Tuesday Tidbits

Congress

Tuesday Tidbits

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

The FEHBlog was wondering today whether the clinical trial review board had given AstraZeneca a heads up about its concerns with the company’s press release before making the midnight press release on that topic. The New York Times reports that

“Only hours after AstraZeneca announced encouraging news about the effectiveness of its Covid-19 vaccine on Monday, a group of medical experts charged with monitoring the company’s clinical trial made a highly unusual accusation: AstraZeneca had essentially cherry-picked data to make its vaccine look better.

The accusation, in a two-page letter sent Monday to the company and federal officials, was a fresh blow to the credibility of a vaccine whose low price and relatively easy storage have made it critical to the global fight against the coronavirus pandemic.”

In other words, AstraZeneca, which is partnering with the University of Oxford, knew about the credibility concerns yet didn’t pull back the press release in the face of such criticism. The company’s failure to respond lead to a “sharply worded” statement  from the the National Institute of Allergy and Infectious Diseases [issued] on Tuesday shortly after midnight, disclosing the panel’s concerns.

The New York Times explains that

The fight is about the degree of effectiveness of a vaccine that is considered highly safe and effective.

While AstraZeneca said on Monday that its vaccine appeared to be 79 percent effective at preventing Covid-19, the panel of independent experts said the actual number may have been between 69 percent and 74 percent. The mass availability of a vaccine with even a 69 percent efficacy rate could help the world conquer the coronavirus.

But the public airing of a conflict between a pharmaceutical company and a board overseeing a clinical trial is almost unheard-of. It is certain to trigger extra scrutiny of the vaccine by the Food and Drug Administration and other regulators if, as expected, AstraZeneca seeks their authorization to use it on an emergency basis in the United States.

This is a sad state of affairs.

And now for some tidbits

  • The Department of Health and Human Services announced today its decision to the extend the Affordable Care Act marketplace special enrollment period for an additional three months. The last day to enroll will be August 15 instead of May 15, 2021.
  • Fierce Healthcare reports that “The Senate is likely to consider a bill this week that would extend a moratorium on 2% cuts to Medicare payments, according to the American Hospital Association. The extension is a major priority for hospital and doctor groups that say providers are still suffering financially due to the COVID-19 pandemic.”
  • In a piece of good news, Healthcare Dive informs us that

After cancer screenings for breast and colon cancers plummeted at the outset of the COVID-19 pandemic, they rebounded by the end of July, according to a new report in the Journal of General Internal Medicine that analyzed the private insurance claims of 6.8 million people ages 45 to 64.

In fact, the rate of women seeking mammograms was higher by the end of July than in the months leading up to the pandemic. Prior to mid-March, or when the public health crisis began, the median weekly rate of mammogram screenings were 87.8 women per 10,000 beneficiaries. That figure improved to 88.2 screenings per 10,000 beneficiaries by the end of July.

However, the rate of colonoscopies did not return to pre-pandemic levels, but returned to near normal, according to the researchers. In the months leading up to the crisis, median weekly colonoscopy rates were 15.1 per 10,000 beneficiaries and later rebounded to only 12.6 per 10,000 beneficiaries.

  • The Federal News Network reports on the Postal Service’s long awaited ten year business plan which was released today.
USPS aims to hit break-even year by 2023 under 10-year infrastructure plan

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Mental health care, OPM–
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.

Weekend update

David Ermer–ACA, AHRQ, Congress, COVID-19, COVID-19 vaccine–
Photo by Mark Tegethoff on Unsplash

The House of Representatives is engaged in committee work this week which will be followed by three weeks of district work. The Senate will engage in a floor voting, including a confirmation vote on the Secretary of Labor nominee Martin Walsh tomorrow, as well as committee work.

Healthcare Dive reports that

  • The House passed a bill Friday to extend the pause on Medicare sequester cuts until Dec. 31. The cuts have been on hold for a year but are set to go back into effect at the end of March.
  • The bill passed on a 246-175 bipartisan vote and also exempts the latest $1.9 trillion pandemic relief bill from budget rules that would have imposed additional cuts on Medicare payments to providers.
  • “We now look forward to working with the U.S. Senate to achieve relief from the pending Medicare sequester cuts before they go into effect,” the American Hospital Association said in a Friday statement.

Medicare sequester cuts tend to boomerang on private sector health plans, including FEHB plans.

Following up on Friday’s Stats and More, the FEHBlog compared new weekly COVID-19 cases and deaths per 100,000 by age groups as of January 2, 2021, and last Wednesday March 17, 2021.

This chart has a left axis measured in hundreds
This chart’s left axis ranged from zero to sixteen.

Because the March 17 new deaths rates are not visible in this chart, here are those numbers that the FEHBlog copied from the CDC’s website for last week’s new death statistics by age group

 Week ended 3-17-202118-2425-3435-5455-6465-7980+
New Deaths  per 100,000 00000.010.03

That, my friends, illustrates the work of the COVID-19 vaccines over the past two and half months. The Wall Street Journal reports today

Both the production and administration of shots have picked up in recent weeks. Now, some 2.5 million people in the U.S. are vaccinated daily on average, up from about 500,000 in early January, though many who want a vaccine still can’t get it.

The increased output should be enough to fully vaccinate 76 million people in the U.S. in March, another 75 million in April and then 89 million more in May, according to estimates from Evercore ISI analysts. The Pfizer-BioNTech and Moderna vaccines require two doses.

By midsummer, 75% of Americans 12 years old and above should be vaccinated, according to Morgan Stanley. The vaccines aren’t currently authorized for anyone younger than 16, but companies may have results this spring for studies of the shots in adolescents 12 and older, which, if positive, could lead to vaccinations for that age group. The companies are also starting to test the vaccines in children younger than 12, but results of those studies aren’t expected until late this year. 

Keep your sunny side up.

In other healthcare news:

  • Katie Keith in the Health Affairs Blog informs us that the impact of American Rescue Plan’s new ACA marketplace subsidies will be made known to consumers on April 1, 2021.

Enhanced subsidies are available for the entire 2021 plan year to anyone who qualifies and enrolls in marketplace coverage. This includes individuals who enrolled during the 2021 open enrollment period (and have had coverage since January 2021), individuals who enrolled before the American Rescue Plan was enacted (during special enrollment periods in 2021), and individuals who will enroll during the rest of 2021.

Consumers will be able to see the availability of the enhanced subsidies at HealthCare.gov beginning on April 1. But the process to “claim” these enhanced subsidies will look slightly different for new consumers versus existing consumers. (This process will also vary for consumers in states with their own marketplaces, which may adopt policies and timelines that differ from those for HealthCare.gov.)

Just like any other year, individuals can choose to receive all or some of the enhanced PTC in advance (i.e., have it paid to the insurer on their behalf each month) or wait to receive PTC at tax time in 2022 (i.e., while paying full premiums to the insurer each month). Because the cost of health insurance is so high for so many people, most marketplace enrollees opt for advance PTCs to reduce the amount they owe in monthly premiums.

The federal ACA marketplace and many state ACA marketplaces are in the middle of a special Open Season that run until May 15, 2021.

  • The HHS Agency for Healthcare Research and Quality’s Director concluded Patient Safety Week with reflections available at this link. Among the observations were the following:

The quest to learn more about what contributes to diagnostic inaccuracies and delays has already been a focus area for AHRQ. We began investing in diagnostic safety and quality research in 2007 and have helped build interest around the topic. Diagnostic error harms too many and costs too much .  

When I think about options for tackling the issue of diagnostic safety, I’m reminded of the progress we’ve made with our successful Healthcare-Associated Infections (HAI) Program. AHRQ’s HAI Program is dedicated to understanding the problems that can harm patients, identifying what works to prevent infections, and then developing, testing, and refining tools to put that knowledge into practice on the front lines of care. AHRQ has achieved a great deal working alongside clinicians, patients, and other stakeholders focused on HAI prevention throughout government and the private sector.

Thursday Miscellany

David Ermer–AHRQ, Congress, Telehealth–
Photo by Juliane Liebermann on Unsplash

In the wake of yesterday’s announcement that Amazon is breaking into the employer sponsored plan telehealth market, there was plenty of news today about telehealth.

STAT News reports that

“The market for virtual care is still massively underpenetrated,” wrote Cowen analysts Charles Rhyee, Calvin Sternick, James Auh, and Gwen Shi in a research note Wednesday. While Teladoc expects to provide 10 million visits in the U.S. in 2021, each year the country sees roughly 850 million outpatient visits, plus 300 million additional visits specific to mental health, according to the Cowen analysts. “This is not a zero sum game by any stretch,” they added.

Med City News effectively seconds this point of view as follows:

Amazon will need to build out relationships with health plans and health systems, so it can have a referral network for patients who need to see a specialist.   Teladoc, for example, says it has partnerships with more than 50 health plans and 600 health systems, perhaps implying that it’s not going to be that easy.

“New entrants to virtual care will continue to confront many of the challenges Teladoc Health has overcome over the past decade as we have built worldwide capabilities to deliver, enable and empower whole-person virtual care,” a Teladoc spokesperson wrote in an email.

While that may well be true, what Teladoc and Amwell encountered and overcame was low utilization — something that Amazon won’t have to contend with given that Covid-19 has ramped up utilization and adoption sky-high.

It will be interesting to see the jockeying for market share, but no matter which company wins, telehealth has already come out on top.

In that regard, Healthcare Dive reports that “Virtual behavioral health visits surged in the first half of 2020 as the COVID-19 pandemic exacerbated mental health needs, according to a new analysis by Milliman and Well Being Trust.”

Healthcare IT News cautions us that “Telehealth experienced sudden and massive growth starting a year ago, but it didn’t happen everywhere. A new report from the RAND Corporation suggests that the biggest upticks in virtual care availability occurred in more affluent and metropolitan communities, and that telemedicine services were mostly enjoyed by patients with private insurance.”

Healthcare Dive offers an interview with Health Affairs editor in chief Alan Weil that features a discussion of telehealth.

In healthcare equity news

  • Health Payer Intelligence reports that “Blue Shield of California has enhanced its provider network to expand COVID-19 vaccine access in underserved communities.”
  • Fierce Healthcare reports that

The Blue Cross Blue Shield Association (BCBSA) is teaming with Feeding America for COVID-19 vaccine outreach in vulnerable communities.

Clinical information and educational materials highlighting the safety and efficacy of the vaccines will be made available at Feeding America’s 200 food banks, which reach 40 million people. BCBSA will provide physical handouts as well as social media posts with information from the Centers for Disease Control and Prevention and its own clinicians.

The materials will be available in both English and Spanish, BCBSA said, and aim to “dispel common myths” that may prevent people from getting vaccinated.

In other healthcare industry news

  • Healthcare Dive reports that the Senate confirmed the President’s nomination of Xavier Becerra to be Health and Human Services Secretary by a 50-49 vote. “Becerra has the support of payer and provider groups including the American Hospital Association and American Medical Association.”
  • Also coming out of Congress,

Senators Dianne Feinstein (D-Calif.) and Chuck Grassley (R-Iowa) and Representatives Scott Peters (D-Calif.) and John Curtis (R-Utah) today introduced the Methamphetamine Response Act, a bill declaring methamphetamine an emerging drug threat which would require the Office of National Drug Control Policy (ONDCP) to develop, implement and make public a national plan to prevent methamphetamine addiction and overdoses from becoming a crisis.

 “In a single year we’ve seen psychostimulant-related overdose deaths, which include meth, spike by 42 percent,” said Feinstein. “The meth available on our streets is pure, potent and cheap and law enforcement is seizing more of the drug than ever. Two of the largest seizures on record occurred in California last year and in just a five month period, U.S. Customs and Border Protection seized more than 75,000 pounds of methamphetamine. Clearly we are in the midst of a meth crisis and we must implement a national, comprehensive plan to address this threat before it claims even more American lives.”

No bueno.

In further celebration of Patient Safety Awareness Week and because the FEHBlog believes that communication plays an important role in patient safety here’s an AHRQ article on using better communication to improve drug safety / avoid medication errors.

Weekend update

David Ermer–Congress, COVID-19 vaccine, Federal employment benefits–
Photo by Thought Catalog on Unsplash

Both Houses of Congress remain in session this coming week for floor voting and committee business.

Bloomberg reports that

New U.S. Covid-19 cases declined by almost 100,000 last week to the fewest since early October, while an average of 1,326 people died of the disease each day, data compiled by Johns Hopkins University and Bloomberg show. The week’s death toll of 9,284 was the lowest since mid-November. U.S. immunization has expanded amid a growing supply of vaccines and a drive by President Joe Biden’s administration to help roll them out. The U.S. vaccination rate over the last week was about 2.5 million doses per day * * *.

Here’s a link to the CDC’s website on demographic characteristics of Americans who have received the COVID-19 vaccination(s).

HHS’s Agency for Healthcare Research and Quality is holding its annual Patient Safety Awareness Week from March 14 to March 20.

From the FEHB front

  • FedWeek recently informed us about how getting married affects federal employee benefits.
  • FedSmith and Govexec each discuss planning for coordination of benefits with FEHB and Medicare in retirement.

Thursday Miscellany

David Ermer–ACA, CDC, Congress, COVID-19 vaccine, Federal employment benefits, OPM–
Photo by Juliane Liebermann on Unsplash

The President signed the American Rescue Plan (H.R. 1319) into law today.

Mercer provides a useful overview of the provisions of the law affecting employers. The COBRA subsidy discussed in the article does not apply to the temporary continuation coverage applicable to federal and postal employees. The COBRA subsidy in any event is only available to employees who lost health coverage due to involuntary termination of employment or reduction in hours.

On the bright side, the new law “increases the income exclusion for employer-provided dependent care assistance programs — for example, employee pretax contributions to dependent care FSAs — from $5,000 to $10,500 (and from $2,500 to $5,250 for a married individual filing a separate return) for 2021.” The FEHBlog expects that OPM will adopt this FSA change because the dependent care FSA is fully funded by the employee with no insurance risk to the employer.

Katie Keith in Health Affairs digs into the law’s financial support for the Affordable Care Act marketplace and its beneficiaries.

From the COVID front —

  • The White House has announced that the Biden administration will seek to “make every adult in the U.S. eligible for vaccination no later than May 1.” This fact sheet explains that steps that will be taken to make good on that plan.  The FEHBlog believes that this is an achievable goal.
  • David Leonhardt in the New York Times offers an interesting take on herd immunity from COVID-19. He explains that

Herd immunity is more like a light dimmer. The more people develop immunity — either from having been infected or from being vaccinated — the less easily the virus will spread.

Nearly 30 percent of Americans have now had the virus, according to Youyang Gu, a data scientist. (That includes many people who have never taken a Covid test.) About 18 percent have received at least one vaccine shot. There is some overlap between these two groups, which means that about 40 percent of Americans now have some protection from Covid.

Had these people been exposed to the virus a year ago, they could have become infected — and then spread Covid to others. Today, many are protected.

What’s more Mr. Leonhardt’s first dose of vaccination figure (18%) reflects the total U.S. population. However the vaccines generally are available only to people over 18 years of age. The Centers for Disease Control reports today that 25.1% of that population has received at least one dose of a COVID-19 vaccine. The FEHBlog nearly fell off his share today when he noticed a new statistic on the CDC site showing that 62.4% of the U.S. population over age 65 has received at least one dose of a COVID-19 vaccine. That’s great news.

In legislative / regulatory news —

  • Healthcare Dive reports that Xavier Becerra will soon receive a Senate floor vote on his nomination to serve as Secretary of Health and Human Services.
  • Govexec reports that “Postmaster General Louis DeJoy will soon request a $40 billion investment into the cash-strapped U.S. Postal Service for organizational and workforce improvements, saying the money will help address longstanding challenges the mailing agency faces.  The funds would go toward infrastructure updates such as larger facilities and new package sortation equipment, DeJoy told a panel of the House Appropriations Committee on Thursday [March 11], and reducing turnover in the USPS workforce.”
  • Healthcare Dive also discusses hospital pricing information that has been gleaned from the online reports required by the federal government’s hospital pricing transparency rule. It’s not pretty.

Midweek update

David Ermer–Congress, COVID-19, U.S. Healthcare–
Photo by Manasvita S on Unsplash

Roll Call reports that the House of Representatives passed the Senate amended version of the $1.9 trillion American Rescue Plan (HR 1319) by a 220 to 211 vote this afternoon. The President plans to sign the bill into law on Friday March 12. Medpage Today recaps the bill’s healthcare provisions, and the Federal Times recaps its federal employment provisions.

From the healthcare front

  • Medscape informs us that “A one-time injection of the monoclonal antibody cocktail casirivimab with imdevimab (REGEN-COV), taken within 72 hours of a household member’s diagnosis with SARS-CoV-2, prevented 100% of COVID-19 illness, 100% of high SARS-CoV-2 viral loads, and cut length of asymptomatic infection to 1 week. ‘It’s fantastic news,’ said Rajesh Gandhi, MD, an infectious disease physician at Massachusetts General Hospital and Harvard Medical School, who has been treating people seriously ill with COVID-19 since the pandemic began a year ago in Boston. ‘For individuals who, for whatever reason, don’t get the vaccine or decline the vaccine or haven’t yet gotten the vaccine, it’s really proof that antibodies can prevent disease’ in COVID-19.”
  • MedPage Today reports that “Data on colorectal cancer (CRC) screening gathered over the past decade have prompted the American College of Gastroenterology (ACG) to update its guidelines, last issued in 2009. The new recommendations, published online in the American Journal of Gastroenterology, state that screening should start at age 45 for persons of average risk.”
  • The Centers for Medicare and Medicaid Services reminds Medicare Part B beneficiaries who are at risk for diabetes type 2 that they can “join the Medicare Diabetes Prevention Program (MDPP)—part of CDC’s National Diabetes Prevention Program—and take steps to lower your risk for type 2 diabetes by more than 70% [with the help of a health coach]. You’ll also learn the skills needed to improve your overall health and build healthy habits that last a lifetime. And if you have Medicare Part B, it’s free!”

From the regulatory front

  • Govexec reports that two Senate committees have approved a floor vote for President Biden’s nominee for Deputy Director of the Office of Management and Budget, Shalanda Young. As the OMB Director nominee has withdrawn, Ms. Young will take over the reins of OMB when Senate confirms her. What’s more, bipartisan calls have been made in Congress for the President to nominate Ms. Young to be OMB Director.
  • Modern Healthcare reminds us that the Department of Health and Human Service has a lot of regulatory work to do in order to launch the No Surprise Billing law’s protections on January 1, 2023.

In healthcare industry news, Beckers Payer Issues informs us that “UnitedHealth Group subsidiary Optum signed a definitive agreement to acquire Atrius Health, a 715-physician group based in Newton, Mass., March 1.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, HIPAA Privacy and Security Rules, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

There are a boatload of tidbits today.

Roll Call reports that “The House [of Representatives] will vote to clear the $1.9 trillion pandemic relief package for President Joe Biden’s signature on Wednesday, Majority Leader Steny H. Hoyer told reporters.”

From the COVID-19 front

  • Fierce Pharma informs us that “Vaccine doses are fanning out around the globe, but officials worry that surging coronavirus variants could make the immunization push less effective. Thanks to a new lab study, Pfizer and BioNTech have some good news for them. “Pfizer and BioNTech’s mRNA shot [which the FEHBlog has received] appeared to work against three worrisome variants in a lab study, researchers from both companies and the University of Texas Medical Branch wrote in the New England Journal of Medicine. That includes the P.1 variant that arose in Brazil and has raised concerns about re-infections.”
  • Fierce Healthcare reports ” As the COVID-19 vaccine rollout continues, payers are gearing up to play a key role in easing vaccine fears and hesitancy. At Humana, for example, this has meant connecting with members at multiple touch points over the past year, and ensuring that vaccine education was not their first conversation with their health plan during the pandemic, Chief Medical Officer William Shrank, M.D., said. “I don’t think any of our members see this as our first outreach,” Shrank said.” But bear in mind health plans better late than never.
  • The Society for Human Resource Management discusses how employers can take steps now to reduce pandemic fatigue in their employees.

From the general healthcare front —

  • The Wall Street Journal informs us that “A federal medical panel is calling for a significant expansion of CT scanning for smokers to detect lung cancer, citing studies that found the imaging studies can save more lives than previously known. The U.S. Preventive Services Task Force is advising people ages 50 to 80 to get the screening if they have smoked on average a pack of cigarettes daily for 20 years, and who currently smoke or have quit within the past 15 years. The panel’s previous recommendation, in 2013, recommended people get screened between ages 55 and 80, and have smoked the equivalent of a pack of cigarettes a day for 30 years, and currently smoke or have quit within the past 15 years.” The USPSTF recommendation will result in FEHB coverage of the CT scan for FEHBP members in the expanded group without member cost sharing in 2023.
  • Health Affairs helpfully reports “Bundled payment has shown promise in reducing medical spending while maintaining quality. However, its impact among commercially insured populations has not been well studied. We examined the impacts on episode cost and patient cost sharing of a program that applies bundled payments for orthopedic and surgical procedures in a commercially insured population. The program we studied negotiates preferred prices for selected providers that cover the procedure and all related care within a thirty-day period after the procedure and waives cost sharing for patients who receive care from these providers. After implementation, episode prices for three selected surgical procedures declined by $4,229, a 10.7 percent relative reduction. Employers captured approximately 85 percent of the savings, or $3,582 per episode (a 9.5 percent relative decrease), and patient cost-sharing payments decreased by $498 per episode (a 27.7 percent relative decrease).” Interesting.
  • Health Payer Intelligence discusses how payers can take action against racial and ethnic healthcare disparities. Because “the payer industry’s core function is to pay for medical care, insurers can play a key role in overturning local care disparities through their payment strategies, offering funds to organizations that reduce disparities, and by spending locally in a way that is conscious of systemic inequities by purchasing from black and minority-owned businesses,” [Kedar] Mate [president and chief executive officer at the Institute for Healthcare Improvement (IHI), president of the IHI Lucian Leape Institute, and a member of the faculty at Weill Cornell Medical College] said.

From the healthcare industry front

  • Forbes informs us that “In the largest advertising blitz ever undertaken by the health insurance lobby, America’s Health Insurance Plans will spend at least $10 million on a national education campaign to show how health plans are ‘are working together to deliver affordable and accessible care and coverage.’”
  • Fierce Healthcare explains that “If there was one key word to come out of Cigna’s investor day on Monday [March 8], it would be “growth.” The insurer spotlighted its ambitions to expand across its enterprise, from its insurance plans to pharmacy to digital tools, at the virtual event for investors Monday morning. CEO David Cordani said that its growth plans “fuel our purpose.”
  • Fierce Healthcare also reports that “COVID-19 accelerated a number of trends already brewing in the healthcare industry, and that’s not likely to change this year, according to a new report from CVS Health. The healthcare giant released its annual Health Trends Report on Tuesday [March 9], and the analysis projects several industry trends that are likely to define 2021 in healthcare, ranging from technology to behavioral health to affordability. “We are facing a challenging time, but also one of great hope and promise,” CVS CEO Karen Lynch said in the report. “As the pandemic eventually passes, its lessons will serve to make our health system more agile and more responsive to the needs of consumers.”
  • Drug Channels lists that fifteen largest U.S. pharmacy chains in terms of market share and revenue. CVS Health leads the pack.

From the regulatory front, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced today “a 45-day extension of the public comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. OCR first released the NPRM to the public on the HHS website on December 10, 2020, and it was published in the Federal Register on January 21, 2021.  The 45-day extension moves the current deadline for the public to submit comments from March 22, 2021, to May 6, 2021. The notice of extension of the comment period is available at https://public-inspection.federalregister.gov/2021-05021.pdf – PDF.” The FEHBlog is pleased that the Biden Administration is giving serious consideration to this proposed rule.

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

The Wall Street Journal reports that

The House [of Representatives] looked on track to pass the latest version of the $1.9 trillion coronavirus relief package later this week, as liberal Democrats swallowed their frustration with the Senate’s changes and prepared to approve the bill for a second time.

The House is expected to narrowly pass the bill Tuesday or Wednesday, sending it to the White House for President Biden’s signature. House Majority Leader Steny Hoyer (D., Md.) had initially said the House would take its first procedural vote on the bill Monday, but processing the bill’s Senate paperwork pushed the vote slightly later in the week, aides said. 

In COVID-19 news

  • The Centers for Disease Control today released guidance for those who are fully vaccinated against the disease (meaning two weeks after the final dose).
  • The Biden Administration announced “an effort to invest $250 million to encourage COVID-19 safety and vaccination among underserved populations. The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) will offer the funding as health literacy grants to localities, who will partner with community-based organizations, to reach racial and ethnic minority, rural and other vulnerable populations. The new initiative – Advancing Health Literacy to Enhance Equitable Community Responses to COVID-19 – is expected to fund approximately 30 projects in urban communities and 43 projects in rural communities for two years. “
  • The Food and Drug Administration has given emergency use authorization for “the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.” Here’s a link to the Cue Health website.

In other healthcare news —

  • Healthcare Dive reports that “for the first time since Fair Health started tracking monthly telehealth claims, COVID-19 became one of the top five diagnoses in the U.S. in December as cases surged, the nonprofit said in a report released Thursday. Overall, telehealth claim lines increased 2,817% year over year, rising from just 0.22% of all medical claim lines in December 2019 to 6.51% in December 2020. Mental health conditions continue to be the No. 1 telehealth diagnosis nationwide.” It’s the last sentence that caught the FEHBlog’s attention.
  • Benefits Pro writes about the important role that employers and their health plans can help in reducing employee obesity issues. “’Overweight and obesity, which require a comprehensive approach, are top health concerns for employers around the world,’ said Ellen Kelsay, president and CEO of Business Group on Health. ‘Employers play a major part in offering quality health care, understanding obesity’s inextricable link to mental health, lessening the stigma surrounding it and addressing some of the social determinants of health.’ By 2025, one in five adults worldwide will be affected by obesity, according to the organization’s new report, ‘The Global Landscape for Overweight and Obesity: A Guide for Employers.’ As overweight and obesity rates surge worldwide, large employers are positioned to address the chronic medical conditions on multiple fronts, the report said.”
  • The New York Times reports that “When the pandemic struck last year, many Americans rushed to stock up on alcohol, causing retail sales of wine, beer and liquor to surge across the country. But the uptick in sales was a worrying sign for health experts focused on cancer prevention. In recent years, a growing number of medical and public health groups have introduced public awareness campaigns warning people to drink with caution, noting that alcohol is the third leading preventable cause of cancer, behind tobacco and obesity. * * * [Consumer S]urveys continue to show that most people remain unaware of the risks. When the American Institute for Cancer Research surveyed Americans two years ago to gauge their awareness of different cancer risk factors, the results were striking: fewer than half were aware of the alcohol-cancer link.”

Thursday Miscellany

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

Roll Call reports that the Senate continues to move forward its modified version of the American Rescue Plan which the House of Representatives passed last week. Here’s a link to the Congressional Budget Office’s report on the Senate bill.

The Senate Homeland Security and Governmental Affairs Committee held a confirmation hearing today on the President’s nominations of Shalanda D. Young to be Deputy Director, Office of Management and Budget, and Jason S. Miller to be Deputy Director for Management, Office of Management and Budget. Federal News Network sums up the hearing as follows: “President Joe Biden’s picks to serve in top positions at the Office of Management and Budget vowed on Thursday to remove hurdles from federal hiring, improve employee morale and help agencies keep their workforces safe during the pandemic.”

David Leonhardt of the New York Times does a great job putting the three current COVID-19 vaccines in perspective:

It’s the latest case of vaccine alarmism.

Many Americans are worried that Johnson & Johnson’s Covid-19 vaccine is an inferior product that may not be worth getting. Gov. Doug Burgum of North Dakota recently told The Washington Postthat he was now seeing not only “vaccine hesitancy” but also “the potential for brand hesitancy.”

The perception stems from the headline rates of effectiveness of the three vaccines: 72 percent for Johnson & Johnson, compared with 94 percent for Moderna and 95 percent for Pfizer. But those headline rates can be misleading in a few ways.

The most important measure — whether the vaccine prevents serious illness — shows the Johnson & Johnson vaccine to be equally effective as the other two. All work for nearly 100 percent of people. The picture is murkier for mild cases, but they are not particularly worrisome.

In promising news, STAT News reports that

Eli Lilly said Thursday that a study showed its experimental diabetes drug, tirzepatide, reduced patients’ blood sugar and body weight more than a rival medicine, Novo Nordisk’s Ozempic. The study compared three doses of tirzepatide — 5 mg, 10 mg, and 15 mg — to a 1 mg dose of Ozempic. Both drugs were given as injections. Tirzepatide reduced A1C, a measure of blood sugar levels, by 2.09% at the 5-mg dose, 2.37% at the 10-mg dose, and 2.46% at the 15-mg dose. For Ozempic, there was a 1.86% reduction. Patients were followed for 40 weeks.

Patients who received tirzepatide also saw their body weight decline by more than those who received Ozempic. They lost an average of 7.8 kilograms, or 8.5% of their body weight at the lowest dose, 10.3 kg, an 11% decrease, on the middle dose, and 12.4 kg, a 13.1% decrease, on the highest dose. For patients on semaglutide, the decrease in body weight was 6.2 kilograms, or 6.7%.

The differences were all statistically significant.

Lilly plans to virtually present the full trial results at the American Diabetes Association’s annual scientific conference in late June 2021.

In concerning news, the Centers for Disease Control informs us that “a new paper from CDC, in partnership with the University of Utah, estimates that the national healthcare costs associated with infections from six multidrug-resistant pathogens can be substantial at more than $4.6 billion annually.   This is one of the largest studies to estimate the cost associated with high-priority antibiotic-resistant pathogens. Issues highlighted in the study align with data and threats in CDC’s 2019 Antibiotic Resistance (AR) Threats Report. This includes the impact of resistant infections in the community, which can put more people at risk, make spread more difficult to identify and contain, and threaten the progress made to protect patients in healthcare.”  

Finally, Fierce Healthcare lets us know that

Greater liquidity, a stable payer mix and higher-acuity patients helped major hospital chains end 2020 with massive profits despite a financial roller coaster caused by the pandemic.

The latest earnings reports from several for-profit and not-for-profit hospital chains come as patient volumes continue to drift below pre-pandemic levels and as major hospital groups have raised the alarm about financial hardship faced by many hospitals around the country. 

And while plenty of health systems around the country are struggling, experts say many of the largest health systems around the nation have remained profitable.

[However] Rural and more independent and smaller facilities already operate on narrower profit margins which have been exacerbated by the pandemic. These financial headwinds could cause more consolidation among such facilities.