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Interferon alphas are naturally occurring glycoproteins which stimulate or regulate a wide range of biologic responses such as interfering with viral multiplication processes (anti-viral), inhibiting tumor growth (antiproliferative), activating the immune system or modifying the immune response (immunomodulatory effects), and stimulating specialization of cells (differentiation-inducing effects). Interferon alpha-2a (Roferon-A®), derived using recombinant DNA technology, shows activity similar to the endogenous human interferon alphas.
FDA APPROVED INDICATIONS
Interferon alpha-2a (Roferon-A®) is indicated for the treatment of chronic hepatitis C and hairy cell leukemia and AIDS-related Kaposi’s sarcoma in patients who are 18 years of age or older. It is also indicated for chronic phase, Philadelphia chromosome positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis).
Related medical policy -
Prior authorization is required.
Interferon alpha-2a (Roferon-A®) is considered medically necessary for patients 18 years of age or older with hairy cell leukemia, AIDS-related Kaposi's sarcoma, and in patients with Philadelphia chromosome positive chronic myelogenous leukemia within 1 year of diagnosis.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
7/1997: Date originally issued
4/1999: Approved by Pharmacy & Therapeutics (P & T) Oncology Committee
1/30/2002: Prior Authorization and Managed Care Requirements deleted
2/15/2002: Investigational definition added
4/30/2002: Type of Service and Place of Service deleted. Code Reference section updated. CPT codes 51720 and 96445 deleted. CPT codes 90782 and 96400 description revised. ICD-9 Procedure code 96.49 deleted. ICD-9 Procedure code 99.28 and 99.29 (Peritoneal instillation of INF deleted) description revised.
8/2/2002: ICD-9 diagnosis code 042 moved to non-covered, ICD-9 diagnosis code range 176.0-176.9 description clarified
11/27/2002: Policy section revised, Code Reference section updated, ICD-9 diagnosis code 154.9 deleted
10/28/2005: Code Reference section updated. Covered CPT-4 code 90782 deleted. Covered ICD-9 diagnosis code 152.0-152.9, 155.0-155.2, 162.2-162.9, 197.0, 197.8 deleted; ICD-9 diagnosis codes 189.2-189.9 added; revised description: 140.0-149.9, 189.0-189.9, 230.9, 233.3; detail code range: 140.0-149.9, 150.0-150.9, 153.0-153.9, 154.0-154.8, 157.0-157.9, 160.0-160.9, 161.0-161.9, 170.0-170.9, 172.0-172.9, 173.0-173.9, 176.0-176.9, 188.0-188.9, 189.0-189.9, 191.0-191.9, 200.00-200.08, 200.10-200.88, 202.00-202.08, 202.10-202.18, 202.20-202.28, 202.30-202.38, 202.40-202.48, 202.50-205.58, 202.60-202.68, 202.80-202.88, 202.90-202.98, 203.00-203.01, 204.10-204.11, 205.00-205.91, . Covered HCPCS code S0145 added. Non-covered Codes table deleted. Non-covered CPT-4 code 51720 deleted. Non-covered ICD-9 procedure code 96.49 deleted. Non-covered ICD-9 diagnosis code 042, 051.0-051.9, 053.0-053.9, 054.0-054.9, 070.20-070.33, 078.11, 078.19, 078.5, 079.3, 079.4, 151.0-151.9, 158.0-158.9, 171.0-171.9, 174.0-174.9, 175.0-175.9, 180.0-180.9, 184.4, 185, 189.2-189.9, 190.1, 190.3, 190.6, 190.9, 197.6, 198.4, 198.81, 201.0-201.9, 204.00-204.01, 206.00-206.01, 208.00-208.01, 228.00-228.09, 230.2, 231.2, 233.0, 233.1, 233.4, 234.0, 234.8, 238.7, 340, 571.40-571.49, 702.0, 771.1, 999.0, 999.3, V02.61, V08 deleted
03/13/2006: Coding updated. CPT4 2006 revisions added to policy.
09/06/2006: FDA approved indications and policy section revised. Removed investigational, off-label uses, and dosing information.
9/13/2007: Code reference section updated per the annual ICD-9 updates effective 10-1-2007.
9/11/2008: Code reference section updated per the annual ICD-9 updates effective 10-1-2008.
01/01/2009: CuraScript preferred provider information removed. BCBSMS information added.
04/01/2014: Policy title changed from "Interferon-alpha-2a (Roferon-A®)" to "Interferon alpha-2a (Roferon-A®)." Policy description updated regarding FDA approved indications. Policy statement updated to add AIDS-related Kaposi's sarcoma as a covered indication.
08/26/2015: Code Reference section updated for ICD-10. Removed ICD-9 procedure code 99.29.
05/27/2016: Policy number L.5.01.440 added. Policy Guidelines updated to add medically necessary and investigative definitions.
11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
Fact and Comparisons, July 1996
American Hospital Formulary Services, 1998
Hayes Medical Technology Directory, July 1996
Lexi-Comp Online (added 09-06-2006)
Roferon-A Prescribing Information (added 09-06-2006)
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.