The NEJM published an article today on the CMS decision on rejecting reimbursement for colonography. They state:
"Regardless of whether we are confronting an economic crisis, a policy of insisting on data relevant to the Medicare population is commendable and has a broader application. We suggest that in future coverage decisions, other subgroup data should also be considered. Our above-mentioned study revealed that 75% of participants in cardiovascular clinical trials are male, whereas men make up only 42% of the Medicare population. Outcome reporting according to sex occurred in only 18% of trials. Given the sex differences in the safety and effectiveness of medical interventions and the fact that most Medicare beneficiaries are women, it is crucial to have data on risks and benefits in women. Furthermore, only 5% of studies reported data on race, and only 1% stratified results according to race. In its decision on CT colonography, the CMS noted in particular the lack of data in black patients, who have an increased rate of death from colon cancer."
Thus they are effectively saying that unless a clinical study is performed where race and gender are included in the analysis then whatever the results may be for the class considered in the study the procedure will be rejected for inclusion. Thus if a study is performed on say white females and ovarian cancer and a a procedure shown to be beneficial for that group, the procedure will not be on the CCE approved list unless the study were also done for any other ethnic group as may be required. This means that the ethnic group on whom the procedure was beneficial will be disenfranchised due to the limits of the study. Perhaps Thallessemia studies must include Scandinavians as well?
They continue:
"Another important fact distinguishes the CMS’s latest decision: screening for colorectal cancer is one of very few procedures for which the CMS is specifically authorized to consider costs. (The Social Security Act grants such authority for colorectal-cancer screening tests, prostate-cancer screening tests, and certain other preventive services.) In our view, given the economic realities facing Medicare, health care reform must include explicit authority for the CMS to consider costs in all its coverage decisions in order to assess the true value of a given procedure."
This seems to imply that costs will become a dominant factor in CCE as well. There is a great deal of reading between the lines here. Perhaps this means that for prostate cancer one would expect watchful waiting required for all!
Finally the authors state:
"We applaud this landmark decision, and we hope that the agency remains firm in its evidence-based approach and extends its application as health care reform proceeds."
One of the authors is director of the Division of Medical and Surgical Services at the CMS and another is medical officer at the Agency for Healthcare Research and Quality. Thus the compliments are rather self serving. They are the agency and it would have been nice to have such a lauding article from non-affiliated parties. It will be interesting to see how much politics will play in medical decision making. Colonoscopy is a well accepted procedure. But denial of the benefit may be determined on economic or purely political bases in the future.
"Regardless of whether we are confronting an economic crisis, a policy of insisting on data relevant to the Medicare population is commendable and has a broader application. We suggest that in future coverage decisions, other subgroup data should also be considered. Our above-mentioned study revealed that 75% of participants in cardiovascular clinical trials are male, whereas men make up only 42% of the Medicare population. Outcome reporting according to sex occurred in only 18% of trials. Given the sex differences in the safety and effectiveness of medical interventions and the fact that most Medicare beneficiaries are women, it is crucial to have data on risks and benefits in women. Furthermore, only 5% of studies reported data on race, and only 1% stratified results according to race. In its decision on CT colonography, the CMS noted in particular the lack of data in black patients, who have an increased rate of death from colon cancer."
Thus they are effectively saying that unless a clinical study is performed where race and gender are included in the analysis then whatever the results may be for the class considered in the study the procedure will be rejected for inclusion. Thus if a study is performed on say white females and ovarian cancer and a a procedure shown to be beneficial for that group, the procedure will not be on the CCE approved list unless the study were also done for any other ethnic group as may be required. This means that the ethnic group on whom the procedure was beneficial will be disenfranchised due to the limits of the study. Perhaps Thallessemia studies must include Scandinavians as well?
They continue:
"Another important fact distinguishes the CMS’s latest decision: screening for colorectal cancer is one of very few procedures for which the CMS is specifically authorized to consider costs. (The Social Security Act grants such authority for colorectal-cancer screening tests, prostate-cancer screening tests, and certain other preventive services.) In our view, given the economic realities facing Medicare, health care reform must include explicit authority for the CMS to consider costs in all its coverage decisions in order to assess the true value of a given procedure."
This seems to imply that costs will become a dominant factor in CCE as well. There is a great deal of reading between the lines here. Perhaps this means that for prostate cancer one would expect watchful waiting required for all!
Finally the authors state:
"We applaud this landmark decision, and we hope that the agency remains firm in its evidence-based approach and extends its application as health care reform proceeds."
One of the authors is director of the Division of Medical and Surgical Services at the CMS and another is medical officer at the Agency for Healthcare Research and Quality. Thus the compliments are rather self serving. They are the agency and it would have been nice to have such a lauding article from non-affiliated parties. It will be interesting to see how much politics will play in medical decision making. Colonoscopy is a well accepted procedure. But denial of the benefit may be determined on economic or purely political bases in the future.
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