Intravitreal Injections: A Coding and Reimbursement Review
The number of claims your practice files will increase as new therapeutic substances become available.
KEVIN J. CORCORAN, COE, CPC, FNAO

Figure. Between 1998 and 2002, the number of claims paid by Medicare for intravitreal injections increased 250.4%.

Ophthalmologists, particularly retina specialists, have recently demonstrated significant enthusiasm for intravitreal injections to treat a variety of conditions. Medicare's database of paid claims from 1998 to 2002 shows a huge increase in the utilization of 67028, intravitreal injection of a pharmacological agent, separate procedure (Figure). As you would suspect, at this time, injections of triamcinolone (Kenalog) account for most of the increase, but several other substances are currently in use, in development or in late-stage clinical trials (Table 1).

Many of the diseases being treated are severe, with poor prognoses and limited treatment options. The dearth of treatment modalities for these conditions is one reason why the National Eye Institute has partnered with QLT to develop a preservative-free triamcinolone acetonide (PFTA), suitable for intravitreal injection. While the clinical trials of PFTA are ongoing, intravitreal Kenalog remains an off-label procedure, but the literature contains numerous citations in support of this approach to treat wet age-related macular degeneration, clinically significant macular edema (CSME), and central retinal vein occlusion.

Table 1. Several substances for intravitreal injection are currently in use or under investigation. *Anecortave acetate (Retaane, Alcon) is an antiangiogenic synthetic analog of cortisol currently in clinical trials for the treatment of wet AMD, but the route of administration is sub-Tenon, not intravitreal.

Coding rules for new treatments delivered by intravitreal injection will be the same as those in place for currently approved treatments.

Some injections and the injected substance are reimbursed as part of a larger procedure. For example, injections of anesthetics at the time of surgery, of fluorescein or indocyanine green during angiography, and antibiotics or antiinflammatory agents at the end of surgery are not separately reimbursed. Intravitreal injections (CPT 67025, 67028) are considered surgical procedures, and whether they are reimbursed by Medicare and other third-party payers depends on the timing and the reason they are performed.

The CPT code 67025 describes an injection of vitreous substitute, pars plana or limbal approach, fluid-gas exchange, with or without aspiration, separate procedure. CPT 67028 describes an intravitreal injection of a pharmacologic agent, separate procedure. 67025 is a major surgery with a 90-day postoperative period; 67028 is a minor procedure with zero postoperative days.

Several considerations affect coding and reimbursement for intravitreal injections:

• medical indication (i.e., FDA-approved, off-label, investigational, experimental)
• substance injected (i.e., pharmaceutical or vitreous substitute)
• concurrent surgical procedure (if any)
• history of prior surgical procedure (if any)
• whether the injection is within the postoperative period of another procedure
• location where the intravitreal injection is given (i.e., physician's office, ambulatory surgery center, hospital outpatient department [HOPD]).

KEY ASPECTS OF PROPER CODING

The significance of these factors is as follows:

	Table 2. Correct use of modifiers as they relate to intravitreal injections performed within the postoperative period of another surgery.

Medical indications. Investigational or experimental procedures are not covered by Medicare and other third-party payers. In such cases, the patient is financially responsible for payment, but you must get the beneficiary's agreement to pay for your services in advance. For Medicare beneficiaries, an Advance Beneficiary Notice (ABN) is required. For non-Medicare beneficiaries, an insurance waiver is needed.

If a substance is used in an off-label manner, insurance coverage is difficult to determine. Is it investigational? That's hard to say. If you can obtain pre-certification or pre-authorization, you're in good shape. Otherwise, an ABN or waiver is the only way to ensure you'll be paid.

Injected substance. As noted previously, the key distinction between 67025 and 67028 is the injected substance. Injections of vitreous substitutes, gases, and spreading agents are associated with 67025. Anti-inflammatory agents, antibiotics, and anticoagulants are associated with 67028. As you read further, you'll find there are large differences in the payment amounts for these two procedures (Table 3).

"Separate procedure." The designation "separate procedure" carries special significance in CPT and is widely misunderstood or ignored. Too many physicians are unaware of the import of this descriptor and overlook the implications. CPT includes these explanations:

"Some of the procedures or services listed in CPT that are commonly carried out as an integral component of a total service or procedure have been identified by the inclusion of the term, 'separate procedure.' The codes designated as 'separate procedure' should not be reported in addition to the code for the total procedure or service of which it considered an integral component.

"However, when a procedure or service that is designated as a 'separate procedure' is carried out independently or considered to be unrelated or distinct from other procedures/services provided at that time, it may be reported by itself, or in addition to other procedures/services by appending modifier -59 to the specific 'separate procedure' code to indicate that the procedure is not considered to be a component of another procedure, but is a distinct, independent procedure. This may represent a different session or patient encounter, different procedure or surgery, different site or organ system, separate incision /excision, separate lesion, or separate injury..."

For example, repair of retinal detachment commonly includes an intravitreal gas injection. Both CPT and the National Correct Coding Initiative treat the intravitreal injection as an incidental part of the RD repair, and no separate claim should be made. However, when intravitreal injections are performed as the sole procedure, then there is no inhibition to reimbursement.

Postoperative period (Table 2). Quite a lot has been written about the rules and regulations surrounding postoperative care. The general rule is simple. The global surgery package includes any additional medical or surgical services during the postoperative period to treat a complication, but not requiring a return to the operating room (Medicare Claims Processing Manual, Ch. 12, §40.1A). Unplanned procedures to cope with a complication are addressed by this concept.

However, when the surgeon's surgical plan includes planned procedures, then special rules apply (i.e., modifier -58). In the case of intravitreal injections, modifier -58 is rarely, if ever, relevant.

Table 3. Medicare reimbursement for intravitreal injections. 1. ASC Group 1 2. APC 236 3. APC 235 4. HCPCS J-codes used on claims; separate payment schedule All rates cited are national; local rates will vary

Place of service. Payment for physician services is reduced for procedures that are subject to the site of service (SOS) differential when the procedure is performed outside of the physician's office. The Medicare Physician Fee Schedule identifies this as "nonfacility" versus "facility" reimbursement (Table 3). The rationale for the reduction is that the practice incurs less expense to perform the service at an ASC or HOPD. The reimbursement differential varies by procedure. If no facility fee exists, no reduction to reimbursement is applied. For example, because an ASC is ineligible for reimbursement for an intravitreal injection (67028), the SOS differential does not apply. However, when the same injection is done in a HOPD, the physician allowable is reduced.

GOOD AND BAD NEWS REGARDING REIMBURSEMENT

Two recent changes in the Medicare program directly affect reimbursement for intravitreal injections. On May 15, 2002, CMS issued a Program Memorandum (PM) to its contractors with guidance for how the Benefits Improvement and Protection Act (BIPA) standard was implemented. The PM addresses how contractors determine whether a drug is usually self-administered by the patient (and therefore not eligible for payment under Medicare). Drugs that are not usually self-administered will be eligible for payment under Medicare. For example, all of the substances that might be used for intravitreal injections would not be self-administered and therefore eligible for separate reimbursement under BIPA.

However, payment is reduced because the Medicare Modernization Act of 2003 (MMA) initiates a new policy for the reimbursement of covered drugs. Prior to January 1, 2004, covered drugs were reimbursed at 95% of average wholesale price (AWP). The MMA adjusted the reimbursement to 85% of average wholesale price for 2004. The system changes in 2005 to 106% of average sales price (ASP). The Office of Inspector General expects to monitor manufacturer pricing closely to ensure that the ASP is not misrepresented.

IN GENERAL, A FAVORABLE REIMBURSEMENT CLIMATE

Not far behind the injectable pharmaceuticals are several new implantable drug-delivery devices, such as the sustained-release fluocinolone acetonide implant (Retisert, Bausch & Lomb) and the dexamethasone implant (Posurdex, Oculex/Allergan).

These hold a great deal of promise for avoiding the pain and infection possible with intravitreal injections. CPT 67027 describes implantation of intravitreal drug delivery system and includes concomitant removal of vitreous.

The reimbursement climate for all of these services and items is favorable.

Kevin Corcoran is president of Corcoran Consulting Group.

Address correspondence to: Kevin J. Corcoran, 1845 Business Center Dr., 108, San Bernardino, CA 92408. Telephone: (800) 399-6565. Fax: (909) 890-1333. E-mail: kcorcoran@corcoranccg.com.