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What Is the Most Favored Nation Model? And Why Is It Scary For Lupus Patients?


"This issue of CMS enacting the Most Favored Nation Model is a big problem. It will have devastating consequences for our senior population on Medicare. Patients are terrified. I'm sorry that instead of lowering drug prices for the general public, they're implementing this instead. Rheumatology and oncology will be groups most affected by these changes." - Dr. Lauren Kim, Rheumatologist

After receiving a 3 page letter from my rheumatologists office stating there may be an interruption with my care due to the new MFN model - I decided to research this law. Through my studies, I have learned of the dangerous impact it could have on the lupus community and beyond. Here is a breakdown of the "Most Favored Nation Model" and why it is scary for lupus patients and risky for our healthcare systems.


What is the Most Favored Nation Model legislation?

The Centers for Medicare and Medicaid services (CMS for short) is set to enact the MANDATORY "Most Favored Nation Model" after the temporary restraining orders, and injunctions issued by Court Judge Catherine Blake and American Hospital Association (to name a few) expire on January 20th. This seven year model was designed in hopes of lowering drug prices for the general population by lowering the reimbursements given to doctors, infusion centers, and hospitals for specialized medications, including biologics.


However, instead of holding drug companies accountable and lowering drug prices (which are significantly higher in the US than other parts of the world) the model slashes payments to hospitals, infusion centers, and private practices for the drugs they purchase for their patients. Unfortunately, the 50 medications included in the model affect primarily rheumatology and oncology patients with moderate to severe disease activity.



The Push Problem:

The aim of the model is for Medicare administrators to push drug companies to lower their prices. The people behind this bill know that physicians, infusion centers, and hospitals won't purchase medications they cannot afford, and their hope is the pressure will force manufacturers to drop prices quickly.


Because of this new policy, doctors offices and infusion centers across American are unsure if they will be able to cover the cost of life-saving biologic medications for their patients with lupus, RA, lymphoma, leukemia, macular degeneration, and other serious conditions. This is frightening to doctors across the nation, as Dr. Don Thomas, author of the Lupus Encyclopedia states, “It is horrible for patients. No doctor will be able to afford to administer these medications (we would have to pay much more for them than what CMS would cover). Therefore, it is the patients who will get hurt.”


Who Does This Affect:

"It could have a big impact on the lupus community if the drugs used to treat lupus are included in the MFN Model." - Dr. Daniel Monson, Lupus Research Program, DOD, CDMRP

Participation in the MFN Model is mandatory for Medicare-participating providers and suppliers that submit a claim for a drug that is a MFN Model drug provided to a MFN beneficiary. As mentioned above, there are 50 medications affected by this ruling. The medications used to treat rheumatological conditions such as lupus and RA that are affected by the MFN include:

  • Rituxan (Rituximab)

  • Actemra (Tocilizumab)

  • Cimzia (Certolizumab)

  • Orencia (Abatacept)

  • Simponi Aria (Golimumab)

  • Prolia (Denosumab)

  • Orthovisc (Hyaluronic acid)

If you have lupus, RA, or osteoarthritis, there are several medications on this list to be concerned about. For instance, Prolia, which is used to treat osteoporosis, is especially worrisome. Reason being, if a patient is not able to access their medication, they can develop rapid bone loss in 1-2 months and be at risk for multiple fractures without it. And If you have the unfortunate circumstance of managing lupus, RA, AND cancer, you are in for triple the trouble. Many of the biologics on the list are used to treat various forms of cancer, including lymphoma and leukemia.


Furthermore, unless the new administration makes changes to the MFN model, the financial impact that this will have on doctors offices, hospitals, and infusion centers will have a significant ripple effect on their sustainability, potentially forcing practitioners to cut back on staff and operating hours.


Eventually the poorly constructed MFN Model may affect EVERYONE.


Updates On The Legislation:

The MFN Model was supposed to become effective on January first; however, there was a temporary restraining order issued by US District Court Judge Catherine Blake placed a few days before Christmas. The two week order expired this week, then was issued an extension until January 20th. In addition to that, multiple lawsuits and injunctions have been filed, including one from the American Hospital Association. In fact, here is what they had to say about the model:

Hospitals and health systems have very deep concerns about the substance and legality of this model, and the AHA filed a Declaration with this lawsuit expressing how the model could negatively impact hospitals, health systems and the patients they care for." -Tom Nickels, AHA Executive Vice President

Because of the news coverage with the Capitol breach, the transition of power, and COVID, it is very difficult to get any sort of updates on this model this week. However, I have heard from a few reliable doctors offices that there is a chance it may be delayed an additional 60 days. If that be the case, there is hope that President Elect Biden will throw it out once in office.



What Can We Do About It?

On behalf of the 1.5 million Americans who live with lupus, and the more than 50 million people covered by the Medicare and Medicaid programs, we are asking that you please copy and paste the letter below and join our call of action to have this model withdrawn. We cannot hurt one population to help another. It is unethical and unamerican. Yes, we need to continue to fight for lower drug prices, but not this way. Because the patients are going to suffer. In fact, I have already heard that patients have had their infusions cancelled for January in anticipation of these changes.


Most Favored Nation Model Advocacy Letter:

Hello Community Health Supporter,
The CMS is set to enact President Trump's MANDATORY "Most Favored Nation Model" after the temporary restraining order issued by US District Court Judge Catherine Blake expires on January 20th. Because of this new policy, doctors offices and infusion centers across American are unsure if they will be able to cover the cost of life-saving medications for their patients with lupus, RA, lymphoma, leukemia, macular degeneration, and other serious conditions.
This model changes the way Medicare reimburses hospitals, doctors offices, and infusion centers for the medications they buy to administer to their patients. Medicare administrators are aiming to force drug companies to lower their prices. The people behind this bill know that physicians, infusion centers, and hospitals won't purchase medications they cannot afford, and their hope is the pressure will force manufacturers to drop prices quickly.
What does this mean for those on Medicare and Medicaid who need infusions and injections in the doctor's office? I don’t want to be an alarmist, but there is no other way to say it - if they are on Medicare and Medicaid, there is a high possibility they will lose access to their life-saving medications. I have already heard from lupus patients who have had their infusions cancelled in January by their infusion centers. And this is not just affecting rheumatology patients, this is affecting oncology patients as well as well as other patients with serious conditions that take biologics or one of the other 50 medications being affected by this law. Furthermore, unless the new administration makes changes to the MFN model, the financial impact that this will have on doctors offices, hospitals, and infusion centers will have a significant ripple effect on their sustainability, potentially forcing practitioners to cut back on staff and operating hours.
Eventually the poorly constructed MFN Model may affect EVERYONE.
On behalf of the 1.5 million Americans who live with lupus, and the more than 50 million people covered by the Medicare and Medicaid programs, we are asking that you please share this letter and join our call of action to have this model withdrawn. We cannot hurt one population to help another. It is unethical and unamerican.
Please contact me at your earliest convenience to discuss this further.
Respectfully,
Lupus Patient Advocate

As patients, it is imperative to be proactive and make our voices heard. Please copy and paste and send to your national representatives. Or, leave a public comment here. Please include in your comments what effects losing access to your treatments will have.


Thank you for your partnership in shining a light on this issue!


Kelli Roseta, Creator, More Than Lupus



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