandate which Congress effectively repealed in 2017.

The FEHBlog listened to three hours of discussion about behavioral telehealth and artificial intelligence during the WLS. It turns out that two types of healthcare AI exist admin AI and operational AI. AI can be assistive to the user’s decision making or can yield autonomous decisions. The Food and Drug Administration oversees the AI devices and the operational devices typically are used with imaging procedures. The FDA has approved two autonomous operational AI devices. The radiologists however has doubts about those devices.

The most interesting thing that the FEHBlog heard during this discussion was a remark from a Doctors on Demand speaker that telehealth companies are facing challenges in filling provider slots for psychiatrists and psychologists because of the enormous demand for mental health telemedicine. That’s a good thing. He noted that the explosion in telehealth use in 2020 is principally due to the government permitting a doctor or psychiatrist licensed in state A to treat a telehealth patient in state B.

The other speakers added that healthcare providers were quick to pick up on telehealth due to the licensing flexibilities and Medicare equivalent payments. They expressed their understanding that telehealth changes the personal dynamics between doctors and patients. Patients feels more in charge in a tele heath setting than they do in the office setting, and providers get social determinants of health data from seeing where the patient lives.