A.  CHANGES RESULTING FROM IMPLEMENTATION OF THE COC’s FORDS MANUAL IN 2003:

Several data items previously required by CoC were deleted in their FORDS Manual, and many new data items were added. CPDMS.net has not deleted any data items with its 2003 release. However, the required new elements have been added. One of these is an ACoS approval flag, which a hospital user may set in order to invoke data entry processes that provide access to and edit checking on all CoC required fields. Otherwise, only KCR data collection requirements will be enforced by the software routines.

The greatest impact of the FORDS Manual is in the collection of therapy information. The site specific surgery codes have been revised significantly since the CoC’s 1998 surgery code revisions. Due to ACoS and SEER reporting requirements, KCR will maintain the old data values in the ROADS surgery fields. These will be identified by the acronym ’ROADS’ beside the field name and they must be coded for diagnoses prior to 1/1/2003. Three of the new CoC data items - Surgery at Primary Site, Scope of Regional Lymph Node Surgery, and Surgery at Distant Sites - will have the acronym ’FORDS’ beside the new field name and they must be coded for diagnoses on or after 1/1/2003. The other ROADS surgery data items will either be discontinued (Surgical Approach, Number of Regional Lymph Nodes Removed, Reconstruction) or converted to generic codes in FORDS, applicable to all sites (Surgical Margins).

There are eight new Radiation Therapy data items required in FORDS. These will be available only to hospitals that set their ACoS flag to ’approved.’ These are NOT required by KCR. Finally, there will be new and separate therapy records specifically for non-definitive surgeries, Hormone Therapy, Immunotherapy, and Transplants/Endocrine procedures. The ’Other’ therapy codes and definitions will be converted and revised accordingly.

B.  CHANGES FOR 2004:

The two most significant changes for 2004 are the implementation of the collaborative staging system and the inclusion of benign and bordering intracranial and CNS tumors in the list of reportable conditions.

C.  CHANGES FOR 2005:

The SEER Rx program is now used to categorize systemic treatments as chemotherapy, hormone therapy or immunotherapy. The most significant change is the classification of drugs according to their mechanism of action. These drugs are now coded as chemotherapy:

- cytostatic agents, including monoclonal antibodies (such as Rituxan and Herceptin), growth factor inhibitors (such as Iressa),  anti-angiogenesis agents (such as thalidomide, Avastin, and Neovastat)

-anti-metabolites (such as Vidaza and Alimta)

The SEER Rx program used to classify drugs may be found at www.seer.cancer.gov/tools/seerrx.

D. CHANGES FOR 2006

The CoC no longer requires class of case 0 cases to be followed by the registry or AJCC staged by the physician.  However, KCR continues to require registries to follow these cases.  Four additional comorbidity fields were added and the data item "Systemic Therapy/Surgery Sequence" was added. 

E.  CHANGES FOR 2007

The SEER 2007 Multiple Primary and Histology Coding rules were implemented effective with cases diagnosed in 2007.  These site-specific rules for determining the number of primary malignancies in solid tumors supersede all previous multiple primary rules.  (Existing rules for determining the number of primary malignancies for lymphatic and hematopoietic diseases, and for benign and borderline intracranial and CNS tumors, remain in effect.)  Along with the new Multiple Primary rules, six additional data items were introduced in 2007: Ambiguous Terminology, Date of Conclusive Diagnosis, Multiplicity Counter, Date of Multiple Tumors, Type of Multiple Tumors, and Managing Physician.  Per ACoS requirements, the National Provider Identification (NPI) numbers were initiated in 2007.  These are unique 10-digit identifiers for health care providers who bill Medicare (CMS) for services.  The NPI data values are stored in the two support files: physician list and institution list.  A lookup for NPI numbers is available at https://npiregistry.cms.hhs.gov/.

F.  CHANGES FOR 2008

For cases diagnosed in 2008, the CoC considers pathologic staging information to be adequately collected by the CS items, and thus physician-assigned pathologic AJCC staging is no longer required to be collected.  Clinical AJCC staging continues to be required for ACoS approved facilities.  Collaborative Stage version 01.04.00 was released and is available at http://cancerstaging.org/cstage/Pages/default.aspx. Clarifications regarding the coding of embolization were issued by the CoC, NPCR, and SEER.  Chemoembolization, in which tumor blood-flow is blocked by other means and a chemotherapy drug is injected into the tumor, is coded as chemotherapy.  Radioembolization, in which tumor blood-flow is blocked and tiny radioactive beads or coils are injected into the tumor, is coded as radiation therapy.  When blood flow to the tumor is blocked using other chemicals or materials (such as alcohol or acrylic), without the use of chemotherapy or radiotherapy, code this treatment in the 'Other' therapy field.  Pre-surgical embolization of hypervascular tumors using particles, coils, or alcohol is NOT coded as therapy.  This type of embolization is performed to make subsequent surgical resection easier, not as cancer-directed therapy.  

G.  CHANGES FOR 2009

Beginning with  2009 diagnoses, maiden name should be collected, when known.  HER2 test results will be recorded for breast cases.  Cases which are diagnosed in utero will use the actual date of diagnosis, rather than the date of birth (note: this situation requires an IF15 override).  Two additional optional following physician fields were added.  The codes 209.0-209.3 and 511.81 were added to the ICD-9-CM casefinding list, and a supplemental list of codes to aid in casefinding was made available as Appendix M - Supplemental ICD-10-CM Codes.  

H.  CHANGES FOR 2010

Collaborative Stage version 2.0 was implemented, which entailed a great number of changes and the conversion of CS data elements for all diagnoses from 2004-2009.  SSF 7-25 were added at this time.  The AJCC Cancer Staging Manual, 7th Edition was adopted for coding the T, N, M, and Stage Group fields.  The Hematopoietic Database (which includes the Hematopoietic and Lymphoid Neoplasm Case Reportability and Coding Manual) was released and replaced all previous coding rules for these malignancies.  New histology codes which are not in ICD-O-3 were added to the Histology Support File and the following diseases were changed from borderline to malignant:  Langerhans cell histiocytosis (9751/3), T cell large granular lymphocytic leukemia (9831/3), and myeloproliferative neoplasm, unclassifiable (9975/3).  

Several new fields were added, including Radiation/Systemic Tx Sequence, Grade Path System, Grade Path Value, Lymph-Vascular Invasion, Treatment Status, Date Case Completed-COC, Surgical Approach 2010, Place of Diagnosis, and Reason No Non-definitive Surgery.  Modifications were made to the existing items Race 1-5, Class of Case, Laterality, Diagnostic Confirmation, AJCC Staging, and Radiation Number of Treatments to This Volume.  

I.  CHANGES FOR 2011

Collaborative Stage version 02.03 was implemented.  Cases diagnosed from January 1, 2011 forward were coded using the new version.  Version 02.03 introduced one new schema (for myeloma/plasma cell malignancies), added and revised codes, incorporated new algorithms, and revised some coding instructions.  It also added the following new SSF's to existing schema: SSF15 for breast, SSF10 for bile duct intrahepatic, and SSF13-16 for testis.  

FORDS 2011 requires that comorbidities be coded using ICD-10, upon a facility's transition from ICD-9.  Minor revisions were made to the surgery codes for liver, breast, and prostate.  

A "Do Not Contact" flag was added as a patient level field so that registries may mark patients who should never be directly contacted.

J.   CHANGES FOR 2013

Country codes were added to address current, address at diagnosis, place of birth and place of death. (See new APPENDIX B). Secondary diagnosis 1-10 were added to capture co-morbidities when they are recorded in the medical record using ICD-10 codes. These data items are no longer required: Ambiguous Terminology, Date of Conclusive Diagnosis, Multiplicity Counter, Date of Multiple Tumors, and Type of Multiple Tumors Reported as One Primary.

Four Clinical Trial data items were added (type, date, site, and text) and these items are repeated to capture up to four different clinical trials per patient.

Also in 2013, these drugs, which were coded as chemotherapy, are now considered immunotherapy:

 - Alemtuzumab/Campath

 - Bevacizumab/Avastin

 - Rituximab

 - Trastuzumab/Herceptin

 - Pertuzumab Perjeta

 - Cetuximab/Erbitux

K. CHANGES FOR 2014

Collaborative Stage Version 02.05 was implemented. Cases diagnosed from January 1, 2014 forward must be entered using CS V02.05. This version contained a few corrections to the mapping algorithm, and several clarifications to the coding instructions with this version, Grade Path System and Grade Path Value were discontinued, as well as all Site Specific Factors that had been defined by never required by any standard setter.

The Tumor Grade field was changed slightly in 2014, with all standard setters (COC, SEER, and NPCR) in agreement with the new coding instructions.

New preferred terms and synonyms were added to the ICD-0-3 histology table.

A revised version of the Hematopoietic and Lymphoid Neoplasm Database was released in 2014.

L. CHANGES FOR 2015

Two new code values were added to the SEX field: 5 - Transsexual, natal male and 6 - Transsexual, natal female.

Pathological stage data elements T, N, M, and stage group are now required to be coded.

Carcinoids of the appendix are now considered reportable (8240/3). Nature teratomas of the testes in adults is malignant and reportable (9080/3). It is not reportable for pre-pubescent males.

New terms for pancreatic cancers are now reportable:

  • Non-invasive mucinous cystic neoplasm (MCN) of the pancreas with high grade dysplasia is reportable. This term replaces mucinous cystadenocarcinoma, non-invasive (8470/2).
  • Cystic pancreatic endocrine neoplasm (CPEN) is reportable. Assign code 8150/3, unless specified as NET grade 1 (8240/3) or NET grade 2 (8249/3).
  • Solid pseudopapillary neoplasm of the pancreas is reprotable as 8452/3.

Directly coded Summary Stage 2000, Treatment Follow-back Text, and Treatment Plan were added as new data items.

M. CHANGES FOR 2016

Code 3 for the data field SEX is now defined as 'Other, (intersex, disorders of sexual development/DSD).'

New data items in 2016 include

  • Mets at diagnosis - Distant Lymph Node
  • Mets at diagnosis - Other (Other than Bone, Brain, Liver, Lung, Distant Lymph Nodes)
  • Tumor size - Clinical
  • Tumor size - Pathological
  • Tumor size - Summary

Staged by - Clinical and Staged-by Pathological have been expanded to 2-digit codes to include more physician specialties. Data entered before 2016 was converted to the new 2-digit codes.

The valid codes for the AJCC T, N, and M categories now contain the prefix 'c' for clinical or 'p' for pathologic. Data entered before 2016 was converted to include these prefixes.

Although CoC and NPCR have discontinued the collection of collaborative stage data, KCR will continue to abstract these fields in 2016. However, CS derived values will no longer be displayed for cases diagnosed on or after 01-01-2016.

N. CHANGES FOR 2018

*Note all changes are in effect for cases diagnosed 01/01/2018 and later only.

Added Schema ID and Schema Discriminators 1, 2, and 3 at the case level for cases diagnosed 01/01/2018 and later. Schema discriminator 3 will not be used for 2018 cases, but we did add the place holder for future years.

Collaborative Stage tab was removed for 2018+ cases and replace with EOD staging tab.

New fields include:

  • EOD--Primary Tumor
  • EOD--Regional Nodes
  • EOD–Mets
  • Date Regional Lymph Node Dissection (for breast and melanoma cases only)
  • Sentinel Lymph Nodes Positive (for breast and melanoma cases only)
  • Sentinel Lymph Nodes Examined (for breast and melanoma cases only)
  • Date of Sentinel Lymph Node Biopsy (for breast and melanoma cases only)
  • Prostate Pathological Extension (For prostate cases only)

Added code a code to Mets at Diagnosis - Other

  • Code 2 for generalized metastases such as carcinomatosis

Tumor grade was removed and replaced on the new SSDI/Grade tab with 3 new grade fields:

  • Clinical Tumor Grade
  • Pathological Tumor Grade
  • Post Therapy Tumor Grade

Site Specific Factors were removed and replaced with site/histology specific SSDIs that were put on the SSDI/Grade tab.

Added SEERSSF1 (HPV Status) for applicable site/histologies

The AJCC staging tab was updated to now include these new fields:

  • AJCC TNM Clin T
  • AJCC TNM Clin T Suffix
  • AJCC TNM Clin N
  • AJCC TNM Clin N Suffix
  • AJCC TNM Clin M
  • AJCC TNM Clin Stage Group
  • AJCC TNM Path T
  • AJCC TNM Path T Suffix
  • AJCC TNM Path N
  • AJCC TNM Path N Suffix
  • AJCC TNM Path M
  • AJCC TNM Path Stage Group
  • AJCC TNM Post Therapy T
  • AJCC TNM Post Therapy T Suffix
  • AJCC TNM Post Therapy N
  • AJCC TNM Post Therapy N Suffix
  • AJCC TNM Post Therapy M
  • AJCC TNM Post Therapy Stage Group

Removed staged by on the AJCC tab for 2018 forward cases.

Radiation Treatment Changes:

Added new tabs to radiation and these new fields

  • Phase I Radiation Primary Treatment Volume
  • Phase I Radiation to Draining Lymph Nodes
  • Phase I Radiation Treatment Modality
  • Phase I Radiation External Beam Planning Tech
  • Phase I Dose per Fraction
  • Phase I Number of Fractions
  • Phase I Total Dose
  • Phase I Therapy Local Hospital ID
  • Phase II Radiation Primary Treatment Volume
  • Phase II Radiation to Draining Lymph Nodes
  • Phase II Radiation Treatment Modality
  • Phase II Radiation External Beam Planning Tech
  • Phase II Dose per Fraction
  • Phase II Number of Fractions
  • Phase II Total Dose
  • Phase II Therapy Local Hospital ID
  • Phase III Radiation Primary Treatment Volume
  • Phase III Radiation to Draining Lymph Nodes
  • Phase III Radiation Treatment Modality
  • Phase III Radiation External Beam Planning Tech
  • Phase III Dose per Fraction
  • Phase III Number of Fractions
  • Phase III Total Dose
  • Phase III Therapy Local Hospital ID
  • Number of Phases of Rad Treatment to this Volume
  • Total Dose
  • Radiation Treatment Discontinued Early

Moved Total Rads and Rad Sites to the Historical Tab.

Date of last cancer (tumor) status was added to the follow up tab.

O. CHANGES FOR 2020

Added new tab for COVID-19 and these new fields

  • COVID-19 - DX PROC - LAB TEST
  • COVID-19 Impact - BMT
  • COVID-19 Impact - BRM
  • COVID-19 Impact - CHEMO
  • COVID-19 Impact - HORMONE
  • COVID-19 Impact - RADIATION OTHER
  • COVID-19 Impact - RADIATION (BEAM)
  • COVID-19 Impact - RADIATION (ICB)
  • COVID-19 Impact - SURGERY
  • COVID-19 TEXT

P. CHANGES FOR 2021

The Grade/SSDI tab was updated to now include these new fields: 

  • Grade Post Therapy Clinical (yc)
  • Grade Post Therapy Pathological (yp)

The AJCC/Docs tab was updated to now include these new fields:

  • AJCC TNM Post Therapy Clin T
  • AJCC TNM Post Therapy Clin T Suffix
  • AJCC TNM Post Therapy Clin N
  • AJCC TNM Post Therapy Clin N Suffix
  • AJCC TNM Post Therapy Clin M
  • AJCC TNM Post Therapy Clin Stage Group
  • AJCC TNM Post Therapy Path T
  • AJCC TNM Post Therapy Path T Suffix
  • AJCC TNM Post Therapy Path N
  • AJCC TNM Post Therapy Path N Suffix
  • AJCC TNM Post Therapy Path M
  • AJCC TNM Post Therapy Path Stage Group

The Admin/No Tx tab was updated to now include these new fields:

  • Neoadjuvant Therapy
  • Neoadjuvant Therapy Clinical Response
  • Neoadjuvant Therapy Treatment Effect