Monday, August 5, 2019

Very Brief Blog: CMS Leadership Highlights Initiatives for Antibiotic Crisis

Somewhat buried in August 2 Friday night inpatient rulemaking, but highlighted separately in a Health Affairs blog by Seema Verma and a summary at Endpoints... New administration inititatives for the antibiotic crisis.

This weekend, concurrent, the CEO of Novartis interviewed in NYT about the global antibiotic crisis - here.
  • Seema Verma blog Health Affairs here.
  • See also Seema Verma's August 6 "Tweetorial" on Abx policy, here.
  • Coverage at Endpoints here.
PEW Charitable Trusts has long taken a public policy lead role on this issue (here), and urged CMS to finalize the ASP rulemaking for hospitals as long ago as November 2018 (here).  IDSA also strongly supports ASP requirements for hospitals (here).  The President's Advisory Council on antibiotic resistance (PAC-CARB) in April 2019 urged CMS to finalize hospital ASP rulemaking in the face of the agency's June 2019 deadline (here).

Finally, to the relief of many stakeholders, in June 2019, CMS extended the imminent deadline for action one year forwards, to June 2020 (here).

Opening the August 2 blog:
The Centers for Medicare & Medicaid Services (CMS) under the Trump Administration has been committed to unleashing medical innovation, with notable policy initiatives including a revolution in interoperability, the expedited approval of transformative new technologies, and the creation of new authority for payment for telehealth benefits for patients in traditional Medicare and Medicare Advantage. 
Antimicrobial resistance (AMR), which affects millions of Americans and results in thousands of deaths annually, is an ongoing public health crisis where CMS is leading the way to remove regulatory barriers and payment disincentives to innovation. In this post, I will outline the agency’s multi-pronged strategy for stimulating access to antibiotic innovation through the Fiscal Year (FY) 2020 Inpatient Prospective Payment System (IPPS) rule, including changes to the New Technology Add-On Payment and severity adjustments to ICD-10 codes for AMR. I will also discuss CMS’s interest in addressing AMR beyond payment reform, such as investments in public health infrastructure like stewardship programs. 

For uses of "Trump Administration" and "Vision of President Trump" in recent CMS press, here.

Specific to Antibiotic Stewardship for hospitals, which HHS proposed in 2016, and extended completion from 2019 to 2020, Verma writes:
While the proposed actions listed above are necessary to fill in the missing market for new antibiotics designed for resistant pathogens, CMS also recognizes the vital importance of going beyond payment reforms and investing in public health infrastructure to slow the development of resistance to existing drugs.
One strategy recommended to the agency by stakeholders during the public comment period on the proposed FY 2020 IPPS rule was regulation for Antibiotic Stewardship Programs. Although stewardship lies outside of the scope of rulemaking for this year’s IPPS, the agency appreciates the feedback from the clinical community. CMS has long been supportive of efforts to address the public health challenge of AMR via clinical guidelines; we already require the implementation of Antibiotic Stewardship Programs at different sites of care (such as long-term care facilities). 

CMS is currently reviewing approaches for implementing guidelines for hospital-based Antibiotic Stewardship Programs via the regulations that govern hospitals’ Conditions of Participation in Medicare. This would provide an avenue for the agency to build on the payment reforms implemented through IPPS, create consistency with parallel actions from our partners (e.g., the Joint Commission’s recently announced stewardship requirements for outpatient facilities), and significantly enhance the safety of Medicare beneficiaries during inpatient stays. The agency also recognizes -- as highlighted by significant stakeholder feedback -- that stewardship programs are necessary to reinforce the effectiveness of payment reforms;  stewardship should steer clinicians towards the appropriate use of new antibiotics, which may include antibiotics designated as QIDPs.

CMS’s Commitment To Addressing AMR 
AMR is both a public health crisis and a national security imperative that demands systemic policy action. CMS is committed to ensuring that its policies support the pipeline of drug development and enable Medicare beneficiaries and all Americans to access life-saving medicines. The removal of disincentives for innovation in the final FY 2020 IPPS rule should pave the way from bench to bedside for new antibiotics, while the agency’s parallel action on stewardship and consideration of DRG redesign should lay the groundwork for future policy action.


Entry point to this blog from Linked In, here.