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Consistency of Pharmaceutical Therapy: AMA
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2010 AMA Annual Meeting, Organized Medical Staff Section (OMSS)
Disposition of Actions
The following actions were taken by the American Medical Association Organized Medical Staff
Section (AMA-OMSS) at its June 10-12, Annual Meeting. Also, where the AMA House of
Delegates (HOD) subsequently acted on the Section’s business it is also noted. If you would like
more information on any of the items listed below, please contact the Department of Organized
Medical Staff Services at (312) 464-5622, or e-mail omss@ama-assn.org.
Resolution 6 – Consistency of Pharmaceutical Therapy
AMERICAN MEDICAL ASSOCIATION ORGANIZED MEDICAL STAFF SECTION
Introduced by: Matthew D. Gold, M.D.
Subject: Consistency in Pharmaceutical TherapyReferred to: Reference Committee
Whereas, Improving health care quality, access, equity, and cost effectiveness as well as promoting a sound public health system are part of the AMA strategic priorities; and
Whereas, Due to the necessity to control health care costs, a number of new initiatives from industry and government have been proposed with little input from practicing physicians; and
Whereas, Certain disorders (e.g., epilepsy) require consistency of pharmaceutical product, specifically bioequivalence, from one manufactured batch to another, in order effectively to be controlled. (Bioavailability is a term that describes the rate and extent that a drug is absorbed, e.g., reaches the inferior vena cava or systemic circulation. Bioequivalence is the term for pharmaceutical equivalents that show similar bioavailability when studied under similar experimental conditions. Blood levels for the generic and standard products should be very similar undefined the inference that equal blood levels of drug for both products result in equal therapeutic effects[1][1]; and
Whereas, In the opinion of many, mandated use of generic products results in prohibitive restrictions on access to, and costs for, consistently manufactured pharmaceuticals (usually in Branded form); and
Whereas, The difference, batch to batch, in bioequivalence of generic products may be as high as 40% (by existing FDA regulation: “Code of Federal Regulation: Bioavailability and Bioequivalence Requirements”, vol. 21, Part 320, U.S. Government Printing Office, Washington, DC 20000) relative to the reference listed (i.e., branded) drug [RLD]; and
Whereas, our AMA represents the position that the practice of medicine should be under the direction of those trained and experienced in that practice, and so licensed; therefore, be it
RESOLVED, That our AMA vigorously oppose any industry or government initiative or existing requirement, proclamation and/or legislation that contradicts the assessment of qualified medical practitioners, and thereby constrains the use of consistently manufactured pharmaceutical products where medical evidence categorically supports that use.
OMSS ACTION: Resolution 6 adopted and transmitted to the HOD for the 2010 Annual
Meeting.
RESOLVED, That our AMA vigorously oppose any industry or government initiative or
existing requirement, proclamation and/or legislation that contradicts the assessment of
qualified medical practitioners, and thereby constrains the use of consistently manufactured
pharmaceutical products where medical evidence categorically supports that use (New
HOD Policy).
HOD Action: Policy H-125.984 Generic Drugs be reaffirmed in lieu of Resolution 525.
OMSS Resolution 9 – Pre-Authorization Abuse
AMERICAN MEDICAL ASSOCIATION ORGANIZED MEDICAL STAFF SECTION
Resolution: A10
Introduced by: Matthew D. Gold, M.D.
Subject: Abuse of Preauthorization Procedures
Referred to: Reference Committee
Whereas, Improving health care quality, access, equity, and cost-effectiveness are AMA strategic priorities; and
Whereas, The practices of mandating preauthorization requirements for prescription medications; using excessively stringent criteria for certain widely performed tests and procedures; and using first-line reviewers unqualified to render competent judgment about clinical appropriateness appears to have escalated; and
Whereas, Numerous inefficiencies employed in the process of preauthorization serve no apparent purpose other than to discourage prescribing/ordering of medications and tests. (For example, automated telephone lines not specifying which choice should be made for preauthorization; repeated requests for basic data at each level of contact; delegated prescription management services who are once removed from the preauthorizing third party without specifying accurate directions where to contact; asking questions already present on the original script or requisition); and
Whereas, The proliferation of said preauthorization has increased to the point of interference in the efficient delivery of quality medical care as practiced by the vast majority of medical practitioners; and
Whereas, The cumulative effect of such preauthorization procedures is an intrusion into the practice of medicine to the point of constituting the practice of medicine itself by non-professionals, non-physicians, and/or non-treating physicians ? or those unqualified to understand the individual circumstances (e.g., allergies, co-morbidities, other patient-centered factors) of a given patient situation; and
Whereas, Emphasis on cost control over the specific medical knowledge and experience that the practitioner has already applied to the individual patient’s care is periodically counterproductive to the cost savings inherent in the care that has been properly provided; and
Whereas, The effect of a denial of payment inexorably leads to the reduction in the patient’s compliance and treatment; and
Whereas, The preauthorization process costs the physician and his/her staff time and the contribution of the physician’s expertise; therefore, be it
1. Preauthorization should not be required where the medication or procedure prescribed is customary and properly indicated, or is a commonly used medication for the indication, as supported by peer-reviewed medical publications. (D)
2. Only a medical professional qualified in the specific area of expertise that is in question, should be a first-line judge of preauthorization. (HP)
3. The full identity, credentials, and contact information of any reviewer, supervisor, and author of the preauthorization criteria should be made readily available.
4. Third parties should be required to make the statistics available in usable form, including the percentages of approval or denial. These statistics should be provided by various categories, e.g., specialty, medication or diagnostic test/procedure, indication offered, and reason for denial, etc.
5. The practice of preauthorization of payment for medically necessary services and treatments constitutes the practice of medicine. Therefore, those involved in such reviews should be held liable for adverse outcomes, and in malpractice actions stemming from any delay and/or denial of care. (HP)
Action: Resolution 9 adopted and transmitted to the HOD for the 2010 Annual Meeting.
RESOLVED, That the AMA oppose the abuse of preauthorization by advocating the
following positions: (Directive to Take Action)
1. Preauthorization should not be required where the medication or procedure
prescribed is customary and properly indicated, or is a commonly used medication
for the indication, as supported by peer-reviewed medical publications.
2. Only a medical professional qualified in the specific area of expertise that is in
question, should be a first-line judge of preauthorization.
3. The full identity, credentials, and contact information of any reviewer, supervisor,
and author of the preauthorization criteria should be made readily available.
4. Third parties should be required to make the statistics available in usable form,
including the percentages of approval or denial. These statistics should be provided
by various categories, e.g., specialty, medication or diagnostic test/procedure,
indication offered, and reason for denial, etc.
5. The practice of preauthorization of payment for medically necessary services and
treatments constitutes the practice of medicine. Therefore, those involved in such
reviews should be held liable for adverse outcomes, and in malpractice actions
stemming from any delay and/or denial of care.
HOD Action: Substitute Resolution 728 adopted and Policies H-320.968 [2,b], H-
285.998 [5], H-285.995, and D-320.995 reaffirmed.
RESOLVED, That the AMA oppose the abuse of preauthorization by advocating the
following positions:
1. Preauthorization should not be required where the medication or procedure
prescribed is customary and properly indicated, or is a treatment for the clinical
indication, as supported by peer-reviewed medical publications or for a patient
currently managed with an established treatment regimen.
2. Third parties should be required to make preauthorization statistics available,
including the percentages of approval or denial. These statistics should be provided by
various categories, e.g., specialty, medication or diagnostic test/procedure, indication
offered, and reason for denial.
[1][1] Ronald D. Schoenwald, Pharmacokinetics in Drug Discovery and Development, (CRC Press, 2002), ISBN 1-56676-973-6.