Reimbursement Challenges for Intravitreal Injectables
Learn what steps you need to take to ensure accurate and timely reimbursement.
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,
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.
TIPS FOR REIMBURSEMENT
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
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
► 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
for Intravitreal Injection
To further complicate reimbursement matters,
consider the intravitreal injection-associated use of paracentesis. Some ophthalmologists
remove aqueous humor from the anterior chamber before administering an intravitreal
injection. Paracentesis (CPT 65800 or 65805) is performed as a prophylactic measure
to avoid elevating intraocular pressure.
Because both CPT codes carry the "separate procedure" designation,
and the paracentesis is performed only as a prelude to the intravitreal injection,
the paracentesis is considered an incidental part of the total service and no additional
claim is merited.
"If it doesn't have its own unique reason for being done
unrelated and distinct from the rest of the injection then don't bill for
it," Corcoran said.
"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:
Reports for Intravitreal Injection
Documentation is always critical in the
gray areas of reimbursement. For this reason, Corcoran recommends an operative report,
which should include:
Indications for surgery
Description of the procedure
Manner in which the surgery was performed
Pre-op and post-op diagnoses
"The report should be somewhat detailed because almost certainly
it will be one of those high-profile areas for the medical legal community," Corcoran
► 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
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."
Retinal Physician, Issue: September 2006