DMERC Coverage Of Treprostinil (Remodulin)

Original Effective Date: 10/01/2002
Revision Effective Date: 11/07/2013

In May 2002, the Food and Drug Administration (FDA) approved treprostinil for the treatment of pulmonary artery hypertension. Treprostinil is administered via subcutaneous injection using a type of infusion pump similar to the pump used for subcutaneous insulin infusion.

Coverage of this therapy, effective for dates of service on or after May 21, 2002, will be considered under the DMERC local medical review policy (LMRP) for external infusion pumps. Beneficiaries with pulmonary artery hypertension must meet the same coverage criteria as for the administration of parenteral epoprostenol:

  • The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease, etc.) or disorders of the respiratory system (e.g., chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders, etc.); and
  • The patient has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, thromboembolic disease of the pulmonary arteries, human immunodeficiency virus (HIV) infection, cirrhosis, diet drugs, congenital left to right shunts, etc. If these conditions are present, the following criteria must be met:
    • The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and
    • The mean pulmonary artery pressure is greater than 25 mm Hg at rest or greater than 30 mm Hg with exertion; and
    • The patient has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and
    • Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.

These coverage instructions will be incorporated into a future revision of the External Infusion Pumps Local Medical Review Policy.

Last Updated May 10 , 2017