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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJune 2016

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Delaware Health and Social Services ("Department") / Division of Medicaid and Medical Assistance initiated proceedings to amend the Title XIX Medicaid State Plan regarding the State's Prescription Drug Supplemental Rebate Agreement, specifically, to amend Delaware's supplemental drug rebate agreement and place Delaware in "The Sovereign State Drug Consortium (SSDC)" Medicaid multi-state purchasing pool. The Department's proceedings to amend its regulations were initiated pursuant to 29 Del.C. §10114 and its authority as prescribed by 31 Del.C. §512.
The Department published its notice of proposed regulation changes pursuant to 29 Del.C. §10115 in the April 2016 Delaware Register of Regulations, requiring written materials and suggestions from the public concerning the proposed regulations to be produced by May 2, 2016 at which time the Department would receive information, factual evidence and public comment to the said proposed changes to the regulations.
1927(a)(1), 1927 (a)(4) of the Social Security Act and 42 U.S.C. §13966-8, authorizes state to enter directly into separate or supplemental rebate agreements with manufacturers
1927(b)(3)(D) of the Social Security Act, confidentiality of information disclosed by manufacturers or wholesalers
1927(d)(1)(A) of the Social Security Act, prior authorization on covered outpatient drug
1927(d)(5) of the Social Security Act, requirements of prior authorization programs
1902(a)(19) of the Social Security Act, care and services under a Medicaid state plan be provided in a manner consistent with simplicity of administration and the best interests of beneficiaries
42 U.S.C. §256b, imposes ceilings on prices drug manufacturers may charge for medications sold to specified health care facilities
In accordance with the federal public notice requirements established at Section 1902(a)(13)(A) of the Social Security Act and 42 CFR 447.205 and the state public notice requirements of Title 29, Chapter 101 of the Delaware Code, Delaware Health and Social Services (DHSS)/Division of Medicaid and Medical Assistance (DMMA) gives public notice and provides an open comment period for thirty (30) days to allow all stakeholders an opportunity to provide input to Delaware's decision amend the state's supplemental drug rebate agreement and place Delaware in "The Sovereign State Drug Consortium (SSDC)" Medicaid multi-state purchasing pool. Comments were to be received by 4:30 p.m. on Monday May 2, 2016.
Agency Response: DMMA thanks the Council for its endorsement. No change was made to the regulation as a result of these comments.
Agency Response: DMMA thanks the Council for its endorsement. No change was made to the regulation as a result of these comments.
THEREFORE, IT IS ORDERED, that the proposed regulation to amend the Title XIX Medicaid State Plan regarding the State's Prescription Drug Supplemental Rebate Agreement, specifically, to amend Delaware's supplemental drug rebate agreement and place Delaware in "The Sovereign State Drug Consortium (SSDC)" Medicaid multi-state purchasing pool is adopted and shall be final effective June 11, 2016.
12.c Prescribed Drugs Continued:
The recommendations of the Drug Utilization Review (DUR) Board shall constitute interpretive guidelines to be used in the determination whether to grant or deny prior authorization of a prescription drug. The makeup and membership authority for the DUR Board complies with 42 U.S.C. s1396r-8.
Drug Supplemental Rebate Agreements
12.c Prescribed Drugs Continued:
Drug Supplemental Rebate Agreements Continued
In addition the State has the following policies for the supplemental rebate program for the Medicaid population:
Last Updated: December 31 1969 19:00:00.
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