Medicare's Part B Experiment With Patient Lives

  • by: Robert Goldberg |
  • 05/06/2016
Following the advice of Peter Bach, who holds the Express Scripts Chair for Rebate-Driven Outcomes Policy at Memorial Sloan Kettering, the Center for Medicare and Medicaid Services (CMS) has proposed paying cancer doctors less for administering the most expensive cancer drugs covered  under Medicare part B.  A lot of people -- including the oncologists themselves --have been complaining about the cut.  But nobody has talked about the most unethical part of the experiment:  As Drug Channel's Adam Fein explains:

"CMS wants to reduce reimbursement for buy-and-bill drugs—but for only half of the country's providers. The other half will retain current reimbursement levels. After five years, CMS will see what happened. .."

As only Adam has pointed out this is an unprecedented experiment on patients.   

Did anyone ask Medicare consumers if they wanted to participate?  Did CMS offer to pay moving costs to people who want to be in the control arm of this experiment?   

Did anyone ask if this was even ethical?  Here's what the NIH Office of Human Research Protection guidance on informed consent requires.  You tell me if the Medicare Part B experiment comes within a light year of this moral galaxy:

" Disclosing the reasonably foreseeable risks of research to prospective subjects recognizes the ethical obligation to give prospective subjects sufficient information to make a knowledgeable decision about whether or not to participate. This reflects the ethical principle of respect for persons, which recognizes the importance of giving individuals sufficient information during the informed consent process to make a considered judgment about whether to participate in research that could affect their health or wellbeing—for better or worse."

The CMS notice does not address any of these issues.  Indeed, the phrase informed consent doesn't even show up in the proposal.


"Providers, suppliers, and beneficiaries who are included in the model will have access to the existing claims appeals process, as well as a proposed Pre-Appeals Payment Exceptions Review process, to resolve disputes arising from the policies implemented by this model. "

In otherwords, no informed consent, not even passive consent.  Instead, patients are being hereded into an experiment that in my opinion, violates EVERY canon of the Nuremberg Code 

To be fair, my guess is the position of CMS is that of many people like Peter Bach who believe that price-driven treatment selection does not required informed consent as long as you create a website for your cancer abacus.  But even those who want limits on informed consent in comparative effectiveness trials would do so if patients were not assigned to the treatment arm.  

CMS informs no patient.  The guidance does not require doctors or  hospitals to do so. 

This is a deliberate attempt to side-step informed consent.  And the Part B human experiment is just one part of a larger effort to limit patient choices in what are actually natural experiments by dressing them up as comparative effectiveness research. 

I suggest anyone involved in the Part B human experiment read George and Catherine Annas' article on Therapeutic Ilusion to understand just how unethical the project is.  The authors note: 

"Historically, misleading and confusing terms such as “therapeutic research,” “experimental treatment,” and “invalidated
treatment” have been used to blur the distinction between research and treatment. Similar misleading terms are being deployed in an effort to make evidence-based medicine research (including comparative-effectiveness research) easier to do by dispensing with or watering down disclosure requirements."

By convincing themselves that the law of informed consent does not apply to treatment...The radically paternalistic result would be that physicians could not only set the “standard of care” for medical interventions—whether research or treatment—but also set the “standard of care” for informed consent for both. That quest is, we think, dangerous to the autonomy and dignity of patients and should be repulsed not only by patients, research subjects, and the public, but by physicians and researchers as well."


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog