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-00254N
Thyroid Testing (Inclusion of ICD-9-Code 733.02 for Idiopathic Osteoporosis)
From: Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Louis Jacques, MD
Director, Division of Items and Devices
Jackie Sheridan-Moore
Technical Advisor, Division of Items and Devices
James Rollins, MD
Medical Officer, Division of Items and Devices
Subject: Coding Analyses for Thyroid Testing
Date: November 23, 2004
I. Decision
CMS has determined that ICD-9-CM diagnosis code 733.02, Idiopathic osteoporosis, flows from the existing narrative for conditions for which thyroid testing is reasonable and necessary. We intend to modify the list of “ICD-9-CM Codes Covered by Medicare” in the NCD for thyroid testing to include this code.
II. Background
On September 27, 2004, CMS began a coding analysis for expansion of the ICD-9-CM covered codes list for the thyroid testing NCD. Thyroid function studies are used to delineate the presence or absence of hormonal abnormalities of the thyroid and pituitary glands. These abnormalities may be either primary or secondary and often, but not always, accompany clinically defined signs and symptoms indicative of thyroid dysfunction.
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 thyroid testing. 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 negotiated 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 thyroid testing 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 September 27, 2004, CMS opened an internally generated coding analysis item regarding thyroid testing after receiving a request noting that the list of covered codes neglected to include the ICD-9-CM diagnosis codes for idiopathic osteoporosis. We posted a tracking sheet to the Internet site (http://cms.hhs.gov/mcd/viewtrackingsheet.asp?id=138), soliciting public comment for 30 days on the appropriateness of adding code 733.02, Idiopathic osteoporosis, to the list of covered diagnoses for thyroid testing. At the end of the public comment period, October 27, 2004, we had received one comment.
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 thyroid testing NCD lists the following as an indication for testing:
“Thyroid function testing may also be medically necessary in patients with metabolic disorders; malnutrition, hyperlipidemia; certain types of anemia; psychosis and non-psychotic personality disorders; unexplained depression; ophthalmologic disorders; various cardiac arrhythmias; disorders of menstruation; skin conditions; myalgias; and a wide array of sign and symptoms, including alterations in consciousness; malaise; hypothermia; symptoms of the nervous and musculoskeletal system; skin and integumentary system; nutrition and metabolism; cardiovascular; and gastrointestinal system.”
We believe that the ICD-9-CM code 733.02, Idiopathic osteoporosis, flows from the existing narrative indications statement quoted above. Specifically, we believe this flows from the statement regarding symptoms of musculoskeletal system. Consequently, we intend to issue a recurring update to the edit module implementing the NCDs to add ICD-9-CM code 733.02 to the list of the ICD-9-CM codes covered for thyroid testing.
We received a comment during the public comment period requesting that ICD-9-CM code 733.00, Osteoporosis, unspecified, also be added to the NCD covered diagnosis list. The commenter felt that since this code could include osteoporosis which is not specified as being due to primary or secondary thyroid dysfunction, it would be appropriate to add this code. We are hesitant to add unspecified codes to the list of covered diagnoses. Often the unspecified code is used when a physician fails to note the cause of the disease. Since some forms of osteoporosis, such as disuse osteoporosis, clearly are not appropriate for thyroid testing, we are not adding the unspecified code to the covered list at this time.
