Submission: Proposal: Add Somatic symptom disorder as inclusion term to ICD-10-CM

Post #309 Shortlink: http://wp.me/pKrrB-3WD

You have until Friday in which to submit comments on any of the numerous diagnosis proposals presented at the March ICD-10-CM Coordination and Maintenance Committee meeting.

Comments should be sent to NCHS, preferably by email, by June 20th deadline: nchsicd9CM@cdc.gov

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The next public meeting of the ICD-10-CM/PCS Coordination and Maintenance Committee is scheduled for September 23–24, 2014. If you are planning to attend the meeting in person you will need to register online by September 12. Registration opens on August 15.

New proposals for the September 23–24, 2014 meeting must be received by July 18.

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September 2013 meeting Diagnosis Agenda

The fall meeting of the ICD-9-CM/PCS Coordination and Maintenance Committee took place on September 18–19.

The Diagnosis Agenda had included the proposals to add the new DSM-5 disorder terms: Somatic symptom disorder and Illness anxiety disorder to the ICD-10-CM Tabular List and the Alphabetical Index.

Note that the proposal was to add the terms as Inclusion Terms under existing ICD-10-CM Chapter 5 codes, not to create unique new codes for these two terms, or to replace or subsume any existing categories:

ICD10CM 4

Source: Page 45, Diagnosis Agenda (Topic Packet), September 18–19, 2013 ICD-10-CM/PCS Coordination and Maintenance Committee Meeting

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March 2014 meeting Diagnosis Agenda

The spring C & M Committee meeting took place on March 19–20, 2014. I was unable to attend either meeting as I live in the UK, and it is not feasible for me to participate in these public meetings via phone link.

The March Diagnosis Agenda included reiteration of the September proposal to add Somatic symptom disorder to the ICD-10-CM Alphabetical Index, coded to F45.1. (But did not include a resubmission to add to the Tabular List.) The reason for its reiteration in the March Agenda is unclear.

When the March Agenda requests for additions and modifications to the Tabular List were reached, CDC’s Beth Fisher had remarked that some of the proposals for additions to the Tabular List may have been proposed at the September 2013 meeting (though no explanation was given for why some of these September proposals were being duplicated in the March Agenda).

Evidently some Index proposals from the September meeting were also duplicated in the March Agenda, including SSD, but not Illness anxiety disorder.

There were no comments or queries from the floor in relation to proposals for SSD. There were no queries about whether NCHS decisions had already been reached on the requests for additions and modifications submitted via the September meeting.

It remains unclear whether the duplications in the March Agenda were due to administrative oversight, were being included for procedural reasons, or were being re-presented in response to NCHS committee decisions made following the September meeting, to which APA, but not the public at large, might be party to. (The outcome of both the September and March proposals may not be evident until 2015, when the next Addendum is posted.)

March Agenda proposal: Add Somatic symptom disorder to the Index as “– somatic symptom F45.1” under “Disorders”:

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March14 ICD-10-CM Cand M SSD to Index

Source: Diagnosis Agenda (Topic Packet) Page 89, March 19-20, 2014 ICD-10-CM/PCS Coordination and Maintenance Committee Meeting; Screenshot Videocast Three

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F45.1 (SSD) and F45.21 (Illness anxiety disorder) are the ICD-10-CM codes to which these two new APA disorders are already cross-walked in the DSM-5:

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SSDcrosswalk

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If NCHS rubber stamps the addition of Somatic Symptom Disorder to the ICD-10-CM it could leverage future proposals (either by NCHS/CMS or by external requestors) for the replacement of some or all of the existing Somatoform disorders categories with this new, single SSD diagnostic construct, in order to bring ICD-10-CM in line with DSM-5.

There are implications for ICD-11, too. Once SSD is inserted into ICD-10-CM, the presence of this term within the U.S. adaptation of ICD-10 may make it easier for the ICD-11 Revision Steering Group to justify proposals to replace the existing ICD-10 Somatoform disorders categories with a single, new ICD construct incorporating SSD-like characteristics, to facilitate harmonization between ICD-11 and DSM-5 disorder terms and diagnostic criteria.

Comments by June 20th deadline, preferably by email, to: nchsicd9CM@cdc.gov

Below is my own submission to NCHS in PDF

Click link for PDF document   NCHS Submission Chapman June 14

and as text:


To: NCHS  nchsicd9CM@cdc.gov

Re: Comment on proposals, March 19-20, 2014 meeting of ICD-10-CM Coordination and Maintenance Committee.

Diagnosis Agenda Page 89: Under “Proposed Index Modifications”: Add Somatic symptom disorder to ICD-10-CM Alphabetical Index (F45.1)

Proposal requestor: Unspecified

Comment submitted by Suzy Chapman DipAD, [Address redacted]

Date submitted: June 15, 2014

I write in objection to the proposed addition of Somatic symptom disorder to the ICD-10-CM Alphabetical Index for consideration for implementation on October 1, 2015 [or on and after October 1, 2016 after the partial code freeze has ended, as applicable].

This March 19-20, 2014 meeting proposal duplicates the request at the September 18-19, 2013 meeting for the addition of Somatic symptom disorder to the ICD-10-CM Index (and to the Tabular List) as an Inclusion Term to existing code, F45.1 Undifferentiated somatoform disorder.

Somatic symptom disorder is a new disorder conceptualization created by the American Psychiatric Association (APA) for DSM-5.

For DSM-5, the Somatoform Disorders have been dismantled. Four DSM-IV categories: somatization disorder [300.81], some presentations of hypochondriasis [300.7], pain disorder, and undifferentiated somatoform disorder [300.82] are eliminated and replaced with a single new diagnosis, Somatic symptom disorder (SSD), cross-walked in DSM-5 to ICD-9 300.82 (ICD-10-CM F45.1).

The Somatic symptom disorder construct de-emphasizes “medically unexplained” as the central defining feature of this disorder group. Instead, the focus shifts away from somatic symptoms to emotional, cognitive and behavioral disturbances and “maladaptive” responses to symptoms: high levels of health anxiety; disproportionate and persistent concerns about the medical seriousness of the symptom(s); or an excessive amount of time and energy devoted to symptoms and health concerns.

Symptoms may or may not be associated with another medical condition: SSD allows for the application of a mental disorder diagnosis in patients with “established general medical conditions or disorders” like diabetes, heart disease and cancer or presenting with “somatic symptoms of unclear etiology” if the clinician considers the patient otherwise meets the new criteria.

To meet the requirements for DSM-IV’s Somatization disorder, a rigorous criteria set needed to be fulfilled: a history of many medically unexplained symptoms before the age of thirty, resulting in treatment sought or psychosocial impairment. And a high diagnostic threshold: a total of eight or more medically unexplained symptoms from four, specified symptom groups, with at least four pain, two gastrointestinal, one psychosexual and one pseudoneurological symptom.

In DSM-5, the requirement for eight symptoms has been dropped to just one or more persistent, non specific, distressing somatic symptoms and the clinician’s perception of “excessive” or “maladaptive” response to the symptom or symptoms.

• These changes for DSM-5 represent a radical restructuring of the DSM-IV Somatoform disorders framework and introduce a new construct for which much remains to be determined.

On Day Two of the September 18-19, 2013 ICD-9-CM Coordination and Maintenance Committee meeting, Dr Darrel Regier had presented and discussed rationales, coding proposals and timings for six new DSM-5 disorders that APA has proposed for insertion into ICD-10-CM. But the Diagnosis Agenda proposals to add the new DSM-5 Somatic symptom disorder and Illness anxiety disorder category terms as inclusion terms to ICD-10-CM did not form part of Dr Regier’s presentation.

As it was unspecified within the Diagnosis Agenda and during the meeting presentations, it is unclear whether these two proposals are being requested by APA, by NCHS/CMS, or by other parties or individuals.

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• My first concern is that no description of Somatic symptom disorder, no rationale for why this ICD-10-CM modification is needed (including clinical relevancy) and no supporting clinical and literature references for the validity of Somatic symptom disorder as a new disorder were published in the Diagnosis Agenda for either the September or March meeting.

At the public meeting, no presentation had been made on behalf of APA, or by representatives of NCHS or CMS, or by anyone else for the specific Agenda proposal to add Somatic symptom disorder as an inclusion term under an existing ICD-10-CM Somatoform disorders code and there was no discussion of this proposal during the course of the meeting [1][2].

There is an expectation that the committees overseeing the development and revision of the draft for ICD-10-CM will give due consideration to the applicability, clinical utility, safety and reliability of any proposal for the inclusion of a new disorder construct before granting approval for its addition to the Tabular List and Index, and that the comments and objections received during the public response period will also be considered. The lack of rationales and references for supportive evidence provided by the requestors hinders public participation in the response process.

• The absence from the Diagnosis Agendas and meeting presentations of rationales, clinical relevancy and supporting clinical and literature references to enable proper public scrutiny, consideration and informed responses to this proposal should disqualify Somatic symptom disorder from consideration for implementation once the partial code freeze has lifted.

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The burden of proof before introducing any new diagnosis into a classification system is that it has a favourable risk to benefit ratio. This new diagnostic construct created by APA and introduced into DSM-5 merits the same level of scrutiny and risk to benefit evaluation as would be expected to be applied to any proposed new disorder/disease that is under consideration for inclusion in any chapter of ICD, whether this is for the updating of the ICD-10-CM draft, updating of WHO’s ICD-10, updating of clinical modifications of ICD-10, or drafting of ICD-11.

A number of papers have noted the paucity of rigorous evidence for the validity, reliability, acceptability, safety and utility of the application of the Somatic symptom disorder construct in adults and children across diverse clinical settings and by a spectrum of health and allied professionals. There is no significant body of published research on the epidemiology, clinical characteristics or treatment of the Somatic symptom disorder construct [3][4][5].

In a paper published in the Journal of Psychosomatic Research, September 2013, the DSM-5 Somatic symptom disorder Work Group concedes the lack of clinical evidence for its new construct and acknowledges the “small amount of validity data concerning SSD” and “that much remains to be determined” about the utility and reliability of the specific SSD criteria and its thresholds when applied in busy, general clinical practice, and there are “vital questions that must be answered” as they go forward [6].

• As an under researched, poorly validated disorder construct, Somatic symptom disorder does not meet NCHS/CMS criteria for new diseases/new technology procedures, and any minor revisions to correct reported errors in these classification and should be rejected for consideration for implementation during a partial code freeze and also rejected for consideration for implementation on or after October 1, 2015 [October 1, 2016].

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Concerns for the looseness of the Somatic symptom disorder definition and the ease with which these new criteria can be met have been discussed in a number of published papers and commentaries [7][8][9][10].

The over-inclusiveness of the SSD diagnosis is borne out by the results of the DSM-5 field trial study reported by Joel E Dimsdale, MD, chair of the Somatic symptom disorder Work Group, at the 2012 annual meeting of the American Psychiatric Association.

15% of the ‘diagnosed illness’ study group, comprising patients with cancer or coronary disease, were caught by SSD and would meet the criteria for application of an additional mental disorder diagnosis.

26% of the ‘functional somatic’ study group, comprising patients with irritable bowel syndrome or chronic widespread pain, met the SSD criteria.

SSD has a high false positive rate – capturing 7% of the ‘healthy’ field trial control group.

It is disturbing that the SSD Work Group (which had included no primary care physicians or pediatricians) appears not to have undertaken any field trials into the safety of application of the SSD criteria in children and adolescents.

NCHS/CMS provides no references for data for the application of SSD in children within the Diagnosis Agenda, although the DSM-5 text clearly indicates APA’s intention that SSD is a diagnosis that may also be applied to children with persistent, distressing somatic symptoms.

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Potential implications for the application of a diagnosis of SSD:

I am not persuaded that the new SSD diagnosis can be safely applied outside the optimal conditions of field trials, in settings where practitioners may not necessarily have adequate time for, or instruction in administration of diagnostic assessment tools, and where decisions to code or not to code may hang on the arbitrary and subjective perceptions of a wide range of end-users who may lack clinical training in the application of mental disorder criteria.

Misapplication of highly subjective and loose, easily met criteria, especially in busy primary care practice, may result in inappropriate diagnoses of mental disorder and inappropriate medical decision making, with considerable implications for patients [11].

A recent study (Plouvier et al, 2014) found more frequent presentation with functional somatic symptoms and multiple prodromal symptoms in the two year period prior to diagnosis with Parkinson’s disease than controls [12].

Incautious application or a pre-existing diagnosis of SSD in the patient’s notes may blunt clinician alertness and receptivity to emerging prodromal symptomotology of serious disease.

Patients with chronic, multiple bodily symptoms due to rare diseases, difficult to diagnose conditions, or multi system diseases like Behçet’s disease, for which it can take several years to arrive at a diagnosis, may be especially vulnerable to missed diagnosis or to misdiagnosis with a mental disorder, impeding access to testing, investigations, timely diagnosis and early intervention (and may result in increased claims against practitioners for medical negligence).

With the elimination of the requirement that symptoms be “medically unexplained” and inclusion of the presence of a co-occurring physical health condition, a mental disorder diagnosis of SSD can be applied as a “bolt-on” to any chronic medical diagnosis: to patients with diabetes, angina, cancer, MS, cardiovascular disease, ME and CFS, IBS, chronic widespread pain (aka fibromyalgia), chronic pain conditions or persistent symptoms of unclear etiology.

Patients with Chronic fatigue syndrome (CFS), “almost a poster child for medically unexplained symptoms as a diagnosis,” according to the SSD Work Group chair, or with chronic Lyme disease, Gulf War illness, chemical injury and chemical sensitivity; women with potential symptoms of gynecological disease, like ovarian cancer – already often late-diagnosed because persistent symptoms had been initially dismissed as IBS or a menopausal-related bladder complaint; or women with endometriosis or interstitial cystitis may be particularly vulnerable to misapplication or misdiagnosis with a mental health disorder under SSD criteria.

(There is also a Brief somatic symptom disorder in DSM-5, cross-walked to ICD-9 F45.8, that can be applied where duration of symptoms is less than 6 months. Just one somatic symptom and one “disproportionate” psychobehavioral response to that symptom, for less than 6 months chronicity, now ticks the box for a mental health diagnosis.)

There has been considerable opposition to the introduction of this new, poorly tested construct into the DSM-5 amongst patients, carers, advocates, consumer organizations, mental health practitioners and clinicians and considerable concern for the implications for diverse patient populations that the Somatic Symptom Disorder category will provide a “dustbin diagnosis” for the so-called “functional somatic syndromes,” for those living with chronic pain and for patients with persistent, but as yet undiagnosed, symptoms of disease.

• NCHS/CMS has published no independent field trial data and provided no rationales or clinical and literature references to inform public responses.

Given the lack of published evidence for the validity and safety of SSD, there is insufficient basis for the approval of SSD for inclusion within ICD-10-CM and it would be scientifically unsafe, premature and against the public interest to include this new diagnostic construct within ICD.

The proposal for the addition of Somatic symptom disorder to the ICD-10-CM as an inclusion term to the Index and Tabular List should be rejected. There should be no implementation in October 2016 as an inclusion term to F45.1, or to any other existing code, or with a unique code created.

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Appendix:

Incautious, inept application of criteria resulting in a “bolt-on” psychiatric diagnosis of Somatic symptom disorder has far-reaching implications for diverse patient populations:

Application of highly subjective and difficult to measure criteria could potentially result in misdiagnosis with a mental disorder, misapplication of an additional diagnosis of a mental disorder or missed diagnoses through dismissal and failure to investigate new or worsening somatic symptoms.

Patients with cancer and life threatening diseases may be reluctant to report new symptoms that might be early indicators of recurrence, metastasis or secondary disease for fear of attracting a diagnosis of SSD or being labelled as “catastrophizers.”

Application of an additional diagnosis of SSD may have implications for the types of medical investigations, tests and interventions that clinicians are prepared to consider and for which insurers are prepared to fund.

Application of an additional diagnosis of SSD may impact payment of employment, medical and disability insurance and the length of time for which insurers are prepared to pay out.

 An SSD diagnosis may negatively influence the perceptions of agencies involved with assessment and provision of social care packages, disability adaptations, workplace accommodations, provision of education arrangements tailored to the needs of children with chronic illness, and the perceptions of medical staff during hospital and accident and emergency admission, and prejudice future employment options.

Patients prescribed psychotropic drugs for perceived unreasonable levels of “illness worry” or “excessive preoccupation with symptoms” may be placed at risk of iatrogenic disease or subjected to inappropriate and costly behavioural therapies.

Multi-system diseases like Multiple Sclerosis, Behçet’s disease or Systemic lupus can take several years before a diagnosis is arrived at. In the meantime, patients with chronic, multiple somatic symptoms who are still waiting for a diagnosis would be vulnerable to being labelled with a mental disorder.

The burden of the DSM-5 changes to Somatoform disorders will fall particularly heavily upon women who are more likely to be casually dismissed when presenting with physical symptoms and more likely to be prescribed inappropriate antidepressants and anti-anxiety medications for them.

Somatic symptom disorder allows for the application of a diagnosis of SSD in children and where a parent is perceived as being excessively concerned about a child’s symptoms.

The diagnostic term “Somatic Symptom Disorder” is already being applied to children despite the lack of a body of evidence for the reliability, safety and validity of the DSM-5 SSD criteria [13].

I am deeply concerned that NCHS/CMS is considering inclusion of a new diagnostic term within ICD when no studies have been carried out into the safety of its application in children and adolescents.

Families caring for children and young people with any chronic disease or condition may be placed at increased risk of wrongful accusation of “over-involvement” with their child’s symptomatology.

Where a parent is perceived as responsible for, or encouraging maintenance of “sick role behavior” or “secondary gains” in a child, this can trigger social services investigation, or court intervention for the forced removal of a sick child out of the home environment and into foster care or in-patient rehabilitation, or placement of the child on the “at risk register.”

This is already happening to families in the U.S., UK and Europe with a child or young adult with chronic illness, notably with Chronic fatigue syndrome or ME. It may happen more frequently with a diagnosis of SSD or of chronic childhood illness + SSD.

Where there are disputes between the family and clinicians over an assigned diagnosis or where there is disagreement between clinicians over the etiology of a child’s symptoms, an earlier or concurrent diagnosis of SSD may prejudice the family’s rights and the rights of the child or young person to determine what treatments are administered, where and by whom; or may be used to override or attempt to override the right to consent to treatments, or as a means of limiting parental access to the child and parental involvement in a treatment plan.

A diagnosis of SSD may also impact on a child’s access to suitable educational arrangements, including part-time school attendance, rest periods, reduced curriculum, home tutoring, examination concessions, provision of an amanuensis etc. and access to disability aids and adaptations, or to unhindered use of existing aids, such as wheelchairs.

Again, there is insufficient basis for the approval of SSD for inclusion within ICD-10-CM for application in children or adults. It is scientifically unsafe, premature and against the public interest to include this poorly tested diagnostic construct within ICD.

Thank you for your consideration.

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References:

1.Diagnosis Agenda,September 18-19, 2013 meeting of the ICD-9-CM Coordination and Maintenance Committee.

2.Summary of Diagnosis Presentations, September 18-19, 2013 meeting of the ICD-9-CM Coordination and Maintenance Committee.

3. DSM-5 Somatic Symptom Disorders Work Group Disorder Descriptions and Justification of Criteria – Somatic Symptoms, published May 2011, for second DSM-5 stakeholder review.

4. Robert L. Woolfolk and Lesley A. Allen (2012). Cognitive Behavioral Therapy for Somatoform Disorders, Standard and Innovative Strategies in Cognitive Behavior Therapy, Dr. Irismar Reis De Oliveira (Ed.), ISBN: 978-953-51-0312-7

5. Ghanizadeh A, Firoozabadi A. A review of somatoform disorders in DSM-IV and somatic symptom disorders in proposed DSM-V. Psychiatr Danub. 2012 Dec;24(4):353-8.

6. Dimsdale JE, Creed F, Escobar J, Sharpe M, Wulsin L, Barsky A, Lee S, Irwin MR, Levenson J. Somatic Symptom Disorder: An important change in DSM. J Psychosom Res. 2013 Sep;75(3):223-8. Epub 2013 Jul 25.

7. Frances A. The new somatic symptom disorder in DSM-5 risks mislabeling many people as mentally ill. BMJ. 2013 Mar 18;346:f1580. doi: 10.1136/bmj.f1580.

8. Frances A. DSM-5 Somatic Symptom Disorder. J Nerv Ment Dis. 2013 Jun;201(6):530-1. doi: 10.1097/NMD.0b013e318294827c.

9. Frances A, Chapman S. DSM-5 somatic symptom disorder mislabels medical illness as mental disorder. Aust N Z J Psychiatry. 2013 May;47(5):483-4. doi:10.1177/0004867413484525.

10. Wolfe F, Walitt BT, Katz RS, Häuser W. Symptoms, the nature of fibromyalgia, and diagnostic and statistical manual 5 (DSM-5) defined mental illness in patients with rheumatoid arthritis and fibromyalgia. PLoS One. 2014 Feb 14;9(2):e88740. doi: 10.1371/journal.pone.0088740. eCollection 2014.

11. Dimsdale JE. Medically unexplained symptoms: a treacherous foundation for somatoform disorders? Psychiatr Clin North Am 2011;34:511-3.

12. Plouvier AO, Hameleers RJ, van den Heuvel EA, Bor HH, Olde Hartman TC, Bloem BR, van Weel C, Lagro-Janssen AL2. Prodromal symptoms and early detection of Parkinson’s disease in general practice: a nested case-control study. Fam Pract. 2014 May 28. pii: cmu025. [Epub ahead of print]

13. Commonwealth of Massachusetts Juvenile Court Department, Court document, Honourable Joseph Johnston, March 25, 2014, Re: Care and Protection of Justina Pelletier: http://cbsboston.files.wordpress.com/2014/03/scan.pdf

Interest:

Carer/advocate for adult with long-term medical condition. Owner of website Dx Revision Watch, Monitoring the revision of DSM-5 and ICD-11. Co-author, journal papers and commentaries on the SSD construct (with Professor Allen Frances).

 

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Reminder: Next meeting of ICD-10-CM/PCS Coordination and Maintenance Committee: March 19-20, 2014

Post #290 Shortlink: http://wp.me/pKrrB-3F1

Update at February 15, 2014:

Tentative diagnosis agenda posted for March 19–20, 2014 meeting on CDC site:

This list of tentative diagnosis agenda topics is not final. The final topics material will be available electronically from the NCHS web site prior to the meeting.

If you are unable to attend the meeting in person there will be conference lines available on the day of the meeting. Individuals do not need to register on line for the meeting if planning to dial in.

NCHS/CMS will be broadcasting the meeting live via Webcast at: http://www.cms.gov/live/

The next meeting of the ICD-10-CM/PCS Coordination and Maintenance Committee is scheduled for March 19–20, 2014. If you are planning to attend the meeting in person you will need to register, online, by March 14.

ICD-10-CM/PCS Coordination and Maintenance Committee Meeting

Public forum to discuss proposed changes to ICD-10-CM and ICD-10-PCS

Wednesday, March 19, 2014 – Thursday, March 2o, 2014

CMS Auditorium, Baltimore, MD

Agendas for the meeting will be posted in February 2014.

If phone lines and live webinar are made available the information will be posted closer to the meeting date.

Day One | Time: 03/19/2014 9:00 AM – 5:00 PM CMS Auditorium

Session: ICD-10-CM/PCS Coordination and Maintenance Committee Meeting
The first day of the meeting, March 19, 2014, will be devoted to procedure code issues.

Day Two | Time: 03/20/2014 9:00 AM – 5:00 PM CMS Auditorium

Session: ICD-10-CM/PCS Coordination and Maintenance Committee Meeting
The second day of the meeting, March 20, 2014 will be devoted to diagnosis code topics.

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The National Center for Health Statistics (NCHS) and the Centers for Medicare and Medicaid Services (CMS) are the U.S. governmental agencies responsible for overseeing all changes and modifications to the ICD-9-CM and draft ICD-10-CM/PCS.

NCHS is also responsible for the development of ICD-10-CM, adapted from the WHO’s ICD-10 for U.S. specific use.

The 2014 release of the draft ICD-10-CM (which replaces the July 2013 release) can be viewed or downloaded here.

ICD-10-CM is scheduled for implementation on October 1, 2014. Until that time the codes in ICD-10-CM are not valid for any purpose or use.

New concepts are added to ICD-10-CM based on the established update process for ICD-9-CM (the ICD-9-CM Coordination and Maintenance Committee) and the World Health Organization’s ICD-10 (the Update and Revision Committee).

Meetings of the Coordination and Maintenance Committee are co-chaired by a representative from NCHS and from CMS. Responsibility for  maintenance of the ICD-9-CM is divided between these two agencies, with classification of diagnoses by NCHS and procedures by CMS.

The name of the Committee will change to the ICD-10-CM/PCS Coordination and Maintenance Committee with the March meeting, as the last updates to ICD-9-CM/PCS took place on October 1, 2013.

Meetings are held twice yearly, in public, at CMS headquarters in Baltimore, MD. The next meeting is scheduled for March 19–20, 2014. The fall meeting is scheduled for September 23–24, 2014.

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Coordination and Maintenance Committee

The Committee provides a public forum to discuss proposed modifications, code changes, updates and corrections to the diagnosis codes in ICD-10-CM and procedural codes in ICD-10-PCS.

Public participation can also take place via phone conference link and live webinar. (Details for both in the Agenda documents.)

Agendas are posted approximately one month prior to the meetings. Diagnostic and procedural proposal Topic Packets, meeting materials, hand outs and presentation slides are posted on the CDC and CMS websites shortly before a meeting.

Up until 2011, transcripts of meeting proceedings were provided. Provision of transcripts is now replaced with videocasts for the full, two-day proceedings, available from the CMS website and posted on YouTube, and a brief Meeting Summary report, available from the CDC site shortly after the meeting.

For attendance in person, prior registration is required, via the CMS meeting registration website. Registration opens approximately one month  prior to a meeting and closes a few days before Day One of a meeting.

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Proposals for modifications, additions, corrections

Suggestions for modifications to ICD-10-CM/PCS come from both the public and private sectors. Since the draft ICD-10-CM is adapted from the WHO’s ICD-10, which is subject to an annual update process, some proposed modifications to ICD-10-CM may reflect updates to the ICD-10.

Interested parties (requestors) must submit proposals for modifications prior to a scheduled meeting and by a specific date. Proposals should be consistent with the structure and conventions of the classification. See Submission of Proposals for submission requirements and proposal samples.

Once proposals have been reviewed, requestors are contacted as to whether their proposal has been approved for presentation at the next Coordination and  Maintenance Committee meeting or not.

Approved proposals are presented at the meetings by representatives for professional bodies, advocacy organizations, clinicians, other professional stakeholders or members of the public with an interest, or are sometimes presented by an NCHS/CMS representative on behalf of a requestor.

No decisions on proposed modifications are made at the meetings. Recommendations and comments are reviewed and evaluated, once the comment period has closed, before final decisions are made.

The Coordination and Maintenance Committee’s role is advisory. All final decisions are made by the Director of NCHS and Administrator of CMS.

Final decisions are made at the end of the year and become effective October 1 of the following year.

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Submitting written comment on proposals presented at meetings

Comments on proposals are invited, at the meeting, at the end of each presentation, or may be submitted in writing following the meeting, during a one to two month duration public comment period.

Addresses for submitting comments are included in the Agenda Topic Packets published before the meetings. NCHS/CMS state that electronic submissions are greatly preferred over snail mail in order to ensure timely receipt of responses.

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Partial code freeze and timing of proposals

According to the Summary of Diagnosis Presentations for the September 18–19, 2013 meeting (for which the comment period closed on November 15):

“Except where noted, all topics are being considered for implementation on October 1, 2015. The addenda items are being considered for implementation prior to October 1, 2014.”

(“ICD-10-CM TABULAR OF DISEASES – PROPOSED ADDENDA” Tabular and Index modification proposals are set out on Diagnosis Agenda Pages 60-66.)

Note that some proposals in the Diagnosis Agenda were requested for insertion in October 2014 as Inclusion Terms to existing codes, with new codes proposed to be created for October 2015, notably, the 6 proposals to insert new DSM-5 disorders into ICD-10-CM presented by Darrel Regier, MD, on behalf of the American Psychiatric Association (Diagnosis Agenda Pages 32-44).

Whether the 17 modifications proposed on Pages 45-46 under “Additional Tabular List Inclusion Terms for ICD-10-CM” which were presented en masse by CDC’s, Donna Pickett, (which include the proposals to add the new DSM-5 “Somatic symptom disorder” and “Illness anxiety disorder” as Inclusion Terms to existing ICD-10-CM F45.x codes) are intended for implementation in October 2014 or in October 2015 is not explicit in the Diagnosis Agenda.

For the September 18–19, 2013 meeting, when submitting written comments, responders were asked to consider the following:

Whether they agree with a proposal, disagree (and why), or have an alternative proposal to suggest. But were also invited to comment on the timing of those proposals that were being requested for approval for October 2014:

Does a request for a new diagnosis or procedure code meet the criteria for implementation in October 2014 during a partial code freeze* based on the criteria of the need to capture a new technology or disease; or should consideration for approval be deferred to October 2015? And separately, to comment on the creation of a specific new code for the condition effective from October 1, 2015 (where requested).

Any code requests that do not meet the criteria [for inclusion during a partial freeze] will be evaluated for implementation within ICD-10-CM on and after October 1, 2015 once the partial freeze has ended and regular (at least annual) updates to ICD-10-CM/PCS resume.

*Partial Code Freeze of Revisions to ICD-9-CM and ICD-10-CM/PCS

  • October  1, 2011 is the last major update of ICD-9-CM. Any further revisions to ICD-9-CM will only be  for a new disease and/or a  procedure  representing new technology.  Revisions will  be posted on this website as addenda (revisions to procedures are posted on  the CMS website).
  • After  October 1, 2011 there will be no further release of ICD-9-CM on CD-ROM.
  • October  1, 2011 is the last major update of ICD-10-CM/PCS until October 1, 2015.
  • Between  October 1, 2011 and October 1, 2015 revisions to ICD-10-CM/PCS will be for new  diseases/new technology procedures, and any minor revisions to correct reported errors in these classifications.
  • Regular (at least annual) updates to ICD-10-CM/PCS will resume on October 1, 2015.

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Public comments not made public

Note that written public comments received by NCHS (Diagnosis) and CMS (Procedural) on proposals requested via these meetings are not aggregated and made publicly accessible. Nor are the names of organizations, professional bodies, individuals or others who have submitted comments listed publicly. It is not possible to scrutinize the number, provenance or substance of the comments received in support of, or in opposition to requests for modifications to ICD-10-CM presented via these meetings. Nor are NCHS/CMS’s rationales for the approval or rejection of requests for modifications to diagnosis or procedural codes on public record.

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September 18–19, 2013 meeting

A substantial number of modifications were proposed via the September 2013 meeting for both procedural and diagnosis codes. These are set out in the Agenda/Topic Packet PDF documents:

Diagnosis Codes Agenda

Procedural Codes Agenda

Meeting Materials

Videocasts for full two day meeting proceedings and Meeting Materials (collated on Dx Revision Watch site)

Summary of Diagnosis Presentations 

The ICD-9-CM timeline (for the remainder of its life) and the ICD-10-CM/PCS timeline are set out on Pages 3-8 of the Diagnosis Agenda.

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Key dates for the forthcoming March 19–20, 2014 meeting

January 17, 2014: deadline for submitting topics to be discussed at the March 19–20, 2014 ICD-10-CM/PCS Coordination and Maintenance Committee (reached).

February 14: registration for attendance opens.

March 14: deadline for registration.

Go here for registration details. (CMS confirmed to me via email on 01.23.13 that the deadline for registration is March 14, not February 14, as incorrectly published in the Diagnosis Agenda timeline.)

April 18, 2014: deadline for receipt of public comments on proposed codes and modifications tabled for March meeting. (Note there is only a 4 week period following this meeting during which written comments can be submitted.)

+++

Key ICD-10-CM/PCS Timeline dates extracted from full timeline, Pages 3-8, September 18-19, 2013 Diagnosis Agenda

March 19–20, 2014: ICD-10-CM/PCS Coordination and Maintenance Committee meeting.

April 1, 2014: There will be no new ICD-9-CM codes to capture new diseases or technology on April 1, 2014, since the last updates to ICD-9-CM will take place on October 1, 2013.

April 2014: Notice of Proposed Rulemaking to be published in the Federal Register as mandated by Public Law 99-509. This notice will include references to the complete and finalized FY 2015 ICD-10-CM diagnosis and ICD-10-PCS procedure codes. It will also include proposed revisions to the MS-DRG system based on ICD-10-CM/PCS codes on which the public may comment. The proposed rule can be accessed at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html?redirect=/AcuteInpatientPPS/IPPS/list.asp

April 18, 2014: Deadline for receipt of public comments on proposed code [at March meeting.]

June 2014: Final addendum posted on web pages as follows:

Diagnosis addendumhttp://www.cdc.gov/nchs/icd/icd10cm.htm

Procedure addendumhttp://cms.hhs.gov/Medicare/Coding/ICD10/index.html

September 23–24, 2014: ICD-10-CM/PCS Coordination and Maintenance Committee 2014 meeting.

October 1, 2014: New and revised ICD-10-CM and ICD-10-PCS codes go into effect along with DRG changes. Final addendum posted on web pages as follows:

Diagnosis addendumhttp://www.cdc.gov/nchs/icd/icd9cm_addenda_guidelines.htm

Procedure addendumhttp://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/addendum.html

November 2014: Any new ICD-10 codes required to capture new technology that will be implemented on the following April 1 will be announced. Information on any new codes to be implemented April 1, 2015 will be posted on the following websites:

http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/addendum.html

http://www.cdc.gov/nchs/icd/icd9cm_addenda_guidelines.htm

Objectors to insertion of DSM-5’s Somatic symptom disorder into ICD-10-CM

Post #283 Shortlink: http://wp.me/pKrrB-3y8

Michael Munoz, Executive Director, Rocky Mountain CFS/ME & FM Association has organized a joint letter of objection signed by 13 U.S. patient organizations and advocates for submission to NCHS. It can be read here:

http://www.rmcfa.org/index.html > http://www.rm-cfs-fms.citymaker.com/f/NCHS.pdf

or download PDF here: Joint response to NCHS 11.15.13

This joint submission had been signed by the following organizations and advocates:

Michael Munoz, Executive Director, Rocky Mountain CFS/ME & FM Association
Lori Chapo-Kroger, RN, President & CEO, PANDORA Org
Charmian Proskauer, President, Massachusetts CFIDS/ME & FM Association
Tamara Staples, President & Co-Founder, Fibromyalgia – ME/CFS Support Center, Inc.
Donna Pearson, Vice President, Massachusetts CFIDS/ME & FM Association
Jean Harrison, President and Founder, MAME – Mothers Against Myalgic Encephalomyelitis
Denise Lopez-Majano, Founder, Speak Up About ME
Rik Carlson, President, Immunedysfunction.org
Jennifer M. Spotila, JD., Occupy CFS blog, Patient Advocate
Billie Moore, Patient Advocate
Charlotte von Salis, JD, Patient Advocate
Mary Schweitzer, Ph.D., Patient Advocate
Mary Dimmock, Patient Advocate

I’d like to thank all those who have submitted objections to NCHS in opposition to the September 2013 C & M Committee meeting proposal to insert Somatic symptom disorder as an inclusion term in ICD-10-CM.

My submission can be read here PDF: Submission NCHS

Some additional organizations and individuals have advised me of their own submissions. If you have submitted a response on behalf of your organization or as a patient, advocate or professional and you would like your name or your organization’s name added to the list of responders below please shoot me an email or contact me via the Contact form with a link to your submission (if it has been placed in the public domain) and a couple of lines of credentials or stakeholder interest, if desired.

Bridget Mildon, Patient advocate and Founder of FND Hope, Inc. FND Hope is the only state registered non profit patient advocacy organization specifically for those assigned a diagnosed of Functional Neurological Disorder. Bridget was misdiagnosed with FND and continues to advocate for those with a FND diagnosis to receive appropriate patient care fndhope.org Submission
Mark Thompson, patient. Submission
Diane O’Leary, Ph.D. is a philosopher focused on the rights of medical patients denied medical care because of mistaken somatoform diagnoses. She is author of the book, Patient, Executive Director of the Sneddon’s Foundation, and author of numerous web and print entries on Sneddon’s Syndrome, a highly threatening cerebrovascular disease generally mistaken for somatoform disorders. Dr. O’Leary is author of “Peculiar Silence: The Problem of Error in Diagnosis of SSD” (a reply piece at BMJ). Dr O’Leary has coauthored several blogs, published and forthcoming, with Prof. Allen Frances at Huffington Post, Psychology Today and Psychiatric Times. New work is forthcoming for the National Organization for Rare Disorders and Ben’s Friends. An audio interview with Dr. O’Leary is available here. PDF Submission also Submission [On LinkedIn]
Suzy Chapman, DipAD, UK carer/advocate for young adult with long-term illness. Owner of website Dx Revision Watch, Monitoring the revision of DSM-5 and ICD-11. Co-author of journal papers and commentaries on the Somatic symptom disorder construct (with Professor Allen Frances). PDF Submission
Richard A. Lawhern, Ph.D. is an 18-year patient advocate. He writes content and moderates for “Living With TN,” a social networking site that supports nearly 5,000 chronic face pain patients in 117 countries – many of whom have been substantively harmed by mis-application of psychosomatic diagnoses. Submission
Angela Kennedy, M.A. (also retired R.G.N.), social science lecturer and researcher. Author of the book Authors of our own misfortune?: The problems with psychogenic explanations for physical illnesses (2012) Village Digital Press. Carer and parent of disabled woman who became ill at 12 years of age.
Gail Kansky, President, National CFIDS Foundation, Inc. Needham, MA http://www.ncf-net.org Submission
Jack Carney, Ph.D., DSW, Brooklyn, NY, Committee to Boycott the DSM-5, contributor to Mad in America. A social worker, Dr Carney writes on the contradictions and hypocrisies of the public mental health system and promotes and applauds acts of resistance to it.
Jennifer Brauer, BA, Women’s Studies, University of Massachusetts. Former certified paramedic, Emergency Medical Technician BLS, Bureau of The Emergency Medical Services, NY City Fire Dept. (1996-2005).
Samuel Wales, author, The Kafka Pandemic

Next meeting of ICD-10-CM Coordination and Maintenance Committee is March 19-20, 2014

Post #282 Shortlink: http://wp.me/pKrrB-3xE

The deadline for receipt of public submissions in response to proposals for updates and changes to ICD-10-CM diagnosis and procedure codes presented at the September 18-19, 2013 meeting of the ICD-9-CM Coordination and Maintenance Committee has now closed.

In 2014, this advisory Committee, which is co-chaired by NCHS and CMS, will be known as the ICD-10-CM Coordination and Maintenance Committee, as there will be no further updates of ICD-9-CM.

A done deal?

Proposals submitted on behalf of the American Psychiatric Association (APA) and presented at the meeting by APA’s Research Director, Darrel Regier, MD, can be found from Page 32 of the Diagnosis Agenda. Additional proposals for inclusion of new DSM-5 disorder terms within ICD-10-CM Chapter 5 Mental and behavioral disorders can be found on Pages 45-46.

The Summary of the September meeting diagnosis presentations can be found here. Links for the four videocasts of the meeting’s two day proceedings are listed in this Dx Revision Watch post and the Meeting Materials are here.

The Timeline for ICD-9-CM (for the remainder of its life) and for ICD-10-CM is set out from Page 3 of the Diagnosis Agenda.

Some diagnosis proposals at the September 18-19, 2013 meeting were requested for October 2014 implementation and some for 2015 implementation. I shall update this site when the outcomes of the various proposals are published, next year.

There is a lack of clarity over which body has requested the addition of Somatic symptom disorder (SSD) and Illness anxiety disorder as inclusion terms to existing ICD-10-CM codes. It isn’t clear whether these two additional DSM-5 constructs have been proposed for inclusion in ICD-10-CM by the APA or by the NCHS/CMS Committee – if the latter, should we assume these two proposals already have the support of NCHS?

Given APA’s determination to achieve harmonization between the two systems, the outcome of its proposals to insert a handful of new DSM-5 disorders into ICD-10-CM may already be a done deal between APA and NCHS: the Director of NCHS may not need much persuasion to ratify their retrofitting into ICD-10-CM.

Loss of public trust and confidence

If NCHS is planning to rubber stamp insertion into ICD-10-CM of DSM-5’s poorly validated Somatic symptom disorder in response to APA diktat, having conducted no field testing and in the absence of a body of supportive evidence for SSD’s clinical relevance, safety and utility, and with disregard for a high level of public concern, what confidence can the public have that this federal agency is meeting its duty of care towards patient populations and towards the clinicians and allied health professionals who may deploy this proposed new ICD term, in its ethics, integrity and methods and for upholding standards of scientific rigour?

APA may re-present proposals next year

If APA is unsuccessful with any of the additions requested via the September meeting, it is possible that the organization may re-present proposals or modified proposals at the next C & M Committee meeting, scheduled for March 19-20, 2014. There are also other new DSM-5 disorders or changes that APA might potentially propose for incorporation into ICD-10-CM at the March 2014 or the September 2014 meeting, or at some later point.

Only a brief public submission period for March 2014 meeting

March 19-20, 2014 meeting

The deadline for Requestors to submit proposals for consideration for the March meeting agenda is January 17, 2014.

The draft agenda will be posted in February 2014.

Registration is required for those wishing to attend the meeting. Register online between on February 14 – March 14.

The two day meeting is scheduled for March 19 – 20.

Note: the deadline for receipt of comments on the March 19-20, 2014 meeting proposals for both procedure and diagnosis codes and changes is given as April 18. So instead of a couple of months for stakeholder responses, it appears there will only be four weeks or so in which to prepare and submit comments or objections.

I will post the Diagnosis Agenda for the March 2014 meeting as soon as it becomes available and links for the videocasts of the proceedings after the meeting has taken place. (Videocasts now substitute for written transcripts of meeting proceedings.)

Extracts from the Timeline that relate to the publication of additions and changes for ICD-10-CM:

April 2014 Notice of Proposed Rulemaking to be published in the Federal Register as mandated by Public Law 99-509. This notice will include references to the complete and finalized FY 2015 ICD-10-CM diagnosis and ICD-10-PCS procedure codes. It will also include proposed revisions to the MS-DRG system based on ICD-10-CM/PCS codes on which the public may comment. The proposed rule can be accessed here.

June 2014 Final addendum posted on web pages as follows:

Diagnosis addendum – http://www.cdc.gov/nchs/icd/icd10cm.htm
Procedure addendum – http://cms.hhs.gov/Medicare/Coding/ICD10/index.html

October 1, 2014 New and revised ICD-10-CM and ICD-10-PCS codes go into effect along with DRG changes. Final addendum posted on web pages as follows:

Diagnosis addendum – http://www.cdc.gov/nchs/icd/icd9cm_addenda_guidelines.htm
Procedure addendum – http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/addendum.html

November 2014 Any new ICD-10 codes required to capture new technology that will be implemented on the following April 1 will be announced. Information on any new codes to be implemented April 1, 2015 will be posted on the following websites:

http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/addendum.html

http://www.cdc.gov/nchs/icd/icd9cm_addenda_guidelines.htm

Submission: Objection to proposal to insert DSM-5’s Somatic symptom disorder into ICD-10-CM

Post #281 Shortlink: http://wp.me/pKrrB-3×1

Information in this post relates to proposals submitted via the September ICD-9-CM Coordination and Maintenance Committee meeting for inclusion of additional codes and changes to the forthcoming US specific ICD-10-CM/PCS.

There are just five days is just one day left in which to submit objections to NCHS to the proposal to insert DSM-5’s Somatic symptom disorder into ICD-10-CM.

Submit objections via email by November 15 to Donna Pickett, CDC: nchsicd9CM@cdc.gov

Further information here: Keep SSD out of ICD-10-CM – November 15 deadline for objections

Please let me know if you or your organization or professional body has submitted comment or objections, with a link if your submission is being placed in the public domain.

We need to keep SSD out of ICD-10-CM

Please consider submitting an objection before the November 15 deadline.

If you submitted comment during any of the three DSM-5 public review periods or you are an advocate or clinician signatory to the Institute of Medicine (IOM) definition issue letters campaign please also consider submitting an objection to NCHS.

I have submitted the following:

PDF: Submission NCHS

Text:

To: Ms Donna Pickett, CDC

Re: Comment on proposals, September 18-19, 2013 meeting of the ICD-9-CM Coordination and Maintenance Committee

Diagnostic Agenda, Page 45: Additional Tabular List Inclusion Terms for ICD-10-CM

Add Somatic symptom disorder to ICD-10-CM Tabular List under F45 Somatoform Disorders as inclusion term to F45.1 Undifferentiated somatoform disorder.

Add Somatic symptom disorder to ICD-10-CM Alphabetical Index.

Requestor for proposal: Unspecified

——————————————————–

I am writing to object to the proposed insertion of Somatic symptom disorder into the ICD-10-CM Tabular List and Alphabetical Index.

Somatic symptom disorder is a new construct created by the American Psychiatric Association (APA) for DSM-5.

For DSM-5, the Somatoform Disorders have been dismantled. Four DSM-IV categories: somatization disorder [300.81], some presentations of hypochondriasis [300.7], pain disorder, and undifferentiated somatoform disorder [300.82] are eliminated and replaced with a single new construct, Somatic Symptom Disorder (SSD), cross-walked in DSM-5 to ICD 300.82 (F45.1).

The Somatic Symptom Disorder construct de-emphasizes “medically unexplained” as the central defining feature of this disorder group. The diagnosis does not require that the somatic symptoms are medically unexplained, instead, the focus shifts away from somatic symptoms to emotional, cognitive and behavioral disturbances and “maladaptive” responses: high levels of health anxiety; disproportionate and persistent concerns about the medical seriousness of the symptom(s); or an excessive amount of time and energy devoted to symptoms and health concerns.

Symptoms may or may not be associated with another medical condition: SSD allows for the application of a mental health diagnosis in patients with “established general medical conditions or disorders” like diabetes, heart disease and cancer or presenting with “somatic symptoms of unclear etiology” if the clinician considers the patient otherwise meets the new criteria.

To meet the requirements for DSM-IV Somatization Disorder, a rigorous criteria set needed to be fulfilled: a history of many medically unexplained symptoms before the age of thirty, resulting in treatment sought or psychosocial impairment. And a high diagnostic threshold: a total of eight or more medically unexplained symptoms from four, specified symptom groups, with at least four pain, two gastrointestinal, one psychosexual and one pseudoneurological symptom.

In DSM-5, the requirement for eight symptoms has been dropped to just one or more persistent, non specific, distressing somatic symptoms and the clinician’s perception of “excessive” or “maladaptive” response to the symptom or symptoms.

• These changes for DSM-5 represent a radical restructuring of the DSM-IV Somatoform Disorder categories and a new construct for which much remains to be determined.

On Day Two of the September ICD-9-CM Coordination and Maintenance Committee meeting, Dr Darrel Regier presented and discussed rationales, coding proposals and timings for six new DSM-5 disorders that the APA has proposed for insertion into ICD-10-CM. But the proposal to add the new DSM-5 Somatic symptom disorder and Illness anxiety disorder category terms to ICD-10-CM did not form part of Dr Regier’s presentation on behalf of the APA.

As it is unspecified within the Diagnosis Agenda and during the meeting presentations, it is unclear whether these two proposals are being requested by the APA, by NCHS/CMS, or by other parties or individuals.

• My first concern is that no description of Somatic symptom disorder, no rationale for why this ICD-10-CM change is needed (including clinical relevancy) and no supporting clinical and literature references for the validity of Somatic symptom disorder as a new disorder term were published in the Diagnosis Agenda.

At the public meeting, no presentation had been made on behalf of APA, or by representatives of NCHS or CMS, or by anyone else for the specific proposal to add Somatic symptom disorder as an inclusion term under the ICD-10-CM Somatoform disorders and there was no discussion of this proposal during the course of the meeting [1][2].

There is an expectation that the committees overseeing the development and revision of the draft for the ICD-10-CM will give due consideration to the applicability, clinical utility and reliability of any proposal for the inclusion of a new disorder construct before granting approval for addition to the Tabular List and Index, and that the comments and objections received during the public response period will also be considered.

The lack of rationales and references for supportive evidence provided by the requestors hinders public participation in the response process.

• The absence from both the Diagnosis Agenda document and the meeting presentations of rationales, clinical relevancy and supporting clinical and literature references to enable public scrutiny, consideration and informed responses to this proposal should disqualify SSD from consideration for implementation during a partial code freeze or for consideration for implementation in October 2015.

The burden of proof before introducing any new diagnosis into a classification system is that it has a favourable risk to benefit ratio. This new construct created by the APA for its DSM-5 merits the same level of scrutiny and risk to benefit evaluation as would be expected to be applied to any proposed new disorder/disease under consideration for inclusion in any chapter of ICD, whether this is for the updating of the ICD-10-CM draft, the international ICD-10, the several clinical modifications of ICD-10 or the drafting of ICD-11.

A number of papers have remarked on the paucity of rigorous evidence for the validity, reliability, acceptability, safety and utility of the SSD construct applied to adults and children in diverse clinical settings and across a spectrum of health and allied professionals.

There is no significant body of published research on the epidemiology, clinical characteristics or treatment of the Somatic symptom disorder construct [3][4][5].

In a paper published in the Journal of Psychosomatic Research, September 2013, the SSD work group concedes the lack of clinical evidence for its new construct and acknowledges the “small amount of validity data concerning SSD”; “that much remains to be determined” about the utility and reliability of the specific SSD criteria and its thresholds when applied in busy, general clinical practice, and there are “vital questions that must be answered” as they go forward [6].

• As an under researched, poorly validated disorder construct, Somatic symptom disorder does not meet NCHS/CMS criteria for “new diseases/new technology procedures, and any minor revisions to correct reported errors in these classifications” and should be rejected for consideration for implementation during a partial code freeze but also rejected for consideration for implementation in October 2015.

Concerns for the looseness of the SSD definition and the ease with which these new criteria can be met have been discussed in a number of published papers and commentaries [7][8][9].

The over-inclusiveness of the SSD diagnosis is borne out by the results of the DSM-5 field trial study reported by the chair of the Somatic symptom disorder work group at the 2012 annual meeting of the American Psychiatric Association.

15% of the ‘diagnosed illness’ study group, comprising patients with cancer or coronary disease, were caught by SSD and would meet the criteria for application of an additional mental disorder diagnosis.

26% of the ‘functional somatic’ study group, patients with irritable bowel syndrome or chronic widespread pain, met the SSD criteria.

SSD has a high false positive rate – capturing 7% of the ‘healthy’ field trial control group.

It is also disturbing that the SSD work group (which included no primary care physicians) appears not to have undertaken any field trials into the safety of application of the SSD criteria in children and adolescents.

NCHS/CMS provides no references for data for the application of SSD in children within the Diagnosis Agenda, although the DSM-5 text clearly indicates APA’s intention that SSD is a diagnosis that may also be applied to children with persistent, distressing somatic symptoms.

Potential implications for the application of a diagnosis of SSD:

I am not persuaded that the new SSD construct and criteria can be safely applied outside the optimal conditions of field trials, in settings where practitioners may not necessarily have adequate time for, or instruction in the administration of diagnostic assessment tools, and where decisions to code or not to code may hang on the arbitrary and subjective perceptions of a wide range of end-users who may lack clinical training in the application of mental disorder criteria.

Misapplication of highly subjective and loose, easily met criteria, especially in busy primary care practice, may result in inappropriate diagnoses of mental disorder and inappropriate medical decision making [10], with considerable implications for patients (see Appendix).

A mental disorder diagnosis of SSD can be applied as a “bolt-on” to any chronic medical diagnosis, eg patients with diabetes, angina, cancer, MS, cardiovascular disease, ME and CFS, IBS, chronic widespread pain (aka fibromyalgia) or to patients with a chronic pain condition or with persistent symptoms of unclear etiology.

Patients with chronic, multiple bodily symptoms due to rare diseases, difficult to diagnoses diseases, or multi-system diseases like Behçet’s disease, which can take several years to arrive at a diagnosis, may be especially vulnerable to missed diagnosis or to misdiagnosis with a mental disorder, which may impede access to further testing, investigations, interventions and effective treatments (and result in increased claims against practitioners for medical negligence).

Patients with chronic fatigue syndrome (CFS), “almost a poster child for medically unexplained symptoms as a diagnosis,” according to SSD work group chair, Joel E Dimsdale, or chronic Lyme disease, Gulf War illness, chemical injury and chemical sensitivity; women with potential symptoms of gynecological disease, like ovarian cancer, already often late-diagnosed, endometriosis or interstitial cystitis, or patients with vague neurological symptoms may be particularly vulnerable to misapplication or misdiagnosis with a mental health disorder under the SSD criteria.

There has been considerable opposition to the introduction of this new, poorly tested construct into the DSM-5 amongst patients, carers, advocates, consumer organizations, mental health practitioners and clinicians and considerable concern for the implications for diverse patient populations that the Somatic Symptom Disorder category will provide a “dustbin diagnosis” for the so-called “functional somatic syndromes,” for those living with chronic pain and for patients with persistent, but as yet undiagnosed, symptoms of disease.

• NCHS/CMS has published no independent field trial data and provided no rationales or clinical and literature references to inform public responses. Given the lack of published evidence for the validity and safety of SSD as a construct in adults and children, there is insufficient basis for the approval of SSD for inclusion within ICD-10-CM and it would be scientifically unsafe, premature and against the public interest to include this new construct within ICD.

The proposal for addition to the ICD-10-CM as an inclusion term during a partial code freeze should be rejected. There should be no implementation in October 2015 as an inclusion term to F45.1 or to any other existing code, or with a unique code created.

Appendix:

Incautious, inept application of criteria resulting in a “bolt-on” psychiatric diagnosis of Somatic symptom disorder could have far-reaching implications for diverse patient populations:

• Application of highly subjective and difficult to measure criteria could potentially result in misdiagnosis with a mental disorder, misapplication of an additional diagnosis of a mental disorder or missed diagnoses through dismissal and failure to investigate new or worsening somatic symptoms.

• Patients with cancer and life threatening diseases may be reluctant to report new symptoms that might be early indicators of recurrence, metastasis or secondary disease for fear of attracting a diagnosis of SSD or of being labelled as “catastrophisers.”

• Application of an additional diagnosis of SSD may have implications for the types of medical investigations, tests and treatments that clinicians are prepared to consider and which insurers are prepared to fund.

• Application of an additional diagnosis of SSD may impact payment of employment, medical and disability insurance and the length of time for which insurers are prepared to pay out. It may negatively influence the perceptions of agencies involved with the assessment and provision of social care, disability adaptations, education and workplace accommodations, and the perceptions of medical staff during hospital admissions and accident and emergency admissions.

• Patients prescribed psychotropic drugs for perceived unreasonable levels of “illness worry” or “excessive preoccupation with symptoms” may be placed at risk of iatrogenic disease or subjected to inappropriate and costly behavioural therapies.

• For multi-system diseases like Multiple Sclerosis, Behçet’s disease or Systemic lupus it can take several years before a diagnosis is arrived at. In the meantime, patients with chronic, multiple somatic symptoms who are still waiting for a diagnosis would be vulnerable.

• The burden of the DSM-5 changes to Somatoform Disorders will fall particularly heavily upon women who are more likely to be casually dismissed when presenting with physical symptoms and more likely to be prescribed inappropriate antidepressants and anti-anxiety medications for them.

• Proposals allow for the application of a diagnosis of SSD to children and where a parent is considered excessively concerned with a child’s symptoms. Families caring for children with any chronic illness may be placed at increased risk of wrongful accusation of “over-involvement” with a child’s symptomatology.

Where a parent is perceived as encouraging maintenance of “sick role behavior” in a child, this may provoke social services investigation or court intervention for removal of a sick child out of the home environment and into foster care or enforced in-patient rehabilitation. This is already happening in families in the U.S. and Europe with a child or young adult with chronic illness, notably with Chronic fatigue syndrome or ME. It may happen more frequently with a diagnosis of a chronic childhood illness + SSD.

Thank you for your consideration.

References:

1. September 18-19, 2013 meeting of the ICD-9-CM Coordination and Maintenance Committee Diagnosis Agenda.

2. September 18-19, 2013 meeting of the ICD-9-CM Coordination and Maintenance Committee Summary of Diagnosis Presentations.

3. DSM-5 Somatic Symptom Disorders Work Group Disorder Descriptions and Justification of Criteria – Somatic Symptoms, pub. May 2011, for second DSM-5 stakeholder review.

4. Robert L. Woolfolk and Lesley A. Allen (2012). Cognitive Behavioral Therapy for Somatoform Disorders, Standard and Innovative Strategies in Cognitive Behavior Therapy, Dr. Irismar Reis De Oliveira (Ed.), ISBN: 978-953-51-0312-7

5. Ghanizadeh A, Firoozabadi A. A review of somatoform disorders in DSM-IV and somatic symptom disorders in proposed DSM-V. Psychiatr Danub. 2012 Dec;24(4):353-8.

6. Dimsdale JE, Creed F, Escobar J, Sharpe M, Wulsin L, Barsky A, Lee S, Irwin MR, Levenson J. Somatic Symptom Disorder: An important change in DSM. J Psychosom Res. 2013 Sep;75(3):223-8. Epub 2013 Jul 25.

7. Frances A. The new somatic symptom disorder in DSM-5 risks mislabeling many people as mentally ill. BMJ. 2013 Mar 18;346:f1580. doi: 10.1136/bmj.f1580.

8. Frances A. DSM-5 Somatic Symptom Disorder. J Nerv Ment Dis. 2013 Jun;201(6):530-1. doi: 10.1097/NMD.0b013e318294827c.

9. Frances A, Chapman S. DSM-5 somatic symptom disorder mislabels medical illness as mental disorder. Aust N Z J Psychiatry. 2013 May;47(5):483-4. doi: 10.1177/0004867413484525.

10. Dimsdale JE. Medically unexplained symptoms: a treacherous foundation for somatoform disorders? Psychiatr Clin North Am 2011;34:511-3.

Interest:

Carer/advocate for young adult with long-term medical condition. Owner of website Dx Revision Watch, Monitoring the revision of DSM-5 and ICD-11. Co-author, journal papers and commentaries on the SSD construct (with Professor Allen Frances).

[End of submission]

DSM-5 publication date May 22: American Psychiatric Association to release DSM-5 between May 18-22, San Francisco

Post #235 Shortlink: http://wp.me/pKrrB-2Lq

DSM-5 publication date May 22: American Psychiatric Association to release DSM-5 between May 18-22, San Francisco

After 14 years and with a staggering $25 million thrown at it, the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) will be launched during the American Psychiatric Association’s (APA) Annual Meeting in San Francisco, May 18-22, 2013.

The Bumper Book of Head Stuff has cost $25,000 a page.

“…ignore DSM 5. It is not official. It is not well done. It is not safe. Don’t buy it. Don’t use it. Don’t teach it.”

Commentary: “Does DSM 5 Have a Captive Audience?” Saving Normal, Allen Frances, MD

Further revisions and refinements to the criteria sets and disorder descriptions, following closure of the third and final stakeholder review and comment period (June 15, 2012) and the finalizing of texts in December and January, are embargoed and won’t be evident until the manual is released, next month.

Draft proposals, as they had stood on the DSM-5 Development site for the third stakeholder review, were removed from the APA’s website last November. Additional pages archiving draft proposals for DSM-5 Development internal use which remained publicly accessible were put behind a webmaster log in, around mid March.

(No drafts of the expanded texts that accompany the disorder sections and categories have been available for public scrutiny at any stage in the drafting process.)

The official publication date for DSM-5 is May 22 for the U.S. (May 31 for UK). The manual is 1000 pages and costs nearly $200 for the hardcover edition. An electronic version of the DSM-5 is understood to be in development for later this year.

According to this December 1 interview with Task Force Chair, David J Kupfer, MD, for the Washingtonian,

…While it will likely be some time before we can expect a DSM-6, it may only be a few years until a DSM-5.1 or -5.2, thanks to the expected digital version of the manual. “We don’t wait to wait another 19 to 20 years to have a new revision of the whole volume,” says Kupfer. “But if there is some unexpected consequence, which we can’t anticipate, we have an opportunity to fix something two to three years from now.”

A DSM-5 Table of Contents listing the new disorder sections and category names for DSM-5 (but not the criteria sets) can be accessed on this APA page.

Also at that URL – fact sheets, articles and videos for selected categories, which are being added to every few weeks (including justifications for some of the more controversial changes and new inclusions), and the following documents relating to the overall development process:

Insurance Implications of DSM-5 (New document)
Highlights of Changes from DSM-IV-TR to DSM-5 (updated April 5, 2013)
From Planning to Publication: Developing DSM-5
The Organization of DSM-5
The People Behind DSM-5

A number of books are publishing around the DSM-5 this April and May:

The Intelligent Clinician’s Guide to the DSM-5® by Joel Paris (Apr 17, 2013)

The Book of Woe: The DSM and the Unmaking of Psychiatry by Gary Greenberg  (May 2, 2013) (also available as an Audio Book and Audio CD)

Saving Normal: An Insider’s Revolt Against Out-of-Control Psychiatric Diagnosis, DSM-5, Big Pharma, and the Medicalization of Ordinary Life by Allen Frances (May 14, 2013)

Essentials of Psychiatric Diagnosis: Responding to the Challenge of DSM-5 by Allen Frances MD (May 17, 2013)

Making the DSM-5: Concepts and Controversies by Joel Paris and James Phillips (May 31, 2013)

Recent press releases

December 1, 2012: APA Release No. 12-43 American Psychiatric Association Board of Trustees Approves DSM-5 (includes Attachment A: Select Decisions Made by APA Board of Trustees)

January 18, 2013: APA Release No. 13-06 DSM-5 Now Available for Preorder

February 28, 2013:  APA Release No. 13-11 APA Annual Meeting in San Francisco, May 18-22; DSM-5 to be Released

April 9, 2013: APA Release No. 13-19 APA 2013 Annual Meeting Special Track to Present DSM-5 Changes

DSM and DSM-5 are registered trademarks of the American Psychiatric Association.
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