For Immediate Release:
Contact: Kelly Broadway, 202-808-8853
[email protected]
Washington, D.C. – The Council for Affordable Health Coverage (CAHC) calls for the Centers for Medicare & Medicaid Services (CMS) to address policies harmful to patients in draft guidance for the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program.
In a comment letter, CAHC focuses on three specific policies that create consequences for vulnerable patients, including those with cancers and rare diseases:
- CMS is aggregating different products to make them subject to drug price controls, likely in violation of the law
- CMS must take steps to make lower prices available to patients at the pharmacy counter through a system that facilitates data and transactions
- The negotiation process should be transparent and accountable to patients and the public
“The Inflation Reduction Act’s drug price negotiation program is shrouded in secrecy and silences the voices of patients,” said Joel White, President of the Council for Affordable Health Coverage. “CMS now has a chance to lift the veil on the decision-making process, hear from cancer and rare disease patients who are the ones most affected by the program. To exclude the public and patients from the conversation is neglectful.”
CAHC believes CMS is creating an overly broad definition for drugs subject to the IRA’s Maximum Fair Price (MFP) by grouping together multiple drug products that should be considered separately. The current draft regulations could lead to a new drug having its price set on the first day it is available to purchase, despite the law stating it must be on the market for seven years before being eligible. The policy will disincentivize research for additional uses for a drug, which will severely hamper finding new treatments for chronic and rare disease patients.
Additionally, CAHC highlights challenges with the set-up and functionality of a payment system where the manufacturer of a drug on the price negotiation list has 14 days to ensure the dispensing pharmacy receives the correct reimbursement amount for the MFP. There is currently not a system to ensure the seamless exchange of data and money. CAHC calls for CMS to take a more prominent role in the implementation of the Medicare Transaction Facilitator (MTF) and to leverage current systems to help ensure prompt payment.
CAHC also called for more transparency, stakeholder engagement, and public feedback in the process for choosing which drugs will be subject to negotiation. Currently, CMS does not disclose how or why specific drugs are chosen. To help manufacturers and the public better understand this process, CMS should release that information. Patients and patient advocacy groups should also be allowed to provide direct insight and feedback to CMS, ensuring that policymakers understand the repercussions and impact on access that their decisions have on the people who need them.
To read CAHC’s complete comments, click here.