This coding analysis does not constitute a national coverage determination (NCD). It states the intent of the Centers for Medicare & Medicaid Services (CMS) to issue a change to the list of ICD-9-CM Codes Covered that are linked to one of the negotiated laboratory NCDs. This decision will be announced in an upcoming recurring update notification in accordance with CMS Pub 100-4, Chapter 16, Section 120.2 and will become effective as of the date listed in the transmittal that announces the revision.
To: Administrative File: CAG – 00312N
Removal of ICD-9-CM Code V76.51, Special screening for malignant neoplasms of colon,
from the list Non- Covered ICD-9-CM Codes for All NCD Edits
From: Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Louis Jacques, MD
Division Director, Division of Items and Devices
Maria Ciccanti, RN
Lead Analyst, Division of Items and Devices
James Rollins, MD, PhD, MSHA
Lead Medical Officer, Division of Items and Devices
Subject: Removal of ICD-9-CM code V76.51, Special screening for malignant neoplasms of colon,
from the list Non-covered ICD-9-CM Codes for All NCD Edits
Date: February 1, 2006
I. Decision
CMS has determined that ICD-9-CM diagnosis code V76.51, Special screening for malignant neoplasms of colon, should be removed from the list "Non-Covered ICD-9-CM Codes For All NCD Edits" and added to the "ICD-9-CM Codes That Do Not Support Medical Necessity" list for blood counts.
II. Background
At the time Medicare developed the national coverage determinations (NCDs) for clinical diagnostic laboratory services under the negotiated rulemaking authority, Medicare did not have a colorectal cancer screening benefit. Consequently, we included ICD-9-CM code V76.51, Special screening for malignant neoplasms of colon, on the list of non-covered ICD-9-CM codes for all NCD edits. Subsequently, the Medicare statute was amended to add colorectal cancer screening as a covered Medicare benefit. In implementing this new statutory benefit, we neglected to remove the code for Special screening for malignant neoplasms of colon, V76.51, from this list.
III. History of Medicare Coverage
In accordance with section 4554 of the Balanced Budget Act of 1997, CMS entered into negotiations with the laboratory community regarding coverage and administrative policies for clinical diagnostic laboratory services. As part of these negotiations, we promulgated a rule that included 23 NCDs. The rule was proposed in the March 10, 2000 edition of the Federal Register (65 FR 13082) and was made final on November 23, 2001 (66 FR 58788). The final rule called for a 12-month delay in effectuating the NCDs in accordance with the recommendations of the negotiating committee. Thus, the NCDs became effective on November 25, 2002.
In the laboratory NCDs, CMS determined that specific tests were reasonable and necessary for certain medical indications. These decisions were evidence-based, relying on scientific literature reviewed by the negotiating committee. The NCDs contain a narrative describing the indications for which the test is reasonable and necessary. We also developed a list of ICD-9-CM codes that designate diagnoses/conditions that fit within the narrative description of indications that support the medical necessity of the test. This list is entitled "ICD-9-CM Codes Covered by Medicare", and includes codes where there is a presumption of medical necessity.
In addition, we developed two other ICD-9-CM code lists. The second list is entitled "Non-Covered ICD-9-CM Codes for All NCD Edits" and lists diagnosis codes that are never covered by Medicare. The third list is entitled "ICD-9-CM Codes That Do Not Support Medical Necessity", and includes codes that generally are not considered to support a decision that the test is reasonable and necessary, but for which there are limited exceptions. Tests in this third category may be covered when they are accompanied by additional documentation that supports a determination of reasonable and necessary.
IV. Timeline of Recent Activities
On December 20, 2005, CMS opened a coding analysis item regarding the removal of ICD-9-CM Code V76.51, Special screening for malignant neoplasms of colon, from the list "Non-covered ICD-9-CM Codes for All NCD Edits." We posted a tracking sheet to the Internet (http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=175) and solicited public comment for 30 days on the appropriateness of removing code V76.51 from the list "Non-covered ICD-9-CM Codes for All NCD Edits" and adding it to the list "ICD-9-CM Codes That Do Not Support Medical Necessity" list for blood counts.
We received two comments during the comment period, which ended January 20, 2006. Both supported the removal of V76.51 from the list of non-covered ICD-9-CM codes for all NCD edits. One commenter noted that removing V76.51 from the list “will correct a long-standing inconsistency between the Medicare colorectal screening statute and CMS coverage policy and will encourage correct coding.”
V. General Methodological Principles
During the negotiation meetings that led to the development of the 23 clinical diagnostic laboratory NCDs, we stated our intent that the narrative of the NCDs reflect the substance of the determinations. The addition of the coding lists was intended as a convenience to the laboratories and as a means of ensuring consistency among the Medicare claims processing contractors as they interpreted the narrative conditions that support coverage. Thus, all of the codes in the covered code list must flow from the narrative indications of the NCD. We reiterated this position in the November 23, 2001 final rule (66 FR 58795) and in subsequent implementing instructions (Program Memorandum AB-02-110).
On February 25, 2005, we announced in a final notice in the Federal Register (70 FR 9355) that we would maintain the accuracy of the coding lists without substantive changes to the narrative policy through an abbreviated process that did not require scientific evidence. We call this abbreviated process the Coding Analysis for Laboratories (CAL).
VI. CMS Analysis
At the time the negotiated rulemaking committee for clinical diagnostic laboratory tests was developing its recommendations for NCDs in 1998, the statutory language governing Medicare in the Social Security Act did not provide for coverage of screening for colorectal cancer. We have historically interpreted section 1862(a)(7), the statutory exclusion of routine physicals, to also exclude coverage of routine testing provided during such visits. Further, we have interpreted the exclusion of services that are not reasonable and necessary in section 1862(a)(1)(A) of the Act to exclude tests for which there are no signs, symptoms or personal history of disease, except where specifically noted in the law. Thus, in developing the list "Non-Covered ICD-9-CM Codes for All NCD Edits", we included all screening diagnoses other than those specifically covered by statute. This resulted in ICD-9-CM diagnosis code V76.51 being included on the list "Non-Covered ICD-9-CM Codes for All NCD Edits" in the NCD proposals.
Effective January 1, 2000, the Social Security Act was amended to add coverage of colorectal cancer screening under section 1861(pp) of the Act. This change in the statute became effective before the negotiated laboratory NCD rule became final in November 2001. The inclusion of the diagnosis codes for colorectal cancer screening on the list "Non-Covered ICD-9-CM Codes for All NCD Edits" went unnoticed by both CMS staff and the public commenters on the proposed rule. Consequently, it was incorporated into the final rule and has remained on the non-covered list without comment for nearly 3 years after implementation.
Given that the statute currently covers colorectal cancer screening, it is inappropriate to include this code on the list "Non-Covered ICD-9-CM Codes For All NCD Edits". We will remove the code in the April 2006 update of the laboratory edit module and NCD coding manual. We do not believe that this error has resulted in inappropriate payment. This is because the appropriate HCPCS code for billing for screening colorectal cancer testing has been G0107. G0107 is not included in any of the 23 NCDs and, therefore, is not edited for the codes on the list of "Non-Covered ICD-9-CM Codes For All NCD Edits".
In addition to the list "Non-covered ICD-9-CM Codes for All NCD Edits", each clinical laboratory NCD includes an "ICD-9-CM Codes Covered by Medicare Program" list. For all clinical laboratory NCDs, with the exception of the Blood Counts NCD, each covered code is enumerated in the list.
Differing from other clinical diagnostic laboratory NCD covered code lists, the Blood Counts NCD covered code list is constructed as an exclusionary rather than inclusionary list, and individual covered codes are not enumerated. Instead, the Blood Count NCD covered codes list includes all ICD-9-CM codes excluding those listed on either the "Non-covered ICD-9-CM Codes for All NCD Edits" list or on the list "ICD-9-CM Codes That Do Not Support Medical Necessity" for blood counts.
Because of this exclusionary aspect of code coverage for blood counts, removal of V76.51 from the non-covered code list would automatically result in inappropriate inclusion of V76.51 on the list of codes covered by Medicare for the Blood Count NCD. Consequently, CMS determined that V76.51 will be removed from the list "Non-covered ICD-9-CM Codes List for All NCD Edits" and added to the "ICD-9-CM Codes That Do Not Support Medical Necessity" list for blood counts.
As previously noted, we intend to issue a recurring update to the edit module implementing the NCDs to remove ICD-9-CM Code V76.51 from the list of "Non-covered ICD-9-CM Codes List for All NCD Edits" and to add it to the "ICD-9-CM Codes That Do Not Support Medical Necessity" list for blood counts.
