@rachelsachs.bsky.social
Law professor. Researching and writing about innovation and access to new healthcare technologies, mostly in health law, FDA law, and patent law.
@rachelsachs.bsky.socialThere's a lot to say about this complaint, from arguments about standing to its description of GLOBE as "import[ing] other countries' QALY-based pricing methodology." Looking forward to reading in more detail. www.statnews.com/2026/10/07/p...
@rachelsachs.bsky.socialGetting ready to teach the Medicaid parts of the case next week in Health Law - glad to have this thread to share with my students to validate their confusion!
@rachelsachs.bsky.socialCMS' new exclusions for manufacturers with GENEROUS deals have significantly shrunk the GLOBE model. The proposed rule had an estimate that 54% of non-dual, non-340B Part B FFS spending would've been included in the model. The final rule? Just 3%. public-inspection.federalregister.gov/2026-20281.pdf
@rachelsachs.bsky.socialThe savings to be expected from GLOBE have shrunk dramatically, in CMS's estimation. Compare Table 13 of the proposed rule (estimating $11.9 billion in federal savings) with Table 13 of the final rule (estimating $440 million in federal savings). 3/3
@rachelsachs.bsky.socialAs a reminder, because it is not clear that manufacturers participating in GENEROUS must put all of their drugs into GENEROUS, this raises the possibility of manufacturers being exempt from GLOBE on the basis of putting different drugs into GENEROUS. 2/3
@rachelsachs.bsky.socialA few notes on issues people were waiting for in particular: as anticipated, the final rule states CMS' intention to waive participation in GLOBE for manufacturers participating in GENEROUS (see pp. 427-430 for a fuller discussion). 1/3
@rachelsachs.bsky.socialFor all drug pricing watchers, the final rule for GLOBE (the Medicare Part B international reference pricing model) is now out. Looking forward to reading and analyzing. public-inspection.federalregister.gov/2026-20281.pdf
@adrianna.bsky.socialReposted by @rachelsachs.bsky.socialHave been wondering when we would start to see real numbers out of Nebraska (the only other estimate circulating, of 200 coverage losses in the first month, cites back to a guesstimate from a pre-implementation interview)
@edwincpark.bsky.socialReposted by @rachelsachs.bsky.socialWhite House is expected today to tout its #Medicaid MFN drug pricing agreements under its GENEROUS model. Many key questions remain unanswered: (1) Can Rx companies pick and choose what products to offer? (2) How do MFN prices compare to existing rebates and will states actually see lower Rx costs?
@rachelsachs.bsky.socialHere's a link to a short thread of mine from months ago, referencing the changes to GENEROUS and how they relate to this issue. bsky.app/profile/rach... 2/2
@rachelsachs.bsky.socialFor all drug pricing watchers - confirmation of what many manufacturers have been saying explicitly, but CMS has only suggested. endpoints.news/internal-cms... 1/2
![“Are we OK being explicit about the GLOBE/GUARD exemption as we speak with small and mid-size manufacturers at this point?” Alberts asked in a March 5 email. Alberts is the deputy director at the division of drug innovation at CMS. “Our last update to the [request for applications] heavily suggested that GENEROUS participants would be exempt, but to my knowledge we’ve not said as much publicly yet,” Alberts added.](https://cdn.bsky.app/img/feed_fullsize/plain/did:plc:qmrsn572b6lzkwlcy4kk3w4f/bafkreigirh45vf3axq744vdk6b2ivmiajiwwnzyrd3relhru2kuj5zfch4@jpeg)
@rachelsachs.bsky.socialMust-read thread and article for health policy watchers - this letter from Paul Ginsburg, who was not only involved with MedPAC but also was the first executive director of the prior Physician Payment Review Commission, is particularly striking. www.statnews.com/2026/09/16/m...
@rachelsachs.bsky.socialExcited to see the piece @pzettler.bsky.social and I wrote, Evaluating the Case Against FDA Independence, is now published! Thanks to @medlawdan.bsky.social for organizing such a timely symposium and issue. dc.law.utah.edu/ulr/vol2026/...
@mlbarnett.bsky.socialReposted by @rachelsachs.bsky.socialyikes
"More than two months after WISeR’s launch, a Medicare administration contractor, Noridian, realized that one of the vendors did not know the difference between Medicare Part A and Part B."
@rachelsachs.bsky.socialAnd of course the funding to send the cards was supposed to come from the (not implemented) MFN proposals. www.statnews.com/2020/09/24/s...
@rachelsachs.bsky.socialI suspect this is an argument we'll be hearing more and more - that CMS "should build on a fallback mechanism built into Part D and create a federally facilitated PDP that would be available nationwide," given the ongoing disruptions in the Part D market. www.healthaffairs.org/content/fore...
@rachelsachs.bsky.socialThread. Always glad to work with @reshmagar.bsky.social, @pzettler.bsky.social, and @hollylynchez.bsky.social - our piece on FDA's new single pivotal trial approach is now out in @jamahealthforum.com: jamanetwork.com/journals/jam....
@rachelsachs.bsky.socialNow up at Health Affairs Forefront, @mcarrier.bsky.social and I analyze the FTC's proposed settlements with leading PBMs and explain why, in our view, the settlements will not fully accomplish their stated goals, with special focus on private-label biosimilars. www.healthaffairs.org/content/fore...
@rachelsachs.bsky.socialWe also have even less visibility into the coverage terms CMS is negotiating with the manufacturers - it's difficult to know whether the combination of the price/non-price terms adds challenges for state choices.
@rachelsachs.bsky.socialSources: www.investing.com/news/analyst... (annual Medicaid sales ~$145-147 mill); jamanetwork.com/journals/jam... (2022 Medicare sales of Jakafi alone estimated at $1.49 B after rebates, to say nothing of other products); www.healthaffairs.org/content/fore... (est. higher 2024 Medicare sales). 2/2
