February 15, 2021 from jameslyonsweiler.com

CLAIMS: “The CDC didn’t introduce a “major rule change” to inflate COVID-19 deaths… The CDC didn’t change the rules on cause-of-death reporting… The guidances on filling out Parts I and II of the death certificate in 2003 and 2020 are identical.” (Source:HealthFeedback.org)

The non-peer-reviewed opinion blog “Health Feedback” has misinformed the public on a very serious matter. This time, they have failed to recognize critical details that had changed reporting practices regarding numbers of cases and deaths associated with COVID19, the disease caused by the SARS-CoV-2 virus and have conflated a biostatistician’s opinion with “evidence.”

In their article, Health Feedback asserts that the CDC did not change the manner in which deaths in persons who test positive for COVID19 are reported.

The guidances on filling out Parts I and II of the death certificate in 2003 and 2020 are identical.

Here is the 2003 guidance document for reporting deaths from the handbook (pgs 11-12): https://www.cdc.gov/nchs/data/misc/hb_me.pdf

“As can be seen, the cause-of-death section consists of two parts. The first part is for reporting the sequence of events leading to death, proceeding backwards from the final disease or condition resulting in death. So, each condition in Part I should cause the condition above it. A specific cause of death should be reported in the last entry in Part I so there is no ambiguity about the etiology of this cause. Other significant conditions that contributed to the death, but did not lead to the underlying cause, are reported in Part II.”

Here is the most recent guidance document from April, 2020 about how to record a COVID death https://www.cdc.gov/nchs/data/nvss/vsrg/vsrg03-508.pdf . This was published after the March 24th, 2020 release which was guidance for using the new ICD-10 code for COVID, i.e., https://www.cdc.gov/nchs/data/nvss/coronavirus/Alert-2-New-ICD-code-introduced-for-COVID-19-deaths.pdf.  

“Part I This section on the death certificate is for reporting the sequence of conditions that led directly to death. The immediate cause of death, which is the disease or condition that directly preceded death and is not necessarily the underlying cause of death (UCOD), should be reported on Line A. The conditions that led to the immediate cause of death should be reported in a logical sequence in terms of time and etiology below it. The UCOD, which is “(a) the disease or injury which initiated the train of morbid events leading directly to death or (b) the circumstances of the accident or violence which produced the fatal injury” , should be reported on the lowest line used in Part I.” “Other significant conditions that contributed to the death, but are not a part of the sequence in Part I, should be reported in Part II.”

Prima facie analysis shows that the wording differs, which should have prompted the review process required, as recognized by Dr. Henele et al. in the article in question.

With an uncareful read, these two documents may appear to offer substantially the same guidance, but there was, in fact, an important material change in how COVID deaths should be recorded from 2003 to the present, missed by Health Feedback.

We refer (again) to the NVSS COVID-19 Alert No. 2 March 24, 2020

(Beginning of Quote:)

Will COVID-19 be the underlying cause?
The underlying cause depends upon what and where conditions are reported on the death certificate.
However, the rules for coding and selection of the underlying cause of death are expected to result in COVID19 being the underlying cause more often than not. (emphasis mine)

What happens if certifiers report terms other than the suggested terms?
If a death certificate reports coronavirus without identifying a specific strain or explicitly specifying that it is not COVID-19, NCHS will ask the states to follow up to verify whether or not the coronavirus was COVID-19.
As long as the phrase used indicates the 2019 coronavirus strain, NCHS expects to assign the new code.
However, it is preferable and more straightforward for certifiers to use the standard terminology (COVID-19).

What happens if the terms reported on the death certificate indicate uncertainty?
If the death certificate reports terms such as ‘probable COVID-19’ or ‘likely COVID-19,’ these terms would be assigned the new ICD code. It Is not likely that NCHS will follow up on these cases.
If “pending COVID-19 testing” is reported on the death certificate, this would be considered a pending record.
In this scenario, NCHS would expect to receive an updated record, since the code will likely result in R99. In this case, NCHS will ask the states to follow up to verify if test results confirmed that the decedent had COVID19.

Do I need to make any changes at the jurisdictional level to accommodate the new ICD code?
Not necessarily, but you will want to confirm that your systems and programs do not behave as if U07.1 is an unknown code.

Should “COVID-19” be reported on the death certificate only with a confirmed test?
COVID-19 should be reported on the death certificate for all decedents where the disease caused or is assumed to have caused or contributed to death. Certifiers should include as much detail as possible based on their knowledge of the case, medical records, laboratory testing, etc. If the decedent had other chronic conditions such as COPD or asthma that may have also contributed, these conditions can be reported in Part II. (See attached Guidance for Certifying COVID-19 Deaths)”

(End of quote)

Health Feedback ignores the obvious, which is that none of this language existed in 2003, and should be subjected to the review process correctly identified as required by law by Dr. Henele and colleagues.

Also relevant to this issue is Dr. Birx’s Announcement in early April 2020 (See: “Birx says government is classifying all deaths of patients with coronavirus as ‘COVID-19’ deaths, regardless of cause“, Fox News, April 7, 2020

This article points out that the number of autopsies conducted to determine the ultimate cause of death would be low due to the increased risk of infection. Thus, the conditions under which a death originally determined by the 2020 guidance to be due to COVID19 would be overruled would tend to not exist, leaving an ascertainment bias in place that would default to Part 1 reporting not being updated.

Health Feedback also missed that the language quoted specifically introduces the new conditions of “probably” and “likely” and that “When NCHS sees this type of entry, they should be assigning the new ICD-10 code for COVID“:

“If the death certificate reports terms such as ‘probable COVID-19’ or ‘likely COVID-19,’ these terms should be assigned the new ICD code. It is unlikely that NCHS will follow up on these cases.”

This is indeed a major shift in the practice of reporting, for which CDC should have sought oversight, as argued by Henele et al. (2020).

We know this because the peer-reviewers who reviewed the article in Science, Public Health Policy & the Law challenged and confirmed these specific and important points, as did I, per my role as Editor-in-Chief.

A real-life example of the effects of CDC’s ad-hoc change in reporting is seen in this interview with Dr. Scott Jensen, which was recorded as part of an IPAK workshop on Advances in COVID19 Medicine for healthcare workers. I offer Dr. Jensen gratitude for sharing his data, and for his sincere call for his colleagues to call for both Situation Updates and audits.

Even if there had been no material change in wording, the use of different wording should have prompted the initiation of the required review process, which is the core assertion by Dr. Henele and colleagues. Instead, CDC proceeded, unchecked, as it all too often does, impacting the perception of risk of COVID19 infection and death by decreeing a new means of ascertainment, codifying a bias that will eventually have to be corrected, and cases and deaths from April 2020 to present, be updated.

Health Feedback used a number of logical fallacies in their article, including the straw man fallacy (Henele et al. never mentioned or commented on “excess deaths”). They resort to the fallacy of authority by replacing a biostatistician’s “opinion” or expectation, with “evidence”. They also resort to a number of unwarranted ad hominem attacks that further investigation on their part would have allowed them to determine were outdated and irrelevant. They cite another so-called “Fact Check” organization but fail to cite my and the medical community’s response, and the subsequent corrections made, to the article they cited.

Health Feedack conflates a biostatistician’s opinion with “evidence” that indicates that the number of COVID-19 deaths were undercounted. While underascertainment bias is necessarily observed in the beginning of an outbreak, accurate accounting of cases and deaths are still required for reality-based public health. CDC’s codified bias compounds uncertainty about risks of infection of SARS-CoV-2 and risk of death due to COVID19. Proper oversight could have prevented compounded errors in COVID19 accounting.

Factually inaccurate: The CDC DID change the rules on cause-of-death reporting without seeking proper oversight. The language introducing non-follow-up procedures and “probable” and “likely” deaths is new and should have been subjected to the required review processes outlined by Dr. Henele and colleagues. The consequences are being seen in real-world reporting requirement discrepancies.

Unsupported: The Health Feedback article provides no evidence that the number of COVID-19 deaths are not inflated. They also conflate a biostatistician’s opinion with “evidence” that indicates that the number of COVID-19 deaths were initially undercounted, as if that bias is the only relevant bias. While that may be that person’s expectation, it is not substantiated by any evidence the article cites.

Take Homes: Henele et al.’s allegation that CDC failed to abide by legal requirements of oversight mandated by Congress has significant merit. Once again, a “Fact Checking” organization has failed to represent reality correctly, in part due to the failure to employ the tried and true practice of blinded peer review. Such organizations appear to be officious opinion columns. The reliability of “Fact Check” organizations is therefore rated “Low.”

Related: Dr. Scott Jensen and Dr. Ealy discuss these topics with Wayne Rhode’s powerful Right on Point Podcast episode.

Two episodes. The first is with Dr. Jensen and Dr. Ealy. The second is Dr. Ealy addressing the key question: Did CDC break the law?

The second is just Dr. Ealy.

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