LCD/NCD Portal

L29007

 

VITAMIN D ANALOGS IN CHRONIC RENAL DISEASE

 

 

03/22/2012

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

This policy addresses the parenteral forms of vitamin D that include Calcitriol (Calcijex®), Paricalcitol (Zemplar®), and Doxercalciferol (Hectorol®).

 

Calcitriol (Calcijex®) – J0636

• Medicare will consider parenteral Calcitriol medically reasonable and necessary for the following indications:

o Management of hypocalcemia in patients undergoing chronic renal dialysis.

 It is recommended that patients receive the oral form of a vitamin D analog prior to initiation of parenteral vitamin D.

 Reimbursement is not dependent on whether the patient has attempted oral vitamin D therapy.

o Management of hypocalcemia in patients undergoing chronic renal dialysis who develop hypercalcemia on the oral form of the drug.

 Hypercalcemia is defined as a serum calcium level greater than 11.2 mg/dL.

o Management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 ml/min) not yet on dialysis.

 It is recommended that patients receive the oral form of a vitamin D analog prior to initiation of parenteral vitamin D.

 Reimbursement is not dependent on whether the patient has attempted oral vitamin D therapy.

o Management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 15 ml/min) not yet on dialysis who develop hypercalcemia on the oral form of the drug.

 Hypercalcemia is defined as a serum calcium level greater than 11.2 mg/dL.

• The recommended initial dose of parenteral Calcitriol is 1-2 mcg 3 times weekly approximately every other day.

o The dose may be increased by 0.5-1 mcg at 2 to 4 week intervals. Calcitriol should be discontinued if hypercalcemia or serum calcium times phosphate (Ca x P) produce totals > 70. Reinitiate at a lower dose.

o Doses may need to be reduced as the PTH levels decrease in response to therapy (see titration table in Facts and Comparisons).

o Note: It is expected that patients taking oral Calcitriol received the recommended dosage as indicated in Facts and Comparisons (i.e., 0.25 mcg/day initially with titration of 0.25 mcg/day at 4-8 week intervals if needed)

 

Doxercalciferol (Hectorol®) – J1270

• Medicare will consider parenteral Doxercalciferol medically reasonable and necessary for the following indication:

o Reduction of elevated iPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis.

 It is recommended that patients receive the oral form of a vitamin D analog prior to initiation of parenteral vitamin D. Reimbursement is not dependent on whether the patient has attempted oral vitamin D therapy.

o Reduction of elevated iPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis who develop hypercalcemis on the oral form of the drug. Hypercalcemia is defined as a serum calcium level greater than 11.2 mg/dL.

• The recommended initial dose of parenteral Doxercalciferol is 4.0 mcg three times a week or every other day for PTH levels > 400. Dose titration is based on the following PTH levels:

o PTH LEVEL DOSE.

o Decreased by <50% & above 300.

o Increase by 1.0-2.0 mcg at 8 week intervals.

o 150-300 Maintain current dose.

o < 100 Suspend times 1 week.

o Resume at least 1.0 mcg lower.

• Note: It is expected that patients taking oral Doxercalciferol receive the recommended dosage as indicated in Facts and Comparisons (i.e., 10 mcgs three times a week with titration to lower blood iPTH levels into the range of 150-300 pg/ml).

 

Paricalcitol (Zemplar®) – J2501

• Medicare will consider parenteral Paricalcitol medically reasonable and necessary for the following indications:

o Prevention and treatment of patients with secondary hyperparathyroidism associated with chronic renal failure.

 It is recommended that patients receive the oral form of a vitamin D analog prior to initiation of parenteral vitamin D. Reimbursement is not dependent on whether the patient has attempted oral vitamin D therapy.

o Prevention and treatment of patients with secondary hyperparathyroidism associated with chronic renal failure who develop hypercalcemia on the oral form of the drug.

 Hypercalcemia is defined as a serum calcium level greater than 11.2 mg/dL.

• The currently accepted target range for intact parathyroid hormone (pith) levels of CRF patients is 1.5 to 3 times the non-ureic upper limit of normal.

o The recommended initial dose of potential Paricalcitol is 0.04-0.1 mcg/kg (2.8-7 mcg) administered as a bolus dose no more frequently than every other day at any time during dialysis.

o If a satisfactory response is not observed, the dose may be increased by 2 to 4 mcgs at 2 to 4 week intervals.

o If an elevated calcium level or a Ca x P product > 75 is noted, immediately reduce or interrupt the drug dosage until parameters are normalized and reinitiate at a lower dose.

o Doses may need to be reduced as the PTH levels decrease in response to therapy (see titration table in Facts and Comparisons).

• Note: It is expected that patients taking an oral vitamin D analog receive the recommended dosage as indicated in Facts and Comparisons.

• All three vitamin D derivatives treat the patient with secondary hyperparathyroidism associated with chronic renal failure by directly suppressing the synthesis and secretion of PTH.

o Because calcitriol, paricalcitol, and doxercalciferol produce the same clinical effects, reimbursement will be based on the drug that is the least costly when given for patients with secondary hyperparathyroidism (diagnosis code 588.8).

• Once CMS communicates the effective date for “Least Costly Alternative Pricing for Vitamin D Analogs”, the MAC - Part Awill implement the following statement per CMS direction:

o All three vitamin D derivatives treat the patient with secondary hyperparathyroidism associated with chronic renal failure by directly suppressing the synthesis and secretion of PTH.

o Because calcitriol, paricalcitol, and doxercalciferol produce the same clinical effects, reimbursement will be based on the drug that is the least costly when given for patients with secondary hyperparathyroidism (diagnosis code 588.81

 

 

Coding Information

 

Bill Type Codes

 

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

13x Hospital Outpatient

72x Clinic - Hospital Based or Independent Renal Dialysis Center

85x Critical Access Hospital

 

 

Revenue Codes

 

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

0250 Pharmacy - General Classification

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

CPT/HCPCS Codes

 

J0636 INJECTION, CALCITRIOL, 0.1 MCG

J1270 INJECTION, DOXERCALCIFEROL, 1 MCG

J2501 INJECTION, PARICALCITOL, 1 MCG

 

 

ICD-9 Codes that Support Medical Necessity

 

Calcitriol (Calcijex) – J0636

275.41 HYPOCALCEMIA

588.81 SECONDARY HYPERPARATHYROIDISM (OF RENAL ORIGIN)

588.89 OTHER SPECIFIED DISORDERS RESULTING FROM IMPAIRED RENAL FUNCTION

 

Doxercalciferol (Hectorol®) – J1270 and Paricalcitol (Zemplar®) – J2501

588.81 SECONDARY HYPERPARATHYROIDISM (OF RENAL ORIGIN)

588.89 OTHER SPECIFIED DISORDERS RESULTING FROM IMPAIRED RENAL FUNCTION

 

 

Documentation Requirements

 

• Medical record documentation maintained by the performing provider must substantiate the medical necessity for the use of parenteral vitamin D analogs.

• The documentation must support the criteria as set forth in the “Indications and Limitations of Coverage and/or Medical Necessity” section of this policy.

• This information is normally found in the office/progress notes, facility/hospital records, and/or laboratory results.

 

 

Treatment Logic

 

• Vitamin D is a fat-soluble vitamin derived from natural sources (fish, liver oils) or from conversion of provitamins (7-dehydrocholesterol and ergosterol).

o In humans, natural supplies of vitamin D depend on ultraviolet light for conversion of 7-dehydrocholesterol to vitamin D 3 or ergosterol to vitamin D 2.

o Following exposure to ultraviolet light, vitamin D 3 must then be converted to the active form of vitamin D (calcitriol) by the liver and kidneys. Vitamin D is considered a hormone.

o Although not a natural human hormone, vitamin D 2 can substitute for D 3 in every metabolic step.

o Biologically active vitamin D metabolites control the intestinal absorption of dietary calcium, the tubular reabsorption of calcium by the kidney, and, in conjunction with parathyroid hormone (PTH), the mobilization of calcium from the skeleton.

o They act directly on bone cells to stimulate skeletal growth and on the parathyroid glands to suppress PTH synthesis and secretion. Vitamin D is also involved in magnesium metabolism.

• In patients with renal failure, the decreased capacity to synthesize 1, 25-(OH) 2D and to excrete phosphate causes secondary hyperparathyroidism.

o This results from the lowering of serum calcium by phosphate, the impairment of calcium absorption in the intestine, and the loss of the feedback inhibitory effect of 1, 25-(OH) 2D on PTH production.

o Hyperparathyroidism is categorized by the severity of disease as determined by the PTH level: mild to moderate (200-600 pg/mL); moderate to severe (>600-1200 pg/mL), and overt severe (> 1200 pg/mL).

o Management of secondary hyperparathyroidism of chronic renal failure requires both prevention and treatment.

o The initial preventive focus is directed at maintaining serum calcium and phosphate levels within the normal range.

o Treatment involves the administration of calcium salts or that of active vitamin D derivatives.

o Prolonged treatment with active vitamin D derivatives requires regular monitoring to avoid the occurrence of complications such as deterioration of chronic renal failure, adynamic bone disease, and extraskeletal calcifications.

 

 

Sources of Information and Basis for Decision

 

Andress, D. L. (2001). Intravenous versus oral vitamin D therapy in dialysis patients: What is the question? American Journal of Kidney Diseases, 38(5, Suppl. 5), S41-S44. Recommended that oral calcitriol should be used for intermittent vitamin D therapy and the monetary and physical costs to dialysis patients who experience side effects makes the benefit to cost ratio unacceptable.

 

Block, G. A., & Port, F. K. (2000). Re-evaluation of risks associated with hyperphosphatemia and hyperparathyroidism in dialysis patients: Recommendations for a change in management. American Journal of Kidney Diseases, 35(6), 1226-1237. Comparison that both Paricalcitol and Doxercalciferol has shown similar results of decreasing PTH levels with a decreased incidence of hypercalcemia and hyperphosphatemia. Supports that current management of phosphorus, Ca x P and PTH are no longer acceptable. Revised treatment goals in dialysis patients: Ca x P < 55 mg²/dL², P range 2.5 – 5.5 mg/dL, Ca 9.2 – 9.6 mg/dL, PTH 100 – 200 pg/mL.

 

Bone Care International. (2001). Package insert for Hectorol injection. [On-line]. Available: http://www.bonecare.com/Product/inject_PI.htm. Provided indications and recommended dosages for Hectorol.

 

Brown, A. J. (2001). Therapeutic uses of vitamin D analogues. American Journal of Kidney Diseases, 38(5, Suppl. 5) S3 – S19. Supported that both Paricalitriol and Doxercalciferol have not been more effective than Calcitriol in decreasing PTH levels, however, they have a reduced tendency to cause hypercalcemia.

 

Diax-Corte, C., & Cannata-Andia, J. B. (2000). Management of secondary hyperparathyroidism: The gap between diagnosis and treatment. The American Journal of the Medical Sciences, 320(2), 107-111. Discussed the use of vitamin D metabolites and the limitation of efficacy of calcitriol due to increased phosphorus and Ca x P product.

 

Drueke, T. B. (2001). Control of secondary hyperparathyroidism by vitamin D derivatives. American Journal of Kidney Diseases, 37(1, Suppl. 2), S58-S61. Documented previous studies indicating that intermittent oral versus intermittent IV treatment with calcitriol led to comparable suppression of plasma iPTH levels.

 

Facts and Comparisons (2000, January). Vitamin D. Drug Facts and Comparisons, 7-12. Identifies FDA – approved indications and recommended dosages for all three vitamin D analogs.

 

FCSO LCD 29007, Vitamin D Analogs in Chronic Renal Disease, 03/22/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Frazao. J., Elangovan, L., Maung, H., Chesney, R. W., Acchiardo, S. R., Bower, J. D., Kelley, B. J., Rodriquez, H. J., Norris, K. C., Robertson, J. A., Levine, B. S., Goodman, W. G., Gentile, D., Mazess, R. B., Kyllo, D. M., Douglass, L. L., Bishop, C. W., & Coburn, J. W. (2000). Intermittent doxercalciferol (1alpha-Hydroxyvitamin D²) therapy for secondary hyperparathyroidism. American Journal of Kidney Diseases, 36(3), 550-561. Multicenter trial shows that intermittent treatment with oral Hectorol effectively suppresses plasma iPTH levels in hemodialysis patients with secondary hyperparathyroidism with acceptable mild hypercalcemia and hyperphosphatemia.

 

Llack, F., & Yudd, M. (2001). Paricalcitol in dialysis patients with calcitriol – resistant secondary hyperparathyroidism. American Journal of Kidney Diseases, 38(5, Suppl. 5), S45-S50. Supports that Paricalcitol is effective in controlling secondary hyperparathyroidism when resistant to Calcitriol therapy. Established a 1:3 dosing regimen when converting from Calcitriol to Paracalcitol.

 

Maung, H. M., Elangovan, L., Frazao, J. M., Bower, J. D., Kelley, B. J., Acchiardo, S. R., Rodriquez, H. J., Norris, K. C., Sigala, J. F., Rutkowski, M., Robertson, J. A., Goodman, W. G., Levine, B. S., Chesney, R. W., Mazess, R. B., Kyllo, D. M., Douglass, L. L., Bishop, C. W., Coburn, J. W. (2001). Efficacy and side effects of intermittent intravenous and oral doxercalciferol (1a-Hydroxyvitamin D2) in dialysis patients with secondary hyperparathyroidism: A sequential comparison. American Journal of Kidney Diseases, 37(3), 532-543. Study indicates similar suppression of iPTH levels with IV and oral Hectorol, however, smaller elevation of calcium levels and phosphorus levels during IV administration. IV preferred to oral in patients who are prone to hypercalcemia.

 

Sprague, S. M., Lerma, E., McCormmick, D., Abraham, M., & Batlle, D. (2001). Suppression of parathyroid hormone secretion in hemodialysis patients: comparison pf paricalcitol with calcitriol. American Journal of Kidney Diseases, 38(5, Suppl. 5), S51-S56. Results of study indicated that IV Calcitriol & Paricalcitol are both effective in suppressing PTH concentrations in chronic hemodialysis patients with moderate – severe hyperparathyroidism and that a Paricalcitol dosed at 4:1 ratio resulted in a greater and more rapid PTH decrease. Increased occurrence of severe hyperphosphatemia in patients receiving Calcitriol.

 

Yudd, M., & Llach, F. (2000). Current medical management of secondary hyperparathyroidism. The American Journal of the Medical Sciences, 320(2), 100-106. Described management of patients with secondary hyperparathyroidism. Indicated that both oral and intravenous therapies are effective for the control of mild and moderate HPT, but for severe HPT, intravenous calcitriol has proven efficacy and is the preferred choice.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD L29007 VITAMIN D ANALOGS IN CHRONIC RENAL DISEASE