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Dec 18 -- The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment by February 16, 2024 on CMS' proposed Collection of Prescription Drug Data from MA-PD, PDP and Fallout Plans/Sponsors for Medicare Part D Payments.

The 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 Coverage Gap Discount Program (CGDP), and the data are part of the report provided to the Secretary of the Treasury for Section 9008.

Sections 11001 through 11004 of the Inflation Reduction Act of 2022 establish a Medicare Drug Negotiation Program for high-expenditure drugs. Section 11102 of the Inflation Reduction Act of 2022 establishes a Part D inflation rebate by manufacturers of certain single source drugs and biologicals with prices increasing at a rate faster than the rate of inflation. CMS will use data reported under sections 1860D–15(c)(1)(C) and (d)(2), in part, to rank drugs by total expenditures under Part D in order to select drugs for negotiation and to identify units to calculate inflation rebates.

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. In addition, the PDE data are used to support operations and program development.

The Inflation Reduction Act (IRA), signed into law on August 16, 2022 (P.L. 117-169), makes a number of changes to the Part D program. Changes that impact the information in this collection requirement are as follows:

• Eliminates the deductible for adult vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) and eliminates coinsurance or other cost-sharing for these vaccines beginning January 1, 2023. § 1860D-2(b)(8) of the Act. For 2023 only, Medicare pays Part D sponsors a temporary retrospective subsidy (Inflation Reduction Act Subsidy Amount, or IRASA) for this reduction in cost sharing and deductible, which must equal the difference between the beneficiary cost sharing for the ACIPrecommended adult vaccine under a Part D plan’s 2023 benefit design (submitted by sponsors to CMS prior to the passage of the IRA) and the applicable statutory maximum cost sharing limit created by the IRA. § 1860D-15(h) of the Act.
• Eliminates the deductible for covered Part D insulin products and limits the beneficiary cost sharing for these insulin products beginning January 1, 2023. § 1860D-2(b)(9) of the Act. For 2023 only, Medicare pays Part D sponsors a temporary retrospective subsidy (IRASA) for this reduction in cost sharing and deductible, which must equal the difference between the beneficiary cost sharing for the covered insulin product under a Part D plan’s 2023 benefit design (submitted to CMS prior to the passage of the IRA) and the applicable statutory maximum cost sharing limit created by the IRA. § 1860D-15(h) of the Act.
• Provides for lower prices for certain high-priced single source drugs through a drug price negotiation process established by the Secretary, whereby a maximum fair price (MFP) is set for negotiation-eligible drugs beginning January 1, 2026. Part E of Tile XI of the Act.
• Requires a manufacturer of a Part D rebatable drug to pay a rebate to the Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund if the drug’s annual manufacturer price in an applicable period (a 12-month period beginning October 1, 2022) exceeds the drug’s inflation-adjusted payment amount, which is based on the drug’s benchmark period manufacturer price, increased by the Consumer Price Index for All Urban Consumers (hereinafter referred to as the “Part D inflationary rebate”). This provision requires that the calculations take into consideration and exclude drugs units that for which the manufacturer has provided a discount under section 340B of the Public Health Service Act. § 1860D-14B of the Act.
• Redesigns the Part D benefit by eliminating the cost-sharing in the catastrophic phase in 2024; capping annual out-of-pocket costs for prescription drugs under Part D at $2,000 beginning in 2025; reducing the government reinsurance in the catastrophic phase of Part D coverage for applicable drugs from 80 percent to 20 percent and for non-applicable drugs from 80 percent to 40 percent beginning in 2025; eliminating the coverage gap phase and coverage gap discount program, and replacing it with a Manufacturer Discount Program (MDP) that requires manufacturers to provide a 10 percent discount in the initial phase, and a 20 percent discount in the catastrophic phase on applicable drugs beginning in 2025; creating a new Selected Drug Subsidy Program, under which Medicare covers the portion the manufacturer would otherwise pay under the MDP in the initial coverage phase of the benefit for the years in which a MFP applies for the drug; and requiring Part D sponsors to provide enrollees with the option to pay out-of-pocket costs under the plan in monthly amounts that are spread out throughout the year (Medicare Prescription Payment Plan). §§ 1860D-2(b), 1860D-15(b), 1860D-14A, 1860D-14C, 1860D-14D of the Act.

The existing approved package is being revised to update burden estimates based on the expansion of the prescription drug event (PDE) record file layout, updates to existing fields on the PDE record, and the addition of new fields on the PDE record. This expansion is being implemented to accommodate future business needs, including but not limited to, updates necessary for the IRA and anticipated updates to the National Council for Prescription Drug Programs (NCPDP) Telecommunications Standard. We are making changes to existing fields and adding new fields to assist Medicare Part D sponsors in submitting complete and accurate data for payment, to be compliant with CMS regulations and statutory provisions, and based on the feedback received from our stakeholders. We are also revising the package to update burden estimates based on the number of contracts as well as the growth of Medicare beneficiaries enrolled in Part D.
 
In this collection of information request, CMS is notifying users that it will also use data reported under sections 1860D-15(c)(1)(C) and (d)(2) to implement the Medicare Drug Negotiation Program and to calculate inflation rebates as required by the Inflation Reduction Act of 2022, as well as to fulfill our statutory obligations under the Social Security Act. This includes the use of PDE data to fulfill obligations or operationalize any future legislative changes to the Social Security Act that impact the Part D program.

Form Number: CMS–10174
Frequency: Monthly
Number of Respondents: 856
Total Annual Responses: 1,499,064,780

Part D Claims Data: https://www.cms.gov/medicare/coverage/prescription-drug-coverage/part-d-claims-data
Draft data collection instruments and technical documentation: https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing-items/cms-10174
FRN: https://www.federalregister.gov/d/2023-27684

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