Presented for your edification, a summary of CER provisions in the House Economic Recovery Bill:
APPROPRIATION OF $1.1 BILLION FOR CER RESEARCH
Subtitle B-Health and Human Services, AHRQ (pg. 141)
• $700 million is appropriated to carry out titles III, IX of the Public Health Service Act( establishes NIH, and AHRQ), title XI of the Social Security Act (CERTs program, peer review), and section 1013 of MMA to conduct or support CER. $400 million will be transferred to NIH (leaving $300 million to AHRQ).
• In addition, $400 million will be allocated at the discretion of Secretary of HHS for efforts that:
o Compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat disease
o Encourage development of networks that can generate outcomes data
o $1.5 million will go to the IOM for a report recommending national priorities for CER
• Public Accountability:
o Secretary shall publish information on grants and contracts awarded with the funds
o Shall disseminate research findings from grants and contracts to clinicians, patients, and the general public
o Recipients of funds shall ensure an opportunity for public comment on the research
• Secretary will provide congressional committees an annual report research being conducted/supported and an operating plan for FY 2009 and FY 2010
ESTABLISHMENT OF ‘FEDERAL COORDINATING COUNCIL FOR COMPARATIVE EFFECTIVENESS RESEARCH
• Council shall coordinate and assist government agencies with conducting CER
• Council will advise Congress and President on CER infrastructure, CER funding, and other opportunities
• Council is composed of 15 members all of whom are federal officials/employees with responsibility for health-related programs, appointed by the president. Includes CMS, AHRQ, FDA, VA, DOD
• At least half the members will be physicians (working in government)
• By June 2009, the council will submit a report to the President and Congress detailing recommendations.
What does all this mean?
1. It is, if not a clone of the UK National Institute for Clinical Excellence (NICE), a kissin' cousin.
2. Absolutely nothing in the current legislative language would stimulate the development of measures and studies to advance personalized medicine.
3. There will be inevitable bias towards large randomized trials a la CATIE and ALLHAT.
4. And who will ARHQ rely on for its research? Most likely entities funded by HMOs and other payers with a goal towards cost containment.
5. The underlying assumption is that comparative effectiveness research will deliver improved outcomes via better quality evidence concerning the best treatment, prevention, and management of any given health condition. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions. But is there any evidence that these assumptions are true?
How about a study to determine whether comparative effectiveness research, compared to other types of research, actually delivers on these lofty goals? How about a meta-analysis to examine how comparatively effective comparative effectiveness research is?
6. And what if such a body swiftly morphs into a New World version of NICE, dictating de facto guidelines for reimbursement and coverage. Doesn't it become an obstacle to access, just like in the UK -- denying patients coverage to innovative uses of new mediccal technologies?
Yes we can ... what? Embrace a healthcare system that is cost-based rather than patient-centric?
No thank you.
APPROPRIATION OF $1.1 BILLION FOR CER RESEARCH
Subtitle B-Health and Human Services, AHRQ (pg. 141)
• $700 million is appropriated to carry out titles III, IX of the Public Health Service Act( establishes NIH, and AHRQ), title XI of the Social Security Act (CERTs program, peer review), and section 1013 of MMA to conduct or support CER. $400 million will be transferred to NIH (leaving $300 million to AHRQ).
• In addition, $400 million will be allocated at the discretion of Secretary of HHS for efforts that:
o Compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat disease
o Encourage development of networks that can generate outcomes data
o $1.5 million will go to the IOM for a report recommending national priorities for CER
• Public Accountability:
o Secretary shall publish information on grants and contracts awarded with the funds
o Shall disseminate research findings from grants and contracts to clinicians, patients, and the general public
o Recipients of funds shall ensure an opportunity for public comment on the research
• Secretary will provide congressional committees an annual report research being conducted/supported and an operating plan for FY 2009 and FY 2010
ESTABLISHMENT OF ‘FEDERAL COORDINATING COUNCIL FOR COMPARATIVE EFFECTIVENESS RESEARCH
• Council shall coordinate and assist government agencies with conducting CER
• Council will advise Congress and President on CER infrastructure, CER funding, and other opportunities
• Council is composed of 15 members all of whom are federal officials/employees with responsibility for health-related programs, appointed by the president. Includes CMS, AHRQ, FDA, VA, DOD
• At least half the members will be physicians (working in government)
• By June 2009, the council will submit a report to the President and Congress detailing recommendations.
What does all this mean?
1. It is, if not a clone of the UK National Institute for Clinical Excellence (NICE), a kissin' cousin.
2. Absolutely nothing in the current legislative language would stimulate the development of measures and studies to advance personalized medicine.
3. There will be inevitable bias towards large randomized trials a la CATIE and ALLHAT.
4. And who will ARHQ rely on for its research? Most likely entities funded by HMOs and other payers with a goal towards cost containment.
5. The underlying assumption is that comparative effectiveness research will deliver improved outcomes via better quality evidence concerning the best treatment, prevention, and management of any given health condition. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions. But is there any evidence that these assumptions are true?
How about a study to determine whether comparative effectiveness research, compared to other types of research, actually delivers on these lofty goals? How about a meta-analysis to examine how comparatively effective comparative effectiveness research is?
6. And what if such a body swiftly morphs into a New World version of NICE, dictating de facto guidelines for reimbursement and coverage. Doesn't it become an obstacle to access, just like in the UK -- denying patients coverage to innovative uses of new mediccal technologies?
Yes we can ... what? Embrace a healthcare system that is cost-based rather than patient-centric?
No thank you.
