Amendment #38 to H4891

Upgrade of Technological Standards for the Transfer of Electronic Prescriptions for Controlled Substances

Mr. Paulino of Methuen moves to amend the amendment by adding the following section:

"SECTION XXXX. Chapter 94C of the General Laws, as appearing in the 2020 Official Edition, is hereby amended by inserting after section 23 the following section:-

Section 24. The Commissioner of Public Health shall promulgate and implement regulations that mandate the adoption and upgrade of the necessary technological standards for the transfer of electronic prescriptions for Schedules II-V controlled substances. This shall be in compliance with DEA regulations as outlined in 21 CFR § 1306.08, CMS, ONC, and state regulations, including 105 CMR 721.000.

The regulations must ensure that all pharmacies within the definition of pharmacy that fill prescriptions for Schedules II-V controlled substances in the state of Massachusetts comply with these standards no later than January 1, 2025. The regulations shall include, but are not limited to, the following requirements:

1. All pharmacies must upgrade their electronic prescription systems to support the necessary technological standards for electronic prescriptions.

2. The electronic prescription systems must facilitate the seamless transfer of electronic prescriptions for Schedules II-V controlled substances between pharmacies.

3. Compliance with 21 CFR § 1306.08, ensuring that all electronic prescriptions are transmitted, received, and processed without alteration and with proper authentication.

4. Procedures for the validation and authentication of electronic signatures and transmission methods, as per federal and state regulations.

5. Measures to ensure the security and confidentiality of prescription information during electronic transmission.

6. A framework for auditing and monitoring compliance with these standards, including penalties for non-compliance.

The Commissioner of Public Health shall oversee the implementation of these regulations and ensure compliance by all pharmacies. The Commissioner is authorized to establish deadlines, conduct audits, and impose penalties for non-compliance to ensure timely adoption of the required technological standards.

This section shall take effect immediately upon passage.

Additional co-sponsor(s) added to Amendment #38 to H4891

Upgrade of Technological Standards for the Transfer of Electronic Prescriptions for Controlled Substances