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L.9.03.410
Ocriplasmin is a recombinant truncated form of human plasmin, a proteolytic enzyme that breaks down protein components at the vitreoretinal interface in the eye, used for symptomatic vitreomacular adhesion and vitreomacular traction. Ocriplasmin is injected into the affected eye (intravitreal) as a single dose and can induce vitreous liquefaction and separation from the retina.
Vitreous is a gel-like fluid within the eye that adheres completely to the surface of the retina. The consistency of the vitreous and its adhesion to the retina are maintained by several proteins, including collagen, laminin, and fibronectin. With aging, the proteins in the vitreous break down, resulting in liquefaction of vitreous and eventual separation of the vitreous from the retina, a process called posterior vitreous detachment.
The process of vitreous detachment usually proceeds without incident, but sometimes the separation is incomplete. Adhesion usually remains at sites where the bonds between the vitreous and retina are the strongest. In some cases, the adhesion can cause visual symptoms. The traction caused by the adherent vitreous can cause deformation of the retina, edema, and full-thickness macular holes. Although the terms are sometimes used synonymously, the International Vitreomacular Traction Study Group has defined vitreomacular adhesion as adhesion at the macula without detectable changes in retinal morphology and vitreomacular traction as adhesion with retinal morphologic changes but without full-thickness defect. Both vitreomacular adhesion and vitreomacular traction can be focal or diffuse.
Treatment
Symptoms of vitreomacular adhesion or vitreomacular traction can vary and may include diminished visual acuity, distorted vision (metamorphopsia), and central field defect. Patients are usually observed until resolution or worsening, in which case vitrectomy is the standard treatment. Spontaneous release of vitreomacular adhesion and vitreomacular traction occurs in about 30% of cases over a period of 1 to 2 years, and observation is usually indicated because vitrectomy has risks and an almost certain occurrence of cataract in the years following the procedure.
Ocriplasmin is a recombinant product that is a shortened form of the protease plasmin. Early studies of ocriplasmin, conducted in patients scheduled to have vitrectomy, established doses that showed some effect in inducing posterior vitreous detachment.
On October 17, 2012, ocriplasmin (Jetrea®, ThromboGenics) was approved by the U.S. Food and Drug Administration for the treatment of symptomatic vitreomacular adhesion. Manufacturing and distribution of ocriplasmin has been discontinued in the United States since 2020.
A single intravitreal injection of ocriplasmin may be considered medically necessary for treatment of an eye with symptomatic vitreomacular adhesion or vitreomacular traction.
The use of intravitreal ocriplasmin is considered investigational in all other situations, including use of repeat injections of ocriplasmin.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
The precise patient indications for treatment are uncertain. Eligibility criteria for the key randomized controlled trial included the following:
Clinical input has suggested that not all trial exclusion criteria should be absolute. However, there was no consensus on the recommended exclusion criteria.
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 Mental Health Disorders, 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 medical necessity, “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.
04/01/2014: Approved by Medical Policy Advisory Committee.
09/22/2014: Policy reviewed; description updated. Policy statement unchanged.
07/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to correct HCPCS code: J7312 was changed to J7316.
08/26/2015: Medical policy revised to add ICD-10 codes.
11/06/2015: Policy description updated regarding vitreomacular traction (VMT). Policy statements unchanged.
04/25/2016: Added vitreomacular traction to the medically necessary policy statement.
05/27/2016: Policy number A.9.03.30 added.
04/03/2017: Policy reviewed; no changes.
04/16/2018: Policy description updated. Policy statements unchanged.
04/11/2019: Policy reviewed; no changes.
04/20/2020: Policy description updated. Policy statements unchanged.
06/10/2021: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."
05/23/2022: Policy reviewed; no changes.
04/21/2023: Policy description updated regarding the manufacturing and distribution of ocriplasmin. Policy statements unchanged.
04/26/2024: Policy description updated. Policy statements unchanged. Policy Guidelines updated regarding clinical input.
07/26/2024: Policy updated to change the medical policy number from "A.9.03.30" to "L.9.03.410."
Blue Cross and Blue Shield Association Policy # 9.03.30
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.
Code Number | Description | ||
CPT-4 | |||
67028 | Intravitreal injection of a pharmacologic agent (separate procedure) | ||
HCPCS | |||
J7316 | Injection, ocriplasmin, 0.125 mg | ||
ICD-9 Procedure | ICD-10 Procedure | ||
ICD-9 Diagnosis | ICD-10 Diagnosis | ||
379.27 | Vitreomacular adhesion | H43.821 - H43.829 | Vitreomacular adhesion code range |
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