In June, several federal litigations were filed against the Inflation Reduction Act’s “maximum fair price” (MFP) mechanism: Merck filed litigation in D.C., the U.S. Chamber of Commerce in Ohio, Bristol Myers Squibb in New Jersey, and, finally, the National Infusion Center Association (NICA), PhRMA, and the Global Colon Cancer Association jointly filed in Texas.

All of the complaints assert constitutional violations related to Medicare’s new price-setting process, which will fully go into effect for selected Part D drugs in 2026. The first group of Part D drugs to be selected for the mechanism will be announced on September 1, 2023, which will likely trigger another round of litigation by some of the manufacturers of the medications on that list.

CSRO will closely monitor the outcome of these litigations to determine the impact on Part B medications, which will be subject to MFPs starting in 2028. In the meantime, the Centers for Medicare and Medicaid Services issued a revised implementation guidance related to the program at the very end of June, but that guidance does not resolve the constitutional concerns alleged in the complaints, so it is unlikely to have any impact on the litigation.

In its calendar year (CY) 2023 Medicare physician fee schedule (PFS), CMS finalized and implemented section 90004 of the Infrastructure Investment and Jobs Act, which requires manufacturers to provide a refund to CMS for discarded amounts from certain single-dose container or single-use package drugs. To assist with this policy, Medicare providers who administer Part B drugs must append the JZ modifier to indicate there were no discarded amounts.

Since 2017, providers have been required to report the JW modifier on their Part B drug claims to indicate discarded amounts, and that will continue. However, CMS will now require reporting of the JZ modifier to indicate there were no discarded amounts. CMS created a transition period to ease practices into the new modifier requirement: the new JZ modifier will be effective January 1, 2023, but not required until July 1, 2023. A newly published Medicare Learning Network (MLN) article provides more information on the JZ modifier policy.  

Don't miss your chance to advocate alongside CSRO during our Virtual Advocacy Day on July 13!

There is still time for rheumatologists from across the country to register and join us in discussing the Safe Step Act, HELP Copays Act, and Protecting Patients Against PBM Abuses Act with health care leaders from the US Senate and US House of Representatives. 

These live conversations will be held through Zoom on Thursday, July 13 and participants are welcome to attend all or part of the day. Visit our website to view the current speaker schedule, which includes representatives from California, Georgia, Florida, Indiana, Washington, and more, and sign up today.

The All Copays Count Coalition, of which CSRO is a member, has created a letter to educate Congressional Leadership on how important the HELP Copays Act is to patients and practices, as it would prohibit the use of copay accumulators in the Affordable Care Act exchanges.

CSRO encourages your state societies and practices to sign on to this letter and help urge Congress to include this important patient-focused legislation in any PBM reform package. The deadline to sign on to the letter is this Monday, July 10 – review the letter and add your organization's name today.

The National Organization of Rheumatology Management (NORM) is gathering information to gauge the impact of rebate maximizers, accumulators, and alternative funding plans. This data will then be used to help enhance advocacy efforts for both NORM and their non-profit partners, like CSRO. Please consider completing their 15-minute survey.

In its June 2023 report to Congress, the Medicare Payment Advisory Commission (MedPAC) included several recommendations related to Part B drug administration and have potential negative ramifications for rheumatologists.

Read more in the latest edition of Rheum for Action, CSRO's advocacy column produced in partnership with Rheumatology News (PDF available here).

Join us this August in Austin, Texas, for our annual Advocacy Conference featuring Dr. Alex Oshmyansky, Founder and CEO of the Mark Cuban Cost Plus Drug Company. Plus, you won't want to miss our special celebration of CSRO's 20 years of serving as a voice for rheumatology!

Registration closes Monday, July 24 – click here to sign up today.

What's Happening in the States

CSRO tracks legislative activity relevant to the rheumatology community and their patients. Check out the list below to see the status of CSRO priority bills from the past two weeks, and click here to view a full status report.

Be sure to check out our interactive legislative map tool for additional details.

NEVADA 

Non-medical Switching 

• SB 57: Signed by the Governor  

Virtual Advocacy Day: July 13, 2023

Advocate alongside CSRO as we host live conversations with health care leaders from the U.S. Senate and U.S. House of Representatives.

Advocacy Conference: August 25-27, 2023

Join us in Austin for our Advocacy Conference and celebration of our 20th Anniversary! 

Business of Rheumatology: October 4, 2023

Don't miss the third seminar in CSRO's virtual series which will discuss advanced practice providers (APPs) and the workforce. Details and registration coming soon.

Action Center

Use CSRO's convenient online platform to easily find out who your elected officials are and engage with them directly

Advocacy Council

Amplify your voice by assembling with other like-minded individuals to enhance CSRO’s advocacy initiatives.

Legislative Map Tool

Find your state on our interactive map tool to learn about current or proposed policy and ways you can take action to make an impact.

Rheum for Action

Learn about the latest advocacy issues in CSRO's advocacy column produced in partnership with Rheumatology News.

Payer Issues Reporting Form

Request assistance with any payer relation issues that may be impacting your patients or office.

Policy Correspondence

Easily access all of CSRO’s policy letters submitted to payers, state, and federal governments as an informational resource.

CSRO is a 501c3 nonprofit organization that has remained dedicated to ensuring access to the highest quality care since 2003 – donate today.

Questions?

Please visit the CSRO website for other news and updates, and do not hesitate to contact us with any questions at info@csro.info.