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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsMarch 2017

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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 Pharmaceutical Services, specifically, to clarify reimbursement methodology for covered outpatient drugs. The Department's proceedings to amend its regulations were initiated pursuant to 29 Delaware Code Section 10114 and its authority as prescribed by 31 Delaware Code Section 512.
The Department published its notice of proposed regulation changes pursuant to 29 Delaware Code Section 10115 in the November 2016 Delaware Register of Regulations, requiring written materials and suggestions from the public concerning the proposed regulations to be produced by December 1, 2016 at which time the Department would receive information, factual evidence and public comment to the said proposed changes to the regulations.
1927 of the Social Security Act, Payment for Covered Outpatient Drugs
42 CFR §447.512, Drugs: Aggregate upper limits of payment
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. Comments were to be received by 4:30 p.m. on December 1, 2016.
Agency Response: The table was inserted to clarify the specific requirements that CMS requires DMMA to address. The table format was adopted to keep each required response addressed. Providers have separate contracts with the managed care plans. State Plan reimbursement policies are for providers that submit fee-for-service claims directly to DMMA for reimbursement.
Agency Response: The ability to obtain a brand product, for multi-sourced products, when clinical necessary is still available to the practitioners who provide service to the DMMA clients.
Agency Response: DMMA is reimbursing for all outpatient drugs based on actual acquisition cost regardless of the source of obtaining these medications. The professional dispensing fee or clinical component of the service should address the additional cost for providing the medication.
Agency Response: The professional dispensing fee is based on the delivery of the medication to the DMMA client for self-administration. Your comments note four areas where counseling and administration are provided. The costs associated with the provision of these services are covered under the office visit or the clinical coverage.
Agency Response: DMMA's approach to the reimbursement of all outpatient drugs is to cover the cost of the product specifically. The service to deliver the product can be reimbursed based on the clinician's scope of effort to provide the medication. With this approach DMMA can treat all providers equally, regardless of the special circumstances regarding the acquisition of the medications.
Agency Response: The proposed regulation, 20 DE Reg. 342, referred to as 16-023 in your letter, sets forth the method by which DMMA will reimburse a covered entity for any claim submitted by that covered entity for reimbursement of a covered outpatient drug (COD). To the extent the cost for most managed care CODs is bundled into the capitated rate paid by DMMA to each of the managed care organizations, such costs are generally not submitted by covered entities directly to DMMA for payment and, therefore, are not contemplated by this proposed regulation. Providers have separate contracts with the managed care plans. State Plan reimbursement policies are for providers that submit fee-for-service claims directly to DMMA for reimbursement. The state plan amendment should not be interpreted as applying to claims paid by other processors.
Agency Response: This question does not relate to the proposed regulation, 20 DE Reg. 342, but rather appears to seek clarification of Delaware's previously approved State Plan Amendment (SPA 16-001), the purpose of which was to clarify reimbursement methodology for entities that purchase 340B drug products. The deadline for any public comments to SPA 16-001, which was noticed for public comment in the November 2015 Delaware Register of Regulations, was November 30, 2015. Furthermore, SPA 16-001 in its final form was approved by the Centers for Medicare and Medicaid Services ("CMS") on October 13, 2016. Because this inquiry falls outside of the deadline for public comments and, more importantly, concerns a regulation that has already been approved by CMS, DMMA declines to address that question.
THEREFORE, IT IS ORDERED, that the proposed regulation to amend the Title XIX Medicaid State Plan regarding Pharmaceutical Services, specifically, to clarify reimbursement methodology for covered outpatient drugs, is adopted and shall be final effective March 11, 2017.
STATE: DELAWARE
National Average Drug Acquisition Cost (NADAC), or if a NADAC is not available the Average Wholesale Price (AWP) minus 19%,
The professional dispensing fee rate is ten dollars ($10.00). There is one-time professional fee per thirty (30)-day period unless the class of drugs is routinely prescribed for a limited number of days.
STATE: DELAWARE
Federal Upper Limit (FUL) - The FUL is a federally defined price and constitutes the upper limit of reimbursement where a DMAC limit does not exist.
Non-Traditional Pharmacy - long term care and specialty pharmacies.
Traditional Pharmacy - retail independent and retail chain pharmacies.
The Actual Acquisition Cost (AAC) for Drug Reimbursement is derived using the methodology in the table below.
Exceptions of the reimbursement of FUL and DMAC can be made if a physician certifies in their own handwriting that a specific brand is medically necessary. The medical necessity must be documented on a FDA Med-Watch form based on the client experiencing an adverse reaction.
Other Exceptions will be made if documentation provided demonstrates that the product can only be obtained at a higher rate.
Last Updated: December 31 1969 19:00:00.
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