Tuesday Tidbits

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Tuesday Tidbits

David Ermer–COVID-19, COVID-19 vaccine, Medicare, U.S. Healthcare–

Happy National Doctors’ Day “It is a day to celebrate the contribution of physicians who serve our country by caring for its’ citizens.”

The American Hospital Association reports that

Anticipating possible congressional action to extend the moratorium on the 2% sequester cut to all Medicare payments, the Centers for Medicare & Medicaid Services today said it has instructed Medicare administrative contractors to hold all claims with dates of service on or after April 1, 2021, for a short period. The MACs will automatically reprocess any claims paid with the reduction applied if necessary, the agency said. 
  
The Senate last week passed a bill that, among other health care provisions, would eliminate the 2% cut to all Medicare payments, known as sequestration, until the end of 2021. The House is expected to take up the Senate-passed bill the week of April 13 when it returns to Washington D.C.

Bloomberg News informs us that

The World Health Organization’s chief said a mission to study the origins of the coronavirus in China was too quick to dismiss the theory of a lab leak, with the U.S. and other governments joining in criticism of the investigation.

WHO Director-General Tedros Adhanom Ghebreyesus said the probe didn’t adequately analyze the possibility of a lab accident before deciding it’s most likely the pathogen spread from bats to humans via another animal. In a briefing to member countries Tuesday, he said he is ready to deploy additional missions involving specialist experts.

“Although the team has concluded that a laboratory leak is the least likely hypothesis, this requires further investigation,” Tedros said in a statement. The WHO chief has consistently said all lines of inquiry are open, but Tuesday’s comments mark the first time he’s speculated about the possibility of an accidental escape.

The American Medical Association offers a podcast in which Christopher J.L. Murray, MD, director of the Institute for Health Metrics and Evaluation at the University of Washington offers his perspective on the future course of COVID-19 in the U.S. this year.

A physician and health economist whose career has focused on improving health globally by improving health evidence, Dr. Murray outlined these three challenges to making herd immunity a reality and preventing another wave of illness this fall or winter:

Vaccines will not be as effective at preventing infection from the SARS-Co-V-2 B.1.351 variant that emerged in South Africa or the P.1 variant that emerged in Brazil, or future variants.

Not enough individuals will receive the vaccine to achieve herd immunity.

Those who had previous COVID-19 infections from one variant may not have protection from being reinfected with a new variant.

When vaccines were approved, everyone thought the U.S. would get to herd immunity by late summer or the fall because the number of people who have been vaccinated combined with the 20% of Americans who had already been infected and had immunity would push America to the level needed for herd immunity, preventing another wave next winter, Dr. Murray said.

“But if it turns out there isn’t cross-variant immunity, then the only way to get to the point where you don’t have a third wave next winter is through vaccination,” he said.

In related news, Kaiser Health News reports that “A new poll of attitudes toward covid vaccinations shows Americans are growing more enthusiastic about being vaccinated, with the most positive change in the past month occurring among Black Americans.”

Closing tidbits —

  • Fierce Healthcare identifies the Centers for Medicare and Medicaid Services “payment models the Biden administration has pulled for review or delayed.”
  • Health Payer Intelligence discusses large insurer platforms designed to help their self-funded customers coordinate their health benefit offerings.

Monday Roundup

David Ermer–CDC, COVID-19, U.S. Healthcare–
Photo by Sven Read on Unsplash

Bloomberg reports that the United States is on pace to administer three million doses of COVID-19 vaccine daily as supplies increase and states widen eligibility.

The Wall Street Journal adds that

Covid-19 vaccines from Moderna Inc. and from Pfizer Inc. and partner BioNTech SE are highly effective in preventing infections in real-world conditions, federal health officials said, further evidence that vaccinations can slow the spread of the virus.

The vaccines were 90% effective at reducing the risk of infection two weeks after a second dose, according to a study of nearly 4,000 healthcare workers, first responders and other essential workers published by the U.S. Centers for Disease Control and Prevention on Monday.

In addition, the data indicated the vaccines can reduce the risk of coronavirus infections whether or not they cause symptoms, the CDC said.

As of today, 49.2% of the U.S. population over age 65 is fully vaccinated against COVID-19, and 72.8% of that population has received at least one dose of the COVID-19 vaccine. What’s more, the Department of Health and Human Services announced issuing grants to help public agencies bring this age group and disabled people as close as possible to 100% vaccinated. “Older adults are more likely to have a severe illness, be hospitalized, or die from COVID-19; adults 65 and older account for 8 of every 10 COVID-19-related deaths. People with disabilities also often are at increased risk; in fact, a recent study found that intellectual disability is the greatest risk factor after age.” 

In relevant business news —

  • Healthcare Dive reports that “The U.S. Department of Justice is embarking on a deeper review of UnitedHealth Group’s $13 billion acquisition of data analytics company Change Healthcare following entreaties from powerful hospital lobby the American Hospital Association over anticompetitive concerns.”
  • The Society for Human Resource Management shares HR professional views on how the pandemic has changed the workplace over the past year. The FEHBlog particularly likes this one :

“We definitely learned that it’s not enough to just set people loose in a work-from-home environment. This isn’t about trusting employees to do their work unsupervised, either. We have complete trust in our employees, and this was never brought into question. The problem is that people have different proficiencies with tech and different abilities to work without guidance.”
—Carter Seuthe, CEO of Credit Summit, based in Austin, Texas  

Weekend update

David Ermer–CDC, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

The House and Senate are on district/state work breaks until April 13.

From the COVID-19 herd immunity front —

The FEHBlog always looks forward to the lead article in the Wall Street Journal’s weekend review section. Yesterday’s thought provoking article was headlined “Herd Immunity Won’t Save Us—but We Can Still Beat Covid-19 — Innovative contact tracing and just-in-time vaccination can get the pandemic under control—and prepare us for the next one.” The article, which was written by a group of epidemiologists, focuses on the worldwide eradication of smallpox which was quite an achievement in 1980 roughly 175 years after the smallpox vaccine was first administered. The article discusses the importance of the vaccine being able to prevent the disease in an infected, asymptomatic person which was the case with smallpox which had a 12 day incubation period.

Wikipedia notes

The 1947 New York City smallpox outbreak occurred in March 1947 and was declared ended on April 24, 1947. The outbreak marked two milestones for America. First, it was the largest mass vaccination effort ever conducted for smallpox in America, and second, it marked the last outbreak of smallpox in America. Within three weeks of the discovery of the outbreak, the U.S. Public Health Service, in conjunction with New York City health officials, had procured the smallpox vaccine and inoculated over 6,350,000 adults and children.[1]Of that number, 5,000,000 had been vaccinated within the first two weeks. The rapid response was credited with limiting the outbreak to 12 people, 10 of whom recovered, while 2 died.

The Wall Street Journal article explains that the COVID-19 vaccines also allow for just-in-time vaccinations:

Despite the rapid onset of viral infection (an average of 6 days after exposure, with a range of 2-14 days), Johnson & Johnson has reported success in preventing moderate to severe disease as early as 7 days after the administration of its single-dose vaccine. In a real-world study in Israel, the Pfizer vaccine also prevented severe disease soon after a single dose.

It is not too late to find, isolate and vaccinate those who do not yet have Covid-19 but are most likely to get it. It is not too late to use just-in-time vaccination to stop outbreaks in midcourse and prevent the spread of infection.

The Wall Street Journal in another herd immunity article reminds us that

“We definitely need to get kids vaccinated if we want to be as close to normal as we can,” said Octavio Ramilo, chief of infectious diseases at Nationwide Children’s Hospital, in Ohio. As governments push to move past the pandemic, vaccinating children is emerging as a key obstacle, along with initially limited supplies of vaccines.

Vaccines probably won’t be ready for use in younger children until early 2022, health experts said, in part because researchers need to test lower doses.

“The dose is not such a big leap to go from adults to teens,” said Katherine Luzuriaga, a pediatric infectious disease physician and the lead investigator of Moderna’s adolescent trial at the University of Massachusetts Medical School site. “Once we start going into the younger age groups, there’s a bit more work to determine the appropriate doses.”

As mentioned in Friday’s post, Pfizer and Moderna are testing on children. Vaccinating older high schoolers and college age kids which already is possible as the Pfizer vaccine is approved for persons over age 16 and the other two vaccines are available to persons over 18.

The FEHBlog believes that we should stay the current vaccination course until supply exceeds immediate demand likely in the next quarter of the year.

Vaccinating those at most risk of severe illness and death has been the first priority of vaccination drives. In most countries, that has meant giving priority to elderly citizens and those with conditions that heighten their risk of severe Covid-19.

The rate of hospitalization is 35 times as high, and the death rate is 1,100 times as high, among people 65 to 74 years old infected with Covid-19, compared with children ages 5 to 17, according to the U.S. Centers for Disease Control and Prevention. 

Health authorities say children don’t need to be vaccinated to start resuming certain activities like in-person learning at schools that are taking precautionary measures. Some experts caution against focusing too heavily on a specific herd immunity target, as building up population-level protection is an incremental process.

From the medical innovation front (non-COVID) —

  • Yesterday the Food and Drug Administration announced that marketing approval for

Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma.

“The FDA remains committed to advancing novel treatment options for areas of unmet patient need,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “While there is no cure for multiple myeloma, the long-term outlook can vary based on the individual’s age and the stage of the condition at the time of diagnosis. Today’s approval provides a new treatment option for patients who have this uncommon type of cancer.”

  • On Friday the FDA announced other hopeful news

The U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs. The device is designed for patients who have severe pulmonary valve regurgitation (blood leaking backward into the right lower chamber of the heart), a condition that often results from congenital heart disease (CHD). The device, called the Harmony Transcatheter Pulmonary Valve (TPV) System, is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, which is the current standard of care. The use of the Harmony valve may delay the time before a patient needs additional open-heart surgery. It can also potentially reduce the total number of open-heart surgeries required over an individual’s lifetime.

CHDs affect nearly 1% of―or about 40,000―births per year in the United States.

Cybersecurity Saturday

David Ermer–Cybersecurity–

On Thursday, the Senate Armed Services Committee held a hearing featuring Gen. Paul Nakasone, the director of the National Security Agency, who also serves as the head of U.S. Cyber Command. A topic of discussion was the SolarWinds and Microsoft Exchanges hack.

The Wall Street Journal reports that these hacks have a “scope, a scale, a level of sophistication that we hadn’t seen previously. * * * “This isn’t simply email phishing attempts—this is the use of supply chains, or this is the use of vulnerabilities we hadn’t seen before.” During a discussion of why the private sector discovered the hacks before the government, it was pointed out that

The NSA, for instance, is only authorized to operate outside U.S. borders, whereas the Federal Bureau of Investigation and other agencies are responsible for cybersecurity law enforcement domestically. Foreign attackers are aware of this and use U.S.-based servers to launch attacks from inside the country, effectively bypassing the NSA, Gen. Nakasone said. “It’s not the fact that we can’t connect the dots. We can’t see all of the dots,” he said.

Gen. Nakasone stopped short of calling for the NSA to be given the authority to surveil domestic networks when questioned directly by Sen. Mike Rounds (R., S.D.). He said that there are a number of ways to tackle the issues revealed by such sweeping and complex attacks, including enhanced cooperation with the private sector. The issue of surveillance, he said, carries both policy and legal concerns and was closely linked to the Fourth Amendment, which protects against unreasonable searches and seizures.

Cyberscoop adds

Part of being able to understand and better track adversarial hacking moving forward, even when it takes advantage of U.S. internet infrastructure, could rely on broader government and private sector information sharing.

“How do we take the best tools not only from the government but also from the private sector to look at what’s occurring and being able to shine that spotlight?” Gen. Nakasone said. “I think a lot of times we look and just say we’ll simply go ahead and downgrade that intelligence rapidly. Sometimes the better answer is, okay where are the other streams of information, how can we use that?”

Gen. Nakasone suggested that incentives for private sector could be introduced, adding that legislation could push private sector internet infrastructure companies to better understand who their customers are, as well.

In a recognition of the importance that information sharing between the public and private sector will play a role in responding to the flurry of Microsoft hacking, the Biden administration has convened an emergency cybersecurity incident response group at the National Security Council and invited private sector participation for the first time ever.

In this regard, Health IT Security reports that recently

The Department of Health and Human Services Cybersecurity and Infrastructure Security Agency unveiled the CISA Hunt and Incident Response Program (CHIRP) tool, which is designed to support entities detect threat activity within on-prem environments. * * *

CISA previously launched an IOC tool to help detect compromises within the cloud. The latest provided tool is specifically meant for on-prem networks.

By default, CHIRP scans for signs of compromise within an on-prem environment, particularly IOCs associated with the malicious activity around SolarWinds threat activities “that have spilled into an on-premises enterprise environment.”

“CHIRP is a command-line executable with a dynamic plugin and indicator system to search for signs of compromise,” CISA explained. “CHIRP has plugins to search through event logs and registry keys and run YARA rules to scan for signs of APT tactics, techniques, and procedures.” 

“CHIRP also has a YAML file that contains a list of IOCs that CISA associates with the malware and APT activity,” they added.

Enterprises can leverage the tool without cost directly from DHS CISA. Officials said they intend to continuously monitor for new threats and will release IOC packages and plugins for new threats, as available.

Fortune Magazine reports that

A tool designed to help businesses protect themselves from further compromises after a global hack of Microsoft email server software has been downloaded more than 25,000 times since it was released last week, the White House’s National Security Council said Monday.

As a result, the number of vulnerable systems has fallen by 45%, according to an NSC spokesperson. 

The one-click Microsoft tool was created to protect against cyberattacks and to scan systems for compromises and fix them. It was developed after a massive hack affecting an estimated tens of thousands of users of servers running Microsoft’s Exchange email program.

From the ransomware front, Business Insurance reports that

CNA Financial Corp.’s computer systems remained down on Friday as the insurer grappled with a cyberattack by a hacker group known as Phoenix. Nearly a week after the insurer discovered it had been attacked, its website remained inaccessible and just contained alternative contact information.

Bleeping Computer offers its analysis of the cyberattack.

BleepingComputer has confirmed that CNA suffered an attack by a new ransomware known as ‘Phoenix CryptoLocker.’

Sources familiar with the attack have told BleepingComputer that the threat actors deployed the ransomware on CNA’s network on March 21, where it proceeded to encrypt over 15,000 devices on their network.

BleepingComputer has learned that it also encrypted the computers of employees working remotely who were logged into the company’s VPN at the time of the attack.

BleepingComputer was further told that CNA would be restoring from backups but has not confirmed that with the company.

Bleeping Computer also discusses possible Phoenix links to Evil Corp. which is a ransomware mastermind that the federal government has sanctioned.

Here is a link to the FBI’s computer hygiene guidance that helps prevent ransomware attacks. As the FEHBlog expects that CNA Financial was following these steps and more, it will be interesting to find out how this happened.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, HSA, Telehealth, U.S. Healthcare, Uncategorized–

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 12th week of this year (beginning April 2, 2020, and ending March 24, 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 period (April 2, 2020, through March 24, 2021):

Finally here is a COVID-19 vaccinations chart for the past three months which also uses Thursday as the first day of the week:

The charts continue to look pretty good. As of today 34.6% of the U.S. population over 18 years old has received at least one dose of the COVID-19 vaccine and 46% of the U.S. population over 65 years old is fully vaccinated.

STAT News reports that

Pfizer and BioNTech said Thursday they are beginning a study aimed at showing their Covid-19 vaccine can be used in children as young as 6 months.

The study follows the launch of a separate and ongoing trial in children ages 12 to 15, which was fully enrolled in January. That study could lead to results by the end of the first half of the year, depending on the data, and then to an emergency use authorization. That will depend on the Food and Drug Administration and the Centers for Disease Control and Prevention. The vaccine already has an EUA for people 16 and older.

“The FDA, if it sees fit to do this, could, grant an EUA and get them into children in that age group by the fall, provided the CDC also agrees and that that should be the vaccine they receive,” said William Gruber, Pfizer’s senior vice president of vaccine clinical research and development.

Moderna began a similar study of their vaccine on children from age 6 months to 12 years old on March 16.

STAT News also offers “A user’s guide: How to talk to those hesitant about the Covid-19 vaccine.” Here’s one good idea:

Have a conversation

Don’t lecture your family and friends, and don’t assume you know what their concerns are. Make sure to listen.

“Try to address their concerns, not what you assume are their concerns,” said Jorge Moreno, an internist and assistant professor at the Yale University School of Medicine. While you may be thinking people are ensnared in the darkest of conspiracy theories, many may have concerns that are much simpler to address. For Moreno, who even had to convince his mother the vaccine was safe, many questions he’s received have centered around side effects, and whether they might make people too sick to work. A Carnegie Mellon University survey released this week showed 70% of vaccine-hesitant people were concerned about side effects.

“Let people know it’s OK to have questions and that having concerns is legitimate,” added Reed Tuckson, the former public health commissioner for Washington, D.C., and a founding member of the Black Coalition Against Covid, which co-developed a campaign called “The Conversation” to provide Black families credible vaccine information. “Letting people have a safe space to have this conversation is essential,” he said. “Wagging your finger against someone is not very useful.”

From the tax front:

  • The Internal Revenue Service recently announced that “amounts paid for personal protection equipment, such as masks, hand sanitizer and sanitizing wipes, for the primary purpose of preventing the spread of the Coronavirus Disease 2019 (COVID-19 PPE) are treated as amounts paid for medical care under § 213(d) of the Internal Revenue Code (Code). * * * Group health plans, including health FSAs and HRAs, under the terms of which expenses for COVID-19 PPE may not be reimbursed, may be amended pursuant to this announcement to provide for reimbursements of expenses for COVID-19 PPE incurred for any period beginning on or after January 1, 2020, and such an amendment will not be treated as causing a failure of any reimbursement to be excludable from income under § 105(b) or as causing a § 125 cafeteria plan to fail to meet the requirements of § 125.”
  • What’s more, Spotlight on Benefits explains how the IRS has clarified Pandemic-Related Relief for Dependent Care FSAs.

In healthcare business news, Healthcare Dive explains why being a hospital chief financial officer is a particularly tough job during the pandemic. Also Fierce Healthcare discusses a CIGNA telehealth study finding that

while virtual visits for other types of services declined after the initial COVID-19 spike, virtual visits for behavioral health remained in high demand. In April 2020, virtual visits made up about 50% of claims for non-behavioral health services and declined over the course of the year to account for nearly 25% today.

“Virtual behavioral health care is not only a way to access mental health services in the wake of social distancing, but it also allows us the option to pursue treatment in the privacy and comfort of our own homes,” Lustig said.

By contrast, in April, 66% of office visits for behavioral health were conducted virtually, and it’s remained largely flat since.

Behavioral telehealth users also reported higher productivity at work, according to the survey. These patients reported a 45% decrease in sick days, compared to a 28% decrease in miss workdays among patients who did not use telehealth.

That’s good news for the spoke and hub telehealth companies and for health plans and consumers because the spoke and hub telehealth network therapists are in-network.

Thursday Miscellany

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

From Capitol Hill, the American Hospital Association gleefully reports that “The Senate today passed by 90-2 vote a bill that, among other health care provisions, would eliminate the 2% across-the-board cut to all Medicare payments, known as sequestration, until the end of 2021. To pay for the change, the bill, which was introduced by Sens. Jeanne Shaheen, D-N.H., and Susan Collins, R-Maine, would increase the fiscal year 2030 sequester cuts. The House is expected to take up the Senate-passed bill when it the week of April 13 when it returns to Washington D.C.”

The U.S. Office of Personnel Management announced six political appointments to the agency which do not require Senate confirmation. Good luck to them.

From the COVID-19 front, the Wall Street Journal observes

In many ways, AstraZeneca, which developed the vaccine in partnership with the University of Oxford, is delivering on its main promises. More than 70 countries, including the U.K. and much of the rest of Europe, have found the shot safe and effective. Although it isn’t a big player in vaccines, AstraZeneca helped make an experimental shot ready for mass use in less than a year. The company has built a manufacturing and distribution network that is delivering doses to the world’s poorest. Unlike most of its big competitors with vaccines or vaccine candidates, it has promised to do all this at no profit. The vaccine has been crucial to the U.K. drive that boasts one of the world’s best per-capita vaccination rates.

But at crucial moments, company executives have fumbled communications with governments, regulators and the public. That has left a reputational cloud over the vaccine effort—an effort that Dr. Soriot has said reflects the company’s desire to play a leading role in battling the pandemic.

The reverse — good public relations by a bad actor — would be a much worse situation. The FEHBlog hopes that the Food and Drug Administration does not delay emergency use authorization for the AstraZeneca vaccine.

Also from the COVID-19 front today, the Centers for Medicare and Medicaid Services issued a fact sheet on the value of monoclonal antibodies (mAb) treatment for high risk Covid-19 positive patients.

mAb treatment for COVID-19 is different from a COVID-19 vaccine. A vaccine triggers your body’s natural immune response, but can take weeks to develop enough antibodies and prevent some kinds of infection. Some vaccines for COVID-19 require two shots, so your body can develop its own immune response to the disease. But if you already have the virus, mAb treatment gives your body the antibodies it needs to protect itself.

That is positive news.

In miscellaneous healthcare news —

Anthem is planning to acquire myNEXUS, a company that manages home-based nursing services for insurers.

According to the announcement, myNEXUS provides support to 1.7 million Medicare Advantage members across 20 states. The company’s platform largely automates the visit and authorization, getting care to the member faster, they said.

MyNEXUS uses a digital analytics tool in tandem with a team of more than 250 clinicians to plan and optimize home care, the companies said. In addition, it works with a nationwide network of providers and nursing agencies for local care.

  • Healio reports that at “the Renal Physicians Association annual meeting, representatives from three companies [led by CVS Health] shared their approach to the changing paradigm of kidney care and emphasized the shift to value-based models that center on the patient.”
  • America’s Health Insurance Plans announced that

Electronic prior authorization (ePA) can significantly reduce the time between a request for prior authorization and a decision and the time to a patient receiving care.  These were two of the top findings from an initiative launched by America’s Health Insurance Plans (AHIP) to better understand the impact of ePA on the prior authorization process.

“Prior authorization is an important tool in helping patients receive safe, effective, clinically appropriate care,” said Kate Berry, Senior Vice President of Clinical Affairs at AHIP.  “We are always looking for ways to enhance the patient and provider experience, and electronic prior authorization is an example.  Today’s analysis provides a blueprint for how to leverage electronic tools to improve prior authorization.”

AHIP launched the Fast Prior Authorization Technology Highway—or Fast PATH—to better understand how electronic prior authorization could impact the process for patients and providers. Six health insurance providers—Blue Shield of California, Cambia Health Solutions, Cigna, Florida Blue, Humana, and WellCare (now Centene)—that collectively cover over 50 million Americans participated in the project, with Availity and Surescripts serving as the technology partners.

Bravo.

  • Health Payer Intelligence informs us that “Payers should prepare for the payer price transparency rule to go into effect by building clear communication paths with members, reassessing their contracting processes, and asking themselves a couple of key questions, according to a report from PricewaterhouseCoopers’s Health Research Institute (HRI).” Check it out.

Midweek update

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

From Capitol Hill, STAT News reports that Senate leaders have reached an agreement to extend a Medicare pay bump for health care providers through 2021, a major lobbying win for hospitals.”

The Wall Street Journal reports two Senate confirmations in healthcare positions:

The Senate [today] confirmed Dr. Rachel Levine as assistant health secretary, making her the first openly transgender federal official approved by the Senate.

The vote was 52 to 48, largely along party lines, with GOP Sens. Lisa Murkowski of Alaska and Susan Collins of Maine joining all 50 Democrats.

The pediatrician and former Pennsylvania secretary of health helped steer the state’s response to Covid-19. She has also worked to increase awareness of equity issues that the LGBT community faces and is a professor of pediatrics and psychiatry at Penn State College of Medicine. 

and

Yesterday, the Senate approved Vivek Murthy, President Biden’s pick for surgeon general, by a 57-to-43 vote, marking his second stint in the post, which he held from 2014 through 2017. Dr. Murthy, who was co-chairman of Mr. Biden’s Covid-19 advisory board, has said he would use his position to provide science-based guidelines for ending the coronavirus pandemic.

From the COVID vaccine front, Medscape informs us that

White House officials said at a briefing Wednesday they are still anticipating updated vaccine data from AstraZeneca, after federal officials called Tuesday’s release of interim phase 3 data from the company “outdated information.”

“Right now, AstraZeneca is getting back with the Data and Safety Monitoring Board and will likely come out with an updated statement,” said Anthony Fauci, MD, a top COVID-19 official and chief of the National Institute of Allergy and Infectious Diseases, the agency that complained to the pharmaceutical company that their current information was “incomplete.”

Andy Slavitt, senior White House adviser for COVID-19 response, added: “Our takeaway is the importance of transparency and trust…. I would urge us not to focus on the process of the last couple days, but instead to focus on what really matters, which is what happens when these applications for these candidates are submitted to the FDA.”

FLASH — The Washington Post reported at 10:30 pm Wednesday night that

An updated company analysis of the coronavirus vaccine developed by AstraZeneca and the University of Oxford showed that the two-shot regimen was robustly effective — 76 percent at preventing symptomatic illness — according to a news release from the drugmaker late Wednesday.

The finding, only slightly lower than results announced days earlier, underscores that the vaccine being widely used by many countries appears to be a powerful tool to help end the pandemic. No severe cases of illness were reported in study volunteers who received the vaccine. Among people 65 and older, the vaccine was 85 percent effective, the company reported.

Yesterday, the FEHBlog watched a Wall Street Journal interview with Mr. Slavitt as part of the WSJ’s Health Forum. The FEHBlog really enjoyed this WSJ video featuring reporter Joanna Stern with a COVID vaccine hunter from New Jersey. It’s certainly worth five and half minutes of your day.

HR Dive reports that

Employers should offer paid sick leave to employees with “signs and symptoms” following COVID-19 vaccination, according to guidance updated March 16 by the Centers for Disease Control and Prevention.

Employers should consider on-site vaccination programs if they have a large workforce with predictable schedules and enough space to run a clinic that meets social distancing requirements, CDC said. Employers that choose to offer vaccinations should record each offer and employees’ decisions. Employers should consider off-site vaccination if they are a small- or medium-sized organization lacking the resources to host a vaccination clinic, it said.

The agency also said that whether an employer may require COVID-19 vaccinations is a matter of state or other applicable law but noted that exemptions may apply: Medical exemptions for people who are at risk for an adverse reaction because of an allergy to one of the components used in the vaccine or a medical condition; and religious exemptions for people who reject being vaccinated because of their religious beliefs.

In healthcare business news, Fierce Healthcare lets us know that

Uber is ramping up its prescription delivery business by teaming up with software company ScriptDrop. The ride-share giant will be the default delivery service for ScriptDrop pharmacies in 37 states and will eventually expand to others.

ScriptDrop works with some of the top grocery chains, pharmacy chains and health systems in the U.S., including Albertsons, Jewel-Osco, Safeway and Vons. Through the tie-up with Uber, those pharmacies will be able to leverage the company’s technology to deliver more prescriptions to more customers.

From the report front, the FEHBlog noticed

Finally March 22 to 28, 2021, is National Drug and Alcohol Facts Week. “Held since 2010, NDAFW brings teens and scientific experts together to discuss the scientific facts about drugs, as well as their potential health effects on teen bodies and brains. ”

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.