training program; new-hire training is defined as within 30 days of personnel beginning employment, and annually thereafter.
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1 c a t a rn a r a n General Pharmacy Information The Centers for Medicare & Medicaid Services ("CMS") mandates that plan sponsors administering a Medicare Advantage program or Medicare Part D prescription drug plan must implement an effective compliance program that meets the regulatory requirements set forth in 42 C.F.R (b)(4)(vi) and 42 C.F.R (b)(4)(vi). In addition, Part D Plan Sponsors must ensure that its first tier, downstream, and related entities ("FDR") have an effective compliance program which includes policies and procedures for preventing fraud, waste, and abuse or conflicts of Interest as well as training and education on applicable Medicare Part D laws, rules, regulations and CMS guidance. As the administrator of pharmacy benefit services on behalf of a either a Medicare Advantage or Medicare Part D prescription drug plan, Catamaran has been delegated the responsibility of ensuring that its participating network pharmacies are in compliance with the applicable laws, rules, regulations as well as applicable Medicare Part D regulations and CMS guidance. Providers are required to maintain proper policies and procedures related to training on Compliance and FWA. Compliance and FWA training is an important component of Provider operations and is required to be completed upon initial hire and annually for all local, state and federally funded pharmacy benefit programs. For example, CMS requires that FWA training be completed by anyone who works with or provides services to or supports a Medicare Part D drug plan benefit. Provider must also have training on a Code of Conduct, HIPAA, and Conflict of Interest policies as part of a newhire training program; new-hire training is defined as within 30 days of personnel beginning employment, and annually thereafter. Provider is required to maintain training logs of all required general compliance and FWA training. Compliance documentation must be made available upon request to Catamaran in case of an audit or CMS request. Please find general compliance training log provided on the OptumRx FWA main page under section titled OptumRx Medicare FWA & General Compliance Training Information DMEPOS Accreditation Our Chain/Pharmacy recognizes that pharmacies DMEPOS* Accredited are exempt from the FWA training. Our Chain will only allow pharmacies with validated DMEPOS accreditation to be exempt and recognize the requirement to document and maintain such information for audit purposes. 1. As an authorized representative of the Chain/Pharmacy, I attest to the statement above regarding the appropriate exemption for only DMEPOS* Accredited providers. 2. I certify that all pharmacy employees engaged in the delivery of Medicare services have completed or are exempt from Fraud, Waste and Abuse Training in 2014, per DMEPOS
2 c a t a rn a r a n accreditation. I understand that this does not exempt DMEPOS from General Compliance training, and that General Compliance training Is still required, as indicated In 42 C.F.R (b)(4)(vl)(c). *DMEPOS is durable medical equipment, medical supplies, home dialysis supplies and equipment, therapeutic shoes, parenteral/enteral nutrition, transfusion medicine and prosthetic devices, and prosthetics and orthotics. DHHS OIG-LEIE and GSA-EPLS Lists Documentation must be made available immediately upon request to Catamaran In case of an audit or CMS request and must be maintained for a period of ten (10) years, or as otherwise required by law. 1) As an authorized representative of the Chain/Pharmacy, I attest that all Pharmacies have taken the necessary courses of action as stated below: A) Implemented policies and procedures to document the review of the Office of Inspector-General ( OIG ) and General Services Administration ("GSA ) exclusion lists prior to initial hire/contracting and monthly thereafter to ensure that all Pharmacy employees, including managers, officers, and governing body directors responsible for administering or delivering Medicare Part D Services are not excluded from participating in federally funded healthcare programs according to the OIG and GSA exclusion lists. I further attest that the Pharmacy has promptly removed from providing Medicare Part D Services on behalf of Catamaran any Pharmacy employees that are excluded from participating in federally funded healthcare programs according to the OIG and GSA exclusion lists. If Provider discovers an individual or entity responsible for the provision of pharmacy services is on the LEIE or EPLS as excluded, Provider must take immediate action to remove the individual or entity and report this issue and all the claims associated with the excluded individual or entity to Catamaran Provider Relations at: provlder.relations@catamaranrx.com immediately upon discovery, (B) Implemented a corporate compliance program in accordance with the Chapter 21 Medicare Managed Care Manual and Chapter 9 - Prescription Drug Benefit Program Manual to ensure that the Medicare Part D Services provided on behalf of Catamaran are In compliance with all applicable laws, regulations, CMS guidance and Medicare Part D program requirements.
3 2) I certify a review was completed on the DHHS OIG List of Excluded Individuals and Entitles (LEIE) and the GSA Excluded Parties List System (EPLS) prior to hiring new employees or contracting pharmacy workers/entiti es, and monthly thereafter, to confirm they do not have any exclusions from provision of government-funded pharmacy services. First Tier, Downstream and Related Entities (FDRs) 1) As an authorized representative of the Chain/Pharmacy, I understand the requirements set forth in the compliance, FWA training and other expectations to include OIG/GSA validation to include any subcontracted staff meeting the definition of a First Tier, Downstream and Related Entities (FDR). 2) On behalf of First Tier, Downstream and Related Entities (FDR) utilized by the Pharmacy to provide Medicare Part D services on behalf of Catamaran, I attest that: (A) FDR requires all of its employees, subcontractors, downstream entitles, related entitles and agents to receive and complete appropriate general compliance, Medicare Part D and HIPAA training as well as the standardized Fraud, Waste and Abuse training and education module developed by the Centers for Medicare and Medicaid Services within the first thirty (30) days where possible, not to exceed ninety (90) days of employment/contracting and annually thereafter. (B) Neither FDR nor its employees are excluded from participating in federally-funded healthcare programs according to the OIG and GSA exclusion lists. First Tier- Any party that enters Into a written arrangement acceptable to CMS with a Sponsor or applicant to provide administrative services or health care services for a Medicare eligible individual under MA and/or Part D. Downstream- Any party that enters into a written arrangement, acceptable to CMS, below the level of the arrangement between a Sponsor and a first tier entity. Examples Include, but are not limited to, mail order pharmacies, firms providing 'agent/broker services, agents, brokers, marketing firms and call center firms. Related Entity- Any entity that is related to the MA organization by common ownership or control and: (A) Performs some function of the organization's management under contract or delegation; (B) Provides services to Medicare enrollees under an oral or written agreement; or (C) Leases real property or sells materials to the MA organization at a cost exceeding $2,500 during a contract period.
4 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 or one of the following United States Territories: American Samoa, Guam, Northern Marianas, Puerto Rico and the Virgin Islands.. 1. 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 Catamaran and attest to the following: A) Each offshore vendor and/or subcontractor has appropriate policies and procedures to ensure that the PHI of Medicare beneficiaries remains secure. B) Each offshore vendor and/or subcontractor s arrangement with Pharmacy prohibits access to data not associated with their contract. C) 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. D) 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 ) and Security (45 CFR Parts, 160, 162 and 164) Rules and Regulations. Reporting Fraud Waste and Abuse Reminder- Reporting Suspect Fraud, Waste and Abuse to Catamaran is Easy by Contacting the Following department by phone, mall or Fraud Hotline: Special Investigations Unit 1600 McConnor Parkway Schaumburg, IL Confidential Fraud SIU@catamaranrx.com. Your information will be kept confidential. YOUR CMS FWA TRAINING REQUIREMENTS FOR CATAMARAN ARE NOW COMPLETE. Please note this is not the completion of your attestation. Please return to the main OptumRx online attestation page to complete your required attestation.
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