Required Public Disclosure for Use of an Arrangement Entered Into Under the Accountable Care Organization Participation Waiver
CHESS NextGen, LLC (the “ACO”), participates in the Next Generation Accountable Care Organization ACO Model under a contract (the “Model Agreement”) with the Centers for Medicare & Medicaid Services’ (“CMS”’) Center for Medicare and Medicaid Innovation (“CMMI”). The Department of Health and Human Services has provided certain waivers of federal fraud and abuse laws pursuant to a Notice of Waiver of Certain Fraud and Abuse Laws in Connection with the Next Generation ACO Model dated December 9, 2015, as amended December 29, 2016, and December 12, 2018, including the Next Generation ACO Participation Waiver (“Participation Waiver”).
The ACO has discovered that certain Next Generation Beneficiaries are unable to afford certain evidence-based medications, potentially resulting in a deterioration in their health conditions, emergency room visits, other hospitalization, and/or disease progression. The ACO desires to improve the health of these Next Generation Beneficiaries by ensuring those with financial need have access to certain medications identified by the ACO as most likely to improve the quality and reduce the overall cost of care (“Eligible Medications”).
On December 18, 2018, the Governing Body of the ACO, via unanimous consent, authorized an arrangement whereby the ACO reimburses certain Preferred Provider pharmacies that waive copays for certain Next Generation Beneficiaries with financial hardship in obtaining Eligible Medications for certain diseases (where such waivers comply with the Pharmacy Safe Harbor (42 C.F.R. 1001.952), the Civil Monetary Penalty Statute’s exception to the definition of remuneration (42 C.F.R. 1003.110), and all other applicable laws and regulation) (the “Arrangement”). The first Preferred Provider pharmacy participating under the Arrangement is Archdale Drug Co Inc. (“Archdale Drug”).
As part of its December 18, 2018, authorization, the Governing Body of the ACO made a bona fide and duly authorized determination, consistent with its duty under Section III.B of the Model Agreement, that the Arrangement is reasonably related to ACO Activities (as defined under the Model Agreement). Specifically, the Arrangement will promote accountability for the quality, cost, and overall care for a Medicare population by enabling certain Next Generation Beneficiaries with financial need to have access to certain medications that could reduce preventable emergency room visits, other hospitalizations, and disease progression, thereby increasing quality and improving care while potentially reducing overall costs.
After determining that the Arrangement meets all conditions to enable the ACO to avail itself of the Participation Waiver, the ACO entered into the Arrangement with Archdale Drug on March 1, 2019, and posted this notice on April 15, 2019.