Article - Billing and Coding: Treatment of Males with Low Testosterone (A58828)

CMS National Coverage PolicyTitle XVIII of the Social Security Act 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claimCMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 50.4.3 Examples of Not Reasonable and Necessary #2. Injection Method Not Indicated and 80, Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic TestsArticle TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for Treatment of Males with Low Testosterone L39086.The Current Procedural Terminology (CPT)/Healthcare Common Procedure Coding System (HCPCS) code(s) may be subject to National Correct Coding Initiative (NCCI) edits. This information does not take precedence over NCCI edits. Please refer to NCCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.General Guidelines for Claims submitted to Part A or Part B MAC:Procedure codes may be subject to NCCI edits or Outpatient Prospective Payment System (OPPS) packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare. For services requiring a referring/ordering physician, the name and National Provider Identifier (NPI) of the referring/ordering physician must be reported on the claim. A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under 1833(e) of the Social Security Act. The diagnosis code(s) must best describe the patient's condition for which the service was performed. For diagnostic tests, report the result of the test if known; otherwise the symptoms prompting the performance of the test should be reported.Coding Guidance:Providers should refer to the applicable American Medical Association (AMA) CPTManual to assist with proper reporting of these services.Injectable testosterone pellets (brand name Testopel) may be covered, by Medicare, for the United States (U.S.) Food and Drug Administration (FDA) approved indication, if the service meets all Medicare coverage requirements quoted in the CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 50.4.3 Examples of Not Reasonable and Necessary #2. Injection Method Not Indicated.Pellet implantation is much less flexible for dosage adjustment and more invasive than oral medication, nasal administration, transdermal administration or intramuscular injection. This A/B MAC believes that the use of this product should be rare since the "accepted method of medical practice" is to administer testosterone transdermally, but there may be reasons that require this injectable medication.The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate titrated to a serum testosterone level in the low normal range for a healthy adult male. The usual dosage is 150 mg to 450 mg subcutaneously every 3 to 6 months, which translates to 2 to 6 pellets every 3 to 6 months. Insertion of more than 6 pellets every 3 months will not be considered reasonable and necessary. Medicare may only cover the number of pellets actually implanted in the patient (maximum of 6 pellets); wastage is not covered.Documentation RequirementsThe patient's medical record must contain documentation that fully supports the medical necessity for services included within the related LCD (seeCoverage Indications, Limitations and/or Medical Necessity). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.Medical record documentation must be available to Medicare upon request.