CMS released the CY2016 Readiness Checklist, which highlights key compliance areas that Medicare Advantage organizations and Part D sponsors should be particularly mindful as they prepare for the 2016 contract year.

The CY2016 Checklist includes new and modified requirements for CY2016 as well as other areas of CMS concern. CMS reminds organizations that, if they need assistance or will not be in compliance with a requirement, the “organization must report those problems to your Account Manager directly by email in a timely manner.”

Included on the checklist are requirements relating to:

  • Medicare Advantage Organizations and Part D Sponsors:
    • Electronic Correspondence Reporting System (ECRS) – Organizations must adhere to the October 1, 2015 implementation of CMS’ International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). ECRS transactions capture diagnosis codes related to a No-Fault, Worker’s Compensation, or Liability Medicare Secondary Payer (MSP) case. Although only Medicare Advantage-Prescription Drug (MA-PD) plans can submit ECRS change requests, all Part D plans may submit inquiries concerning possible MSP coverage and use the diagnosis codes reported on the inquiry response and on the Medicare Advantage Prescription Drug (MARx) COB file to identify prescription drug claims that may be subject to MSP payment rules
    • Reporting and Returning Medicare Advantage Organization and/or Sponsor- Identified Overpayments – CMS reminds MA organizations and Part D sponsors that they are required to report and return to CMS any overpayment it received no later than 60 days after the date on which the organization or sponsor identified the overpayment.
    • Complaints Tracking Module – Resolve at least 95% of Complaints Tracking Module (CTM) complaints designated as “immediate need” within two calendar days, complaints designated as “urgent” within seven days, and resolve at least 95% of all CTM complaints designated without an issue level within 30 days.
    • Websites – Provider and Pharmacy Directories must be updated at least monthly and contain, among other things, a provider’s ability to accept new patients.
    • Compliance and Fraud, Waste, and Abuse (FWA) Compliance Program –Starting January 1, 2016, organizations must accept from first tier, downstream and related entities (FDRs) (including the FDR’s employees) certificates of completion of CMS’ training located on the Medicare Learning Network (MLN). CMS will accept either the MLN system generated certificates of completion, or, an attestation confirming that the organization has completed the appropriate compliance and FWA training. Use of the web-based training via the CMS MLN website is optional for Sponsors’ employees. Updated training modules will be available in November 2015.


  • Part D Sponsors:
    • Prescriber Enrollment –No later than June 1, 2016 physicians and other eligible professionals who write prescriptions for Part D drugs are required to be enrolled in Medicare in an approved status or to have a valid opt-out affidavit on file for their prescriptions to be coverable under Part D, unless the prescriber is an “Other Authorized Prescriber.” Part D sponsors should utilize the enrollment file that identifies physicians and eligible professionals who are enrolled in Medicare in an approved status or have a valid opt-out affidavit on file with a Medicare Administrative Contractor (MAC) to determine a prescriber’s Medicare enrollment or opt-out status when processing Part D pharmacy claims.
    • Medicare Plan Finder (MPF)
      • Pricing Data and Pharmacy Network Files – Ensure preferred cost-sharing pharmacy arrangements are accurately identified in MPF pricing files. A pharmacy may only be associated with the plan’s preferred cost-sharing network if a lower differential cost sharing applies to some tiers of formulary drugs at that pharmacy than applies at pharmacies in the standard cost-sharing network.
      • Quality Assurance Testing – Ensure your organization performs quality assurance activities prior to submitting MPF files to CMS.

      Part D sponsor face program compliance and enforcement actions as a result of MPF suppressions or inaccurate data submissions.

  • Any Willing Pharmacy (AWP) Contracting Requirements –Part D sponsors must make standard terms and conditions available for all Part D plans it offers. For those terms to meet the “reasonable and relevant” requirement, they must identify for the pharmacy the plan(s) to which they apply, and the offer must include language that obligates the Part D sponsor to include the pharmacy in the identified plan(s) upon the pharmacy’s acceptance of the terms and conditions. CMS expects Part D sponsors to provide the applicable standard terms and conditions document to the requesting pharmacy within two business days of receipt of the request
  • MAC Pricing – MAC Pricing. Effective January 1, 2016, Part D sponsors are required to update MAC drug prices at least every seven days and to disclose all individual MAC drug prices to be updated to the applicable pharmacies in advance of their use. In addition, the disclosure must be made in a manner that enables the pharmacies to validate prices.

The Readiness Checklist can be accessed here.