In The News

What Can Providers Give to Patients?

Elizabeth A. Hogue recently sent the series of articles below about what providers can give to patients. Please do not hesitate to contact her at (877) 871-4062 or [email protected] with comments, questions, or requests for additional information.

Copyright, 2021. Elizabeth E. Hogue, Esq. All rights reserved.  No portion of this material may be reproduced in any form without the advance written permission of the author.

Part 1 – Applicable federal statutes and exceptions

Part 2 – Exception for items and services of nominal value

Part 3 – Circumstances under which free items and services may be given to patients who have a demonstrated financial need

Part 4 – Recent OIG guidance regarding incentives to promote COVID-19 vaccination

Part 5 – Exception for preventive items or services

Part 6 – Exception for free items or services that promote access to care

Part 7 – Case example from OIG Advisory Opinion No. 09-11



Janssen and Moderna COVID-19 Vaccine Boosters Update

The Vaccines and Related Biological Products advisory committee will meet on Oct. 14 and 15  to discuss the use of booster doses of the Janssen and Moderna COVID-19 vaccines Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The group will also discuss available data on the use of a booster of a different vaccine than the one used for the primary series.  

Read more in the FDA news release.


Placebo Effect

National Center for Complimentary and Integrative Health

The “gold standard” for testing interventions in people is the “randomized, placebo-controlled” clinical trial, in which volunteers are randomly assigned to a test group receiving the experimental intervention or a control group receiving a placebo (an inactive substance that looks like the drug or treatment being tested). Comparing results from the two groups suggests whether changes in the test group result from the treatment or occur by chance.

The placebo effect is a beneficial health outcome resulting from a person’s anticipation that an intervention will help. How a health care provider interacts with a patient also may bring about a positive response that’s independent of any specific treatment.

Research supported by NCCIH has explored several aspects of the placebo effect. One study identified a genetic marker that may predict whether someone will respond to a placebo, another supported the idea that placebo responses may occur outside of conscious awareness, and a third suggested that placebos may be helpful even if patients know they’re receiving placebos.

This publication is not copyrighted and is in the public domain. Duplication is encouraged.

NCCIH has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your health care provider(s). We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy is not an endorsement by NCCIH.

Placebo Effect - Systematic Reviews/Reviews/Meta-analyses (PubMed®)

Placebo Effect - Randomized Controlled Trials (PubMed®)


Moderna COVID-19 vaccine generates long-lasting immune memory

National Institutes of Health (NIH)

The Moderna and Pfizer mRNA vaccines against COVID-19 have shown greater than 90% effectiveness soon after the second dose. Studies suggest that protective immunity remains high, with only slight decreases, over six months. However, scientists are still working to understand how immunity against the virus develops after vaccination and changes over time.

Researchers believe that strong responses from both neutralizing antibodies and immune cells called T cells are necessary for immunity. Memory T cells linger in the body to recognize and protect against previously encountered pathogens. Recent studies indicate these may be crucial for lasting protection against COVID-19. 

A research team led by Drs. Daniela Weiskopf, Shane Crotty, and Alessandro Sette of the La Jolla Institute for Immunology looked at immune memory six months after vaccination. They were also interested in how immune memory from previous exposure to coronaviruses, which can cause common colds, might affect the vaccine-induced immune response.

The work was primarily funded by NIH’s National Institute of Allergy and Infectious Diseases (NIAID). Results appeared in Science on September 14, 2021.

The study examined 35 participants enrolled in a phase 1 clinical trial of the Moderna vaccine. They had received two 25-microgram injections—a quarter of the standard dose authorized for emergency use by the FDA.

The team assessed antibody and T cell levels after the first and second doses, and again six months later. They measured two subsets of T cells: CD8+ T cells, or “killer” T cells, which destroy virus-infected cells, and CD4+ T cells, “helper” T cells involved in antibody production.

Levels of antibodies, CD4+ T cells, and CD8+ T cells remained strong six months after receiving the vaccine. This was found even among participants over 70 years of age, who are particularly vulnerable to severe COVID-19. Memory CD4+ T cells were still present in nearly everyone six months after full vaccination. Memory CD8+ T cells were detected in 67% of participants six months after full vaccination. Until this study, it was uncertain whether the Moderna vaccine elicited these memory T cells. 

The team also found that the vaccine generated similar immune memory against the SARS-CoV-2 spike protein to that of natural infection. Levels of antibodies, CD4+ T cells, and CD8+ T cells six months after vaccination were comparable to those in recovered individuals.

In addition, the researchers found that “cross-reactive” T cells—those made during infection with other coronaviruses that can cause the common cold—enhanced the vaccine response. People with cross-reactive T cells before vaccination had significantly stronger CD4+ T cell and antibody responses.

Taken together, the study suggests that immune memory resulting from the Moderna vaccine, even at low doses, is long-lasting.

“The immune memory was stable, and that was impressive,” Crotty says. “That’s a good indicator of the durability of mRNA vaccines.”

—by Erin Bryant


Pfizer Booster for High-Risk Workers

In a statement released earlier this month, the CDC said that high risk of occupational exposure, such as healthcare workers, may receive the Pfizer booster shot at least 6 months after the two-dose primary series, based on their individual benefits and risks. The agency’s Advisory Committee on Immunization Practices (ACIP) had previously voted 6-9 against recommending a booster in this population.

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