(1) Monthly during the past twelve (12) months, and going forward on at least a monthly basis, Participating Pharmacy has and will continue to review the Office of Inspector General List of Excluded Individuals and Entities (LEIE) and General Services Administration (GSA) System for Awards Management (SAM) exclusion list and no Participating Pharmacy employee, contractor, or agent providing services directly or indirectly (“Covered Individual”), and no Participating Pharmacy, is excluded from participation in government funded health care programs. Participating Pharmacy is subscribed to the OIG LISTSERV via the OIG website or is subscribed via a third-party exclusion screening provider to receive immediate notice of updates to the LEIE. If any such Participating Pharmacy and/or Covered Individual appear on either the LEIE or GSA SAM list, Participating Pharmacy or Pharmacy Services Administration Organization (PSAO), on behalf of Pharmacy, has and will continue to promptly remove that Covered Individual from the performance of services in support of government funded healthcare programs, including but not limited to Medicare Part D services.

(2) Indicate the applicable statement by checking the appropriate box:
All Covered Individuals have participated in a compliance and fraud, waste and abuse training program which complies with all applicable CMS and Federal regulations related to Medicare Part D and Chapters 9 and 21, Section 50.3.2 of the Medicare Part D Prescription Drug Benefit Manual. In accordance with CMS 4182-F Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program guidance dated April 2, 2018, Reducing the Burden of the Compliance Program Training Requirements (“Guidance”); effective January 1, 2019, Plan Sponsor’s First Tier Downstream Related Entities (FDRs) are no longer required to complete the CMS generated FWA training. Plan Sponsors are still required to ensure FWA oversight of Participating Pharmacies and their Covered Individuals. To meet this requirement, Participating Pharmacies and their Covered Individuals are required to complete FWA and general compliance training that meets all applicable CMS and Federal requirements. Participating Pharmacy provides additional, specialized or refresher training on issues posing fraud, waste and abuse risks specific to a Covered Individual as follows: (i) appointment to the job function, (ii) changed requirements, (iii) when a Covered Individual is found to be noncompliant, (iv) as a corrective action to address a noncompliance issue, and (v) when a Covered Individual works in an area implicated in past fraud, waste and abuse. In addition to this certification, Participating Pharmacy has and will maintain for ten (10) years training records, copies of training material, including the date of the training, attendance, training completion records, test results or test scores (where applicable) and a copy of the training materials, all of which records shall be available upon request. In addition, Medicare Part D Plan Sponsors may distribute to Participating Pharmacy the Medicare Part D Plan Sponsor’s standards of conduct and/or general compliance and fraud, waste and abuse policies and procedures. Participating Pharmacy has and will continue to distribute such materials to its Covered Individuals, provided it has not done so through its own general compliance program and code of conduct, setting forth the Medicare Part D Plan Sponsor’s compliance expectations for Participating Pharmacy and FDRs that do not have their own general compliance or code of conduct training. A Participating Pharmacy that does not have its own fraud, waste and abuse, general compliance or code of conduct program is required to use a Medicare Part D Plan Sponsor’s training that meets Chapters 9 and 21 requirements. Participating Pharmacy will document which Medicare Part D Plan Sponsor’s material is used for training.

"Participating Pharmacy is deemed to have met the fraud, waste, and abuse training certification requirements through enrollment into Parts A or B of the Medicare program or accreditation as a supplier of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). (NOTE TO CHAIN PHARMACIES: If this box is checked, it must be true for each individual pharmacy location). Specify the date and organization that provided accreditation." Organization Accreditation Commission for Health Care, Inc. American Board for Certification in Orthotics & Prosthetics, Inc. Board of Certification/Accreditation International Commission on Accreditation of Rehabilitation Facilities HealthCare Quality Association on Accreditation Community Health Accreditation Program National Association of Boards of Pharmacy The Compliance Team, Inc. The Joint Commission Date .

(3) Participating Pharmacy’s managers, officers, and directors responsible for the administration or delivery of Medicare Part D benefits are free from any conflict of interest in administering or delivering Medicare Part D benefits.

(4) Participating Pharmacy has reported and will continue to promptly report in writing to the Medicare Part D Plan Sponsor’s or Pharmacy Benefits Manager’s (PBM’s) Compliance Officer any concerns related to compliance, suspected or actual violations of law or policy related to the services provided to beneficiaries covered by the Medicare Part D Plan Sponsor or PBM. Participating Pharmacy or Covered Individuals may report fraud, waste, and abuse to the Medicare Part D Plan Sponsor’s or PBM’s hotline, email, or other reporting method

(5) Participating Pharmacy has provided and will continue to provide Medicare Part D beneficiaries with notices as required by CMS instructing the beneficiaries to contact their plans to obtain a coverage determination or request an exception if the beneficiary disagrees with the information provided by the pharmacist.

(6) Participating Pharmacy’s FDRs have attested to the Participating Pharmacy compliance with the attestation requirements set forth herein.

For purposes of this attestation, the term “Offshore” shall be determined in accordance with CMS rules, regulations and guidance and the Health Insurance Portability and Accountability Act of 1996, as amended and all rules and regulations promulgated there under (“HIPAA”) and currently refers to any location that is not one of the fifty (50) United States or one of the territories of the United States (American Samoa, Guam, Northern Marianas, Puerto Rico and the United States Virgin Islands). Please check the appropriate box below regarding the use of Offshore subcontractors to perform activities that involve receiving, processing, transferring, handling, storing, or accessing PHI under or in connection with Medicare Part D:

Participating Pharmacy DOES NOT utilize Offshore subcontractors who have access to PHI.

Participating Pharmacy DOES utilize Offshore subcontractors who have access to PHI. If this box is checked, Participating Pharmacy will be asked by the Part D Plan Sponsor or its PBM to provide all necessary information required to comply with CMS rules and regulations.

If there are any changes to the statuses of Section I or Section II indicated above during the current Plan Year, Participating Pharmacy shall promptly notify the Medicare Part D Plan Sponsor or its PBM.

Dear Pharmacy Manager:

If you indicate on the Participating Pharmacy Annual Compliance/FWA Attestation form that you share PHI with an offshore subcontractor, you must also complete the attached Offshore Subcontracting Attestation. This information is needed so our plan sponsors can enter the information into the Health Plan Management System (HPMS) and submit per CMS requirements.

Please complete and sign the Offshore Subcontracting Attestation form contained in this credentialing packet. In addition, you must also provide electronic or written copies of:

• your pharmacy’s policies and procedures that ensure Medicare beneficiary protected health information (PHI) shared with the offshore subcontractor remains secure;
• your pharmacy’s policies and procedures that allow for immediate termination of the subcontract upon discovery of a significant breach;
• copies of or excerpts from your agreement with the subcontractor demonstrating that the agreement contains all required Medicare Part C and D language (e.g. record retention requirements, compliance with all Medicare C and D requirements, etc.) as well as language that prohibits subcontractor’s access to Medicare data not associated with your contract with the offshore subcontractor; and
• results of the most recent annual audit your pharmacy conducted of the offshore subcontractor.

Include the above documentation when you return your credentialing application.

Thank you for your attention to this matter.

OFFSHORE SUBCONTRACTOR ATTESTATION

Enter your pharmacy name, name and title of person completing this form, and the date that you completed this attestation:
Name:	Title:
Signature:	Date:
Please provide a copy to: Navitus Health Solutions, LLC Provider Services 361 Integrity Dr Madison, WI 53717 You may also email the form to credentials@Navitus.com or fax to 608-298-5876.

Part I. Offshore Subcontractor Information
Offshore Subcontractor Name:
Offshore Subcontractor Country:
Offshore Subcontractor Address:
Describe Offshore Subcontractor Functions:
State Actual Effective Date for Offshore Subcontractor: (Month, Day, Year: Example January 15, 2015)

Part II. Precautions for Protected Health Information (PHI)
Describe the PHI that will be provided to the offshore subcontractor:
Discuss why providing PHI is necessary to accomplish the offshore subcontractor objectives:
Describe alternatives considered to avoid providing PHI, and why each alternative was rejected:

Part I. Attestation of Safeguards to Project Beneficiary Information in the Offshore Subcontract
Item	Attestation	Response: Yes or No
I.1	Offshore subcontracting arrangement has policies and procedures in place to ensure that Medicare beneficiary PHI and other personal information remains secure	Yes No
I.2	Offshore subcontracting arrangement prohibits subcontractor’s access to Medicare data not associated with the sponsor’s contract with the offshore subcontractor	Yes No
I.3	Offshore subcontracting arrangement has policies and procedures in place that allow for immediate termination of the subcontract upon discovery of a significant security breach	Yes No
I.4	Offshore subcontracting arrangement includes all required Medicare Part C and D language such as record retention requirements, compliance with all Medicare Part C and D requirements, etc.	Yes No

Part II. Attestation of Audit Requirements to Ensure Protection of PHI
Item	Attestation	Response: Yes or No
II.1	Organization will conduct an annual audit of the offshore subcontractor	Yes No
II.2	Audit results will be used by the Organization to evaluate the continuation of its relationship with the offshore subcontractor	Yes No
II.3	Organization agrees to share offshore subcontractors audit results with CMS upon request	Yes No