New Laws & Regulations

On October 6, the Drug Enforcement Agency (DEA) and the U.S. Department of Health and Human Services (HHS) announced the extension of current telemedicine flexibilities in place during the national Public Health Emergency (PHE) through December 31, 2024. The full text of the extension, entitled “Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications,” can be found here.

The Second Temporary Rule Extension Does Two Things:

• Extends the full set of PHE telemedicine flexibilities regarding the prescription of controlled medications until the end 2024, allowing practitioners to prescribe controlled medications without conducting an in-person evaluation of that patient; and
• Authorizes all practitioners who are registered with the DEA and otherwise meet the requirements of state law to prescribe schedule II-V controlled medications via telemedicine through December 31, 2024, regardless of whether the patient and
 practitioner established a telemedicine relationship on or before November 11, 2023.

The DEA and HHS plan to promulgate final telemedicine prescription rules by Fall of 2024. Stay tuned to TNP practice updates for more information.

The Department of Health and Human Services, through the Substance Abuse and Mental Health Services Administration (SAMHSA), and in consultation with the Drug Enforcement Administration (DEA), has issued a final rule that permanently extends flexibilities in the prescribing of medications for opioid use disorder (MOUD). The final rule takes 4/2/2024.

The final rule:

• Allows practitioners in Opioid Treatment Programs (OTPs) to prescribe buprenorphine via telehealth – both audio-video and audio-only – without the need for an in-person visit.
• Allows for the use of audio-visual telehealth for any new patient treated by the OTP with methadone if an adequate evaluation can be accomplished via telehealth; however, audio-only telehealth cannot be used to conduct this examination unless the
 patient is in the presence of a licensed practitioner who is registered to prescribe and dispense controlled medications.
• Defers to the judgment of the practitioner regarding take-home doses of methadone, when operating as part of an OTP; the final rule now allows up to 28 days’ supply for stable patients and up to 14 days for less stable patients who can still safely
 handle the medication, at the discretion of the OTP provider.
• Eliminates the requirement for a patient to have a diagnosis of opioid use disorder (OUD) for at least one year prior to admittance to an OTP.
• Modifies requirements for the initial and periodic medical exams.

You can see a full FAQ on the new rule here.

The General Appropriations Act, House Bill 1 (H.B. 1), Article II, Rider 40, is effective September 1, 2023. Rider 40 prohibits the Department of State Health Services (DSHS) from using appropriated funds to promote or advertise COVID-19 vaccinations.
 Rider 40 applies to DSHS and contractors that receive DSHS-appropriated funds.

DSHS-funded programs may inform patients of all available vaccines, including COVID-19. They may also include COVID-19 vaccines in their education materials.
 However, COVID-19 vaccinations should not be singled out from other vaccines, listed alone, or otherwise listed in a manner meant to promote or advertise COVID-19 vaccinations.

This does not affect the administering of COVID-19 vaccines.
 DSHS, contractors, the Texas Vaccines for Children program (TVFC), and Adult Safety Net program (ASN) providers can order, distribute, and administer COVID-19 vaccinations to patients.

Rider 40 will be in effect until August 31, 2025.
 See FAQ from DSHS.

Last year Congress passed the Consolidated Appropriations Act of 2023(CAA 2023), which
 requires all Drug Enforcement Administration (DEA) registrants to complete at least eight hours of training on the treatment and management of patients with opioid or other substance use disorders. This is a one-time requirement and will apply to
 most TNP Members. Completion of the eight-hour training requirement must be affirmed on the DEA registrant’s next scheduled DEA registration occurring on or after June 27, 2023. For more information, see our article here.

During the 88th Legislative Session (2023), the Texas legislature passed HB 3009, which allows NPs to certify the health or condition of a person proposed for
 guardianship, effective September 1, 2023. Under current law, only a licensed physician is authorized to complete the medical certification for guardianship proceedings. This legal barrier has created delays in access, as a growing number of patients
 rely on NPs as their health care providers.

HB 3009 amends current law to allow NPs to complete the patient exam and letter/certificate for guardianship proceedings. The NP’s delegating physician is required to sign the NP’s letter or certificate of evaluation.

During the 87th Legislative Session (2021), TNP helped advance and pass HB 4048, which allows APRNS to complete the medical certification for a death certificate,
 effective June, 2021. HB 4048 amended Chapter 193 of the Texas Health and Safety Code to permit NPs to compete the medical certification, if the death occurred while under their care in connection with the treatment of the condition or disease process
that contributed to the death.

In order to complete death certificates in Texas, which must now be done electronically, NPs have to register with the TxEVER system. There are detailed instructions on the Texas Department of State Health Services website.

When providing medical aspects of care, Texas Board of Nursing (BON) Rule 221.13 requires NPs to utilize written mechanisms which provide authority for that care. Delegation of authority to complete the medical certification for a death certificate or
 fetal death certificate should be included in the written mechanism used by an NP, per guidance from the Texas Board of Nursing in their October 2021 bulletin.

To learn more about the NP’s role in signing death certificates, and related laws and requirements in Texas, you can see TNP’s webinar offering here.