Monday, August 5, 2019

Perspective: The Coodinated Roll-out of New Kidney Care Plans by Trump Administration

The "Mainstream Media" e.g. Bloomberg, has sometimes criticized the Trump administration for "scattershot and at times contradictory" handling of health policy (here).

In contrast, there was a thoroughly planned and quite well-coordinated roll-out of broad sets of plans to improve renal care under CMS, across the prevention, dialysis, and transplant levels.   This occurred around July 10, so we can look back now with some perspective.



Azar Addresses National Kidney Foundation (April 2019)

In April, Secretary Alex Azar gave a detailed speech to the National Kidney Foundation (online here).   He focuses on renal disease as one of the areas of long-accumulated policy failures and an issue the Trump administration wants to address.  He highlighted the long transplant waiting lists, the burdens and morbidity of dialysis, and the lack of home dialysis in the U.S.  (He compared our home dialysis rates to Hong Kong and Guatemala, both of which do better).  He highlighted the public private partnership of KidneyX, designed to speed the creation of wearable or implantable dialysis options.

He concludes by noting, "We just need renewed ambition and the right policies. President Trump has the kind of ambition we need to deliver much better care for Americans, even if it means bold change."

July 10, 2019, Program Roll-Out

The program roll-out was complex and well-coordinated, with numerous documents springing up online, from White House to HHS to CMS.

White House

  • The president gave a speech, including several brief speakers with personal or family kidney problems.
    • Full speech here at Youtube here.
    • See in particular an edit for the President's remarks, here.
    • The level of enthusiasm the President brings to the speech and participants is palpable. 
    • While there are certainly sections based on the teleprompter, there is an interesting digression where he talks about his Administration's efforts on Right-to-Try laws, which I've seen him spontaneously mention before.
  • See also the White House Press Release here.
  • See also the White House Executive Order here.
  • See also the video remarks full transcript here.
Health and Human Services
  • HHS had its own press release, here.
  • The Assistant Secretary For Planning & Evaluation office created a home page for ESRD initiatives.
    • ESRD ASPE Home Page here.
    • ASPE 42-page white on ESRD policy work, projects, and vision, here.
  • See also HHS documents on KidneyX:
    • Press release here.
    • KidneyX home page here.
    • 2018 launch of KidneyX press release here.
CMS Press Sources
  • CMS had a press release here.
  • CMS had a press release about the mandatory CMMI demonstration project here.
  • CMS had a press release about the voluntary CMMI demonstration project here.
CMS/CMMI Treatment Choices Models

Within CMS, CMMI had its own webpage and documents: here,
The Federal Register official publication was pre-released for July 10 and formally published on July 18:
  • 84 Fed Reg 34478-34595 (118 pages) here.
    • PDF here.
    • Comment open til September 16, 2019.
 I've put key documents like the CMMI rule and the Executive Order and most press releases in one cloud zip file here.   My point is that the above reflects a monumental amount of effort and coordination and the launch was highly organized over the different executive divisions.   While a recent 300-page book highly critical of the current Cabinet was recently published, the book had essentially not one critical word to say about HHS (except some a couple references to Joe Price's air travels in 2017).

Trade Press Coverage

Trade press coverage was generally favorable.
  • Health Payer Intelligence here.
  • Roll Call here.
  • JDSupra, Faegre Baker Daniels, here.
  • Renal Physicians Association here.
  • Becker Hospital Review here.
  • Modern Healthcare here.
  • Healthcare Dive here.
  • Politico here.
  • Marketwatch here.
  • From September 2019, see two articles in JAMA here and here.

General Press Coverage

General press coverage was also generally favorable.
  • NYT here.
  • WSJ here.
  • WaPo here.
  • CNN here.
  • NPR here.
  • Forbes here and here.
  • CNBC here.
    • CNBC follow-up; renal stocks rise, here.
  • Fox News here.
  • LA Times here.
    • Noting that CMMI ESRD program is tied to ACA which is under court threat, as a whole.
  • In the next week, there was also coverage of CVS moving toward home dialysis with new technologies, here and here, at Bloomberg and Healthcare Dive, respectively.
  • A little further afield, see favorable press as diverse as Breitbart here, and Al-Jazeera here.


Summary

Overall, this was a very impressive roll-out, especially when you consider the relatively hostile media environment and the fact that the roll-out of anything is ten (or a hundred) times harder than it looks on the surface.

Another point is that this Administration often flags what will happen 3-6 months in advance.  Even for people far outside the Beltway, the April 2019 speech by Azar (which I opened with) flagged most of the emphasis points for the ESRD roll-out in July.  Similarly, speeches by Joe Grogan and Seema Verma early in the year (blog here, links to full text therein) flagged themes on out-of-network payments and price transparency (Grogan) and CMS's new approaches to breakthrough technology (Verma) that would burst into wider attention in the summer.

Any reservations?  Maybe a few.  There are a few bullets in the Executive Order that seem superfluous - "FDA shall accept PMA applications for artificial kidneys..." - I'm pretty FDA would do that with or without an E.O. bullet point.  And my sense, as an outsider, is that a lot of really smart organizations and experts already work full time and really hard on donor allocation (e.g. one entry point here, but there are many).  But good luck to them on the implementation work ahead.


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A key policymaker for ESRD and other recent efforts was Abe Sutton, a millennial and McKinsey graduate, who leaves White House for law school in August 2019 - here.  He was part of the Domestic Policy Council from the first Trump year, 2017, until now, rising to be head of health policy for the DPC.
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In JULY, the big theme in healthcare was ESRD.   In JUNE, it had been payment transparency and out of network billing, here.  In AUGUST, one big theme is Antibiotics policy, here.   

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For an August 25, 2019, Los Angeles Times expose' of money and politics in the dialysis industry, here.    For an August 26, 2019, WSJ Op Ed on liver transplant policy and incentives, here.   For an August 26 news story and JAMA Internal Medicine on US rates of donor kidney wastage, here, here, here.

For September 2019 JAMA articles on dialysis ownership vs results, here and here.
   For a 2018 article on current state incentives for organ donation, Levy, here.
   For a November 2019 JAMA perspective on Trump proposals, Thomas et al, here.

For a September 2019 trade journal view on reactions to the Trump plan, here.