I. Abstract

Innovation in ophthalmology has always been central to our culture. While offering exciting opportunities for physician growth and patient care, innovation can affect coverage, patient access and reimbursement for physicians in complex ways, both directly and indirectly. The recent MIGS/cataract valuation highlights the challenges posed by balancing innovation, coverage and reimbursement. These require collaboration between external stakeholders, participation in coding valuations, advocacy with payers and negotiations with regulatory agencies.

II. Background Information

David B. Glasser, MD, secretary for Federal Affairs and RUC advisor, American Academy of Ophthalmology

III. Summary of Comments from Guest Speakers

John McAllister, MD, Health Policy Committee member and RUC alternate member, American Academy of Ophthalmology; Northern Virginia Ophthalmology Associates

Case Study: Minimally Invasive Glaucoma Surgery (MIGS)

Dr. McAllister started the session by introducing iStent, one of several available device-implant options used during minimally invasive glaucoma procedures that have been brought to market in the last 10 years. He explained that iStent is a representative example of a novel device’s potential impact on reimbursement for the entire family of codes associated with a procedure, as any new product must go through Food and Drug Administration (FDA) approval, Current Procedural Terminology (CPT) code creation, and RUC valuation processes to be used by physicians.

Emily P. Jones, MD, Health Policy Committee member, American Academy of Ophthalmology; American Glaucoma Society; Devers Eye Institute

MIGS Nomenclature & Clinical Practice

Dr. Jones defined the 6 subcategories of minimally invasive glaucoma surgery by presenting the differences between procedures that utilize trabecular bypass, aqueous shunting and/or take different approaches around the eye to enhance its aqueous outflow. She also covered the varied stents and devices associated with these different approaches to MIGS procedures.

Jella Angela An, MD, MBA, associate professor of ophthalmology, Johns Hopkins Wilmer Eye Institute

Study Design and FDA Approval

Dr. An detailed the path to FDA approval for new medical devices. She explained this study and approval process varies according to a product’s level of medical device classification, which is determined by its complexity and risk posed to patients. As the highest-risk classification, Class III devices require premarket approval. That approval involves conducting a feasibility study and later a more-extensive pivotal study, both focused on device safety and effectiveness necessary to obtain an investigational device exemption. From first enrollment to final FDA approval, this process can take a decade or more. Dr. An then highlighted the market considerations managed by device manufacturers while navigating FDA approval and the milestones in this seven-year process for iStent, which was approved for use in conjunction with cataract surgery in June 2012. Similarly structured trials for Horizon’s Hydrus Microstent followed soon after.

David B Glasser, MD, secretary for Federal Affairs, RUC advisor; Health Policy Committee member, American Academy of Ophthalmology

Impacts on the CPT Process

Dr. Glasser explained how new CPT codes are developed for the market introduction of new products such as iStent and Hydrus. A CPT code can be requested for a product before or after it’s submitted for FDA approval, and the description of a CPT code later informs its recommended valuation for reimbursement. Many manufactures initially seek a Category III CPT code because it is easier to obtain than a Category I code for a new product and allows the manufacturer up to five years to collect utilization data before a code is reviewed again for Category I status. However, this comes with drawbacks. Payer coverage for Category III codes is more difficult to obtain than Category I codes, and reimbursement tends to be lower. Dr. Glasser walked through iStent’s transition from Category III CPT Code 0191T to Category I codes 66989 and 66991 and Category III code 0671T, explaining that FDA approval for iStent only in combination with cataract surgery required a combination Category I CPT code. This brought the entire family of cataract surgery codes up for review by the Relative Value Scale (RVU) Update Committee, which likely would have led to devalued reimbursement for the procedures. Academy advocacy helped delay this code-family revaluation to year 2025.

Jeff P Edelstein, MD, RUC member; associate secretary of Health Policy Committee, American Academy of Ophthalmology

Physician Payment: RUC Process

Dr. Edelstein pulled these concepts together by describing the AMA/Specialty Society RVU Update Committee (RUC) process that recommends values to Centers for Medicare & Medicaid Services (CMS) for use in setting physician payment rates for new or updated CPT codes. He explained the three components of the Resource Based Relative Value Scale (RBRVS) (physician work, practice expense and professional liability insurance expense) and their component parts. He described the importance of the member-survey process and Academy collaboration with subspecialty societies that drives the RUC valuation of these components; and how this results in a total Relative Value Units (RVU) number recommended by the RUC to CMS. RVUs are then multiplied by the Medicare conversion factor to result in a physician payment allowable for a CPT code.

Sara Rapuano, MBA, CPC, COE, OCS, Eye Health America

ASC Facility Reimbursement and Access

Sara Rapuano explained how facility payment differs from physician payment for procedures delivered in the ambulatory surgical center or hospital outpatient department settings. Here instead, CPT codes are grouped into ambulatory payment classifications based on clinical intensity, resource utilization and cost. Payment for most drugs and supplies are included in the ambulatory payment classification unless they are granted pass-through status. The number of ophthalmology-specific ambulatory payment classifications has been reduced over the last decade, making it more difficult to properly reimburse facilities for new procedures.

Ambulatory surgery center reimbursement to the facility for a given ambulatory payment classification is approximately 50% of hospital outpatient department reimbursement under Medicare. However, procedures such as MIGS, where a device accounts for more than 30% of a procedure’s mean cost, use an alternative payment conversion to ensure payment covers device costs. Ms. Rapuano discussed how Academy activism in response to publication of the proposed calendar year 2022 Hospital Outpatient Department-Ambulatory Surgery Center Payment Rule helped reverse a decision that would have reduced facility reimbursement for combination cataract/MIGS procedures by 25%. CMS ultimately followed the Academy’s advice to temporarily assign the codes to a new technology ambulatory payment classification and gather additional utilization and cost data for a more appropriate revaluation in the future. Ms. Rapuano closed by explaining the access challenges such a reimbursement cut would have caused, and the need for an increase in the number of ophthalmic ambulatory payment classifications to accommodate new technology. 

IV. Summary of Audience Comments

Audience questions were varied, and topics ranged between:

• The purpose of the conversion factor, a tool for budget neutrality multiplied against the total RVUs for all CPT codes, and how it is determined every year
• What is asked of physicians in an average RUC survey, and what direct and indirect practice expenses are used as inputs to determine a procedure code’s total RVUs
• The future of a standalone iStent CPT code (0671T, used without cataract surgery) and emerging add-on codes (including one for intensity), both still in development
• Whether the current Category III code for corneal collagen cross-linking will be converted to a Category I equivalent: Category III code recently renewed for another 5 years

There was lively discourse around:

• Criticism of the RUC survey and evaluation process’s effect on physician payment from the perspective of both ophthalmologists and outside organizations:
  • RAND corporation study, noted as flawed by moderator David Glasser, MD, finds that most physicians over-estimate service times and number of post-op visits preformed on RUC surveys
  • Budget neutrality (conversion factor) applied to all RVUs can be triggered by introduction of new services and limits physician reimbursement to unsustainable levels with respect to inflation
  • Little incentive for the American Medical Association or CMS to account for pediatric sub-specialists when determining reimbursement
  • Inaccurate process to amortize equipment use for practice expense
• Near-future innovations anticipated for cataract/MIGS devices, and consequentially, procedure coding

V. High Priority Objectives

• Obtain recent evaluation and management code reimbursement increases for those same services that are part of the postoperative global period.
• Pediatric ophthalmologists would benefit from an intensity-modifier to add on to existing ophthalmology office visit (E/M) CPT codes, as well as payer-coverage for pediatric corneal collagen cross-linking.