Board delays adoption of telehealth consent rule after debate over who must document consent

The Texas State Board of Pharmacy on May 11 returned a proposed rule on pharmacist-provided telehealth services to staff for rework after lengthy discussion about who must document patient consent and how that documentation should be retained.

Mr. Griffith, presenting the rule labeled 291.13 and drafted to implement House Bill 1700, told the board the proposal would require a pharmacist providing telehealth services to collect informed consent that covers treatment, data collection and data sharing and to document that consent ‘‘by recording the initials or identification code of the pharmacist who obtained the consent’’ in the pharmacy’s data processing system, an electronic logbook, or a paper log. The draft would require those records to be kept at the licensed location and retained for at least two years and produced within 72 hours if requested by the board; failure to produce records within that window would be prima facie evidence of a violation.

Board members pressed whether the rule should require the pharmacist personally to obtain consent or permit someone else (a pharmacy technician, medical assistant or other agent) to obtain it, with the pharmacist instead verifying that a written or electronic consent was already on file. ‘‘We don’t have the authority to narrow a statutory definition,’’ Megan, a board staff member, cautioned during the discussion, noting the board must stay within the scope of the legislature’s language. She added that any substantial change in who must obtain consent would likely be substantive and require a new comment period.

Members described operational scenarios in hospitals, FQHCs and other collaborative-practice settings where consents are obtained electronically by another provider or by an administrative process, and said requiring a pharmacist to re-document a previously signed written consent could create duplicative administrative burden. Several members suggested differentiating written and verbal consent in the documentation requirement: retaining patient-signed written consents as-is while requiring pharmacists to record initials or an electronic signature when consent is given verbally.

After the discussion, the board voted to send the proposed rule back to staff for revision and for another public comment cycle, with staff directed to consider language that clarifies whether pharmacists must ‘‘obtain’’ consent or may ‘‘ensure/verify’’ it and to limit the pharmacist-initials requirement to verbal consent situations.

The board’s action stops short of adopting the rule; staff will circulate revised language and likely reopen the proposal for public comment before returning to the board for potential adoption.

What happens next: staff will draft amended text reflecting the board’s guidance and present it as a proposed rule, with another opportunity for comment before a final adoption vote.