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.
Instead:
"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."
"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.
Instead:
"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."
