As we have written many times before, there is an ongoing process of CCE in the medical community. It is a day to day exercise as now means and methods are used to do studies and report on them. The journals are filled with the results and the Government for the most part funds them now. So why set up a Government controlled effort.
Let us look at HR 3962 and see what it says. First this is in the Medicare section and that seems to be the backdoor approach to establishing this center. The Bill section is:
TITLE IV—QUALITY Subtitle A—Comparative Effectiveness Research
SEC. 1401. COMPARATIVE EFFECTIVENESS RESEARCH.
Now the specific words are:
(2) DUTIES.—The Center shall—
(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;
(C) continuously develop rigorous scientific methodologies for conducting comparative effectiveness studies, and use such methodologies appropriately;
(D) submit to the Comparative Effectiveness Research Commission, the Secretary, and Congress appropriate relevant reports described in subsection (d)(2);
(E) not later than one year after the date of the enactment of this section, enter into an arrangement under which the Institute of Medicine of the National Academy of Sciences shall conduct an evaluation and report on standards of evidence for highly credible research;
(F) encourage, as appropriate, the development and use of clinical registries and the development of clinical effectiveness research data networks from electronic health records, post marketing drug and medical device surveillance efforts, and other forms of electronic health data; and
(G) appoint clinical perspective advisory panels for research priorities under this section, which shall consult with patients and other stakeholders and advise the Center on research questions, methods, and evidence gaps in terms of clinical outcomes for the specific research inquiry to be examined with respect to such priority to ensure that the information produced from such research is clinically relevant to decisions made by clinicians and patients at the point of care.
The three key points above are the establishment of a massive Government controlled infrastructure to control the CCE effort, then the establishment of national registries of results, and these are not delimited to Medicare, and then to send the recommendations to physicians as to how they should practice medicine. It is akin to my ongoing fear that the Government will take over the writing of Harrison's.
The it continues:
(B) DATA COLLECTION.—In order to carry out its functions, the Center shall—
(i) utilize existing information, both published and unpublished, where possible, collected and assessed either by its own staff or under other arrangements made in accordance with this section;
(ii) carry out, or award grants or contracts for, original research and experimentation, where existing information is inadequate; and
(iii) adopt procedures allowing any interested party to submit information for the use by the Center in making reports and recommendations. In carrying out clause (ii), the Center may award grants or contracts (or provide for intergovernmental transfers, as applicable) to private entities and governmental agencies with experience in conducting comparative effectiveness research, such as the National Institutes of Health and other relevant Federal health agencies.
Thus the Government is empowered with great authority to seek out and obtain whatever it needs for whatever purposes it deems appropriate. It does all of this with a CER Commission as follows:
(b) COMPARATIVE EFFECTIVENESS RESEARCH COMMISSION.—
(2) DUTIES.—The Commission shall—
(A)(i) recommend to the Center national priorities for research described in subsection (a) which shall take into account—
(I) disease incidence, prevalence, and burden in the United States;
(II) evidence gaps in terms of clinical outcomes;
(III) variations in practice, delivery, and outcomes by geography, treatment site, provider type, disability, variation in age group (including children, adolescents, adults, and seniors), racial and ethnic background, gender, genetic and molecular subtypes, and other appropriate populations or subpopulations; and
(IV) the potential for new evidence concerning certain categories, health care services, or treatments to improve patient health and well-being, and the quality of care; and
(ii) in making such recommendations consult with a broad array of public and private stakeholders, including patients and health care providers and payers;
(B) monitor the appropriateness of use of the CERTF described in subsection (g) with respect to the timely production of comparative effectiveness research recommended to be a national priority under subparagraph (A);
(C) identify highly credible research methods and standards of evidence for such research to be considered by the Center;
(D) review the methodologies developed by the center under subsection (a)(2)(C);
(E) support forums to increase stakeholder awareness and permit stakeholder feedback on the efforts of the Center to advance methods and standards that promote highly credible research;
(F) make recommendations to the Center for policies that would allow for public access of data produced under this section, in accordance with appropriate privacy and proprietary practices, while ensuring that the information produced through such data is timely and credible;
Thus unlike the current mode of medical research where researchers and practicing physicians are motivated by what they see in situ as the major issue to be studied, this approach is a centralized Government selection process whereby the Commission will decide in a fully centralized manner what needs to be studied. It thus can select what it sees as important. In many ways it is reminiscent of the old Soviet system of research where such things as genetics were not studied because it was viewed as anti Marxian.
It continues:
(I) make recommendations to the Center for the broad dissemination, consistent with subsection (e), of the findings of research con- ducted and supported under this section that enables clinicians, patients, consumers, and payers to make more informed health care decisions that improve quality and value; and
This is the critical element because it them gets to not only choose the research issues but also it gets to tell the physicians what the results are and then tie the results to how they are to practice medicine.
The Commission is composed as follows:
(A) IN GENERAL.—The members of the Commission shall consist of—
(i) the Director of the Agency for Healthcare Research and Quality or their designee;
(ii) the Chief Medical Officer of the Centers for Medicare & Medicaid Services or their designee;
(iii) the Director of the National Institutes of Health or their designee; and
(iv) 16 additional members who shall represent broad constituencies of stakeholders including clinicians, patients, researchers, third-party payers, and consumers of Federal and State beneficiary programs. Of such members, at least 10 shall be practicing physicians, health care practitioners, consumers, or patients.
The Commission is specifically to be composed of:
(I) Epidemiology.
(II) Health services research.
(III) Bioethics.
(IV) Decision sciences.
(V) Health disparities.
(VI) Health economics.
and
(I) Patients.
(II) Health care consumers.
(III) Practicing Physicians, including surgeons.
(IV) Other health care practitioners engaged in clinical care.
(V) Organizations with proven expertise in racial and ethnic minority health research.
(VI) Employers.
(VII) Public payers.
(VIII) Insurance plans.
(IX) Clinical researchers who conduct research on behalf of pharmaceutical or device manufacturers.
This should be a real get together. One need not imagine too far as to how the agenda will be agreed to. It will be a tower of Babel with this collection of interests all chosen is a highly political manner. Politicians will pack this with friends and useful associates.
This is not the way that medical research or any research for that matter is conducted. At best if it even holds together a few Nobel Peace Prizes should be awarded.
The fear is that the structure of this entity may take good research funds away from where they are being productively used today and place them in politically correct areas where they will be wasted. The true fear is that the results obtained therefrom will be used to mandate medical practice methods which will create harm on the people.
Let us look at HR 3962 and see what it says. First this is in the Medicare section and that seems to be the backdoor approach to establishing this center. The Bill section is:
TITLE IV—QUALITY Subtitle A—Comparative Effectiveness Research
SEC. 1401. COMPARATIVE EFFECTIVENESS RESEARCH.
Now the specific words are:
(2) DUTIES.—The Center shall—
(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;
(C) continuously develop rigorous scientific methodologies for conducting comparative effectiveness studies, and use such methodologies appropriately;
(D) submit to the Comparative Effectiveness Research Commission, the Secretary, and Congress appropriate relevant reports described in subsection (d)(2);
(E) not later than one year after the date of the enactment of this section, enter into an arrangement under which the Institute of Medicine of the National Academy of Sciences shall conduct an evaluation and report on standards of evidence for highly credible research;
(F) encourage, as appropriate, the development and use of clinical registries and the development of clinical effectiveness research data networks from electronic health records, post marketing drug and medical device surveillance efforts, and other forms of electronic health data; and
(G) appoint clinical perspective advisory panels for research priorities under this section, which shall consult with patients and other stakeholders and advise the Center on research questions, methods, and evidence gaps in terms of clinical outcomes for the specific research inquiry to be examined with respect to such priority to ensure that the information produced from such research is clinically relevant to decisions made by clinicians and patients at the point of care.
The three key points above are the establishment of a massive Government controlled infrastructure to control the CCE effort, then the establishment of national registries of results, and these are not delimited to Medicare, and then to send the recommendations to physicians as to how they should practice medicine. It is akin to my ongoing fear that the Government will take over the writing of Harrison's.
The it continues:
(B) DATA COLLECTION.—In order to carry out its functions, the Center shall—
(i) utilize existing information, both published and unpublished, where possible, collected and assessed either by its own staff or under other arrangements made in accordance with this section;
(ii) carry out, or award grants or contracts for, original research and experimentation, where existing information is inadequate; and
(iii) adopt procedures allowing any interested party to submit information for the use by the Center in making reports and recommendations. In carrying out clause (ii), the Center may award grants or contracts (or provide for intergovernmental transfers, as applicable) to private entities and governmental agencies with experience in conducting comparative effectiveness research, such as the National Institutes of Health and other relevant Federal health agencies.
Thus the Government is empowered with great authority to seek out and obtain whatever it needs for whatever purposes it deems appropriate. It does all of this with a CER Commission as follows:
(b) COMPARATIVE EFFECTIVENESS RESEARCH COMMISSION.—
(2) DUTIES.—The Commission shall—
(A)(i) recommend to the Center national priorities for research described in subsection (a) which shall take into account—
(I) disease incidence, prevalence, and burden in the United States;
(II) evidence gaps in terms of clinical outcomes;
(III) variations in practice, delivery, and outcomes by geography, treatment site, provider type, disability, variation in age group (including children, adolescents, adults, and seniors), racial and ethnic background, gender, genetic and molecular subtypes, and other appropriate populations or subpopulations; and
(IV) the potential for new evidence concerning certain categories, health care services, or treatments to improve patient health and well-being, and the quality of care; and
(ii) in making such recommendations consult with a broad array of public and private stakeholders, including patients and health care providers and payers;
(B) monitor the appropriateness of use of the CERTF described in subsection (g) with respect to the timely production of comparative effectiveness research recommended to be a national priority under subparagraph (A);
(C) identify highly credible research methods and standards of evidence for such research to be considered by the Center;
(D) review the methodologies developed by the center under subsection (a)(2)(C);
(E) support forums to increase stakeholder awareness and permit stakeholder feedback on the efforts of the Center to advance methods and standards that promote highly credible research;
(F) make recommendations to the Center for policies that would allow for public access of data produced under this section, in accordance with appropriate privacy and proprietary practices, while ensuring that the information produced through such data is timely and credible;
Thus unlike the current mode of medical research where researchers and practicing physicians are motivated by what they see in situ as the major issue to be studied, this approach is a centralized Government selection process whereby the Commission will decide in a fully centralized manner what needs to be studied. It thus can select what it sees as important. In many ways it is reminiscent of the old Soviet system of research where such things as genetics were not studied because it was viewed as anti Marxian.
It continues:
(I) make recommendations to the Center for the broad dissemination, consistent with subsection (e), of the findings of research con- ducted and supported under this section that enables clinicians, patients, consumers, and payers to make more informed health care decisions that improve quality and value; and
This is the critical element because it them gets to not only choose the research issues but also it gets to tell the physicians what the results are and then tie the results to how they are to practice medicine.
The Commission is composed as follows:
(A) IN GENERAL.—The members of the Commission shall consist of—
(i) the Director of the Agency for Healthcare Research and Quality or their designee;
(ii) the Chief Medical Officer of the Centers for Medicare & Medicaid Services or their designee;
(iii) the Director of the National Institutes of Health or their designee; and
(iv) 16 additional members who shall represent broad constituencies of stakeholders including clinicians, patients, researchers, third-party payers, and consumers of Federal and State beneficiary programs. Of such members, at least 10 shall be practicing physicians, health care practitioners, consumers, or patients.
The Commission is specifically to be composed of:
(I) Epidemiology.
(II) Health services research.
(III) Bioethics.
(IV) Decision sciences.
(V) Health disparities.
(VI) Health economics.
and
(I) Patients.
(II) Health care consumers.
(III) Practicing Physicians, including surgeons.
(IV) Other health care practitioners engaged in clinical care.
(V) Organizations with proven expertise in racial and ethnic minority health research.
(VI) Employers.
(VII) Public payers.
(VIII) Insurance plans.
(IX) Clinical researchers who conduct research on behalf of pharmaceutical or device manufacturers.
This should be a real get together. One need not imagine too far as to how the agenda will be agreed to. It will be a tower of Babel with this collection of interests all chosen is a highly political manner. Politicians will pack this with friends and useful associates.
This is not the way that medical research or any research for that matter is conducted. At best if it even holds together a few Nobel Peace Prizes should be awarded.
The fear is that the structure of this entity may take good research funds away from where they are being productively used today and place them in politically correct areas where they will be wasted. The true fear is that the results obtained therefrom will be used to mandate medical practice methods which will create harm on the people.
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