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-00283N Hepatitis Panel (Removal of ICD-9-CM Code, 784.69,
Other symbolic dysfunction, from the list of Codes Covered by Medicare)
From: Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Louis Jacques, MD
Director, Division of Items and Devices
James Rollins, MD, PhD, MSHA
Medical Officer, Division of Items and Devices
Technical Advisor, Division of Items and Devices
Subject: Coding Analyses for Hepatitis Panel
Date: March 11, 2005
CMS has determined that ICD-9-CM diagnosis code 784.69, Other symbolic dysfunction, does not flow from the existing narrative for conditions for which hepatitis panel is reasonable and necessary. We intend to modify the list of “ICD-9-CM Codes Covered by Medicare” in the NCD for hepatitis panel by removing code 784.69.
On December 23, 2004, CMS began a coding analysis for evaluation of the ICD-9-CM covered codes list for the hepatitis panel NCD. Hepatitis is an inflammation of the liver resulting from viruses, drugs, toxins, and other etiologies. The most common viral hepatitis forms are caused by hepatitis A virus, hepatitis B virus or hepatitis C virus. The hepatitis panel tests for antibodies for these viruses as well as hepatitis B surface antigen.
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. These NCDs included the hepatitis panel. 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 “ICD-9-CM Codes Denied,” 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. We determined in the hepatitis panel NCD that any ICD-9-CM code not listed in either of the ICD-9-CM covered or not covered sections would be categorized into this group that does not support medical necessity.
IV. Timeline of Recent Activities
On December 23, 2004, CMS open an internally generated coding analysis item regarding hepatitis panel after noting the inclusion of ICD-9-CM code 784.69 on the list of covered codes. We did not believe this code flowed from the narrative indications for hepatitis. We posted a tracking sheet to the Internet site (http://cms.hhs.gov/mcd/viewtrackingsheet.asp?id=146), soliciting public comment for 30 days on the appropriateness of deleting code 784.69 from the list of covered diagnoses for hepatitis panel. At the end of the public comment period, January 21, 2005, we had not received any comments.
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).
VI. CMS Analysis
As noted above, we have taken the position that the “ICD-9-CM Codes Covered by Medicare” list is intended to contain only those codes that flow from the narrative of the indication in the NCD. The hepatitis panel tumor NCD lists the following as indications for testing:
“1. To detect viral hepatitis infection when there are abnormal liver function test results, with or without signs or symptoms of hepatitis.
2. Prior to and subsequent to liver transplantation.”
We believe that the ICD-9-CM code 784.69, Other symbolic dysfunction, does not flow from the existing narrative indications statement quoted above. Code 784.69 is a speech disorder and does not necessarily reflect abnormal liver function or liver transplantation. We suspect that this code was put on the list in error during the negotiations and was not noticed due to the extremely high volume of codes being evaluated during the development of the NCD negotiated policies. Consequently, we intend to issue a recurring update to the edit module implementing the NCDs to remove ICD-9-CM code 784.69 from the list of the ICD-9-CM codes covered for hepatitis panel.