1. (a) As used in this section:

   1. (1) “Hormone replacement therapy” means medical treatment, approved by the United States Food and Drug Administration, that replaces a hormone that an individual’s body is no longer making or no longer making enough of, as determined by a licensed health-care professional. “Hormone replacement therapy” includes prescribing any of the following:

      1. a. A cream.
      2. b. An oral medication.
      3. c. A vaginal device.
      4. d. Another method approved by the United States Food and Drug Administration.

   2. (2) “Medically necessary” means providing of health-care services or products that a prudent licensed health-care professional would provide to a patient for the purpose of diagnosing or treating an illness, injury, disease or its symptoms in a manner that is all of the following:

      1. a. In accordance with generally accepted standards of medical practice.
      2. b. Consistent with the symptoms or treatment of the condition.
      3. c. Not solely for anyone’s convenience.
      4. d. Not including investigational or experimental health-care services.
   3. (3) “Menopause” means the permanent end of menstruation due to loss of ovarian follicular function, characterized by the end of ovulation and a decline in estrogen and progesterone production.

   4. (4) “Menopause and perimenopause symptoms” include any of the following:

      1. a. Irregular menstrual periods.
      2. b. Hot flashes.
      3. c. Vaginal or bladder changes, including genitourinary syndrome of menopause.
      4. d. Decreased fertility.
      5. e. Loss of bone density, including osteoporosis.
      6. f. Elevated low-density lipoprotein cholesterol levels.
      7. g. Sleep disturbances, including night sweats.
   5. (5) “Perimenopause” means the transitional period leading to menopause, marked by fluctuating hormone levels and changes in the menstrual cycle.

2. (b) (1) Carriers shall provide coverage for medically diagnostic services and necessary treatment for menopause, perimenopause, and menopause and perimenopause symptoms in all health benefit plans delivered or issued for delivery under § 505(3) of this title, including all of the following:

   1. a. Consultation and diagnostic testing.
   2. b. Hormonal therapies, including hormone replacement therapy and bioidentical hormone treatments, that are approved by the United States Food and Drug Administration.
   3. c. Nonhormonal treatments, including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, neurokinin B antagonists, and other medications to manage menopause and perimenopause symptoms.
   4. d. All drugs, devices, and combination products approved by the United States Food and Drug Administration for the treatment of menopause and perimenopause symptoms.
   5. e. Therapy to treat menopause induced by a hysterectomy.
   6. f. Behavioral health care services.
   7. g. Pelvic floor physical therapy.
   8. h. Bone health treatments due to hormonal changes related to menopause and perimenopause, including screenings and medications.
   9. i. Preventative services for early detection and treatment of health conditions related to menopause and perimenopause, including osteoporosis and cancer.
   10. j. Counseling and education regarding menopause management.
   11. (2) A carrier shall provide clear and accessible information to each recipient regarding covered diagnostic services and treatment for menopause, perimenopause, and menopause and perimenopause symptoms.

   12. (3) Except as otherwise provided by federal law, coverage for medically necessary hormone replacement therapy provided under this section may not be any of the following:

       1. a. Denied or limited, if the use of the hormone replacement therapy is supported by national clinical guidelines, national standards of care, or peer-reviewed medical literature for the treatment of menopause, perimenopause, or menopause and perimenopause symptoms.
       2. b. Subject to prior authorization or step therapy requirements.
   13. (4) Except as otherwise provided by paragraph (b)(3) of this section and federal law, assistance provided under this section must be provided to recipients to the same extent as other assistance for any other medical condition provided under § 505(3) of this title.

85 Del. Laws, c. 482, § 4