AAO/ASCRS/ASRS/OOSS COMMENTS ON MAP PRE- RULEMAKING REPORT

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Arnold Lawson
5 years ago
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1 AAO/ASCRS/ASRS/OOSS COMMENTS ON MAP PRE- RULEMAKING REPORT The American Academy of Ophthalmology (The Academy) is the largest association of eye physicians and surgeons Eye M.D.s in the world with more than 22,000 members in the United States. The mission of The Academy is to advance the lifelong learning and professional interests of ophthalmologists to ensure that the public can obtain the best possible eye care. The American Society of Cataract and Refractive Surgery (ASCRS) is a medical specialty society representing over 10,000 ophthalmologists who share an interest in cataract and refractive surgical care. The Outpatient Ophthalmic Surgery Society (OOSS) is a professional medical association representing over 1,100 ophthalmologists, nurses, and administrators who specialize in providing high-quality ophthalmic surgical services in costeffective outpatient surgical environments, particularly ASCs. The American Society of Retina Specialists (ASRS) is the largest retinal organization in the world, representing over 2,400 members. Retina specialists are board certified ophthalmologists who have completed fellowship training in the medical and surgical treatment of retinal diseases. The mission of the ASRS is to provide a collegial open forum for education, to advance the understanding and treatment of vitreoretinal diseases, and to enhance the ability of its members to provide the highest quality of patient care. Our members, operating in over 900 ophthalmic ASCs, provide the vast majority of eye surgical procedures performed in ASCs in the United States. Herein, we provide our comments regarding MUC ID XDEMB: High Acuity Care Visits after Outpatient Cataract Procedure, as included in the MAP s Under Considerations List. The cataract measure under consideration is intended to measure the combined rate of unplanned admissions, emergency department visits, and observations stays among Medicare FFS beneficiaries within 7 days after receiving a cataract surgery at an ambulatory surgery center or other outpatient facility. We have long been advocates of ASC quality reporting and have

2 worked closely with the agency in the development of meaningful quality measures with respect to the Medicare ASC Quality Reporting Program (ASC QRP), as well as the Physician Quality Reporting System (PQRS). CMS recently reported that 98 percent of ASCs have been reporting quality data since the advent of the ASC QRP in Medicare ASC quality reporting has, to date, been a promising collaborative enterprise because stakeholders have been guided by several fundamental principles: Any measure developed for the ASC setting must relate specifically to the ASC episode and evaluate the practices and, ultimately, the quality of the care provided by the facility. Compliance with such a measure should involve reporting by the facility of data available in the ASC chart. The outcomes data produced should be actionable by the ASC. Moreover, reporting on the measure should be financially and administratively manageable. Our organizations believe that the cataract measure under consideration fails on each of these points. Therefore, AAO, ASCRS, ASRS and OOSS concur with the ASC Quality Collaboration s recommendation that the measure be tabled and evaluated at a later date when the measure has been completed, testing has been performed in all environments that would be subject to reporting, and it is submitted to NQF for consideration for endorsement. The MAP should issue a Do Not Support decision with respect to MUC ID XDEMB, High-Acuity Care Visits After Outpatient Cataract Procedure. The following summarizes our concerns: It is Premature for the MAP to Support the Measure at This Time. While the measure topic is of interest, the measure specifications are incomplete and the information currently available to the ASC and surgical communities is insufficient to allow a meaningful evaluation of the measure. Little information is available in the materials provided the public regarding the most important elements of the measure, e.g., details regarding the numerator and denominator, the exclusions from the measure, and, indeed, which providers would be required to report. It is, indeed, uncertain whether ASCs would be required to report on the measure or whether data would, instead, be garnered from the claims submitted by the hospital to CMS. These fundamental components of a measure must be developed and tested and, we believe, endorsed by NQF before it is submitted to CMS for

3 inclusion in a rulemaking. The data reported by the ASC needs to be available within the records of the ambulatory surgical center; facilities should not be required to report data that is only available to other providers, such as a hospital or a physician s office. The ASC Is Not Capable of Reporting on this Measure. Our organizations support the goal of harmonizing quality measures across the health care environments responsible for providing surgical and related services to the patient -- where appropriate. However, the cataract measure under consideration, if it contemplates reporting by the ASC entity, reflects a fundamental misunderstanding of the operation and capabilities of the surgery center. The ASC has no ability to access regarding a hospital admission, an emergency department visit, or observation stay that follows cataract surgery in its facility. The facility should not be required to report data that is not available on the patient s ASC chart. While it is possible that the surgeon would have knowledge of his patient s post-surgery visit to the hospital, e.g., the patient might contact the surgeon and be referred to the hospital, the facility would not be privy to this information. Under the Medicare program, an ASC operates exclusively for the purpose of furnishing ambulatory surgical services to patients. Although the governing regulations permit the surgical facility to exist adjacent to a physician s office or within the hospital complex under certain circumstances, Medicare ASC Conditions for Coverage state very clearly that the entities must be physically, administratively, and financially separate from one another. For purposes of consideration of this measure, it is important to note that medical recordkeeping must always be maintained separately and exclusively from other operations; the hospital, under its Conditions of Participation, is under similar restrictions regarding the separation of its medical records from those of other providers. It would be Administratively and Financially Burdensome for ASCs to Report on this Measure. Because ASCs are generally small providers CMS acknowledges that about three-quarters of surgery centers would be classified as small businesses it is imperative that the financial and administrative burdens of

4 complying with a quality measure should be as modest as possible. This is particularly the case with respect to ophthalmic centers. An annual benchmarking survey of over 200 ophthalmic ASCs, 80% of which are members of OOSS, indicates that the average (median) number of ORs per facility is 2.0. Moreover, the average (median) of FTE employees in ophthalmic ASCs, including business and clinical staff, totals eleven (11). ASCs operate under greater resource constraints than hospitals: their rates are significantly lower (only 55 percent of HOPD rates) and they provide only surgical services. Moreover, unlike physicians and hospitals, ASCs are not afforded financial incentives for the adoption of electronic health records systems. Since surgery centers are not able to access hospital records, it would be virtually impossible and certainly unreasonably burdensome -- for ASCs to comply with the measure. There Are Alternative Cataract Measures that Would Better Accomplish Quality Reporting Objectives. The AAO, ASCRS, ASRS, and OOSS understand that CMS has prioritized inclusion of a cataract measure in the ASC Quality Reporting program. To date, we have enjoyed a productive and collaborative relationship with the agency and hope to develop a more extensive one with the MAP -- with respect to the development and adoption of quality reporting measures and implementation issues. In this spirit, we look forward to working with you and others in designing appropriate ASC-level measures for cataract surgery. Our organizations have identified several potential measure topics that would meet the above criteria to improve quality, including: Wrong intraocular lens implant: Number of cataract cases performed where the patient received the incorrect intraocular lens implant. Endophthalmitis infection rate: Number of cataract cases performed where there is an instance of endophthalmitis. Unplanned vitrectomy: Number of cataract cases performed where an unplanned vitrectomy is performed during the cataract procedure on the day of surgery.

5 These measures reflect the most prevalent factors related to cataract complications that are within the purview of the facility and its staff. The measure topics are well-supported by the clinical literature, and we believe that measuring these events in the ASC and HOPD settings presents an opportunity to improve the quality of cataract surgery for Medicare patients. These measures would serve as an important complement to the outcomes measures already being reported through the Physician Quality Reporting System (PQRS). We are committed to working with the MAP, CMS and other interested stakeholders to fully develop measures that address these measure concepts.

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