Photodynamic therapy with verteporfin (Visudyne®) involves an intravenous injection of verteporfin, a photosensitizer, or light-activated drug. After the infusion, the verteporfin is activated by illumination with light from a laser source at the wavelength that corresponds to the absorption peak of the drug but is not strong enough to create thermal damage to the overlying visual cells.
Therapeutic benefit from this therapy has been proven for patients with Age-Related Macular Degeneration (AMD), pathologic myopia and ocular histoplasmosis.
Age-Related Macular Degeneration
Prior to initiation of treatment, documentation of the patient’s condition must include a fluorescein angiogram that demonstrates predominantly classic subfoveal Choroidal Neovascularization (CNV) where the area of classic CNV occupies at least 50 percent of the entire lesion with a greatest linear dimension that is equal to or less than 7000-7500 microns.
The patient who meets all of the indications and demonstrates none of the limitations will be eligible for the initial therapy and follow-up for up to five treatments per eye, per year for no more than two years.
Note: These criteria are intended to apply only to the first treatment. Further treatments will depend on clinical evidence of deterioration as demonstrated by persistent fluorescein leakage from CNV.
Ocular Histoplasmosis or Pathologic Myopia
Prior to initiation of treatment, documentation of the patient’s condition must include the indications below:
  • Subfoveal CNV leakage secondary to ocular histoplasmosis or pathologic myopia.
  • Treatment should be considered when the treatment outcome is anticipated to be better than the resulting absence of treatment.
Age-Related Macular Degeneration
Ocular Photodynamic Therapy (OPT) should not be carried out in the following four situations:
  • Inability to obtain photographs to document classic CNV.
  • History of CNV in the eye(s) to be treated that has received conventional laser treatment for subfoveal classic CNV, unless there is fluorescein leakage within the area of prior treatment.
  • Active hepatitis or clinically significant liver disease, unless cleared by an appropriate medical evaluation.
  • Porphyria or other porphyrin sensitivity.
Additional care should be taken when there is evidence or history of a tear of the retinal pigment epithelium or subfoveal lesions are contiguous to the optic nerve. The treatment spot should be placed at least 200 um away from the optic nerve.
Ocular Histoplasmosis or Pathologic Myopia
OPT should not be considered if retinal arteriolar or retinal venular non-perfusion exists.
Additional care should be taken when subfoveal lesions are contiguous to the optic nerve. The treatment spot should be placed at least 200 um away from the optic nerve.
Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
As published in CMS IOM 100-08, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical need.
    • At least as beneficial as an existing and available medically appropriate alternative.
Drug Wastage
Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug and made good faith efforts to minimize the unused portion of the drug in how it is supplied, then the program will cover the amount of drug discarded along with the amount administered. Documentation requirements are given below. Coding and billing instructions can be referenced in the attached article. Reference to national policy:Medicare Claims Processing Manual – Pub. 100-04, Chapter 17, Section 40.
Note: The JW modifier is not used on claims for drugs or biologicals provided under the Competitive Acquisition Program (CAP). Reference to national policy: Medicare Claims Processing Manual, Pub. 100-04, Chapter 17, Section 100.2.9.
Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 18X, 21X, 22X, 23X, 71X, 73X, 77X, 85X
Bill Type Note: Code 73X end-dated for Medicare use March 31, 2010; code 77X effective for dates of service on or after April 1, 2010.
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Note: TrailBlazer has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/orRevenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual Publication 100-04, Claims Processing Manual, for further guidance.
0250, 051X, 0636, 092X
Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
Ocular photodynamic ther
Eye photodynamic ther add-on
Injection, verteporfin, 0.1 mg
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes 67221, 67225 and J3396:
Covered for:
Histoplasma capsulatum retinitis
Progressive high (degenerative) myopia
Retinal neovascularization, NOS
*Note: 362.16* MUST be accompanied by either 115.02 for ocular histoplasmosis or 360.21 for pathologic myopia for coverage to occur.
Macular degeneration (senile), unspecified
Exudative senile macular degeneration
Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
Diagnoses That Support Medical Necessity
ICD-9-CM Codes That DO NOT Support Medical Necessity
Nonexudative senile macular degeneration
Diagnoses That DO NOT Support Medical Necessity
All diagnoses not listed in the “ICD-9-CM Codes That Support Medical Necessity” section of this LCD.
Documentation Requirements
Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to Medicare upon request.
Drug Wastage Documentation Requirements
Any amount wasted must be clearly documented in the medical record, regardless of whether the JW modifier will be used in billing for the drug/biological, with:
  • Date and time.
  • Amount of medication wasted.
  • Reason for the wastage.
Utilization Guidelines
Patients may receive retreatment as often as every three months (plus or minus two weeks) after a previous treatment if there is any fluorescein leakage from the CNV, as documented with a recent angiogram.
Retreatment could be considered earlier than three months (plus or minus two weeks) if a patient complains of vision loss, has documented visual acuity loss and fluorescein angiography shows enlargement of CNV when compared with the previous, most recent angiography.
Medicare would not expect to see more than five treatments within a 12-month period.
Treatment should be discontinued:
  • With the documented absence of CNV leakage.
  • When the entire area of fluorescein leakage cannot be covered by the largest treatment spot on the laser.

Notice: This LCD imposes utilization guideline limitations. Despite Medicare’s allowing up to these maximums, each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services.