Orals in the Bundle: Meds Matter

Patients with ESRD are the most medication-burdened of all the chronically ill. They take an average of 8 to 10 different medications, consuming more than 20 pills per day. It is not surprising, therefore, that the ability of nephrologists, dialysis facilities and patients to manage these medications is a challenge. Patients often do not know what medications they are on, and the monthly “pill check”—usually a shoebox filled with medication bottles—is notoriously inaccurate (1). More importantly, it has been estimated that up to a third of hospitalizations among the frail elderly (which includes a significant number of ESRD patients), and nearly half of re-hospitalizations in this population, are related to medication errors or adverse reactions. Finally, because of the large pill burden, the high costs of some medications and the significant occurrence of adverse events, adherence to prescribed medications is suboptimal (2).

Integrated pharmacy services can help resolve many of these issues for ESRD patients, as recently demonstrated by Weinhandl et al (3). This study compared nearly 9,000 patients enrolled in the DaVita Rx full-service pharmacy program to more than 40,000 control patients not in the program. Propensity score matching was used in comparisons of DaVita Rx and control patients with regard to hospitalizations and mortality, and both intention-to-treat and as-treated analyses were performed. The authors concluded, “Receipt of integrated pharmacy services was associated with lower rates of death and hospitalization in hemodialysis patients with concurrent Medicare and Medicaid eligibility.” When looking at the as-treated analysis, considering the time patients were in the program, DaVita Rx patients experienced a 21 percent longer life expectancy, a 7 percent lower rate of hospitalizations and a 14 percent lower number of hospital days. We had previously shown that adherence to prescribed medication regimens was significantly greater in patients using the integrated pharmacy program than in those who were not, suggesting that if patients take their prescribed medications (after doctors have ensured that the medications are appropriate) clinical outcomes are better.

Making integrated pharmacy services available to ESRD patients is not only a way of achieving the Triple Aim of improving the health of the population, delivering patient-centric care and controlling the costs of care—it is an important step in responding to the Centers for Medicare & Medicaid Services plan to include certain oral medications in the ESRD Prospective Payment System (PPS) in 2016. Doing so could be a great gift to patients if providers are able to deliver the service effectively and efficiently and if the payment contribution to the bundle is appropriately determined. Feldman and colleagues recently provided an analysis from the public-policy perspective on the issues around moving Medicare Part D (the “drug benefit”) medications into Medicare Part B (in this case, the ESRD bundle or PPS) (4). They pointed out the many policy and methodological issues that need careful consideration to avoid unintended consequences on patients and dialysis facilities.

These include the following (quoted directly from Feldman et al):

• What definition and metric to use for “utilization”
• What data source to use as the basis to measure historic utilization”
• What year to use as the base year to estimate utilization
• How best to represent estimated utilization as dialysis facility “acquisition cost”
• How to account for dispensing and administrative costs
• How utilization is affected by differences in patient out-of-pocket costs when moving from Part D to Part B

One of the most important issues in calculating an appropriate payment in the bundle is drug utilization. Again, Feldman et al point out the many issues that confound this calculation: “Prescriptions are filled at variable increments ranging up to 90 days. Therefore, accurate estimation of volume per treatment should be based on patients receiving dialysis for periods of 6 months or longer; drug volume needs to be calculated in relation to treatments received by the same patients over the defined time period so that the numerator of drug volume and denominator of treatments are correctly matched—this was not done in CMS’s 2010 analyses; the National Drug Codes for different versions of a single product sold in different doses need to be rolled up together and converted to milligrams; once volume of each drug is calculated on a per treatment basis, it is monetized by applying the most appropriate price proxy. The authors used 2010 and 2011 wholesale acquisition cost for branded drugs and a blended acquisition cost reported by pharmacies that donated data for generic calcium acetates. The monetized volume per treatment is summed across all products to produce the total ingredient valuation per treatment for the mean utilization.” Although this approach to utilization is likely to yield accurate estimates of current utilization, it does not take into account the impact of improved adherence to medications on total medication use and cost, something that may be expected as enhanced pharmacy services are made available to patients. It is of note that the approach to and benefits of integrated pharmacy services provided in the dialysis facility closely mirror those described recently for patients with other complex illnesses (5).

The authors conclude by stating that the complex care of ESRD patients may be improved or worsened by the inclusion of certain oral medication in the bundle in 2016. To achieve its goal of incentivizing better outcomes using the PPS approach, CMS would be wise to approach this issue with the same rigor and intensity as have Feldman and colleagues.

In summary, meds matter to ESRD patients, and the inclusion of selected medications in the PPS in 2016 is an opportunity to further improve the lives of patients with kidney disease. But that improvement will happen only if this part of the PPS is carefully and thoughtfully developed with full input and collaboration from the stakeholders in the kidney care community—including patients, dialysis facilities and physicians.

As Hippocrates said,
“Life is short, and Art long; the crisis fleeting; experience perilous, and decision difficult. The physician must not only be prepared to do what is right himself, but also to make the patient, the attendants, and externals cooperate.”

References:

1. Manley HJA, Canella CAA, Bailie GRA, St. Peter WLA. Medication-Related Problems in Ambulatory Hemodialysis Patients: A Pooled Analysis. Amer J Kidney Dis 2005, 46:669–680.
2. Manley HJ, Garvin CG, Drayer DK et al. Medication Prescribing Patterns in Ambulatory Hemodialysis Patients: Comparisons of the USRDS to a Large Not-for-Profit Dialysis Provider. Nephrol Dial Transplant 2004; 19:1842–1848.
3. Weinhandl ED, Arneson TJ, St. Peter WL. Clinical Outcomes Associated with Receipt of Integrated Pharmacy Services by Hemodialysis Patients: A Quality Improvement Report. Am J Kidney Dis 2013 Apr 15. pii: S0272-6386(13)00571-4. doi: 10.1053/j.ajkd.2013.02.360. (Epub ahead of print.)
4. Feldman RL, Desmarais MP, Muller JS. Orals in the Bundle: A Policy Framework. CJASN ePress 2013 Apr 18. doi: 10.2215/CJN.11621112.
5. Viswanathan M, Golin CE, Jones CD et al. Interventions to Improve Adherence to Self-Administered Medications for Chronic Diseases in the United States—A Systematic Review. Ann Intern Med 2012; 157:785–795.