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Fraud and Abuse Waivers

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.

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 for specified arrangements involving accountable care organizations (ACOs) participating in the Pioneer ACO Model. This model began in 2012 and the 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.

BPCI Model 1 began in 2013 and the final performance year concluded on December 31, 2016.  BPCI Models 2, 3 and 4 are still in effect. 

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 for patient engagement arrangements in the HCIA Model.  

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, 456KB] and small dialysis organizations (non-LDOs) [PDF, 461KB] participating in the CEC Model.  

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, 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 being made by the CMS to the CJR Model and on their effective date supersede the original waiver 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 29, 2016, the OIG and CMS jointly issued amended waivers for specified arrangements involving ACOs participating in the Next Generation ACO Model as a result of certain programmatic changes being made by the CMS to the Model.  The original waiver notice was jointly issued by OIG and CMS on December 9, 2015.

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 for specified arrangements permitted under the Oncology Care Model.

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 for certain beneficiary incentives provided by PDP Sponsors in the MTM Model.

See the Innovation Center’s page for additional information on the MTM Model.

Maryland All-Payer Model Care Redesign Program

On April 27, 2017 the OIG and CMS jointly issued waivers for specified arrangements entered into pursuant to the Maryland All-Payer Model Care Redesign Program.

See the Innovation Center’s page for additional information on the Maryland All-Payer Model Care Redesign Program

Medicare Diabetes Prevention Program (MDPP) Expanded Model

On March 01, 2018 the OIG issued a waiver 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.

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 August 9, 2018, OIG and CMS jointly issued special guidance 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 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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