State reimbursement pilot turns into national pharmacy struggle
Anticoagulation credentialing heightens debate
In May, when the Baltimore-based Health Care Financing Admin is tration (HCFA) approved a plan by Mississippi's state pharmacy board and Medicaid program to pay pharmacists for clinical disease management in that state, the program was hailed as a breakthrough with national implications. But when HCFA told the state it had to establish a pharmacist credentialing process by July 1 or the plan couldn't go forward, the breakthrough threatened to break down.
No one disagreed that credentialing can help assure payers, patients, and physicians that pharmacists are qualified to run clinics in the four approved disease states - asthma, diabetes, dyslipidemia, and anticoagulation - but credentialing for pharmacists had never been done in Mississippi.
Not wanting to lose momentum, the state board turned to the National Association of Boards of Pharmacy (NABP) in Park Ridge, IL, as well as the National Association of Chain Drug Stores (NACD) and the National Community Pharmacists Association (NCPA), both in Alexandria, VA, for help. To start with, NABP looked to an existing set of clinical objectives already drawn up by NCPA under the auspices of its National Institute for Pharmacist Care Outcomes, then went on to produce credentialing tests and workshops for Mississippi pharmacists to take for three of the four approved disease states. But the three organizations didn't stop there. The triumvirate's leadership decided to expand the Mississippi effort by forming the National Institute for Standards in Pharmacist Credentialing (NISPC) and began positioning its credentialing process as a national model.
To say that the other dozen or so national pharmacy organizations were caught off guard is an understatement. And for formidable players like the Washington, DC-based American Pharmaceu tical Association; the American Association of Colleges of Pharmacy and the Academy of Managed Care Pharmacy, both in Alexandria; and American Society of Health-System Pharma cists (ASHP) in Bethesda, MD, for example, injury was added to insult in this case when the newly formed NISPC sent out a letter in late June asking these and four other national groups to join their effort.
The letter, signed by the directors of all three organizations, read in part, "NCPA, NACDS and NABP view this collaborative effort as an opportunity for all interested groups to come together and support a single process, a national model, for developing standards and credentialing pharmacists in disease state management. . . . We invite your organization to join with us on this important project."
Some question credentialing plan
And though couched in embracing terms, none of the organizations receiving the letter hugged back. Credentialing is not new to the industry, and various efforts within and among other national organizations have been under way, which their leaders don't want to see thwarted.
Also, some have questioned whether it's appropriate for a regulatory agency like the NABP to be involved in a voluntary credentialing program. Methods, or their lack, for oversight were mentioned. And why were education-related organizations like the Commission for Certification in Geriatric Pharmacy in Alexandria and the Ameri can Council on Pharmaceutical Education in Chicago left out of the original planning?
Some say egos were (and are) at play, while others contend that a decisive course was taken to solve an immediate problem and move the industry forward. Still others maintain that what's appropriate for Mississippi may not be appropriate for other states.
By initially not taking a big-tent approach to credentialing, the NISPC has courted the alienation of other pharmacy groups, but as NABP executive director Carmen Catizone has repeated, "Time was, and is, running out." Given the time constraints, it wouldn't have been feasible to have 20 organizations work together to hammer out a credentialing process, adds Calvin Anthony, executive vice president of NCPA. "If we wait until everybody gets on board, sometimes we never [reach our destination]," he says.
Still, critics say that what happened in Mississippi is less worrisome than what happened next. Most alarming, they say, are the subsequent efforts to turn the Mississippi process immediately into a national program that would affect thousands of pharmacists without soliciting broader input or the input of their member organizations.
"If people feel uncomfortable, it's because the three organizations reached some conclusions that people probably don't think they're at complete liberty to reach," says Lucinda Maine, senior vice president for professional affairs and communication for the American Pharmaceutical Association (APhA).
Richard Penna, executive director of the American Association of Colleges of Pharmacy, says, "AACP would throw its support behind a much broader coalition of organizations."
The ASHP responded by releasing a statement from its executive vice president, Henri Manasse: "These advances merit praise as well as scrutiny and constructive input by all sectors of pharmacy to ensure that the profession's performance meets public needs and expectations."
Rhetoric aside, two issues threaten the formation of a broad-based coalition and therefore a broad-based credentialing plan: One is the debate on whether pharmacist credentialing should be specific to disease states or done via a general practitioner model covering a lot of clinical ground. The other issue is whether an independent agency should be established solely for credentialing, instead of an umbrella organization of just three existing pharmacy groups.
The APhA, for one, is adamant about both points. "The critical question is whether credentialing by disease state is the real answer," Maine says. "For example, if I have an asthmatic diabetic patient, do I have to run out and take another [credentialing] test? Is that in the best interest of patient care?" Certifying general knowledge skills and ability to deliver practice that's different from dispensing makes more sense, she says. "One can argue that the payers have spoken by saying they will pay for specific disease states, but it doesn't mean credentialing should only follow that path."
Minnesota's state pharmacy association, for example, already has embraced a nonspecific approach and is proposing its own general examination process. Maine also has problems with the NABP's involvement in general.
"It's uncommon for regulatory boards to have a role in voluntary certification," she says. The NISPC leadership counters by stressing it will not mandate what types of educational tools, coursework, continuing education hours, or experiential requirements pharmacists need before taking certification exams. "The practitioner will be allowed to choose," says Catizone.
The groups also deflected some criticism by attending a two-day conference on certificate programs called by the American Association of Colleges of Pharmacy, where some signs of consensus began to emerge. With 15 national pharmacy organizations represented - including all three groups making up NISPC - it was unanimously agreed that an outside agency, the American Council on Pharmaceutical Education, would act as the accrediting body of certificate programs. Maine calls the conference "a very positive step, very successful."
In the meantime, things are moving forward in Mississippi. Sixty-three pharmacists have taken a total of 95 exams in one or more of the three disease states available for testing - asthma, diabetes, and dyslipidemia. Following the written tests, pharmacists moved on to one-day credentialing workshops overseen by the state pharmacy board, state association, and the University of Mississippi School of Pharmacy.
The workshops include six pharmacists and two faculty members. During the workshops, pharmacist candidates offer case studies they've been involved with and take on case study scenarios from faculty. Other aspects include instrumentation skills tests based on the specific disease state. The total cost of testing is $125, and recertification will be required every two years.
Pharmacists who pass both parts of the test will be listed with the state Medicaid program as credentialed in a specific disease state. They will receive a Medicaid provider number for filing claims and then can begin seeing physician-referred patients. Newly certified pharmacists will be listed on both the state pharmacy board and NABP Web sites as having passed the testing for each disease state sought.
In Mississippi, the state's Medicaid program expects to pay about $20 for a 15- to 30-minute office visit, with that payment going directly to the pharmacist as opposed to the pharmacy department to which he or she belongs.
For anticoagulation, the fourth disease state approved by HCFA, the NISPC plans to construct a certification test by fall. Here the overall debate is expected to intensify because anticoagulation monitoring is seen as a much more delicate and complicated clinical field. It also includes even more organizations involved in existing training and certification efforts.
Anticoagulation models stir controversy
"Anticoagulation medication is the NTI [narrow therapeutic index] of all NTI drugs," says Gordon Vanscoy, PharmD, MBA. "It's more of an art than a science in managing these patients. Too little could lead to another clot, DVT, stroke, or heart attack. Too much and a patient can bleed to death."
As director of anticoagulation services since 1987 for the VA in Pittsburgh and chairman of the national Certified Anticoagulation Working Group, he has his own ideas about what an anticoagulation certification model should be, which don't jibe with the Mississippi model NISPC is pursuing nationally. "Anticoagulation is interdisciplinary, and to take it the pharmacy credentialing route would be shooting ourselves in the foot," says Vanscoy, who also is assistant dean of managed care at the University of Pittsburgh School of Pharmacy and vice president of the managed care division at Stadtlanders Managed Phar macy Services, also in Pittsburgh. "Nurse practitioners and physician assistants are involved in this, too. We need a credentialing process that recognizes and designs participation by these groups."
The working group Vanscoy chairs has been pursuing certification standards for two years and offers credentialing exams. The organization also works with the Anticoagulation Forum as a venue for education within the field. He says certifica -tion should be a part of pharmacists' involvement with anticoagulation therapy. But, he maintains, it would be shortsighted to link certification just with pharmacist pay through a national model adopted without widespread input.
Like Vanscoy, Maine says anticoagulation is a particularly intricate field that needs special credentialing attention. "I'd say there is a higher level of anxiety in effectively managing patients on anticoagulation therapy," she says.
And like Maine, Vanscoy says one national standard of certification is unnecessary for paying to move forward. "It would simplify life, but the reality is, there's different credentialing for everything. In this case, I would find it self-serving. Anybody can create his or her own credentialing process, but who's going to recognize it?"
So far it appears HCFA and Mississippi Medicaid will recognize the NABP-led exams, but in addition to Vanscoy's organization, the potential lobbying clout against its expansion includes ASHP, which has its own anticoagulation training program (as does drugmaker DuPont through its Coumadin clinic training). Overall, training opportunities for pharmacists within the clinics themselves are poor, though physicians in general are increasingly open to pharmacists advancing in this field. (See related stories, pp. 169-170.)
Timing also is seen as a factor in anticoagulation credentialing. New guidelines, techniques, and attitudes for clinical management and patient care are revamping many of the standards of therapy just as the credentialing debate heats up. Every three years, chest physicians establish therapy guidelines that include aspects like the international normalized ratio (INR) alert benchmarks. Last published in 1995, new guidelines are expected later this fall. Though the new guidelines are not expected to radically change patient care, some changes are on the way.
"More clinics are being asked to manage patients who have been discharged or who are on low molecular weight heparin," says Vanscoy. "Many patients with DVT [deep vein thrombosis] don't have to be admitted and can be managed with low molecular weight heparins [LMWHs] and clinics have transitioned patients to oral anticoagulation therapy. LMWHs won't replace warfarin, but you can transition patients from inpa - tient to outpatient care."
Self-care also is advancing with at-home, INR finger-stick assessments just coming to market. Given the development of these new standards of care, it's an interesting, if not a potentially precarious, time to pursue anticoagulation credentialing.
A certified pharmacist: To be or not to be
Ultimately, those involved say the industry must overcome the growing pains thrust upon credentialing by the "Mississippi Miracle." Most also agree the process should not be payer-driven. "It's up to the profession to step up. I don't think payers want to dictate this. It's pharmacy's responsibility to get this done," says Maine. Those who fail risk the embarrassment and delays the turf wars and contrasting theories threaten.
Of course, many pharmacists already are involved in disease management. Vanscoy's VA program includes pharmacists dealing with 6,000 patient visits annually, and nationwide there are at least 300 anticoagulation clinics with a pharmacist or physician coordinator in charge.
That makes the question not whether to pursue credentialing, but on which side of the debate to throw your allegiance. Where does your organization stand? Right now, no one can say when paying and credentialing will even expand beyond Mississippi, although everyone believes it will. From there, determining what educational paths to follow to prepare for examination becomes a consideration, as well as what disease states to pursue.
Right now it's clear the NABP-led exams specifying disease states have the upper hand as a final process. But if general credentialing should take hold, the question is whether to pursue that as a career option or get left behind. One of two things must happen: Payers must recognize various types and methods of credentialing, or the industry must agree on one unified process that gets refined along the way, similar to the accreditation agreement reached in August.
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