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H 4497

An Act ensuring access to specialty medications

194th Legislature (2025-2026) Introduced by Dan Sena

Creates a licensed framework for specialty pharmacies in MA and prohibits insurers from blocking licensed pharmacies from dispensing specialty drugs.

Reporting date extended to Friday, July 31, 2026
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Bill Summary · H 4497

Summary: H.4497 — An Act ensuring access to specialty medications (Massachusetts)

Overview

H.4497, introduced September 18, 2025, and reported favorably by the Financial Services Committee, would create a licensing framework for specialty pharmacies in Massachusetts and limit discriminatory practices by insurers regarding the dispensing of specialty medications. The bill would add new licensing requirements for specialty pharmacies, define responsibilities for a designated pharmacist in charge, and empower the Division of Insurance to adopt implementing regulations. It also amends the state’s health insurance law to prevent carriers from blocking licensed pharmacies from dispensing specialty drugs, provided the pharmacy can meet required handling and monitoring standards.

What the bill would do

  • Establish a licensing framework for “specialty pharmacies” (not including mail-order pharmacies) that dispense specialty medications as defined in chapter 176D, section 3B.
  • Require the state board to license specialty pharmacies and to ensure compliance for shipments from in-state pharmacies to out-of-state destinations.
  • Create duties for a designated Pharmacist in Charge (PIC) at each licensed specialty pharmacy, including licensing in good standing, annual reporting to the board, and ongoing verification that the pharmacy maintains an unrestricted license and complies with applicable laws.
  • Require annual certification that the pharmacy maintains records of all drugs dispensed in Massachusetts and provides a yearly list of drugs dispensed in the commonwealth.
  • Prohibit out-of-state pharmacies or pharmacists from prescribing, shipping, selling, transferring, or dispensing drug preparations in Massachusetts unless they have a specialty license under this section.
  • Authorize the Division of Insurance to adopt policies and regulations necessary to implement these provisions.

Section 2 (amendment to Chapter 176D, §3B)

  • Carriers (insurers) may not prohibit the dispensing of specialty drugs (as defined in §3B) by any licensed pharmacy, as long as the pharmacy can comply with the drug’s special handling, administration, and monitoring requirements.
  • Carriers must permit any network pharmacy to provide specialty drugs if the pharmacy agrees to the same reimbursement terms and conditions (i.e., no discriminatory blocking of network pharmacies if terms are met).

Who is affected

  • Specialty pharmacies operating in Massachusetts or serving Massachusetts patients.
  • Pharmacists in charge at specialty pharmacies, who must be licensed in the jurisdiction where the pharmacy is located and maintain good standing.
  • Massachusetts patients who rely on specialty medications, including those receiving drugs through out-of-state shipments.
  • Insurers and health plans operating in Massachusetts, which would be subject to new non-discrimination requirements for dispensing specialty drugs.
  • Massachusetts Division of Insurance and the board (state pharmacy licensing board), which would implement licensing and regulatory processes.

Key procedural and timeline aspects

  • Status: Reported favorably by the Committee on Financial Services and referred to the Health Care Financing Committee; introduced September 18, 2025.
  • Legislative actions recorded: 2025-09-18 — Reported from Financial Services; 2025-09-18 — New draft of House Bill 1322; 2025-09-18 — Reported favorably by committee and referred to Health Care Financing.
  • The bill would take effect through the licensing and regulatory processes established by the board and the Division of Insurance; specific effective dates are not provided in the text.

Potential impact

  • Aims to improve access to specialty medications by reducing insurer-era barriers and ensuring a standardized licensing framework for specialty pharmacies.
  • Enhances regulatory oversight of specialty drug dispensing, including cross-border shipments and transparency in drug dispensing records.
  • Shifts some compliance responsibilities to insurers, requiring them to align network dispensing rules with licensed, compliant pharmacies.

Compiled from official sources — confirm details with the bill’s official record.

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