Tag Archives: Bradley S. Davidsen

Law Urging DEA to Promulgate Rules for “Special Registration” Likely This Summer

At first blush, the passage of House Bill 5483, entitled the “Special Registration for Telemedicine Clarification Act of 2018” (the “Bill”), appears to address the issue concerning the lack of regulatory guidance regarding the “Special Registration” exception to the Ryan Haight Act of 2008; however, a deeper and more careful analysis reveals that the Bill may not be as effective as most health care practitioners may hope. The Bill, sponsored by Rep. Carter (R-Georgia), a pharmacist, Rep. Bustos (D-Illinois), and nine others, cleared the House on June 12, 2018 without objection. The Bill would require the federal Drug Enforcement Agency (“DEA”) to promulgate rules that would allow health care providers to apply for a “Special Registration” that would allow a provider to prescribe controlled substances via telehealth without first conducting an initial in-person examination of the patient. A transcript of the testimony in support of the Bill (“Transcript”) reveals enthusiasm by the sponsors of the Bill, as well as by Representatives Pallone (D-New Jersey) and Walden (R-Oregon), who called the Bill “a commonsense measure that cuts through the red tape to provide more treatment options to underserved communities through the use of telemedicine.” While Section 413 of the current version of S.B. 2680 would only give the DEA six months to promulgate such rules, the two bills are very similar and almost guarantee that a law will be signed in the coming months that will require DEA to promulgate rules that will finally create a Special Registration exception to the Ryan Haight Act. While the prospect of rules implementing the Special Registration may be exciting for many practitioners, it should be noted that the DEA has been obligated to create these regulations, and has ignored this obligation, for a decade.

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Letter from U.S. Senators Applies Additional Pressure to DEA to Promulgate “Special Registration” Rules Under the Ryan Haight Act

The calls for utilizing telemedicine in battling the opioid crises in the U.S. are growing louder. On January 30, 2018, Senators Claire McCaskill (D-Mo.), Lisa Murkowski (R-Alaska), and Dan Sullivan (R-Alaska), sent a letter to Robert W. Patterson, the Acting Administrator of the U.S. Drug Enforcement Administration (DEA), urging the agency to promulgate regulations that would allow healthcare providers to prescribe medication-assisted treatments via telemedicine for persons with opioid dependence disorder.

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Opioid Addiction Treatment Through Telemedicine: How Federal Law Prohibits, but Could Permit, Controlled Substance Prescribing

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.

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Considerations When Treating Natural Disaster Victims Through Telemental / Telebehavioral Health Programs

You need not spend much time reading the news to know that recent Hurricanes Harvey and Irma have disrupted the lives of tens of thousands of individuals, many of whom may already have behavioral health needs; however, the trauma caused by these recent natural disasters, and others, has created an immense need for additional behavioral and mental health services. For example, a 2012 study entitled “The Impact of Hurricane Katrina on the Mental and Physical Health of Low-Income Parents in New Orleans” reported elevated rates of incidence of Post-Traumatic Stress Disorder (“PTSD”), depression, and a need for mental health services for as much as 50 percent of the low-income population affected by Hurricane Katrina, which hit in August 2005. A Fortune Magazine article reported elevated incidences of PTSD, depression, and anxiety experienced by victims of Hurricane Sandy, which hit in October 2012. In the wake of Hurricane Harvey, some telehealth providers have offered free telehealth services to hurricane victims and a few behavioral health providers have established specific programs focused on providing access to behavioral health services. However, additional services are still needed to treat the long-term mental health needs of these victims.

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Balancing State and Federal Informed Consent Law

The passage of the 21st Century Cures Act (“Cures Act”) and revisions to the Common Rule (45 CFR Part 46) (“Common Rule”) in the last year mandated significant changes to informed consent laws.  As a result of these changes, sponsors of research (“Sponsors”), institutions conducting research (“Institutions”), and the institutional review boards (“IRBs”) approving research will need to review policies and practices involving informed consent.  As explained below, a recently published FDA guidance document makes a first step toward implementing some of these changes by permitting waiver of certain consent requirements for low risk research involving human subjects. Additionally, a recent ruling by the Pennsylvania Supreme Court discussed below reminds investigators, Institutions, and Sponsors performing clinical research in Pennsylvania that state informed consent laws and common law must also be considered before conducting clinical research involving human subjects.  The following brief discussion provides some insight into how Sponsors, Institutions, and IRBs should take into account varying sources of law when determining when to require consent for research involving human subjects.

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New Virginia Telehealth Law Benefits Optometrists and Ophthalmologists

After July 1, 2017, optometrists and ophthalmologists (“Ophthalmic Providers”) in Virginia will be able to practice through telehealth. Va. Code § 54.1-2400.01:2 permits Ophthalmic Providers to establish a bona fide provider-patient relationship “by an examination through face-to-face interactive, two-way, real-time communication” or through “store-and-forward technologies.” Licensed Ophthalmic Providers may establish a provider-patient relationship so long as the provider conforms to the in-person standard of care.  To the extent that an Ophthalmic Provider actually writes a prescription, the Ophthalmic Provider must also obtain an updated patient medical history and make a diagnosis at the time of prescribing.  However, like most telehealth laws in other states, the Virginia law prohibits issuing a prescription solely by use of an online questionnaire.

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Commissioner Scott Gottlieb’s Priorities as Newly Approved FDA Commissioner

On May 9, 2017, Scott Gottlieb, M.D. was confirmed by the Senate as the new Commissioner of the Food and Drug Administration (“FDA”).  As Commissioner, he will be immediately responsible for shaping FDA policy on a number of current issues, including addressing and implementing several mandates stemming from the 21st Century Cures Act, (“Cures Act”), which was signed into law on December 13, 2016 with tremendous bipartisan support. The Cures Act contains over 200 sections that create new obligations for FDA; however, most pressing for Commissioner Gottlieb are three requirements that must be fulfilled within 180 days of the Cures Act’s passage (June 11th, 2017).

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