Insurance Coverage for Prescription Drugs Used in Manner Different Than Use Authorized by Fda

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  2. Georgia Code
  3. Insurance
  4. Insurance Generally
  5. General Provisions
  6. Insurance Coverage for Prescription Drugs Used in Manner Different Than Use Authorized by Fda

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  1. As used in this Code section, the term:
    1. "Chronic and seriously debilitating" means diseases or conditions that cause significant long-term morbidity and that require ongoing treatment to maintain remission or prevent deterioration.
    2. "Health benefit policy" means any individual or group plan, policy, or contract for health care services issued, delivered, issued for delivery, executed, or renewed in this state, including, but not limited to, those contracts executed by the state on behalf of state employees under Article 1 of Chapter 18 of Title 45, by an insurer; provided, however, that "health benefit policy" shall not include the limited benefit policies as defined in paragraph (4) of subsection (e) of Code Section 33-30-12.
    3. "Insurer" means any person, corporation, or other entity authorized to provide health benefit policies under this title.
    4. "Life-threatening" means:
      1. Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted;
      2. Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival; or
      3. The natural process of aging shall not be construed as a disease or condition for the purposes of this definition or this Code section.
  2. No health benefit policy issued, delivered, or renewed in this state that, as a provision of hospital, medical, or surgical services, directly or indirectly covers prescription drugs shall limit or exclude coverage for a drug on the basis that the drug is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration, provided that all of the following conditions have been met and subject to the prior authorization process or other restrictions of the insurer:
    1. The drug has been approved by the federal Food and Drug Administration;
      1. The drug is prescribed by a contracting licensed health care professional for the treatment of a life-threatening disease or condition;
      2. The drug is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating disease or condition, the drug is medically necessary to treat that disease or condition, and the drug is on the insurer's formulary or preferred drug list, if any; or
      3. The drug is prescribed by a contracting licensed health care professional to treat a disease or condition in a child where the drug has been approved by the federal Food and Drug Administration for similar conditions or diseases in adults and the drug is medically necessary to treat that disease or condition; and
    3. The drug has been recognized for treatment of that disease or condition or pediatric application by one of the following:
      1. The American Medical Association Drug Evaluations;
      2. The American Hospital Formulary Service Drug Information; or
      3. The United States Pharmacopoeia Dispensing Information, Volume 1, "Drug Information for the Health Care Professional"; or
      4. Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.
  3. It shall be the responsibility of the contracting prescriber to submit to the insurer documentation supporting compliance with the requirements of subsection (b) of this Code section, if requested by the insurer.
  4. Any coverage required by this Code section shall also include medically necessary services associated with the administration of a drug subject to the conditions of the contract.
  5. The provisions of this Code section shall not be deemed to require coverage for any of the following:
    1. The treatment of a condition or disease that is excluded under the terms of the health benefit policy;
    2. An experimental drug not approved for indication by the federal Food and Drug Administration; or
    3. Drug treatment by a drug not listed on the health benefit plan formulary or preferred drug list.
  6. The benefits provided in this Code section shall be subject to the same annual deductibles or coinsurance established for all other covered benefits within a given health benefit policy.

(Code 1981, §33-24-59.11, enacted by Ga. L. 2003, p. 872, § 2; Ga. L. 2019, p. 386, § 73/SB 133.)

The 2019 amendment, effective July 1, 2019, in paragraph (a)(2), in the middle, deleted "on or after July 1, 2003" following "renewed in this state", and substituted "the state" for "the State of Georgia".

Cross references.

- Standards, labeling, and adulteration of drugs and cosmetics, § 26-3-21 et seq.

Law reviews.

- For article, "Free Speech and Off-Label Rights," see 54 Ga. L. Rev. 463 (2020).


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