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DEA Takes a Rare Step Forward for Telehealth

Author: Matt Brockmeier, Emerge Of Counsel Attorney

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) amended the Controlled Substances Act (CSA) to help prevent the illegal distribution of controlled substances on the internet. The Act required an in-person medical evaluation before prescribing or otherwise dispensing controlled substances online. It also established seven exceptions to that requirement, allowing practitioners to prescribe medications for a patient without first evaluating that patient in person. One exception allowed DEA to waive the in-person requirement during the COVID Public Health Emergency (PHE). During the pandemic several companies began providing large volumes of controlled substances via telehealth under that exception, including ketamine and Adderall. However, the exception it is set to expire on May 11, 2023, threatening the future of the nascent telehealth prescription industry.

Falling within the Act’s definition of the ‘‘practice of telemedicine’’ is ‘‘a practitioner who has obtained from the [DEA Administrator] a special registration under [21 U.S.C. 831(h)].’’ 21 U.S.C. 802(54)(E) contemplates that the DEA must issue regulations to effectuate this special registration provision. In 2017, under President Trump, DEA was statutorily instructed to finalize a rule on the registration’s application process and procedures. Disappointingly, as of this writing, DEA has yet to promulgate “special registration” rules, despite pleas from patients, clinicians, and the medical and business communities.

Analysts familiar with DEA’s intransigence and stall tactics predicted that the expiration of the PHE declaration would devastate the ketamine telehealth industry. In a surprise to most, including this author, on March 1 DEA issued a notice of rulemaking that would authorize telemedicine where 1) the prescribing practitioner has not conducted an in-person medical evaluation with the patient; 2) the prescription was issued pursuant to a telemedicine encounter and 3) the telemedicine encounter results in a prescription for controlled medications. There are some limitations, including that prescribing practitioners could only issue telehealth prescriptions for up to a 30-day supply, and there are labeling and recordkeeping requirements. Nonetheless, this is an encouraging development from an agency with a reputation for being dilatory and obstructionist, especially when it comes to making regulated medicines available to patients in need.

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PsychedeLinks – March 3, 2023

PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.

 Emerge’s Hot Take

DEA Proposes New Telemedicine Regulations
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) amended the Controlled Substances Act (CSA) in an attempt to prevent the illegal distribution of controlled substances on the internet. Among other things, the Act required an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances online. One exception allowed DEA to waive the in-person requirement during the COVID Public Health Emergency (PHE). During the pandemic a number of companies began providing a not insignificant volume of controlled substances via telehealth, namely ketamine and Adderall, subject to this exception. However, that exception is set to expire on May 11, 2023, thrusting a nascent industry into uncertainty over the past few months. Analysts familiar with DEA’s intransigence and stall tactics predicted that the ketamine telehealth industry would be devastated by the expiration of the PHE declaration. In a surprise to most, on March 1, 2023, DEA issued a notice of rulemaking that would authorize telemedicine where 1) the prescribing practitioner has not conducted an in-person medical evaluation with the patient; 2) the prescription was issued pursuant to a telemedicine encounter and 3) the telemedicine encounter results in a prescription for controlled medications. There are some limitations, including that prescribing practitioners will only be able to issue telehealth prescriptions for up to a 30-day supply of a controlled substance, and there are labeling and recordkeeping requirements. Some telehealth providers and advocates have concerns about some of the limitations in the DEA’s proposed rules, but for ketamine in general, “this is an encouraging development from an agency that has earned a reputation for being dilatory and obstructionist at times”, says Emerge Of Counsel attorney, Matt Brockmeier.

 Other Noteworthy News

Bill Seeks Personal Data Collection On People Who Use Legal Psilocybin in Oregon
“State Sen. Elizabeth Steiner, D-Portland, wants the state to monitor whether Oregon’s landmark law allowing the controlled use of psilocybin is working as intended — and not just for ‘rich white people.’ The Oregon Senate Health Committee on Monday heard her bill, Senate Bill 303, which would require psilocybin service centers to collect data on the health, education, race, income and other sensitive information of adults that use the hallucinogenic drug under their supervision. Steiner’s bill is in response to concerns that Oregon’s psilocybin program will only be accessible to those who can afford what could be hefty price tags service centers charge. It’s also meant to answer questions about the effectiveness of the first-of-its-kind program, which was pitched to voters as a means to address mental health and included a requirement that a report be issued on safety and efficacy after the first two years. Opponents of the bill argue it will mean another administrative burden that will further drive up the cost of psilocybin sessions. They also say its data collection requirement will have a chilling effect on people who may already be wary of using the federally illegal drug for its purported benefits.”
New Mexico Lawmakers Approve Psilocybin Study Bill
“New Mexico lawmakers advanced legislation on Wednesday to create a state body that would study the possibility of launching a psilocybin therapy program for patients with certain mental health conditions who could benefit from using the psychedelic. The House Health and Human Services approved the bill, sponsored by Rep. Christine Trujillo (D), in a unanimous voice vote. The measure now heads to the House Appropriations & Finance Committee. The legislation would establish an eight-member Psilocybin Advisory Group appointed by the governor that would be responsible for studying and making recommendations on the ‘feasibility’ of creating a psilocybin therapy program. Members would specifically need to consider policies to create a regulatory framework for psilocybin cultivation, manufacturing and dispensing, as well as ‘treatment guidelines for the use of psilocybin-derived products to treat certain mental health issues, including patient selection and provider training and certification.’”
More and More Psychedelic Reform Bills in the Pipeline Throughout United States
“2023 has already shown extensive advances in the realm of psychedelic policy reform. About a dozen states in the US have put forward legislation that would see multiple psychedelic substances from ketamine, MDMA, psilocybin, and more receive downgraded criminalization designations. In addition, lawmakers are as open as ever to the idea of psychedelics’ therapeutic potential. Special task forces or state-sponsored research bodies have been created or are set to be voted on which would seek to properly educate voters and state governing bodies on the possibilities associated with psychedelic therapy. With direct support from the Governor’s office, two new psychedelic research bills have been unanimously approved by Hawaii’s Senate Ways & Means Committee. While not exactly psychedelic policy, an important bill is brewing in Colorado’s state legislature. It would allow cities throughout the state to institute “overdose prevention centers”, similar to those seen in Europe, where citizens could use drugs regardless of their legality in a medically supervised environment.”
Untangling Anorexia: Psychedelics Offer Hope for a Neglected Condition
“Characterised by self-starvation, anorexia nervosa is a psychiatric disorder that mainly affects adolescent women, who become invested in restricting their food intake. A fear of weight gain can morph into a general fear of loss of control. In the past, clinicians have looked to pharmaceuticals for help, but several antidepressants, antipsychotics and nutritional or hormonal supplements have failed in clinical trials[4]. As a result, no medicine has been licensed. Another approach attempts to reset the outlook of a person with anorexia nervosa with psychedelics. Several clinical trials of psilocybin — the active ingredient in magic mushrooms — are underway. ‘If you experience that you can still have life, that you can still have hope, this helps to motivate the patient for further therapy,’ says Hubertus Himmerich, a clinician and researcher at King’s College London, who is leading a trial of psilocybin for anorexia, using ‘COMP360’ tablets of synthesized psilocybin manufactured by COMPASS Pathways. Two other trials of psilocybin therapy for anorexia nervosa are also ongoing.”

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PsychedeLinks by Emerge Law Group
PsychedeLinks is a curated selection of top news stories impacting business, research, and culture in the psychedelics ecosystem, crafted by Emerge Law Group’s groundbreaking Psychedelics Group.
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FRANCHISE LAW

Franchisors

Franchise law is a heavily regulated area of law.  We help clients expand their businesses through franchising and other distribution methods. We have experience in many industries including, restaurants, health, and beauty, alcohol, and cannabis among others. Our representative services include the following:

Franchisees

We also help potential franchisees interested in buying a franchise. We are able to assist with evaluation of franchise opportunities with respect to:

Alternative Structures

However, not all businesses are suited to franchise. We are also experienced with helping clients structure alternative distribution methods to prevent classification as a franchise.

MERGERS AND ACQUISITIONS

Our M&A attorneys are highly experienced in counseling clients who are considering acquisitions or exit strategies.  We have many years of experience handling deals of various types and sizes, ranging from sales of small closely-held business, private companies, and publicly-traded corporations.  We have represented business owners, private equity firms and investment banks in a wide range of industries. 

We have a deep business bench, and Emerge attorneys have handled transactions of all shapes and sizes.  Whether your deal is valued at $100,000 or $100,000,000, our experienced attorneys will guide you through the deal process.

We understand the intensity, technical skill and judgment needed to get deals done, and we provide our clients with timely, practical and cost-effective legal advice.  We are highly capable in all aspects of M&A, including the following:

CANNABIS INDUSTRY

Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.

Emerge attorneys were instrumental in the drafting and passage of Oregon Measure 91, legalizing marijuana in the State of Oregon, and have represented cannabis businesses well before many law firms were willing to enter the cannabis industry. As a firm that has provided legal services in the cannabis space for many years, we are familiar with the unique and complex issues businesses and individuals face in an emerging and highly regulated industry.

We regularly help clients with:

Cannabis laws and rules are also regularly changing.  Members of our team are dedicated to attending legislative hearings, state agency and local city and county meetings to stay up-to-date on any new changes and how to adjust to any new changes.

See our Cannabis Industry page for more information.

PSYCHEDELICS

There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including terminally ill patients suffering with anxiety and depression. Until recently, psychedelic substances have been accessible only in the illicit market and are illegal under federal and state to manufacture, distribute, or possess. These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application. As such, no one invested in this area or required legal services, outside of the criminal context.

Today, researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the Controlled Substances Act. Companies are now actively raising money to develop intellectual property and seize market opportunities associated with psychedelic drugs.

In addition, advocates at the state and local levels are not waiting for the rescheduling of these substances and are active in undertaking efforts to decriminalize these substances and/or make them affirmatively legal under state and/or municipal law. Decriminalization already has occurred in cities including Denver, Oakland, Santa Cruz, and Ann Arbor. Oregon is poised to be the first state to make psilocybin therapy affirmatively legal. Emerge Law Group is working with a wide array of clients pushing forward in this emerging area.

See our Psychedelics Practice Group page for more information.

TAXATION

CORPORATE AND PARTNERSHIP TAX

Businesses of all kinds benefit from a customized but systematic approach to structuring legal relationships. Emerge Law Group helps businesses and business owners with a variety of tax planning matters.

Representative client services include:

ESTATE PLANNING

Estate planning encompasses everything from a will and power of attorney to combined estate and business succession planning. In almost all cases, the purpose of the plan is to help the client protect those they care about most in the event they can no longer be there for them.

Emerge Law Group has experience with a wide range of tools used in estate planning, including wills, trusts, and family business entity planning.

TAX CONTROVERSIES

Emerge Law Group can assist with the resolution of difficult tax controversies. Our areas of emphasis and experience include:

REAL ESTATE TRANSACTIONS

Emerge Law Group assists clients with a wide range of real estate transactional matters.  We regularly help clients with:

LAND USE

Emerge Law Group also assists clients with all aspects of local government land use and development processes, ranging from preliminary property analyses and building permit issues to complex land use reviews and hearings. Our attorneys are experienced in obtaining land use entitlements and development permits for a wide range of uses.

We regularly help clients with:

Above all, we understand the value of working with cities and counties to enhance communities while developing the land to its potential. We strive to create solutions to land use issues that serve to better our clients and the communities in which they live and work.

LITIGATION AND ALTERNATIVE DISPUTE RESOLUTION

The attorneys in Emerge Law Group’s Litigation and Alternative Dispute Resolution practice group litigate commercial, intellectual property, and public interest matters in state and federal courts, as well as private mediation and arbitration proceedings.  Our lawyers have represented national and regional financial institutions, major media, entertainment and technology companies, and other Fortune 500 companies in a broad array of high-stakes disputes.  Our team of litigators has handled leading cases that have shaped the law in cutting-edge business, technology, free speech, and public interest impact lawsuits in trial and the courts of appeal.

We have particular expertise in handling civil litigation and regulatory enforcement matters in the cannabis and psychedelic industries.  While many firms claim expertise in the these industries, few have our depth of experience successfully litigating contract, trademark, partnership, shareholder, land use, and real estate disputes in court and arbitration.  Even fewer firms have our level of experience handling writ of mandate proceedings against the government regulators.

Our litigators practice in California, Oregon, and Washington, but have appeared in state and federal courts nationwide.  Our knowledge of our clients’ businesses, goals and concerns, and our experience litigating at the highest levels, give us unique insight into possible outcomes and pitfalls as we continuously confront issues of new impression.

No matter what the industry, we pride ourselves in achieving our clients’ objectives through efficient and creative solutions primarily designed to avoid disputes in the first place—which is always the best litigation strategy.  Many times, our clients obtain excellent outcomes before or at the earliest stages of litigation because our adversaries quickly recognize the challenges they will face in litigating against us.  When litigation is unavoidable, however, we work hard to provide our clients with both cost-efficient and “big firm” quality representation.

 

INTELLECTUAL PROPERTY

Your intellectual property (or “IP”) strategy can harness your most valuable information and intangible assets including your name, your brand, your designs, your content, your services, and your products — what makes your business stand apart in a competitive world.  We can help you evaluate and build your IP portfolio, then secure it, monetize it, and protect it.

IP encompasses multiple areas of law and different types of information or material.

Our Intellectual Property practice focuses on:

TRADEMARK

Trademarks include names, signs, logos, designs, phrases, slogans, expressions, and sometimes even colors, sounds, or smells that identify or distinguish one business compared to others.  Trademark protection is fundamental in securing your “brand.”

COPYRIGHT

Copyright covers original works of creative authorship fixed in a tangible medium of expression.  This includes literary, dramatic, musical, and artistic works, such as poetry, novels, designs, movies, songs, computer software, and architecture. Copyright does not protect facts, ideas, systems, or methods of operation, although it may protect the way these things are expressed.  Depending upon the type of work, “moral rights” (such as the right of attribution) may be implicated as well.

TRADE SECRET

Trade secret laws can vary somewhat between states, but generally trade secrets cover information, including drawings, cost data, customer lists, formulas, recipes, patterns, compilations, programs, devices, methods, techniques or processes that derive economic value from not being generally known and are the subject of efforts that are “reasonable under the circumstances” to maintain secrecy.

PRIVACY

Depending upon where you live or operate, there is a special patchwork of laws and regulations that protect and regulate personal information.  If you are handling or giving out personal or potentially sensitive information, you may be implicating privacy laws.

PUBLICITY

Publicity rights address the commercial use of an individual’s face, name, image, or likeness.  These rights vary state-to-state.  Marilyn Monroe, for example, lived in multiple states which created complex questions about her publicity rights.

Our Intellectual Property services include:

FINANCIAL INSTITUTIONS

In states where new cannabis banking opportunities exist, Emerge Law Group has the proven expertise in creating canna-banking programs to efficiently capitalize on those opportunities. Our Banking Practice Group specializes in working with banks and credit unions to develop regulatory compliant programs and operational best practices. We also train banking staff to become experts in canna-banking so they can effective understand and manage the risk affiliated with canna-banking.

We regularly help clients with:

EMPLOYMENT LAW

At Emerge Law Group, we recognize that employees are the heart and soul of any successful business.  Our Employment Law Practice Group works with employers to help them effectively manage their workforce, navigate the complex web of federal, state and local employment laws and, if necessary, defend against claims before administrative agencies and in court.

We regularly help clients with:

CORPORATE FINANCE AND SECURITIES

Our corporate finance and securities lawyers are experienced attorneys who have practiced at large law firms, worked as in-house counsel for public companies and investment banks, and owned and operated start-up companies. We work with clients to help achieve their financing goals while safely navigating the highly technical securities law landscape. 

In addition to representing issuers, we also routinely represent institutional and individual investors, including in connection with fund formation and investments.

Our expertise includes:

We have a deep understanding of the financing options available to businesses, including simple unsecured loans, asset-backed financing, convertible debt, common and preferred equity, crowdfunding and various other structures.  We work closely with our clients to understand their business and financing needs, ensure they are prepared to approach investors and choose the right partners, structure and negotiate terms, navigate the due diligence process and successfully close the deal.

COMPLIANCE AND LICENSING

ALCOHOL AND BEVERAGE INDUSTRY

Emerge attorneys have represented businesses in the alcohol and beverage industry, including wineries, breweries, distilleries, restaurants, bars, movie theaters, golf courses, and gas stations.  We can help you vet new locations, acquire existing locations, and apply for the appropriate liquor license.  We also provide training to comply with applicable rules and regulations, prepare operating procedures, submit renewals, and keep clients protected in the event of any potential violations or administrative hearings.

CANNABIS INDUSTRY

Emerge Law Group is highly experienced in the cannabis industry.  We have helped many clients obtain state licenses and local permits to operate cannabis businesses throughout California, Oregon, and Washington.  We regularly help clients with:

Cannabis laws and rules are also regularly changing.  Members of our team are dedicated to attending legislative hearings, state agency and local city and county meetings to stay up-to-date on any new changes and how to adjust to any new changes.

See our Cannabis Industry page for more information.

PSYCHEDELICS INDUSTRY

Emerge Law Group is a leader in the psychedelics industry.  There is tremendous excitement about the potential for psychedelic drugs to benefit a wide variety of populations, including veterans struggling with PTSD and terminally ill patients suffering with anxiety and depression.  Until recently, psychedelic substances have been accessible only in the underground; they are illegal under state and federal law to manufacture, distribute, or possess.  These substances have, since 1970, been treated as having no legitimate medical use, and no commercial application.  As such, businesses have not invested in this area or required legal services, outside of the criminal context.

Today, psychedelics are proceeding toward legalization on multiple paths.  Researchers in a multitude of clinical studies are proving the medical safety and efficacy of these medicines, with the objective of changing the treatment of these substances under the federal Controlled Substances Act, opening legal access to them.  Private and public companies are now actively raising money to develop intellectual property and capitalize on the market opportunities associated with psychedelic drugs.  Opportunities to be early actors in this new arena are tremendous.

See our Psychedelics Practice Group page for more information.

BUSINESS AND CORPORATE

Our business transactions team is made up of highly experienced transactional attorneys who have practiced at large law and accounting firms, worked as in-house counsel for public companies and investment banks, and owned and operated start-up companies. We understand complex legal matters and provide high quality legal services in a cost-effective manner.  Our clients value our experience, knowledge and judgment.

ENTITY FORMATION

Our team routinely advises clients regarding:

CORPORATE GOVERNANCE

Emerge attorneys also advise on-going concerns with: