On May 23, the Senate passed its version of the Fiscal Year 2025 budget. The budget bill will now advance to a legislative conference to work out differences before the end of the fiscal year, June 30, 2024. The relevant issue to pharmacies is language included in the House, but not in the Senate, that would authorize a registered pharmacist to administer a prescription for testosterone for gender-affirming care and for the treatment and prevention of sexually transmitted infections including the prevention of HIV infections. The administration of these therapies shall be in accordance with regulations promulgated by the Department of Public Health in consultation with the Board of Pharmacy and the Department of Mental Health. This proposed change amends the current law which authorizes pharmacists to administer drugs for the treatment of mental health and substance abuse disorders. NACDS will continue to monitor the budget process. 

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.

MassHealth posted a bulletin that MassHealth will not pay for certain high-cost drugs if purchased through the 340B Drug Pricing Program. This change applies to claims for MassHealth members in Fee-for Service, the Primary Care Clinician (PCC) Plan and Primary Care Accountable Care Organizations. Providers serving MassHealth members enrolled in Accountable Care Partnership Plans (ACPPs), Managed Care Organizations (MCOs), One Care plans, Senior Care Organizations or the MassHealth behavioral health vendor should refer to Managed Care Entity Bulletin 7 for additional information regarding payment policies applicable to those plans.

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.

MassHealth issued the following two updates on March 26: 

• Transmittal Letter ALL-246 – This letter transmits updates to 130 CMR 450.000: Administrative and Billing Regulations. Subsection 130 CMR 450.130 has been amended to reflect that MassHealth members will no longer be required to make copayments. Copayments have been temporarily eliminated since May 1, 2023; this update extends this policy indefinitely. These regulations are effective April 1, 2024.  
• Managed Care Entity Bulletin 112 – This bulletin relates to certain drugs that may be used for the treatment of obesity that a provider purchased through the 340B Drug Pricing Program (340B stock). The bulletin applies to Accountable Care Partnership Plans (ACPPs), Managed Care Organizations (MCOs), One Care Plans and Senior Care Organizations (SCOs) (collectively referred to as “Managed Care Entities”). In MCE Bulletin 109, the Executive Office of Health and Human Services (EOHHS) directed Managed Care Entities not to pay for specified GLP-1 agonist drugs if those drugs were purchased through the 340B Drug Pricing Program, effective April 1, 2024. Through this Bulletin, EOHHS is delaying the effective date of this policy until July 1, 2024.  

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.

The Massachusetts Joint Legislative Committee on Financial Services has reported H4066, a bill to expand pharmacist’s scope of practice, favorably out of the committee. Specifically, the bill directs the Board of Pharmacy to establish protocols for pharmacies to test, screen and initiate treatment or therapy for qualified health conditions: Influenza, Streptococcal infections, COVID-19, HIV, and any other conditions approved by the Board. H4066 also allows pharmacists to delegate the tasks of performing a CLIA–waived test to pharmacy technicians acting under the supervision of the pharmacists. Lastly, the bill requires insurance carriers to make available provider and consult codes for pharmacy compensation which shall be at the standard contracted rate that they reimburse for the same services by any other healthcare provider. H4066 will now be assigned to a committee of second jurisdiction. NACDS will continue to partner with the Massachusetts Chain Pharmacy Council to advocate for final passage of the bill.

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.

The Board of Pharmacy updated its standing order regarding Naloxone. Pharmacists and other pharmacy licensees may administer naloxone to someone appearing to be experiencing an opioid-related overdose and will not be subject to criminal or civil liability or any professional disciplinary action in accordance with state law. 

Also in Massachusetts, the Department of Public Health (DPH) proposed changes to 105 CMR 222 which regulates the Massachusetts Immunization Information System (MIIS). The changes will: 

• Expand the application of the MIIS regulations to also cover authorized recipients of the information transmitted through the system in addition to health care providers. DPH is authorized to designate other appropriate users of the MIIS. 
• Shorten the time timeframe for healthcare providers to report all new immunizations through the system from 7 days to within 72 hours (3 days) of immunization administration.  
• Add the following new information about the recipient that must be transmitted: the recipient’s sex, gender, race, ethnicity and preferred language. 
• Authorize an immunization recipient’s legally authorized representative to object to the sharing of a patient’s immunization information.  
• Add a definition of “Authorized Recipient” to include an individual or agency that the DPH may release immunization information to for specified purposes without further consent from immunization recipients or their legal authorized representatives. An authorized recipient may not access the MIIS until they register as an authorized user. 
• Authorize the Department to enter into collaborative agreements with other states for the purposes of exchanging immunization information. 

Comment deadline is March 15.  

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.

On February 1, the Massachusetts Board of Pharmacy held its regularly scheduled meeting. Two actions were taken by the board: 

1. A proposed change to 247 CMR 3.00 will create two different licensing categories for pharmacy technicians. This proposed change is designed to attract more individuals to serve as pharmacy technicians. Once approved, the new regulations will create a Pharmacy Technician 1 (PT1) and a Pharmacy Technician 2 (PT2). The new PT1 applies to persons 16 years of age or older, is of good moral character, and has a high school education or are enrolled in a program that awards that degree or certificate. The PT1 can be licensed by the Board if they meet those qualifications. The PT1 will not be required to participate in a training program, complete a minimum hours on-the-job-training or pass a certification exam. The requirements for PT2 mirror the current regulations the licensing of pharmacy technicians. This proposed regulation must be reviewed and approved by the Governor’s office. After the Governor’s approval, a public hearing will be held to receive public comments. 
2. A new policy on non-sterile compounding that provides some exemptions to the current USP (United States Pharmacopeia) mandate was also acted upon.  

Also in Massachusetts, MassHealth provided an update to the pharmacy benefit concerning obesity drugs. To maximize the state’s ability to collect drug rebates on the following drugs, the Executive Office of Health and Human Services, which oversees MassHealth, is directing Managed Care Entities to not pay for the following drugs if the provider uses 340B stock: Saxenda® (liraglutide), Victoza® (liraglutide), Ozempic® (semaglutide), Rybelsus® (semaglutide), Wegovy® (semaglutide), Mounjaro® (tirzepatide) and Zepbound® (tirzepatide) 

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.

Gov. Maura Healey (D) released her Fiscal Year 2025 budget. Included in the proposal are the following policy changes impactful to retail pharmacies: 

• Authorizing pharmacies to administer injections for those persons with prescriptions for testosterone for gender affirming care and for treatment of sexually transmitted infections. This language builds on the previous expansion of pharmacist practice that authorized pharmacists to administer medications for the treatment of behavioral health conditions and substance use disorders. 
• Enabling pharmacies to fill prescriptions for expedited partner therapy beyond the current authorization for Chlamydia to include other sexually transmitted infections based on national standards including the Centers for Disease Control and Prevention Sexually Transmitted Infections Treatment Guidelines. 
• Increasing the maximum fill for certain classes of medication to increase access, including testosterone for gender-affirming care, stimulants for ADD (attention deficit disorder)/ADHD (attention deficit hyperactivity disorder) and medications for opioid use disorder which do not have a potential for abuse. 
• Authorizing a standing order for prenatal vitamins and oral contraceptives so that federal financial participation is available for these products when pharmacies dispense them to MassHealth members and persons whose claims are paid by the Health Safety Net. 
• Eliminating co-payments for persons enrolled in the Children’s Medical Security Plan.  
• Authorizing MassHealth to negotiate drug rebate agreements for drugs not subject to the Medicaid Drug Rebate Program such as certain non-drug products and durable medical equipment (DME). 

The Governor’s proposal will be considered and redrafted by the House Committee on Ways and Means over the next two months.  

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.

The Board of Pharmacy issued the following updates on January 11.  

• Emergency Contraceptive (EC) Dispensing Report: Any EC dispensed pursuant to the standing order within a calendar year (January 1 – December 31) must be reported using the Annual Emergency Contraception Standing Order Report.  
• Policy 2024-01 Naloxone Dispensing: Reviews the dispensing of over-the-counter (OTC) naloxone. 
• Policy 2019-02 Automated Dispensing Device Use: Information for Hospice Inpatient Facility acute use was added.  
• Policy 2018-01 Permitted Prescription Changes and Additions: Flavoring agent information was added. 
• 247 CMR 22.00: Monetary Penalties: Draft Regulation.  

The Board also sent a reminder to community pharmacies that the Board regulations require all community pharmacies to provide non-sterile compounding services to their customers. It has come to the Board’s attention that some pharmacies have discontinued their non-sterile compounding services. The Board cited the two regulations below that require this practice to be available; see below. The Board urged any pharmacy that has any questions about these regulations to contact them. The Board is discussing the need for further Board guidance on this issue, which they expect to discuss at a future meeting. 

• 247 CMR 6.02: Conditions for Continuing Registration and Operation of a Pharmacy or Pharmacy Department 

• • (4) The pharmacy or pharmacy department shall maintain on the premises at all times a sufficient variety and supply of medicinal chemicals and preparations which are necessary to compound and dispense commonly prescribed medications in accordance with the usual needs of the community. 

• 247 CMR 9.01: Code of Professional Conduct for Registered Pharmacists, Pharmacies and Pharmacy Departments 

• • (16) A pharmacist shall not refuse to compound customary pharmaceutical preparations except upon extenuating circumstances.

Also in Massachusetts, on January 10, the Public Health Council voted to make permanent the current emergency regulations at 105 CMR 700.004 (15) that authorize pharmacists to prescribe and dispense certain hormonal contraceptives. The Department of Public Health and the Council did not make any changes to the original emergency regulations. As a result, there will be no change to the current practice in this area.

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.

MassHealth has issued a new draft of the Pharmacy Manual at 130 CMR 406. The new regulations make the following changes:  

• Adds compounded drugs, and medically necessary cosmetic drugs for the treatment of alopecia or gender identity that are listed on the MassHealth Drug list, to the list of Covered Drugs and Medical Supplies at 406.412. 
• Deletes the language in the current regulations at 406.413 that prohibits MassHealth from paying for any drug used for the treatment of obesity. The prohibition has been eliminated and MassHealth will now pay for drugs to treat obesity that are included on the MassHealth Drug List. 
• Adds the new section 406.446 relative to Pharmacy Drug Review and Counseling that requires pharmacies that are servicing MassHealth patients to offer prospective drug review and counseling that are consistent with the current MA law that requires pharmacists to make an offer to counsel. Only a patient’s refusal of counseling must be documented. 

These changes will become effective on January 1, 2024. 

For more information, please contact NACDS’ Ben Pearlman at 617-515-2603.