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June 23 -- The Centers for Medicare & Medicaid Services (CMS) invite public comment by August 23, 2021 regarding Collection of Prescription Drug Data from MA-PD, PDP and Fallout Plans/Sponsors for Medicare Part D Payments.

Prescription Drug Event (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, and 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.

Our view is that in order to fulfill the statutory requirements of the Act, we will need the following data categories:
• Entity identification (for example, submitter ID, contract number and PBP ID)
• Beneficiary identification (for example, Medicare beneficiary identifier (HICN or MBI), date of birth, gender)
• Event identification information (for example, claim control number, and adjustment/deletion code)
• Drug and Quantity identification information (for example, date of service, fill number, and Compound Code)
• Cost information (for example, paid date, ingredient cost, dispensing fee, vaccine administration fee, and sales tax)
• Payment Breakout information (for example, catastrophic coverage code, Total Gross Covered Drug Cost Accumulator, True Out-of-Pocket Accumulator, beneficiary amount paid and low income cost sharing subsidy amount)
• Prescriber information (for example, prescriber ID, prescriber ID qualifier and DAW/product selection code)
• Service Provider Information (for example service provider ID and pharmacy service type)
• Benefit Design information (for example, beginning benefit phase, ending benefit phase, brand/generic code)

Based on three years of enrollment data (2017, 2018, and 2019), CMS estimates that an annual average of 46,793,272 Medicare beneficiaries enroll in Part D prescription drug coverage. The average number of PDEs per year is1,499,238,090 based on data from 2017, 2018, and 2019. To compute the average number of PDEs per beneficiary, we divide the average number of PDEs per year by the average number of beneficiaries enrolled per year. This computation leads to an average of 32 PDEs per beneficiary per year.

Draft CMS proposal -- data layout and technical documentation: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-10174
FR notice inviting public comment: https://www.federalregister.gov/documents/2021/06/23/2021-13194/agency-information-collection-activities-proposed-collection-comment-request

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