Physicians, facilities navigate reimbursement landscape with emerging technologies

Medicare coverage was quickly established for the iStent, with some coverage by commercial insurance carriers.

Cataract surgery is the most common refractive procedure performed on aging eyes, and it is often considered the “bread-and-butter” surgery in ophthalmology. Likely due to its popularity, Medicare and commercial insurance carriers have thus made cataract surgery a primary target when searching for cost savings. The Medicare physician payment was decreased by 12% in 2013, with an additional proposed decrease of 3% for 2014, partially attributed to changes in work value for cataract and complex cataract surgery. Combining cataract surgery with glaucoma treatment may be a value-added prospect for the physician and patient.

An estimated 20% of cataract patients are prescribed at least one glaucoma medication at the time of surgery, making it an ideal time to address both pathologies. The iStent trabecular micro-bypass (Glaukos), approved by the U.S. Food and Drug Administration in June 2012, is aimed at providing a low-risk, efficacious option to lower IOP. In conjunction with cataract surgery, the micro-stent is inserted into Schlemm’s canal and provides a patent bypass for aqueous to drain from the anterior chamber. Studies show that cataract surgery and iStent implantation combined can lower IOP by 33%, and overall, a single iStent by itself reduces the required topical therapy by a mean of 1.2 medications.

Establishing coverage

The iStent is the first device of a newly developing class called microinvasive glaucoma surgery (MIGS) and, as such, underwent a lengthy and rigorous premarket approval pathway through the FDA. Fortunately, the randomized, controlled, multicenter trial required for FDA approval also allowed Glaukos to establish a favorable reimbursement climate. The procedure that describes iStent implantation has been assigned CPT code 0191T, a Category III code that designates it as an emerging technology or service. Category III CPT codes allow for data collection and tracking for these specific services and procedures, and they are re-evaluated after 5 years. Category III CPT codes are eligible for coverage and reimbursement by payers, and Medicare payment to the facility is based on the national fee schedule and is the same as that for tube shunt surgery. However, physician payment is determined by each local Medicare contractor, and submitted claims are often subject to manual review.

The iStent is a novel glaucoma device with a new CPT code, and like other new technologies, securing coverage from payers is an involved process. With that in mind, Medicare coverage was established in a relatively short amount of time, with 100% of Medicare contractors covering as of February 2013. Regarding the national commercial payers, United and Aetna have agreed to cover iStent implantation. Other commercial payers are approving procedures on a case-by-case basis. Of course, it is wise to seek approval from commercial insurance carriers before proceeding with any procedure.

Because the iStent is labeled for use by the FDA only in conjunction with cataract surgery for patients with mild to moderate glaucoma who are currently on medical therapy, the reimbursement criteria for simultaneous procedures play a role in receiving payment. When a Medicare contractor establishes coverage for a Category III code that is routinely performed in conjunction with another procedure, generally the higher-paying procedure is reimbursed at 100% and the second procedure is paid at 50% its typical reimbursement. Glaucoma procedures tend to receive higher reimbursement rates than cataract surgery because they require greater surgeon skill and time and increased postoperative care. This increase in postoperative care has deterred many comprehensive ophthalmologists from performing glaucoma procedures. Implantation of the iStent, while technically challenging, is well within the skill set of most comprehensive ophthalmologists and can be effectively combined with cataract surgery.

Physician payments for iStent implantation vary widely among Medicare contractors and other payers. However, in most localities, physicians can expect to be paid an incremental $400 to $700 more than what they are paid for cataract surgery, which has an average physician payment of $667, when implanting iStent in conjunction with cataract surgery (Table 1). Facilities also see a net benefit, with ambulatory surgical centers earning approximately $1,200 more and hospital outpatient settings earning approximately $2,100 more than with cataract surgery alone (Table 2).

table 1
table 2

In addition, it is important to note that payment for a procedure can only occur when supported by a diagnosis code that supports medical necessity as determined by the payer. Reimbursement for the iStent implantation is most likely with ICD-9 code 365.11, primary open-angle glaucoma. It is wise to check the coverage policies of payers because some cover other diagnosis codes such as pigmentary glaucoma (365.13) and low-tension glaucoma (365.12). In addition, some payers require the reporting of the staging code for mild (365.71) and moderate (365.72) disease states. For example, payment is typically denied for off-label uses such as ocular hypertension or secondary glaucoma; thus, proper coding from patient diagnosis throughout the iStent surgery is crucial in securing reimbursement.

Complementing premium cataract surgery

The compatibility of iStent implantation with cataract surgery also has an important impact on physician earnings. While the majority of cataract surgeries performed still involve standard lenses, there is a significant and growing shift among cataract surgeons toward a more refractive approach, which involves offering patients premium options such as femtosecond laser-assisted cataract surgery, intraoperative aberrometry and premium IOLs. Premium IOLs, usually packaged with the other technology, generate an average of $1,979 more revenue per eye. The patients who are willing to pay privately for greater vision improvement via these opt-in, value-added services expect that visual outcomes will not be compromised by adjunct glaucoma surgery. The U.S. pivotal trial showed that placement of the iStent in conjunction with cataract surgery does not negatively affect the safety profile of cataract surgery, and the absence of any additional incisions to the astigmatically neutral cataract incisions already created means there is no difference in refractive outcomes after iStent implantation. This allows a surgeon to positively address a patient’s glaucoma, remove the cataract and provide the patient with outstanding visual acuity, while at the same time increasing the revenue stream to the practice.

Cost of integration

Compared with the capital outlay for a new laser or an imaging machine, the investment required to adopt this MIGS device is minimal and the return on investment exceeds the minor upfront costs. The training process to become iStent certified is a combination of online modules and live training with the manufacturer. The facility makes an initial investment in a supply of iStent devices, which are not consigned by the company. A portion of the initial supply is used in initial proctored cases. Recouping of the initial investment comes when the iStent is placed and successful reimbursement follows.

Conclusion

The large body of published literature on the iStent has facilitated quick adoption of positive coverage policies by key payers, including Medicare, in comparison to other previously approved technologies. Because Medicare is the primary payer in the majority of cataract surgery cases and all the Medicare contractors currently cover iStent implantation, physicians and facilities are finding that offering the iStent can have a positive impact on revenue and earnings. The increase in patient quality of life, a positive reimbursement climate and an increased return on investment on a commonly performed procedure are all encouraging factors in adopting the use of iStent into practice.

References:
Bellen L. Geriatrics and Aging. 2008;11(6):328-332.
Nichamin LD. Middle East Afr J Ophthalmol. 2009;doi:10.4103/0974-9233.56227.
Samuelson TW, et al. Ophthalmology. 2011;doi:10.1016/j.ophtha.2010.07.007.
For more information:
Robert J. Noecker, MD, MBA, can be reached at Ophthalmic Consultants of Connecticut, 75 Kings Highway Cutoff, Fairfield, CT 06824; 203-366-8000; fax: 203-330-4598; email: noeckerrj@gmail.com.
Disclosure: Noecker has received grant support from Glaukos.

Cataract surgery is the most common refractive procedure performed on aging eyes, and it is often considered the “bread-and-butter” surgery in ophthalmology. Likely due to its popularity, Medicare and commercial insurance carriers have thus made cataract surgery a primary target when searching for cost savings. The Medicare physician payment was decreased by 12% in 2013, with an additional proposed decrease of 3% for 2014, partially attributed to changes in work value for cataract and complex cataract surgery. Combining cataract surgery with glaucoma treatment may be a value-added prospect for the physician and patient.

An estimated 20% of cataract patients are prescribed at least one glaucoma medication at the time of surgery, making it an ideal time to address both pathologies. The iStent trabecular micro-bypass (Glaukos), approved by the U.S. Food and Drug Administration in June 2012, is aimed at providing a low-risk, efficacious option to lower IOP. In conjunction with cataract surgery, the micro-stent is inserted into Schlemm’s canal and provides a patent bypass for aqueous to drain from the anterior chamber. Studies show that cataract surgery and iStent implantation combined can lower IOP by 33%, and overall, a single iStent by itself reduces the required topical therapy by a mean of 1.2 medications.

Establishing coverage

The iStent is the first device of a newly developing class called microinvasive glaucoma surgery (MIGS) and, as such, underwent a lengthy and rigorous premarket approval pathway through the FDA. Fortunately, the randomized, controlled, multicenter trial required for FDA approval also allowed Glaukos to establish a favorable reimbursement climate. The procedure that describes iStent implantation has been assigned CPT code 0191T, a Category III code that designates it as an emerging technology or service. Category III CPT codes allow for data collection and tracking for these specific services and procedures, and they are re-evaluated after 5 years. Category III CPT codes are eligible for coverage and reimbursement by payers, and Medicare payment to the facility is based on the national fee schedule and is the same as that for tube shunt surgery. However, physician payment is determined by each local Medicare contractor, and submitted claims are often subject to manual review.

The iStent is a novel glaucoma device with a new CPT code, and like other new technologies, securing coverage from payers is an involved process. With that in mind, Medicare coverage was established in a relatively short amount of time, with 100% of Medicare contractors covering as of February 2013. Regarding the national commercial payers, United and Aetna have agreed to cover iStent implantation. Other commercial payers are approving procedures on a case-by-case basis. Of course, it is wise to seek approval from commercial insurance carriers before proceeding with any procedure.

Because the iStent is labeled for use by the FDA only in conjunction with cataract surgery for patients with mild to moderate glaucoma who are currently on medical therapy, the reimbursement criteria for simultaneous procedures play a role in receiving payment. When a Medicare contractor establishes coverage for a Category III code that is routinely performed in conjunction with another procedure, generally the higher-paying procedure is reimbursed at 100% and the second procedure is paid at 50% its typical reimbursement. Glaucoma procedures tend to receive higher reimbursement rates than cataract surgery because they require greater surgeon skill and time and increased postoperative care. This increase in postoperative care has deterred many comprehensive ophthalmologists from performing glaucoma procedures. Implantation of the iStent, while technically challenging, is well within the skill set of most comprehensive ophthalmologists and can be effectively combined with cataract surgery.

Physician payments for iStent implantation vary widely among Medicare contractors and other payers. However, in most localities, physicians can expect to be paid an incremental $400 to $700 more than what they are paid for cataract surgery, which has an average physician payment of $667, when implanting iStent in conjunction with cataract surgery (Table 1). Facilities also see a net benefit, with ambulatory surgical centers earning approximately $1,200 more and hospital outpatient settings earning approximately $2,100 more than with cataract surgery alone (Table 2).

table 1
table 2
PAGE BREAK

In addition, it is important to note that payment for a procedure can only occur when supported by a diagnosis code that supports medical necessity as determined by the payer. Reimbursement for the iStent implantation is most likely with ICD-9 code 365.11, primary open-angle glaucoma. It is wise to check the coverage policies of payers because some cover other diagnosis codes such as pigmentary glaucoma (365.13) and low-tension glaucoma (365.12). In addition, some payers require the reporting of the staging code for mild (365.71) and moderate (365.72) disease states. For example, payment is typically denied for off-label uses such as ocular hypertension or secondary glaucoma; thus, proper coding from patient diagnosis throughout the iStent surgery is crucial in securing reimbursement.

Complementing premium cataract surgery

The compatibility of iStent implantation with cataract surgery also has an important impact on physician earnings. While the majority of cataract surgeries performed still involve standard lenses, there is a significant and growing shift among cataract surgeons toward a more refractive approach, which involves offering patients premium options such as femtosecond laser-assisted cataract surgery, intraoperative aberrometry and premium IOLs. Premium IOLs, usually packaged with the other technology, generate an average of $1,979 more revenue per eye. The patients who are willing to pay privately for greater vision improvement via these opt-in, value-added services expect that visual outcomes will not be compromised by adjunct glaucoma surgery. The U.S. pivotal trial showed that placement of the iStent in conjunction with cataract surgery does not negatively affect the safety profile of cataract surgery, and the absence of any additional incisions to the astigmatically neutral cataract incisions already created means there is no difference in refractive outcomes after iStent implantation. This allows a surgeon to positively address a patient’s glaucoma, remove the cataract and provide the patient with outstanding visual acuity, while at the same time increasing the revenue stream to the practice.

Cost of integration

Compared with the capital outlay for a new laser or an imaging machine, the investment required to adopt this MIGS device is minimal and the return on investment exceeds the minor upfront costs. The training process to become iStent certified is a combination of online modules and live training with the manufacturer. The facility makes an initial investment in a supply of iStent devices, which are not consigned by the company. A portion of the initial supply is used in initial proctored cases. Recouping of the initial investment comes when the iStent is placed and successful reimbursement follows.

Conclusion

The large body of published literature on the iStent has facilitated quick adoption of positive coverage policies by key payers, including Medicare, in comparison to other previously approved technologies. Because Medicare is the primary payer in the majority of cataract surgery cases and all the Medicare contractors currently cover iStent implantation, physicians and facilities are finding that offering the iStent can have a positive impact on revenue and earnings. The increase in patient quality of life, a positive reimbursement climate and an increased return on investment on a commonly performed procedure are all encouraging factors in adopting the use of iStent into practice.

References:
Bellen L. Geriatrics and Aging. 2008;11(6):328-332.
Nichamin LD. Middle East Afr J Ophthalmol. 2009;doi:10.4103/0974-9233.56227.
Samuelson TW, et al. Ophthalmology. 2011;doi:10.1016/j.ophtha.2010.07.007.
For more information:
Robert J. Noecker, MD, MBA, can be reached at Ophthalmic Consultants of Connecticut, 75 Kings Highway Cutoff, Fairfield, CT 06824; 203-366-8000; fax: 203-330-4598; email: noeckerrj@gmail.com.
Disclosure: Noecker has received grant support from Glaukos.