This version of the policy will become effective 06/03/2019.
This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling, including age requirements. Dosing and frequency requirements were added for all the agents. Laboratory and/or genetic testing requirements were added to all diagnoses.
When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
E76.01 Hurler's syndrome
E76.02 Hurler-Scheie syndrome
E76.03 Scheie's syndrome
E76.1 Mucopolysaccharidosis, type II
E76.210 Morquio A mucopolysaccharidoses
E76.29 Other mucopolysaccharidoses
J1322 Injection, elosulfase alfa, 1 mg
J1458 Injection, galsulfase, 1 mg
J1743 Injection, idursulfase, 1 mg
J1931 Injection, laronidase, 0.1 mg
J3397 Injection, vestronidase alfa-vjbk, 1 mg
Policy: 08.00.15e:Off-label Coverage for Prescription Drugs and/or Biologics