Episode 115 – Drug Pricing and Market Access: Highlights From Recent CMS and AHLA Conferences
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In this episode of Connected with Latham, Chris Schott, Danny Machado, and Evan Rothkoff discuss key takeaways from two major healthcare conferences: the American Health Law Association's Institute on Medicare and Medicaid Payment Issues and the CMS Quality Conference. The conversation centers on the latest developments in drug pricing and market access, including the implementation of the Inflation Reduction Act, the evolving Most Favored Nation (MFN) pricing policy under Globe and Guard, and the ongoing debate around 340B drug pricing reform. The panel highlights CMS's growing role in shaping policy, with government officials emphasizing fraud prevention, data tracking challenges, and the expansion of payment models through the Center for Medicare and Medicaid Innovation (CMMI). A major focus is on GLP-1 drugs and the upcoming voluntary balance program that will cap out-of-pocket costs at $50 per month for certain Part D beneficiaries starting in 2027, with a short-term bridge model launching in July. The episode underscores the increasing complexity and pace of regulatory change, requiring pharmaceutical manufacturers to adopt coordinated, multidisciplinary strategies to navigate compliance and innovation incentives. The hosts conclude with a lighthearted discussion comparing the drug pricing landscape to Olympic sports—baseball/softball for CMS’s team-based structure, hockey for its intensity, and the 4x400 relay for the need for seamless collaboration across departments. Key takeaways include: (1) The U.S. drug pricing landscape is rapidly evolving with multiple overlapping initiatives like Globe and Guard, MFN pricing, and 340B reform, requiring manufacturers to stay agile; (2) CMS is investing heavily in infrastructure and staffing—CMMI plans to double its drug-focused team—to implement and monitor new payment models; (3) The upcoming $50/month cap on GLP-1 costs via the BRIDGE program signals a shift toward patient affordability, but manufacturers must prepare for mandatory participation in future MFN-based models; (4) Industry conferences are critical for real-time intelligence on government priorities and stakeholder sentiment; (5) Success in this environment demands cross-functional collaboration, with legal, compliance, and commercial teams working in sync. The episode ends on a positive note, emphasizing that while the regulatory environment is complex, it also presents opportunities for strategic innovation and market leadership.
Manufacturers must prepare for mandatory MFN pricing under Globe and Guard, with CMS expected to issue final rules after reviewing over 20,000 public comments.
The BRIDGE program launching in July 2024 will serve as a short-term bridge to the 2027 rollout of the $50/month GLP-1 cost cap under the Part D initiative.
CMMI is expanding its drug-focused team to double in size, signaling a major push to test and implement new payment models for drug reimbursement.
The 340B drug pricing reform and duplication tracking remain unresolved challenges, with CMS and industry still grappling with data transparency and compliance.
Stakeholders should attend upcoming conferences like Pricing and Contracting USA (May 18–20, Philadelphia) to stay ahead of regulatory shifts and network with government and industry leaders.
…and 3 more takeaways available in PodZeus
Introduction to the Drug Pricing Series and Today's Topic
Chris Schott introduces the 25th episode of the Latham & Watkins Drug Pricing and Market Access series, welcoming co-hosts Danny Machado and Evan Rothkoff. The episode focuses on key insights from two major conferences: the AHLA Institute on Medicare and Medicaid Payment Issues and the CMS Quality Conference.
AHLA Conference Takeaways: Policy, Data, and 340B Reform
“We've had this issue dogging the program since 1992—how do we track duplication? First with Medicaid, now with IRA rebates, and going forward with Global Guard MFN rebates.”
CMS Quality Conference: Focus on GLP-1s and Payment Models
“The BRIDGE program begins this July—it's not an acronym, just a literal bridge between now and when the balance program starts in 2027.”
CMMI’s Role in Innovation and Future Payment Models
“The purpose of this waiver is to test novel ways to reimburse pharmaceuticals—without congressional action—so we can learn what works before making permanent changes.”
Olympic Sport Analogy and Closing Remarks
The hosts conclude with a fun segment comparing the drug pricing landscape to Olympic sports: Evan chooses baseball/softball for CMS’s coordinated team structure, Chris picks the 4x400 relay for the need for seamless collaboration, and Evan adds hockey for the intensity of regulatory competition. The episode ends with a recommendation to attend the upcoming Pricing and Contracting USA conference and a personal dining recommendation from Chris.
“It's really going to take a good team like a task force... to come get to the finish line all at once, kind of all in one group.”
“It's really going to take a good team like a task force and a team of specialists inside your organization... to adapt strategy to not just comply but to maybe have upside.”
“We've had this issue dogging the program since 1992—how do we track duplication? First with Medicaid, now with IRA rebates, and going forward with Global Guard MFN rebates.”
Host
Guests
CMS
organization
Chris Schott
person
Evan Rothkoff
person
CMMI
organization
Danny Machado
person
Inflation Reduction Act
other
GLP-1 Drugs
product
Globe and Guard
other
340B Drug Pricing Program
other
American Health Law Association
organization
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