Tennessee Code Title 71. Welfare § 71-7-103

(a)(1) The Tennessee rare disease advisory council shall advise the DUR, the PAC, and other state entities in their review of products or medications for the treatment of rare and orphan diseases, and drugs or biological products within the emerging fields of personalized medicine and non-inheritable gene editing therapeutics.

(1) Beneficiary access to drugs and biological products for rare diseases, as defined in the federal Orphan Drug Act of 1983 (21 U.S.C. §§ 360aa -- 360ff-1);

(2) Drugs and biological products that are approved by the United States food and drug administration; and

(3) The emerging fields of personalized medicine and non-inheritable gene-editing therapeutics.

(1) Rare diseases;

(2) The severity of rare diseases;

(3) The unmet medical needs associated with rare diseases;

(4) The impact of particular coverage, cost-sharing, tiering, utilization management, prior authorization, medication therapy management, or other medicaid policies on access to rare disease therapies;

(5) An assessment of the benefits and risks of therapies to treat rare diseases;

(6) The impact of coverage, cost-sharing, tiering, utilization management, prior authorization, medication therapy management, or other medicaid policies on patients' adherence to the treatment regimen prescribed or otherwise recommended by their physicians;

(7) Whether beneficiaries who need treatment from or a consultation with a rare disease specialist have adequate access and, if not, what factors are causing the limited access; and

(8) The demographics and the clinical description of patient populations.