September 8, Dear Acting Administrator Slavitt:

Transcription

1 September 8, 2015 Mr. Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services 7500 Security Boulevard Baltimore, MD Re: CMS-5516-P; Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services Dear Acting Administrator Slavitt: On behalf of the more than 50 million adults and children in the U.S. who have doctordiagnosed arthritis, and the more than 9,500 rheumatologists who treat them, the Arthritis Foundation and the American College of Rheumatology welcome the opportunity to comment on the proposed CMS Comprehensive Care Joint Replacement Payment Model (CCJR). Arthritis is a chronic, debilitating disease that can result in joint and bone damage, requiring interventions such as joint replacements. Rheumatologists routinely care for such patients and early and appropriate treatment by rheumatologists can improve outcomes and prevent costly procedures such as joint replacements. More than 700,000 knee replacements and 300,000 hip replacements are conducted each year, contributing to more than $7 billion in cost for the hospitalizations alone. Our organizations support the effort to address the variations in cost and quality of care of patients undergoing lower extremity joint replacements, and share the goal of creating a more efficient, streamlined, and coordinated system of care for patients. However, we have some questions and concerns about the CCJR proposal. Overlap with Ongoing CMS Efforts We are pleased that CMS recognizes potential implications of program overlap, including steering beneficiaries from one program to another. While the language preserving beneficiary choice would help ensure patients receive care from the providers of their choice, we urge CMS to implement a robust monitoring system to ensure that beneficiary choice is in fact preserved, and that beneficiaries are not unduly encouraged to choose providers that they would not otherwise have chosen based on financial reasons. CMS has indicated it will monitor for these types of practices, but there is not a robust explanation of what this monitoring process would entail. We seek further comment on the extent to which beneficiary choice and access will be monitored and what action will be taken if patient steering occurs.

2 Additionally, we believe the CCJR bundle might compete for savings with successful CMS programs such as Accountable Care Organizations if CCJR episodes are excluded from ACO financials. Many ACOs have invested heavily to improve efficiency and improve outcomes of hip and knee replacements. We ask that CMS establish consistent and transparent incentives for reduced costs and improved quality and take steps to ensure the programs do not conflict or compete. Mandatory Participation / Limited Options and Settings We have concerns about the mandatory nature and timing of the program. Beginning this model on January 1, 2016 is too soon for many hospitals, physician practices, and other facilities to effectively implement the model. Additionally, this mandatory test could preclude evaluation of alternative approaches that may prove more effective. In previous bundledpayment initiatives, hospitals and other providers were encouraged to apply to participate, while this CCJR proposal will require hospitals to participate. We are concerned that while inclusion of all hospitals within a certain geographic location may yield good data on feasibility and scalability of the program, not all hospitals and facilities will have the infrastructure or means to implement the requirements. Additionally, we are concerned that the CCJR proposal could limit patient treatment options by accelerating provider consolidation, as mandatory participation of all hospitals within designated Metropolitan Statistical Areas (MSAs) may lead hospitals to place undue pressure on physicians and other parties to sign Participation Agreements and CCJR Sharing Arrangements, and force them to take on risk for the episodes. We strongly recommend that CMS either delay implementation of the program until 2017 or modify the proposal so that the initiative is voluntary rather than mandatory. If CMS chooses not to delay the program in order to allow sufficient preparation, then making the program voluntary would be necessary to ensure that only those that are ready for this challenge will enter the program, avoiding unintended negative consequences for patients and the system. We also seek more information on how CMS will address infrastructure challenges for facilities that are not equipped to meet the standards in this proposal, particularly since the program as proposed would begin in less than 6 months. Further, it appears that participation in the program is mandatory for participants, but not for collaborators. CMS has indicated that preservation of patient choice is a requirement of the program. We seek clarification on whether a scenario could occur in which a hospital does not contract with a certain provider(s) and therefore a patient does not have access to all providers of their choice, e.g. their surgeon of choice participates in the program but their rheumatologist does not. We would appreciate more information about any safeguards in place to prevent such a scenario, and the recourse available to correct the problem if this scenario were presented. We are also concerned about the central role that hospitals will retain over the program as currently proposed. We understand the intent of choosing hospitals to act as participants and all other facilities and providers to act as collaborators, but we feel this is not the best way to implement the program for the following reasons: Patients have more interaction with their physicians than with hospitals, and while the hospital may be the initial point of entry into the 90-day episode, the majority of care the patient will receive over those 90 days rests with physicians and other providers.

3 Because one of the goals of the program is to improve care coordination, it is important that the physician have a larger role as a participant in the program, since physicians are best suited to coordinate care long-term for their patients. There could be unintended consequences, such as hospitals cherry picking post-acute facilities and providers based on cost and volume, rather than quality of care and patient choice. While the proposal takes many steps to monitor and safeguard against adverse actions that could limit or disrupt patient access, placing the responsibility of the program in the hands of only one participant could still result in practices that serve to limit patient choice and negatively impact health outcomes. The CCJR episode has fewer options than have been available in other models. The CCJR includes all Medicare Part A and B services, while some of the previous models do not, and rather than offering a choice of episode durations (30-, 60-, or 90- day, for example), the CCJR episode can only be 90 days. We recommend revising the proposal to allow providers and physician groups the ability to be in charge of the bundle, or create a mechanism allowing the provider or group to participate with a facility or a third party to manage the episode, collect payments, recoup overpayments, and return shared savings across the spectrum of care. Having the hospital solely in charge of the bundle could give the hospital inappropriate leverage over other participants and may allow some hospitals to exclude care providers if those parties do not wish to meet the hospital s terms, disadvantaging the care of the patient and their right to choose a provider. Appropriateness / Potential for Unnecessary Hip and Knee Surgeries We are concerned that this procedural bundled payment mechanism does not address the appropriateness of the procedure for the patient. Even if these procedures are efficiently performed, they should be judiciously offered based on the needs of the patient. We are concerned that the model may create a financial incentive for hospitals to encourage younger, healthier patients to undergo hip and knee surgery even though the patients may be able to be managed through medication and other approaches. Because these patients would likely have lower costs for their overall episode, the hospital s overall average spending per episode would be reduced, helping them to avoid penalties for spending above the average per episode. The proposal may also discourage physicians and hospitals from developing innovative approaches to managing patients hip and knee pain. Additionally, the model offers no distinction for selecting outpatient rather than inpatient procedures when appropriate. Beneficiary Protections Because improving patient outcomes is the most important component of testing new payment models, we appreciate CMS s inclusion of a section on beneficiary protections. Ensuring that beneficiaries retain access to high quality care, and that they have opportunities to receive more coordinated care are of the upmost concern to our organizations. Our specific comments on this section are as follows: Patient notification. Patient notification and education about the program are essential to ensuring beneficiary protections. We urge CMS to require notices to be clear, easy to

4 understand, and available in multiple formats, including paper and electronically. There should be information on who to contact in case the beneficiary has questions or concerns, both within the participating hospital and at CMS. While the most expedient, least burdensome method to give patients notification upon may be upon hospital admission, we also recognize that patients receive extensive information at the time of admission, and may not fully read or understand details about this program among the many other details of the procedure with which they will be confronted. Therefore, we recommend that, in addition to disclosing information about the program upon admission and discharge, basic fact sheets about the program should be available in physician offices, so that physicians have the opportunity to talk to their patients about the program once they determine the path of joint replacement. Monitoring. CMS has indicated the program will be monitored to ensure that beneficiaries are protected from practices such as delays in care. We support this effort and encourage CMS to use its authority to evaluate claims data on a continual basis and audit program participants as necessary. Financial Arrangements We support the CMS proposal to allow participants to offer beneficiaries incentives to encourage adherence to treatment regimens and other benefits that will help improve their care. Patient engagement in their care and adherence to treatment regimens are critically important to improving health. Chronic care coordination is particularly important for people with arthritis, as arthritis itself is a chronic disease, and many people with arthritis suffer from multiple chronic conditions, particularly heart disease, diabetes, and hypertension. Any and all of these conditions can be affected by an episode of care like joint replacement, which could negatively impact the overall goal of the program to improve patient outcomes. Ultimately, treatment adherence and care coordination are important to the long-term health of the patient, not just during the 90-day episode. If an item or service makes a demonstrable impact on patient health during the 90-day episode, we encourage CMS to create an exceptions process to allow the beneficiary to continue using that item or service after the 90-day episode. CMS proposes that items and services involving technology provided to beneficiaries may not exceed $1,000 in retail value at the time of donation for any one beneficiary in any one CCJR episode, that items over $50 be retrieved after the episode of care, and that any item or service over $10 be recorded. CMS should review these cost-based requirements to ensure they are not overly restrictive and that the recording requirement is appropriate and not excessively burdensome. We are also concerned that financial agreements between hospitals and collaborators will result in patient steering or other practices that could adversely impact beneficiaries by reducing their access to care. CMS has addressed this in the proposal, and prohibits any gain sharing agreements from limiting medically-necessary care, or interfering in the ability of providers to make decisions about the best interests of their patients, including the selection of devices, supplies and treatments. We urge CMS to adopt strict safeguards to ensure the preservation of the provider-patient relationship and to discourage patient steering in the final rule.

5 Waivers We agree with CMS that it would be beneficial to waive certain Medicare program requirements to improve the chance of success for this program. We support the proposal to waive the geographic and origination site requirements from the Medicare telehealth program, and the expansion of the incident-to rule to allow 9 in-home visits during the 90-day episode. The ability of patients to access telehealth services and home visits could greatly improve treatment adherence and other positive health behaviors that may come as a result of easier access to their providers. We encourage CMS to implement these waivers early in the program, so participants and collaborators have a sufficient period of time to test the waivers before financial arrangements begin. Again, thank you for the opportunity to comment on the CCJR proposal. We look forward to future opportunities to engage with CMS on this and other programs that affect Medicare beneficiaries with arthritis. Should you have any questions or if we can be of assistance, please contact Sandie Preiss, AF Vice President of Advocacy and Access, at spreiss@arthritis.org or (202) or Adam Cooper, ACR Senior Director of Government Affairs, at acooper@rheumatology.org or (404) Sincerely, William F. Harvey, MD, MSc Chair, Government Affairs Committee American College of Rheumatology Sandie J. Preiss Vice President, Advocacy and Access Arthritis Foundation