Tuesday, June 21, 2022

Congress: Make ARPA-Health More Independent of NIH



The usually reliable "Government Executive" trade journal has an article today that "Defying Biden, Congress Moves to Give New Health Research Agency More Independence."  The trigger is, they say that H.R. 5585, the Advanced Research Project Agency-Health (ARPA-H) is close to moving forward on the hill.  And it sets up ARPA-H as a largely independent agency, not just a new division inside NIH.

  • See the article here.
  • See the text of HR 5585 here.
  • See June 23 article on ARPA location  here.
  • (See also a June 27 op ed at WSJ here.)

The article emphasizes this was not the direction desired by either the White House or HHS itself.  (By the way, see Federal Register organizational postings from NIH and HHS on ARPA-H on May 27 here (87FR32174) and April 20 here (87FR23526).  See also a March 2022 article in Science about "the way it was" a few months ago - here.  See a May article, search down for ARPA (here).

The overall goal is that ARPA will resemble the impact and flexibility of DARPA and BARDA (Defense and Biodefense research institutions), and recreate the impact and flexibility of "Operation Warp Speed" for COVID in 2020.   

See my blog collating some OWS resources in January 2022 (here).  There's definitely been a bit of an uptick lately in the ARPA-H echo chamber.   See a May 2022 anti-ARPA-H article here.  See a STAT-PLUS article on ARPA-H's future "independentness," June 3, 2022, here.


Related Theme: Payers and Health Innovation

ARPA-H is meant to greatly increase the resources and effectiveness of translational research and implementation of innovations.  There have been a handful of articles on this general topic lately.  See an article this week (June 21) by Blanco et al. (NIH and CMS authors) in JAMA:

  • From Scientific Discovery to Covered Treatments: Understanding the Payer Perspective as a Keystone to Achieving High-Value Care.  JAMA 327:2285, Blanco et al., 6/2022.  (This quite short article has a title word to text word ratio of 1:88, not sure if that is a good thing or a bad thing.)

There was also an article on the same theme in Cancer a few months ago regarding industry, payors, and MCED:

  • Industry engagement: Accelerating discovery, application, and adoption through industry partnerships.  Cancer 128:S4:918, Peralta et al. (authors include Exact and Grail), 2/2022.

I'm not sure it's a natural partnership, or even a possible one, as Blanco and Peralta might content.  See a Supreme Court decision today allowing health plans to turf ESRD patients efficiently to Medicare ESRD programs, by making dialysis almost impossible to receive within the commercial health plan.  This does not discriminate against ESRD patients, which would be illegal, because the plan has negligible dialysis benefits equally both for ESRD patients and patients without ESRD.   The case is called Marietta.  (That stretch for a non discrimination stance reminds me of an argument with the Loving v West Virginia case in the 1960s, where it was argued that laws banning inter-racial marriage were not racially discriminatory because they prevented black period from marrying whites but equally, prevented white people from marrying blacks.  Pari passu, Marietta makes it equally difficult for the ESRD people and the non-ESRD people to get dialysis.)  

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For more on Operation Warp Speed, I have three book titles at hand: