Texas E-Health Alliance Issues Public Comment on DEA Proposed Rule

WASHINGTON, Jan. 25 -- The Texas e-Health Alliance, Austin, has issued a public comment on the Drug Enforcement Administration proposed rule entitled "Regulation of Telepharmacy Practice". The comment was written on Jan. 18, 2021, and posted on Jan. 21, 2022:

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The Texas e-Health Alliance is a 501(c)(6) trade association, founded in 2009, with the mission of being the state's leading advocate, from local communities to the national level, for the use of information technology to improve the health care system for patients. As such, we have worked for over a decade on legislation that is intended to support that goal, including but not limited to the expansion of telemedicine, telehealth, and telepharmacy services.

After our review of the DEA's notice of proposed rulemaking, and recognizing that we are not a state regulatory authority nor are we a provider, we would like to offer several observations based on our experience in response to your request for "any information that could be used to help DEA quantify or discuss qualitatively the potential costs and benefits of a rule that would either promote or restrict the use of telepharmacy."

In developing our state's approach to expanding the use of telemedicine and telehealth, we had similar conversations to the one currently happening around telepharmacy. In 2017, the passage of SB 1107 allowed for the establishment of a treating relationship via technology, opening up the home as a site of service for physical health services along with supporting the existing Texas Medical Board rules for establishing treatment for mental health services. There were two very important components of that legislation: a provision for joint rulemaking across licensing boards to ensure consistency of policies, and a statement that telemedicine and telehealth services would be evaluated by the same standard of care as in-person services. TeHA built upon the work of SB 1107 with the passage of SB 670 in 2019, which created coverage parity for telemedicine and telehealth services in Texas Medicaid's managed care program and removed a number of old restrictions on these services from our statutes. With the implementation of the "same standard of care" provision, Texas has aggressively removed artificial barriers to the provision of virtual services such as blanket requirements for in-person visits, distance requirements, and rural service area carveouts. It is just as possible, particularly in a state that is as large and diverse as Texas, to have access issues in urban areas as it is in rural areas. Over the last two years it became clearer than ever that access to the internet- or a lack of access to the internet- can significantly impact an individual's health status. As a result, Federal, State and Local governments, have invested billions of dollars into broadband infrastructure to support access to education, healthcare, and other essential services being delivered virtually.

Obviously, the COVID-19 pandemic caused enormous growth in the use of these services, and because of the work Texas had already done, we were well-prepared to meet that challenge. During the 2021 session of the Texas Legislature, we worked to pass HB 4, an omnibus telemedicine and telehealth package that made permanent most of the COVID-19 flexibilites in Texas for programs like Medicaid and Children's Health Insurance. During the debate on HB 4, we heard compelling evidence from our partner organizations in the mental health community that the shift to virtual services had some unexpected positive benefits, such as increasing consistency in participation by reducing no-shows, especially for people with physical mobility limitations or transportation issues. Adherence to mental health treatment is a challenge in normal times for patients, and while this was exacerbated by the pandemic, it also became clear that the use of telemedicine and telehealth could be very successful in meeting the needs of those patient populations.

Similarly, we have supported telepharmacy legislation because we believe that it is a modality that meets the same goals as telemedicine and telehealth- increasing access, and therefore adherence- to medications. The impact to patients, and to the healthcare system in general, has been well-documented, with the CDC reporting in 2017 that "direct health care costs associated with non-adherence have grown to approximately $100-$300 billion of U.S. health care dollars spent annually". The Texas telepharmacy model, which was established in SB 1633 to support the use of remote dispensing sites and modified in 2019 by SB 670 to include federally qualified health centers, has proven to be successful in providing that increased access. Any new rules that alter or remove this capacity to provide telepharmacy services would have a negative impact on patients, who would continue to lack access to their medications and put them at risk for non-adherence or noncompliance with their treatment regimens. As we know, this could have devastating impacts, not just to their individual health, but to the system as a whole.

In conclusion, TeHA sees telepharmacy as a tool in the toolkit that providers can use to better serve patients, and any tool is only as good as the problem it solves and the context in which it is used. TeHA supported the implementation of mandatory e-prescribing in Texas and also serves on the Texas State Board of Pharmacy's Prescription Monitoring Program oversight committee. As such, we are aware of the concerns about diversion of medications. We would argue that the use of properly implemented and integrated digital tools- like the PMP, EHRs, and telepharmacy systems- can reduce the opportunities for diversion by implementing audit trails, using role-based access and multi-factor authentication, and creating real-time tracking of pharmacy activities.

Thank you for the opportunity to provide comment. Please contact Nora Belcher, TeHA Executive Director, at 512-820-7828 or by email at nora@txeha.org if you need any additional information.

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The proposed rule can be viewed at https://www.regulations.gov/document/DEA-2021-0027-0001

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