Testopel Coverage - JF Part B

Injectable testosterone pellets (brand name Testopel™) may be covered, by Medicare, for the FDA approved indication, if the service meets all Medicare coverage requirements quoted below verbatim in the CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.3.2

Injection Method Not Indicated

Medication given by injection (parenterally) is not covered if standard medical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration. For example, the accepted standard of medical practice for the treatment of certain diseases is to initiate therapy with parenteral penicillin and to complete therapy with oral penicillin. Carriers exclude the entire charge for penicillin injections given after the initiation of therapy if oral penicillin is indicated unless there are special medical circumstances that justify additional injections."

The Noridian Contractor Medical Directors (CMDs) believe 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. Compliance with Medicare requirements is subject to review by the Recovery Auditors.

A submitted claim form must contain the below information.

• Item 19 of CMS-1500 paper claim or Loop 2400/SV101-7 for electronic claims
  • Enter word "Testopel"
  • Enter drug dosage given (include milligrams delivered only)
• Note: Medicare may only cover the number of pellets actually implanted in the patient (maximum of six pellets); wastage is not covered. Use of additional pellets may be paid on appeal if the documentation supports medical necessity as determined by the FDA approved drug label and the service complies with all Medicare requirements as indicated above.
• Item 24D or electronic equivalent
  • Enter "J3490"