Fauzea succinctly describes the complicated and contradictory aspects of the Centers for Medicare & Medicaid Services' Final Rule on Best Price, a.k.a. the Medicaid copay accumulator rule. She then outlines how the rule, if implemented, is likely to hurt patients.
For information about the Best Price Rule and how CoverMyMeds can help identify solutions, contact them at: InfoBP@mckesson.com. To learn more about solutions to help patients access, afford and adhere to their medications, read CoverMyMeds’ 2022 Medication Access Report.
Read on for Fauzea’s insights.
How the Medicaid Copay Accumulator Rule Will Hurt Prescription Affordability
By Fauzea Hussain, Vice President of Public Policy, McKesson
Half of all patients surveyed in the 2022 Medication Access Report said they made sacrifices related to their medications and essential items, an increase over 2020. Eighty-four percent had to delay or skip healthcare visits. And two-thirds said they experienced an increase in anxiety, depression and/or insomnia.
And yet, patient support leaders are “deeply concerned about the patient harm” right around the corner—particularly for “minorities and those with rare, life-threatening or complex chronic conditions.” Should the Centers for Medicare & Medicaid Services (CMS) Final Rule on Best Price go into effect on January 1, 2023, as it currently stands, patient support leaders fear patients will no longer be able to afford the medications they need to live healthier lives.
In the meantime, several legal challenges to the rule hang in the balance. The Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit challenging the rule in May 2021. On January 4, 2022, McKesson filed an amicus brief in support of PhRMA's position. Another copay program provider has done similarly.
The clock, meanwhile, continues to countdown toward 2023.
WHY THE CURRENT BEST PRICE RULE WON’T WORK
Manufacturers provide financial support to help patients get on and stay on medications. But when plans and their pharmacy benefit managers (PBMs) “accumulate” those funds, they don’t return or repay any of the funds to the manufacturers that provided them. Nor do they use the accumulated amounts to reduce patient cost-sharing. Instead, plans and their PBMs use those accumulated funds to generate savings for themselves. As CMS explained when it revised the Best Price Rule, PBM accumulator programs “result in the health plan delaying the application of its plan benefit to the patient to the detriment of the patient or consumer, thus generating savings for the plan.”
We appreciate CMS’ intent with its revision to the Best Price Rule. They want to preserve biopharma manufacturer-sponsored patient assistance while making sure plans and their PBMs count that assistance toward the patients meeting their deductibles and out-of-pocket maximums. Unfortunately, many aspects of the Best Price Rule as revised will do just the opposite — making it more difficult for these drug savings to be passed on to the patients who rely on them.
Here's why.
Under the revised rule, manufacturers must make sure health plans and their PBMs count patient copay assistance toward the patients meeting their deductibles or maximum out-of-pocket expenses. If a manufacturer fails to do so, even once, the manufacturer may face severe financial consequences. To make sure there’s no PBM accumulator program behind a particular prescription transaction, manufacturers must, at a minimum, have complete and timely visibility into every instance where PBM copay accumulator programs apply.
This is not possible for several reasons.
Nearly all prescription transactions occur through the electronic prescription claims-processing infrastructure, which run on NCPDP standards. There’s no field in the NCPDP data set to report whether a plan uses a PBM accumulator program for a given prescription transaction. Thus, there’s no way for a manufacturer or a manufacturer’s broker to receive timely information confirming whether a PBM accumulator program applies.
Additionally, adding such fields to the NCPDP standard before the Best Price Rule goes into effect isn’t possible. As a HIPAA-named standard, it can take years for NCPDP workgroups to review, approve and ratify them, and for pharmacy systems to code to the new standard. Furthermore, once these standards are approved, they would then require rulemaking from the Department of Health and Human Services, which is another lengthy process—one that hasn’t even begun yet.
Even if such fields already existed, there are additional barriers. CMS expressly permitted plans and their PBMs to withhold the very information it stressed manufacturers must obtain to comply with the rule. Health plans and their PBMs aren’t required to disclose proprietary information about their benefit designs, in this case, copay accumulator programs. CMS also didn’t provide any guidance on what’s considered proprietary versus what must be disclosed.
In other words, plans and their PBMs can unilaterally withhold information about their accumulator programs, leaving manufacturers without the information they need to avoid a Best Price Rule violation. And even if manufacturers had that information, that would still mean less patient assistance.
As McKesson noted in its brief, “CMS effectively made compliance with its own rule impossible.”
WHAT’S NEXT?
Should the Best Price Rule go into effect, many manufacturers could opt instead to reduce or eliminate their patient assistance programs, leaving fewer patients able to afford their medications.
As an alternative, CMS suggested manufacturers limit the ability of PBM accumulator programs to see the copay assistance. To do this, biopharma would provide patient assistance funds outside of the electronic prescription claims-processing infrastructure.
This pathway could prove challenging for patients. McKesson noted in its brief that patients turn to patient-assistance programs because they can’t afford the cost-sharing obligations for their prescription medications. This cost-sharing approach, which shifts point-of-sale savings to after-sale reimbursements, could cost many patients thousands of dollars a year.
Additionally, this approach can be defeated if a plan requires its patients to disclose manufacturers’ patient assistance and then excludes that assistance from deductibles and out-of-pocket maximums. CMS’s alternative approach could also impact the industry’s ongoing efforts to leverage the electronic claims-processing infrastructure to identify and prevent Medicare Part D beneficiaries from receiving assistance.
So where does this leave patients? Without innovations both inside and out of the existing copay assistance channels, manufacturers will be at risk of significant financial penalties, which could lead them to reduce financial assistance programs or eliminate them altogether.
We’re committed to supporting patients in their journeys to afford the medications they need. The question now becomes: Who will join us?
While we wait for answers, we’re hopeful the courts will overturn this rule and help us all overcome this challenge. So much hangs in the balance for patients.
For information about the Best Price Rule and how we can help identify solutions, contact us at: InfoBP@mckesson.com. To learn more about solutions to help patients access, afford and adhere to their medications, read our 2022 Medication Access Report.
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