ICD-11 Revision releases External review and Response: shifts projected WHA adoption to 2018

Post #321 Shortlink: http://wp.me/pKrrB-44N

Update: August 6, 2015

ICD Revision has now published a revised Project Plan and Communication Schedule:

ICD Project Plan 2015 to 2018

 

As previously posted

2017

And so it goes on…

The revision of ICD-10 and development of ICD-11 kicked off in April 2007. The original projected WHA adoption date was 2011/12 [1].

Then a shift to 2015, then to 2017.

WHO has just kicked the can further down the road to May 2018.

In July 2014, the World Health Organization (WHO) Office of the Assistant Director General, Health Systems and Innovation, posted a call for expressions of interest from suitable contractors to conduct an interim assessment of the 11th Revision for International Classification of Diseases (ICD).

External assessment was prompted by concerns raised by WHO Member States, UN Statistical Commission and other stakeholder organizations about the status of the revision and the utility of the ICD-11 product.

The External review of ICD-11 Revision’s progress has now been completed.

Last week, WHO quietly released a report on the status of the ICD revision process, its management and resources, the feasibility of meeting its goals and timelines, and its fitness for purpose.

The reviewers’ assessment and recommendations can be read here: External report

Read WHO’s initial response to the report’s findings and the actions ICD Revision proposes to take here: WHO Response to External Report

WHO says:

WHO welcomes the constructive messages of the Report of the ICD-11 Revision Review. WHO is initiating the second phase of the revision process, acting immediately on the Review’s recommendations.

A revised workplan will be formulated before the end of June and submitted for approval to the RSG-SEG. During 2015 the WHO secretariat will be strengthened in terms of project management, communication of progress and plans, documentation and transparency of decision-making and classification expertise, as recommended by the reviewers.

As I predicted, a further shift in the development timeline from WHA adoption in May 2017 to May 2018 is proposed, along with other measures.

References

1 Exhibit 1 WHO Letter August 2007
Letter Saxena, WHO, to Ritchie, IUPsyS (International Union for Psychological Science), August 2007

2 External Review ICD-11 (Consultancy Interim Assessment of 11th ICD Revision, January – March 2015)

3 WHO Response to External Review of ICD-11 (Initial WHO response to the report of the external review of the ICD-11 revision,Department of Health Statistics and Information Systems, May 12 2015)

Extension to timeline official: ICD-11 rescheduled for 2017

Post #292 Shortlink: http://wp.me/pKrrB-3H9

Update at February 8, 2014: ICD Revision has now updated its Timeline page:

May 2017 Present the ICD-11 to the World Health Assembly”

ICD-11_20177

In the last day or so, edited text on two WHO webpages confirms a decision by ICD Revision to postpone release of ICD-11 by a further two years, from 2015 to 2017.

From WHO site: “The International Classification of Diseases 11th Revision is due by 2017”

Also ICD Information Sheet: “…The development phase will continue for three years and ICD-11 will be finalized in 2017.”

And from a note accompanying a slide presentation: “…Now ICD 11 is scheduled in 2017 and ICD-10-CM can be made as a National Linearization.” Bedirhan Üstün, January 29, 2014 [1]

ICD-11 Revision has yet to issue a formal announcement or news release or update its Timeline page to reflect this decision.

There are no reports on the revised schedule on ICD-11 on Facebook or Twitter @WHOICD11 – all very low key.

Delaying the release of ICD-11 has been under consideration for several months.

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Slipping targets

The development process for ICD-11 began in April 2007, with ICD-11 scheduled for dissemination by 2012 and the timelines for the development of ICD-11 and DSM-5 running more or less in parallel [2,3].

Early on in the revision process, the ICD-11 dissemination date was extended. By 2009, the final draft was scheduled for World Health Assembly (WHA) approval in 2014. The WHA approval date was subsequently shunted to 2015 – four years later than originally planned.

ICD-11 is now scheduled for finalization in 2017.

Rationales for extending the timeline:

Pages 8-10: Committee for the Coordination of Statistical Activities, Twenty-second Session 4-6 September 2013, Items for discussion and decision: Item 8 of the provisional agenda, 3 September 2013 [4].

Slide presentation, Bedirhan Üstün, September 9-10, 2013, Slides 29-35: [5].

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Related reports from Dx Revision Watch

January 22, 2014: WHO Collaborating Centre confirms Revision Steering Group seriously considering extension to ICD-11 timeline: http://wp.me/pKrrB-3E8

September 15, 2013: WHO considers further extension to ICD-11 development timeline: http://wp.me/pKrrB-3sc

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References

1. Slideshare: AHIMA ICD-10 ICD-11 switch to ICD-10-CM in the USA, presentation note, Bedirhan Üstün, Coordinator at World Health Organization, January 29, 2014

2. Agenda Item No. 25: Revision of the International Classification of Diseases (ICD-10) and Involvement of Psychology International Union of Psychological Science Committee on International Relations Action, March 28–30, 2008
IUPsyS Mar 08 Agenda Item 25 ICD-10

3. Letter Saxena, WHO, to Ritchie, IUPsyS (International Union for Psychological Science), August 2007
Exhibit 1 WHO Letter Aug 07

4. Committee for the Coordination of Statistical Activities, Twenty-second Session 4-6 September 2013, Items for discussion and decision: Item 8 of the provisional agenda, 3 September 2013, Pages 8-10:
http://unstats.un.org/unsd/accsub/2013docs-22nd/SA-2013-12-Add1-Health-WHO.pdf

5. Slide presentation: ICD Revision: Where are we? Bedirhan Üstün, World Health Organization Classifications, Terminologies, Standards, ICD Revision: Quality Safety Meeting 2013, September 9-10, 2013, Slides 29-35:
http://www.slideshare.net/ustunb/icd-2013-qs-tag-260276686

WHO Collaborating Centre confirms Revision Steering Group seriously considering extension to ICD-11 timeline

Post #289 Shortlink: http://wp.me/pKrrB-3E8

Update at January 30, 2014:

ICD-11 Revision has confirmed that a decision has now been taken to postpone ICD-11 by a further two years, from 2015 to 2017.

From WHO site: “The International Classification of Diseases 11th Revision is due by 2017”

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Information in this report relates to the development of the World Health Organization’s ICD-11. It does not apply to the forthcoming US specific, NCHS developed, clinical modification of ICD-10, known as ICD-10-CM.

Ustun 34

Source: Slide 34: Where are we? What remains to be done? Shall we have ICD WHA submission in 2015 or later? B Üstün, World Health Organization Classifications, Terminologies, Standards ICD Revision: Quality Safety Meeting, September 2013

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The December newsletter of the WHO Collaborating Centre for the Family of International Classifications (FIC) in the Netherlands reports that ICD-11 Revision Steering Group (RSG) is reviewing options for a further extension to the ICD-11 development timeline [1]:

Newsletter on the WHO-FIC, Volume 11, Number 2, 2013, Latest News, Page 3 [PDF]

The Revision Steering Group and WHO Secretariat seriously consider amending the timeline of submitting the ICD-11 for endorsement by the World Health Assembly to allow more time for field testing in multiple countries and settings, and following up on resulting edits. WHO currently discusses options and scenarios with stakeholders.

This announcement from WHO-FIC’s Marijke de Kleijn-de Vrankrijker reinforces information and resources provided in my September report (WHO considers further extension to ICD-11 development timeline) – that ICD-11 Revision is failing to meet development targets and delaying submission of ICD-11 for WHA for approval until 2016, or alternatively, extending the timeline by a further two years, for WHA approval in 2017, is under consideration.

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ICD-11 already four years behind original targets

The revision of ICD-10 and development of the structure for ICD-11 began in 2007. WHO’s original goal had been to complete the revision and release of ICD-11 by 2011-12, Archived documents [2] [3].

By 2009, the date for submission of ICD-11 for WHA approval had been extended to 2014. The launch of the public version of the Beta drafting platform was later postponed from May 2011 to May 2012.

The current projection for submission of ICD-11 for approval to WHA is May 2015, with dissemination in 2015+ [4].

Mayo’s Christopher Chute, MD, chairs the ICD-11 Revision Steering Group. According to Chute, in this paper published in March 2012, publication of ICD-11 is “expected around 2016″:

Chute CG, Huff SM, Ferguson JA, Walker JM, Halamka JD. There Are Important Reasons For Delaying Implementation Of The New ICD-10 Coding System. Health Aff March 2012 DOI: 10.1377/hlthaff.2011.1258
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ICD Revision considers its options

In September, WHO posted this meeting materials document [5] and this slide presentation [6]. The document summarized, inter alia, ICD-11’s progress, current development status, timelines for finalization date and approval by WHO Governing Bodies, and rationales and options for a further shift in the timeline.

You can read extracts from the document and view slides setting out the options currently under consideration in this report: WHO considers further extension to ICD-11 development timeline, selected of which I am appending to this post.

The earliest ICD-11 might be ready for dissemination is late 2015/16 – which may require some further scaling back of the project’s goals.

But if ICD-11 Revision Steering Group does elect to postpone submission for World Health Assembly approval until May 2017, dissemination of ICD-11 may not be viable before 2018.

I will update this post if and when WHO or ICD-11 Revision Steering Group publish a statement of clarification on the WHO website or issue a news release, or if other information becomes available that confirms a revision to the timeline.

Implementation date

I’ve noted some confusion in reporting and comments around ICD-11 approval by WHA and dissemination and implementation dates.

Unlike the U.S. specific ICD-10-CM, there is no mandatory date by which Member States must switch from using ICD-10 to ICD-11.

World Health Assembly adoption of ICD-11 and ICD-11 implementation dates are separate. WHA adoption enables official use for countries who wish to move on to the next edition. But Member States using ICD-10 will transition to the next version at their own convenience [6].

Once approved, prepared for implementation and released, global adoption of ICD-11 isn’t going to happen overnight. It may take several years before WHO Member States transition from ICD-10 to ICD-11. Low resource and developing countries may take longer to prepare for and transition to the new edition.

The annual update process for ICD-10 will continue during the creation of ICD-11.

Extracts from document [5] setting out the rationale and options for postponement of WHA Approval:

[…]

3. Progress and Current Status of ICD Revision:

[…]

BETA PHASE:

At this point in time, 1 September 2013, an ICD2013 Beta version has been produced for review purposes and field trials after 6 years of drafting phases.

The current ICD 2013 Beta version has relatively stable classification lists (i.e. linearizations) for Mortality and Morbidity recording. It will be reviewed by the specific Mortality Reference Group and the Morbidity Reference Group to see how well it fits the purpose and proposed transition from ICD‐10.

In addition, the Beta version has planned processes for:

(i) Systematic international scientific peer review (ii) Submission of additional proposals from public groups and scientists (iii) Conducting field trials for its applicability and reliability (iv) Production support in multiple languages (translations) starting with WHO official languages (v) Preparations for transitions from ICD‐10 to ICD‐11.

[…]

6. Timelines

The current ICD Revision Process timeline foresees that the ICD is submitted to the WHA in 2015 May and could then be implemented. Between now and 2015, there remains 20 months to conduct the remaining tasks summarized above as: 1. Reviews, 2. Additional Proposals, 3. Field Trials, 4. Translations, and 5. Transition Preparations.

Given the technical requirements these steps could be expedited in the next 20 months. The experience obtained thus far, however, suggests that this timeframe will be extremely tight for paying due diligence to the work especially in terms of: appropriate consultations with expert groups; communication and dissemination with stakeholders; and sufficient time for field testing in multiple countries and settings, and carrying out the resulting edits.

WHO Secretariat would like to discuss this with all stakeholders and evaluate the possible options:

a. Keep ICD submission to WHA to 2015 as originally planned and implementation / adoption date may be free by any Member State (current position – no change).

b. Postpone submission to WHA to a later year to allow longer time for field trials and other transition preparations.

[…]

In conclusion:

(a) WHO Secretariat could produce an ICD 2015 ready including Mortality and Morbidity Linearizations, Reference Guide and Index with the appropriate resolution to go to the World Health Assembly. This timeframe, however, is extremely tight for paying due diligence to the work especially in terms of: appropriate consultations with expert groups; and sufficient time for field testing in multiple countries and settings, and carrying out the resulting edits

(b) If the timeline is advanced to 2016, there will be more time to have ICD 2016 version with more translations and incorporations of some field tests results.

(c) If the timeline is advanced to 2017, ICD 2017 will be ready with most Field Test results incorporated and maintenance scheme tested.

[…]

Slide presentation: B Üstün, World Health Organization Classifications, Terminologies, Standards, ICD Revision: Quality Safety Meeting 2013 September 9-10

Where are we? What remains to be done? Shall we have ICD WHA submission in 2015 or later?

Slide 34:

Ustun 34rule

Slide 35: [WHA Approval timeline – options under consideration]

Ustun 35rule

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References:

1. Newsletter on the WHO-FIC, Volume 11, Number 2, 2013, Latest News, Page 3. WHO Collaborating Centre for the Family of International Classifications (FIC) in the Netherlands.

2. IUPsyS Mar 08 Agenda Item 25 ICD-10 International Union of Psychological Science COMMITTEE ON INTERNATIONAL RELATIONS ACTION, March 28–30, 2008, Agenda Item No. 25: Revision of the International Classification of Diseases (ICD-10) and Involvement of Psychology.

3.  Exhibit 1 WHO Letter Aug 07 Letter Saxena, WHO, to Ritchie, IUPsyS (International Union for Psychological Science), August 2007.

4. ICD-11 Timeline: http://www.who.int/classifications/icd/revision/timeline/en/index.html

5. Committee for the Coordination of Statistical Activities, Twenty-second Session 4-6 September 2013, Items for discussion and decision: Item 8 of the provisional agenda, 3 September 2013, Pages 8-10: http://unstats.un.org/unsd/accsub/2013docs-22nd/SA-2013-12-Add1-Health-WHO.pdf

6. Slide presentation: ICD Revision: Where are we? Bedirhan Üstün, World Health Organization Classifications, Terminologies, Standards, ICD Revision: Quality Safety Meeting 2013, September 9-10, 2013, Slides 29-35: http://www.slideshare.net/ustunb/icd-2013-qs-tag-260276686

ICD-10-CM Release for 2014 now available

Post #270 Shortlink: http://wp.me/pKrrB-3iT

ICD-10-CM Release for 2014 now available

Prior to implementation, the codes in ICD-10-CM are not valid for any purpose or use.

The World Health Organization’s (WHO) International Classification of Diseases (ICD-10) was published in 1992 and is used in over a hundred countries worldwide.

A number of countries have been authorized by WHO to develop “Clinical Modifications” – adaptations of ICD-10 for country specific use. These differ in the number of chapters, codes and subcategories. Specific conditions are present in some adaptations but not all clinical modifications [1]. All modifications to the ICD-10 must conform to WHO conventions for ICD.

Canada uses an adaptation called ICD-10-CA, Australia uses ICD-10-AM, Germany uses ICD-10-GM and Thailand uses ICD-10-TM.

The U.S. lags behind most of the rest of the world and is still using a Clinical Modification of the WHO’s long since retired, ICD-9.

A U.S. specific adaptation of ICD-10 has been under development for a considerable length of time but is scheduled for implementation on October 1, 2014.

Transition to ICD-10-CM is required for everyone covered by the Health Insurance Portability Accountability Act (HIPAA).

Implementation schedules for Large Practices; Small and Medium Practices; Small Hospitals and Payers can be found on the CMS website, here: Implementation Timelines.

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2014 release of ICD-10-CM

The 2014 release of ICD-10-CM is now available from the CDC website. It replaces the July 2012 release.

Prior to the implementation date of October 1, 2014, the codes in ICD-10-CM are not valid for any purpose or use.

The ICD-10-CM code set is currently subject to partial code freeze. For information on the code freeze see Partial Freeze of Revisions to ICD-9-CM and ICD-10-CM/PCS.

October 1, 2011 was 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 or minor revisions to correct any reported errors in these classifications. Regular (at least annual) updates to ICD-10-CM/PCS will resume on October 1, 2015.

Information on the ICD-9-CM and ICD-10-CM/PCS update and revision processes and the public NCHS/CDC Coordination and Maintenance Committee meetings can be found on this CDC page: Coordination and Maintenance Committee.

Downloading the ICD-10-CM code sets

The ICD-10-CM Preface, Guidelines, Tabular List, Index and associated documentation can be downloaded from this page: http://www.cdc.gov/nchs/icd/icd10cm.htm#10update.

The PDF of the Preface is in a single PDF file here: ICD-10-CM Preface 2014

The PDF of the Guidelines is in a single PDF file here: ICD-10-CM Guidelines

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To access the PDFs for the ICD-10-CM Tabular List and Index, the files need extracting from Zip files from this link:

ICD-10-CM List of codes and Descriptions (updated 7/3/2013)

( ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/ICD10CM/2014/ )

Select this file, below, on the CDC site and open it. It is a large file of over 15MB so you will need to allow sufficient time for it to fully load:

06/19/2013 08:28AM 15,223,965 ICD10CM_FY2014_Full_PDF.zip

It will unpack these five PDF files, which can be opened and viewed in situ or saved:

ICD10CM_FY2014_Full_PDF_DIndex  4,222 KB  [ICD-10-CM INDEX TO DISEASES and INJURIES]

or open unzipped PDF on Dx Revision Watch: ICD-10-CM 2014 Full Index

ICD10CM_FY2014_Full_PDF_EIndex   [401 KB]  [ICD-10-CM External Cause of Injuries Index]

ICD10CM_FY2014_Full_PDF_TableOfDrugs   [2,193 KB]

ICD10CM_FY2014_Full_PDF_TableOfNeoplasms   [646 KB]

ICD10CM_FY2014_Full_PDF_Tabular   [7, 398 KB]  [ICD-10-CM TABULAR LIST of DISEASES and INJURIES]

or open unzipped PDF on Dx Revision Watch: ICD-10-CM Tabular List

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For five PDF files of Addenda go to this page:

ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/ICD10CM/2014/

and select this file:

06/19/2013 08:28AM 582,584 ICD10CM_FY2014_Addenda.zip

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Comparison between classifications and codings in ICD-10-CM and ICD-10

The WHO’s ICD-10 Volume 1 The Tabular List isn’t made available as a PDF file but can be accessed on a searchable electronic browser platform here: ICD-10 Version: 2010.

The Tabular List for ICD-10 contains more textual descriptions for the categories in Chapter V (the mental and behavioural disorders chapter) than other chapters in ICD-10.

There are also two “speciality” volumes for ICD-10 Chapter V for Clinical descriptions and diagnostic guidelines (known as the “Blue Book”) and Diagnostic criteria for research (known as the “Green Book”).

The U.S. specific ICD-10-CM will not contain this depth of textual content within its Chapter 5.

CDC’s, Donna Picket, has confirmed that CMS/CDC does not plan to adapt the “Blue Book” specifically for U.S. use in conjunction with Chapter 5 of ICD-10-CM [2]. Nor are there plans for an official CMS/CDC crosswalk between ICD-10-CM’s Chapter 5 classifications and codes and those in ICD-10 Chapter V [3].

In the U.S., since 2003, the ICD-9-CM diagnostic codes have been mandated for third-party billing and reporting by HIPAA for all electronic transactions for billing and reimbursement. Following implementation on October 1, 2014, the ICD-10-CM codes sets will become mandatory.

This also applies to the coding of mental and behavioural disorders. APA’s DSM-IV disorder diagnoses are crosswalked to ICD-9-CM codes, or their nearest equivalent, for billing and reimbursement.

The DSM-5, published in May this year, includes the crosswalk codes for both the existing ICD-9-CM and the forthcoming ICD-10-CM codes.

For comparison between

ICD-10-CM Chapter 5 Mental, Behavioral and Neurodevelopmental disorders (F01-F99)

and ICD-10 Chapter V Mental and behavioural disorders (F00-F99) see the ICD-10 online browser or

The ICD-10 Classification of Mental and Behavioural Disorders Clinical descriptions and diagnostic guidelines (The “Blue Book”)

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References and further resources

1. The development, evolution, and modifications of ICD-10: challenges to the international comparability of morbidity data. Jetté N, Quan H, Hemmelgarn B, Drosler S, Maass C, Moskal L, Paoin W, Sundararajan V, Gao S, Jakob R, Ustün B, Ghali WA; IMECCHI Investigators. Med Care. 2010 Dec;48(12):1105-10. doi: 10.1097/MLR.0b013e3181ef9d3e [PMID: 20978452].

The development, evolution and modifications of ICD-10: challenges to the international comparability of morbidity data: Nathalie Jetté MD, November 2009, Slide Presentation [5 MB].

2. Personal communication.

3. Personal communication.

4. Information for providers, payers and vendors on transition to ICD-10-CM can be found here on the CMS website.

5. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services: ICD-10-CM/PCS MYTHS AND FACTS ICN 902143, April 2013.

6. American Psychological Association: Nine frequently asked questions about DSM-5 and ICD-10-CM, APA Practice staff answer questions about billing, determining diagnoses and more related to the two diagnostic classification systems. Practice Update, May 16, 2013.

7. American Psychiatric Association: Insurance Implications of DSM-5

8. AAPC What is ICD-9-CM?

Psychologists’ perspectives on the diagnostic classification of mental disorders: Results from the WHO-IUPsyS Global Survey

Post #263 Shortlink: http://wp.me/pKrrB-3dj

Psychologists’ perspectives on the diagnostic classification of mental disorders: Results from the WHO-IUPsyS Global Survey

Int J Psychol. 2013 Jun 10. [Epub ahead of print]

Psychologists’ perspectives on the diagnostic classification of mental disorders: Results from the WHO-IUPsyS Global Survey.

Evans SC, Reed GM, Roberts MC, Esparza P, Watts AD, Correia JM, Ritchie P, Maj M, Saxena S.
Source
a Clinical Child Psychology Program, University of Kansas, Lawrence , KS, USA.

Abstract

This study examined psychologists’ views and practices regarding diagnostic classification systems for mental and behavioral disorders so as to inform the development of the ICD-11 by the World Health Organization (WHO). WHO and the International Union of Psychological Science (IUPsyS) conducted a multilingual survey of 2155 psychologists from 23 countries, recruited through their national psychological associations. Sixty percent of global psychologists routinely used a formal classification system, with ICD-10 used most frequently by 51% and DSM-IV by 44%. Psychologists viewed informing treatment decisions and facilitating communication as the most important purposes of classification, and preferred flexible diagnostic guidelines to strict criteria. Clinicians favorably evaluated most diagnostic categories, but identified a number of problematic diagnoses. Substantial percentages reported problems with crosscultural applicability and cultural bias, especially among psychologists outside the USA and Europe. Findings underscore the priority of clinical utility and professional and cultural differences in international psychology. Implications for ICD-11 development and dissemination are discussed.

PMID: 23750927

[PubMed – as supplied by publisher]

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Slide Presentation: Aug 3, 2012

The WHO-IUPsyS Global Survey of Psychologists’ Attitudes Toward Mental Disorders Classification.

Download PDF WHO-IUPsyS Global Survey slides

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More information on this WHO study can be found on Page 7 (3.) of this report:

http://www.apa.org/international/outreach/icd-report-2012.pdf

2012 Annual Report of the International Union of Psychological Science to the American Psychological Association

Revision of World Health Organization’s ICD-10 Mental and Behavioural Disorders

Pierre L.-J. Ritchie, Ph.D., Main Representative to the World Health Organization, International Union of Psychological Science, January, 2013

Click link for PDF document    WHO-IUPsyS ICD Survey Report Report 2012

This report also sets out the responsibilities of ICD Revision working groups, on Page 3 (1.1), and gives some information on the field studies for ICD-11 and ICD11-PHC, on Page 8 (4.)

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The earlier study: WPA-WHO Global Survey of Psychiatrists’ Attitudes Towards Mental Disorders Classification can be downloaded here: 

The WPA-WHO Global Survey of Psychiatrists’ Attitudes Towards Mental Disorders Classification

World Psychiatry 2011;10:118-131

Research report

Geoffrey M Reed, João Mendonça Correia, Patricia Esparza, Shekhar Saxena, Mario Maj

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Response to Recommendations from November 2011 CFSAC meeting

Response to Recommendations from November 2011 CFSAC meeting

Post #203 Shortlink: http://wp.me/pKrrB-2ur

The response from the Assistant Secretary for Health to Recommendations from the November 2011 CFSAC meeting is now available on the CFSAC website at: http://1.usa.gov/OghDXF

http://www.hhs.gov/advcomcfs/asst-sect-letter2012.pdf

or open here  asst-sect-letter2012

Text:

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Office of the Assistant Secretary for Health Washington, D.C. 20201
AUG -3 2012
Gailen Marshall Jr., MD, PhD

Chair, Chronic Fatigue Syndrome Advisory Committee
Professor and Chair Professor of Medicine and Pediatrics
The University of Mississippi Medical Center 2300
North State Street, N416 Jackson, MS 39216-4505

Dear Dr. Marshall:

I have received the recommendations developed by the Chronic Fatigue Syndrome Advisory Committee (CFSAC) during its November 8-9, 2011, meeting. The advice and counsel provided by CFSAC serves as a valuable resource in the Department of Health and Human Services’ (HHS) efforts to properly address the issues and concerns pertaining to chronic fatigue syndrome.

Since the meeting the Department has carefully considered your recommendations. Dr. Nancy Lee, the Designated Federal Officer for CFSAC, has worked collaboratively with the ex officio representatives to the committee to provide responses to the recommendations developed at the meeting. The enclosed document contains information about activities currently undertaken by HHS to work with public health experts and members of the chronic fatigue syndrome community to increase knowledge and provide a better understanding of this debilitating health condition.

I have shared the committee’s recommendations with Secretary Kathleen Sebelius.

The Department is committed to addressing this condition. I commend you and your committee members for the important work you do.

Sincerely yours,
/s/Howard K. Koh
Howard K. Koh, M.D., M.P.H. Assistant Secretary for Health

Enclosure

cc: Dr. Christopher R. Snell
U.S. Public Health Service

RESPONSES TO RECOMMENDATIONS FROM THE CHRONIC FATIGUE SYNDROME ADVISORY COMMITTEE (CFSAC)

REF: November 8-9, 2011 CFSAC Meeting

Recommendation 1: This recommendation addresses the process by which CFSAC transmits recommendations to the Secretary and the Secretary communicates back to CFSAC whether or not a recommendation was acted upon. CFSAC recommends that this process be transparent and clearly articulated to include regular feedback on the status of the Committee’s recommendations. This communication could originate directly from the Office of the Secretary or be transmitted via the relevant agency or agencies.

Procedures are in place to ensure that recommendations made by federal advisory committees are properly handled. The CFSAC charter stipulates that the Committee provides advice and recommendations to the Secretary, through the Assistant Secretary for Health (ASH). Initially, the CFSAC recommendations are sent to the ASH for review. After reviewing the recommendations, the ASH forwards them to appropriate officials within the Office of the Secretary and the Operating and/or Staff Divisions that may be impacted by the Committee’s recommendations. A letter is sent to acknowledge receipt of the recommendations. A response may be prepared to accompany the letter which describes any actions that the Department may take in response to the recommendations made by the Committee. All pertinent information about the recommendations is provided to the designated Federal officer (DFO). The DFO then provides the information to the Chair and the Committee.

Recommendation 2: CFSAC recommends to the Secretary that the NIH or other appropriate agency issue a Request for Application (RFA) for clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS).

The National Institutes of Health (NIH) funds research on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS); investigators are encouraged to submit proposals for ME/CFS research, including clinical trials, through two funding announcements that are currently open for submission of applications. The next deadline for receipt of applications is October 24, 2012. In fiscal year 2011, NIH funded two applications for clinical trials on ME/CFS. NIH has received few applications proposing ME/CFS research, and even fewer applications proposing ME/CFS clinical trials. It is unclear whether the paucity of ME/CFS clinical trial applications reflects the current status of the field or an acknowledgement that clinical trials are difficult to design for a complex and multi-faceted illness. Clinical trials are challenging to design and conduct for all diseases, with basic requirements of a well-defined patient population, valid measurement instruments, appropriate safeguards for subjects, and generalizability of the clinical trial outcomes to the larger affected patient population. NIH is taking action to stimulate ME/CFS research across NIH through the regular monthly meetings of the Trans-NIH ME/CFS Working Group (WG). The WG discusses the current status of ongoing research on ME/CFS and proposes methods to increase the number and quality of research applications submitted to NIH ranging from preclinical research to clinical trials. In addition, the WG is focusing on the recommendations from the April 2011 State of the Knowledge Workshop on ME/CFS to develop priorities. The outcome from these planning sessions will suggest a range of activities and research.

Recommendation 3: CFSAC would like to encourage and support the creation of the DHHS Interagency Working Group on Chronic Fatigue Syndrome and ask this group to work together to pool resources that would put into place the “Centers of Excellence” concept that has been recommended repeatedly by this advisory committee. Specifically, CFSAC encourages utilizing HHS agency programs and demonstration projects, available through the various agencies, to develop and coordinate an effort supporting innovative platforms that facilitate evaluation and treatment, research, and public and provider education. These could take the form of appropriately staffed physical locations, or be virtual networks comprising groups of qualified individuals who interact through a variety of electronic media. Outreach and availability to underserved populations, including people who do not have access to expert care, should be a priority in this effort.

HHS leadership has identified the need for a Department-wide plan to address ME/CFS. The Department established the HHS Ad Hoc Workgroup on ME/CFS to develop a plan and to identify opportunities for interagency collaboration. The HHS ME/CFS plan will highlight recently initiated programs and future agency-specific and cross-agency activities. In developing the report, the Ad Hoc Workgroup will consider recommendations made by CFSAC. After completion, the ME/CFS plan will be posted on the CFSAC website. The DFO, Nancy C. Lee, M.D. is responsible for providing leadership and coordination for development of the HHS ME/CFS report.

Recommendation 4: This multi-part recommendation pertains to classification of CFS in ICD classification systems:

a) CFSAC considers CFS to be a multi-system disease and rejects any proposal to classify ME/CFS as a psychiatric condition in the U.S. disease classification systems.

b) CFSAC rejects the current classification of ME/CFS in Chapter 18 of ICD-9-CM under R53.82, chronic fatigue unspecified, chronic fatigue syndrome, not otherwise specified.

c) CFSAC continues to recommend that ME/CFS should be classified in ICD-IO-CM in Chapter 6 under Diseases of the Nervous System at G93.3 in line with ICD-IO, the World Health Organization, and ICD-I-CA [sic], the Canadian Clinical Modification and in accordance with CFSAC’s recommendations of August 2005 and May 2011. CFSAC rejects CDC’s National Center for Health Statistics (NCHS) Option 2 and recommends that ME/CFS remain in the same code and the same subcode as myalgic encephalomyelitis because CFS includes both viral and non-viral triggers.

d) CFSAC recommends that an “excludes one”* be added to G93.3 for chronic fatigue, R53.82, and neurasthenia, F48.8. CFSAC recommends that these changes be made in ICD-10-CM prior to its rollout in 2013.**

[*Ed: Should read “Excludes 1”. For definitions for “Excludes1″ and “Excludes2″ see Post #118]

[**Ed: On August 3, HHS announced Final Rule to delay compliance date for ICD-10-CM/PCS to October 1, 2014.]

Development and implementation of the guidelines for the lCD-10 fall within HHS under the purview of the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services. Use of the revised codes will provide robust and specific data that will improve patient care and enable the international comparability of health care data. On February 16, 2012, the Department issued a press release announcing that HHS would initiate a process to postpone the date that certain health care entities must comply with the ICD-10.

A proposal to change the classification of ME/CFS in ICD-10-CM was presented at the September 2011 Coordination and Maintenance (C & M) Committee/CDC/NCHS; a subsequent proposal was received on January 12, 2012 and will be presented at the September 19, 2012 C & M meeting for additional discussion.

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Related posts

Notice of Meeting of the ICD-9-CM Coordination and Maintenance Committee

Coding CFS in ICD-10-CM: CFSAC and the Coalition4ME/CFS initiative

Extracts: ICD-9-CM Coordination and Maintenance Committee Meeting Summary document (CFS coding)

Extracts: ICD-9-CM Coordination and Maintenance Committee Meeting September 14, 2011 (Coding of CFS in ICD-10-CM)

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