Commonwealth of Massachusetts Executive Office of Health and Human Services Office of Medicaid 600 Washington Street Boston, MA 02111 www.mass.gov/masshealth MassHealth Transmittal Letter CHC-81 August 2008 TO: Community Health Centers Participating in MassHealth FROM: Tom Dehner, Medicaid Director RE: Community Health Center Manual (Revised Pharmacy Regulations) This letter transmits revisions to the pharmacy regulations to eliminate the requirement that 340B entities submit a copy of the form used to register with the federal 340B program when they enroll in the MassHealth 340B program. This is no longer necessary due to changes in the federal 340B program. These regulations are effective September 15, 2008. If you have any questions about the information in this transmittal letter please contact MassHealth Customer Service at 1-800-841-2900, e-mail your inquiry to providersupport@mahealth.net, or fax your inquiry to 617-988-8974. NEW MATERIAL (The pages listed here contain new or revised language.) Community Health Center Manual Pages iv-a, 4-25, and 4-26 OBSOLETE MATERIAL (The pages listed here are no longer in effect.) Community Health Center Manual Pages iv-a, 4-25 and 4-26 — transmitted by Transmittal Letter CHC-74 Commonwealth of Massachusetts MassHealth Provider Manual Series Subchapter Number and Title Table of Contents Page iv-a Community Health Center Manual Transmittal Letter CHC-81 Date 09/15/08 4. Program Regulations (cont.) 405.451: Electrocardiogram (EKG) Services: Introduction ............................................. 4-23 405.452: Electrocardiogram (EKG) Services: Eligibility to Provide Services ................. 4-23 405.453: Electrocardiogram (EKG) Services: Payment Limitations ................................ 4-23 (130 CMR 405.454 through 405.460 Reserved) 405.461: Audiology Services: Introduction ...................................................................... 4-24 405.462: Audiology Services: Eligibility to Provide Services ......................................... 4-24 405.463: Audiology Services: Payment Limitations ........................................................ 4-24 (130 CMR 405.464 and 405.465 Reserved) 405.466: Pharmacy Services: Participation in the 340B Drug-Pricing Program for Outpatient CHC Pharmacies .......................................................................... 4-25 405.467: Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Services........ 4-25 (130 CMR 405.468 through 405.470 Reserved) 405.471: Optional Reimbursable Services ........................................................................ 4-26 405.472: Tobacco-Cessation Services ............................................................................. 4-26 (130 CMR 405.473 through 405.495 Reserved) 405.496: Utilization Management Program....................................................................... 4-27 Commonwealth of Massachusetts MassHealth Provider Manual Series Subchapter Number and Title 4. Program Regulations (130 CMR 405.000) Page 4-25 Community Health Center Manual Transmittal Letter CHC-81 Date 09/15/08 405.466: Pharmacy Services: Participation in the 340B Drug-Pricing Program for Outpatient CHC Pharmacies (A) Notification of Participation. A CHC 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 by submitting to the MassHealth agency a copy of the form used to register with the Health Resources and Services Administration, Office of Pharmacy Affairs (OPA), as a 340B-covered entity and, if applicable, a copy of the OPA form used to certify the contracted pharmacy services. The CHC may bill for 340B drugs to MassHealth members, either provided directly or through a subcontract, after the MassHealth agency confirms, in writing, its receipt of the CHC’s notification and copy of its OPA registration form, in accordance with 130 CMR 405.466(A). (B) Subcontracting for 340B Outpatient CHC Pharmacy Services. (1) A CHC 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 CHC 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 agency approval. (2) The CHC is legally responsible to MassHealth for the performance of any subcontractor. The CHC 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. (C) Termination or Changes in 340B Drug-Pricing Program Participation. A CHC must provide the MassHealth agency 30 days’ advance written notice of its intent to discontinue, or change in any way material to MassHealth, the manner in which it provides 340B outpatient drugs for its MassHealth patients. (D) Payment for 340B Outpatient CHC Pharmacy Services. MassHealth pays the 340B-covered entity for outpatient CHC pharmacy services, whether provided and billed directly or through a subcontractor, at the rates established in DHCFP regulations at 114.3 CMR 31.00. 405.467: Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Services The MassHealth agency pays for all medically necessary community health care for EPSDT- eligible members in accordance with 130 CMR 450.140 et seq., without regard to service limitations described in 130 CMR 405.000, and with prior authorization. (130 CMR 405.468 through 405.470 Reserved) Commonwealth of Massachusetts MassHealth Provider Manual Series Subchapter Number and Title 4. Program Regulations (130 CMR 405.000) Page 4-26 Community Health Center Manual Transmittal Letter CHC-81 Date 09/15/08 405.471: Optional Reimbursable Services A CHC may elect to provide the following services on site or by referral, but it is not required to do so under 130 CMR 405.000. The CHC must notify the MassHealth agency in writing of each service listed in 130 CMR 405.471(A) through (F) that the CHC will provide on site. All services provided on site must be provided and payment claimed in compliance with the applicable MassHealth regulations for each service, including applicable fee schedules. Services the CHC may elect to provide include: (A) adult day health services; (B) adult foster care; (C) day habilitation; (D) family planning; (E) psychiatric day treatment; and (F) speech and hearing services as described in 130 CMR 413.000. 405.472: Tobacco-Cessation Services (A) Introduction. MassHealth members are eligible to receive tobacco cessation counseling services described in 130 CMR 405.472(B) and pharmacotherapy treatment, including nicotine replacement therapy (NRT), in accordance with 130 CMR 406.000. (B) Tobacco Cessation Counseling Services. (1) MassHealth covers a total of 16 group and individual counseling sessions per member per 12-month cycle, without prior authorization. These sessions may be any combination of group and individual counseling. All individual counseling sessions must be at least 30 minutes, except for intake sessions, which must be at least 45 minutes. Intake sessions are limited to two per member per 12-month cycle, without prior authorization. (a) Individual counseling consists of face-to-face tobacco-cessation counseling services provided to an individual member by a MassHealth-qualified provider of tobacco- cessation services as set forth in 130 CMR 405.472(B) and (C). (b) Group tobacco treatment counseling consists of a scheduled professional counseling session with a minimum of three and a maximum of 12 members and has a duration of at least 60 to 90 minutes. (c) Individual and group counseling also includes collaboration with and facilitating referrals to other health-care providers to coordinate the appropriate use of medications, especially in the presence of medical or psychiatric comorbidities. (2) The individual and group tobacco-cessation counseling services must include the following: (a) education on proven methods for stopping the use of tobacco, including: (i) a review of the health consequences of tobacco use and the benefits of quitting; (ii) a description of how tobacco dependence develops and an explanation of the