According to the Department of Health and Human Services (HHS) website We have one week to comment on the criteria for the $1 billion + comparative effectiveness criteria. The deadline for submitting comments is 5:00pm on Wednesday June 10th.
The purpose of comparative effectiveness research (CER) is to conduct and analyze systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions.
As a result, the information obtained from this kind of research is used to inform patients, providers, and decision-makers (health plans and CMS bureaucrats), responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.
Consequently, in order to determine what information and data from comparative effectiveness should be used, the Council has offered criteria to determine priority:
Specifically, there is a threshold Minimal Criteria (i.e. must meet these to be considered):
– Research must be included within statutory limits of Recovery Act and FCC definition of CER
– Responsiveness to expressed needs and preferences of patients, clinicians, and other stakeholders, including community engagement in research
– Feasibility of research topic (including time necessary for research)
In addition, HHS and the CER Council also have criteria for scientifically meritorious research and investments such as:
– The Potential Impact (based on prevalence of condition, burden of disease, variability in outcomes, and costs of care)
– The Potential to evaluate comparative effectiveness in diverse populations and patient sub-populations
– The uncertainty within the clinical and public health communities regarding management decisions
– If it addresses need or gap unlikely to be addressed through other funding mechanisms
– Potential for multiplicative effect (e.g. lays foundation for future CER or generates additional investment outside government)
Interestingly, and despite these guidelines, recent studies conducted by NPR and researchers at the Kaiser Family Foundation and the Harvard School of Public Health, showed that patients are by in large happy with their physicians, and skeptical that government guidelines-mandates on test, procedures and medications are going to be beneficial to them.
Moreover, the findings from this poll most importantly show that people do not want someone else to decide which treatment is best for them, and that people have a tremendous amount of trust for their own doctors, with “nearly two-thirds responding that their doctor is already taking steps to keep down the cost of their medical care.”
Accordingly, the study revealed that people began to worry that their doctors would lose control over their health decisions when respondents were informed that the government would appoint members to the comparative effectiveness council to make expert recommendations about certain treatments.
Ultimately, the biggest worry Americans have today is not necessarily whether a medicine they choose is going to be comparatively effective versus another brand or generic: Americans are worried about whether they can even afford health insurance, whether their prescription will be covered by Medicare or Medicaid, and what kind of out-of-pocket expenses will be associated with such drugs. Americans don’t need the government involved in their health care any more then we need the government to run the automotive industry (GM).
The only person or people who should be determining what is comparative and effective for patients and consumers are their own doctors; not some bureaucrat looked in a cubical looking at global numbers without concern that perhaps “that drug doesn’t work on that patient.”
The Deadline for Comments is Next Week — 5:00pm EDT Wednesday June 10th . Your comments matter and you are encouraged to submit them.