On October 26, 2017, President Trump directed the Secretary of the Department of Health and Human Services (“Secretary”) to declare a National Public Health Emergency on the opioid epidemic. While the President offered few details regarding how his administration will address the challenge of treating patients struggling with opioid addiction, a previous statement from the White House indicated that the Administration plans to expand access to treatment via telemedicine and more specifically, remote prescribing of the necessary controlled substances used to treat these patients. While this is a logical step, and one that has been advocated at length by states and health care experts, alike, expanding health care providers’ capabilities to utilize remote prescribing to treat opioid addiction will likely run afoul of existing federal law.
The Ryan Haight Online Pharmacy Consumer Protection Act (“Act”) was passed by Congress in 2008 following the death of Ryan Haight, an 18-year-old honor student who overdosed on prescription narcotics delivered to his door by an internet pharmacy based on a prescription written by a physician he had never seen. The Act amended the federal Controlled Substances Act and requires a prescribing practitioner to be physically present when prescribing, or allowing to be prescribed by a remote practitioner, a controlled substance, if the prescribing practitioner has not previously conducted an in-person physical examination of the patient. However, some have viewed the Act as establishing a significant barrier to the progress of telemedicine. In the words of former Rep. Mary Bono (R-Calif.), “the issue back then is very different from what the issue has become.”
Today, telemedicine has exploded. In just the last year, nearly every state has enacted new legislation that either expands access to telemedicine services, expands parity for reimbursement for telemedicine services, and/or loosens previous restrictions on telemedicine interactions (e.g., establishing practitioner-patient relationships) and remote prescribing. In stark contrast, the federal government has made little to no attempt to modify the antiquated Act to keep up with the telemedicine advancements since it was passed in 2008. Practitioners must now navigate their telemedicine practices around the Act since there are few exceptions to the Act and violations of the Act are considered violations of the Controlled Substances Act, which include fines, penalties, disbarment, and incarceration. With such stiff consequences and the lack of guidance or regulatory measures promulgated by the Drug Enforcement Agency, practitioners are unlikely to prescribe drugs to treat opioid-addicted patients that are most vital to their treatment.
Ironically, the World Health Organization deemed methadone and buprenorphine, two controlled substances, to be “essential medicines” in the treatment of opioid addiction. Studies have shown strong inverse linear association between heroine overdose deaths and patients being treated with opioid agonist treatments, including methadone and buprenorphine. As such, the ability to treat patients effectively through telemedicine and remote prescribing will often require prescribing drugs currently prohibited for such prescription. This realization has come to many policy makers and telemedicine organizations. Most of these individuals and organizations have called for amendment or repeal of the Act; however, one possible interpretation of the Act could allow for remote prescribing of controlled substances to treat opioid addiction under the telemedicine public health emergency declaration exemption of the Act.
Within the Act, Section 802(54)(D) (21 U.S.C. 802(54)(D)) permits the remote prescribing of controlled substances “during a public health emergency declared by the Secretary” and to the extent that the prescribing “involves patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of the Attorney General, designates . . . .” On October 26, 2017, the Secretary, as directed by the President, issued the following statement regarding the public health emergency:
As a result of the consequences of the opioid crisis affecting our Nation, on this date and after consultation with public health officials as necessary, I, Eric D. Hargan, Acting Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby determine that a public health emergency exists nationwide.
Although a declaration of a public health emergency normally includes specific geographic parameters rather than blanket “nationwide” issuance, based upon the Secretary’s declaration, one could argue that health care practitioners seeking to treat patients dealing with opioid addiction now must only await the list of controlled substances (to be issued by the Secretary and the U.S. Attorney General) before they are able to remotely prescribing controlled substances to treat opioid addiction. However, even if the Attorney General were to agree with this interpretation of Section 802(54)(D)’s application and to provide a list of controlled substances that can be prescribed thereunder, 42 U.S.C. 247d only permits a declaration of a “public health emergency” to be in place for a maximum of 90 days. Therefore, utilizing Section 802(54)(D) to allow remote prescribing to treat opioid addiction through telemedicine will only serve as a temporary patch, while the bigger issue of amending the Ryan Haight Act needs to be addressed by Congress. In the words of Ms. Bono, “if the Ryan Haight Act needs to be updated, then let’s update it.”