Nationally Recognized Expert in Health Care and Life Sciences, Educator, Regulatory Consultant, Patient Access Advocate, Independent Director, and Retired Sidley Austin Partner
CMS’ “Year 2” IRA Guidance Concedes Agency Patient Engagement Has Been a Bust A number of patient groups have quietly expressed frustration with #CMS’ “listening sessions” on the #InflationReductionAct “fair price” negotiations. If you read CMS’ “year 2” guidance carefully, it effectively admits the patient complaints are real and legitimate. The Complaints: Patient groups sat on the sidelines in the litigation challenging the constitutionality of the IRA, at least in part, because they believed that they could shape IRA implementation through agency engagement. But some groups are now expressing frustration. They expected CMS to explain how it was approaching negotiation and the underlying evaluation of the selected drugs. With that context, they expected to be able to provide meaningful feedback to CMS’ plans and preliminary assessments. According to the groups I have spoken to, that is not how things have gone. CMS is tight-lipped—in “listen only” mode. Unclear what CMS is considering and how it sees the “value” question, “patient interaction” on the IRA has devolved into CMS and patient groups staring at each other blankly. Confirmation: When you read the “year 2” guidance, it confirms the patient complaints. Deploying diplomatic “regulatory speak”, CMS says it “intends to improve upon the design of the patient-focused listening sessions”. Note the reference to “listening sessions”—confirming the agency has been in “listen only” mode. CMS admits the need for change, saying it “is soliciting comments from interested parties on event format, scope, and logistics”; it then indicates it “is considering events where there is discussion among speakers and in which CMS may ask clarifying questions”. But even this proposal isn’t getting to the core of the problem—patient groups shouldn’t have to be expert mind readers regarding CMS’ intent based on a few interspersed “clarifying questions”. CMS offers some other alternatives, too: “CMS is also weighing different event formats, such as round table sessions on broader topics with a mix of speaker types (e.g., patients, providers, and health data experts) or focus groups on targeted topics with one speaker type (e.g., patients or caregivers)”. But all that doesn’t commit CMS to doing any speaking. Just that others—patients, providers, and “experts” will be asked to speak. Patient groups can’t react in, or to, a vacuum. No Time: The guidance concedes that they can’t fix the problem for “year 1”. After all, July 31, 2024 is the deadline for manufacturers of selected drug to accept or reject CMS's final MFP offer. Indeed, CMS acknowledges that its proposed changes in patient engagement will be effective only “for…price…year 2027”. So, in another words, at least for “year 1”, we are going to get “fair prices” that don’t reflect meaningful patient input. #drugdevelopment #drugpricing #Medicare #managedcare #rarediseases #patientsfirst #lifesciences
Health Policy Regulatory and Legislative Expertise; Market Innovator
2moRespectfully I have a more nuanced read. What rules of information have been lifted? What is the risk of material information leaking if CMS was open in even a private meeting? (The rules, liability and risk on that kind of exchange have just gotten higher and higher over the last several decades and I suggest the groups should read what the SEC considers a breach of material information.) I suspect information exchange for instance post a CMS meeting, between a patient group member and a company presents legal risks, especially pharma funded groups. To me CMS is trying to find a workable legal structure to collect information such as a MedCAC like environment.