Fraud and Abuse Waivers
Guidance for Fraud and Abuse Waivers for Select CMS Models and Programs
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: August 31, 2020
Fraud and Abuse Waivers for Select CMS Models and Programs
Fraud and Abuse Waivers Issued by the Department
The Department of Health and Human Services (Department) has issued fraud and abuse waivers and related guidance documents in connection with the following programs. Important additional information about the application of these waivers is described below.
- Pioneer Accountable Care Organization (ACO) Model
- Bundled Payment for Care Improvement (BPCI) Models
- Health Care Innovation Awards (HCIA) Round Two
- Comprehensive ESRD Care (CEC) Model
- Comprehensive Care for Joint Replacement (CJR) Model
- Next Generation ACO Model
- Oncology Care Model (OCM)
- Part D Enhanced Medication Therapy Management (MTM) Model
- Part D Payment Modernization Model
- Maryland All-Payer Model Care Redesign Program
- Maryland Total Cost of Care Model Care Redesign Program
- Medicare Advantage Value-Based Insurance Design Model
- Medicare Diabetes Prevention Program (MDPP) Expanded Model
- Bundled Payments for Care Improvement Advanced (BPCI Advanced) Model
- Vermont All-Payer ACO Model Vermont Medicare ACO Initiative
- Part D Senior Savings Model
- Comprehensive Kidney Care Contracting (CKCC) Options of the Kidney Care Choices Model
- Global and Professional Options of the Direct Contracting Model
- Primary Care First (PCF) Component of the Primary Care First Model
- Medicare Shared Savings Program
Waivers for Innovation Center Models
Section 1115A(d)(1) of the Social Security Act (the Act) authorizes the Secretary of Health and Human Services to waive certain fraud and abuse laws as necessary solely for purposes of testing payment and service delivery models developed by the Center for Medicare and Medicaid Innovation (the Innovation Center).
In connection with each of the Innovation Center models listed below, unique waivers of certain fraud and abuse laws have been made generally available. However, not all model-specific waivers are necessarily available to all participants in a given model. Individuals or entities seeking waiver protection should keep in mind that a waiver will apply to their arrangement(s) only if they are eligible to use the waiver and all conditions of the waiver are met. We encourage all parties to consult with legal counsel as necessary to ensure that waivers are available to them and that arrangements for which they seek waiver protection meet all required conditions.
Pioneer Accountable Care Organization (ACO) Model
On December 8, 2011, the Department’s Office of Inspector General (OIG) and CMS jointly issued waivers (PDF) for specified arrangements involving accountable care organizations (ACOs) participating in the Pioneer ACO Model. This model's final performance year concluded on December 31, 2016.
See the Innovation Center’s page for additional information on the Pioneer ACO Model.
Bundled Payment for Care Improvement (BPCI) Models
On the dates specified below, the OIG and CMS jointly issued waivers for specified arrangements involving BPCI Model participants.
- On September 13, 2012, BPCI Model 1 waivers were issued (PDF)
- On July 26, 2013, BPCI Model 2 waivers were issued (PDF)
- On July 26, 2013, BPCI Model 3 waivers were issued (PDF)
- On July 26, 2013, BPCI Model 4 waivers were issued (PDF)
BPCI Model 1's final performance year concluded on December 31, 2016. BPCI Models 2, 3 and 4 's final performance year concluded on September 30, 2018.
See the Innovation Center's page for additional information on BPCI Models.
Health Care Innovation Awards (HCIA) Round Two
On January 20, 2015, the OIG issued waivers (PDF) for patient engagement arrangements in the HCIA Model. This model’s final performance year concluded on September 1, 2017.
See the Innovation Center's page for additional information on the HCIA Model.
Comprehensive ESRD Care (CEC) Model
On July 15, 2015, the OIG and CMS jointly issued waivers for specified arrangements involving large dialysis organizations (LDOs) (PDF) and small dialysis organizations (non-LDOs) (PDF) participating in the CEC Model. This model’s final performance year concluded on March 31, 2021.
See the Innovation Center's page for additional information on the CEC Model.
Comprehensive Care for Joint Replacement (CJR) Model
On December 05, 2017, the OIG and CMS jointly issued new waivers (PDF), effective January 1, 2018, for specified arrangements permitted under the Comprehensive Care for Joint Replacement Model. These new waivers are the result of certain programmatic changes made by CMS to the CJR Model and on their effective date supersede the original waiver (PDF) notice, which was jointly issued by OIG and CMS on November 16, 2015.
See the Innovation Center’s page for additional information on the Comprehensive Care for Joint Replacement Model.
Next Generation ACO Model
On December 12, 2018 the OIG and CMS jointly issued a second amended notice of waivers (PDF) for specified arrangements involving ACOs participating in the Next Generation ACO Model. The second amended notice of waivers was issued as a result of certain programmatic changes made by CMS to the Model. The December 12, 2018 amended notice supersedes the amended notice of waivers jointly issued by OIG and CMS on December 29, 2016 (PDF). The December 29, 2016 notice of amended waivers superseded the original waiver (PDF) notice jointly issued by OIG and CMS on December 9, 2015. This model’s final performance year concluded on December 31, 2021.
See the Innovation Center’s page for additional information on the Next Generation ACO Model.
Oncology Care Model (OCM)
On July 1, 2016, the OIG and CMS jointly issued waivers (PDF) for specified arrangements permitted under the Oncology Care Model. This model’s final performance year concluded on June 30, 2022.
See the Innovation Center’s page for additional information on the Oncology Care Model.
Part D Enhanced Medication Therapy Management (MTM) Model
On June 2, 2016 the OIG issued a waiver (PDF) for certain beneficiary incentives provided by PDP Sponsors in the MTM Model. This model's final performance year concluded on December 31, 2021.
See the Innovation Center’s page for additional information on the MTM Model.
Part D Payment Modernization Model
On November 15, 2019 the OIG issued a waiver (PDF) for certain beneficiary incentives provided by Part D Sponsors in the Part D Payment Modernization Model. This model's final performance year concluded on December 31, 2021.
See the Innovation Center’s page for additional information on the Part D Payment Modernization Model.
Maryland All-Payer Model Care Redesign Program
On April 27, 2017 the OIG and CMS jointly issued waivers (PDF) for specified arrangements entered into pursuant to the Maryland All-Payer Model Care Redesign Program. This model’s final performance year concluded on December 31, 2018.
See the Innovation Center’s page for additional information on the Maryland All-Payer Model Care Redesign Program.
Maryland Total Cost of Care Model Care Redesign Program
On December 14, 2018 the OIG and CMS jointly issued waivers (PDF) for specified arrangements entered into pursuant to the Maryland Total Cost of Care Model Care Redesign Program.
See the Innovation Center’s page for additional information on the Maryland Total Cost of Care Model Care Redesign Program.
Medicare Advantage Value-Based Insurance Design (VBID) Model
On August 18, 2020 the OIG issued an amended notice of waivers (PDF), effective January 1, 2021, for certain beneficiary incentives provided by Medicare Advantage Organizations in the VBID Model. These new waivers are the result of certain programmatic changes made by CMS to the Medicare Advantage VBID Model and on its effective date amends and restates the original waiver notice (PDF), which was issued by the OIG on November 15, 2019.
See the Innovation Center’s page for additional information on the VBID Model.
Medicare Diabetes Prevention Program (MDPP) Expanded Model
On March 01, 2018 the OIG issued a waiver (PDF) for certain beneficiary engagement incentive arrangements that are part of the MDPP expanded model.
See the Innovation Center’s page for additional information on the MDPP expanded model.
Bundled Payments for Care Improvement Advanced (BPCI Advanced) Model
On December 13, 2019 the OIG and CMS jointly issued an amended notice of waivers (PDF) for specified arrangements entered into pursuant to the BPCI Advanced Model. The amended notice of waivers was issued as a result of certain programmatic changes made by CMS to the Model. The December 13, 2019 amended notice supersedes the original waiver notice (PDF) jointly issued by OIG and CMS on May 25, 2018.
See the Innovation Center’s page for additional information on the BPCI Advanced Model.
Vermont All-Payer ACO Model Vermont Medicare ACO Initiative
On December 20, 2018 the OIG and CMS jointly issued waivers (PDF) for specified arrangements entered into pursuant to the Vermont Medicare ACO Initiative within the Vermont All-Payer ACO Model.
See the Innovation Center’s page for additional information on the Vermont Medicare ACO Initiative within the Vermont All-Payer ACO Model.
Part D Senior Savings Model
On August 11, 2020 the OIG issued a waiver (PDF) for certain beneficiary incentives provided by Part D Sponsors in the Part D Senior Savings Model. This model’s final performance year concluded on December 31, 2023.
See the Innovation Center’s page for additional information on the Part D Senior Savings Model.
Comprehensive Kidney Care Contracting (CKCC) Options of the Kidney Care Choices Model
On September 11, 2020 the OIG and CMS jointly issued a waiver (PDF) for specified start-up arrangements entered into by certain individuals and entities participating in the Implementation Period of the CKCC Options of the Kidney Care Choices Model.
See the Innovation Center’s page for additional information on the CKCC Options of the Kidney Care Choices Model.
Global and Professional Options of the Direct Contracting Model
On September 18, 2020 the OIG and CMS jointly issued a waiver (PDF) for specified start-up arrangements entered into by certain individuals and entities participating in the Implementation Period of the Global and Professional Options of the Direct Contracting Model.
See the Innovation Center’s page for additional information on the Global and Professional Options of the Direct Contracting Model.
Primary Care First (PCF) Component of the Primary Care First Model
On December 16, 2020 the OIG issued waivers (PDF) for certain beneficiary incentives entered into by specified individuals and entities participating in the PCF Component of the Primary Care First Model.
See the Innovation Center’s page for additional information on the Primary Care First Component of the Primary Care First Model.
Shared Savings Program Waivers
Under section 1899(f) of the Act, as added by the Affordable Care Act, the Secretary of Health and Human Services may waive certain fraud and abuse laws as necessary to carry out the provisions of the Medicare Shared Savings Program.
Medicare Shared Savings Program
On May 8, 2020, OIG and CMS jointly issued special guidance (PDF) on the start date and end dates of the ACO Pre-Participation Waiver for the 2021 application cycle.
On August 9, 2018, OIG and CMS jointly issued special guidance (PDF) on the start date and end dates of the ACO Pre-Participation Waiver for the 2019 application cycle.
On October 29, 2015, the OIG and CMS jointly published the Medicare Program; Final Waivers in Connection with the Shared Saving Program Final Rule.
On February 12, 2015, OIG and CMS jointly issued additional guidance (PDF) concerning three areas: (1) public disclosures required under the accountable care organization (ACO) Pre-Participation and ACO Participation Waivers, (2) notification of failure to submit a timely application by parties who used the ACO Pre-Participation Waiver, and (3) requests for an extension of the ACO Pre-Participation Waiver period.
On October 17, 2014, OIG and CMS jointly published the Final Waivers in Connection with the Shared Savings Program; Continuation of Effectiveness and Extension of Timeline for Publication of Final Rule, extending the effectiveness of the interim final rule and the timeline for publication of a final rule through November 2, 2015.
On November 2, 2011, the OIG and CMS jointly published the Medicare Program; Final Waivers in Connection with the Shared Saving Program interim final rule.
See the program page for additional information on the Medicare Shared Savings Program.
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DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.