LIFE SCIENCES REGULATORY & COMPLIANCE

CODING FOR SUCCESS: ARE YOU MAKING THE MOST OF ICD CLASSIFICATION?

INTRODUCTION

Recent trends in the life sciences industry have seen a shift towards more patient-

centric business models and a drive towards personalised medicine. Life sciences

companies strive for innovative ways to better identify and segment their patient

populations, as well as further advance the understanding of diseases, including disease

progression and management, in order to continue to develop novel therapeutics and

ensure that patients receive the most effective treatments.

In this context, real-world evidence and big data combined with comprehensive data

analytics are vital sources of information to help achieve the overall goal of better

patient outcomes.

THE ICD CLASSIFICATION SYSTEM

The International Classification of Diseases (ICD) classification system, created by the

World Health Organisation (WHO), is an international standard for reporting diseases

and health conditions. The ICD classification system comprises of an index of diseases

categorised by specific codes and has a variety of uses, including:

• identification of global health trends and statistics

• monitoring the incidence and prevalence of disease

• comparison of data across different time periods in the same location

• reimbursement

• used for research purposes to aid in defining diseases

According to the WHO, over 100 countries use the ICD classification system to record

mortality data, with a similar number also using it to record morbidity data, as around

70% of global health expenditures are allocated using the ICD system in reimbursement

and resource allocation procedures1.

1. World Health Organization - Classification of Diseases (ICD) http://www.who.int/classifications/icd/en/

32

HOW LIFE SCIENCES COMPANIES CAN GAIN FROM THE ICD CLASSIFICATION SYSTEM

The ICD classification system is a powerful real-world evidence

tool that, when maximised to its full potential, offers a multitude

of benefits for pharmaceutical and medical device companies,

which include but are not limited to:

• stratifying patient populations for more refined and accurate

recruitment for clinical trials

• ensuring that the right patient gets access to the right

treatment (personalised medicine) through improved and

more precise reporting of their disease state

• enhanced accuracy with reimbursement and pricing

strategies

• better identification and understanding of target patient

populations (e.g. epidemiology), especially in the case of rare

and orphan disease indications

VERSIONS AND MODIFICATIONS OF THE ICD CLASSIFICATION SYSTEM

The version of the ICD system currently in use is the ICD-

10, which came into effect in the early 1990s2. The US has

only recently begun to use ICD-10 as of October 2016 after

a delay of three years3. The next version, ICD-11, is currently

in development with an expected launch date of 2018. It

will incorporate a different coding structure and has been

designed to better support electronic health records and

be more compatible with SNOMED CT, a comprehensive

and standardised multilingual database of medical terms4.

Nonetheless, it is expected that ICD-10 will remain predominant

for the upcoming years, with the earliest use of ICD-11 in country

healthcare systems anticipated to be 20235.

The WHO version of ICD-10 has been translated into over 40

languages and has been modified by certain countries so that

its use for morbidity data can be specifically tailored to fit

with their own healthcare and reimbursement systems. The

main country level modifications can be seen in the figure

below. The key difference between the WHO version and the

different country level modifications are the number of codes

available for use in the classification system. For example, the

ICD-10 WHO version has around 16,000 codes compared to

around 70,000 codes for the ICD-10 CM. Interestingly, country

level modifications are not restricted to the country that has

created them as other countries are freely able to choose which

version/modification of ICD-10 that they want to adopt into

their system. For example, the UK currently uses the ICD-10

WHO version, whereas the Republic of Ireland uses the ICD-10

AM (Australian Modification) and Spain uses the ICD-10 CM

(Clinical/US Modification).

THE ICD REVISION PROCESS

For companies to truly take advantage of the benefits of the ICD system, the relevant

codes need to be present in the classification system. This raises the question: what if

the code required doesn’t exist or is not coded to the degree of specificity needed?

To enable the ICD system to stay relevant and accurately capture advancements in

our understanding of diseases and diagnoses, regular revisions are made to both the

WHO version and the country level modifications. Any individual or organisation is

allowed to submit a proposal for a revision to the ICD WHO version or to the country

level modification, with the exception to the rule being the ICD-10 GM, where only

medical/scientific societies and associations are able to request that a change be made.

This therefore provides companies within the life sciences industry the opportunity

to request for revisions to be made to the ICD-10 classification system. Revisions can

include changes to existing codes and their descriptions and the addition of new codes.

Table 1. List of qualifying reasons for requesting a revision to ICD-10 WHO

1. Need to identify a new disease

2. Need to reflect a change in clinical knowledge

3. Need to reflect a change in clinical terminology

4. Need for compatibility with the WHO Family of Classifications

5. Need for change in rules, guidelines or conventions

6. Need to improve clarity or reduce ambiguity in the tabular list

7. Need to create, delete or correct an index entry

8. Need for greater or less specificity

9. Need to correct typographical errors

Country level modifications add a layer of complexity to the revision process but

also additional strategic opportunities for life sciences companies. As country level

modifications are all derived from ICD-10 WHO, the governing bodies of the country

level modifications usually inclusively incorporate revisions that are implemented at

the WHO level. Revisions can also be made directly at the country level and these are

not immediately implemented back up to the WHO level or into the other country level

modifications unless separate applications are made to each of the other country level

modifications. When deciding which route to choose when submitting a proposal for a

revision, factors that need to be taken into consideration are:

• The specific revision process for the different versions of ICD-10 and their overall

timings, as the timelines from proposal submission to approval and implementation

vary (e.g. ICD-10 CM and GM take an average of one year, whereas ICD-10 WHO

takes between 2 – 5 years)

• The likelihood of the proposed revision being approved

• The market(s) being targeted for the revision or that would benefit most from the

revision

• The key stakeholders involved in the revision process

• The type of revision being requested

ICD-10 WHO VERSION

ICD-10AMAustralian

Modification

ICD-10FRFrench

Modification

ICD-10GMGerman

Modification

ICD-10CACanadian

Modification

ICD-10CMClinical

Modification

Country level modifications

New edition published annually

New edition published biannually

New edition published annually

New edition published annually

New edition published annually

New edition published every 3 years

Figure 1 - Schematic of the current country level modifications of ICD-10

2. World Health Organization - Classification of Diseases (ICD) http://www.who.int/classifications/icd/en/

3. Health Data Management (2016) http://www.healthdatamanagement.com/news/thousands-of-new-icd-10-codes-slated-for-october-release

4. Australian Institute of Health and Welfare. ‘ICD-11 A new way to build the ICD’ (www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=10737419475)

5. ICD10 monitor (2015) ‘ICD-11: A Code Set for the Future’ http://www.icd10monitor.com/enews/item/1399-icd-11-a-code-set-for-the-future

4 5

CASE STUDY 1

Revision to ICD-10 CM proposed by a life sciences company

In 2014, Forest Laboratories LLC, now part of Allergan submitted two proposals requesting that additional codes be added to

the ICD-10 CM. The first proposal put forward was for the addition of the following codes K58.1 - Irritable bowel syndrome with constipation and K58.8 – Other irritable bowel syndrome to be added to irritable bowel syndrome (K58) category. The second

proposal was for the addition of the code K59.04 – Chronic idiopathic constipation to the constipation (K59.0) category.

Forest made the request stating that IBS can be classified into three main subtypes: IBS with constipation (IBS-C), IBS with

diarrhea (IBS-D), a mixture of both constipation and diarrhea (IBS-M) or neither (IBS-U) and that the current ICD-10 coding for

irritable bowel syndrome did not reflect this. As treatment varies for the different patient subtypes, Forest wanted the new codes

implemented for more accurate disease identification for patients. They put forward the same argument for chronic idiopathic

constipation of wanting a more specific code for increased accuracy in disease identification.

At the time the proposal was submitted, Forest had recently received FDA approval in 2012 for their therapeutic Linzess

(linaclotide) to treat patients with irritable bowel syndrome with constipation and chronic idiopathic constipation.

Forest’s proposals were accepted into the next edition of the ICD-10 CM, with a key factor for the approval of their proposals being

the support and backing of their proposal by the American Gastroenterological Association. The addition of a code for mixed IBS

was also added despite not being included in Forest’s original proposal because the revision committee felt that if changes were to

be made to the current coding then this should also be included. At this point in time, these revisions are present only in the ICD-10

CM version6.

ORIGINAL CODES REVISED CODES

CODE CODE DESCRIPTION CODE CODE DESCRIPTION

K58 Irritable bowel syndrome K58 Irritable bowel syndrome

K58.0 Irritable bowel syndrome with diarrhea K58.0 Irritable bowel syndrome with diarrhea

K58.9 Irritable bowel syndrome without diarrhea K58.1 Irritable bowel syndrome with constipation

K59.0 Constipation K58.2 Mixed irritable bowel syndrome

K59.00 Constipation, unspecified K58.8 Other irritable bowel syndrome

K59.01 Slow transit constipation K58.9 Irritable bowel syndrome without diarrhea

K59.02 Outlet dysfunction constipation K59.0 Constipation

K59.09 Other constipation K59.00 Constipation, unspecified

K59.01 Slow transit constipation

K59.02 Outlet dysfunction constipation

K59.03 Drug induced constipation

K59.04 Chronic idiopathic constipation

K59.09 Other constipation

6. http://www.cdc.gov/nchs/data/icd/topic_packet_09_23_2012.pdf

Although submissions are made publicly available for most

versions/modifications, the ICD-10 CM provides the clearest

information on proposals submitted that are reviewed by their

revision committee. At the moment, medical societies make

up the majority of submissions for revisions to changes to the

ICD-10 CM, with less than 10% of submissions in the last 5 years

coming from life sciences companies. Of the submissions made

by life sciences companies, currently there is an approval rate

of just over half. The backing of medical societies appears to be

instrumental in the success of submissions made by life sciences

companies with lack of support being a reason frequently

cited for why their requests were denied. In addition, medical

associations can submit revision proposals directly or indirectly

on the behalf of a life sciences company.

CASE STUDY 2

Example of revision to the ICD-10 CM proposed by medical societies

In September 2012, the American Academy of Ophthalmology (AAO) and the American Society of Retina Specialists (ASRS)

requested that modifications be made to the existing ICD-10 CM codes H35.31 and H35.32 and that new codes be added to better

distinguish the different stages of both wet and dry AMD and the laterality of the disease in the eye. Furthermore, they requested

changes to be made to the codes related to diabetes mellitus with proliferative diabetic retinopathy (E08-E11, E13) to include the

severity levels and laterality of the disease, to enable better tracking of the disease. They also requested changes be made to the

coding for diabetic macular oedema (DME) to reflect the laterality. Finally, they proposed changes to the codes for retinal vein

occlusion (RVO) (H34.8) to also code for the severity of the disease. The purpose of these modifications was to reflect the change

in current standard of care from laser or incisional surgery to treatment with anti-VEGF drugs, such as EYLEA (aflibercept) and

Lucentis (ranibizumab).

Although there is no direct connection between the proposal of these changes to ICD-10 CM by the AAO and the AARS to

Regeneron/Bayer or Genentech/Roche, all the additions and revisions proposed were accepted into the latest version of the ICD-

10-CM and have direct impacts on the reimbursement for EYLEA and Lucentis, both drugs that are approved for all the indications

in which revisions to the coding where suggested. This is because with the new codes reimbursement can now be made for each

individual eye that is treated with anti-VEGF therapy.

This highlights the indirect benefit that life sciences companies can gain when ICD-10 revisions are made to reflect advancements

in the diagnosis and treatment of diseases. It is likely that had Regeneron/Bayer and/or Genentech/Roche submitted the

proposal themselves with the backing of the medical societies then they would have still been successful in having the revisions

implemented. Similarly to the previous case study, the revisions are only present in the ICD-10 CM7.

Medical Societies

Gov

ernm

ent

Other

Pharma/Med

Dev

Revision Approved

Revision Rejected

Figure 2. Submission rate for proposals to revise ICD-10 CM and the success rate for life sciences companies

When deciding to submit a proposal to revise a version/modification of the ICD classification system, it is crucial that all key

stakeholders are aware of the situation and are actively involved and engaged from the early stages. The key stakeholders will vary

depending on the strategy chosen and can include not only medical/scientific associations, but also clinical coders, physicians and

nurses, insurance and reimbursement bodies and government officials.

7. http://www.cdc.gov/nchs/data/icd/topic_packet_for_september_19_2012.pdf

76

CASE STUDY 4

Example of Revision to the ICD-10 WHO

In 2007, a proposal was submitted to revise the ICD-10 classification system for chronic renal failure (N18) by the Australian ICD-10

committee in order that the ICD-10 WHO version was aligned to the revisions that had already been made to the ICD-10 AM version.

The revisions included modifying the title of the category from chronic renal failure to chronic kidney disease and to add new codes

to reflect the different stages of chronic kidney disease. The argument presented for the revision was that the ICD-10 codes needed

to reflect the current clinically used classification of chronic kidney disease which is frequently used in treatment recommendations.

The proposal was accepted by the WHO and implemented into the 2010 version of the ICD-10 WHO version. These revisions were

subsequently implemented into the country level modifications also9.

ORIGINAL CODES REVISED CODES

CODE CODE DESCRIPTION CODE CODE DESCRIPTION

N18 Chronic Renal Failure N18 Chronic kidney disease

N18.0 End-stage renal disease N18.1 Chronic kidney disease, stage 1

N18.8 Other chronic renal failure N18.2 Chronic kidney disease, stage 2

N18.9 Chronic renal failure, unspecified N18.3 Chronic kidney disease, stage 3

N18.4 Chronic kidney disease, stage 4

N18.5 Chronic kidney disease, stage 5

N18.9 Chronic kidney disease, unspecified

As highlighted in the case study examples, revisions to the ICD-10 classification system that would have a significant impact on

reimbursement have a greater chance of being implemented at the country level modifications compared to the WHO level. This is

because as country level modifications were introduced to ensure more accurate reimbursement, it is possible to present this argument

when submitting a proposal to them; however, this would not be a valid argument for a revision to be made at the WHO level.

CASE STUDY 3

Example of Revision to the ICD-10 GM

In 2006, a proposal was submitted by a member of the Association of Private Health Insurance (Verband der privaten

Krankenversicherung e.V.) to the ICD-10 GM requesting the introduction of additional codes for the different severity levels of

Parkinson’s disease based on the Hoehn and Yahr Scale, as at the time there was only one code specifically for Parkinson’s disease

(G20). The proposal also requested that an additional fifth digit also be added to code for the presence of response fluctuations.

The additions were requested for reimbursement purposes and to aide with accurate resource allocation in the German DRG system

as treatment varies depending on the stage of Parkinson’s that a patient is in. This revision is only present in the ICD-10 GM8.

CODE CODE DESCRIPTION

G20.0[0,1] Parkinson Disease with no to mild disability (Stages 0 to under 3 of the Hoehn and Yahr scale) [without response fluctuations; with response fluctuations]

G20.1[0,1] Parkinson Disease with moderate to severe disability (Stages 3 or 4 of the Hoehn and Yahr scale) [without response fluctuations; with response fluctuations]

G20.2[0,1] Parkinson Disease with severe disability (Stage 5 of the Hoehn and Yahr scale) [without response fluctuations; with response fluctuations]

G20.9[0,1] Parkinson’s Disease, unspecified [without response fluctuations; with response fluctuations]

8. http://www.dimdi.de

9. WHO ICD-10 Revision Platform

CONCLUSION

The benefits of the ICD classification system as a real-world evidence tool for improving

patient outcomes and reimbursement is evident. Pharmaceutical companies seeking to

take advantage of this classification tool will need to understand how to capitalise on it

(including deciding what revisions should be proposed and which versions or country

modifications to target for these proposals), as well as how to access and effectively

analyse the data.

In developing their approach, companies should seek advice from an experienced

expert with a comprehensive understanding of ICD (including both ICD-10, the country

level modifications for ICD-10 and ICD-11) who is well versed in the technical aspects of

the ICD system, the regulatory processes involved with requesting the implementation

of the revision/addition of new codes, potential commercial strategy opportunities, and

global ICD-10 data analysis and interpretation.

Important Notice

The views expressed in this article are those of the authors and do not necessarily

represent the views of Navigant Consulting Inc. or any of our clients.

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