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Nationally Recognized Expert in Health Care and Life Sciences, Educator, Regulatory Consultant, Patient Access Advocate, Independent Director, and Retired Sidley Austin Partner

#340b Issues Left All Kinds of Fuzzy in the #IRA Draft Guidance Rich Daly’s 340B Report article charts a course through the 340B aspects of the “Year 2” #CMS #Medicare “fair price” guidance. I’m quoted. As Rich’s article explains, the guidance leaves stakeholders with more questions than answers. The article, which is definitively worth a read, makes the following 3 points: 1) There’s no provision for reliably identifying 340B duplicates. The use of 340B identifiers is “voluntary”, meaning that the #MTF data won’t be able to serve as a meaningful “screen” for 340B duplicates. 2) 340B #coveredentities, #contractpharmacies, and other #pharmacies are deeply concerned about the lack of details explaining how they will be paid the “fair price” by manufacturers. Well, manufacturers are equally concerned—in part because of CMS’s repeated threats, sprinkled throughout the guidance document, to subject #drug makers to #enforcement if their payments are inaccurate or untimely. The guidance’s vague and ill-formed provisions increase the enforcement risk, exponentially. 3) The guidance is marred by the agency’s lack of understanding of how distribution and data flows currently operate—and what can and needs to change to effectuate “fair price”. Ignorance and naïveté never lead to clear, dependable guidance. Implications: #Drug makers, if they have not already done so, need to partner ASAP with a contractor to do what the MTF won’t be capable of doing. You can’t rely on the MTF, and you don’t have much time to implement your own solution. One last note: I’ve expressed concerns about the timeline to get the MTF stood up. Comments to this proposed guidance are due July 2. Realistically, to review those comments and to address the gaping holes in the draft guidance, we may not get final guidance until October or November. After that, an RFP and contracting process would follow. This could mean that work would not begin, in a meaningful way, until November or December, with the holidays in full swing. That means just about a year, maybe less, of actual work time to get an MTF designed, implemented, and tested. I’m not saying that’s impossible, but it sure ain’t going to be easy. https://lnkd.in/eXvd2J-X

IRA Draft Guidance Leaves 340B Details Unclear - 340B Report

IRA Draft Guidance Leaves 340B Details Unclear - 340B Report

https://340breport.com

Deborah Williams

Health Policy Regulatory and Legislative Expertise; Market Innovator

2mo

It’s equally important that the systems be beta tested prior to launch. For that they need I think 6 months. And they should ask pharmacies to test them. I found out in the OPPS launch that the people who work on the line submitting claims know more. for example they need to be submitted with the wrong info and see what happens.

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