The New MSSP Final Rule; What's Next for the Future of ACOs?

Transcription

1 Title of Webinar/Roundtable The New MSSP Final Rule; What's Next for the Future of ACOs? Date Time This webinar July is 31, sponsored 2015 l 2:00-3:30 by pm EST This webinar is brought to you by the Accountable Care Organizations Task Force, a joint endeavor of the 16 AHLA Practice Groups. Faculty : Date Time Name Faculty: Company/Firm, City, State address This webinar David is T. sponsored Morris by Jones Day, San Francisco, CA Name dmorris@jonesday.com Company/Firm, City, State address Company, firm, city, state, address Danielle A. Lloyd, MPH Premier, Company, Inc., firm, Washington, city, state, D.C. address Name VP, Policy and Advocacy; Deputy Director Company/Firm, Danielle_Lloyd@PremierInc.com City, State address Debra A. Silverman, Esq. (moderator) Name Garfunkel (moderator) Wild, P.C., Great Neck, NY Company/Firm, dsilverman@garfunkelwild.com City, State address 1

2 Total Public and Private Accountable Care Organizations 2011 to January 2015 Source: Leavitt Partners,

3 Number of ACOs by State January 2015 Source: Leavitt Partners,

4 Percent of ACOs by Provider Type Source: Leavitt Partners,

5 Number of ACO Covered Lives 2011 to January 2015 Source: Leavitt Partners,

6 Practice Transformation Care Coordination Prevention and Disease Management Care Protocols Cost-Conscious Decision Making Expanded Access Technology 6

7 New MSSP ACO Rules Published in June 9, Federal Register Generally effective January 1, Allows second Track 1 contract at 50% sharing rate. Allows choice of MSR in Tracks 2 and 3. Creates Track 3 with up to 75% sharing, prospective attribution, choice of MSR and SNF-3-day stay waiver. Equally weights the historical benchmark years and adds back savings for rebasing. Streamlines data opt-out and provides additional data. Makes numerous changes to the definitions, governing body and leadership and management requirements. 7

8 MSSP Application Application Process Sample Applications Posted to CMS Website Application Submission Period Application Deadline Application Approval or Denial Decision Sent to Applicants Reconsideration review deadline Deadlines Released June 11 July 1, 2015 August 7, 2015 August 7, 2015, at 8:00 p.m. Eastern Time Fall Days from Notice of Denial CMS application website: 8

9 Definitions Final Rule revises several existing definitions ACO participant an entity identified by a Medicare-enrolled billing TIN through which one or more ACO providers/suppliers bill Medicare, that alone or together with one or more other ACO participants compose an ACO, and that is included on the list of ACO participants that is required under ACO professional an individual who is Medicare-enrolled and bills for items and services furnished to Medicare fee-for-service beneficiaries under a Medicare billing number assigned to the TIN of an ACO participant in accordance with applicable Medicare regulations and who is [a physician, a physician assistant, a nurse practitioner; or, a clinical nurse specialist]. ACO provider/supplier a Medicare-enrolled Provider (as defined at ) or Supplier (as defined at ) who or that [b]ills for items and services furnished to Medicare fee-for-service beneficiaries during the agreement period under a Medicare billing number assigned to the TIN of an ACO participant in accordance with applicable Medicare regulations and is included on the list of ACO providers/suppliers that is required under

10 Definitions assignment the operational process by which CMS determines whether a beneficiary has chosen to receive a sufficient level of the requisite primary care services from ACO professionals so that the ACO may be appropriately designated as exercising basic responsibility for that beneficiary s care during a given benchmark or performance year. hospital a hospital as defined in section 1886(d)(1)(B) of the Act. newly assigned beneficiary a beneficiary that is assigned to the ACO in the current performance year who was neither assigned to nor received a primary care service from any of the ACO participants during the assignment window for the most recent prior benchmark or performance year. continuously assigned beneficiary a beneficiary assigned to the ACO in the current performance year who was either assigned to or received a primary care service from any of the ACO participants during the assignment window for the most recent prior benchmark or performance year. agreement period the term of the participation agreement, which is 3 performance years unless otherwise specified in the participation agreement. 10

11 Definitions Final Rule also adds new defined terms participation agreement the written agreement between the ACO and CMS that, along with the regulations in this part, govern the ACO s participation in the Shared Savings Program. ACO participant agreement the written agreement between the ACO and ACO participant in which the ACO participant agrees to participate in, and comply with, the requirements of the Shared Savings Program. assignment window the 12-month period used to assign beneficiaries to an ACO. 11

12 Legal Structure and Governance Legal entity ACO must be a separate legal entity if formed by two or more ACO participants, each of which is identified by a unique TIN. ACO formed by single ACO participant may choose to use its existing legal entity, but must satisfy all other requirements related to structure and governance. ACO governing body ACO governing body must have ultimate authority to execute the functions of an ACO. Governing body must be the same as the governing body of the legal entity that is the ACO. If ACO is formed by multiple ACO participants, ACO s governing body must be separate and unique to the ACO, and may not be the same as the governing body of any single ACO participant. Single TIN ACOs may use their existing legal entity and board. 12

13 Legal Structure and Governance ACO must establish mechanism for shared governance among the ACO participants or combinations of ACO participants. ACO must provide ACO participants meaningful participation in the composition and control of the ACO governing body. Medicare beneficiary representative cannot be an ACO provider/supplier or a person who has (or whose immediate family member has) a conflict of interest with the ACO. ACO governing body members must have (and must act in accordance with) fiduciary duty to the ACO, including duty of loyalty. Leadership and management ACO medical director need not be an ACO provider/supplier, but must be physically present on a regular basis at any clinic office or other location of the ACO, an ACO participant or an ACO provider/supplier. No flexibility to develop alternative leadership and management structures. Applicants required to submit documentation regarding the qualified healthcare professional responsible for ACO s quality assurance and improvement programs. 13

14 Agreements With ACO Participants and ACO Provides/Suppliers ACO participant agreement must: be signed by authorized individuals; expressly require the ACO participant to agree, and to ensure that each ACO provider/supplier agrees, to participate in the MSSP and to comply with the requirements of the MSSP and all other applicable laws and regulations (e.g., Anti-Kickback, Stark, CMP); set forth the rights and obligations flowing from participation in the ACO, including quality reporting requirements, beneficiary notification requirements, impact participation may have on ability to participate in other Medicare demonstration projects or programs that involve shared savings; describe how the opportunity to receive shared savings or other financial arrangements will encourage the ACO participant to adhere to the quality assurance and improvement program and evidence based medicine guidelines established by the ACO; 14

15 Agreements With ACO Participants and ACO Providers/Suppliers require the ACO participant to update its enrollment information (including the addition and deletion of ACO professionals and ACO providers/suppliers) on a timely basis in accordance with Medicare program requirements and to notify the ACO of any such changes within 30 days after the change; permit the ACO to take remedial action against the ACO participant, and must require the ACO participant to take remedial action against its ACO providers/suppliers to address noncompliance with the requirements of the MSSP and other program integrity issues; be for a term of at least 1 performance year and articulate potential consequences for early termination from the ACO; and require completion of a close-out process upon termination or expiration of the agreement that requires the ACO participant to furnish all data necessary to complete the annual assessment of the ACO s quality of care. 15

16 Agreements With ACO Participants and ACO Providers/Suppliers Only the ACO and the ACO participant may be parties to the ACO participant agreement. Do not need to incorporate required provisions in ACO participant agreements for 2016 performance year, but must satisfy requirements for 2017 performance year. ACO has ultimate responsibility for ensuring that all ACO providers/suppliers have also agreed to participate in MSSP and comply with program requirements 16

17 Identification of ACO Participants and ACO Providers/Suppliers ACO Participant and ACO Provider/Supplier Lists Prior to the start of each agreement period and each performance year, ACO must submit to CMS complete and certified list of all ACO participant TINs, together with a list of all ACO providers/suppliers. From information contained in PECOS, CMS will generate NPI level ACO provider/supplier list for review by ACO. ACO must make necessary corrections and return certified list of all ACO providers/suppliers. No longer need to indicate provider/supplier is primary care physician. Changes Generally ACO must ensure that all changes to enrollment information for ACO participants and ACO providers/suppliers are timely reported to CMS through PECOS. o ACO not required to make changes itself, but must require ACO participants and ACO providers/suppliers to update PECOS within 30 days. ACO must notify CMS within 30 days after such changes have occurred. 17

18 Identification of ACO Participants and ACO Providers/Suppliers Changes to ACO participant ACO must submit a request to add an ACO participant mid-year. o If approved by CMS the ACO participant and its TIN will be added to the ACO participant list as of January 1 the following year. ACO must notify CMS within 30 days of an ACO participant termination o The ACO participant will be removed from the ACO participant list as of the effective date of termination. Absent unusual circumstances, CMS will not make mid-year adjustments to the ACO s assignment, historical benchmark, performance year financial calculations, the quality reporting sample, or the obligation of the ACO to report on behalf of ACO providers/suppliers for CMS quality initiatives. 18

19 Identification of ACO Participants and ACO Providers/Suppliers Changes to ACO Provider/Suppliers ACO must notify CMS of addition of ACO provider/supplier within 30-days of the date the person or entity begins billing Medicare through ACO participant TIN. o New ACO provider/suppliers will be added to the ACO provider/supplier list effective on the date specified in ACO s notice, but no more than 30 days prior to the date notice given to CMS. If ACO fails to give notice within 30 days, addition will be effective upon date of notice to CMS. ACO must notify CMS of deletion of ACO provider/supplier within 30-days of the date the person or entity ceases to bill Medicare through ACO participant TIN. 19

20 Merged/Acquired TINs An ACO may request that CMS consider (for purposes of beneficiary assignment and establishing the ACO s benchmark) claims billed by entities that have been acquired through sale or merger by an ACO participant. An ACO may include an acquired entity s TIN on its ACO participant list under the following circumstances: o The ACO participant has subsumed the acquired entity s TIN in its entirety, including all of the providers and suppliers that reassigned their right to receive Medicare payment to the acquired entity s Medicare-enrolled TIN; o Each provider or supplier that previously reassigned his or her right to receive Medicare payment to the acquired entity s TIN has reassigned his or her right to receive Medicare payment to the TIN of the acquiring ACO participant; and o The acquired entity s TIN is no longer used to bill Medicare. ACO must attest to compliance with the above and provide documentation sufficient to demonstrate that the acquired entity s TIN was merged with or acquired by the ACO participant. 20

21 Significant Changes to ACO Significant change occurs when ACO is no longer able to meet the eligibility or program requirements. o CMS proposed to specify that a significant change occurs when the number or identity of ACO participants included on the ACO participant list changes by 50% or more during an agreement period, but did not finalize this rule. ACO must notify CMS within 30 days of any significant change. CMS will review the situation to determine if termination of participation agreement is necessary. 21

22 Participation Agreement and Renewals Final Rule clarifies process by which CMS evaluates applications for participation in MSSP. Applications are approved or denied on the basis of the following: o Information contained in and submitted with the application by an application deadline specified by CMS. o Supplemental information that was submitted in response to a CMS request and by a deadline specified by CMS. o Other information available to CMS. CMS may deny an application if an ACO applicant fails to submit requested information by the deadlines established by CMS. Final Rule also establishes a process for renewal of participation in MSSP. ACO may request renewal prior to expiration of current participation agreement. o Deadlines and form and manner of request to be specified by CMS in guidance. 22

23 Participation Agreement and Renewals In reviewing renewal request, CMS will consider: o Whether the ACO satisfies the criteria for operating under the selected risk model; o The ACO s history of compliance with program requirements; o Whether ACO has established that it is compliant with eligibility and other program requirements, such as ability to repay losses, if applicable; o Whether ACO satisfied quality performance standards during at least 1 of the first 2 years of the previous participation agreement; o For ACOs under a 2-sided model, whether ACO repaid losses generated during the first 2 years of previous participation agreement; and o The results of CMS program integrity screening of the ACO and its ACO participants and ACO providers/suppliers. 23

24 Changes to Program Requirements During Term of Participation Agreement ACOs are subject to all mid-agreement regulatory changes, with the exception of changes to the eligibility requirements concerning ACO structure and governance and the calculation of the sharing rate. o Removes beneficiary assignment exception. However, CMS will apply such changes to the following performance year. In addition, CMS will adjust all benchmarks at the start of the first performance year in which the new assignment rules are applied so that the historical benchmark for an ACO reflects the use of the same assignment rules that will apply in the performance year. ACOs are subject to all changes if directed by statute. 24

25 Care Coordination Requires detail in application: How partner with long-term care and post-acute care providers to coordinate care; and How will use enabling technology to coordinate care (e.g. EHR, HIE, data analytics, home monitoring etc.). Does not require: Specific actions such as hospitals notifying primary care of inpatient admission or ED visit; and Milestones and performance targets. Will continue to monitor ensure designing, establishing, implementing, evaluating and periodically updating care coordination processes.

26 Claims and Beneficiary Identifiable Reports ACOs currently receive Name, DOB, sex, HICN on all preliminarily prospectively assigned beneficiaries. The rule now provides: These elements for beneficiaries who received a primary care service during the previous 12 month with an ACO participant that submits claims for primary care services that are part of assignment (Tracks 1 & 2, not Track 3). New beneficiary identifiable data fields to historical, quarterly, and reconciliation reports for preliminarily/prospectively assigned beneficiaries (all Tracks): Demographic data such as enrollment status, Health status information such as risk profile and chronic conditions, Utilization rates of services such as use of E/M, hospital, emergency, and post-acute services, including dates and place of service, and Expenditure information related to utilization of services. Will be effective January 1, 2016 and detailed in operations guidance.

27 Data Opt-out ACOs currently must either provide notice at the point of care or mail letters (with follow up at next visit) and wait 30 days to request data. The final rule: Removes the ACO mail notification option. Requires written notification at the point of care through signs. posted in the facilities that include template language. Ensures a written form is available upon request. Includes information in Medicare & You Handbook. Directs beneficiaries to Medicare to decline data sharing. Makes policy effective November 1, Must still notify beneficiaries at point of care about participation in MSSP regardless of whether request data. Claims for preliminarily/prospectively assigned beneficiaries and those with primary care in past 12 months at the start of the program year (prospective only for Track 3).

28 Definition of Primary Care Services Primary care services defined as HCPCS codes , , , the Welcome to Medicare visit (G0402), and the annual wellness visits (G0438 and G0439). Adds CPT codes and for transitional care management services for a patient following discharge to community setting from hospital, SNF, outpatient observation status in a hospital or partial hospitalization. Adds code for chronic care management services furnished to patients with two or more chronic conditions expected to last 12+ months, or until death, that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. Other changes will be included in Physician Fee Schedule.

29 Attribution Currently, two step attribution process based on the plurality of primary care services furnished by: 1. Primary care physicians, General Practice Family Practice Internal Medicine Geriatric Medicine Pediatric Medicine (*New) 2. Specialist physicians, nurse practitioners, physician assistants, and clinical nurse specialists. Moves up non-physician practitioners who were used in Step 2 to Step 1 of the attribution process. Removes certain specialty types whose services are not indicative of primary care services from Step 2. Will propose beneficiary attestation in 2017 Physician Rule

30 Attribution Specialty Codes to be Used in Step 2 06 Cardiology 46 Endocrinology 12 Osteopathic 70 Multispecialty clinic or group practice 13 Neurology 79 Addiction medicine 16 Obstetrics/gynecology 82 Hematology 23 Sports medicine 83 Hematology/oncology 25 Physical medicine and rehabilitation 84 Preventive medicine 16 Psychiatry 86 Neuro-psychiatry 27 Geriatric psychiatry 90 Medical Oncology 29 Pulmonary disease 98 Gynecology/oncology 39 Nephrology

31 Track 1 Removes requirement that Track 1 ACOs (1-sided) must transition to Track 2 (2-sided) after one agreement period. If, satisfied quality performance standards such that eligible to share in savings in at least one of first two years of previous agreement. Does not reduce sharing rate to 40% for second contract. Removes requirement that the ACO could not have generated losses beyond the negative MSR in the first two performance years of the previous agreement. Allows Track 1 ACOs that terminated their contract to reapply for Track 1. If termination occurred less than halfway through the contract, the ACO could reapply as if for its first agreement period If more than halfway through the contract, the ACO must reapply as if for second agreement period.

32 Track 2 & 3 Modifies Track 2 and 3 to offer choice of no MSR/MLR, 0.5 increments between 0.5 and 2.0 (symmetrical), or variable by size (2-3.9%) for the entire agreement period. Allows Track 1 ACO that terminated its second contract: Less than halfway through the contract, to apply as Track 1, or More than halfway through the contract, must apply for Track 2. Creates new Track 3: Prospective beneficiary assignment, Most recent 12-months of claims, offset from calendar year, Track 3 assignment trumps Tracks 1 and 2 75% ACO share on savings/losses; 25% CMS, 40% least share of losses after application of quality score, and 15% of benchmark cap on losses, 20% cap on gains. Will explore splitting TINs into multiple risk tracks

33 Establishing, Updating and Resetting Benchmarks In subsequent agreement periods, uses equally weighted previous 3 years to reset benchmark. Adds back in prior period per beneficiary savings payments with average quality policy applied and capped at prior period average number of beneficiaries. Will issue new proposed rule this summer to: Establish benchmark based on three years of historical data (10/30/60 weighting); Reset benchmark based on a blend historical (30%) and regional (70%) FFS costs; Will be effective for agreements starting 2017, Agreements starting 2016 would not be able to use this rebasing methodology until 2019 (start of 3 rd agreement), and Region defined by where beneficiaries live (could be MSA/non- MSA). Will consider slowly replacing regional trend component with regionally-based FFS costs.

34 Payment Waivers Skilled Nursing Facility FINALIZED for Track 3 Eliminate requisite 3-day inpatient stay for coverage of inpatient SNF care (directly admitted or inpatient stay less than 3 days) Billing for Payment of Telehealth Services TESTING Ease restrictions on payment for telehealth services (originating site requirements on geographical areas, entities, and eligible individuals) Home Health Homebound Requirement NOT FINALIZED Eliminates the homebound requirement to allow payment of home health services provided to otherwise qualified beneficiaries Referrals to Post-acute Care Settings NOT FINALIZED Would allow discharge planners in hospitals that are ACO participants or ACO providers/suppliers to recommend high quality providers with whom they have clinical/financial relationships for the purpose of improving continuity of care

35 Modifications to repayment mechanism requirements ACOs in a two-sided model will be required to establish a repayment mechanism once, at they beginning of the contract, instead of the current annual requirement. ACOs must demonstrate the ability to repay 1 percent of its total per capita Medicare A & B FFS expenditures at the time of the application. ACO must replenish any payments to owed to CMS within 90 days of payment. Seeks comments on the appropriate threshold that should trigger a requirement that the ACO increase the amount guaranteed by the repayment mechanism. Removes option of reinsurance or other alternatives.

36 Public Reporting and Transparency Currently, ACOs must receive CMS approval to alter the information publically reported on its website. New rule requires ACOs to: Maintain a dedicated website, report the address to CMS and changes to the address; Use a template format for the information provided on the website, and will not need CMS marketing approval for this information; and Publicly identify key clinical and administrative leaders and the type of ACO participants (or combination); Report all quality measures and waiver if any. Allows CMS to publicly report ACO-specific information, including the information the ACO is required to report publicly.

37 Termination of the Participation Agreement Permits termination for failure to timely comply with requests for documents and other information and for submitting false or fraudulent data. Adds a requirement ACO to implement certain close-out procedures upon termination and nonrenewal around: Notice to ACO participants, Record retention, Data sharing, Quality reporting, and Beneficiary continuity of care. Specifies ACOs who voluntarily terminate are not eligible for shared savings in that performance year unless: The effective date of termination is 12/31, and By a date specified by CMS, the ACO completes its close-out process for the performance year in which termination becomes effective.

38 Reconsideration Review Procedure An ACO may appeal an initial determination that is not subject to the statutory preclusion on administrative or judicial review, specifically the: specification of quality and performance standards, assessment of the quality of care furnished by an ACO, assignment of beneficiaries, determination of whether the ACO is eligible for shavings, percent of and the limit on the total amount of shared savings, and termination of an ACO for failure to meet the quality standards. Permits only on-the-record reviews of reconsideration requests. Allows both ACO and CMS to submit one brief each in support of its position by the deadline. Any additional briefs or evidence at sole discretion of the reconsideration official

39 Physician Fee Schedule: MSSP Proposed Changes CMS proposed rule for the Medicare Physician Fee Schedule published in Federal Register July 15, with comments due September 8 Adds one measure to Preventive Health Domain: Statin Therapy for Prevention and Treatment of Cardiovascular Disease bringing total number of measure to 34. New policy on measure suspension when the measure no longer aligns with clinical guidelines Keep pay for reporting or converts pay for performance back to reporting. Assignment of beneficiary changes: Excludes evaluation and management services provided at SNFs, Creates work around to include Electing Teaching Amendment (ETA) hospitals. Alignment with PQRS: Clarifies that ACO report on behalf of EPs in a similar manner to PQRS GPRO, Replaces the phrase ACO providers/suppliers who [that] are EPs with the phrase EPs who bill under the TIN of an ACO participant. 39

40 The New MSSP Final Rule; What's Next for the Future of ACOs? 2014 is published by the American Health Lawyers Association. All rights reserved. No part of this publication may be reproduced in any form except by prior written permission from the publisher. Printed in the United States of America. Any views or advice offered in this publication are those of its authors and should not be construed as the position of the American Health Lawyers Association. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is provided with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice or other expert assistance is required, the services of a competent professional person should be sought from a declaration of the American Bar Association. 40