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 coding guidelines that are linked to the negotiated laboratory NCD for urine culture, bacterial. 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-00298N Coding Guidelines for Urine Culture
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
Jackie Sheridan-Moore
Technical Advisor, Division of Items and Devices
RE: Coding Analyses for Coding Guidelines for Urine Culture
Date: November 14, 2005
I. Decision
CMS has determined that Coding Guideline 1 in the Urine Culture, Bacterial National Coverage Determination (NCD) is obsolete. Recent revisions of several of the IDC-9-CM codes in the annual ICD-9-CM updates and changes in the covered codes list related to pre-operative examination have superseded the information in Coding Guideline 1. We will delete Coding Guideline 1 from the Clinical Diagnostic Laboratory Services NCD Coding Policy Manual in a future update.
II. Background
On August 29, 2005, CMS began a coding analysis for evaluation of coding guideline 1 for the Urine Culture, Bacterial NCD. This guideline addresses pre-operative use of urine culture. In short, it lists a series of codes that may support the medical necessity of a pre-operative urine culture. However, since the coding guideline was developed several of the codes in this list have been deleted through annual updates of the ICD-9-CM. Further, past coding analyses have removed some of the codes from the list of ICD-9-CM codes that are covered for Urine Culture, Bacterial, rendering the list inaccurate.
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 “ICD-9-CM Codes Denied,” and lists diagnosis codes that are never covered by Medicare. The ICD-9-CM Codes Denied are applicable to all 23 of the negotiated clinical diagnostic laboratory NCDs. 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.
The negotiated Laboratory NCDs include a list of general coding guidelines that apply to each of the 23 negotiated laboratory NCDs. Further, there are specific coding guidelines that apply to many of the individual test specific NCDs. These coding guidelines can be found on pages 9-13 of the Laboratory NCD Coding Policy Manual.
IV. Timeline of Recent Activities
On August 29, 2005, CMS opened a coding analysis regarding revision of the coding guideline 1 for the urine culture NCD. We posted a tracking sheet to the Internet site (http://cms.hhs.gov/mcd/viewtrackingsheet.asp?id=171), soliciting public comment on the coding guideline for 30 days.
At the end of the public comment period, September 29, 2005, we had received two comments. Neither of the comments was specific to the coding guideline, but addressed general issues with the urine culture NCD covered code list. The commenters related personal conclusions and did not provide any scientific literature to support their conclusions.
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 and coding guidelines 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. 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 material 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
Coding guideline number 1 for the Urine Culture, Bacterial NCD states:
“In the case of pre-operative examination (V72.84), the following codes may support medical necessity: 585, 586, 592.0-592.9, 594.0-594.9, 600.0-600.9, 602.0-602.9, 939.0, 939.3.”
Subsequent to the inclusion of this coding guideline in the negotiated NCDs, CMS has made a number of changes that impact on the guideline as outlined below.
On April 1, 2004, CMS issued a Coding Analysis for Laboratories (CAL) determination regarding renal failure codes in the urine culture NCD (see cms.hhs.gov/mcd/viewdecisionmemo.asp?id=100). This decision memorandum explained our belief that several codes, including ICD-9-CM code 586, acute renal failure, unspecified, do not flow from the narrative indications for urine culture. This decision also stated our belief that code 585, chronic renal failure, was supported only to the extent that it indicated patients about to undergo renal transplantation.
On July 26, 2004, CMS issued a CAL determination regarding inclusion of ICD-9-CM code V72.84, pre-operative examination, unspecified in the list of ICD-9-CM codes covered by Medicare for Urine Culture, Bacterial. (See cms.hhs.gov/mcd/viewdecisionmemo.asp?id=127.) This decision stated our conclusion that ICD-9-CM code V72.84 was placed on the list of covered codes erroneously in that the Medicare statute excludes coverage of screening services.
Effective October 1, 2003, the ICD-9-CM codes in the 600.0-600.9 series were expanded to include a fifth digit. Thus, the 600.0-600.9 series was deleted from the list of covered codes following a 90-day grace period. Similarly, ICD-9-CM code 585 was deleted by the annual ICD-9-CM update effective October 1, 2005. This code was replaced with a series of codes recognizing differing stages of kidney disease. In keeping with the CAL decision memorandum issued April 1, 2004 regarding renal failure codes, only code 585.6 indicating renal transplantation was added to the urine culture NCD.
The NCD narrative indication regarding pre-operative use of urine culture states the following:
“In surgical procedures involving major manipulations of the genitourinary tract, preoperative examination to detect occult infections may be indicated in selected cases (for example, prior to renal transplantation, manipulation or removal of kidney stones, or transurethral surgery of the bladder or prostate).”
We are concerned that the Urine Culture, Bacterial coding guideline 1 is no longer current with ICD-9-CM and CAL changes. Specifically, of the nine code ranges identified in the guideline, four are no longer accurate. While we could retain and correct the coding guideline, we do not believe this is the best course of action. The NCD narrative indication is sufficient to support appropriate coverage of urine cultures. Further, future changes to ICD-9-CM codes would render the guideline again inaccurate.
Moreover, we do not believe that the information in this statement is appropriately considered as a coding guideline. Coding guidelines are general statements providing overall guidance on how to appropriately code for various situations. Coding guideline 1 is more appropriately characterized as a subset of the ICD-9-CM Covered Codes List. We do not believe that such a list is necessary or appropriate for this NCD. Consequently, we will be deleting this coding guideline in an upcoming version of the coding manual and renumbering the remaining urine culture coding guidelines.
