Section 71-7-103 - Rare disease advisory council recommendations - Use of information - Input of advisory council(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.(2)(A) All advisory council recommendations must be presented in writing to members of the PAC and DUR and explained to members of the PAC and DUR by representatives of the advisory council during their public meetings.(B) The advisory council has no authority on any matter relating to TennCare, nor may it require the DUR or PAC to follow its recommendations.(b) The DUR and PAC shall consider information submitted to them by the advisory council on rare diseases and personalized medicine when making recommendations or determinations regarding: (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.(c) The DUR and PAC shall seek the input of the advisory council on rare diseases and personalized medicine to address topics for consultation under this chapter, including, but not limited to: (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.(d) Nothing in this chapter requires the advisory council, the DUR, or the PAC to consult with a person on any matter or requires those entities to meet with any specific expert or stakeholder.Added by 2020 Tenn. Acts, ch. 645, s 1, eff. 7/1/2020.