On December 6, the Board of Pharmacy published new regulations relative to pharmacy licensing and the Continuous Quality Improvement Program.

Amendments to 247 CMR 6.00

Created six new license categories for certain types of pharmacy practice:

1. sterile compounding,
2. complex sterile compounding,
3. institutional sterile compounding,
4. non-resident drug stores,
5. non-resident sterile compounding,
6. non-resident complex non-sterile compounding.

The proposed changes explain which license types are needed for which activities, set forth the eligibility requirements and procedures for obtaining each type of license, and set forth grounds for denial of licensure due to lack of suitability. The proposed changes update requirements related to the change of a pharmacy’s manager of record, location or ownership, pharmacy renovations and the closure of a pharmacy. The proposed changes remove practice standards from this section in order that all such practice standards may be aggregated at 247 CMR 9.00.

Amendments to 247 CMR15.00

Requires pharmacies to establish and implement a “Continuous Quality Improvement Program,” meaning a system for identifying and documenting prescription dispensing errors; notifying affected patients, and health care providers as necessary; analyzing the error to identify causes and contributing factors; and using the information to improve pharmacy systems and workflow.

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

The Board of Pharmacy issued the following two updates:

• Policy 2024-02: Implantable Infusion Pumps – Outlines requirements for extended infusion times of compounded sterile preparations via implanted pumps.
• 247 CMR 13.00: Nuclear Pharmacy Licensure Requirements and Professional Practice Standards – The most significant change was to remove the requirement for the separate nuclear pharmacist license and defer nuclear pharmacist qualifications to the nuclear regulations at 105 CMR 120.526: Training for an Authorized Nuclear Pharmacist.

Also in Massachusetts, MassHealth released the latest Pharmacy Facts that includes a COVID-19 Vaccination Reimbursement Update.

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

On October 4, MassHealth released the results of its cost of dispensing study. It was announced that the proposed updated dispensing fee for chain pharmacies will be reduced by $1.51 per prescription from $10.02 to $8.51. This proposed change is scheduled to take effect on July 1, 2025. The dispensing fee for independent pharmacies will be increased by 19 cents to $10.21.  The division also announced a policy change that will require managed care organizations (MCOs) to pay the MassHealth fee-for-service rate to independent pharmacies instead of the current managed care contract rate.  MCOs will continue to pay chain pharmacies the negotiated contract rate. The raw data from the cost of dispensing survey is expected to be made available within the next two weeks. The proposed amendments will be submitted to CMS for its approval.

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

The Board of Pharmacy issued notice that licensing of non-resident pharmacies will become available in the coming months. At least one pharmacist at each non-resident pharmacy must hold a Massachusetts pharmacist license. (This pharmacist does not have to be the store’s pharmacist-in-charge.) In preparation for non-resident pharmacy licensing, it is strongly recommended to begin the licensing process for the pharmacists as the process can take 30-60 days. Applications and instructions can be found online. Please see the FAQ document for other information regarding non-resident pharmacy licensing.

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

The Massachusetts Board of Registration in Pharmacy posted its August newsletter. Included in this newsletter is information about pharmacy license renewals.

Also in Massachusetts, the formal legislative session ended early in the morning on August 1. The legislature failed to pass a conference report for S2520, an Act relative to pharmaceutical access, costs and transparency. The bill would have included reporting to the Health Policy Commission, PBM licensure, audit regulations, prohibition of spread pricing and other fees and required drug rebates returned to consumer. As both chambers have unanimously passed their versions of the bill, there is a slight chance the legislature could advance the bill during informal sessions; however, only one member of a chamber is needed to prevent floor action. NACDS will continue to advocate for PBM policy principles in Massachusetts during the informal legislative session for the remainder of the year and prepare for the new session in 2025.

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

On July 22, the House Committee on Ways and Means released H4891, an act relative to pharmaceutical access, costs and transparency, that includes PBM reforms. The bill was brought to the floor of the House on July 24. NACDS worked with the Massachusetts Chain Pharmacy Council to offer several friendly amendments to improve the bill. NACDS will continue to work to ensure final passage of PBM reform in the Massachusetts legislative session that ends on July 31. 

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

On June 25, MassHealth published its regular pharmacy facts update that includes revisions to the MassHealth Drug List.

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

NACDS will be joining the Massachusetts Chain Pharmacy Council and other members of the Patients Not PBMs coalition in support of PBM reform legislation at the Massachusetts State House on Wednesday, June 26, 2024, at 11:00am.  The event will include speakers from the pharmacy and patient communities.  NACDS encourages members to send as many pharmacists and associates as possible.  

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

MassHealth published its June “All Provider Bulletin 391” with orders ALL 361, ALL 376 and ALL 380 announcing the start dates for enforcing the ordering, referring and prescribing (ORP) requirements. With the exception of the information in the bulletin, all information in ALL 361, ALL 376 and ALL 380 remains in effect. Opportunity for payment of claims initially denied due to unenrolled ORP provider as described in ALL 376, billing providers should take certain steps to avoid claim denials due to unenrolled ORP providers. If a claim is denied because of an unenrolled or unauthorized ORP provider on or after June 9, 2024, the claim will be placed in suspense status. The claims system will continue to check to see if the ORP provider has enrolled with MassHealth for up to 90 days after the first date of service on the claim. Once the ORP provider is enrolled, the claim will then be payable. This will allow billing providers time to follow the steps related to unenrolled ORP providers outlined in ALL 376. If the ORP provider is not enrolled by 90 days from the first date of service on the claim, the claim will be denied. Also, effective June 9, 2024, billing providers can resubmit claims that were previously denied due to an unenrolled or unauthorized ORP provider if the first date of service on the claim is no earlier than September 1, 2023. If the ORP provider is enrolled with MassHealth within 90 days of the first date of service on the claim, the claim will be payable. 

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