Is there a role for you in renal dialysis?
Is there a renal dialysis center in your future? There could be if the Centers for Medicare & Medicaid Services gets its wish.
A new proposed rule for Medicare coverage of end-stage renal disease (ESRD) calls for a laboratory profile and medication history for every renal dialysis patient. The question is, who will provide and act on those profiles and histories? Pharmacists may seem to be the obvious candidates, but CMS is not making that leap. Instead, the agency is asking for public comment on what role, if any, pharmacists should play in the dialysis facility and the facility's responsibility for pharmaceutical services and the efficient use of medications.
"That was a brand-new idea that CMS put into the regs," said Doug Marsh, executive director, Southern California Renal Disease Council, one of 19 networks nationwide that oversee dialysis centers and treatment. The typical dialysis patient spends 10 days as an inpatient each year, he noted. Nearly all dialysis patients are taking multiple drugs for multiple conditions in addition to drugs associated with renal failure. Patients are cared for by teams that usually include a physician, nurses, and dialysis technicians. "I don't know that anyone in dialysis has ever thought in terms of a pharmacist on the team," he said.
That is just the problem, said Alan Mutnick, assistant director of pharmacy services at the University of Virginia Health System. A predecessor to CMS had issued a rule on Medicare coverage for ESRD in 1976. While that initial rule established the concept of team care for renal patients, the original team composition has not been changed as care for renal failure has changed.
The original 1976 ESRD rule has been tweaked, but never rewritten, Mutnick said. The role of specific drugs such as erythropoietins for the treatment of anemia has been added, but the overall role of pharmacy has never been addressed until now.
"Pharmacists are not the only answer," Mutnick said. "But a growing body of literature in medicine, not just in pharmacy, shows that care teams need somebody focusing on drug therapy who can provide necessary insight to manage the total medication picture."
CMS noted that except in a few hospital-based dialysis centers, ESRD patients have seldom had access to clinical pharmacy services on a regular basis.
Drug regimen review for ESRD patients is not entirely new. In New Jersey, state regulations require drug regimen reviews for dialysis patients, noted Edward Foote, chair of the department of pharmacy practice at Wilkes University Nesbitt School of Pharmacy. Until recently, he reviewed medication regimens for New Jersey dialysis providers. "There is a select group of pharmacists, usually associated with universities, who do this kind of thing gratis," he said. "But the New Jersey regulations are vague, both in terms of what should be done and who should do it."
Vague requirements are not enough as far as Foote is concerned. He applauded CMS for recognizing the need for drug regimen review and other pharmacy services in dialysis centers. "This is a wonderful opportunity for pharmacists and just as good for patients," he said. "Compliance is an incredible issue in dialysis patients, and drug regimens are unbelievably complex."
At the same time, Foote is not at all confident that pharmacists will actually find a new role in ESRD. It is not a matter of dialysis managers failing to recognize the need for pharmacy services. Rather, it is the cost involved. "Most dialysis centers run on a razor-thin margin as it is. Unless there is a funding source tagged to this program, I'd expect ESRD providers and dialysis center managers to fight it as an added cost they cannot support," he said.
Mutnick sees the same financial barrier. "Most physicians, nurses, and technicians would welcome pharmacist participation," he said. "The question is how to pay for the service."
The proposed rule was published in the Federal Register on Feb. 4. The period for comments, including comments on a potential role for R.Ph.s, closes on May 5.