(Reproduced by permission from Medicare Focus, March, 1999)
Description
Viral load testing is the direct measurement of the amount of free virus ribonucleic acid (RNA) in the blood of Human Immunodeficiency Virus (HIV) infected individuals.
The recent development of highly sensitive molecular methods for detection of HIV-1 of human immunodeficiency nucleic acids has both accelerated our virus understanding of HIV-1 pathogenesis and provided new tools for monitoring of viral infection.
Type of Bill
12X, 13X, 14X, 22X, 23X, 71X, 72X
Revenue Code
30X
Indications and Limitations of Coverage and/or Medical Necessity
Indications
Quantitative testing for HIV-1 viral load is indicated in the following situations:
· | As an aid in determining activity of disease at any stage of infection |
· | To assess response to chemotherapy |
Viral load testing is a prognostic test and is not used for diagnosis of HIV. Viral load testing is indicated in patients infected with the HIV as determined by HIV-ELISA testing with confirmatory Western Blot.
Viral load testing and CD4+ cell counts may be measured in parallel. Increased viral load measurements may be indicative of other metabolic occurrences such as immunizations.
Limitations
The only method approved by the FDA for HIV-1 Viral load quantitation is AmplicorTM HIV MonitorTM Test (quantitative PCR assay from Roche Diagnostic Systems).
Currently, two methods are available on an investigational basis for HIV-1 viral quantitation:
· | Quintiplex HIV RNA-assay (branched DNA technology from Chiron Corporation). |
· | NASBATM (Nucleic Acid Sequence-Based Amplification from Organon Teknika). |
Promising ultra-sensitive testing methods are pending FDA approval.
Though both the FDA approved and non-FDA approved HIV Viral load tests are clinically accepted and used, current guidelines caution that when doing sequential Viral load tests in a given patient, the assays must be done by the same facility using the same technique. It is generally recommended that at least two baseline assays be taken about two (2) weeks apart, followed by additional viral load tests every three to four months while a patient is stable and on therapy. More frequent testing may be required when adding or switching a patient's drug therapy.
Viral load testing should be avoided for three to four weeks following an immunization (including flu shots) or within one month of an infection.
HCPCS Code
87536 | Infectious agent detection by nucleic acid (DNA or RNA); Bartonella | |
HIV-1, quantification | ||
ICD-9 Codes That Support Medical Necessity
Diagnosis Definition
Human Immunodeficiency Virus (HIV) Infection
042
HCPCS Section and Benefit Category
Pathology/Laboratory
Microbiology
HCFA National Coverage Policy
Title XVIII of the Social Security Act, Section 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be reasonable and medically necessary, i.e., reasonable and necessary are those tests used in the diagnosis and management of illness or injury or to improve the function of a malformed body part.
Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
Reasons For Denial
HIV-1 Viral load testing (87536) used for predicting maternal-fetal transmission of HIV-1 is considered investigational. Medicare does not pay for investigational testing methodology.
Viral load testing performed by investigational methods not approved by the FDA such as Chiron Quintuples (BDNA), Nucleic Acid Sequence - Based Amplification (NASBA), and testing procedures developed in-house by individual laboratories and commonly referred to as _home brews" are subject to medical review by this Intermediary. See "Comments."
Non-Covered ICD-9 Diagnosis Codes
Any diagnosis not listed in this policy.
Sources of Information
PMIC AB-97-9, June 1997
PMIC AB-97-23, December 1997
Simple Facts Index - http://www.aidsinfonyc.org/network/simple/viral.html
Department of Health and Human Services - HCFA, June 1997
Coding Guides
Only HIV Viral load testing should be billed using HCPCS Code 87536.
Reconsiderations and Appeals - Claims resubmitted with a different diagnosis code must include medical record documentation to justify the diagnosis code change. Submission with diagnosis codes other than those listed as "Covered Codes" will be individually reviewed by this Intermediary for medical necessity.
Documentation Requirements
If the provider of service is other than the original referring physician, that provider must maintain hard copy documentation of test results and interpretation along with copies of the ordering/referring physician's order for the studies. The physician must state that the clinical indication/medical necessity for the study in his order for the test.
All coverage criteria must be documented in the patient's medical record and made available to Medicare upon request. This information should be generally submitted on reconsideration only (or with the claim if the services are unusual or if denial is anticipated). See _Coding Guidelines" section above.
ICD-9-CM diagnosis codes are required on claim.
Medical records must clearly document the medical necessity for the test and the frequency of the test.
If documentation is requested for review, submit the following:
· History and Physical
· Physician orders/progress notes
· Diagnosis/reason for test
· Test results
· Itemization of charges
Comments
The service must be considered acceptable under state standards of practice to be a specific and effective treatment for the beneficiary's condition.
This policy should be interpreted to incorporate future changes in the ICD-9-CM or CPT/HCPCS coding systems such that its original intent and scope will not be substantively changed.
Start Date of Comment Period: | September 4, 1998 |
Start Date of Notice Period: | March 1, 1999 |
Effective Date: | April 1, 1999 |
This policy does not reflect the sole opinion of the Intermediary/Medical Director. This policy was developed in cooperation with representatives from physician specialties and other Intermediaries.