You can read about the DPP problems at Kaiser. My take on it, is that it's surprising how often relatively simple concepts at CMS explode into huge rulemaking activities. I'm not blaming CMS at all; it may be intrinsic to the job. But let me give a few examples.
Small Policies Generate Colossal Rules and Complexities
Case Study 1: Explosion of Complexity
Diabetes Prevention Program
The Medicare Center for Innovation can create demo programs at will, evaluate them, and extend them if they improve quality and don't increase costs. They ran a Diabetes Prevention Program demo - these are CDC-endorsed programs - and found it improved quality and saved costs.
The program itself is simple: the provider has to be a CDC-certified provider of DPP. The beneficiary has to meet a couple criteria for weight and blood glucose. Then they get about 16 sessions over a year in a group-learning format. Got it?
Rulemaking and policy making involved literally hundreds of pages of fine print in the Federal Register over a period of two years, pages of new regulations, and many other pages of application forms, criteria, rules, and penalties. This takes hundreds of pages and several years to implement.
Case Study 2: Explosion of Complexity
Sepsis Early Intervention Program for Hospitals
In 2015, CMS initiated hospital requirements for sepsis intervention programs. The core rules are very simple: if a patient is septic, a few key actions like blood tests and starting IV fluid should occur within 3-6 hours. The basic rules are described in 214 words.
This took a several years to implement, has generated a crescendo of complaints in the peer-reviewed policy literature, and has a 160-page manual of rules and definitions plus a legacy of long town hall meetings, question/answer sessions, and transcripts. See the thorny story in an article by Faust here and one by Rhee here. See articles in the April Annals of Internal Medicine here and here.
Case Study 3:
CMS NCD for Genomic Testing in Cancer Patients
In March 2018, CMS issued a National Coverage Decision for the use of next generation sequencing tumor panels in patients with advanced cancer. This document is only a month old, and the "coverage" section of the document is only a few paragraphs long (275 words).
However, it's already foreseeable that interpreting it in the context of the great range of possible cancers, tests, and drugs is going to be very complicated, and there at least several likely dilemmas or unintended consequences caused by the way the short policy is written. See my own blogs on this topic here and here.
MIPS/MACRA Physician Quality Reporting
I've listed this one last; you kind of know that Physician Quality Reporting and financial penalties are going to be complicated in any health system. But of note this week, a new report by the main internists' association - the Amercian College of Physicians - finds that many of the laboriously implemented quality metrics don't even make sense. Here. This isn't a new topic; Richard Nixon gave a speech to the AMA in 1971 promising to reduce the government' s "burden of bureaucracy on physicians."
