In evaluating parts of HR 3200 as we did yesterday we have now begun to delve into the more arcane parts.Let us address the parts of the bill that refer to CCE. There appear to be two. and they are:
DIVISION B—MEDICARE AND MEDICAID IMPROVEMENTS
TITLE IV—QUALITY
Subtitle A—Comparative Effectiveness Research
SEC. 1181. (a) CENTER FOR COMPARATIVE EFFECTIVENESS RESEARCH ESTABLISHED.—
(1) IN GENERAL.—The Secretary shall establish within the Agency for Healthcare Research and Quality a Center for Comparative Effectiveness Research (in this section referred to as the "Center") to conduct, support, and synthesize research (including research conducted or supported under section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003) with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically.
Thus the Secretary of HHS shall establish another Government Agency to do this CCE effort. Amongst its duties will be:
"(A) conduct, support, and synthesize research relevant to the comparative effectiveness of the full spectrum of health care items, services and systems, including pharmaceuticals, medical devices, medical and surgical procedures, and other medical interventions;
(B) conduct and support systematic reviews of clinical research, including original research conducted subsequent to the date of the enactment of this section;"
Yet it does not end here for it further states:
"(1) IN GENERAL.—The Secretary shall establish an independent Comparative Effectiveness Research Commission (in this section referred to as the "Commission") to oversee and evaluate the activities carried out by the Center under subsection (a), subject to the authority of the Secretary, to ensure such activities result in highly credible research and information resulting from such research..."
Thus we have a new Government body plus an oversight group. Its purpose is:
"(A) determine national priorities for research described in subsection (a) and in making such determinations consult with a broad array of public and private stakeholders, including patients and health care providers and payers;"
Thus this group will decide what the research priorities should be. This is a bit bassakwards to say the least. There is a well established infrastructure in the US and elsewhere where such research is being done in a peer review manner on a daily basis. Why do we need a Government entity and oversight. As far as one can see this is acting as the guiding light. Research is NOT done that way, it is highly distributed and combative. Ideas and data are thrown into the arena and allowed to be digested and the truth, whatever it may be, is supposed to emerge. I continue to come back to the prostate studies and the rebuttals. This can be done and is done daily in NEJM and the other professional journals. Why have the Government do what is already being done, and done well.
Then the Bill continues as follows:
"DIVISION C—PUBLIC HEALTH AND WORKFORCE DEVELOPMENT
TITLE IV—QUALITY AND SURVEILLANCE
Subtitle D—Adapting Workforce to Evolving Health System Needs
SEC. 2401. IMPLEMENTATION OF BEST PRACTICES IN THE DELIVERY OF HEALTH CARE.
‘‘PART D—IMPLEMENTATION OF BEST PRACTICES IN THE DELIVERY OF HEALTH CARE
‘‘SEC. 931. CENTER FOR QUALITY IMPROVEMENT."
It is to create:
"(a) IN GENERAL.—There is established the Center for Quality Improvement (referred to in this part as the ‘Center’), to be headed by the Director."
Its function is to:
‘‘(1) identify existing best practices under sub section (e);
‘‘(2) develop new best practices under sub section (f);
‘‘(3) evaluate best practices under subsection (g);
‘‘(4) implement best practices under subsection (h);
‘‘(5) ensure that best practices are identified, developed, evaluated, and implemented under this section consistent with standards adopted by the Secretary..."
Now in reading the above one sees that implementing under subsection (h) is most critical. This states:
"(h) IMPLEMENTATION OF BEST PRACTICES.—
‘‘(1) IN GENERAL.—The Director shall enter into voluntary arrangements with health care providers (including hospitals and other health facilities and health practitioners) in a State or region to implement best practices identified or developed under this section. Such implementation—
‘‘(A) may include forming collaborative multi-institutional teams; and
‘‘(B) shall include an evaluation of the best practices being implemented, including the measurement of patient outcomes before, during, and after implementation of such best practices.
‘‘(2) PREFERENCES.—In carrying out this sub section, the Director shall give priority to health care providers implementing best practices that—
‘‘(A) have the greatest impact on patient outcomes and satisfaction;
‘‘(B) are the most easily adapted for use by health care providers across a variety of health care settings;
‘‘(C) promote coordination....""
Thus as best we can see, there are now two new CCE institutions and several committees but the implementation is voluntary.
This question is why is this necessary since it is being done and done well already, and why does the Government believe that it can not only do this but do it better! This is centralizing medical research and the results when the process is naturally a distributed process. No one study is ever definitive, no two patients are the same, and no Government plan ever works as anticipated.
DIVISION B—MEDICARE AND MEDICAID IMPROVEMENTS
TITLE IV—QUALITY
Subtitle A—Comparative Effectiveness Research
SEC. 1181. (a) CENTER FOR COMPARATIVE EFFECTIVENESS RESEARCH ESTABLISHED.—
(1) IN GENERAL.—The Secretary shall establish within the Agency for Healthcare Research and Quality a Center for Comparative Effectiveness Research (in this section referred to as the "Center") to conduct, support, and synthesize research (including research conducted or supported under section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003) with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically.
Thus the Secretary of HHS shall establish another Government Agency to do this CCE effort. Amongst its duties will be:
"(A) conduct, support, and synthesize research relevant to the comparative effectiveness of the full spectrum of health care items, services and systems, including pharmaceuticals, medical devices, medical and surgical procedures, and other medical interventions;
(B) conduct and support systematic reviews of clinical research, including original research conducted subsequent to the date of the enactment of this section;"
Yet it does not end here for it further states:
"(1) IN GENERAL.—The Secretary shall establish an independent Comparative Effectiveness Research Commission (in this section referred to as the "Commission") to oversee and evaluate the activities carried out by the Center under subsection (a), subject to the authority of the Secretary, to ensure such activities result in highly credible research and information resulting from such research..."
Thus we have a new Government body plus an oversight group. Its purpose is:
"(A) determine national priorities for research described in subsection (a) and in making such determinations consult with a broad array of public and private stakeholders, including patients and health care providers and payers;"
Thus this group will decide what the research priorities should be. This is a bit bassakwards to say the least. There is a well established infrastructure in the US and elsewhere where such research is being done in a peer review manner on a daily basis. Why do we need a Government entity and oversight. As far as one can see this is acting as the guiding light. Research is NOT done that way, it is highly distributed and combative. Ideas and data are thrown into the arena and allowed to be digested and the truth, whatever it may be, is supposed to emerge. I continue to come back to the prostate studies and the rebuttals. This can be done and is done daily in NEJM and the other professional journals. Why have the Government do what is already being done, and done well.
Then the Bill continues as follows:
"DIVISION C—PUBLIC HEALTH AND WORKFORCE DEVELOPMENT
TITLE IV—QUALITY AND SURVEILLANCE
Subtitle D—Adapting Workforce to Evolving Health System Needs
SEC. 2401. IMPLEMENTATION OF BEST PRACTICES IN THE DELIVERY OF HEALTH CARE.
‘‘PART D—IMPLEMENTATION OF BEST PRACTICES IN THE DELIVERY OF HEALTH CARE
‘‘SEC. 931. CENTER FOR QUALITY IMPROVEMENT."
It is to create:
"(a) IN GENERAL.—There is established the Center for Quality Improvement (referred to in this part as the ‘Center’), to be headed by the Director."
Its function is to:
‘‘(1) identify existing best practices under sub section (e);
‘‘(2) develop new best practices under sub section (f);
‘‘(3) evaluate best practices under subsection (g);
‘‘(4) implement best practices under subsection (h);
‘‘(5) ensure that best practices are identified, developed, evaluated, and implemented under this section consistent with standards adopted by the Secretary..."
Now in reading the above one sees that implementing under subsection (h) is most critical. This states:
"(h) IMPLEMENTATION OF BEST PRACTICES.—
‘‘(1) IN GENERAL.—The Director shall enter into voluntary arrangements with health care providers (including hospitals and other health facilities and health practitioners) in a State or region to implement best practices identified or developed under this section. Such implementation—
‘‘(A) may include forming collaborative multi-institutional teams; and
‘‘(B) shall include an evaluation of the best practices being implemented, including the measurement of patient outcomes before, during, and after implementation of such best practices.
‘‘(2) PREFERENCES.—In carrying out this sub section, the Director shall give priority to health care providers implementing best practices that—
‘‘(A) have the greatest impact on patient outcomes and satisfaction;
‘‘(B) are the most easily adapted for use by health care providers across a variety of health care settings;
‘‘(C) promote coordination....""
Thus as best we can see, there are now two new CCE institutions and several committees but the implementation is voluntary.
This question is why is this necessary since it is being done and done well already, and why does the Government believe that it can not only do this but do it better! This is centralizing medical research and the results when the process is naturally a distributed process. No one study is ever definitive, no two patients are the same, and no Government plan ever works as anticipated.
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