CODING AND REIMBURSEMENT
Overcoming Reimbursement Challenges for Intravitreal Injectables
Learn what steps you need to take to ensure accurate and timely reimbursement.

Intravitreal injectables for the treatment of age-related macular degeneration (AMD) and other neovascular pathologies has become the fastest growing procedure used in ophthalmology. As a result, practice-management concerns, such as documentation and coding and reimbursement issues, are prompting ophthalmologists to reassess the rate at which they use these agents and how they process claims.

Given the size of the AMD patient population and the increasing use of therapies administered via intravitreal injection, the potential number of injections each year could be as high as 25 million, said coding and reimbursement specialist Kevin J. Corcoran, COE, CPC, FNAO, president of Corcoran Consulting Group, at the May 2006 Retinal Physician Symposium.

In addition to AMD therapies, such as triamcinolone acetonide (Kenalog), pegaptanib sodium (Macugen) and ranibizumab (Lucentis), physicians are increasing their usage of the spreading agent ovine hyaluronidase (Vitrase) as well, Corcoran said.

While being clinically savvy about these increasingly popular injectable agents is critical to maintaining a successful retina practice today, Corcoran stressed it is also important to consider how to effectively integrate them from a practice-management standpoint.

Reimbursement rates, advance beneficiary notices (ABNs) and time management — given the frequency with which intravitreal injections are administered — are chief among the issues retinal specialists and their office administrators must consider, according to Corcoran. Medicare reimbursement for an intavitreal injection (CPT 67028) is currently in the range of $135 to $264, depending on whether the surgeon participates in Medicare, whether the injection is provided in a facility or in the surgeon's office, and geographic location. Corcoran doesn't expect payment rates to change much in the foreseeable future.

Reimbursement for intravitreal injectable drugs used off-label is not so clear-cut, Corcoran said. Clinicians are using bevacizumab (Avastin) to treat AMD, clinically significant macular edema and macular edema from central retinal vein occlusion (CRVO), although it is not FDA-approved for these uses.

"It is a really good idea to consider a rigorous informed consent," Corcoran said. However, he noted, even a thorough informed consent might be insufficient, adding that it is prudent to at least provide patients with information about alternative treatments.

Off-label use of intravitreal injectables may complicate reimbursement, but the good news is that it does not automatically exclude coverage. The decision to reimburse you ultimately lies with local Medicare carriers, Corcoran noted, but Medicare likely will reimburse you if you satisfy certain criteria set forth in its regulations. Off-label use can be considered the standard of care if you answer "yes" to the following questions:

► Were standard accepted treatments, including approved drugs, tried or contraindicated before considering this drug for an off-label use?

► Do any of the major drug compendia and related peer-reviewed scientific articles support this off-label use?

► Do any specialty society publications recommend this off-label use?

► Is this off-label use an accepted standard of medical practice?

► Is authoritative medical literature available to support this use? Are the level of evidence, endpoint measured, and number of patients adequate?

"If a medication is determined not to be reasonable and necessary for diagnosis or treatment of an illness or injury, according to these guidelines, the carrier excludes the entire charge for both the drug and its administration," Corcoran said. "Carriers also exclude any charges for other services, such as office visits primarily for the purpose of administering a noncovered injection," he added. As of May 2006, 20 states officially cover the use of bevacizumab, but only for the treatment of wet AMD.

Retinal specialists who are using bevacizumab off-label should have patients sign an ABN before treatment. "If you do not use an ABN, you are not permitted to bill the Medicare beneficiary in the event the claim is denied, because you have more knowledge about [the coverage for off-label use] than the patient," Corcoran said. The ABN should specify the items and services in question and the reason they are being prescribed or performed.

The appropriate code for reimbursement of intravitreal bevacizumab used to treat AMD is J3490 (unclassified drug), which is the generic descriptor for a medication that doesn't have a specific description, Corcoran said. Do not use the code J9035 (subcutaneous, intramuscular or intravenous injection of bevacizumab for chemotherapy), which only applies if this agent is given intravenously for the treatment of colon cancer.

All of the reimbursement principles concerning intravitreal bevacizumab injections also apply to the off-label use of hyaluronidase for the treatment of vitreous hemorrhages and diabetic retinopathy, Corcoran said.

MANAGING TIME AND MONEY

Just as important as filling out the right documentation for reimbursement is managing the time you and your staff will spend administering intravitreal injections.

"When you think about how many intravitreal injections you'll be performing, and how rapidly this treatment area is growing, it can pose a time management problem to your practice," Corcoran said. "I've heard retinal specialists complaining that they're being taken over by intravitreal injections, and they don't have time to see new patients," he added. Corcoran recommends allotting sufficient time in the office schedule for what is considered minor surgery.

Corcoran also suggests negotiating favorable payment terms and conditions from drug manufacturers and marking up the price of the drug to cover shipping and handling, taxes and other miscellaneous costs. "One of my clients spends $2 million a year on [intravitreal injectables]. That's a major cost in the practice that requires careful management," he said.

Other strategies Corcoran recommends include:

► Require prompt payment at the time of service for noncovered procedures and drugs.

► Adopt measures to ensure collection of copayments for covered drugs, particularly for Medicare and Medicaid patients.

► Institute prudent medical protocols for patients who require additional diagnostic testing before receiving repeated intravitreal injections.

One of the top priorities of the Office of the Inspector General (OIG) is to scrutinize reimbursements for pharmaceuticals this year, Corcoran said. "If you didn't follow the appropriate protocols for off-label use and didn't use an ABN, you are going to have to refund the payment not only for the drug, but for the office visit and the procedure," he added.

Medicare carriers, without exception, urge physicians to make these overpayment refunds voluntarily, and to do it soon, Corcoran said. "Because this has become so high profile, Medicare will surely investigate [these overpayments], which raises the specter of fines, penalties and the possibility of litigation."