A Proposed Rule by the Veterans Affairs Department on 02/05/2019 (US format - UK format 05/02/2019)

[MeSci]

Source: U.S. Federal Register

Vol. 84, #24, p 1678-1690

Date: February 5, 2019

URL:
https://www.federalregister.gov/doc...immune-disorders-and-nutritional-deficiencies

https://www.govinfo.gov/content/pkg/FR-2019-02-05/pdf/2019-00636.pdf

[A Proposed Rule by the Veterans Affairs Department]

Schedule for Rating Disabilities: Infectious Diseases, Immune Disorders, and Nutritional Deficiencies
----------------------------------------------------------

AGENCY:

Department of Veterans Affairs.

ACTION:

Proposed rule.

SUMMARY:

The Department of Veterans Affairs (VA) proposes to amend the section of the VA Schedule for Rating Disabilities (VASRD or Rating Schedule) that addresses infectious diseases and immune disorders. The purpose of these changes is to incorporate medical advances since the last revision, update medical terminology, and clarify evaluation criteria. The proposed rule considers comments from experts and the public during a forum held from January 31 to February 1, 2011, on revising this section of the VASRD.

DATES:

Comments must be received by VA on or before April 8, 2019.

ADDRESSES:

Written comments may be submitted through www.regulations.gov; by mail or hand-delivery to Director, Regulation Policy and Management (00REG), Department of Veterans Affairs, 810 Vermont Ave. NW, Room 1063B, Washington, DC 20420; or by fax to (202) 273-9026. (This is not a toll free number.) Comments should indicate that they are submitted in response to 'RIN 2900-AQ43-Schedule for Rating Disabilities: Infectious Diseases, Immune Disorders, and Nutritional Deficiencies.' Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at

www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Ioulia Vvedenskaya, M.D., M.B.A., Medical Officer, Part 4 VASRD Regulations Staff (211C), Compensation Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-9700. (This is not a toll-free telephone number.)

 

[Sly Saint]

paragraph  4.88a Chronic Fatigue Syndrome

Currently, paragraph  4.88a specifies older diagnostic criteria for the diagnosis of CFS and uses outdated terminology to refer to this complex disease. VA proposes to update the nomenclature for this disease, which is also known as systemic exertion intolerance disease (SEID) or myalgic encephalomyelitis (ME), by changing the diagnostic code name to 'Systemic Exertion Intolerance Disease (SEID)/Chronic Fatigue Syndrome (CFS).' This new name captures a central characteristic of the disease that reflects negative effects of any exertion (physical, cognitive, or emotional) on patients' many organ systems. IOM (Institute of Medicine),
Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness (2015),

http://www.nationalacademies.org/hmd/~/media/Files/Report Files/2015/MECFS/MECFScliniciansguide.pdf

this is not good, they plan to remove ME

SEID/CFS

@JaimeS

eta: I, and I imagine a lot of others, would rather see CFS removed

 

[adambeyoncelowe]

It's odd that they want the SEID name but the Fukuda criteria? Surely that's a mistake?

 

[rvallee]

(3) These symptoms:

(i) Cannot have first appeared before the fatigue

I did not experience significant fatigue until years into. Or, well, I did but it was ordinary fatigue, the kind that is easy to brush off and has nothing to do with the flu-like heavy crushing "fatigue" of flu-like symptoms.

We can't even have the most basic definitions right. Not sure if this is genuine progress.

 

[JaimeS]

New diagnostic criteria will take into consideration whether this severe chronic fatigue significantly
interferes with daily activities and work, if the affected individual concurrently has four or more of the eight symptoms as outlined in CDC evidence-based criteria

So SEID but actually Fukuda?

(2) The individual concerned concurrently has four or more of the following eight symptoms:

(i) Post-exertion malaise lasting more than 24 hours
(ii) Unrefreshing sleep
(iii) Significant impairment of short-term memory or concentration
(iv) Muscle pain
(v) Pain in the joints without swelling or redness
(vi) Headaches of a new type, pattern, or severity
(vii) Tender lymph nodes in the neck or armpit
(viii) Sore throat that is frequent or recurring

This is the Fukuda criteria.

 

[JaimeS]

"We have fully updated and modernized our criteria to [checks clipboard] the 1990s criteria."

"Additionally, we have chosen to call it by a completely different name."

Ok?

 

[MeSci]

I've been asked to reduce the size of the entry, but you should be able to read it all at the link, although unfortunately not edited for ME as the entry was.

 

[Dx Revision Watch]

https://s4me.info/threads/usa-nchs-cdc-proposal-for-icd-10-cm-adding-seid.5929/page-9#post-143598

 

[Dx Revision Watch]

Latest release of SNOMED CT US Edition posted:

The March 01, 2019 release of SNOMED CT US Edition was posted today on the SNOMED CT browser platform.

I can confirm that no new SNOMED CT Concept code or Synonym term under an existing SNOMED CT Concept code for either "Systemic exertion intolerance disease" or "SEID - Systemic exertion intolerance disease" has been added to the US Edition's March release.

The US Edition posts a release twice yearly. The next release for the US Edition will be the September 01, 2019 release.

The US release can be accessed from this page - click on the blue button for "Go browsing United States edition 2019-03-01" https://browser.ihtsdotools.org/

 

[WillowJ]

Note: For the purpose of evaluating this disability, incapacitation exists only when a licensed physician prescribes bed rest and treatment.

Are they dreaming?

 

[rel8ted]

Are they dreaming?

You rarely even see a "licensed physician" there anymore in primary care. They have figured out it is cheaper to use PAs and treating pharmacists (forgot the exact name). Since it is a federal facility, they can make up whatever exceptions they choose. Even the civilian contracted opticians in my state are allowed to operate on federal property without a license, but a license is required by the state for operation of an optical business.

Source: I was a licensed optician before I became to ill to work and filled in at the VA. Found out the guy who runs the dispensary is unlicensed and was told that is how it works.

 

[Dx Revision Watch]

has this shift already started in the States?
spotted it on one of the slides at the OMF conference (June 8th)

The outcome (if any) of the proposals under discussion at the September 2018 ICD-10-CM Coordination and Maintenance Committee for potentially adding SEID to ICD-10-CM isn't known yet.

Whose slide presentation is in your image?

 

[Dx Revision Watch]

The FY 2020 release for ICD-10-CM is scheduled to be posted at some point this month.

 

[Dx Revision Watch]

If SEID has not been included in the FY 2020 release of ICD-10-CM, then one of the following applies:

a) no decision was made by NCHS Director on the proposals presented at the September 2018 meeting and the topic has been left hanging;

or

b) no decision was made by NCHS Director on the proposals presented at the September 2018 meeting and proposals are intended to be re-presented for further discussion, potentially with proposed amendments, at the September 2019 meeting or at some future C & M Committee meeting.

or

c) the proposals presented at the September 2018 and the comments received during the public review period were considered by the NCHS Director and the proposals were not approved.


The next meeting of the NCHS/CDC C & M Committee will be September 10-11, 2019.


Edited to insert c).

 

[Medfeb]

has this shift already started in the States?
spotted it on one of the slides at the OMF conference (June 8th)

View attachment 7547

A few clinical guidance providers initially used the name "CFS/SEID" when the IOM report came out but have since changed to ME/CFS. The VA recently used the name "SEID/CFS" in a rule change they were proposing (which also proposed using Fukuda) but I will be surprised if its accepted. And it appears that a few doctors have used the term "SEID" in medical records

At this point, CDC, NIH, and many/most US medical ed providers use the term ME/CFS while some (e.g. Mayo) still use CFS.

 

[Dx Revision Watch]

See also thread:

USA - NCHS/CDC Proposal for ICD-10-CM - adding SEID

https://s4me.info/threads/usa-nchs-cdc-proposal-for-icd-10-cm-adding-seid.5929/

 

[alex3619]

eta: I, and I imagine a lot of others, would rather see CFS removed

Ditto

 

[rel8ted]

Are they dreaming?

I was stuck in the VA system for 2 decades bc I did not have private insurance. I was told everything from conversion disorder to flat out faking. My primary was the ONLY doc that believed me, but prescribing bedrest is not something that is done and we all know that. VA doesn't indicate bed rest for much of anything, including recovery from hernia surgery when my hub had that. No doc in the VA system will even acknowledge that I have ME/CFS/SEID or whatever their flavor of the day is. A neuro told me I have a disease that "has not been discovered yet"

 

[rvallee]

Ditto

With extreme prejudice. As in: this was a massive mistake that needs to be rectified and steps should be taken to assure something like this never happens again.

It will take some time because of liabilities but it has to happen. It was a massive blunder of disastrous impact, one that added nothing but confusion for health care providers and harm to sufferers.

 

[Sly Saint]

Multiple commenters including individual veterans, Veterans Advocacy Organizations, Veterans Service Organizations, and other professional organizations expressed a wide range of concerns regarding the proposed changes to the definition of chronic fatigue syndrome (CFS) under § 4.88a and the name change for DC 6354.
Commenters thought the name change of Chronic Fatigue Syndrome (CFS) to Systemic Exertion Intolerance Disease/Chronic Fatigue Syndrome (SEID/CFS) was unwarranted and that it would create unnecessary confusion among medical providers, including non-VA medical providers. Commenters also stated that that the new name, Systemic Exertion Intolerance Disease (SEID), has not been adopted by any federal agency, nor by researchers and clinicians and that the CDC, National Institutes of Health (NIH), research publications, and materials for patients and health care providers all use the term ME/CFS.
Commenters felt that VA's use of the term SEID/CFS would introduce confusion among medical providers and patients at VA and reduce VA's ability to coordinate with other federal agencies.

Commenters expressed that the proposed changes to the definition of CFS does not conform to the Kansas Start Printed Page 28229Criteria (2000), the Centers for Disease Control (CDC) Chronic Multisymptom Illness (CMI) criteria, and to those used in VA-funded research into Gulf War Illness (GWI) and that the proposed definition is not compatible with the department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP) for CMI.

Commenters stated that VA's proposed combination of the Institute of Medicine (IOM) reevaluation of CFS as SEID with the 1994 Fukuda criteria for CFS presents an amalgamation that is not based in evidence nor discussed in any publications.

The commenters expressed concern that VA did not follow any recommendations from the IOM, the Gulf War Research Advisory Committee (RAC), CDC, or other agencies and this combination is for an entirely new entity that is not known by World Health Organization, International Classification of Diseases, Tenth Revision (ICD-10) or other medical classification system and that the VA proposed definition is not compatible with the one mandated by DoD's CDMRP for CMI and the Kansas Criteria to qualify for GWI research funding.

Commenters noted that VA did not consult the RAC on these proposed changes and stated that the RAC is responsible for understanding the definitions and entirety of the condition.

Commenters also were concerned that the proposed changes would leave those Gulf War veterans who receive care and services for CFS, vulnerable to VA manipulation of their care and services. The commenters suggested that CFS should be studied by the Gulf War research community, the veteran community, CFS researchers, the RAC, and independent medical professionals and that VA rely on the recommendations from these parties as a guide for new criteria updates and to ascertain if these changes are even warranted.

Commenters also stated that VA would be directly and negatively impacting more than 300,000 Gulf War veterans suffering from Gulf War Illness by not relying on the studies from these parties and by combining, in whole or in part, the 2015 Systemic Exertion Intolerance Disease (SEID) and the 1994 Fukuda CDC criteria for Chronic Fatigue Syndrome (CFS) into what would be called SEID/CFS.

Commenters felt that VA's adoption of the Fukuda criteria is a step backwards that will perpetuate diagnostic inaccuracy and cause harm to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients served by the VA.

Commenters referenced the 2015 IOM Report to state that the Fukuda criteria were overly broad because they do not require the hallmark symptom of post-exertional malaise and should not be used because of the possibility of misdiagnosing patients with other conditions.

Commenters believed that VA's reliance on outdated Fukuda diagnostic criteria would cause harm to veterans with ME/CFS through misdiagnosis and cause a mismatch with the diagnostic criteria in use elsewhere.

Commenters suggested that VA adopt ME/CFS or ME/CFS/SEID title for the illness to stay in alignment with the greater ME/CFS community, to include patients, doctors, and researchers. Commenters felt that VA's proposed revisions were based on financial reasons in order to revoke benefits from existing veterans and prevent other veterans from receiving this combined diagnosis of SEID/CFS.

Commenters also provided questions and recommended that VA adopt ME/CFS instead of SEID/CFS; reject the Fukuda criteria; and adopt the IOM diagnostic criteria.

While VA received some support for updating its definition of CFS, VA considered these comments and concerns and concluded that this proposed update to § 4.88a is premature and that additional research is needed to provide a more comprehensive way to determine the disabling effects of CFS and associated conditions.

Therefore, VA is withdrawing its proposal to amend § 4.88a Chronic Fatigue Syndrome. To ensure that the full range of relevant factors is adequately addressed, VA intends to establish a work group to specifically address this condition. Upon assessment of the work group's findings, VA will determine whether amendments to § 4.88a are necessary and such amendments, if any, will be addressed in a future proposal.

https://www.federalregister.gov/doc...immune-disorders-and-nutritional-deficiencies