Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: L-63-004
Topic: Vitamin D Assay
Section: Laboratory
Effective Date: October 1, 2016
Issue Date: October 3, 2016
Last Reviewed: March 2016

Vitamin D metabolites are used to assess serum vitamin D level and metabolism. Specifically, 25-hydroxy vitamin D, referred to as 25(OH)D, and 1,25-dihydroxyvitamin D. The 25 (OH)D metabolite  has an estimated half- life of approximately 2 to 3 weeks, and provides a measure of the vitamin D originating from both dietary/supplement sources and from cutaneous(e.g. sun exposure) production. Vitamin D stored in other body tissues are, however, not reflected in the serum 25(OH)D levels. Serum levels of the active vitamin D metabolite, 1,25-dihydroxyvitamin D, may not accurately indicate the individual’s vitamin D status due to its short half-life (15 hours). Since it’s closely regulated by parathyroid hormone and the intake of calcium and phosphate, serum levels of 1,25-dihydroxyvitamin D may appear normal in individuals with vitamin D deficiency.

Vitamin D deficiency is defined as a 25(OH)D below 20 ng/ml (50 nmol/liter), and vitamin D insufficiency as a 25(OH)D of 21–29 ng/ml(525–725 nmol/liter).

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Measurement of cholecalciferol 25-hydroxyvitamin D [25 (OH) D] levels may be considered medically necessary for individuals with: (not all inclusive).

25-OH Vitamin D-3 may be tested up to four times per year for Vitamin D deficiencies when the above criteria are met.

Testing and screening for vitamin D deficiency with 25-hydroxyvitamin D [25(OH)D] serum testing is considered not medically necessary for all other indications.

Procedure Codes
82306


Measurement of 1,25(OH)2D may be considered  medically necessary for evaluation of patients with a clinically documented underlying disease or condition associated with increased or decreased 1,25(OH)2D, including:

Measurement of 1,25(OH)2D may be tested up to four times per year for Vitamin D deficiencies when the above criteria is met.

With exception in very complex cases (e.g. hypercalcemia with reportedly low endogenous levels of 25-hydroxy vitamin D), there are rarely indications for ordering both 25-hydroxy vitamin D and1,25-dihydroxy vitamin D on the same specimen at the same time.  In the presence of renal disease, 1,25-dihdroxy vitamin D levels may be needed to adequately assess vitamin D status.

Testing and screening for vitamin D deficiency with 1,25 dihydroxyvitamin D [1,25(OH)2D] serum testing is considered not medically necessary for all other indications.

Procedure Codes
82652

Professional Statements and Societal Positions

Guidelines are in accordance with The Endocrine Society’s Clinical Practice Guidelines: Treatment, and prevention of Vitamin D Deficiency.  The Endocrine Society recommends screening for vitamin D deficiency in individuals at risk for deficiency.  The society does not recommend population screening for vitamin D deficiency in individuals who are not at risk.  It is recommended using the serum circulating 25-hydroxyvitamin D [25(OH)D] level, measured by a reliable assay to evaluate Vitamin D status in patients who are at risk for vitamin D deficiency. The society recommends using the serum 1,25-dihydroxyvitamin D [1,25(OH)2D] assay in monitoring certain conditions, such as acquired and inherited disorders of vitamin D and phosphate metabolism.


Place of Service: Outpatient

A vitamin D assay is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


FEP Guidelines

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as non-covered. A network provider cannot bill the member for the non-covered service.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer: If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.