Feature Story

Hot on the trail of scope of practice, other state issues

August 2001
Karen Southwick

The CAP’s stepped-up political participation at the state level has given state pathology societies the backing they need to stem pharmacists’ campaign to expand their practices into the lab arena.

In the past, the CAP focused on the federal level, notes David Jadwin, DO, chair of CAP’s State Affairs Committee. "But we’ve now realized that all politics is local," he says. Consequently, the CAP has reinvigorated its state affairs office by more closely monitoring state issues and, in some cases, working to get legislation amended at the request of state pathology societies.

In many cases, the state pathology societies lack the resources to track and influence the state legislative process from day to day, says Dr. Jadwin, who is chief of pathology at Kern Medical Center, Bakersfield, Calif. Meanwhile, the CAP had a State Advisory Committee charged with collecting information on local issues and passing it on. But with the realization that "we needed to get more proactive," the name of the group was recently changed to the State Affairs Committee, and the CAP now has greater responsibility for identifying state issues important to pathologists and aiding the advocacy work of state pathology societies.

"Now the charge is to actively monitor legislative and regulatory activities," says Dr. Jadwin, noting that the CAP is planning next year to contract with a state legislative reporting service to track state legislation. Barry Ziman, the CAP’s assistant director of state affairs, says the CAP communicates with state issue advisors and local pathologists "to provide guidance and support" for state pathology associations.

"Since we have taken this new, active stance," Dr. Jadwin says, "the program has identified 85 bills in 30 state legislatures impacting pathology." One of the hottest areas in the states now is expansion of scope of practice by nonphysicians, especially pharmacists.

So-called collaborative practice agreements, which provide for a physician to work with a pharmacist in managing drug therapy, have been passed in 31 states, according to the American Pharmaceutical Association, which represents pharmacists. While the CAP does not generally object to these practice agreements, the College does object when the agreements are expanded to include laboratory testing, as has been the case in South Dakota, Virginia, Georgia, Mississippi, and California.

"There’s a concerted effort by national pharmacy groups to expand these [collaborative practice agreements] to encompass ordering, performing, and interpretation of tests," Dr. Jadwin says. "This encroaches on the practice of pathology by nonphysicians."

Mitch Rothholz, vice president of professional affairs for the American Pharmaceutical Association, counters that lab tests performed by pharmacists are almost invariably CLIA-waived tests that the Food and Drug Administration has approved for use by health care professionals. With more complex testing, "pharmacists typically don’t have the equipment to run it, so they send it to the lab."

When pharmacists do order or perform tests, he notes, it’s under the direction of a physician-approved protocol. "CAP’s members see this as a threat to divert patients away from them," Rothholz says. "We see it as working with physicians to do what is best for the patient."

The CAP and American Medical Association have adopted resolutions in opposition to nonphysicians ordering or performing lab tests. Passed in 1999, the CAP’s resolution reads: "...that the College of American Pathologists encourage state pathology societies to urge state governments to follow these recommendations in defining the practice limits of pharmacists regarding the extent of testing that pharmacists should be allowed to perform."

A year later, the AMA House of Delegates passed Resolution 307, which says the AMA "affirms that laboratory testing and interpretation of laboratory results should only be performed by those individuals who possess appropriate clinical education and training, and solely under the supervision of licensed physicians." The resolution also says the AMA, "through appropriate legislative and regulatory efforts," will seek to limit lab test ordering and interpretation to licensed physicians and dentists. The AMA policy resolution is not binding on state medical societies.

This year the CAP has helped three state pathology societies amend legislation where collaborative practice provisions would have given pharmacists responsibility, or expanded responsibility, for laboratory testing: Pennsylvania, Rhode Island, and California.

In Pennsylvania, House Bill 751 would have allowed pharmacists, under the umbrella of "managing drug therapy," to order and perform laboratory and diagnostic tests. The Pennsylvania Medical Society (PMS) got the bill modified to allow this process only in institutional settings, such as hospitals and nursing homes. But the Pennsylvania Association of Pathologists (PAP) and the CAP felt the changes didn’t go far enough.

"PMS met for a long time with the pharmacists and felt that by limiting it to institutions, it would fall within the purview of the medical staff," says Debbie Faesel, PAP’s executive director, who also works with the PMS.

"But the pathologists aren’t satisfied with that," she adds. "We feel that it allows a foot in the door for pharmacists in other settings to argue for equal treatment." That is, community pharmacists could insist that they be treated the same as institutional pharmacists in managing drug therapy.

"It’s a slippery slope," says Michael Berman, MD, CAP state issue advisor for Pennsylvania and a staff pathologist at Jefferson Hospital, Pittsburgh. "Once you allow institutional pharmacists to do testing, a drugstore would argue its pharmacists are just as capable."

It’s also a quality-of-care issue, he maintains. "The state society is not sure that pharmacists will do the tests appropriately because they don’t have the same training, experience, and mindset as laboratory personnel."

Arthur Abt, MD, PAP’s president and chair of the Department of Pathology at Penn State University, Hershey, says he has no objection to pharmacists ordering tests, but they shouldn’t perform or interpret them "because they have no training in those areas." He adds, "Most physicians approve of collaborative practice in terms of monitoring drug therapy," but if pharmacists want to move into lab testing, "there should be proficiency testing and standards that they meet."

The Pennsylvania Medical Society and the Pennsylvania Pharmacists Association had signed off on HB 751 before consulting with the state pathology society. "PMS had struck a deal with the pharmacists approving this bill," Dr. Abt says. "Then it subsequently came to the attention of the pathologists."

At the state pathology society’s request, the CAP wrote a letter to the Pennsylvania House of Representatives asking for further changes. The letter raised these objections: No parameters on the types of tests a pharmacist can perform. No laboratory standards for performance of tests. Lack of clarification as to who interprets the lab tests conducted by pharmacists.

"The College believes that the interpretation of laboratory tests constitutes the practice of medicine, for which pharmacists are not licensed," said the CAP letter, signed by president Paul Bachner, MD. The letter urged Pennsylvania legislators to amend the bill to permit pharmacists to order but not perform lab tests, and to have the results reviewed by a physician.

Carmen A. DiCello, executive director of the state pharmacists association, criticized the CAP for coming in at the last moment after an agreement had been forged with the medical society. "We’re moving to do these things because, as the most accessible health care providers, we want to improve patient care," he says. "The captain of the ship is still the physician."

Collaborative agreements, he maintains, are entirely voluntary, meaning the physician, the patient, and the pharmacist all sign off. "It’s not the pharmacists doing their own thing contrary to what the physician wants."

John Scott, vice president of the CAP Division of Government and Professional Affairs, rejects the notion that the CAP and pathologist advocacy on this issue were belated. "Negotiations on a bill are inherently part of the legislative process. Negotiations don’t end after a bill is introduced," he says.

After the CAP and Pennsylvania Association of Pathologists made their objections known to legislators, the bill was amended slightly to eliminate wording related to the "performing of laboratory tests," but pharmacists may still order and perform other diagnostic tests needed to manage drug therapy.

The changes fall short of addressing the CAP and PAP’s concerns. "Pathologists are still against the bill," says the PAP’s Faesel. "They don’t mind pharmacists ordering tests, but they don’t want them performing or interpreting." The bill as it stands "implies they will interpret the results" in the course of managing drug testing.

The battle now shifts to the Senate, where a companion bill, Senate Bill 878, has been introduced with language identical to the un-amended House version. Both bills are now in the Senate Consumer Protection and Professional Licensure Committee, where they’re on hold until the fall, Faesel says, because the chair of that committee is ill.

Meanwhile, the PAP has also written a letter to Senate Consumer Protection and Professional Licensure Committee members and House members urging changes in the bills. The letter says: "The language in the bills would appear to allow pharmacists to evaluate the results of laboratory tests. The PAP believes this would adversely affect patient health and safety as pharmacists are not clinically educated and trained to perform laboratory and diagnostic tests or evaluate them."

Dr. Abt says it’s premature for pathologists to start writing their state senators, because the bills won’t be considered until the fall, "but we certainly want [pathologists] to be aware of the issue."

Scott Wang, MD, chairman of the Department of Pathology at Newport Hospital and the CAP federal key contact coordinator for Rhode Island, says he tipped off the Rhode Island Pathology Society to House Bill 5798 as a result of his participation in the state medical society’s Public Laws Committee.

The bill, a collaborative practice agreement, would have allowed pharmacists to undertake "ordering and evaluating the results of laboratory tests directly related to drug therapy when performed in accordance with approved protocols applicable to the practice setting." CAP’s Scott says no required level of physician oversight was specified.

Says Dr. Wang: "The state pathology society was initially not that concerned, because the state medical society had downplayed any effect the bill would have on pathologists." Though Dr. Wang raised some objections early on—that pharmacist testing should be in accordance with CLIA ’88 rules, for example—he wasn’t aware pharmacists could use the bill’s "vague or nebulous" language to expand their scope of practice. "It appeared to be nothing more than a collaborative practice agreement between physicians and pharmacists to manage drug therapy, which is going on in hospitals today," Dr. Wang says.

It wasn’t until five months later when the CAP’s Ziman called him that he learned the "magnitude of this issue at the national level," says Dr. Wang, who recently became a CAP state issue advisor. "Through CAP’s initiative and with its assistance, I took the charge to make the changes."

At the request of the Rhode Island Pathology Society, the CAP wrote a letter to the bill’s sponsor seeking an amendment specifying that pharmacists could order and evaluate lab tests only "under the supervision of or in direct consultation with a physician." The CAP also sought to make explicit that the lab tests conducted by pharmacists "not include any diagnostic component."

The bill’s sponsor ultimately added the CAP language to the legislation before it passed the Rhode Island House. In addition, as the bill moved through the Rhode Island legislature, language sought by the CAP to require any pharmacist testing to conform with CLIA ’88 was added. The Rhode Island bill was enacted into law in July.

Steve DeToy, director of government and public affairs for the Rhode Island Medical Society, says the society had worked with pharmacists on the bill for one-and-a-half years to devise acceptable language. Then CAP came in "like a bull in a china shop," he charges.

Calling the state legislature "hardly a china shop," Scott counters it’s not unusual for groups with an interest in legislation to advocate amendments once a bill is introduced, "especially if they haven’t been a party to the negotiations that produced the bill." After conferring with the state pathology society on the bill, he says, "we notified the state medical society of pathology’s concerns." There was ample time in the legislative process to address them, Scott says.

The original Rhode Island language provided that any drug therapy management had to involve physicians. To get CAP’s additional proscription in, the medical society, DeToy says, was forced to agree to an amendment weakening the requirement for pharmacist education. "We reluctantly swallowed that to satisfy CAP," DeToy says.

Though Dr. Wang acknowledges that negotiations on the bill "may have hurt our relationship with the medical society," he believes the pathologists’ concerns were valid and plans to work to mitigate misunderstanding in the future.

DeToy says if the CAP is going to be involved in state issues, it must learn to tread local politics more delicately. "It’s incredibly important on any state issue that specialty societies and the medical society work together."

CAP’s Dr. Jadwin agrees. "We want to work in a cooperative manner with state medical societies," he says. But the state medical societies’ belief that "the CAP and state pathology societies should acquiesce after they’ve taken a position doesn’t do justice to pathologists."

The "pattern" of state medical societies signing off on laboratory practice agreements with pharmacist associations, without consulting with pathologists, troubles the CAP, Scott says. "The basic fact the state medical societies are overlooking is that the CAP’s position on this issue is consistent with the policy developed by the AMA House of Delegates, in which they’re represented," he says. "To refuse now to support a policy that state medical societies supported in the House is disappointing."

He adds: "It’s pretty difficult to argue against the AMA policy when you are part of the family. We’re grateful the state medical society supported our position, however reluctantly."

In California, in contrast to Pennsylvania and Rhode Island, the CAP, California Society of Pathologists, pharmacists, and the state medical society reached an agreement with little acrimony. California had existing statutes governing clinical laboratory and pharmacy practice that had contradictory portions, says Bob Achermann, executive director of the California Society of Pathologists in Sacramento. Assembly Bill 586 was an attempt to reconcile the contradictions.

The bill continues to allow pharmacists to perform certain lab tests, confined to skin punctures, but adds that this must be done under the supervision of a laboratory director. "We were concerned with the kinds of tests pharmacists might be doing," says Achermann, noting that current law already allowed them to do waived and moderate-complexity testing.

The California Medical Association, pharmacists, and pathologists, in consultation with the CAP, "worked out the amendments," Achermann says. The state medical association pushed for language, which was included, requiring pharmacists to report test results to a physician designated by the patient. The state pathology society lobbied successfully for the language about a laboratory director.

"This is going to require oversight by a lab director for both community and institutional pharmacists," he says. "As a practical matter, you’re probably not going to see Rite-Aid have a lab director because it doesn’t make economic sense." Consequently, Achermann believes the vast majority of pharmacist laboratory testing will take place in institutions.

Carlo Michelotti, chief executive of the California Pharmacists Association, praises the cooperation of the medical groups on AB 586. "When we all sit down together and work in the spirit of compromise, everybody gains," he says. "There could have been friction, but all the groups made a concerted effort to do the necessary clarifications. It’s in the public interest that [pharmacists] are able to provide these services."

The bill has passed the Assembly and gone to the Senate. Achermann and Michelotti expect it to be enacted.

Karen Southwick is a writer in San Francisco.