Thursday, November 14, 2019

Very Brief Blog: CDC Releases Antibiotic Resistance Report; CMS Tie-Ins

Watching the 6 am cable news in a Boston hotel prior to today's Personalized Medicine Coalition conference held at Harvard Medical School, local news provides a 30 second clip about a new CDC report on antibiotic resistance in the US.

Some sources for New CDC Report:
  • STAT summary of new CDC report on antibiotic resistance, here.
  • CDC homepage for the new 2019 report, here.
  • Download the actual 148-page report from CDC, here.
    • The new report updates the prior 2013 report.
    • Pages 41-47 focus on diagnostics.
Some policy tie-ins at CMS:
  • CMS administrator Seema Verma had an Op Ed in Stat last wek on CMS efforts on antibiotic resistance.
  • November 6 Op Ed in Stat, here.
  • August 2 Op Ed by Verma in Health Affairs, here.
As detailed in her November 6 Op Ed, recent CMS efforts to encourage antibiotic best practices and drug development include (1) raising the New Technology Add-on Payment for inpatient costly drugs (albeit only for 2-3 years per new drug), (2) upgrading the DRG payment for some DRGs that involve sepsis, and (3) finalizing Conditions of Participation to require hospital antibiotic stewardship committees.   Updates 1 and 2 were in August final inpatient rulemaking (entry point here); the CoP requirement was a special rule issued September 25 (entry point here).


For those who aren't familiar with it, the national biodefense agency BARDA provides substantial funding for antibiotic resistance technologies (including diagnostics as well as drugs), and an international public-private funding agency, CARB-X, is an innovative approach to funding.

There is a President's Advisory Commission on Antibiotic Resistance (PAC-CARB), which last spring held a special session to urge HHS to finalize the Conditions of Participation for hospitals to require antibiotic stewardship committees.   HHS also is producing a second five-year National Action Plan for coordinated federal efforts in antibiotic resistance policy and investments (here).

Antibiotic Stewardship Programs: JC, CMS, CDC

Antibiotic Stewardship Programs (ASPs) are required both by the Joint Commission on hospital accreditation and CMS, but CMS worked to insure its requirements were met by meeting JC requirements.   Both sets of rules are predicated on Core Elements of ASP's, produced several years ago by CDC.  CDC is said to be in the midst of revising the Core Elements in the next month or two.

IDSA, Pew Foundation

Two of the independent organizations heavily involved in antibiotic stewardship policy are Infectious Disease Society of America (IDSA) and Pew Foundation.

Diagnostics and Hospital Budgets

On October 31, 2019, 360Dx ran an excellent (subscription) article discussing how "one of the hottest categories in diagnostics is antibiotic resistance testing," while such new molecular tests frequent collide against fixed hospital inpatient budgets.  And fixed outpatient budgets too - Medicare since 2014 bundles all clinical chemistry and microbiology tests to hospital outpatient visits or surgeries (with an exception only for human genetic tests). 

DISARM Bill and AdvamedDx

On the Hill, the DISARM bill has been introduced in both houses.  This is the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019, see press release here and full bill here (S. 1712).  DISARM would pay for certain priority antibiotics on an average-sales-price basis for Medicare inpatients, on the requirement that hospitals participate (1) in the CDC national data registry for antibiotic resistance (NHSN) and (2) have ASP in place [the latter is now required by CMS, which it wasn't when the bill was introduced]. 

In a six-page public letter to the Senate, in July 2019, AdvamedDx suggested that the DISARM bill should have more policy initiatives related to diagnostics (here).  Advamed's proposed revisions include requiring a lab director on ASP committees, and upgrading lab technology with faster turnaround times and clearer reports with better decision support capabilities electronically integrated. 

(On the latter point, Biomerieux is supporting advanced analytics software to take the diagnostics lab far beyond historic "sensitivity and resistance" reporting; here. BARDA is also supporting Beckman Coulter to integrate advanced EHR-based algorithms with lab test reporting in sepsis, here.)

Medicare Won't Cover FDA-Approved HIV-1 Genotyping Due in Cancer Patients, Due to Stupid Policy Glitch

In March 2018, CMS released a blanket policy for all uses of NGS testing in Medicare patients with cancer.  The policy limits NGS testing to patients with "advanced cancer" (metastatic, recurrent, stage 3 or 4).   By my reading of the NCD, and I think most readings, the limits are absolute, as the policy is worded, it applies to all NGS tests and doesn't distinguish by type of NGS test.  Therefore, if you had a small skin cancer and a doctor ordered the FDA "Sensa" HIV-1 NGS-based resistance test, Medicare wouldn't pay for it. 

Obviously, CMS staff were thinking of tests like NGS Foundation One test (which they were reviewing at the time) when they limited all NGS test payment exclusively to "advanced cancers."   The policy really has got to be updated to only control testing in areas the NCD actually reviews (I read Medicare law this way; here).   If an NCD reviews A and B, they can then create policy cover A and perhaps not cover B; but they can't non-cover topics C or D that they never reviewed.