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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsFebruary 2016

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Delaware Health and Social Services ("Department") / Division of Medicaid and Medical Assistance (DMMA) initiated proceedings to amend the Delaware Title XIX Medicaid State Plan regarding Pharmaceutical Services, specifically, to clarify reimbursement methodology for entities that purchase 340B drug products. 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 November 2015 Delaware Register of Regulations, requiring written materials and suggestions from the public concerning the proposed regulations to be produced by November 30, 2015 at which time the Department would receive information, factual evidence and public comment to the said proposed changes to the regulations.
Veterans Health Care Act of 1992, Public Law 102-585, Section 602, limitations on prices of drugs purchased by certain clinics and hospitals, as amended by the Patient Protection and Affordable Care Act (Pub. L. No. 111-148), Health Care and Education Reconciliation Act of 2010 (Pub. L. No. 111-152) and Medicare and Medicaid Extenders Act of 2010 (Public Law 111-309)
1927(a)(1) and 1927 (a)(4) of the Social Security Act, authorizes state to enter directly into separate or supplemental rebate agreements with manufacturers
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
Section 340 of the Public Health Service Act, 42 U.S.C. §256b, imposes ceilings on prices drug manufacturers may charge for medications sold to specified health care facilities
42 CFR Part 10, 340B Drug Pricing Program
42 CFR §440.120, Prescribed drugs
42 CFR §447.201, State plan requirements
42 CFR §447.205, Public notice of changes in Statewide methods and standards for setting payment rates
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 the methods and standards governing payment methodology for pharmaceutical services. All comments were to be received by 4:30 p.m. on November 30, 2015.
Agency Response: DMMA thanks BIO for its support of the proposed changes to our outpatient drug reimbursement regulations. We are grateful for the insight and suggestions that you have shared with us. We will take your comments into consideration as we move forward with implementation of this regulation. 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 Delaware Title XIX Medicaid State Plan regarding Pharmaceutical Services, specifically, to clarify reimbursement methodology for entities that purchase 340B drug products, is adopted and shall be final effective February 11, 2016.
REVISION: ATTACHMENT 4.19-B
STATE: DELAWARE
[Contracted] [Ee]ntities that qualify for special purchasing under Section 602 of the Veterans Health Care Act of 1992, Section 340-B of the Public Health Service Act covered entities, selected disproportionate share hospitals and entities exempt from the Robinson-Patman Price Discrimination Act of 1936 must charge the DMAP no more than their actual acquisition cost (AAC) plus a professional dispensing fee. The AAC must be supported by invoice and payment documentation.
[Contracted] [Ee]ntities that purchase Section 340B of the Public Health Service Act products are prohibited from using their stock for DMAP patients either directly or through coverage of the Managed Care Organization.
Last Updated: December 31 1969 19:00:00.
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