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Virginia Administrative Code
Title 14. Insurance
Agency 5. State Corporation Commission, Bureau of Insurance
Chapter 216. Rules Governing Internal Appeal and External Review
11/23/2024

14VAC5-216-65. Exception request for prescription drugs.

A. For plan years beginning on or after January 1, 2016, notwithstanding any other provision of this chapter, a health carrier shall have a process in place that allows for a covered person or his prescribing physician (or other prescriber) to request and gain access to clinically appropriate drugs not otherwise covered by the health benefit plan, known as an exception request, in accordance with the requirements of 45 CFR §156.122(c).

1. A standard exception request shall be reviewed and acted upon within one business day of receipt of the request, and a coverage determination shall be provided to the covered person and prescribing physician no later than 72 hours following receipt of the request.

2. An expedited exception request may be made when exigent circumstances exist. Exigent circumstances exist when the covered person is suffering from a health condition that may seriously jeopardize the covered person's life, health, or ability to regain maximum function or when the covered person is undergoing a current course of treatment using a nonformulary drug. An expedited exception request shall be reviewed and a coverage determination provided to the covered person and prescribing physician no later than 24 hours following receipt of the request.

3. If a health carrier denies coverage as a result of a standard exception request or an expedited exception request, the covered person or prescribing physician may submit an external exception request to the health carrier, requiring that the original exception request and subsequent denial be reviewed by an independent review organization. Such request shall be reviewed and a coverage determination provided to the covered person and prescribing physician no later than 72 hours following receipt of the request if the original request was a standard exception request, or 24 hours following receipt of the request if the original request was an expedited exception request.

B. The health carrier shall provide the nonformulary drug or drugs for the duration of the prescription (including refills) if coverage is granted under a standard exception request, or for the duration of the exigency if coverage is granted under an expedited exception request, including those granted through an external exception request. Coverage for each drug approved by an exception request shall be applied as if the drug was part of the prescription formulary.

C. A health carrier shall contract with at least one accredited independent review organization to conduct reviews in accordance with the requirements of subdivision A 3 of this section.

Statutory Authority

§§ 12.1-13 and 38.2-223 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 12, eff. February 1, 2016.

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