New CMS Medicare Drug Price Guidance | CLE Course

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Course Details

Course Information

smart_display Format
On-Demand
signal_cellular_alt Difficulty Level
Intermediate
work Practice Area
Health

Date & Time

event Date
Wednesday, June 7, 2023
schedule Time
1:00 p.m. ET./10:00 a.m. PT
timer Program Length
90 minutes

Credit Information

This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00

CLE

ALL

This CLE webinar will guide healthcare counsel on the new CMS guidance on the Medicare Drug Price Negotiation Program. The panel will examine the guidance, discussing the drug selection criteria and the negotiation process. The panel will also address other areas of guidance and offer best practices for navigating drug price negotiations.

Faculty

Steven J. Schnelle

Partner

McDermott Will & Emery, LLP

Mr. Schnelle delivers business-focused legal solutions to investors and business operators in the US healthcare market. He is particularly focused on legal matters involving healthcare providers and suppliers, equipment and device manufacturers and suppliers, pharmacies, health tech and digital solutions providers, and market innovators. Mr. Schnelle regularly assists clients with matters involving government and commercial payor audits and investigations, administrative appeals and investment strategies for assets in dispute with government or commercial payors.

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Mimi Moll Alexandre

Partner

McDermott Will & Emery, LLP

Ms. Alexandre counsels clients across the healthcare industry with a particular focus on entities in the managed care arena. She routinely works with health plans, health maintenance organizations, private equity funds and vendors, helping them navigate complex regulatory schemes and facilitate business objectives.

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Description

In March 2023, the CMS issued guidance related to the implementation of the Medicare Drug Price Negotiation Program. The guidance provides the criteria for the selection of the drugs subject to negotiation. Under the negotiation program, Medicare is permitted to negotiate prescription drug pricing. The guidance also provides the program's requirements.

Negotiated prices are referred to as the drug's maximum fair price (MFP). Manufacturers of drugs with MFPs must provide pharmacies and other dispensers access to the MFPs for the drugs they dispense to those enrolled in Part D plans. Similarly, Part D plans must provide their enrollees with access to the MFPs.

The guidance sets forth requirements for manufacturers subject to the 340B program and what must be provided to 340B covered entities. Further, the guidance describes the process for the issuance of CMPs for violations under the negotiation program. Manufacturers that do not comply with the program's requirements could pay a stiff price and be removed from Part D or Part B coverage and excise tax liability.

Listen as our authoritative panel of healthcare attorneys examines CMS' guidance for the Medicare Drug Price Negotiation Program. The panel will discuss the drug selection criteria and the negotiation process. The panel will also address other areas of guidance and offer best practices for navigating drug price negotiations. The panel will frame the discussion with the precedent changes to the Medicaid drug rebate program in the American Rescue Plan Act, as well as the newly announced Center for Medicare and Medicaid Innovation (CMMI) drug pricing models.

Outline

American Rescue Plan Act
1. Medicaid inflation rebate changes
Medicare Drug Price Negotiation Program guidance
1. Drug selection criteria
2. Negotiation process
Additional guidance
1. Negotiations related to 340B drugs
2. Issuance of CMPs for violations
Best practices for navigating drug price negotiations
What's on deck: Center for Medicare and Medicaid Innovation Models