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01/12/2021

Where Do We Stand with The Most Favored Nation Model Implementation

UPDATE AS OF JANUARY 12, 2021

What happens after the 14-day temporary injunction from the Maryland lawsuit against CMS implementing the MFN? 

While the Maryland injunction was extended until January 20th, a second case was filed. The U.S. District Court for the Northern District of California issued a nationwide preliminary injunction blocking implementation of the Most Favored Nation (MFN) Model. The decision prevents the Centers for Medicare & Medicaid Services (CMS) from implementing the MFN Model until the agency completes the notice and comment procedures required by the Administrative Procedure Act, which requires CMS to solicit comments on a proposal and respond to those comments before finalizing any rules implementing a new payment model.

This is VERY good news and delays implementation for some time and possibly, forever.  The incoming Biden administration will have time to review and respond to both cases.

The public can now post comments on the Most Favored Nation Rule Document webpage. Click the ‘Comment Now” button in the upper right-hand side of the screen. If you have questions, please direct them to MFN@cms.hhs.gov. The public comment period on the MFN Model interim final rule ends on Tuesday, January 26, 2021.

UPDATE AS OF DECEMBER 23, 2020

Today, a federal court issued a temporary restraining order (TRO) blocking the Center for Medicare & Medicaid Services from implementing its Most Favored Nation (MFN) Interim Final Rule on January 1, 2021.

This TRO allows time for the court to hear arguments on permanently blocking the rule. In the meantime, three other cases challenging the rule have been filed in different courts and may be decided in the next few weeks.

If implemented, the MFN Interim Final Rule will radically change and lower reimbursement for almost all cancer practices and programs.

For more information on this ongoing litigation, please visit the Most Favored Nation Drug Pricing Model Page on the ACCC website.

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CMS released the Most Favored Nation Model pricing that replaces the current reimbursement for 50 drugs with a significantly lower reimbursement on every single drug. 

This new reimbursement is now at a level that is most likely less than the actual cost of the drugs.

Below you will find the information from CMS

MFN Pricing Released

The MFN Model Drug HCPCS Codes List and MFN Model Drug Pricing File will be updated on a quarterly basis.

For more information:  https://innovation.cms.gov/innovation-models/most-favored-nation-model

For questions regarding the MFN Model, please email: MFN@cms.hhs.gov.

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For your convenience, MSHO has created a spreadsheet comparing the MFN reimbursement to the ASP +6% reimbursement CLICK HERE.  Keep in mind, for most of the codes, the negative number reflects the HCPCS unit, not the entire dose the patient will receive, so the actual impact is MUCH worse.

MSHO has submitted comments to CMS opposing the interim rule and encourages you to do the same! ACT NOW

ACCC, COA, and others have filed lawsuits to stop this for occurring but at this moment, this new pricing model is to begin on January 1, 2021.   

ASH joined dozens of other patient and provider organizations in a letter to Congressional leaders to oppose the Most Favored Nation Model. The letter, led by the Part B Access for Seniors and Physicians (ASP), highlights the potential harm this model could cause for Medicare beneficiaries. ASH is sending an additional letter to the Centers for Medicare and Medicaid Services (CMS) ahead of January 1 to express the Society’s extreme concern on the impact this model could have on Medicare beneficiary access to drugs and the potential impact on community hematology/oncology practices, which may not be able to withstand the financial impact. 

ASCO took steps to stop Most Favored Nation Model in Amicus Curiae Brief and submits comments to CMS. The analysis reflected in the amicus brief shows dire consequences for people with cancer under the MFN Model. CMS projects that the model will cause 19% of beneficiaries to lose access to its 50 targeted drugs, 38 of which are used in cancer treatment

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