Public transcript

E14: USA - Ross Margulies

By: The Payer Exchange
Length: 48 min
Published: 23 September 2026
Language: English
Text from: the audio
Transcribed: 28 September 2026

Read the full transcript Open on Spotify

Notes in English.

Summary

In this season finale of The Payer Exchange, host Omar Ali speaks with Ross Margulies, a Washington-based healthcare attorney at Manat, about how US drug pricing policy is reshaping global launch and market access strategy. They cover international reference pricing, the MFN (Most Favored Nation) agenda, the Guard and Globe models, the Generous agreement, and the evolution of the CMS drug price negotiation program into its third cycle (IPA3). The discussion closes with a look ahead to the midterm elections and the prospect of bipartisan drug pricing reform.

Key points

Ross Margulies is a healthcare attorney at Manat, a hybrid policy and legal firm, with about 17 years of experience working across the drug supply chain and life sciences industry.
Most of his clients believe international reference pricing is here to stay regardless of the outcome of the November midterm elections, and many manufacturers are holding ex-US launches in response.
Guard and Globe rules have reached the Office of Management and Budget and are expected to be finalized this year, but Ross is highly confident they will face legal challenge because Congress has never authorized international reference pricing.
The 17 largest manufacturers have signed voluntary MFN pricing agreements with the Trump administration, exempting them from Guard and Globe, and smaller manufacturers are now negotiating similar deals.
MFN reporting works in two ways: method one relies on third-party commercial data sources, while method two is a voluntary process where manufacturers open their books to report their true net prices.
IPA3 brings Part B physician-administered drugs into CMS drug price negotiations for the first time and moves the program from guidance-driven to a formal rulemaking process.
Products with a negotiated MFP are still subject to MFN models like Guard and Globe, but their MFP price is protected from being overridden by an MFN price in renegotiation.
Spain is considering legislation to make confidential discounts contractually non-disclosable, which could complicate MFN reporting but is unlikely to be a sustainable long-term solution.

Questions it answers

00:00Introduction and guest background

Who is Ross Margulies and why is he on the podcast?

Ross Margulies is a healthcare attorney at Manat, a hybrid policy and legal firm in Washington, with about 17 years of experience focused on the drug supply chain and life sciences. He helps manufacturers navigate federal policy and legal changes affecting their business.

Ross has spent much of his career helping manufacturers navigate drug pricing policy challenges.
His practice sits at the intersection of policy and law.

05:00MFN and international reference pricing in the US

How is international reference pricing affecting US manufacturers and payers?

Ross says the recognition that international reference pricing is here to stay has led many manufacturers to freeze and hold international launches. Payers are further behind and are waiting to see whether these concepts become embedded, though they see cost-saving opportunities.

Manufacturers are delaying launches in ex-US jurisdictions to avoid triggering US price impacts.
Both payers and manufacturers have shifted their thinking on international reference pricing in the past year.

11:00Legal hurdles for Guard and Globe

What are the legal and constitutional obstacles to Guard and Globe?

Congress has not authorized international reference pricing, so CMS is relying on demonstration authority, which is more legally vulnerable. Ross expects Guard and Globe rules to be finalized this year but is highly confident they will face legal challenge. If Congress legislates on international reference pricing, the chances of survival are much higher.

Guard and Globe rules have reached OMB, the last step before finalization.
If Congress authorizes international reference pricing, legal challenges on constitutional grounds become much harder to win.

15:00MFN agreements and strategic launch delays

How are manufacturers responding to MFN agreements and can launch delays avoid them?

The 17 largest manufacturers have signed voluntary MFN pricing agreements, exempting them from Guard and Globe, and smaller manufacturers are now negotiating similar deals. Ross says some companies can strategically delay ex-US launches to avoid the broadest effects of current MFN agreements, though every manufacturer's circumstances are unique.

Manufacturers signing MFN agreements get tariff relief and Guard and Globe exemptions.
There are two schools of thought in the Trump administration: one comfortable with lower US reimbursement, another focused on forcing other countries to pay more.

21:00Method one and method two price reporting

How does CMS get access to previously confidential net prices?

Method one relies on third-party commercial data sources like Eversana's Navlin and IQVIA, while method two is voluntary, where manufacturers open their books to report their true net prices. Both use the second lowest price of the grouping of countries.

Method one creates uncertainty and loss of control for manufacturers relying on third-party data.
Many manufacturers have been forced to subscribe to these databases to understand what is being reported.

25:00IPA3 and the shift to rulemaking

What changes with IPA3 and the move from guidance to regulation?

IPA3 brings Part B physician-administered drugs into negotiations and moves the program from guidance-driven to formal rulemaking. Ross says CMS has been remarkably consistent and has largely put into regulation the program as it operated over the first two IPAs, so the program feels institutionalized already.

CMS has proposed regulations and is currently in a 60-day comment period.
Legal counsel attended IPA1 meetings but has been absent in IPA2 and IPA3.

32:00Part B drugs and the buy-and-bill question

How will Part B negotiations affect providers and prescribing behavior?

Ross says CMS has continued to kick the can down the road on how to make providers whole on Part B drugs under the negotiation program. He expects to see changes in prescribing behavior where physicians buy and bill products reimbursed at MFP, especially if competing products offer better margins.

CMS has not addressed provider reimbursement for Part B drugs even though IPA3 will be the first year they are negotiated.
Small rural providers may particularly struggle if Part B margins are significantly reduced.

37:00Advising manufacturers on long-term strategy

How should pharma plan US and ex-US launches under this uncertainty?

Ross says the most fundamental piece is that MFN, Guard, Globe and drug price negotiation must now be built into launch and market access plans. Companies need to think about launch indications and sequencing differently, though it is a difficult time to plan because the policy landscape is not stable.

No organization should go through product planning without accounting for these factors.
The lack of certainty about where all of this is going is keeping C-suite folks up at night.

Notes

Guest and Context

Ross Margulies is a healthcare attorney at Manat, a hybrid policy and legal firm, with roughly 17 years of experience focused on the drug supply chain and life sciences.
His practice sits at the intersection of policy and law, acting as his clients' ears and eyes in Washington.

International Reference Pricing and MFN

Ross notes that international reference pricing has been proposed since the Obama administration, but the second Trump administration has leaned into it most strongly.
His clients generally believe international reference pricing is here to stay irrespective of the November election outcome.
Many manufacturers are holding international launches to avoid triggering future US price impacts. Some have publicly said they will not launch in Germany.
The Guard and Globe models have reached the Office of Management and Budget and are expected to be finalized this year. Ross is highly confident they will face legal challenge.
Congress has not authorized international reference pricing. CMS is using demonstration authority, which is legally more vulnerable than statutory authority.
The 17 largest manufacturers have signed voluntary MFN pricing agreements with the Trump administration, exempting them from Guard and Globe. Smaller manufacturers are now negotiating similar deals.
The Generous model would offer international reference price in Medicaid and require manufacturers to commit to prospective MFN pricing at launch.

Price Reporting

Method one relies on third-party data sources such as Eversana's Navlin and IQVIA (IQEMIDAS).
Method two is voluntary, where manufacturers open their books to report their true net prices in international countries.
Both methods ultimately use the second lowest price of the grouping of countries as the reference point.
Manufacturers have been forced to subscribe to these databases to understand what prices are being listed.

CMS Drug Price Negotiations (IPA3)

IPA3 brings Part B physician-administered medicines into negotiations for the first time and moves from guidance-driven to formal rulemaking.
CMS has largely put into regulation the program as it operated over the first two IPAs, with the program feeling rule-based and institutionalized already.
Legal counsel attended most IPA1 meetings but has been absent in IPA2 and IPA3.
Litigation against the program continues at the circuit court level but none has succeeded. Ross sees more potential in narrow challenges, such as the treatment of fixed-dose combination products with hyaluronidase.
CMS has not yet addressed how providers will be made whole on Part B drugs under the negotiation program.
Products with a negotiated MFP can still be included in MFN models, but the MFP price is protected from being overridden by an MFN price in renegotiation.

Strategic Outlook

Ross is advising clients to build MFN, Guard, Globe and drug price negotiation into their launch and market access plans from the beginning.
Spain is considering legislation to make confidential discounts contractually non-disclosable to block MFN reporting, which Ross sees as potentially workable short-term but unlikely to be sustainable.

Transcribed automatically from the audio. Summary and notes written by AI from the transcript, so check anything important against the recording.