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Controversies in Nephrology Nursing

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Who Should Be Paying for Vitamin D Analogues –
Medicare or the Patients?
Christy Price Rabetoy, Department Editor

IV Versus PO Vitamin D:
The Road Already Traveled
Gayle Hall, BSN, RN, CNN
Director of Training and Development
MIQS, Inc.
Boulder, CO
President, ANNA’s First Coast Chapter

Patients with chronic kidney disease (CKD) Stages 3-5 experience decreased calcitriol (1,25 (OH2)D3) levels when the kidney can no longer convert Vitamin D to its active form (Parker, 1998).  Although most often associated with suppression of parathyroid hormone (PTH), Vitamin D performs a multitude of other body functions; among them, suppression of renin expression, modulation of the immune and inflammatory system, and promotion of vascular endothelial health (Teng et al., 2005).

Advantages of Injectable D

Vitamin D analogues are available in oral form –  Rocaltrol (calcitriol) (Roche; Nutley, NJ), Hectorol (doxercalciferol) (Genzyme Corporation, Cambridge, MA), or Zemplar™ (paricalcitol) (Abbott Laboratories, Abbott Park, IL) or injectable form – Hectorol, (Genzyme Corporation, Cambridge, MA), Calcijex®, and Zemplar™ (Abbott Laboratories, Abbott Park, IL). Of note is that oral paricalcitol (Zemplar™) does not carry an indication for patients with CKD Stage 5. Although the price for injectable vitamin D is higher than that of oral products, clinicians prefer it for patients on hemodialysis for several reasons.
  1. Intravenous (IV) Vitamin D is perceived as having superior efficacy and fewer side effects than oral preparations.
  2. Administering Vitamin D IV while patients are on hemodialysis is convenient for patients and providers and the exact dosage received is quantifiable (Nephrology Pharmacy Associates, 2000).
  3. The Medicare reimbursement system has historically encouraged use of pharmaceuticals.
In contrast, parenteral administration of Vitamin D for patients on peritoneal dialysis does not offer the same advantage. Unlike patients on hemodialysis, patients on peritoneal dialysis do not have ready venous access. Calcitriol adsorption to the plastics of the dialysate bag and tubing makes intraperitoneal administration undesirable (Bailie & Johnson, 2002). There are ongoing studies to determine the best possible therapies for patients on peritoneal dialysis. For now, oral Vitamin D analogues remain the treatment of choice for them.

Least Costly Alternatives

Vitamin D coverage for patients on hemodialysis has received more than its share of attention. In 2000, the Wall Street Journal explored the issue with their article entitled, “Medicare Could Save Over $100 Million If It Covered Drug for the Dialysis Patients” (McGinley, 2000). Based on a study performed by the House Committee on Government Reform, the implication was that if Medicare offered coverage of oral Vitamin D analogues, it would save money over reimbursing dialysis units for injectables. This was followed by several Fiscal Intermediaries (FIs) considering a Least Costly Alternative (LCA) policy for Vitamin D. Some policies would have required patients to first “fail” oral agents, then intravenous calcitriol, before finally receiving the more expensive paricalcitol.

A timely study of 51,037 patients initiating dialysis between 1996 and 1999 compared survival between patients receiving injectable Vitamin D (n = 37,173 patients) versus those who did not (n = 13,864). Results showed a 2-year survival of 75.6% in patients who received injectable vitamin D versus 58.7% in the group that did not. This benefit persisted among patients with low intact PTH and elevated serum calcium and phosphorus levels (Teng et al., 2005). Another study demonstrated a survival advantage for patients on hemodialysis receiving paricalcitol over calcitriol (Teng et al., 2003). The FIs abandoned their LCA proposals and patients were able to continue to receive physician-prescribed injectable Vitamin D.

For years, inadequate payment for treatment has left many dialysis providers scrambling to make up the difference through pharmaceuticals. The majority of the Large Dialysis Organizations (LDOs) have been under investigation for Vitamin D claims as the government attempts to contain costs for this expensive segment of the Medicare population. However, Medicare spending on Vitamin D and other injectables comprised only $154 per patient per month in 2003, while Epogen® and IV Iron preparations cost $609 per patient per month in the same period (USRDS, 2005).

Problems with Oral Medications
One may argue the Medicare Part D will now provide medication coverage for outpatient medications; or that patients on home peritoneal dialysis have historically had to pay for their vitamin D analogues.  Why should the standard of care be different?

Oral medication regimens of any nature have many disadvantages. Compliance is a major concern.  In chronic illnesses, such as ESRD, compliance has been demonstrated to diminish over time.  Complex treatment regimens have also been negatively associated with compliance (Curtin, Svarstad, & Keller, 1999). Treatment for ESRD is complex: the average patient  with CKD Stage 5 receives 8-12 medications (Nephrology Pharmacy Associates, n.d.) with many receiving more as needed for their various comorbidities. In addition, compliance has been found to be most likely with medications that relieve a known problem and have immediate discernable effects, such as pain relief. The need for Vitamin D analogues may not be perceived as important (Brunier, 1994; Curtin et al., 1999), therefore further decreasing the probability of compliance with the oral form.

Payment for oral medications is another concern. As Medicare Part D went into effect January 1, 2006, the media have been replete with stories of confusion and payment problems. Many patients find themselves struggling with even more out of pocket costs than they bore under their former programs. Newly prescribed medications may not be covered under a plan carefully chosen to provide coverage for the medications the patient was taking at sign up. Should we add yet another oral medication to these patients’ regimens?

Programs That Work
PContrast the Medicare Part D scenario with a program studied by University of Michigan researcher Dr. Mark Fendrick and others to base co-pay costs on need rather than drug price. The city of Asheville, NC reduced the average annual cost of care for its workers with diabetes by $2,000 per person when they began to provide free diabetes medication. Compliance was enhanced and sick days decreased (Merx, 2005). By continuing to provide patients with the least problematic therapy at the least cost to them, both compliance and outcomes improved.

Conclusion
Patients on in-center hemodialysis make up 91.3% of the population of patients on dialysis. Instead of penalizing the 91.3%, let’s work toward providing better care for the 8.7%. Studies to examine calcimimetics and Vitamin D analogues are needed in order to more closely tailor therapies in concert.  We have already traveled down the road of the least costly alternative. Let us not waste time and resources on the same path.

References
Bailie, G., & Johnson, C. (2002).  Comparative review of the pharmacokinetics of vitamin D analogues.  Seminars in Dialysis 15(5), 352-357.

Brunier, G.  (1994).  Calcium/phosphate imbalances, aluminum toxicity and renal osteodystrophy.  ANNA Journal, 21(4) 171-177.

Curtin, R., Svarstad, B., & Keller, T. (1999).  Hemodialysis patients’ noncompliance with oral medications.  ANNA Journal, 26(3), 307-316.

McGinley, L. (2000, January 10).  Medicare could save over $100 million if it covered drug for dialysis patients.  The Wall Street Journal.

Merx, K. (2005, December 28). Employers save by paying more: Covering employees and apos; drug expenses keeps them healthier and at work. Detroit Free Press.

Nephrology Pharmacy Associates. (n.d.)  Improving medication use is the primary reason we exist.  Retrieved January 10, 2006, from http://www.nephrologypharmacy.com

Nephrology Pharmacy Associates. (2000). Vitamin D economics in the ESRD Market. Medfacts, 2(2). Retrieved January 10, 2006, from http://www.nephrologypharmacy.com

Parker, K. (1998). Acute and chronic renal failure. In Parker, J. (Ed) Contemporary nephrology nursing (pp. 199-265). Pitman, NJ: American Nephrology Nurses’ Association.

Teng, M. Wolf, M., Lowrie, E., Ofsthun, N., Lazarus, J.M., & Thadhani, H. (2003).  Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. New England Journal of Medicine, 349(5), 446.

Teng, M., Wolf, M., Ofsthun, M.N., Lazarus, J.M., Hernán, M., Camargo, C., et al. (2005).  Activated injectible vitamin D and hemodialysis survival: A historical cohort study. Journal of the American Society of Nephrology, 16(4), 1115-1125.

United States Renal Data System (USRDS). (2005). Annual Data Report. Retrieved January 10, 2006, from http://www.usrds.org

It is Time For a Change From the Status Quo
Jennifer Grotegut, RN
Home Dialysis Coordinator
Wasatch Dialysis
Murray, UT

Are we punishing people for being willing to take an active role in their care? Do we discriminate against patients on home dialysis? Do patients on home dialysis have to settle for substandard care, if they cannot afford to pay for medications? These are some of the questions I must consider everyday.

As coordinator of an active home dialysis program, I am frustrated! Tighter guidelines for calcium, phosphorus, and PTH control are becoming harder and harder to achieve in the population of patients on home dialysis – not because of compliance issues or the difference in the treatment modality. It is directly related to outrageous prescription costs for the medications needed to control calcium, phosphorus, and especially PTH.  Every month at our regular monthly PD clinic, I have nearly half of my patients complain about their cost for vitamin D. I am alarmed to hear from so many patients, that even with their insurance, their out of pocket price for vitamin D ranges from $75 to $150 for a month supply. Those without prescription coverage might as well forget about trying to buy  vitamin D analogs, as my patients report that it would cost them from $360 to $540 dollars a month. Generics, although available, inherently cause additional problems with calcium balance.  No one should have to be forced to choose between buying their medications and being able to eat. The high cost of the vitamin D analogs has forced several of my patients to skimp on food or other family needs. It comes as no surprise that they refused further medications.

So what are we as clinicians to do?  We can use assistance programs, provide patients with free samples, or change patients to cheaper generic forms of vitamin D. None of those options prove to be ideal. I spend countless hours a day on the phone tracking down forms and filling out paper work to enroll patients in assistance programs. The dietician and social worker assist when possible. Only moderate success is achieved for obtaining these medications at prices that patients can afford. I can rely on my nephrologists to provide free samples to patients who cannot pay for them. The availability of those samples is usually limited and never predictable enough for long-term use. I can change patients to cheaper generic forms of vitamin D and loose the benefits of increased calcium absorption.

It seems very unfair and discriminatory to me that patients on incenter dialysis have access to the newer vitamin D analogs regardless of their ability to pay. Why do patients on home dialysis have to suffer the high prescription cost burden alone? Because patients on home dialysis (both peritoneal and home hemodialysis) have chosen to be more independent in their care, they should not have to go without access to the same medications that patients on incenter dialysis have. There needs to be something in place that would provide the same medication coverage to patients on both home dialysis and incenter dialysis. Medicare should not be paying for patients on incenter dialysis and refuse to cover patients on home dialysis.

No doubt, any long-term fix to this injustice is years away. It would probably take tremendous amounts of bureaucratic red tape, long and tedious debates from both sides of the issue, years of evaluation, and cost and outcome analysis before any attempt could be made to solve the problem. When it was all said and done, we would likely have a band-aid fix at best. Band-aids are great for minor cuts and scrapes, but not for major cuts, and this is a major problem. Band-Aids frequently fall off, and fail to provide adequate protection or coverage. In this case the patients will only continue to suffer from lack of access to appropriate care.

Medicare should stop providing intravenous vitamin D analogs to patients on incenter hemodialysis and let these patients share in the burden that patients on home dialysis currently experience.  Patients on incenter dialysis should be made to buy their medications the same way patients on home dialysis must. It would stop the discrimination and provide a different band-aid fix until a long-term solution can be found.
The Controversies in Nephrology Nursing department focuses on exploring ethical and clinical issues within the nephrology clinic practice in a point/counterpoint format. Address correspondence to: Christy Price Rabetoy, Department Editor, through the ANNA National Office; East Holly Avenue/Box 56; Pitman, NJ 08071-0056; (856) 256-2320; or by emailing her at christycpr@comcast.net. You may also log onto this column at www.nephrologynursingjournal.net (clink on Department link) and email your comments to the Editor (see Discussion Area). The opinions and assertions contained herein are the private views of the contributors and do not necessarily reflect the views of the American Nephrology Nurses' Association.



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