Weekend update

Weekend update

Photo by Tomasz Filipek on Unsplash

Both Houses of Congress are working on floor and committee business this week. Here are links to the House floor schedule, the Senate floor schedule and the Committee business schedule. Nothing particularly interesting from an FEHBP standpoint.

In contrast, this week from Tuesday through Thursday, the U.S. Office of Personnel Management and America’s Health Insurance Plans will hold the annual FEHB carrier conference. This will be the longest conference in the FEHBlog’s memory.

In that regard, “The Alliance for Fertility Preservation (AFP) commends the U.S. Office of Personnel Management (OPM) for including coverage for fertility preservation in its annual call for benefit and rate proposals from Federal Employee Health Benefit (FEHB) Program carriers. This coverage would allow for fertility preservation services related to infertility caused by medical treatment (iatrogenic infertility).”

The AFP estimates that in the United States, approximately 160,000 people between ages 0-44 are diagnosed with cancer each year. Most of these patients will face treatments including chemotherapy, radiation, and/or surgery that can damage reproductive cells (eggs and sperm), reproductive organs, or impact the ability to carry a pregnancy. Because this damage treatment-based, it can affect patients with any type of cancer. Patients with other conditions requiring similar therapies are also at risk.

Fertility preservation is now considered part of the standard of care for age-eligible patients. Guidelines supporting fertility preservation have been issued by the relevant medical associations, including the American Society of Clinical Oncology (ASCO), the American Society for Reproductive Medicine (ASRM), and the American Medical Association (AMA).

This new benefit for 2022 is a carrier conference topic on Tuesday.

From the COVID-19 front, the FEHBlog and his wife attended the socially distanced and fan-masked Washington Nationals game this afternoon. Walking from the parking lot to Nationals Park, we walked by a CVS pharmacy which had a sign reading COVID-19 vaccinations available here. We went into the pharmacy, and the FEHBlog noticed a staff member at a table waiting to sign up people for the vaccine. The FEHBlog was so happy.

Health Payer Intelligence discusses how the Blue Cross Blue Shield plans are “aiming to be a community resource to ensure shots are administered. Reed Melton, vice president of clinical operations at the Blue Cross Blue Shield Association (BCBSA), told Fierce Healthcare that the group’s member plans are partnering with regional and community organizations to tackle vaccine hesitancy and support administration efforts. “We have a full-court press from Honolulu to San Juan,” Melton said.  At the national level, BCBSA has partnered with Feeding America to offer educational materials on COVID-19 vaccines to people at 200 food banks, which can reach 40 million Americans.”

Last week the Centers for Disease Control reported to providers of care about so-called vaccine breakthrough cases of COVID-19.

Vaccine breakthrough cases occur in only a small percentage of vaccinated persons. To date, no unexpected patterns have been identified in the case demographics or vaccine characteristics among people with reported vaccine breakthrough infections.COVID-19 vaccines are effective. CDC recommends that all eligible people get a COVID-19 vaccine as soon as one is available to them.

The Wall Street Journal reports today that

President Biden’s chief medical adviser said he expects Johnson & Johnson’s Covid-19 vaccine to return to use in the U.S. by Friday, after a pause because of concerns about blood clots in several patients. “I would be very surprised…if we don’t have a resumption in some form by Friday,” Dr. Anthony Fauci told CBS’s “Face the Nation,” echoing remarks he made on other networks Sunday.

The American Medical Association has shared information about what physicians should know about this blood clot issue.

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

From Capitol Hill, Govexec reports that yesterday, “a Senate panel advanced President Biden’s pick [Jason Miller] to be deputy director for management for the Office of Management and Budget to the full chamber. Today, Fierce Healthcare reports Chiquita Brooks-LaSure’s confirmation hearing to be Centers for Medicare Service administrator before the Senate Finance Committee. “The hearing didn’t highlight any major opposition from Republicans to her nomination, likely signaling her confirmation as the head of CMS.”

From the Johnson & Johnson vaccine pause front, Healthcare Dive discusses “What Happens Next, A call by regulators to stop J&J vaccinations won’t dramatically disrupt U.S. supply. But changes in labeling are possible, as is a renewed debate over vaccine hesitancy.” The Wall Street Journal adds that

A study by the University of Oxford found the risk of rare but sometimes-deadly blood clotting is roughly eight to 10 times greater in Covid-19 sufferers than among people who have received any of the first three Western-developed vaccines widely available. The study, involving vaccinations from Pfizer Inc. and BioNTech SE, another from Moderna Inc. and one from AstraZeneca PLC, adds to competing evidence related to blood clotting that regulators and governments may need to take into account as they weigh continued deployment of vaccines

While the Johnson & Johnson vaccine was not included in this study, the Astra-Zeneca vaccine uses the same adenovirus technology as the Johnson & Johnson vaccine.

In other COVID-19 vaccine news, the HHS Office of Inspector General issued a warning that provider must not charge patients for the COVID-19 vaccine.


OIG is aware of complaints by patients about charges by providers when getting their COVID-19 vaccines. Providers that charge impermissible fees must refund them and ensure that individuals are not charged fees for the COVID-19 vaccine or vaccine administration in the future. Consistent with the CDC Vaccination Program, providers are permitted to bill third-party payers (such as Medicare, Medicaid, the HRSA COVID-19 Uninsured Program, or a private insurer) for an administration fee, in accordance with the payer’s applicable billing rules.

In FEHB news, today the Office of Personnel Management issued a benefit administration letter to employing agencies and a letter to FEHB carriers instructing them to tighten up on the process of adding family members to an FEHBP enrollment. For the employing offices —

An employing office must require proof of family member eligibility for coverage through the FEHB Program for: 

• new employees during their initial opportunity to enroll (IOE) 

• employees requesting FEHB changes due to all other QLEs2 

Due to the large volume of transactions during the annual Federal Benefits Open Season, employing offices may, but are not required to, verify family member eligibility. 

When reviewing a new family member’s eligibility, employing offices may take this opportunity to verify the eligibility of family members currently enrolled who have not previously been verified. 

For the carriers — “Before adding a family member to an existing Self and Family enrollment, an FEHB Carrier must require that the enrollee provide proof of that family member’s eligibility for coverage through the FEHB Program.” In the middle of the last decade, OPM considered but never implemented an audit of family member eligibility records.

From the Centers for Disease Control reports front

  • Health Day informs us that “Emergency department visits were lower during December 2020 to January 2021 compared with prepandemic levels one year earlier, according to research published in the April 16 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report. * * * The researchers found that after an initial decrease during March to April 2020, there was an increase in emergency department visits through July 2020, but at levels below those during 2019; during December 2020 to January 2021, there was a decrease of 25 percent in visits compared with prepandemic levels.”
  • The New York Times reports that

More than 87,000 Americans died of drug overdoses over the 12-month period that ended in September, according to preliminary federal data, eclipsing the toll from any year since the opioid epidemic began in the 1990s.

The surge represents an increasingly urgent public health crisis, one that has drawn less attention and fewer resources while the nation has battled the coronavirus pandemic. Deaths from overdoses started rising again in the months leading up to the coronavirus pandemic — after dropping slightly in 2018 for the first time in decades — and it is hard to gauge just how closely the two phenomena are linked. But the pandemic unquestionably exacerbated the trend, which grew much worse last spring: The biggest jump in overdose deaths took place in April and May, when fear and stress were rampant, job losses were multiplying and the strictest lockdown measures were in effect

That’s quite sad.

In other news —

  • Becker’s Hospital Review informs us that “UnitedHealth Group posted nearly $5 billion in profit for the first quarter of 2021 as its UnitedHealthcare and Optum businesses continue to grow.”
  • STAT News offers an interesting report on the burgeoning market for increasingly inexpensive continuous glucose monitors for folks with Diabetes I.

Glucose monitors are becoming the backbone of a new movement in consumer tech — one that so far is outpacing the evidence. “You kind of have this dichotomy with the perceived value of CGM,” said Susan Schembre, a researcher at the University of Arizona who has studied the use of CGMs in healthy people. “We have the consumers really driving the market on one end, and then the science kind of resisting it on the other.”

Eventually, the devices and the evidence will converge. Already, clinical CGMs have expanded from their initial patient population: Doctors regularly prescribe them to people who manage their type 2 diabetes with insulin, and sometimes to help type 2 patients tweak their habits and avoid going on medication. Manufacturers are planning for a future in which patients use the devices to both treat and prevent metabolic issues — dramatically increasing their market share. Consumer tech companies are looking for their slice of the pie.

Weekend update

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

On the COVID-19 front —

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

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

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

Bravo.

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

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

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

Fingers crossed.

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

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

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

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

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

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

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

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

Weekend update

Photo by Michele Orallo on Unsplash

Happy Easter!

Congress remains on State/district work breaks for the coming week.

As of the beginning of this week, according the CDC’s website, 75.4% of the U.S population over age 65 and 40.2% of the U.S. population over age 18 has received at least one dose of the COVID-19 vaccine. 54.5% of the over age 65 population and 23.2% of the over 18 age population have been fully vaccinated.

That’s progress. Here are a couple of interesting angles on the vaccine distribution process:

  • The Wall Street Journal reports that “Johnson & Johnson’s Covid-19 vaccine has found a niche among organizations that work with the homeless, who say the one-dose shot is better-suited for a population that can be difficult to reach twice.”

[H]ealthcare workers say they have been surprised to find many homeless people specifically requesting the J&J vaccine, which is branded as Janssen, a unit of J&J. Some of them point out that the shot was still effective even though it was tested after Covid-19 variants entered the mix. Others say they are worried about getting a vaccine once, let alone twice, given the potential side effects.

“If you’re in a shelter, or don’t have a home, those side effects are different than if you can stay at home,” said Bobby Watts, chief executive of the National Health Care for the Homeless Council, which supports hundreds of providers that cater to the homeless.

  • Health Payer Intelligence informs us that “To ensure COVID-19 vaccine access for homebound individuals, the Commonwealth of Massachusetts has partnered with the Commonwealth Care Alliance (CCA), a health plan that says it has proven best practices for vaccinating this population.” “The Commonwealth defines a “homebound” individual as anyone who needs assistance from two or more people to leave home. In Massachusetts, there are about 20,000 individuals who meet this definition.”

As one of the first healthcare organizations in the country to vaccinate homebound individuals, CCA has also been part of the national discussion around strategies to ensure COVID-19 vaccine access for this population. Last month, CCA joined AHIP in briefing the White House, promoting the prioritization of homebound individuals in COVID-19 vaccine delivery efforts and underlining CCA’s best practices in this endeavor.

Speaking of AHIP, the organization on Friday announced

AHIP’s new SEP landing page also features other important resources to help guide consumers through the SEP, including fast facts, an educational blog, a link to a Get Covered Connector tool offered by Young Invincibles, and a link to a Health Insurance Marketplace Calculator provided by the Kaiser Family Foundation.

“Health insurance coverage is an important way to protect your health and financial stability, especially during the COVID-19 pandemic,” said Matt Eyles, president and CEO of AHIP.  “Health insurance available through the individual marketplaces cover products and services such as COVID-19 care and vaccines, mental health care and support, $0 copay preventive care, regular doctor visits and prescription medications to keep you healthy, and much more.”

In other COVID-19 news, Kaiser Health News provides details on over-the-counter COVID-19 testing kits.

Even with vaccines, epidemiologists say, rapid tests are desperately needed because more testing, along with mask-wearing and physical distancing, will get people back in offices and classrooms and help catch cases that go undetected. * * *

[M]any experts support the widespread distribution of cheap, rapid tests, even if they aren’t as sensitive as lab-run alternatives, and see a demand. In Germany, the supermarket chain Aldi began selling rapid tests in early March, roughly $30 for a five-pack, and sold out within hours. One recent study found that if a pack of tests was mailed to every household in the U.S. — even assuming that up to 75% would go into the garbage — they would save thousands of lives and avert millions of infections. “Don’t let perfect be the enemy of good,” said study co-author and Yale University professor A. David Paltiel. “This doesn’t have to work perfectly to make a huge difference.”

The Federal News Network shares opinions that it obtained from former OPM officials on the recent National Academy of Public Administration report on the agency.

Janice Lachance, the Clinton-era OPM director, sees the budget as a good starting point for the Biden administration and the new director. The president nominated Kiran Ahuja, a former chief of staff for the agency, for the role.

“The new director has a tremendous opportunity to go in there, do a very effective assessment of the situation and make a reasonable request that covers all of the things that need to be done — and that we want to do,” said Lachance, who currently serves as an executive vice president for the American Geophysical Union. “The NAPA report is very aspirational. What is it going to take to get OPM from where it is today to this desired state that’s articulated in the NAPA report over how many years?”

The new director, Lachance added, will need to make the case why an empowered OPM will help resolve the federal government’s talent problems.

Thursday Miscellany

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

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

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.

Monday Roundup

Photo by Sven Read on Unsplash

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

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

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

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

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

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

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

CAVEAT: Bloomberg reports Tuesday morning that

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

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

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

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

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

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

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

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

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

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

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

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

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

From the healthcare innovation front —

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

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

Weekend update

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

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.