Required online attestation
Once you have completed the Centers for Medicare & Medicaid Services’ (CMS) required compliance steps, you are required to submit an online attestation.
This attestation acknowledges that you have satisfied the following steps:
- Complete CMS’ two web-based trainings
- Provide your staff with links to required documents
In addition, you, the Network Pharmacy Provider hereby attest to the following:
- No exclusion from participation in federal health care programs by checking your status in the exclusion lists maintained by the Office of Inspector General (OIG) U.S. Department of Health & Human Services (HHS) and U.S. General Services Administration (GSA) System for Award Management (SAM).
- You, the Network Pharmacy Provider, have reviewed the OIG-HHS and GSA-SAM lists prior to hiring/contracting and monthly thereafter for your current employees/contractors, health professionals or subcontracted delegates, working with Plan Sponsor programs to ensure none are excluded from participating in these programs.
Note: Organizations contracted to administer federal and state health care programs are prohibited from hiring, continuing to employ, contract, make payments to persons/entities previously excluded/debarred from participation or procurement with Federal and/or State health care programs.
You are required to review the OIG-HHS and GSA federal programs exclusion lists prior to hiring/contracting employees who are involved in the administration/delivery of Plan Sponsor benefits/services to ensure none of these persons/entities are excluded or become excluded from participation in federal programs. You are required to continue to monitor the federal exclusions lists on a monthly basis thereafter.
If you serve state health plans (e.g. UnitedHealthcare Community & State), you are also required to review state exclusion lists prior to hire and monthly thereafter, as referenced in the regulatory appendix of your vendor contract(s) or as modified by state requirements since contract execution.
These requirements are included in the following regulatory references:
Medicare - Medicare Managed Care Manual and Prescription Drug Benefit Manual Chapter 9/Chapter 21 - Section 50.6.8 at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c21.pdf
The Social Security Act §1862(e)(1)(B), 42 CFR §§ 422.503(b)(4)(vi)(F), 422.752(a)(8), 423.504 (b)(4)(vi)(F), 423.752(a)(6), 1001.1901.
Medicaid - The authority for the requirement to review for exclusions is 42 CFR 1001.1901 (b). The extension to state exclusion lists is under the authority of: 42 CFR 1002.2; applicable state law; and state Medicaid contracts, which control for all services performed for State health plans (e.g. UnitedHealthcare Community & State) in any given state, if applicable.
This information is available at the following sites:
Office of Inspector General's (OIG) - U.S. Department of Health & Human Services (HHS) ~ List of Excluded Individuals/Entities (LEIE)- http://oig.hhs.gov/exclusions/index.asp
General Services Administration (GSA) - System for Award Management (SAM) ~ Excluded Parties Listing System (EPLS) - https://www.sam.gov/portal/SAM/#1
- You, the Network Pharmacy Provider, hereby attest to maintaining attendance logs, materials, training documents and other evidence in support of compliance with the two steps listed in the above, “Required online attestation” section. You ensure supportive evidence is available to OptumRx or an auditor during on-site visits for inspection or other review processes. This inspection may also be conducted by the Payer(s) and other federal regulatory agencies as outlined in 42 CFR 422.504(e) and 422.503(d)(2).
- You, the Network Pharmacy Provider, hereby attest to maintaining clearly defined processes to determine if your contracted vendors meet the definition of an FDR as per CMS requirements. Process documentation regarding auditing and monitoring of your FDR must be made available upon request.
Offshore vendors, subcontractors and downstream or related entities
For the purposes of this attestation, the term "offshore" shall refer to any country that is not one of the fifty United States (U.S.) or the U.S. Territories.
As an authorized representative of the Chain, I understand the requirements set forth should a pharmacy utilize an offshore vendor and/or subcontractor or any downstream or related entity to provide Medicare Part D Services on behalf of OptumRx and attest to the following:
- Each offshore vendor and/or subcontractor has appropriate policies and procedures to ensure that the PHI of Medicare beneficiaries remains secure.
- Each offshore vendor and/or subcontractor’s arrangement with Pharmacy prohibits access to data not associated with their contract.
- Each offshore vendor and/or subcontractor arrangement with Pharmacy allows for the immediate termination of the respective agreement upon the discovery of a security breach.
- Each offshore vendor and/or subcontractor arrangement with Pharmacy requires the offshore vendor and/or subcontractor to comply with Medicare Part D record retention requirements and the HIPAA Privacy (45 CFR Parts 160 - 164) and Security (45 CFR Parts, 160, 162 and 164) Rules and Regulations.
As per June 17, 2015 CMS memo, beginning in 2016 only CMS training materials located on the Medicare Learning Network (MLN) will be allowed and the content of these materials cannot be modified in order to ensure the integrity and completeness of the training.
Currently closed, reopens August 2017