Sunday, October 6, 2019

It's True: New Book on the Policy of Medicare Evidence & Coverage

This past week, President Trump signed an executive order asking Medicare to do a dozen things, one of which is "define reasonable-and-necessary."  For background and links, here

The Trump E.O. led a friend to point me to a 2016 court case on "reasonable-and-necessary" as used in a PET NCD, Kort v Burwell, and that led to a fascinating and well-written 2018 CMS follow-up document (apologia pro NCD sua) published in Federal Register, 2018.  And while googling "Kort," Google Books popped up the book title discussed in this blog.

New Book

Along the way, I discovered there's a major 2018 book on how CMS makes policy decisions for coverage:  "Debating Modern Medical Technologies: The Politics of Safety, Effectiveness, and Patient Access." 

It's available in both eBook and hardcover (Amazon here, publisher here.)


The authors are:  Karen J. Maschke, a research scholar at The Hastings Center, and Michael K. Gusmano, a Hastings Center research scholar and an associate professor of health policy at Rutgers University School of Public Health.

For Maschke at PubMed, here.  For Gusmano, here.


The book isn't devoted solely to Medicare, but most of the topics are focused on Medicare.  There is a chapter on the history of the federal governing setting up, then dismantling, technology assessment bodies.  (For one open access article on this topic, Grey, Gusmano, Collins, here.)  The authors then devote meticulously researched chapters to:
  • Mammography policy, esp. women ages 40-49 and annual vs. biennial tests.
  • Brain imaging (amyloid) for Alzheimer's; the NCD history.
  • Introduction of high-cost hepatitis C treatments.
  • FDA/CMS responses to FDA withdrawal of breast cancer from Avastin labeling.
  • Regulation of stem cell therapies; some discussion of CAR-T.  (See also their Health Affairs article, here.)
Some of this I lived through day by day as a policy consultant (especially the amyloid story).  All of it was interesting.


I haven't read it yet, but there's also a 2017 book, "Unhealthy Politics: Battle over Evidence-based Medicine."  Amazon here.  One author or "Unhealthy Politics" is Alan Garber MD PhD, long a health economist at Stanford, and now Provost of Harvard.

For a book on politics & society for a topic not discussed by Marschke and Gusmano, see "False Hope: Bone Marrow Transplantation for Breast Cancer," by Rettig et al., 2007 (here).


Unrelated to coverage, but also delving equally deep into CMS policy, see the 2016 book on the AMA RUC and CMS RVUs, Miriam Laugesen, "Fixing Medical Prices: How Physicians Are Paid."  Press here, Amazon here.  My blog on Laugesen, here.