130 CMR, § 410.468

Current through Register 1533, October 25, 2024

Section 410.468 - Participation in the 340B Drug-pricing Program for Pharmacy Services

(A)Notification of Participation. Except for drugs that cost $100,000 (gross cost per utilizer per year) that are designated as excluded from coverage for MassHealth members through the 340B Drug Pricing Program, a hospital outpatient department or a hospital-licensed health center that is a 340B-covered entity may provide drugs to MassHealth members through the 340B Drug Pricing Program provided that it notifies the MassHealth agency that the 340B-covered entity is registered and approved by the federal Office of Pharmacy Affairs (OPA). Any high-cost drug designated for exclusion from coverage for MassHealth members through the 340B Drug-Pricing Program will be communicated by provider bulletin or other written issuance from the MassHealth agency, and be consistent with all requirements of M.G.L. c. 118E, §13L, and shall include an opportunity for eligible providers to provide input regarding the designation. The MassHealth agency may designate up to 25 drugs for exclusion from coverage for MassHealth members through the 340B Drug Pricing Program. Any exclusion from coverage for MassHealth members through the 340B Drug Pricing Program does not apply to claims paid using the adjudicated payment amount per discharge (APAD) or adjudicated payment per episode of care (APEC) methodology, other than for drugs listed on the Acute Hospital Carve-Out Drugs List section of the MassHealth Drug List.

(B)Subcontracting for 340B Outpatient Pharmacy Services.

(1) A hospital outpatient department or hospital-licensed health center that is a 340B-covered entity may contract with a MassHealth pharmacy provider to dispense 340B drugs for the 340B-covered entity's MassHealth patients. All such subcontracts between the 340B-covered entity and a pharmacy provider must be in writing, ensure continuity of care, specify that the hospital pays the pharmacy, specify that such payment constitutes payment in full for 340B drugs provided to MassHealth members, be consistent with all applicable provisions of 130 CMR 406.000: Pharmacy Services, and are subject to MassHealth agency approval.

(2) The hospital is legally responsible to MassHealth for the performance of any subcontractor. The hospital must ensure that every pharmacy subcontractor is licensed by the Massachusetts Board of Registration in Pharmacy and is a MassHealth pharmacy provider, and that services are furnished in accordance with 130 CMR 406.000: Pharmacy Services and all other applicable MassHealth requirements, including but not limited to, those set forth in 130 CMR 450.000: Administrative and Billing Regulations.

(C)Termination or Changes in 340B Drug-pricing Program Participation. A hospital outpatient department or hospital-licensed health center must provide the MassHealth agency 30 days' advance written notice of its intent to discontinue, or change in any way material to the MassHealth agency, the manner in which it provides 340B outpatient drugs for its MassHealth patients.

(D)Payment for 340B Outpatient Pharmacy Services. The MassHealth agency pays the 340B-covered entity for outpatient hospital pharmacy services, whether provided and billed directly or through a subcontractor, at the rates established in 101 CMR 331.000: Prescribed Drugs.