16 Del. Admin. Code § 4470-6.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4470-6.0 - Addition of Debilitating Medical Conditions

6.1 Any citizen may petition the Department to add conditions or treatments to the list of debilitating medical conditions listed in 16 Del.C. § 4902A(3).

6.2 The Department shall not add a condition or treatment to the list of debilitating medical conditions unless it finds that (1) the medical condition or treatment is debilitating and (2) marijuana is more likely than not to have the potential to be beneficial to treat or alleviate the debilitation associated with the medical condition or treatment.

6.3 Contents of the petition: In connection with any petition to add conditions or treatments to the list of debilitating medical conditions listed in 16 Del.C. § 4902A(3), a petitioner shall provide the following information to the Department:

6.3.1 The extent to which the condition is generally accepted by the medical community and other experts as a valid, existing debilitating medical condition;

6.3.2 If one or more treatments of the condition, rather than the condition itself, are alleged to be the cause of the patient's suffering, the extent to which the treatments causing suffering are generally accepted by the medical community and other experts as valid treatments for the condition;

6.3.3 The extent to which the condition or treatments cause severe suffering, such as severe or chronic pain or severe nausea or vomiting, or otherwise severely impair the patient's ability to carry on activities of daily living;

6.3.4 The ability of conventional medical therapies other than those that cause suffering to alleviate suffering caused by the condition or treatment;

6.3.5 The extent to which evidence that is generally accepted among the medical community and other experts supports a finding that the use of marijuana alleviates suffering caused by the condition or treatment; and

6.3.6 Letters of support from physicians or other licensed health care professionals knowledgeable about the condition or treatment.

6.3.7 The evidence must indicate the intended patient population and whether it is generally accepted for both adult and pediatric use or limited to a particular population.

6.4 Evaluation of a petition

6.4.1 Upon review of materials submitted in response to subsection 6.3 above, the Division of Public Health (DPH) shall make a determination as to whether the petition has merit.

6.4.2 A petition will be determined to have merit if it contains all of the material required in subsection 6.3 above and the debilitating condition that is the subject of the petition has not been considered through this process in the prior two years, unless significant, generally accepted, scientific discoveries have been made that are substantially likely to reverse the prior decision.

6.4.3 A decision that a petition does not have merit will be made in writing, stating the reason or reasons it has been determined not to have merit and that it is the final decision, subject to judicial review.

6.4.4 A final decision on a petition determined to have merit will be made within 180 days of receipt of the petition in response to the following process.

6.4.4.1 DPH will post the complete petition on the Department's website for a 60-day public comment period.

6.4.4.2 DPH will post notice of a public hearing no fewer than 10 days prior to the public hearing

6.4.4.3 DPH will hold a public hearing within the 60-day public comment period.

6.4.4.4 After the public hearing and closure of the 60-day public comment period, DPH will review the petition and comments. During this review, DPH may conduct additional research, including consultation with additional experts.

6.4.4.5 DPH will draft a written decision on whether to grant the petition and add the debilitating medical condition for review and ultimate decision by the Department Secretary. This written decision will be detailed enough to provide the specific grounds and references to support the decision. The Department Secretary will issue the final decision on the petition.

6.4.4.6 If the petition to add a debilitating medical condition is granted, draft regulations adding the condition to Section 2.0 will be drafted and published in response to the Administrative Procedures Act Process.

6.5 The approval or denial of any petition is a final decision of the Department subject to judicial review. Jurisdiction and venue are vested in the Superior Court.

16 Del. Admin. Code § 4470-6.0

17 DE Reg. 738(1/1/2014)
23 DE Reg. 667(2/1/2020)
24 DE Reg. 485( 11/1/2020) (Final)