AMA Votes to Limit Lab Testing
AMA Votes to Limit Lab Testing
Effect of AMA Resolution on Pharmacists Uncertain
As pharmacy practice moves toward an expanded role in medication management, the national media have paid close attention. However, reporters and editors are not the only ones who have been keeping tabs on the transition.
In June, the American Medical Association (AMA) House of Delegates passed Resolution 307, a motion to restrict lab test ordering and interpretation to physicians and dentists. The final version of the resolution bans all nonphysicians from performing and interpreting results unless they are supervised by a doctor or dentist. However, the original draft sought to restrict pharmacists in particular and mentioned "pharmacists' expanded role of practice" in its title.
"[The resolution] reference committee heard extensive testimony that pharmacists and other nonphysicians are expanding their scope of practice to include the performance and interpretation of laboratory testing," an addendum to Resolution 307 noted. "Further information was reported that these activities have significant potential to increase the risk to patients as a result of inaccuracy or misinterpretation of laboratory results."
Although hundreds of resolutions were considered at the June meeting, number 307 was the focus of intense debate. It eventually passed the AMA house by a wide margin, according to Donald J. Schroeder, MD, an orthopedic surgeon in Eugene, Oregon, and chairman of the reference committee that introduced the measure. The "further information" about risks to patients was not based on actual evidence, Schroeder told Pharmacy Today. Only the potential for harm was discussed.
"Pharmacists can't expect organized medicine to stand up and welcome our efforts to expand our practices," said APhA Executive Vice President John A. Gans, PharmD. "It becomes a 'turf issue' instead of a plus for patient care. APhA works with medical organizations to explain the benefits of what pharmacists are doing, but pharmacists and physicians who work at the local level must underscore those benefits."
Spilling onto the National Stage
Resolution 307 was introduced by members of the American Society of Clinical Pathologists. It was the national debut of what had been until now a state-level campaign by pathologists to block pharmacists from expanding their scopes of practice.
Most recently, the Georgia Association of Pathologists has spearheaded an as-yet-unsuccessful attempt to repeal a law in that state that allows pharmacists to perform capillary blood tests to screen for or monitor disease-risk factors. The group, joined by the Medical Association of Georgia, was also instrumental in limiting pharmacists in the state to performing only CLIA-waived tests.
"CLIA" stands for Clinical Laboratory Improvement Amendments, regulations by which HCFA oversees laboratory testing. Tests can fall into one of three CLIA categories: waived, moderately complex, or highly complex. Waived tests include all those approved for home use by patients. Georgia pathologists lobbied hard to prevent pharmacists from winning the right to perform higher-level tests in part because pharmacists -- unlike pathologists -- would not have been required to have a state license to perform them under the proposed bill.
The red flag goes up when pathologists learn that pharmacists are monitoring cholesterol and blood glucose, managing anticoagulation, screening for osteoporosis, and performing other tests. "The pathologists who own the labs want to protect their turf," Schroeder said. "There is a certain amount of income generated from being the only one that can do these tests. Physicians in general are very threatened on all sides these days. Everyone in the world is trying to be a doctor.
"However, the AMA is making it a quality-of-care issue," Schroeder continued. "Their concern is that pharmacists and other nonphysicians don't have the proper background to read and interpret results. If pharmacists could prove that they have the background and training we get as residents to do these things, AMA might back off. How much more training it would take to convince them is a question."
Clash of the Titans?
Resolution 307 instructed AMA "to limit laboratory test ordering [to] licensed physicians...and dentists" through "appropriate legislative and regulatory efforts." The resolution has since been referred for action to AMA's lobbying office in Washington, D.C.
If AMA decides to throw its considerable political clout behind 307, Schroeder has no doubt it could affect pharmacy initiatives across the nation. "Could this shut down osteoporosis, cholesterol, diabetes screening? Absolutely," he said. "If these practices become widespread, my guess is that AMA would try to obtain some type of state legislative prohibition or go through the board of medical examiners in each state and let the board decide who should be interpreting results."
But a national turf war seems unlikely judging from the way clashes between pharmacy and medical groups have played out in state legislatures. If anything, compromises have been reached that benefit both groups.
For instance, the Texas Medical Association (TMA) and Texas Pharmacy Association recently negotiated to allow pharmacists to perform fingerstick glucose monitoring in that state under physician orders. TMA and the Texas Society of Pathologists had objected strongly when the state's department of health and human services first suggested including pharmacists in diabetes management programs, but backed off when they realized test results would be reported back to the physician, according to an article in the April issue of the CAP Today, a publication of
the College of American Pathologists. "Pharmacy and medicine are going to be far more effective if we work together," a TMA executive told the paper.
Making Sense
Should push come to shove, however, APhA Group Director of Policy and Advocacy Susan C. Winckler believes pharmacists have the law on their side. "Pharmacists already have the authority to administer CLIA-waived tests in at least 46 states and the District of Columbia," Winckler said. "For physicians to come in and say they should supervise and order the use of these tests is like saying that OTC products shouldn't be used without a physician intervention. It just doesn't make sense.
"Pharmacists aren't diagnosing with these tests," Winckler added. "Instead, they perform a triage and referral function and monitor medication use. If a pharmacist comes across someone with a high blood glucose level, they are not turning to the patient and saying 'you have diabetes.' They are saying 'this could be the indication of a problem and you need to see a doctor about it.' Pharmacists are directing patients to physicians, not taking them away, and freeing physicians from screening hundreds of people so they can focus on patients who really do need help."
Effect of AMA Resolution on Pharmacists Uncertain
As pharmacy practice moves toward an expanded role in medication management, the national media have paid close attention. However, reporters and editors are not the only ones who have been keeping tabs on the transition.
In June, the American Medical Association (AMA) House of Delegates passed Resolution 307, a motion to restrict lab test ordering and interpretation to physicians and dentists. The final version of the resolution bans all nonphysicians from performing and interpreting results unless they are supervised by a doctor or dentist. However, the original draft sought to restrict pharmacists in particular and mentioned "pharmacists' expanded role of practice" in its title.
"[The resolution] reference committee heard extensive testimony that pharmacists and other nonphysicians are expanding their scope of practice to include the performance and interpretation of laboratory testing," an addendum to Resolution 307 noted. "Further information was reported that these activities have significant potential to increase the risk to patients as a result of inaccuracy or misinterpretation of laboratory results."
Although hundreds of resolutions were considered at the June meeting, number 307 was the focus of intense debate. It eventually passed the AMA house by a wide margin, according to Donald J. Schroeder, MD, an orthopedic surgeon in Eugene, Oregon, and chairman of the reference committee that introduced the measure. The "further information" about risks to patients was not based on actual evidence, Schroeder told Pharmacy Today. Only the potential for harm was discussed.
"Pharmacists can't expect organized medicine to stand up and welcome our efforts to expand our practices," said APhA Executive Vice President John A. Gans, PharmD. "It becomes a 'turf issue' instead of a plus for patient care. APhA works with medical organizations to explain the benefits of what pharmacists are doing, but pharmacists and physicians who work at the local level must underscore those benefits."
Spilling onto the National Stage
Resolution 307 was introduced by members of the American Society of Clinical Pathologists. It was the national debut of what had been until now a state-level campaign by pathologists to block pharmacists from expanding their scopes of practice.
Most recently, the Georgia Association of Pathologists has spearheaded an as-yet-unsuccessful attempt to repeal a law in that state that allows pharmacists to perform capillary blood tests to screen for or monitor disease-risk factors. The group, joined by the Medical Association of Georgia, was also instrumental in limiting pharmacists in the state to performing only CLIA-waived tests.
"CLIA" stands for Clinical Laboratory Improvement Amendments, regulations by which HCFA oversees laboratory testing. Tests can fall into one of three CLIA categories: waived, moderately complex, or highly complex. Waived tests include all those approved for home use by patients. Georgia pathologists lobbied hard to prevent pharmacists from winning the right to perform higher-level tests in part because pharmacists -- unlike pathologists -- would not have been required to have a state license to perform them under the proposed bill.
The red flag goes up when pathologists learn that pharmacists are monitoring cholesterol and blood glucose, managing anticoagulation, screening for osteoporosis, and performing other tests. "The pathologists who own the labs want to protect their turf," Schroeder said. "There is a certain amount of income generated from being the only one that can do these tests. Physicians in general are very threatened on all sides these days. Everyone in the world is trying to be a doctor.
"However, the AMA is making it a quality-of-care issue," Schroeder continued. "Their concern is that pharmacists and other nonphysicians don't have the proper background to read and interpret results. If pharmacists could prove that they have the background and training we get as residents to do these things, AMA might back off. How much more training it would take to convince them is a question."
Clash of the Titans?
Resolution 307 instructed AMA "to limit laboratory test ordering [to] licensed physicians...and dentists" through "appropriate legislative and regulatory efforts." The resolution has since been referred for action to AMA's lobbying office in Washington, D.C.
If AMA decides to throw its considerable political clout behind 307, Schroeder has no doubt it could affect pharmacy initiatives across the nation. "Could this shut down osteoporosis, cholesterol, diabetes screening? Absolutely," he said. "If these practices become widespread, my guess is that AMA would try to obtain some type of state legislative prohibition or go through the board of medical examiners in each state and let the board decide who should be interpreting results."
But a national turf war seems unlikely judging from the way clashes between pharmacy and medical groups have played out in state legislatures. If anything, compromises have been reached that benefit both groups.
For instance, the Texas Medical Association (TMA) and Texas Pharmacy Association recently negotiated to allow pharmacists to perform fingerstick glucose monitoring in that state under physician orders. TMA and the Texas Society of Pathologists had objected strongly when the state's department of health and human services first suggested including pharmacists in diabetes management programs, but backed off when they realized test results would be reported back to the physician, according to an article in the April issue of the CAP Today, a publication of
the College of American Pathologists. "Pharmacy and medicine are going to be far more effective if we work together," a TMA executive told the paper.
Making Sense
Should push come to shove, however, APhA Group Director of Policy and Advocacy Susan C. Winckler believes pharmacists have the law on their side. "Pharmacists already have the authority to administer CLIA-waived tests in at least 46 states and the District of Columbia," Winckler said. "For physicians to come in and say they should supervise and order the use of these tests is like saying that OTC products shouldn't be used without a physician intervention. It just doesn't make sense.
"Pharmacists aren't diagnosing with these tests," Winckler added. "Instead, they perform a triage and referral function and monitor medication use. If a pharmacist comes across someone with a high blood glucose level, they are not turning to the patient and saying 'you have diabetes.' They are saying 'this could be the indication of a problem and you need to see a doctor about it.' Pharmacists are directing patients to physicians, not taking them away, and freeing physicians from screening hundreds of people so they can focus on patients who really do need help."
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