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CMS Highlights Medicare Drug Negotiation Submissions, CMP Updates, DDPS Changes & Website Decommission (Week of 5/12/25–5/16/25)

Beacon Alert 2025-020 Weekly Regulatory Updates

CMS issued several critical updates this week, ranging from Medicare Drug Price Negotiation submission protocols and civil money penalties to Drug Data Processing System (DDPS) edits and digital infrastructure transitions. This alert is essential reading for compliance, Part D operations, pharmacy data teams, and Medicare Advantage plan sponsors.

Medicare Drug Price Negotiation: Data Submission for 2028 Cycle

CMS has opened the comment period for its Information Collection Request (ICR) related to the 2028 Initial Price Applicability Year under the Medicare Drug Price Negotiation Program.

Key Components:

  1. Small Biotech Exception – Manufacturers may request to exclude a single source drug from negotiation.

  2. Biosimilar Delay – Manufacturers can apply to delay inclusion of biosimilar products.

  3. Renegotiation Eligibility – Voluntary submissions to help CMS evaluate previously selected drugs.

  • Submission Portal: CMS HPMS and CMS-designated Box folders

  • Comment Deadline: July 14, 2025

  • Instructions: CMS HPMS User Access

📌 Impact Area: Compliance
🕒 Action Required By: July 14, 2025

Updated Medicare Prescription Payment Plan Model Documents

CMS seeks feedback on proposed model materials for the Medicare Prescription Payment Plan, reflecting updates required under CMS-4208-F for CY 2026.

  • Federal Register Identifier: CMS-10882 (OMB 0938-1475)

  • Public Inspection Notice

  • Supporting docs available via the CMS PRA listing

📩 Comments Due: July 14, 2025
📌 Impact Area: Part D, Finance, Compliance

Revised Civil Money Penalty (CMP) Amounts for 2025

CMS reaffirmed its methodology for calculating CMPs for Medicare Parts C & D.

  • The revised rule (est. June 2019) includes inflation-adjusted minimum penalty and aggravating factor amounts.

  • 2025 figures are now posted online:
    CMS CMP Enforcement Actions

📧 Questions: part_c_part_d_audit@cms.hhs.gov

Medicare Transaction Facilitator (MTF): Operational Documents Released

In preparation for the January 1, 2026 implementation of the Maximum Fair Price (MFP), CMS published finalized materials related to the MTF:

  • MTF ICR: Final versions now available

  • User Agreements: Cover Data and Payment Modules (onboarding begins June 2025)

  • Technical FAQs: Address manufacturer-initiated reversals, credit/debit ledgers, and operational workflows

📌 Impact Area: Part D, Pharmacy, Compliance
🕒 Deadline (MTF ICR): Passed – May 1, 2025
📧 Contact: CMS Drug Price Negotiation Support Teams

DDPS Edits Update – Compounded Insulin Handling

CMS has updated the Drug Data Processing System (DDPS) edits to reflect the Inflation Reduction Act’s insulin pricing provisions:

Effective: May 19, 2025

Key Changes:

  • Edits 787, 900, 904, 906, 908 updated to reject/bypass compounded insulin products (Compound Code = ‘2’)

  • Edit 879 now rejects PDEs with Ingredient Cost + Sales Tax ≤ $0.02

📧 Questions: PDE-Operations@cms.hhs.gov
📌 PDEs rejected previously under these criteria can be resubmitted after May 19, 2025

CSSC Operations Website Decommission Notice

CMS announced the decommission of the CSSCOperations.com website effective May 31, 2025.

  • Resources related to Risk Adjustment and PDE submissions will migrate to CMS.gov

  • Users are advised to download commonly used files before the cut-off

  • Help Desk remains available at:
    📧 csscoperations@palmettogba.com | ☎ 1-877-534-2772

📌 Impact Area: IT, Compliance, Systems Teams

Medicaid.gov Federal Register Notices – May 2025

CMS submitted five regulatory comment requests for review on May 15–16, 2025. These include updates related to Medicaid funding, deeming authority renewals, health tech ecosystems, and payment policies.

🔗 Visit: FederalRegister.gov Document Search

Additional Modules

Todd Petersen,

Chief Executive Officer & Board Member

Todd brings 22 years of experience in scaling SaaS-based companies within the health plan payer market. He has a proven track record of fostering strong client relationships and building high-performing teams. Todd joined Beacon Healthcare Systems from HighRoads, where he played a pivotal role in providing SaaS solutions for health plan design and modification. His extensive career includes significant contributions to sales and growth at HealthSparq, a web-based consumer enablement solution provider; InstaMed, which facilitates financial transactions among payers, members, and providers; DestinationRx, specializing in Medicare shopping for government and commercial programs; and Ingenix, known for its cost containment technology services. Todd is also an acting board member for Beacon Healthcare Systems.

Jeremy Hays

Vice President of Strategic Accounts

Jeremy is an accomplished executive with extensive experience in health insurance and supporting technology. He is a seasoned sales and operational leader passionate about driving revenue growth and elevating customer satisfaction He has a long track record in Medicare leading teams to consistently exceed revenue targets by developing and executing highly effective growth strategies within organizations like United Healthcare, DestinationRx, and InstaMed, all while nurturing enduring, mutually beneficial customer relationships. Jeremy will be leading the existing Account Management team.

Alexis Elam JD, CHC

Vice President of Compliance

Alexis is a trusted and valued healthcare compliance, privacy, and risk leader with 18+ years of audit, oversight, and effective program management across payors, providers, and SaaS support tools. She specializes in implementing corporate initiatives and software solutions that promote adherence to government contracting and service delivery regulations.

Ayman Mohamed

Chief Technology Officer

With over 20 years of senior leadership, strategic, and operational product management experience, Ayman brings a wealth of knowledge and expertise to his role. Ayman is a seasoned technology leader with a proven track record of launching innovative products in new and existing markets, generating significant revenue streams, and creating profitable enterprises. His passion for building high-quality products and commitment to servant leadership have earned him a reputation for building trust and fostering collaborative, high-performing teams. Throughout his career, Ayman has demonstrated a deep understanding of software architecture and broad hands-on technical skills. He has successfully helped organizations succeed, with experience spanning startups and larger companies in the San Francisco Bay and Washington, D.C. metro areas.

Chris Mahoney

Chief Financial Officer

Chris Mahoney is a resourceful and results-driven senior finance executive with 25+ years of CFO-level experience leveraging keen financial expertise to create cost-efficient and sustainable financial results across both small and large corporate organizations. He consistently demonstrates the ability to critically evaluate and respond to rapidly evolving environments while identifying business-critical financial enhancements and developing proactive and actionable improvement initiatives.
Chris also utilizes business acumen and cross-functional communication skills to routinely produce sophisticated solutions and align all financial activities with strategic business goals. Chris has acquired and integrated businesses, assisted in raising millions in $30mm equity and debt through private placements, transformed a business from a Perpetual to a SaaS model, assisted in growing businesses from $250mm to $1bn, and has implemented Project Accounting systems, cost, and management information systems.

Ken Stockman

Chief Executive Officer
Ken Stockman, Founder and Chief Executive Officer of Beacon Healthcare Systems, is a seasoned healthcare executive with strong Payer and Provider experience focused on bringing innovative solutions to Government program revenue management, operations, compliance, and risk adjustment. Ken was an early leader in the Medicare Advantage Risk Adjustment industry building a full suite of tools such as Full Enrollment, Member Reconciliation And Part D Platform to support the health plans’ initiatives in 2006 as co-founder and former CEO of Dynamic Healthcare Systems, Inc. His expertise in Risk Adjustment Strategy, Transaction Processing And Analytics positions him as a unique subject matter expert. Additionally, his experience in CMS Transaction Processing And Regulatory Requirements led to the successful design and implementation of industry-leading information systems.