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Sept 2 -- The Centers for Medicare & Medicaid Services (CMS), U.S. Department of Health and Human Services (HHS), invites the public to submit comments to OMB by October 4, 2021 regarding Collection of Prescription Drug Event (PDE) Data From Contracted Part D Providers for Payment.
 
The PDE data is used in the Payment Reconciliation System to perform the annual Part D payment reconciliation. Any PDE data within the Coverage Gap Phase of the Part D benefit is used for invoicing in the CGDP.  The data are part of the report provided to the Secretary of the Treasury for Section 9008.

CMS has used PDE data to create summarized dashboards and tools, including the Medicare Part D Drug Spending Dashboard & Data, the Part D Manufacturer Rebate Summary Report, and the Medicare Part D Opioid Prescribing Mapping Tool. The data are also used in the Medicare Trustees Report. Due to the market sensitive nature of PDE data, external uses of the data are subject to significant limitations. However, CMS does analyze the data on a regular basis to determine drug cost and utilization patterns in order to inform programmatic patterns and to develop informed policy in the Part D program.

The information users will be Pharmacy Benefit Managers (PBMs), third party administrators and pharmacies, and the PDPs, MA-PDs, Fallbacks and other plans that offer coverage of outpatient prescription drugs under the Medicare Part D benefit to Medicare beneficiaries. The statutorily required data is used primarily for payment and is used for claim validation as well as for other legislated functions such as quality monitoring, program integrity and oversight.
 
The Drug Data Processing System (DDPS) is the information system that collects, validates and stores PDE data received from PDPs, MA-PDs, Fallback and other plans offering coverage of outpatient prescription drugs under the Medicare Part D benefit.  PDE records enter the DDPS through the Prescription Drug Front-End System (PDFS). The PDFS receive the PDE records at least monthly, once the plans’, organizations’, or sponsoring entities’ PBMs or other third-party administrators have received drug claims from pharmacies and completed their “in-cycle” events. Plans or their third-party submitters must submit PDE records electronically. The PDFS perform file format and face validity checks. Once the file has passed the front-end checks, it moves through the DDPS where detail level edits are performed and the data are stored.  The DDPS also receives corrected and adjusted PDE records.  
 
Part D Claims Data: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PartDData  
Part D Drug Spending Dashboard & Data: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs/MedicarePartD   
CMS Research Data Assistance Center: https://resdac.org/
PDE Data Collection submission to OMB:  https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202108-0938-009 Submit comments through this webpage. Click IC List for form CMS-10174, View Supporting Statement for technical documentation.
FR notice inviting comment to OMB (see #2): https://www.federalregister.gov/documents/2021/09/02/2021-19012/agency-information-collection-activities-submission-for-omb-review-comment-request
 
Point of contact: CMS Research Data Assistance Center resdac@umn.edu
 
For AEA members submitting comments to OMB, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at https://www.aeaweb.org/content/file?id=5806

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