CMS foreshadows reimbursement actions/ GARDP’s 5-year plan / WHO toolkit / UK AMR Review update

Dear All,

Today’s topics all share the theme of Less Talk, More Action! Here we go…

First up … news from the US. I’ve written before about tweets from US CMS (Centers for Medicare and Medicare Services) administrator Seema Verma (link) on the need for changes in antibiotic reimbursement as well as the very concrete steps taken in CMS’s IPPS FY2020 Final Rule to recognize the overall cost of managing drug-resistant infections and pay appropriately for novel antibiotics (link). Note: If you’ve not read the second blog in detail, now would be a good time to do so … it summarizes some new and very important fundamental ideas on how Medicare will change its payment approach for hospital antibiotics. And as reminder, comments are due soon to CMS on the IPPS FY2021 rule: the proposed rule will be published in late April 2020.  

On 6 Nov, Administrator Verma is back with an editorial in STAT (link). You should read the full article, but here are a few excerpts to give you a flavor:

  • “Thousands of deaths every year are attributed to drug-resistant microbes, as well as billions of dollars in health expenditures.
  • “The business model for developing new antibiotics is fundamentally broken:
    • “Antibiotics for drug-resistant bacteria are meant to be used as a last resort, but no one wants to develop drugs that will rarely be prescribed.
    • “Unless we act now to address the financial barriers to drug development, doctors will be powerless to fight off the drastically increasing number of cases of antimicrobial resistance.
  • “In the short-term … first, she reviews the IPPS FY2020 changes. Then she continues with…
  • “We’re also committed to scaling up antibiotic stewardship protocols
  • “In the long-term, CMS will lead a broader effort to modernize Medicare’s payment systems for antibiotics and other endangered innovations.
  • “By removing regulatory roadblocks and reimagining financial incentives, we can fire up the engine of American innovation to arm our doctors for their battle against drug-resistant bacteria.”

Read that next-to-last bullet again: “CMS … the world’s largest antibiotic purchaser… will lead a broader effort to modernize Medicare’s payment systems for antibiotics and other endangered innovations.”

And, you can hear her say this in person via a YouTube video from a recent Milken Institute workshop! Go to this link and then scroll to just past minute 15. There’s not a lot of detail yet, but this level of attention to the AMR problem is marvelous news!

Second, we have strong actions on the global stage:

  • GARDP has announced (link) its ambitious 5-year strategic plan to deliver by 2025 on 5 objectives spanning serious bacterial infections, neonatal sepsis, pediatric infections, and sexually transmitted diseases.
  • WHO has published (link) its “Practical Toolkit: Antimicrobial Stewardship Programmes in Health-Care Facilities in Low- and Middle-Income Countries.” The title says it all on this one … it’s a practical road map for program implementation.
  • A follow-up report (link) authored by Chatham House on progress vs. the goals set out by the UK AMR Review highlights areas where we are still struggling to make progress (e.g., lack of infrastructure changes, lack of control of over-the-counter antibiotics) and summarizes the obstacles that need to be overcome.

Finally, be sure to review the forward meeting list … there is a new listing for a Gordon Research Conference and for a Duke-Margolis workshop.

All action in the right direction! Best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future:

Upcoming meetings of interest to the AMR community:

  • 12-19 Nov 2019 (cyberspace): CARB-X Funding Round 4 is open for Expressions of Interest (EOIs). Go here for details. This round is limited to new classes and/or new targets in early development phases (hit-to-lead through Phase 1) targeting a specific list of Gram-negative pathogens (see link, but in brief is Carbapenem-resistant AbauPae, E’bacteriaceae as well as FQ-R Salmonella, Shigella, and Neisseria.
  • 14-15 Nov 2019 (Hamilton, Ontario): “Fueling the Fight Against Antimicrobial Resistance”, a 2-day Gairdner Foundation-sponsored symposium in collaboration with the Michael G. DeGroote Institute for Infectious Disease Research and the David Braley Centre for Antibiotic Discovery at McMaster University. Go here for details.
  • 18-19 Nov 2019 (FDA, White Oak Campus): FDA-IDSA-NIAID-Pew-sponsored workshop: “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States.” Register here.
  • 19 Nov 2019 (London): BSAC seminar entitled “Into clinical practice: Meeting the challenges of Gram-negative infection management”. A one-day conference on treatments for Gram-negative infections. Go here for details.
  • 26 Nov 2019 (webinar, 9:30-11:00 CET): REVIVE webinar entitled “Innovation in point-of-care diagnostics for sepsis and bloodstream infections.” Go here to register.
  • 28-29 Nov 2019 (Birmingham, UK): BSAC workshop entitled “ARM (Antibiotic Resistance & Mechanisms)”. This meeting is a research forum for UK-based researchers at all levels, including PhD students and technicians. Go here for details.
  • 5 Dec 2019 (Monthey, Switzerland): The BioArk technology park is holding a one-day workshop on AMR. Entitled “The Ark Life Sciences Series #1”, you can get more details here.
  • 16-18 Dec 2019 (Bangkok, Thailand): 3rd International Symposium on Alternatives to Antibiotics in Animal Production. Go here for details:
  • [NEW] 16 Jan 2020 (Washington, DC): Duke-Margolis meeting entitled (approximately) “improving Payment Policies for Antibiotics.” This meeting will run 10:30am – 4:30pm ET, details to follow.
  • 21 Jan 2020 (London): BSAC’s 2nd Antimicrobial Chemotherapy Conference – An ABC for everyone involved in developing new antimicrobials. Go here for details.
  • 20 Feb 2020 (London, UK): Westminster Health Forum conference entitled “Antimicrobial resistance – coordinating a global response and progress on the UK strategy.” Go here for details.
  • 26-27 Feb 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): GRC on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Go here for details.
  • 12-13 Mar 2020 (Basel, I’m told): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Final location is TBD, details will appear here, and you should mark your calendar now. 
  • 16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details. 
  • 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
  • 25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • [NEW] 27-28 Jun 2020 (Bryant University, Rhode Island): Drug Resistance Gordon Research Seminar entitled “Mechanisms and Approaches to Overcoming Drug Resistance in Cancer, Infectious Disease and Agriculture” for graduate students and postdoctoral scientists. Go here for details … this immediately precedes the GRC listed just next
  • [NEW] 28 Jun-3 Jul 2020 (Bryant University, Rhode Island): Gordon Research Conference (GRC) entitled “Strategies to Disrupt Drug Resistance in Infectious Disease, Cancer and Agriculture.” Go here for details.
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)
  • 1-4 Sep 2020 (Dublin): Annual ASM-ESCMID Conference on Antibiotic Development #5! Mark your calendar now and go here for details.
  • 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.


17 April 2023: FREE Masterclass from FDA / CARB-X wants you!

Dear All, Two quick items today. First, FDA have announced an Antimicrobial Drugs Advisory Committee on 17 April 2023 (9a-4.30p ET). The committee will “discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The Applicant’s proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and

WHO 2023 Pipeline Update: Share Your Preclinical Antibacterial Projects!

Dear All, As you know, WHO updates their preclinical and clinical pipeline summaries at regular intervals. The most current reviews are summarized on These excellent summaries are invaluable for researchers of all types and are also used to inform policy work. There is now a call to for current information on antibacterial pre-clinical projects. Go here

PASTEUR: Sign a letter to make it happen this year!

Dear All, As all regular readers of this newsletter know, I think that creation of suitable Pull incentives by passage of the PASTEUR Act in the United States is THE key to building a vibrant pipeline of products to address the international problem of AMR. PASTEUR came very close to passage at the end of 2022 …

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