Re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017

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Eileen Pope
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September 6, 2016 Andy Slavitt Acting Administrator Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 Re: Medicare Program; Revisions to Payment Policies Under the

$Slavitt: The American Society of Cataract and Refractive Surgery (ASCRS) is a medical specialty society representing nearly 9,000 ophthalmologists in the United States and abroad who share a$

1 September 6, 2016 Andy Slavitt Acting Administrator Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD Re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017 Dear Mr. Slavitt: The American Society of Cataract and Refractive Surgery (ASCRS) is a medical specialty society representing nearly 9,000 ophthalmologists in the United States and abroad who share a particular interest in cataract and refractive surgical care. The Outpatient Ophthalmic Surgery Society (OOSS) is a professional medical association of more than 1,100 ophthalmologists, nurses, and administrators who specialize in providing high quality ophthalmic surgical procedures performed in cost effective outpatient environments, including ambulatory surgical centers (ASCs). Thank you for the opportunity to provide comments on CMS proposed rule for the CY 2017 Medicare Physician Fee Schedule (MPFS). Our comments specifically focus on the following topics: ASCRS and OOSS oppose CMS proposal to collect data on all 10- and 90-day global surgical services, by using a set of un-tested G-codes to record post-operative services in 10-minute intervals. ASCRS and OOSS support CMS proposal to revise work RVUs for certain glaucoma and retina procedure codes, and urges the proposal be finalized. We will work with the ophthalmic community through the RUC process regarding CPT code 66986, Exchange of Lens Prosthesis, which was identified as potentially inconsistent in instances where there are direct PE inputs included in the facility post-service period even though postoperative visits are not included in a service. AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY 4000 Legato Road Suite 700 Fairfax, Virginia (703) Facsimile (703) OUTPATIENT OPHTHALMIC SURGERY SOCIETY 6564 Umber Circle Arvada, CO Facsimile

2 Page 2 We request CMS remove several ophthalmic-related codes from the list of 0-Day global services that are typically billed with an evaluation and management (E/M) service with modifier 25, as they do not meet the criteria for the screen for potentially misvalued codes. We are concerned that initiatives included in this proposed rule, such as the misvalued code initiative and the global surgery data collection proposal, are intended to increase primary care services at the expense of specialty care, including ophthalmology, and may limit Medicare beneficiaries access to specialty services. OPPOSTION TO COLLECTING DATA ON RESOURCES USED IN FURNISHING GLOBAL SERVICES ASCRS and OOSS strongly oppose CMS burdensome proposal to collect data on all 10- and 90-day global surgical services from all physicians who provide them, and urges CMS not to finalize the proposal. Not only will this proposal add to physicians already heavy administrative burden, it is in direct opposition to Congress intention in the Medicare Access and CHIP Reauthorization Act (MACRA), which required CMS to collect information on global services on a representative sample beginning January 1, Further, we continue to believe the current RUC process accurately and fairly values surgical services at appropriate levels that ensure Medicare beneficiaries continued access to specialty care. The scope of the proposal far exceeds what Congress authorized in the MACRA statute regarding the collection of data for 10- and 90-day global services. Following CMS policy in the CY 2015 MPFS final rule to transition all 10- and 90- day global surgical services to 0-day, Congress included a provision in MACRA to prohibit CMS from going forward with the policy. MACRA instructed CMS to collect data from a representative sample on global surgical bundles. Requiring all physicians to report data on all global services performed is not a representative sample. We believe that the current proposal will levy a similar administrative burden on physicians and practices that the previous policy to eliminate the global codes would have imposed. CMS original policy to eliminate the 10- and 90-day bundles would have added an enormous administrative burden on physicians and practices. Congress recognized this, and therefore, required the data collection to be limited only to a representative sample. Requiring surgeons to report all post-operative services in 10-minute intervals would constitute an overwhelming undertaking that will be disruptive to clinical and administrative processes. Currently, physicians performing global services are not required to code for post-operative care such as follow-up visits or, in the case of ophthalmologists, services such as post-surgical manifest refractions, visual acuity tests, or intraocular pressure checks. Assuming the final rule will be released in November, and the policy would go into effect on January 1, 2017, physicians and practices would only have two months to implement the new coding processes into their administrative and clinical processes. Surgeons from all specialties, not only ophthalmologists, believe this proposal will add significantly to their administrative burden, and are unsure how to implement this policy in

3 Page 3 their practices. ASCRS participated in an effort with other surgical specialty societies to survey our collective memberships to determine how this policy would likely affect surgical practices. Overwhelming majorities of respondents representing several different specialties, practice sizes, locations, and ownership models reported that if finalized, the proposal would require new processes to track, process, and distinguish between pre- and post-operative visits; require modifications to EHR and/or billing systems; additional staff; and additional physician time spent on documentation. Nearly 90% of all respondents predicted there would be difficulties with physician compliance with this proposal. In addition, nearly 90% of respondents reported they would have to create a process to distinguish between Medicare and non-medicare patients for coding purposes. While ophthalmologists treat a high percentage of Medicare patients, they also treat non-medicare patients, for whom they would not be required to report this data. In addition, 47% of ophthalmologists responding to the survey specifically noted that the proposal will likely require the hiring of additional scribes as opposed to 35% of all surgeons responding to the survey. Finally, nearly 75% of surgeons responding to the survey believed the use of G- codes would not be appropriate for gathering data on post-operative services. We continue to support the RUC process as the appropriate methodology for ensuring surgical services are accurately valued. The process, which is well understood by physicians, ensures that every code is carefully evaluated, accounting for pre- and post-operative care, and the practice expense (PE) units which in the case of ophthalmology are unique to our specialty are included. Unlike the RUC s detailed process, CMS proposal is a one-size-fits-all methodology that categorizes all post-operative care in broad categories represented by the proposed G-codes. The G-codes do not accurately reflect the diversity in post-operative care that specialists provide to Medicare beneficiaries. We support the second and third provisions of CMS three-pronged proposal to conduct a targeted survey of approximately 5,000 physicians and direct observation studies, rather than require data collection from all physicians on all global services. CMS proposes the smaller, targeted survey and observational studies, in addition to requiring data collection from all physicians, as part of the overall proposal for collecting data on global services. We believe the targeted survey and limited observation more closely reflects Congress intent to conduct research based on a representative sample and encourage CMS to implement these provisions of the policy instead of requiring data collection on all services by all physicians. Use of G-Codes to Record Post-Operative Care ASCRS and OOSS oppose CMS proposal to create a set of G-codes to report on post-operative care in 10-minute intervals. We believe these un-tested codes do not accurately describe a typical vs. complex post-operative visit and do not account for the specialized equipment included in PE units, particularly for ophthalmic services. Ophthalmic post-operative care may typically include services such as visual acuity testing, manifest refractions, or intraocular pressure checks, which not only require specialized

4 Page 4 equipment, but contribute to the higher work RVUs of the global service because they include a higher level of intensity than traditional E/M codes. As we have stated above, we believe the current RUC values accurately represent postoperative work, in incorporating both the type and number of post-operative visits. The RUC process ensures that the unique type of post-operative care required following ophthalmic procedures is accurately valued relative to the specific post-operative requirements of other specialties. The proposed G-codes do not incorporate the wide diversity of post-operative care across all specialties and do not correspond with the post-operative services already bundled into the global packages. In addition, the proposed G-codes have not undergone the same level of testing and review, such as through the CPT and RUC processes, as have codes included in the global packages. In particular, the proposal to select G-codes as either typical or complex demonstrates the lack of correlation between the G-codes and current post-operative care included in the global packages. Under CMS proposal, surgeons coding their post-operative care for patients have the option to select either inpatient or office-based encounters and whether the visit was typical or complex. Office-based encounters would comprise the majority of post-operative visits for ophthalmic procedures. CMS defines typical post-operative services in Table 10, which include dressing changes, management of medications, patient counseling, and other services. Complex codes would be used when patients have comorbidities or are at the risk of death. However, as noted above, ophthalmic post-operative care differs greatly from post-operative care provided by other specialties. Not only does CMS definition of typical services exclude these ophthalmic services, physicians or practice coding staff may have difficulty identifying which code to use. RAND s proposal for Developing Codes to Capture Post-Operative Care created the set of eight G-codes included in the 2017 proposed rule. RAND s proposal considers several different possibilities for how to collect data on post-operative care and recognizes that there is no easy way to represent the diversity of services provided by surgeons and so in creating the G-codes, recommends that CMS develop a pilot test to ensure these codes are accurate. CMS has taken the un-tested codes proposed by RAND as whole cloth and not conducted any of the recommended testing. It is unwise to begin requiring all physicians furnishing global services to use these codes without properly pilot testing them to ensure they are understandable by physicians and provide the appropriate data. We recommend CMS institute a pilot testing program before requiring the G-codes systemwide. We recognize that MACRA required data collection to begin on January 1, 2017, and CMS must comply with the law. However, we contend that if CMS goes ahead with the G-code option, pilot testing on a limited basis could begin on that date and satisfy the statutory requirement of beginning the data collection on January 1, 2017.

5 Page 5 VALUATION OF SPECIFIC GLAUCOMA AND RETINA CODES CY 2017 PROPOSED CODES THAT WERE ALSO CY 2016 PROPOSED CODES ASCRS and OOSS support the proposal to revalue certain codes related to glaucoma and retina procedures to their original RUC-recommended work RVU values, and we urge CMS to finalize these values for CY We offer our thanks to CMS for listening to our arguments and accepting the original RUC-recommended values. We continue to believe the RUC process accurately values codes and urge CMS to maintain its previous policy of accepting the majority of the RUC s recommended values. In the CY 2016 MPFS interim final rule, CMS identified several ophthalmic codes related to glaucoma and retina procedures as misvalued and proposed new work RVU values for the following codes: o (trabeculoplasty) o (trabeculectomy) o (trabeculectomy with scarring) o (retinal detachment with scleral buckle) o (retinal detachment with vitrectomy) o (retinal detachment by injection) The 2016 interim final rule reduced the values for these sight-saving procedures significantly in 2016 and Glaucoma surgical procedures would have been cut between 25% and 33% and procedures repairing retinal detachments would have been cut between 16% and 32%. ASCRS, OOSS, and others in the ophthalmic community argued that the RUC process is in place to ensure that physician services are properly valued and the resource-based relative value of the codes maintained. For all the aforementioned codes, CMS rejected the RUC recommendations that contained significant cuts to these codes, and made deeper cuts. We concluded that CMS had erroneously failed to consider intensity as part of the scope of physician work when reviewing these codes, and strongly urged CMS to revise the reductions. APPROPRIATE DIRECT PE INPUTS IN THE FACILITY POST-SERVICE PERIOD WHEN POST-OPERATIVE VISITS ARE EXCLUDED CMS identified one code, CPT Exchange of Lens Prosthesis, performed by ophthalmology as potentially inconsistent in instances where there are direct PE inputs included in the facility post-service period, even though post-operative visits are not included in a service. In looking at this code more closely, we would note what must be an error in the RUC database. This is a procedure that would always have post-operative visits associated with it. In the RUC database we found that there were 110 minutes of immediate post-operative time. It would be highly unusual for any physician to spend nearly two hours with a patient directly following the exchange of a previously implanted intraocular lens. This is a low-volume procedure that is performed less than 6,200 times on Medicare patients. ASCRS and OOSS will work with the ophthalmic community through the RUC process in order to determine the appropriate next steps for this service.

6 Page 6 POTENTIALLY MISVALUED SERVICES CMS has identified several 0-Day Global Services that are Typically Billed with an Evaluation and Management (E/M) Service with Modifier 25. Nine services on this list are performed by ophthalmologists. Of those, six of them do not meet the criteria for inclusion in this screen because they have been RUC surveyed and been revalued by CMS within the last 5 years. Additionally, all of those considerations were done taking into account that the services were done a majority of the time with an E/M or eye visit code. We request CMS remove the following codes from this screen: Simple repair of superficial wounds of face, ears, eyelids, nose, lips and mucous membranes; 2.5 cm or less (CMS revalued in 2013 based on 2011 RUC Survey) Simple repair of superficial wounds of face, ears, eyelids, nose, lips and mucous membranes; 2.6 cm to 5.0 cm (CMS revalued in 2013 based on 2011 RUC Survey) Removal of foreign body, external eye, cornea with slit lamp examination (CMS revalued 2013 from 2011 RUC Survey) Biopsy of eyelid (CMS revalued in 2013 from 2011 RUC Survey) Removal of eyelashes by forceps (RUC surveyed in April 2016 for 2018 MPFS) Injection into conjunctiva (CMS revalued 2013 from 2011 RUC Survey) We will work with the ophthalmic community through the RUC process for the remaining three eye related codes CPT Removal of foreign body in external eye, conjunctiva, Removal of foreign body in external eye, conjunctiva or sclera and CPT Injection of medication or substance into membrane covering eyeball. CONCERNS REGARDING IMPROVING VALUATION OF PRIMARY CARE, CARE MANAGEMENT, AND PATIENT-CENTERED SERVICES ASCRS and OOSS recognize the importance of ensuring services provided by all physicians, both specialists and primary care, are accurately valued. Despite positive intentions of providing support for programs aimed at managing and improving Medicare beneficiaries overall health, we are concerned that CMS proposals continue to seek to increase reimbursement for primary care services at the expense of specialty services, such as ophthalmology. CMS dedicates no new funds to these primary care initiatives, and so must make cuts to other services. While ophthalmologists do not typically manage the whole health of a patient, they do provide important ongoing care for chronic diseases such as glaucoma, diabetic retinopathy, and macular degeneration. Without ongoing care management from an ophthalmologist, patients with these diseases would go blind and potentially incur far more direct healthcare costs and indirect costs to society. If reimbursement for specialty services continues to decline, patients may have difficulty accessing the care they need. We encourage CMS not to shortchange Medicare beneficiaries who require both ongoing and episode-based care from specialists by focusing significant resources on primary care initiatives at the expense of specialty care.

7 Page 7 CONCLUSION Thank you again for the opportunity to provide comments on the 2017 Medicare Physician Fee Schedule proposed rule and for revising the RVU values for the glaucoma and retina codes to the original RUC recommendations. We reiterate our strong opposition to CMS burdensome proposal to collect data on all global surgical services from all physicians who provide them in 10-minute increments, and urge CMS to revise its proposal to be in line with the MACRA statute, which requires data collection from a representative sample. If you have questions, or need additional information, please contact Allison Madson, ASCRS manager of regulatory affairs, at amadson@ascrs.org or or Michael Romansky, Washington counsel, OOSS, at mromansky@ooss.org or Sincerely, Kerry Solomon, MD President, ASCRS Jeffrey Whitman, MD President, OOSS

Re: CMS Patient Relationship Categories and Codes Second Request for Information

January 6, 2017 Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 Re: CMS Patient Relationship Categories and Codes Second Request