What do these rules do to your margin per dose?
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Contact usMFN stands for “most favored nation.” In trade it means a country gives every partner the same terms it gives its best one; in drug pricing it means tying what Americans pay for a medicine to the lowest price paid in other wealthy countries. As of October 19, 2026, MFN reaches drugs through voluntary manufacturer deals, a finalized Medicare Part B model called GLOBE that starts in 2027 and leaves ASP + 6% in place, and a Part D model, GUARD, that is not yet final.
What MFN means: trade first, then drugs
The first article of the General Agreement on Tariffs and Trade: a lower tariff granted to one WTO member must be granted to all, with limited exceptions such as free trade agreements. Contracts borrow the idea in an “MFN clause.”
On May 20, 2025, HHS set the target as “the lowest price in an OECD country with a GDP per capita of at least 60 percent of the U.S. GDP per capita,” for brand drugs without generic or biosimilar competition.
The term now covers several separate programs. Only one of them changes what Medicare pays your practice:
| Program | Status, October 19, 2026 | Changes your Part B payment? |
|---|---|---|
| 2020 MFN Model (Part B) | Blocked December 2020; rescinded 2022 | Never started |
| Executive Order 14297 | In force since May 12, 2025 | No |
| Manufacturer deals (26 companies) | Signed; terms largely confidential | Not in any published term |
| TrumpRx.gov | Live since February 5, 2026 | No |
| GENEROUS (Medicaid) | Running since January 2026 | No |
| GLOBE (Part B) | Final; effective November 30, 2026; challenged in court | No change to ASP + 6% |
| GUARD (Part D) | Proposed; final rule under review | Not a Part B model |
| Medicare negotiation, Part B | Prices due November 30, 2026; effective January 1, 2028 | Yes: 106% of the negotiated price |
- Nov 27, 2020Blocked or not final: The 2020 MFN Model rule is published
- Dec 2020Blocked or not final: Courts in Maryland and California block it
- Feb 28, 2022Blocked or not final: Its rescission takes effect
- May 12, 2025In force: Executive Order 14297 is signed
- Jul 31, 2025In force: Letters go to 17 manufacturers
- Sep 30, 2025In force: The first manufacturer deal
- Dec 23, 2025Blocked or not final: GLOBE and GUARD are proposed
- Jan 2026In force: GENEROUS, the Medicaid model, starts
- Jan 27, 2026In force: Xolair is selected for Medicare negotiation
- Feb 5, 2026In force: TrumpRx.gov launches
- Jun 15, 2026Blocked or not final: GUARD’s final rule goes to White House review
- Aug 31, 2026In force: 26 manufacturers have deals
- Sep 30, 2026In force: GLOBE is final
- Oct 7, 2026In force: PhRMA sues to block GLOBE
- Oct 19, 2026Today
- Nov 30, 2026Scheduled: GLOBE takes effect; negotiated prices are due
- Apr 1, 2027Scheduled: GLOBE coinsurance cuts begin
- Jan 1, 2028Scheduled: Part B pays 106% of negotiated prices
- Mar 31, 2032Scheduled: GLOBE’s performance period ends
The 2020 MFN Model, and why it never started
CMS published the Most Favored Nation Model as an interim final rule on November 27, 2020. Unlike today’s programs, it cut what practices were paid. For about 50 of the highest-spend Part B drugs, payment would have phased down to the lowest GDP-adjusted price among wealthy OECD countries, and the 6% add-on would have become a flat fee per dose.
Many older MFN articles describe this 2020 design, which would have paid practices less. The 2026 GLOBE design does not.
The 2025 executive order and the manufacturer deals
Executive Order 14297 (May 12, 2025) directed HHS to send manufacturers MFN price targets and, without “significant progress,” to propose rules and consider importation. On July 31, 2025, letters asked 17 manufacturers for four things: MFN prices for every Medicaid patient, MFN prices at launch, direct sales to patients at or below MFN, and the return of increased foreign revenue. The deals that followed share those terms.
| Announced | Companies | What the published terms add |
|---|---|---|
| Sep 30, 2025 | Pfizer | The first deal; cash discounts |
| Oct 10, 2025 | AstraZeneca | $50 billion US investment by 2030 |
| Oct 16, 2025 | EMD Serono | Discounted IVF drugs |
| Nov 6, 2025 | Eli Lilly, Novo Nordisk | $245 Medicare price for four GLP-1 brands |
| Dec 19, 2025 | Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Gilead, GSK, Merck, Novartis, Sanofi | 14 deals by this date |
| Jan 2026 | Johnson & Johnson, AbbVie | Announced by the companies |
| Apr 23, 2026 | Regeneron | 17 deals; 86% of the branded market |
| Aug 31, 2026 | Alcon, Astellas, BeOne, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva, UCB | 26 companies; 89% of the branded market |
What the deals mean for a practice:
- Medicaid, not MedicareThe deals give every state Medicaid program MFN prices through GENEROUS, a voluntary CMS model; 40 states and Puerto Rico had signed by September 18, 2026. Medicaid rebates are not counted in ASP.
- Launch pricesEach company promises “MFN prices on all new innovative medicines.” How that is measured is not public; KFF notes the details “remain confidential.”
- TrumpRx is a cash channelIt launched February 5, 2026 with 40 drugs from five manufacturers, for patients paying cash. It does not touch office-administered biologics.
GLOBE and GUARD: the two Medicare models
Bills manufacturers of certain high-spend Part B drugs when Medicare pays more than an international benchmark. About 25% of Original Medicare patients, April 2027 to March 2032. Leaves ASP + 6% in place.
Effective November 30, 2026. Challenged in court since October 7, 2026.
A similar rebate for Part D drugs, in areas covering 25% of enrollees. For allergy practices it matters mainly for pharmacy-filled drugs such as Dupixent.
Final rule under White House review since June 15, 2026; not published as of October 19, 2026.
GLOBE, checked against the final rule
- How it works
- It changes the existing Part B inflation rebate for selected drugs. The manufacturer owes, per unit, the larger of the normal inflation rebate or the gap between Medicare’s payment and an international benchmark built from 19 countries, adjusted for GDP.
- Which drugs
- Single-source drugs and biologics in seven USP classes with over $100 million a year in Original Medicare Part B spending. Excluded: drugs with a negotiated price in effect, orphan-only drugs, listed cell and gene therapies, plasma-derived products, and reference biologics once a biosimilar is marketed. CMS posts the code list before each quarter.
- Which patients
- About 25% of Original Medicare Part B patients, in randomly chosen ZIP areas. The list is due by January 16, 2027.
- Reach
- CMS waives any manufacturer taking part in GENEROUS, which it estimates leaves four manufacturers. Projected savings fell from about $11.9 billion in the proposal to $440 million.
- In court
- PhRMA sued in Washington, DC on October 7, 2026 (No. 1:26-cv-03498). No ruling had been reported as of October 19, 2026.
“The GLOBE Model does not change the Medicare Part B payment limit or add-on payment (generally, ASP+6 percent).”
GLOBE final rule, 91 FR 62936
For your claims: you bill as usual, with no modifier. For a patient in the model, coinsurance drops and Medicare pays more: on a $100 allowed amount with coinsurance cut to 10%, Medicare pays $90 and the patient $10. The remittance shows the patient’s share, so coinsurance collected up front may need a partial refund. CMS also acknowledges manufacturers “may change list prices or price concessions in the U.S. across all payers,” which “could in turn indirectly impact the ASP amount.”
How MFN fits with Medicare negotiation and ASP
Medicare pays 106% of a Part B drug’s average sales price, updated each quarter from what manufacturers report within 30 days after the quarter ends. ASP is net of volume and prompt-pay discounts, chargebacks and rebates, but not Medicaid rebates.
The Inflation Reduction Act adds a second rule for negotiated drugs. On January 27, 2026, CMS selected 15 drugs for 2028 prices, the first cycle to include Part B drugs. Xolair is on the list, with $1.08 billion in Medicare spending over the year to October 2025, along with Orencia, Entyvio, Cimzia and Botox. CMS must publish the agreed prices by November 30, 2026, and they take effect January 1, 2028.
MFP is the “maximum fair price,” the negotiated price. The manufacturer must sell to you at or below it, or refund the difference from your purchase price. CMS’s July 16, 2026 draft guidance proposes a 14-day refund window; it is not final. GLOBE drops a drug once its negotiated price is in effect, so the two never stack.
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TodayASP $1,000; add-on $60Allowed amount $1,060
-
GLOBE patientSame ASP; Medicare covers the cutAllowed amount $1,060
-
ASP falls 10%ASP $900; add-on $54Allowed amount $954
Under GLOBE, the manufacturer pays Medicare a rebate. The practice is not part of that payment.
| Line | Today | ASP falls 10% | GLOBE patient |
|---|---|---|---|
| Allowed amount | $1,060 | $954 | $1,060 |
| Practice cost per dose | $980 | $882 if the price cut reaches you; $980 for stock bought before it | $980 |
| Margin per dose | $80 | $72, or −$26 on old stock | $80 |
A made-up Part B biologic, Medicare primary, sequestration and secondary insurance left out. A lower ASP shrinks the add-on and can turn stock bought at the old price into a loss. Under negotiation, a $700 negotiated price would pay $742 per dose, and the margin would depend on the manufacturer’s refund arriving on time.
What your practice should do now
- WatchXolairOn the 2028 negotiation list. Its negotiated price is due by November 30, 2026; plan for 106% of it from January 1, 2028.
- WatchThe GLOBE listOmalizumab is classed as an immunological agent; the IL-5 and TSLP drugs as respiratory agents, a class GLOBE does not list. CMS’s quarterly list is the authority.
- WatchNew launchesAll 26 companies promised MFN pricing at launch. Model a new biologic from its first ASP, not its list price.
- Model the margin per drug, per payer: payment, net purchase cost, margin per dose. Rerun it with each quarterly CMS payment file.
- Stress-test a 10% ASP drop. Note which drugs turn negative and how many doses you hold.
- Keep inventory lean on exposed drugs, so little stock is bought at an old price.
- Read your purchase terms. Ask your distributor or purchasing group about price protection and credits on stock on hand.
- Set coinsurance collection for GLOBE ZIP areas before April 1, 2027, to avoid refunds.
- Prepare for negotiated-price refunds in 2028: track Xolair purchases by NDC and invoice, and name who matches refunds to claims.
- Recheck buy and bill against specialty pharmacy for any drug whose math changes; see buy and bill or specialty pharmacy.
Many commercial contracts pay drugs as a percentage of Medicare’s ASP, so an ASP change can reach them too.
MFN legislation: what Congress has and has not done
No MFN bill has become law. Each bill below was referred to committee with no further action as of October 19, 2026.
| Bill | Introduced | What it would do |
|---|---|---|
| S. 1587, Fair Prescription Drug Prices for Americans Act (House: H.R. 3375) | Sen. Hawley with Sen. Welch, May 5, 2025 | Cap US list prices at the average in certain other countries |
| H.R. 3493, Global Fairness in Drug Pricing Act | Rep. Khanna with Reps. Luna, Kaptur and Biggs, May 19, 2025 | Write the executive order’s approach into law |
| H.R. 7837, Most Favored Patient Act of 2026 | Rep. Meuser, March 5, 2026 | Companies without a deal by December 2028 would owe Medicare MFN pricing for five years |
| S. 4355, Drug Deal Disclosure Act | Sen. Wyden, April 21, 2026 | Make HHS release the MFN agreements |
The President’s January 2026 “Great Healthcare Plan” asked Congress to write the deals into law. Until it does, MFN rests on voluntary agreements and the CMS Innovation Center’s authority, which PhRMA’s lawsuit challenges.
Where Medico fits
Our Biologics Management team runs benefit checks, prior authorizations and buy and bill for member practices. Members can model a biologic’s cost and reimbursement in their portal before stocking it, so when an ASP or a negotiated price moves, you see the margin per dose before you reorder.
Medico also pools members’ biologic volume to reach manufacturer rebate tiers, and pays each practice its share every quarter with a one-page statement. If you want to know what MFN, GLOBE or the 2028 negotiated prices do to the biologics you stock, ask us.
3,600+
prescribers in the network
36
states
$9M+
saved by participating practices
Questions and answers
What does MFN mean?
MFN stands for “most favored nation.” In trade, a WTO member must give all members the best tariff terms it gives any one. In drug pricing, it means a US price no higher than the lowest paid in comparable wealthy countries.
Does MFN drug pricing lower what Medicare pays my practice for a biologic?
Not directly, as of October 2026. GLOBE leaves ASP + 6% unchanged and raises Medicare’s share when coinsurance is cut. Payment falls if ASP falls, and for negotiated drugs Medicare pays 106% of the negotiated price from 2028.
What is the GLOBE model, and when does it start?
A mandatory CMS model that bases manufacturer rebates on certain high-spend Part B drugs on prices in 19 countries. It takes effect November 30, 2026, and reduced coinsurance in selected ZIP areas starts April 1, 2027. PhRMA has sued to block it.
Is the GUARD model final?
No. The Part D model was proposed on December 23, 2025, and its final rule has been under White House review since June 15, 2026.
Which allergy and asthma biologics are affected?
Xolair, through Medicare negotiation: from January 1, 2028, Part B pays 106% of its negotiated price. Whether any asthma biologic is in GLOBE depends on its drug class, its spending and its maker’s GENEROUS status; CMS’s quarterly list will say.
What is TrumpRx, and does it matter for buy and bill?
TrumpRx.gov, live since February 5, 2026, lists discounted cash prices for patients buying pharmacy drugs. It does not change how office-administered biologics are bought or billed.
Has Congress passed an MFN law?
No. Bills including S. 1587, H.R. 3493 and H.R. 7837 remain in committee. MFN rests on executive action, voluntary deals and CMS models.
Sources
- 01Executive Order 14297, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients, 90 FR 20749, May 15, 2025
- 02HHS, CMS set most-favored-nation pricing targets, HHS, May 20, 2025
- 03Most Favored Nation (MFN) Model, interim final rule, 85 FR 76180, November 27, 2020
- 04Most Favored Nation (MFN) Model, rescission, 86 FR 73986, December 29, 2021
- 05Fact sheet on the letters to 17 manufacturers, The White House, July 31, 2025
- 06Fact sheet on nine additional manufacturer deals, The White House, August 31, 2026
- 07Fact sheet on the TrumpRx.gov launch, The White House, February 5, 2026
- 08CMS announces participants in the GENEROUS Medicaid model, CMS, September 18, 2026
- 09Proposal to codify MFN drug pricing deals: key details are missing, KFF, January 15, 2026
- 10GLOBE Model final rule, 91 FR 62936, October 2, 2026
- 11GLOBE Model frequently asked questions, CMS Innovation Center
- 12GUARD Model proposed rule, 90 FR 60338, December 23, 2025
- 13The GLOBE final rule: a narrow model that may be a bellwether, Gibson Dunn, October 14, 2026
- 14PhRMA v. Kennedy, Georgetown Health Care Litigation Tracker, updated October 9, 2026
- 15Selected drugs for initial price applicability year 2028, CMS, January 2026
- 16Medicare Drug Price Negotiation Program final guidance, 2028, CMS, September 30, 2025
- 17Manufacturer effectuation of the MFP: draft guidance for 2028, CMS, July 16, 2026
- 1842 CFR 414.904 and 414.804, eCFR
- 19Principles of the trading system, World Trade Organization
- 20Bill records for S. 1587, H.R. 3375, H.R. 3493, H.R. 7837 and S. 4355, Congress.gov