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In about one year, the Centers for Medicare & Medicaid Services will add another item to the growing number of dialysis services inside the payment bundle: oral medications related to end-stage renal disease. Those products include any phosphate binders, iron products, calcium supplements, and other drugs. Oral Vitamin D was already included in the bundle when it was first implemented in 2010.
Are dialysis clinic managers getting ready for the transition?
Impact on oral pharmas
A recent survey done by BioTrends Research Group addressed the possible fallout for pharmaceutical companies when the bundle expands to include oral medications in 2014. Responses to the survey of 170 medical directors and clinic administrators suggested that drugs like Amgen's Sensipar (Cinacalcet) used to treat secondary hyperparathyroidism, and phosphate binders like Shire's Fosrenol (Lanthanum), and Sanofi's Renagel/Renvela (sevelamer), are likely to be used less often because of their cost.
"From a non-calcium based binder perspective, Sanofi's Renagel/Renvela and Shire's Fosrenol are both expected to take a hit with share shifts toward less expensive calcium carbonate,” the researchers said in the BioTrends report, Special Report: Planning for the Inclusion of Oral Medications in the Dialysis Bundle. The survey did show, however, that very few changes in practice patterns have been made thus far in anticipation of the inclusion of oral medications in the dialysis bundle.
Getting pharmaceuticals to dialysis patients
The most commonly reported changes that have been made focused on distribution strategies, BioTrends said. Plans for how dialysis units will distribute oral medications and confidence in their ability to distribute oral medications vary by dialysis unit affiliation.
"The consensus seems to be that the initial bundle implementation in January 2011 was not as bad as many anticipated and that a number of dialysis units are either the same or actually better off financially now than they were pre-bundling," said BioTrend's Associate Therapeutic Class Director of Nephrology Rob Dubman. "But, many U.S. medical directors feel that the inclusion of oral medications in the bundle may be more difficult. The high cost of oral medications, the expected lack of adequate reimbursement, and the associated financial burden to dialysis units, along with ensuring good patient outcomes and dealing with the logistics of dispensing oral medications, are considered to be real challenges with the inclusion of oral medications in the bundle."
Those challenges may be larger for smaller dialysis chains and physician-owned clinics.
Larger dialysis providers, like DaVita Inc. and Fresenius Medical Care have planned ahead; they have their own pharmacy divisions. Small- to mid-sized chains may not see the change yet on their radar screen.
The National Renal Administrators Association (www.nraa.org) recently hired Creekside Healthcare Consulting to help members evaluate provider pharmacy needs, assess various pharmacy options, and recommend services. The NRAA is asking active members to complete a survey to help the consultants determine what is needed.