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Rachel Sachs

@rachelsachs.bsky.social
4.3K followers 286 following 332 posts

Law professor. Researching and writing about innovation and access to new healthcare technologies, mostly in health law, FDA law, and patent law.

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Rachel Sachs @rachelsachs.bsky.social · 30/09/2026
CMS' 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
The CMS Office of the
Actuary relied on the CMS Innovation Center for a list of drugs that would have been included in
the model in 2024, and we estimate that GLOBE Model drugs would have comprised
approximately 3 percent of non-dual eligible, non-340B OM Part B drug spending for 2024. This
reflects the exclusion of drugs from manufacturers that, at the time of this analysis, we assumed
have signed agreements with CMS to participate in the GENEROUS Model, offering discounts
for drugs provided to Medicaid enrollees.
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Rachel Sachs @rachelsachs.bsky.social · 30/09/2026
A 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
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Rachel Sachs @rachelsachs.bsky.social · 30/09/2026
For 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
public-inspection.federalregister.gov
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Adrianna McIntyre @adrianna.bsky.social · 22/09/2026
Have 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)
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Edwin Park @edwincpark.bsky.social · 18/09/2026
White 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?
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Rachel Sachs @rachelsachs.bsky.social · 17/09/2026
For 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.
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Rachel Sachs @rachelsachs.bsky.social · 16/09/2026
Must-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...
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Rachel Sachs @rachelsachs.bsky.social · 15/09/2026
Excited 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/...
dc.law.utah.edu
Evaluating the Case Against FDA Independence
Many former FDA officials, both politically-appointed leaders and those from the career ranks, as well as numerous FDA scholars have advocated for increased FDA independence in varied forms, and for g...
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Michael L. Barnett @mlbarnett.bsky.social · 15/09/2026
yikes "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." www.statnews.com/2026/09/15/m...
statnews.com
Medicare's AI prior authorization pilot was rushed and full of problems, new documents reveal
The rushed launch of a Medicare pilot to use AI for prior authorization led to delayed care in some instances, new documents reveal.
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Rachel Sachs @rachelsachs.bsky.social · 11/09/2026
I 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...
healthaffairs.org
An Old Idea Whose Time Has Come: Why Medicare Needs A Federal Backstop For Part D | Health Affairs Forefront
Congress required CMS to offer a fallback prescription drug plan when no private PDP was available. Rather than waiting until total market failure, the agency should explore creating a federally facil...
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Rachel Sachs @rachelsachs.bsky.social · 04/09/2026
Thread. 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....
jamanetwork.com
Opportunities and Risks of a Single-Trial Default for FDA Drug Approval
This Viewpoint describes potential concerns and opportunities with a single-trial default for US Food and Drug Administration (FDA) drug approval.
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Rachel Sachs @rachelsachs.bsky.social · 02/09/2026
Now 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...
healthaffairs.org
Analyzing The Federal Trade Commission’s Pharmacy Benefit Manager Settlements | Health Affairs Forefront
Despite the FTC’s promises, its settlements with PBMs will not be fully effective at accomplishing their stated goals. One concern of note: The settlements neglect the recent development of PBMs marke...
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Rachel Sachs @rachelsachs.bsky.social · 01/09/2026
Sarah highlights another important factor in assessing these deals. The agreement seems to allow Incyte to insulate its larger Medicare market entirely (with spending on Jakafi alone in the billions of $ each year) by offering a discount of unknown size w/in its much smaller Medicaid market. 1/2
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Rachel Sachs @rachelsachs.bsky.social · 01/09/2026
This seems to suggest that by putting one product (Jakafi) into GENEROUS (a product that's older (first approved in 2011) and possibly highly rebated under Medicaid already), Incyte expects that itself ("it") and its other products will be exempt from GUARD/GLOBE. Do others read it differently?
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Rachel Sachs @rachelsachs.bsky.social · 31/08/2026
For many years, the annual "year in p/review" articles regarding prescription drug policy I wrote for Health Affairs Forefront had a section focusing on cases before Judge O'Connor. As noted here, Judge O'Connor heard several cases involving the ACA (striking down both the full law & pieces of it).
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Adrianna McIntyre @adrianna.bsky.social · 31/08/2026
Missed this on Friday: HHS staffing is down to a two-decade low. For all the talk of "waste and duplication," gotta wonder what that's going to mean for future outsourcing of essential bureaucratic responsibilities — at a mark-up, of course. www.politico.com/news/2026/08...
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Rachel Sachs @rachelsachs.bsky.social · 27/08/2026
Useful information on how many Part D beneficiaries are getting access to GLP-1s through the Bridge model: "Less than two months in, CVS and Walgreens tell NPR they've each filled around 100,000 such prescriptions." www.npr.org/2026/08/26/n...
npr.org
Drugstores say Medicare's $50 obesity drug program is catching on
The Bridge program, which began July 1, makes some Medicare beneficiaries eligible for obesity drugs for $50 a month. CVS and Walgreens say they've each already filled 100,000 such prescriptions.
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Rachel Sachs @rachelsachs.bsky.social · 11/08/2026
Drug pricing law & policy watchers may want to look at pages 140-142 of today's Medicaid gender-affirming care rule. Particularly those who've tracked efforts to limit Medicaid coverage for other drugs, including accelerated approval products. public-inspection.federalregister.gov/2026-16508.pdf
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Adrianna McIntyre @adrianna.bsky.social · 10/08/2026
Some red states are prohibiting people from attesting to being too sick to meet Medicaid work reqs, meaning people will need to gather medical paperwork to prove frailty — and states will need to be ready to process it quickly and accurately. Both of those are cracks people will slip through.
politico.com
The Trump admin offered sick Medicaid patients a 1-year lifeline. These red states are rejecting it.
Several conservative states will require proof from people who say they're too sick to work.
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KFF @kff.org · 07/08/2026
A change to Medicare’s proposed hospital outpatient rule would reduce spending on 340B drugs while increasing it for other services. The average net effect: A 5.8% decrease for safety-net hospitals and a 7.4% increase for for-profit hospitals. on.kff.org/4fH1rPQ
The KFF bar chart shows the estimated percentages changes for OPPS reimbursement in 2027 based on the type of hospital.
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Larry Levitt @larrylevitt.bsky.social · 30/07/2026
We don't have real-time data showing the number of people uninsured with enhanced ACA premium subsidies expiring, but these reports from hospitals of more patients unable to pay their bills is a pretty good indication of what's happening. @reedabelson.bsky.social www.nytimes.com/2026/07/30/b...
nytimes.com
After Obamacare Cuts, Hospitals Are Treating More Uninsured Patients
More people who lost coverage after congressional Republicans ended enhanced federal subsidies are now seeking care in emergency rooms and unable to pay bills.
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Juliette Cubanski @jcubanski.bsky.social · 28/07/2026
CMS has just announced the agency is ending the Part D premium stabilization demonstration after 2026. The demo provided extra subsidies to Part D stand-alone drug plan sponsors amid uncertainty about the impact on plan bids from the IRA's changes to the Part D benefit. www.cms.gov/files/docume...
cms.gov
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Christina Jewett @by-cjewett.bsky.social · 24/07/2026
NEW: A panel of advisers to the FDA, several of them sellers of experimental peptides, dismissed the concerns of the agency’s scientists on Thursday, voting in favor of allowing broad production of poorly understood peptide treatments. www.nytimes.com/2026/07/23/h...
nytimes.com
A Peptide Showdown: F.D.A. Scientists May Clash With R.F.K.’s Agenda (Gift Article)
Agency scientists are advising against allowing widespread use of several peptide injections. Robert F. Kennedy Jr., the health secretary, has said people should be free to experiment.
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Don Moynihan @donmoyn.bsky.social · 21/07/2026
This is the first main part of the One Big Beautiful Bill Act kicking in. The second part, restricting Medicaid, is timed to happen after the midterms.
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Rachel Sachs @rachelsachs.bsky.social · 17/07/2026
Really excited to read this piece from CBO staff illustrating their thoughtful approach to these questions of nonfinancial factors that mediate insurance uptake. 1/2
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Rachel Sachs @rachelsachs.bsky.social · 16/07/2026
CMS has now published a draft guidance document focusing on pharmaceutical manufacturer effectuation of the Medicare Drug Price Negotiation Program negotiated prices within Part B for 2028. www.cms.gov/newsroom/fac... (guidance and fact sheet linked from press release)
cms.gov
Manufacturer Effectuation of MFP Draft Guidance for 2028 Medicare Drug Price Negotiation | CMS
Medicare Drug Price Negotiation Program: Draft Guidance for Manufacturer Effectuation of the Maximum Fair Price in 2028
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Rachel Sachs @rachelsachs.bsky.social · 14/07/2026
This piece, by HHS Secretary Kennedy and CMS Admin. Oz, is quite a read for many reasons. It's particularly worth reading for those who recall the first Trump Administration's choice not to defend the constitutionality of the ACA in the lawsuit brought by Texas. www.wsj.com/opinion/were... 1/2
wsj.com
Opinion | We’re Defending ObamaCare From Lawfare
Democracy Forward keeps filing lawsuits seeking subsidies the law doesn’t allow.
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Rachel Sachs @rachelsachs.bsky.social · 06/07/2026
"Industry analysts and hospital groups pointed out that cutting Medicare payments for 340B drugs while increasing nondrug payments is effectively a monetary transfer from nonprofit hospitals to for-profit hospitals." www.statnews.com/2026/07/02/m...
statnews.com
Medicare takes another swing at 340B cuts to hospitals
Reducing Medicare payments for 340B drugs is the latest proposal focused on the hotly debated drug discount program.
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Scott Hulver @scotthulver.bsky.social · 02/07/2026
CMS is proposing to lower Medicare reimbursement for 340B drugs by almost $5 billion in CY2027. Because the proposal is budget neutral, those $5 billion will be redistributed to all hospitals through higher payments for non-drug outpatient services.
public-inspection.federalregister.gov
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Rachel Sachs @rachelsachs.bsky.social · 02/07/2026
For others watching ongoing developments in the 340B program, the 2027 OPPS proposed rule just came out, and unsurprisingly the Trump Administration is aiming to bring back its efforts to reduce reimbursement rates for 340B drugs. public-inspection.federalregister.gov/2026-13656.pdf 1/2
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Rachel Sachs @rachelsachs.bsky.social · 24/06/2026
Today in @jama.com, Kristi Martin and I discuss the Trump Administration's Bridge demonstration to expand seniors' access to GLP-1 products, scheduled to take effect next Wednesday. Our piece is focused on the policy, operational, and financing issues involved. jamanetwork.com/journals/jam... 1/2
jamanetwork.com
CMS’ GLP-1 Bridge Demonstration
This Viewpoint discusses the US Centers for Medicare & Medicaid Services’ (CMS) extension of the Medicare Glucagon-Like Peptide-1 (GLP-1) Bridge and outlines unanswered questions related to how th...
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Rachel Sachs @rachelsachs.bsky.social · 24/06/2026
Now up at Health Affairs Forefront, Kristi Martin and I analyze the proposed rule for the 2029 cycle of the Medicare Drug Price Negotiation Program. This is the first rulemaking for the program, an important procedural milestone (after 3 cycles of guidance). www.healthaffairs.org/content/fore...
healthaffairs.org
Administration Releases Medicare Drug Price Negotiation Program Proposed Rule For 2029 | Health Affairs Forefront
The proposed changes are relatively modest, yet they represent an important procedural step forward in the implementation of the Medicare Drug Price Negotiation Program.
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Rachel Sachs @rachelsachs.bsky.social · 24/06/2026
"Jonsson said Lilly would seek reimbursed prices that were consistent with the company's interpretation of the MFN framework." Because pharma companies' "deals" with the Trump Admin have not been made public, it's not clear what the companies have agreed to do. www.reuters.com/business/hea...
reuters.com
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Rachel Sachs @rachelsachs.bsky.social · 16/06/2026
Of note, the review website currently says that there is a statutory legal deadline to finalize this model. The website's review of the proposed rule, however, said there was no such deadline. www.reginfo.gov/public/do/eo...
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Rachel Sachs @rachelsachs.bsky.social · 16/06/2026
For those who haven't seen it yet, the final rule for GUARD is now at OMB. Given that Part D plan bids/designs have already been submitted for 2027, the timing is tight to meet CMMI's proposed 2027 implementation schedule (with the August update window). www.reginfo.gov/public/do/eo... 1/2
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Rachel Sachs @rachelsachs.bsky.social · 12/06/2026
The Medicare drug price negotiation proposed rule is now out. It's a lengthy (434 page) document, but upon first look it appears CMS is proposing a route-of-administration related addition to the combination drug policy. public-inspection.federalregister.gov/2026-12059.pdf
public-inspection.federalregister.gov
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Rachel Sachs @rachelsachs.bsky.social · 12/06/2026
Looking forward to reading the proposed rule for the Medicare drug price negotiation program upon its release. As a reminder, key policy issues to watch for this cycle include (but are not limited to) CMS's analysis of combination drugs and effectuation of the MFP for 2028. 1/2
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Rachel Sachs @rachelsachs.bsky.social · 09/06/2026
The 2026 Medicare Trustees Report is now out. Looking forward to reading more closely - lots of implications for prescription drug spending and policy in Parts B/D. www.cms.gov/oact/tr/2026
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Rachel Sachs @rachelsachs.bsky.social · 03/06/2026
In reading more about OMB's federal funding proposed rule, it's hard to avoid this quote, from @jtimmer.bsky.social: "If you wanted to cripple science research and were disappointed that Congress continued to fund it, this is the sort of document you would produce." arstechnica.com/science/2026...
arstechnica.com
Proposed new US funding rules: We can cancel any grant at any time
Peer review now optional, political staff would screen grants for forbidden topics.
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Rachel Sachs @rachelsachs.bsky.social · 01/06/2026
ICYMI, thread - key issues to look for with the release of the Medicaid work requirement IFR, expected this afternoon.
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Adrianna McIntyre @adrianna.bsky.social · 01/06/2026
Great story from over the weekend on how states — red and blue — are struggling with the costs of rushing to stand up work requirements. These concerns could get worse if the IFR (expected this afternoon) includes "surprises" that contradict implementation choices states have already made
politico.com
States balk at the high price of Medicaid work requirements amid budget crunch
States dealing with budget shortfalls are facing tens of millions of dollars in new costs ahead of the federal Jan. 1 deadline.
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Rachel Sachs @rachelsachs.bsky.social · 08/05/2026
Now up at Health Affairs Forefront, @michaelannica.bsky.social and I analyze CMS's proposed rule regarding prior authorization for prescription drugs, contextualizing it as an extension of the 2024 prior auth rule and considering its broader implications. www.healthaffairs.org/content/fore...
healthaffairs.org
Understanding CMS’s Proposed Rule Regarding Prior Authorization For Drugs | Health Affairs Forefront
The proposed rule aims to improve prior authorization for prescription drugs by establishing and requiring electronic prior authorization, setting coverage decision deadlines, and promoting transparen...
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Rachel Sachs @rachelsachs.bsky.social · 02/05/2026
Out now in @nejm.org, @lucamaini.bsky.social, @michaelannica.bsky.social, Pragya Kakani, and I analyze the opportunities and challenges associated with GENEROUS, the Trump Admin's most-favored-nation drug pricing model in Medicaid. www.nejm.org/doi/full/10....
nejm.org
Medicaid’s GENEROUS Most-Favored-Nation Pricing Model — Promise and Limitations | NEJM
A new pilot Medicaid program — GENEROUS — combines centralized pharmaceutical-coverage negotiations with most-favored-nation pricing in an effort to lower drug costs, but it has some limitations.
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Rachel Sachs @rachelsachs.bsky.social · 24/04/2026
For those following the drug pricing deals, the WH fact sheet about Regeneron includes a limitation not present in the fact sheets about other deals: that Medicaid will get MFN prices on "new" products. Assuming this addition is intentional, what does it mean? www.whitehouse.gov/fact-sheets/... 1/2
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Pam Herd @pamherd.bsky.social · 22/04/2026
The number of NIH competitive awards is down 50% from 2025, and down ~70% from prior years. Even if they catch up by the end of the year, only wealthy institutions can bridge these huge funding gaps.They're killing science-and violating the constitution-by weaponizing the bureaucracy
figure showing the trends I detail in the tweet text
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Rachel Sachs @rachelsachs.bsky.social · 21/04/2026
CMS also has not published projections of how costly it expects the Bridge program to be, especially if it's running through 2027 rather than only in 2026. 1/2
cbo.gov
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Juliette Cubanski @jcubanski.bsky.social · 21/04/2026
CMS has just announced that the BALANCE program for GLP-1 coverage will not launch in Medicare Part D in 2027 and the BRIDGE program will be extended through 2027 (it was set to run from July-Dec 2026). This could add billions to Medicare spending in 2027. www.kff.org/quick-take/w...
kff.org
What Medicare's Temporary Program Covering GLP-1s for Obesity Means for Beneficiaries
CMS’s efforts to expand Medicare coverage of GLP-1s for obesity could provide substantial benefits to millions of Medicare beneficiaries, given the potential demand for these highly effective medicati...
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Juliette Cubanski @jcubanski.bsky.social · 20/04/2026
Today, April 20, is the deadline for Medicare Part D plans to apply to participate in the BALANCE model for Medicare coverage of GLP-1 obesity drugs. Without robust plan participation, the model will not move forward in 2027. See our @kff.org brief for details. www.kff.org/medicare/wha...
kff.org
What to Know About the BALANCE Model for GLP-1s in Medicare and Medicaid | KFF
This brief describes current coverage of GLP-1s in Medicare and Medicaid, the Centers for Medicare & Medicaid Services’ (CMS) efforts to expand access and lower costs for GLP-1s through temporary demo...
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Daniel Payne @danielpayne.bsky.social · 18/04/2026
Illuminating detail on how (at least some) health policymaking is done in the Trump administration:
A screenshot of story text that says:

Trump said he was called by influential podcaster Joe Rogan and people who had taken psychedelics, who joined him at the signing ceremony, about the need to open access to the drugs.

Rogan said he texted Trump about research around ibogaine, and the president’s response was quick: “Sounds great. Do you want FDA approval? Let’s do it.”
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Rachel Sachs @rachelsachs.bsky.social · 18/04/2026
FDA leadership has pushed back against concerns from outside observers about the politicization of FDA's new Commissioner's National Priority Voucher program. Today, the President ordered that FDA "shall provide" such vouchers to certain psychedelic drugs. 1/2 www.whitehouse.gov/presidential...
whitehouse.gov
Accelerating Medical Treatments for Serious Mental Illness
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered: Section 1.  Purpose and
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