Re: Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations

February 6, 2015 Marilyn Tavenner, Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1461-P P.O. Box 8013 Baltimore, Md. 21244-8013 Re: Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations Dear Administrator Tavenner: As President of the American Osteopathic Association (AOA), which represents the nation s 110,000 osteopathic physicians (DOs) and osteopathic medical students, I appreciate the opportunity to provide comments on the agency s proposed rule for Accountable Care Organizations (ACO). The AOA supports physician-led ACOs that are built upon a patient-centered medical home (PCMH), which we believe is the foundation of shared savings delivery models. Our comments focus on the proposed rule as it relates to the core principles and orientation of osteopathic medicine. Osteopathic physicians practice medicine based on key values of holistic, patient-centered care. These values drive high quality care which is tailored to the patient s needs. By delivering patient-centered care, osteopathic physicians are increasingly demonstrating that care delivery models which place the patient first, are the best not only in terms of quality of care, but also in terms of cost containment. RECOMMENDATIONS ACOs are an innovative approach to providing patient care outside of the traditional fee-for-service structure. The AOA commends the Centers for Medicare and Medicaid Services (CMS) for its efforts to reinvigorate its ACO program. Integrated health care delivery models, like ACOs, that achieve better care for individuals, better health for the population, and lower spending for Medicare beneficiaries must be encouraged to grow, as well as attract small and medium-sized practices to participate. The AOA believes the Medicare Shared Savings Program (MSSP) should be accelerated and expanded in concert with improving the program. ACOs, as they currently exist under MSSP, are not without their financial risks and administrative challenges which hamper participation. To succeed in improving care coordination through an integrated health care system that rewards quality over volume, the medical profession requires greater incentives and flexibility as well as fewer administrative burdens. We offer the following recommendations: 1

1. Osteopathic Manipulative Treatment (OMT) should be recognized as a service that can be performed by physicians who self-identify with primary care or specialty care, and it should be clarified that Osteopathic Manipulative Medicine, not Osteopathic Manipulative Therapy, is a specialty. 2. With the PCMH model as the foundation for ACOs, greater participation of small and mid-sized practices should be encouraged within the program. 3. Health information technology (HIT) should be cost-effective and interoperable, and support increased access to care, particularly in rural and underserved areas. To achieve these goals, the challenges related to interoperability and certification must be resolved. 4. CMS should use its authority to waive certain requirements which will improve access to care and provide regulatory relief to ACOs. 5. The transition into a two-sided risk agreement requires greater time and flexibility to ease the burden on smaller, physician-led ACOs. Financial incentives should be used to encourage ACOs to take on more risk. 6. CMS should allow prospective beneficiary assignment for all ACOs. Benchmarks also should be set prospectively. 7. Availability of complete information on the Medicare beneficiary to the ACOs is necessary to allow them focus on the sickest of their patients with more exacting care and treatment. 8. Inpatient Evaluation & Management (E&M) codes should be included in primary care services along with those codes identified by CMS in the proposed rule. In addition, CMS should clarify the use of code GXXX1. 9. Modify the Medicare enrollment process so that NPPs can designate a specialty. Require NPPs to attest that they are primarily providing primary care services in order to be included in the beneficiary assignment process. 1. AOA Recommendation: Osteopathic Manipulative Treatment (OMT) should be recognized as a service that can be performed by physicians who self-identify with primary care or specialty care, and it should be clarified that Osteopathic Manipulative Medicine, not Osteopathic Manipulative Therapy, is a specialty. Under MSSP, beneficiaries are assigned to ACOs based on the primary care services they receive, using a two-step process. The agency s proposal to modify the assignment process has a direct impact on osteopathic medicine. Under Step Two, the agency proposes to exclude services provided by certain physician specialties from the beneficiary assignment process to ensure that beneficiaries are assigned to the appropriate ACO which actually provides primary care. CMS contends these specialties should be excluded because they rarely provide primary care services. Among the specialties listed is Osteopathic Manipulative Therapy. The proposal s listing of Osteopathic Manipulative Therapy as a specialty is incorrect. Osteopathic physicians are fully qualified physicians licensed to prescribe medication and perform surgery. In addition, DOs can choose to practice in any medical specialty. With that premise, DOs receive extra training in the musculoskeletal system. Osteopathic manipulative treatment (OMT), not Osteopathic Manipulative Therapy, as listed in the rule, is incorporated into the training of all osteopathic physicians. 2

CMS even acknowledged as such on August 27, 2010, when it issued Transmittal 2035, changing the name of Physician Specialty Code 12 from Osteopathic Manipulative Therapy to Osteopathic Manipulative Medicine. We urge CMS to make this correction regarding the specialty designation for the ACO regulation and any other pertinent regulation. OMT services are provided by osteopathic physicians with primary care designations as well as with other specialty designations. Primary care physicians offering OMT services should not be excluded from the beneficiary assignment process and neither should OMM specialists. CMS contended that its proposed excluded specialties rarely provide primary care services, yet OMM specialists do. 2. AOA recommendation: Through the expansion of the Patient-Centered Medical Home (PCMH) model, encourage greater participation of small and mid-sized practices within the program. Participation of small and medium-sized practices in the ACO program is critical to establishing a patient-centered, integrated, health care delivery system. At the center of an integrated health care delivery system is a high-performing primary care provider who can serve as a medical home for patients. Given the comprehensive approach of osteopathic medicine, which emphasizes prevention while addressing the patient s entire spectrum of health care needs, the AOA believes a high-performing PCMH network will enhance an ACO s capability to engage patients, families, and caregivers and improve their overall health care experience. The patient-centered medical home is a necessary component of integrated care and can provide the foundation and infrastructure of the ACO s medical neighborhood. According to CMS, about half of the ACOs participating in the MSSP are small, provider-based or rural ACOs. They are characterized as networks of individual practices. The other half includes hospitals. We believe additional action can be taken to enable more small and mid-sized physician practices, operating as PCMHs already, to enter the ACO program. We recommend: ACOs should be offered a larger percentage of the shared savings of up to 80 percent. CMS should explore providing additional technical and financial support to physician-led ACOs, particularly in rural areas. CMS also should scale back the number of quality measures for ACOs and focus more on outcome-based measures. Physician-led ACOs should be exempt from certain Meaningful Use requirements under the EHR Incentive Program that are duplicative of MSSP reporting. ACOs should be encouraged to embrace the National Committee on Quality Assurance s (NCQA) principles and standards of the PCMH. We also request that CMS provide more information to stakeholders on which physician-led ACOs are patient-centered medical homes. 3

3. AOA Recommendation: Health information technology (HIT) should be cost-effective and interoperable, and support increased access to care, particularly in rural and underserved areas. We urge CMS to address existing interoperability and certification challenges. CMS believes ACOs should coordinate care between all types of providers and across all services, and that the secure electronic exchange of health information across all providers in a community is of utmost importance to the success of MSSP. CMS proposes to require: An ACO to describe in its application how it will encourage and promote the use of technologies for improving care coordination for beneficiaries (technologies can include telehealth services); An applicant to describe how the ACO intends to partner with long-term and post-acute care providers to improve coordination of care; and An ACO to define and submit major milestones or performance targets as it relates to the use of HIT. The AOA agrees with CMS that the secure electronic exchange of health information across all providers in a community is of utmost importance to the success of the MSSP. The AOA supports the adoption of cost-effective HIT and we support efforts to ensure all patient-populations, especially those in rural and underserved communities, benefit from HIT. We realize the Department of Health and Human Services (HHS) has taken on several initiatives to accelerate health information exchange (HIE) and the use of HIT. While we commend HHS for its efforts, existing challenges relating to interoperability and certification must be addressed in order for HIT to be used effectively by ACOs. Standards are lacking which make it difficult to exchange information and to permit interoperability within the health care system. Interoperability is cornerstone to developing a robust HIT network that could be used to improve quality and efficiency in an ACO. According to HHS, its initiatives are designed to improve care delivery and coordination across the entire care continuum. While we believe the agency s proposals for ACOs are reasonable, we question the degree of success ACOs will have in implementing the agency s proposed requirements if HHS, CMS, and the Office of the National Coordinator for HIT do not develop effective solutions to the interoperability and certification challenges. The AOA believes that as physicians provide care in a variety of new ways, advanced technology can be used to improve patient care. The AOA further believes that online medicine policies directly tie into the PCMH model for care, and recognizes that we must simultaneously implement advancements in telemedicine in order to be successful in PCMH models and ACOs. 4. AOA Recommendation: CMS should use its authority to waive certain requirements which will improve access to care and provide regulatory relief to ACOs. CMS is considering using its authority to waive certain requirements to provide more flexibility to increase ACOs willingness to participate in the MSSP two-sided performance-based risk arrangements. 4

The AOA agrees that CMS should use its authority to waive certain requirements which will improve access to care and provide regulatory relief to ACOs. Many rules in Medicare are meant to address inappropriate utilization in the fee-for-service program, however these rules may create barriers for ACOs in their efforts to provide high quality care in a cost efficient manner. We believe CMS should reduce barriers that prevent ACOs from encouraging patients to stay within the ACO program for their health care needs. We recommend that the waivers apply to all two-sided risk arrangements. The AOA appreciates that CMS is considering its waiver authority for telehealth services. We agree that such technology enables physicians and other providers to deliver care to patients in remote locations, improving the accessibility and timeliness of needed care. We concur that when used appropriately telehealth services can increase communication, enhance care coordination, and improve the efficiency of care. The AOA believes that the standard of care provided through the use of technology should be equivalent to that of care provided when the physician and patient are within close physical proximity. Technology must not be used in a way that would diminish patient-centered comprehensive personal medical care or the quality of care being provided to the patient. The scope of care being delivered by the physician and other health care providers through telehealth should not exceed education, training and applicable state and federal laws. Providers must provide complete transparency to their patients regarding their location, jurisdiction of licensure, and any limitations of the technology used to deliver care. CMS says it would likely provide a waiver of originating site requirements that limit telehealth payment to services furnished within specific types of geographic areas or in an entity participating in a Federal telemedicine demonstration project. It would also likely provide a waiver of the originating site requirements that specify the particular sites at which the eligible telehealth individual must be located at the time the service is furnished. Providing greater access to telehealth and telemonitoring services would produce cost savings and improve care. Patients who are immobile or have limited mobility would certainly benefit particularly from telemonitoring and routine checkups that do not require physical interactions, which provides better continuity of care. If CMS moves forward with providing waivers, we recommend that CMS study the impact within ACOs and through pilot projects in other models, including the PCMH. 5. AOA Recommendation: The transition into a two-sided risk agreement requires greater time and flexibility to ease the burden on smaller, physician-led ACOs. Financial incentives should be used to encourage ACOs to take on more risk. The agency s goal is to encourage the continued participation of existing ACOs in the MSSP by easing the transition from non-risk-bearing (Track One) to risk-bearing ACO (Track Two) models; reducing the risks for risk-bearing ACOs, and adding a new ACO Track (Track Three) that enables ACOs to qualify for increased shared savings. The AOA commends CMS for its efforts to address the challenges facing ACOs. A very small percentage of the current ACOs have agreed to share risks, and without any changes, CMS estimates fewer than one in four ACOs would opt for continued participation since they would have to assume 5

downside risk under the current regulations. Creating more flexibility and easing the transition into a two-sided risk agreement would help the smaller, physician-led ACOs. In our May 31, 2011 comment letter, we recommended a five-year agreement period for all ACOs with no risk-bearing requirements. At the time we were concerned that the initial three-year agreement was not a sufficient amount of time for the formation and success of ACOs. ACOs need the first two years to ramp up their program by creating the primary care infrastructure needed to be successful in the program and make the necessary investments to achieve the quality and performance standards. Those concerns materialized and CMS now acknowledges that the current transition from one to twosided risk may be too steep for some organizations, putting them in a situation where they must decide whether to take on more risk or drop out of the program. CMS recognizes that smaller and less experienced ACOs are likely to drop out of the program when faced with this choice. Under the agency s proposal, ACOs would be permitted to enter into another three-year agreement under Track One if: They satisfied quality performance requirements so that they were eligible to share in savings in at least one of the first two performance years; and They did not generate losses in excess of the negative Minimum Savings Rate in at least one of the first two years. In addition, The sharing rate would be reduced by 10 percentage points in the second agreement period for Track 1. The maximum sharing rate would be 40 percent. We support allowing ACOs to continue participating under Track One without risk-bearing for an additional three-year period and without reducing the savings rate. In addition, we believe CMS should consider the direction the ACO s performance is trending, instead of just absolute performance, when determining whether to permit renewal of an ACO s participation agreement under Track One. In proposing modifications for Track Two, we commend CMS for its efforts to ease the transition from a one-sided track to a two-sided track. We believe doing so will give ACOs the incentive to advance and take on more risk. Yet instead of transitioning from a fixed Minimum Savings Rate (MSR) and Minimum Loss Rate (MLR) to a variable MSR/MLR as CMS proposes, we recommend instead allowing ACOs to choose the option that best fits their needs. We recommend CMS allow Track Two ACOs the choice of a variable MSR and MLR, a fixed MSR/MLR of 2.0 percent, or no MSR/MLR. Small and rural ACOs can be dis-incentivized from moving into Track Two if they are held to an MSR of 3.9 percent when larger entities have an MSR of 2.0 percent. Additionally, in order to provide consistency and further encourage adoption of risk, we recommend this option be extended to Track Three ACOs as well. 6. AOA Recommendation: CMS should allow prospective beneficiary assignment for all ACOs. Benchmarks also should be set prospectively. CMS proposes a prospective beneficiary assignment for Track Three. In our May 31, 2011 comment letter, we expressed our support for a prospective beneficiary assignment that is updated quarterly with a retrospective review to adjust for any changes to the beneficiary population that may occur during the performance year. We believe it is fundamental to population management to be able to profile a 6

population, identify individuals at high risk, develop outreach programs, and proactively work with patients and their families to establish care plans. A prospective beneficiary assignment process with a retrospective review should apply to all tracks. In addition, we believe benchmarks should be set prospectively across the ACO programs so that ACOs will know their performance targets at the beginning of their contract year. It also is our belief that, unless beneficiaries are encouraged to seek and receive care within an ACO, the ability to improve quality and achieve programmatic savings is hindered. We recognize the desire to ensure that beneficiaries retain their ability to seek and receive care from any physician or institution. However, we believe that modest financial incentives are warranted. To this end, we recommend that the beneficiary co-pay be reduced to 10 percent for care provided by an ACO-participating provider or institution. The traditional 20 percent co-pay should remain for care provided outside the ACO. We believe the reduction in the co-payments should apply to all three tracks. 7. AOA Recommendation: Greater specificity of data will help ACOs focus on the sickest of their patients with more exacting care and treatment. CMS believes it can improve its data sharing policies and processes to streamline access to data to better support the program and better serve Medicare beneficiaries. The AOA commends CMS for taking into account stakeholder feedback in the effort to improve its data sharing policies. We also applaud CMS for recognizing the importance of having complete information on the Medicare beneficiary available to the ACOs to allow them to understand the totality of care provided to beneficiaries, and help ACOs provide better care to their beneficiary population. The greater specificity of the data will help ACOs focus on the sickest of their patients with more exacting care and treatment. We also believe the agency s proposals will help alleviate the administrative burden and confusion surrounding the current opt-out provision. In addition, we think the agency s proposals are steps in the right direction to provide ACOs timelier access to much needed data. Lacking access to timely information is an obstacle to proper and patient-centered care management. We recommend that the expanded availability of this information should be available to all tracks. 8. AOA Recommendation: Inpatient E&M codes should be included in primary care services along with those codes identified by CMS in the proposed rule. CMS defines primary care services as the set of services identified by the following HCPCS/CPT codes: 99201 through 99215, 99304 through 99340, 99341 through 99350, the Welcome to Medicare visit (G0402) and the annual wellness visits (G0438 and G0439). CMS proposes to update the definition of primary care services to include Transitional Care Management codes 99495 and 99496 and the Chronic Care Management Code (HCPCS code GXXX1). CMS also proposes to make any future changes to the primary care definition through the Physician Fee Schedule rulemaking process. The AOA supports the agency s proposals and recommends the inclusion of inpatient E&M codes: Observation 99218-99220/Initial, 99224-99226/Subsequent; Hospital Inpatient 99221-99223/Initial, 99231-99233/Subsequent; and Hospital Inpatient Consultation 99251-99255. 7

In addition, we request a clarification regarding the use of HCPCS code GXXX1. In the 2015 Medicare Physician Fee Schedule final rule, CMS opted to use CPT code 99490 for the Chronic Care Management (CCM) services instead of HCPCS code GXXX1. We would appreciate the agency s reasoning for using the G code in the ACO program for CCM services. 9. AOA Recommendation: Modify the Medicare enrollment process so that NPPs can designate a specialty. Require NPPs to attest that they are primarily providing primary care services in order to be included in the beneficiary assignment process. CMS proposes to include non-physician practitioners (NP, PA, CNS) in Step One of the assignment method. CMS would continue to first identify all patients that have received a primary care service from a physician who is an ACO professional. CMS believes all primary care services furnished by ACO professionals, including the entire primary care physician and practitioner team (including NP, PA, CNS with or under the supervision of physicians), would be considered for determining where the beneficiary received a plurality of primary care services. The AOA agrees with the agency s concern that adding non-physicians to Step One may cause the agency to ultimately assign some beneficiaries to an ACO inappropriately based on specialty care over true primary care. The reason being specialty codes reported on claims for NPs, PAs, and CNSs are not broken down by specific specialty areas. For example, a number of PAs work strictly as surgical specialists. CMS asks: Are there ways to distinguish between primary care services and non-primary care services billed by non-physician practitioners? Non-physician practitioners, who provide care in states that allow independent practice, should designate the specialty that they will be working with as part of their Medicare enrollment application process. We believe this modification would help to provide the distinction between primary care services and non-primary care services billed by NPPs. Only those with a primary care designation would qualify for Step One of the ACO assignment method. CMS also could have an attestation process under which NPPs would attest that they are primarily providing primary care services. Their services would be included in Step One. CONCLUSION The AOA commends the agency for its efforts to improve the Medicare Shared Savings Program which has proven to be challenging and complex. We urge CMS to enhance its educational efforts to help the medical profession understand the options, implications, and benefits related to the agency s ACO program. The ACO program must be flexible enough and provide sufficient options to meet the needs of patients and physician practices. We also encourage CMS to continue to solicit feedback from ACO professionals as it works to improve the program. The AOA looks forward to working with CMS this year on issues of importance to the osteopathic profession and their patients. Sincerely, Robert S. Juhasz, DO President 8