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 for Information 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. Thank you for another opportunity to provide comments on CMS patient relationship categories. We appreciate that CMS has further refined its proposed patient relationship categories to more closely align with the recommendations of ASCRS and others in the medical community. However, we are concerned CMS has not provided adequate information for how a physician, such as an ophthalmologist, who provides both surgical care and ongoing chronic care, would report a combination of relationships. Most importantly, we are concerned that CMS still has not provided any information regarding how the costs of care attributed by the patient relationship codes will be used to calculate physicians resource use scores, and how those scores will be risk adjusted. As we noted in our comments on the first request for information, our key recommendation remains that CMS develop a system for measuring resource use that accurately aligns the cost of the care provided by a physician with the type of relationship he or she reports to have with a particular patient. In addition to making information available about how the data from the codes will be incorporated in the cost measurement methodology, we request that CMS provide additional information regarding the relationship to episode-based measures. In addition, the resource use measures must reflect the severity of the disease being treated and be risk adjusted to account for other factors outside the physician s control, such as patient compliance and socioeconomic conditions, which may ultimately affect the cost of treating a particular patient. The need to adjust for risk and the severity of the patient is particularly pertinent when treating patients with chronic conditions, such as glaucoma or macular degeneration. Finally, we urge CMS to make information available well in advance of the time when physicians are required to report patient relationship codes. If the goal of these modifiers is to change physician behavior, then it should be easily understood how these modifiers will be used to determine a cost score. Physicians must understand what costs they will be responsible for, and CMS must only attribute the costs of care that would be in a physician s control based on the relationship reported. AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY 4000 Legato Road Suite 700 Fairfax, Virginia 22033-4055 (703) 591-2220 Facsimile (703) 591-0614
Page 2 In response to CMS request for information, we have responded below to the specific questions posed by CMS and provided general comments on the patient relationship categories framework with a particular focus on how resource use measures should be constructed. ASCRS Response to CMS Questions in Summary: We generally support CMS revised patient relationship categories, as they better reflect specialty care and should be understandable by physicians. However, we continue to question how the categories will be applied when a physician, especially an ophthalmologist who may provide both surgical and chronic care to the same patient, is supposed to document that relationship. We support the use of HCPCS modifiers on Medicare claims to denote patient relationships. Additional Feedback: The categories must reflect that the severity of a patient s disease affects the type of relationship a physician has with a patient and may impact how the physician manages the care with other providers and ultimately the cost of care. We continue to contend that CMS has yet to provide any information regarding how resource use measures are risk adjusted, and urge CMS to work with the medical community in a transparent manner to develop a risk adjustment methodology. We continue to recommend extensive testing of reporting the relationships through pilot programs before all physicians are required to comply with this requirement. We urge CMS to provide adequate training and technical assistance for providers implementing the new codes. CMS QUESTIONS FOR CONSIDERATION 1. Are the draft categories clear enough to enable clinicians to consistently and reliably self-identify an appropriate patient relationship category for a given clinical situation? We again thank CMS for responding to ASCRS and medical community feedback in simplifying the overall categories, and believe they will be understood my most physicians. We also thank CMS for removing the word primary to refer to a physician in a leadership role, since that would likely cause confusion among specialists, such as ophthalmologists, who do not provide primary care, but may function as the main provider in a particular patient s care. Confusion may still exist, however, when two of the types of relationships overlap, or if two physicians co-manage the care of a surgical patient. These concerns and our suggestions to address them are discussed more fully in our response to question 2, below.
Page 3 2. As clinicians furnishing care to Medicare beneficiaries practice in a wide variety of care settings, do the draft categories capture the majority of patient relationships for clinicians? If not, what s missing? As noted above and in our previous comments, ASCRS recommends CMS develop a category that includes both ongoing chronic care and surgical care. Ophthalmologists are one of a few specialties that provide both chronic and surgical care such as caring for patients with glaucoma medically or with occasional surgical interventions and therefore, these instances account for a significant portion of most ophthalmologists practice. We are concerned that without a clear way to address these situations, ophthalmologists may be disadvantaged in their resource use calculations if they do not reflect the true nature of the relationship they have with a particular patient. ASCRS recommends creating an additional category for when specialists treat the same patient for both chronic disease and acute episodes, such as surgery. For example, treatment of glaucoma would be considered a continuous/focused relationship as a chronic disease, but oftentimes, treatment may incorporate some episodic care, such as surgical interventions. As noted in the previous request for information, Section 1848(r)(3)(B) of MACRA requires CMS to establish categories to reflect different types of relationships between the physician and patient, and the codes may reflect combinations of such categories. We recommend that CMS either create another category of relationship that incorporates both types of care, or create modifiers that address the overlapping relationships. We also urge CMS to provide clear guidance on how reporting each type of relationship will impact how a provider s resource use is measured. Patients suffering from glaucoma are the most likely to need continuing care and occasional surgical procedures. There is no cure for glaucoma; however, there are surgical procedures, such as Selective Laser Trabeculoplasty (SLT), which may be performed at the outset of glaucoma treatment or if topical treatments, such as eye drops, either are not adequately lowering intraocular pressure or are causing side-effects. In addition, glaucoma surgery is often performed at the same time as cataract surgery. Despite these acute surgical interventions, glaucoma patients continue to need ongoing care later in the disease. In some cases, the physician who provides continuing care for managing the chronic disease may not be the surgeon performing the cataract or glaucoma surgery, so each physician would be able to claim a relationship he or she has with the patient under the proposed categories. However, if the same physician provides all care to the patient, it is unclear how these categories should be applied. We suggest that the creation of an additional category incorporating both chronic and acute care would help ophthalmologists treating a patient with glaucoma or other diseases to more accurately describe the type of care he or she is providing to a particular patient. Co-management of post-operative care must also be addressed. Previously, CMS proposed a consulting role during an acute episode, which described a co-managing relationship, but none of the new categories retain that role. ASCRS recommends that current existing comanagement modifiers (54/55) should be used as patient relationship modifiers, rather than develop new modifiers to indicate when one physician performs a surgery and another
Page 4 provides post-operative care. Co-management of post-operative care is unique to ophthalmology. An ophthalmologist may perform a patient s cataract surgery, but postoperative care is provided by another ophthalmologist or an optometrist. This is frequently at the request of the patient who may prefer not to travel long distances for follow-up care, or wishes to continue a relationship with an existing physician who does not perform surgery. Currently, the 54 and 55 modifiers are used by the two physicians treating the patient to indicate their role in the surgical and post-surgical care. These modifiers are widely used and well understood by physicians and should be continued as patient relationship modifiers. 3. Are HCPCS modifiers a viable mechanism for CMS to use to operationalize this work to include the patient relationship category on the Medicare claim? If not, what other options should CMS consider and why? HCPCS modifiers are a viable mechanism to use to identify patient relationships. As mentioned above, the 54 and 55 modifiers are already in use to designate co-managed postoperative care, and are widely used by ophthalmologists. We urge CMS to maintain the 54 and 55 modifiers as the mechanism to report co-managed care. While we understand new modifiers must be created to identify other types of relationships, we oppose creating new modifiers that reflect particular relationships already in use. In our comments on the first request for information on patient relationship categories and codes, we urged CMS to implement this requirement in the least burdensome manner possible. We were concerned that developing new codes would add even more administrative burden to practices that are dealing with several current quality reporting programs and transitioning to the new programs under MACRA all while still providing top quality care to patients. We support CMS proposal to use modifiers to identify patient relationships because they are well understood and widely used already. We recommend CMS develop the modifiers in a way that will allow physicians to report the severity of the patient s disease when reporting the type of relationship. Oftentimes, the severity of a patient s disease determines how the care will be managed, and therefore the cost of the treatment. For example, patients with co-morbidities, such as other ocular conditions, dense or white cataracts, or small pupils, will necessitate using the complex cataract surgery code, which is reimbursed at a higher value than routine cataract surgery. For chronic care, the most severe glaucoma patients may require more intense surgical interventions as the disease progresses, while less severe glaucoma cases may be well controlled with topical treatments, such as eye drops. Without a way to differentiate between the patients who require the most intensive and thus expensive care from patients with mild or moderate cases of particular diseases, resource use cannot be accurately measured and compared. If treating the least severe positively affects resource scores, this may lead to cherry-picking the least expensive patients, a concept that is anathema to most physicians. Modifiers must be developed to indicate the severity of a patient s disease, to ensure physicians resource use scores accurately reflect the cost of care for the sickest patients and do not lead to cherry-picking of patients.
METHODOLOGY FOR DETERMINING RESOURCE USE Patient Relationship Codes Page 5 ASCRS has long opposed CMS existing policies for attributing patients for resource use measures first as part of the Value-Based Payment Modifier (VBPM) and now to continue in the MIPS program because the measures are primary care-based and potentially hold certain physicians, particularly specialists such as ophthalmologists, responsible for care they did not provide. Under CMS current twostep attribution process, beneficiaries who remain unassigned to a primary care provider are assigned to a non-primary care provider who billed the plurality of evaluation and management services for the patient during the reporting period. Because ophthalmologists often bill evaluation and management codes, they are particularly at risk for being held responsible for care they did not provide. Further, the current resource use methodology does not incorporate appropriate risk adjustment for factors outside the physician s control, such as patient compliance and socioeconomic status. Patient relationship categories and modifiers have the potential to more accurately identify which physician is responsible for a patient s care. Since the current methodology for determining cost is not effective, it is imperative that CMS ensure these categories and modifiers are tested and developed in a way that accurately holds physicians, particularly specialists such as ophthalmologists, accountable for the cost of the care they provide and control. When developing the relationship codes that correspond to the overarching categories, we urge CMS to include a method for reporting the severity of a particular disease, which will impact the cost of the care provided. Without a way to account for differences in patient severity, the sickest patients are at the greatest risk of losing access to the care they need if physicians know they could potentially be penalized for treating a patient who will require more expensive care. The categories and codes should also be risk adjusted, and since we are not aware of any current model that provides adequate risk adjustment, we urge CMS to develop an appropriate methodology that accounts for factors outside the physician s control. When designing a framework for how patient relationship categories and modifiers will be used to determine a physician s resource use, ASCRS urges CMS to develop a proposal that does not hold physicians who report a specific patient relationship accountable for the costs of care they did not provide and cannot control. Similar to the current resource use attribution method, it is possible that an ophthalmologist might be the only physician a patient sees in a particular year or performance period who claims a relationship of leading the management of care for a chronic disease or acute episode. However, if a patient is treated for another disease or acute episode unrelated to the care the ophthalmologist provides, and no other physician claims to have the overall management of that unrelated care, the ophthalmologist should not be attributed the cost for all of the care provided to the patient which is out of an ophthalmologist s control. CMS must clearly define how costs will be attributed to specific physicians based on the relationship they report. We urge CMS to provide additional information regarding how these patient relationship categories and modifiers will be used in determining resource use for episode groups. Given the example above of an ophthalmologist or optometrist providing postoperative care to a cataract surgery patient, physicians should know in advance what costs they are responsible for based on the type of relationship they are claiming. In addition, physicians claiming to have the ultimate responsibility for the patient should know what costs will be included in the episode, and have the opportunity to indicate what costs within the episode are within their control, so they are not held accountable for the cost of care unrelated
Page 6 to the disease or acute episode or from other providers. Physicians also should not be attributed the extra costs for particular treatments required due to other care the patient is receiving from other physicians. As mentioned above, if a cataract patient is prescribed Tamsulosin by a primary care physician, that patient will likely require the use of iris retractors, leading to the use of the complex cataract surgery code 66982, reimbursed at a higher value than cataract surgery, 66984. It is not currently possible to determine how those costs would be attributed from the patient relationship categories request for information or the proposed episode groups. The framework for determining resource use should also take into account the severity of the patient s disease, which impacts the type and cost of care a physician may provide. Treating patients with diabetic retinopathy, for example, may involve several different courses depending on severity. Patients with well-controlled blood sugar may not have a severe case of diabetic retinopathy and not require more than annual exams. However, patients with severe cases may require extensive intravitreal injections to curb the progression of the disease. If the injections are not sufficient to curb the progression of the disease, laser treatment or surgery may be required to prevent the patient from losing their sight completely. Treating the more severe case would become much more expensive than a mild or moderate case. In addition, the presence of certain co-morbidities may impact the complexity of cataract surgery, and may lead to complications during surgery. Physicians should not be held accountable for care they, or other physicians, are required to provide due to issues, such as patient compliance or socioeconomic factors, that are beyond their control. For instance, glaucoma patients will never fully regain their vision, but preventing further progression of the disease generally depends on the patient s use of prescribed topical treatment of eye drops and following up with the ophthalmologist s office for regular eye pressure checks and other glaucoma-related testing. Patient compliance can have an impact on the progression of their disease, and ultimately the cost of their care. If a patient cannot make his or her regularly scheduled appointments, or does not regularly use prescribed eye drops, it may require costlier treatment, such as surgical intervention. In addition, older patients with glaucoma may have difficulty withstanding visual field testing in both eyes in one visit and may require additional visits. Patients with severe diabetic retinopathy must come to the physician s office for regular intravitreal injections. If a patient misses several appointments, the treatment cannot simply be restarted, and may require surgery. The ophthalmologist treating this type of patient should not be penalized for having to provide the more expensive care when the patient could not comply with the original course of treatment depending on severity. There are also a variety of socioeconomic factors that impact overall care for certain patients. For example, lower income patients or patients in rural areas may have difficulty making regularly scheduled appointments if they do not have access to reliable transportation or must travel longer distances. In general, ophthalmologists tend to treat older Medicare patients, who may not have the manual dexterity required to administer their drops. In addition, older patients have mobility issues and rely on other caregivers to bring them to the physician s office. All of these factors can impact their ability to receive regular care or the ultimate cost of the care. Finally, the site of service which is not always in the physician s control should be accounted for in the resource use methodology. Ophthalmic surgery can be performed in either hospital outpatient departments (HOPDs) or ambulatory surgery centers (ASCs). The
Page 7 facility reimbursements for ASCs are well below HOPDs. Cataract surgery, for example, is reimbursed 45% less in the ASC than in the HOPD. While some ophthalmologists have the option of building and owning their own ASC, state certificate of public need laws prevent some physicians from opening new ASCs, so they may be forced to operate in HOPDs. In addition, some physicians, especially sole practitioners, may not have the resources to construct and manage their own ASC, and must operate in whatever facility, either ASC or HOPD, is available. Currently, the Supplemental QRURs CMS publishes on cataract surgery do not differentiate whether the surgeon performed the surgeries in an ASC or HOPD and compares the surgeon to an average. It is unclear if this average is adjusted to take into account the differential in the facility charge. The resource use methodology must take site of service into account by only comparing the cost of episodes that were performed in the same type of facility, since the site of service is not always in the control of the physician. ADDITIONAL TESTING REQUIRED ASCRS recommends that CMS conduct rigorous testing on the relationship modifiers before requiring all physicians to comply. Despite the fact that physicians and practice administrators are familiar with modifiers, noting a particular relationship with a patient for purposes of determining resource use is a new concept that will require a change in workflows and likely EHRs and other health IT systems. We recommend a pilot program be developed and implemented in several practices of varying size, specialty, and location to determine how well they capture the myriad types of relationships physicians may have with patients, and the administrative burden the proposed system may place on practices. We realize that under MACRA, physicians must report the codes beginning in 2018, and therefore, we urge CMS to begin the pilot program immediately. MINIMIZING THE BURDEN ON PHYSICIANS AND PRACTICES While we believe the simplified categories and the use of modifiers to report the relationship will reduce the burden on practices, we continue to urge CMS to consider the administrative burden this proposal in conjunction with other reporting requirements places on physicians and practices. The Congressional sponsors of MACRA intended the new law to streamline quality reporting after hearing from physicians and practices who have lost patience with the overlapping and sometimes conflicting requirements of the current programs. It is imperative that CMS view the implementation of the patient relationship modifiers and other programs under MACRA as a holistic program and consider the totality of the requirements these programs place on physicians and practices. We urge CMS to move away from the current fragmented approach to quality reporting, and incorporate these and other requirements into a streamlined program that is easy for physicians to comply with and understand. We continue to urge CMS to provide adequate time to ensure EHR systems are equipped to incorporate these modifiers as a key component in limiting the burden on physicians and practices. New regulations, or changes to existing regulations, require updates to information technology (IT), and oftentimes, practices are disadvantaged by delays or high costs of system upgrades from EHR vendors. We encourage CMS to provide sufficient time and technical
Page 8 assistance to ensure Health IT systems are capable of capturing and reporting the relationship modifiers. CONCLUSION In summary, ASCRS urges CMS to consider our comments closely and, of foremost importance, develop a system for measuring resource use that is properly risk adjusted and does not hold physicians responsible for care they did not provide or that is based on factors beyond their control. In addition, we urge CMS to add a new relationship category that reflects the overlap between continuing and surgical care for the same patient. We recommend extensive testing of the modifiers before they are implemented so as not to overly burden physicians and practices, and that CMS provide adequate notice and training prior to the implementation. ***** Thank you for providing our organization with the opportunity to present our comments on the request for information. Should you have any questions regarding our comments, please do not hesitate to contact Allison Madson, manager of regulatory affairs, at amadson@ascrs.org or 703-591-2220. Sincerely, Kerry D. Solomon, MD President, ASCRS