Section 406.404 - Provider Eligibility(A)All Providers. A pharmacy must be a participant in MassHealth on the date of service in order to be eligible for payment.(B)In-state Providers. To be eligible for participation as a MassHealth provider, a pharmacy must(1) have a retail establishment located and doing business in the Commonwealth of Massachusetts;(2) be licensed by the Massachusetts Board of Registration in Pharmacy in accordance with M.G.L. c. 112, and 247 CMR 6.00: Registration, Management and Operation of a Pharmacy or Pharmacy Department or be licensed by the Massachusetts Department of Public Health as a pharmacy in a clinic setting in accordance with M.G.L. c. 111;(3) be licensed by the federal Drug Enforcement Administration (DEA) and possess a DEA registration number (if a pharmacy is licensed to dispense only Schedule VI drugs, the pharmacy may possess a Massachusetts Controlled Substance Registration number instead of a DEA registration number); and(4) agree to use the MassHealth Pharmacy Online Processing System (POPS) in real-time mode to submit claims.(C)Out-of-state Providers.(1)All Out-of-state Providers. A provider that does not meet the requirements of 130 CMR 406.404(B) may participate in MassHealth only if the provider meets the following requirements of 130 CMR 450.109: Out-of-state Services; and (a) is licensed by the Board of Registration in Pharmacy (or the equivalent) in the state in which the provider primarily conducts business and in accordance with applicable provisions of 247 CMR 6.00: Registration, Management and Operation of a Pharmacy or Pharmacy Department;(b) possesses a DEA registration number;(c) participates in the Medicaid program or equivalent of the state in which the provider primarily conducts business; and(d) agrees to use the MassHealth agency Pharmacy Online Processing System (POPS) in real-time mode to submit claims.(2)Limited Purpose Out-of-state Providers. (a) If a pharmaceutical manufacturer supplies a drug only to a pharmacy that is located outside of Massachusetts, and the drug is medically necessary for a MassHealth member, the MassHealth agency may enroll such a provider for the limited purpose of dispensing the drug, and may only reimburse the pharmacy for the dispensing of that drug. The provider must agree to this restriction as a condition of enrollment and meet the requirements of 130 CMR 406.404(C)(1)(a) through (d).(b) If a member is covered by other primary insurance and that carrier requires use of an out-of-state pharmacy, MassHealth may enroll that pharmacy for the purpose of submitting secondary claims only.(c) If the drug later becomes readily available within Massachusetts, the MassHealth agency may disenroll the limited purpose out-of-state pharmacy.(D)Participation in the 340B Drug Pricing Program for Outpatient Pharmacy Services. (1)Notification of Participation. Except for drugs that cost $100,000 or more (gross cost per utilizer per year) that are designated as excluded from coverage for MassHealth members through the 340B Drug Pricing Program, a 340B-covered entity may provide drugs to MassHealth members through the 340B Drug Pricing Program, provided that it notifies the MassHealth agency by submitting to the MassHealth agency in writing 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, be consistent with all requirements of M.G.L. c. 118E, §13L, and 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 in the MassHealth Drug List.(2)Subcontracting for 340B Outpatient Pharmacy Services.(a) 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 340B-covered entity 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, and are subject to MassHealth approval.(b) The 340B-covered entity is legally responsible to the MassHealth agency for the performance of any subcontractor. The 340B-covered entity 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 MassHealth pharmacy regulations at 130 CMR 406.000 and all other applicable MassHealth requirements including, but not limited to, those set forth in 130 CMR 450.000: Administrative and Billing Regulations.(3)Termination or Changes in 340B Drug-pricing Program Participation. A 340B-covered entity 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.(4)Payment for 340B Outpatient Pharmacy Services. The MassHealth agency pays the 340B-covered entity for eligible pharmacy services, whether provided and billed directly or through a subcontractor, at the rates established in 101 CMR 331.00: Prescribed Drugs.Amended by Mass Register Issue 1319, eff. 8/12/2016.Amended by Mass Register Issue 1461, eff. 1/21/2022.Amended by Mass Register Issue 1511, eff. 1/1/2024.