Finalized Changes to the Medicare Shared Savings Program Background: On June 4, 2015, the Centers for Medicare and Medicaid (CMS) issued a final rule that updates implementing regulations for the Medicare Shared Savings Program (MSSP). Final implementation regulations for the MSSP program were issued in November 2011. In December 2014, CMS published a proposed rule updating MSSP implementing regulations to “advance the ACO models, codify existing guidance, reduce administrative burden and improve program function and transparency in a number of program areas.” Most provisions of the final rule go into effect on August 3, 2015. This memo provides a summary of key provisions included in the MSSP final rule. It also provides a chart that compares the final rule to comments submitted by the consumer Coalition for Better Care (CBC) Coalition on the proposed MSSP rule. The MSSP program now includes 400 Accountable Care Organizations (ACOs) across 49 states. More than 7.3 million beneficiaries are receiving care through the program.1 Summary of Major Provisions in the MSSP Final Rule: CMS added a new performance-based risk model (“Track 3”) for ACOs. Track 3 offers a higher sharing rate than Tracks 1 and 2. Beneficiaries will be prospectively assigned to Track 3 ACOs; there will be no retrospective reconciliation. Current Track 1 (one-sided risk) MSSP ACOs are permitted to participate in one additional three-year agreement under Track 1 and maintain the same maximum sharing rate applicable in their first agreement period. Extended participation in an addition Track 1 three-year agreement cycle is only available to current Track 1 MSSP ACOs that have met the quality performance standards in at least one of the first two years of their agreement. 1 http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-06-04.html 1 A waiver of the three-day inpatient stay rule for SNFs services will be made available to Track 3 MSSP ACOs. (This waives the requirement of a three-day inpatient hospital stay prior to the provision of Medicare covered post-hospital extended care services for beneficiaries that are prospectively assigned to Track 3 MSSP ACOs.) This waiver will be effective no earlier than January 1, 2017. The other waivers proposed in the proposed rule (Billing and Payment for Telehealth Services; Homebound Requirement Under the Home Health Benefit; Referrals to Post-acute Care Settings; Waiver of Other Payment Rules) were not included in the final rule. CMS plans to conduct further development and testing of other selected waivers through the CMS Innovation Center prior to deciding whether it is appropriate to incorporate such waivers into MSSP. CMS anticipates a telehealth waiver being available to ACOs no earlier than January 1, 2017, after notice and comment and rulemaking. CMS finalized data-sharing proposals that would discontinue individual beneficiary notifications of data-sharing and the opportunity to opt out. Under the final rule, MSSP ACOs must provide written notification at the point of care through signs posted in facilities. These signs must provide information about data sharing and beneficiary ability to decline data sharing by calling 1-800-Medicare. Beneficiaries will now directly notify CMS, rather than the ACO, of their decision to opt out of data sharing. CMS will now also include primary care services provided by nurse practitioners, physician assistants, and clinical nurse specialists for purposes of assigning beneficiaries to an MSSP ACO based on utilization of primary care services provided by primary care providers. However, CMS states that beneficiaries will not be assigned to ACOs based solely on the services provided by non-physician providers. CMS will continue to first identify patients who have received a primary care service from a physician participating in the ACO before counting the primary care services provided by non-physician ACO providers. Comparison Chart: Final Rule on Medicare Shared Savings Program Category Program Evolution Sub-Issue Quality Measures CBC Comment/Recommendation Strongly urge CMS to prioritize outcomes measures, with a focus on coordination of care, including transitions of care, hospital admissions and readmissions, use of emergency departments, and 2 MSSP Final Rule Not addressed in the final rule. (As expected. MSSP ACO quality measures are determined in/by the Physician Fee Schedule.) medication management. Governance Consumer/Beneficiary Urge CMS to strengthen Representation in requirements for meaningful ACO Governance involvement of consumer/beneficiary representatives and to exercise greater oversight to ensure the success of engagement efforts CMS should encourage ACOs to pursue additional approaches, such as involving patient/family representatives on ACO quality and safety improvement bodies. Encourage CMS to offer guidance and assistance to ACOs with respect to developing onboarding and orientation processes for consumer/beneficiary representatives In the preamble, HHS states that a focus on the beneficiary in all facets of ACO governance is critical for ACOs to achieve the three-part aim and that beneficiary representation is important. HHS encourages ACOs to consider seriously how to provide opportunities for beneficiaries and others to be involved in ACO governance through both governing body representation and other appropriate mechanisms. However, HHS states that they believe their current regulations balance the overall objectives for the program while permitting ACOs flexibility to structure their governing bodies appropriately and are not incorporating suggestions to increase the beneficiary representation requirement. HHS finalized the proposed revision to explicitly prohibit an ACO provider/supplier from being the beneficiary representative on the governing body (§ 425.106(c)(2)) 3 Beneficiary Assignment Definition of Primary Care Services Strongly support including transitional care management codes (CPT codes 99495 and 99496) and chronic care management codes (HCPCS code GXXXI) as primary care services. HHS finalized the proposal to update the definition of primary care services to include both TCM codes (CPT codes 99495 and 99496), the CCM code (CPT code 99490), and to include these codes in the beneficiary assignment methodology (§ 425.20 and § 425.402) Definition of Primary Care Providers Strongly support inclusion of Nurse Practitioners, Physician Assistants, and Clinical Nurse Specialists as primary care providers for the purposes of beneficiary assignment. HHS finalized the proposal to include claims for primary care services furnished by NPs, PAs, and CNSs under step 1 of the assignment process, after having identified beneficiaries who received at least one primary care service by a physician participating in the ACO. (§ 425.402(a)) Voluntary Beneficiary Alignment, Education and Outreach Support enhanced beneficiary choice with respect to their alignment with an ACO. HHS agreed with commenters who recommended implementing a policy to revise the beneficiary assignment methodology to permit beneficiaries to indicate who they believe is the "main doctor" responsible for their care coordination. Before beneficiaries can be expected to elect into their primary care provider’s ACO, however, they must have access to materials that help them understand what an ACO is, how this new model of care functions, what alignment means to them, and what their rights are with respect to accessing care inside and outside of the ACO. 4 HHS expects to propose to implement beneficiary attestation for purposes of beneficiary assignment under the Shared Savings Program beginning January 1, 2017, in the 2017 Physician Fee Schedule (PFS) rulemaking. This timeline will allow for further Beneficiary education on Medicare ACO programs must accompany dissemination of any voluntary alignment materials. Other key issues that CMS should address: How and when beneficiaries are informed of the opportunity to align Ensuring that written materials and verbal communications resonate and effectively reach beneficiaries and their families Ensuring that beneficiaries are contacted by appropriate, trusted messengers Ensuring that beneficiaries are able to contact assistors with questions and know whom to contact if they have questions Ensuring maintenance and enforcement of necessary and appropriate consumer protections, particularly with respect to direct outreach and communication with Medicare beneficiaries Prohibition on Financial Inducements To Incentivize Voluntary Alignment Strongly support the prohibition of the use of gifts or other financial inducements to beneficiaries or use of penalties as part of a voluntary alignment process 5 development and testing of this approach through the Pioneer ACO Model and the Next Generation ACO Model and development of appropriate safeguards against abusive or coercive marketing associated with beneficiary attestation. Initially, until CMS can gain additional operational experience, they anticipate limiting the beneficiary attestation process to ACOs participating under Tracks 2 or 3. HHS did not create a specific prohibition on the use of gifts but stated in the preamble that they did not believe ACOs or others should be permitted to offer gifts or other inducements to beneficiaries, nor should they be allowed to withhold or threaten to withhold services, for the purposes of coercing or influencing their alignment decisions. Assignment to ACOs that include FQHCs, RHCs, CAHs, and/or ETA Hospitals Support including FQHCs, RHCs, CAHs, and ETA hospitals in ACOs; the beneficiaries who rely on these providers, many who reside in rural and underserved populations, could benefit from the improved care coordination ACOs may provide. HHS finalized the proposal to use FQHC/RHC physician attestation information only for purposes of determining whether a beneficiary is eligible to be assigned to an ACO. If a beneficiary is identified as "assignable" then CMS will use claims for primary care services furnished by all ACO professionals submitted by the FQHC or RHC to determine whether the beneficiary received a plurality of his or her primary care services from the ACO under Step 1. (§ 425.404) HHS will continue including claims for primary care services billed by method II CAHs in the beneficiary assignment process under established procedures. (§ 425.402) Beneficiary Notification and Data Sharing Support the goals of improving beneficiary notification of data sharing and the opportunity to opt out. Expressed concerned about the changes proposed, however. Proposal was to replace individual notice to beneficiaries with non-specific/group notice provided via the Medicare & You handbook and signs posted in practice sites. 6 HHS finalized the proposed modifications to a “streamlined” process by which beneficiaries may decline claims data sharing. HHS finalized requiring ACO participants to use CMS-approved template language to notify beneficiaries regarding participation in an ACO and the opportunity to decline data at the point of care. ACOs are no Urged CMS to maintain individual notice of data sharing and the ability to opt out; support communications to beneficiaries and their doctors (or practice staff) about ACOs and data sharing; utilize community resources; and consider offering patients realtime, electronic access to their health information which may bolster trust and better equip beneficiaries to make more informed decisions regarding data sharing longer required to send individualized notification. (§ 425.708 and § 425.312(a)) HHS finalized their proposal to honor any beneficiary request to decline claims data sharing until such time as the beneficiary may reverse his or her claims data sharing preference to allow data sharing. These changes are effective November 1, 2015. (§ 425.708(c)) Urged CMS to require ACOs to work with beneficiaries and consumers to ensure language clearly describes why and how their health information will be stored, exchanged, used and protected, the opportunity to opt-out, and other beneficiary rights Eligibility Requirements for MSSP ACOs Care Planning and Coordination, Patient-Centeredness Criteria Support requiring ACOs, as part of the application process, to have a mechanism in place for coordinating patient care and to detail the kinds of processes that will be used Strongly support maintaining the existing requirements in this section and continuing to require documentation of specific plans and processes for implementing these criteria as part of the ACO application process 7 Applicants to MSSP must provide a description, or provide documents sufficient to describe, how the ACO will implement the required processes and patient-centeredness criteria. An ACO must establish processes to accomplish the following: promote evidence-based medicine; promote patient engagement; develop an infrastructure to internally report on quality and cost metrics required for monitoring and feedback; and coordinate care across and among primary care physicians, specialists and Commend HHS’ continued support for shared decision-making in ACOs and urge HHS to include even more support for shared decision making through strong program requirements and quality measures Emphasize that true beneficiary engagement goes beyond an occasional focus group or an annual patient experience to encompass mutually beneficial partnerships at every level of care. Patients and family caregivers must be systematically and meaningfully involved in all decisions concerning their care, and at every level – in care design and redesign, in policy and governance, and at the community level. acute and postacute providers and suppliers. (§ 425.204(c)(1)(ii), § 425.112, § 425.112(b)) Additionally, HHS states that beneficiary engagement is an important element in the ACO's ability to meet its goal of improving quality and reducing costs. For this reason, the rules require ACOs to develop a process to promote patient engagement. CMS believes that patient engagement works best at the point of care and the development of the patient-doctor relationship. CMS highlights that several ACOs that achieved first year success in the program have observed that patient engagement improves when engaged providers improve patient care. Encourage HHS to work with ACOs to support “hard-wiring” patient and family-centered care and partnerships by incorporating patient and family centered care criteria and principles into hiring practices, job descriptions, etc.; supporting strong leadership commitment to patient and family centered care Requirement to Demonstrate Intent to Promote Strongly support the proposal to require MSSP ACO applicants to describe how it will promote use of 8 HHS finalized the proposal to add a new requirement to the eligibility requirements to require an ACO to Acceleration of Health IT health IT to improve care coordination, including plans to partner with long-term and postacute care providers, and to identify performance targets for assessing progress Encourage HHS to consider requiring ACOs to delineate their plans for partnering with patients and families to make health information electronically available and useful to patients and families Encourage HHS to regard beneficiary electronic access to and sharing of health information as core elements that will advance interoperability efforts describe in its application how it will encourage and promote the use of enabling technologies for improving care coordination for beneficiaries. Specifically, such enabling technologies and services may include electronic health records and other health IT tools (such as population health management and data aggregation and analytic tools), telehealth services, remote patient monitoring, health information exchange services, or other electronic tools to engage patients in their care. (§ 425.112(b)(4)(ii)(C)) HHS states that enabling technologies should be adopted thoughtfully with the goal of improving care, and not just adoption for its own sake. However, HHS did not finalize additional specific requirements because they believe ACOs should have flexibility to define their care coordination processes and use of enabling technologies. HHS believes this flexibility can encourage innovative methods of engaging both beneficiaries and providers in the coordination of a patient's care. In addition, HHS will assess general progress through ACO performance on measures related to HIT adoption and use, for instance, the current MSSP quality measure around participation in the EHR Incentives program, or a 9 future measure which would reflect ACO providers' ability to electronically exchange data to support care transitions. HHS encourages providers to monitor the degree of interoperability and exchange across providers in their ACO, which could include evaluating performance on the transition of care or health information exchange measures in the EHR Incentives Program. Regulatory Waivers Waiver of 3-Day Inpatient Rule for SNF Services Support proposal to waive the 3-day inpatient requirement for SNF care. However, strong beneficiary protections and quality standards must be in place to prevent abuse and ensure ACOs are providing high quality, patient- and family- centered discharge planning Any proposal to waive the SNF requirement must include strong beneficiary protections, including: Assurances that beneficiaries would not be liable for the cost of SNF care Significant education efforts to explain the waiver and its limitations Network adequacy protections Patient choice protections Urge CMS to clearly require ACOs to 10 HHS finalized the proposal to waive the 3-day SNF rule for eligible beneficiaries that are prospectively assigned to ACOs that participate in Track 3. An ACO's use of the 3-day SNF rule waiver will be associated with a distinct and easily identified event (admission of a prospectively assigned beneficiary to a SNF without prior hospitalization or after an inpatient hospitalization of fewer than 3 days). CMS is limiting the waiver to ACOs in Track 3 because under the prospective assignment methodology used in Track 3. This waiver under will be effective for services provided on or after January 1, 2017. All ACOs electing to participate in Track 3 will be offered the opportunity Referrals to PostAcute Care Settings elicit and accommodate patient and family preferences when it comes to discharge planning and transitions of care, including referrals to SNFs. to apply for a waiver of the SNF 3-day rule for their prospectively assigned beneficiaries at the time of their initial application to the program. In their request to use the waiver, ACOs must demonstrate that they have the capacity to identify and manage patients who would be either directly admitted to a SNF or admitted to a SNF after an inpatient hospitalization of fewer than three days. Specific criteria will be set forth in the materials for both initial applications and renewals under Track 3. If ACOs are permitted to affiliate themselves more closely with certain providers, strong quality measures must be in place to ensure recommended entities deliver the highest standards of care. ACOs must be transparent about these affiliations and continue to make beneficiaries aware of the full range of providers available to them, beyond the recommended few. Proposal was not included in the final rule. Waiver must be accompanied by strong oversight, monitoring, and enforcement mechanisms. 11 Billing and Payment for Telehealth Services Homebound Requirement for Home Health Services HHS should carefully consider appropriate use of telehealth services, and how it impacts more vulnerable beneficiaries, especially dually eligible beneficiaries. Support the opportunity to waive the Medicare homebound requirement for home health services for Track 3 ACOs. However, need to ensure beneficiaries retain choice of home health providers to the greatest extent possible. 12 Proposal was not included in the final rule. HHS expects to focus on further development of a waiver of certain billing and payment requirements for telehealth services. HHS intends to offer such a waiver starting as early as in 2017, with specific requirements to be determined based on HHS’ experience implementing such a waiver in the Next Generation ACO Model. HHS anticipates a telehealth waiver being available to ACOs no earlier than January 1, 2017, after notice and comment and rulemaking. Proposal was not included in the final rule. Additional Program Requirements and Beneficiary Protections Transparency of Information: Participating ACO Providers We support CMS’s efforts to improve the integrity and timeliness of information about ACO participants, providers, and suppliers and to improve the process for reporting changes in a timelier manner. CMS will require that each ACO maintain a dedicated Web page on which the ACO must publicly report designated information via a template specified by CMS (§ 425.308 (b)). ACO must report, for example: We support requiring each ACO to create and maintain a dedicated webpage on which it must report information in a standardized way. To be successful, the webpage must be easy to find, contain easy-to-read information about the providers, and be updated regularly. Further, the webpage should not just include the names of the participating providers but also information about the physical accessibility of the office as well as information about languages spoken. We also encourage requiring ACOs to provide non-online sources of information for beneficiaries, such as mailing this information to beneficiaries once per year. Finally, we encourage standardized reporting of complaints and problems into a centralized unified tracking system (like the complaint tracking module). 13 (1) Name and location. (2) Primary contact. (3) Organizational information, including all of the following: Identification of ACO participants. Identification of participants in joint ventures between ACO professionals and hospitals. Identification of the members of its governing body. Identification of key clinical and administrative leadership. Identification of associated committees and committee leadership. Identification of the types of ACO participants or combinations of ACO participants (as listed in § 425.102(a)) that formed the ACO. (4) Shared savings and losses information, including the following: Amount of any payment of shared savings received by the ACO or shared losses owed to CMS. Total proportion of shared savings invested in infrastructure, redesigned care processes and other resources required to support the three-part aim goals of better health for populations, better care for individuals and lower growth in expenditures, including the proportion distributed among ACO participants. (5) The ACO's performance on all quality measures. Transparency of Information: Quality Performance Additional Priorities Grievance and Appeals Processes Urge HHS to require ACOs to publicly report cost information in a consumer-friendly manner. ACOs should publicly report Medicare total costs for beneficiaries assigned to the ACO and total costs for the commercially insured receiving care in the ACO. ACOs also should publicly disclose their prices for routine procedures for Medicare and an average price (blended fee schedules) for commercial payers. Urge HHS to require ACOs to report quality and cost information at the provider level, as well as at the ACO level. HHS should ensure appropriate grievance and appeals processes for beneficiaries in ACOs and clearly communicate these rights to 14 (6) Use of payment rule waivers under § 425.612, if applicable. CMS finalized the proposal to require ACOs to report all quality measure data on their public websites (see above for full list of reporting requirements). HHS states in the preamble that beneficiaries maintain the ability to dispute charges or file an appeal for a claim under the fee-for-service (FFS) beneficiaries. Processes should be standardized across plans, with regular reporting to a HHS official with oversight authority. ACOs should: Require providers to state all treatment options available to a beneficiary Communicate to beneficiaries that they have the option to seek a second opinion by a non-ACO provider; and Assist beneficiaries in submitting complaints or grievances. 15 program and the Shared Savings Program does not change any FFS beneficiary choices or benefits.
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