While digital health innovation empowers us to better manage our health and live more productive lives, it also poses myriad regulatory, strategic and operational challenges. Edited and authored by McDermott’s team of distinguished digital health lawyers, The Law of Digital Health offers an overview of the highly dynamic and integrated components of the digital health ecosystem, with the goal of helping businesses thrive in this ever-evolving landscape. Over five chapters, we explore a broad spectrum of digital health innovation opportunities and the corresponding value proposition; review current and evolving legal and regulatory frameworks, theories, interpretations, and policy and enforcement initiatives in both the public and private sectors; and provide practical planning and implementation strategies for achieving the appropriate balance between the benefits of digital health innovation opportunities and the need to manage associated legal and regulatory risks.
Marshall E. Jackson, Jr. focuses his practice on transactional and regulatory counseling for clients in the health care industry, as well as advises clients on the legal, regulatory and compliance aspects of digital health. Marshall provides counseling and advice to hospitals and health systems, private equity firms and their portfolio companies, post/sub-acute providers, physician practices, and other public and private health care companies in a variety of complex transactions and health regulatory compliance matters. Read Marshall Jackson's full bio.
President Trump declared the opioid addiction epidemic a public health emergency yesterday. The White House made it clear that this declaration would allow officials to remove barriers to the prescribing of controlled substances via telemedicine, which would permit DEA registered providers to prescribe anti-addiction medications, such as Naloxone, to patients in need without first performing an in-person exam.
As background, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Haight Act) requires a telemedicine provider who is prescribing a controlled substance to a patient to perform an in-person medical evaluation of the patient prior to prescribing a controlled substance, unless one of the narrow telemedicine exceptions set forth in the Haight Act applies. Additional information on the Ryan Haight Act and the implications of this declaration can be found here.
There are many important questions remaining to be answered, including whether any funding will be available to support the implementation of this declaration and whether the declaration will be renewed upon its expiration in 90 days. The answers to these questions are important to healthcare providers who will need to invest resources and time into developing telemedicine programs to reach more substance use disorder patients, which may take longer than 90 days to implement.
On July 31, 2017, President Donald Trump’s Commission on Combating Drug Addiction and the Opioid Crisis recommended that he declare the opioid epidemic a national emergency. In August 2017 and again on October 16, 2017, the president indicated he would declare the opioid crisis a national emergency. While it is apparent that the nation is suffering a drug overdose and opioid-specific crisis, the question remains as to what effect such a declaration would have on combatting the crisis.
The president’s powers to declare a national emergency arise from the Stafford Act, and once a national emergency is declared, it enables 1) access to US Department of Homeland Security ‒ Federal Emergency Management Agency (FEMA) funding, with states able to request grants for the specific purposes of treating opioid addiction; 2) the ability to re-appropriate federal agency workers, such as those employed by the agencies under the US Department of Health and Human Services (HHS) umbrella, to specifically research and treat opioid addiction; and 3) waiver of federal Medicaid regulations to provide additional aid to beneficiaries, ensuring sufficient health care items and services are available to meet the needs of beneficiaries. Such a declaration would undoubtedly open up both federal and state governments to formulate a comprehensive, unified strategy to combat the opioid epidemic sweeping the nation. Continue Reading The Opioid Crisis: Declaring a National Emergency and the Effect on Remote Prescribing through Telemedicine
On September 15, 2017, the Texas Medical Board (Board) released proposed rules regarding telemedicine and mental health services (Proposed Rules) to implement Senate Bill 1107, which was passed on May 11, 2017. Most notably, the Proposed Rules provide that a physician-patient relationship can be established solely by the delivery of care via telemedicine services and eliminates the prior requirement that services for new patients be provided at an established medical site and with a telemedicine presenter. These changes to the Board’s approach create the same standard of care for in-person and telemedicine services.
McDermott previously reported on Senate Bill 1107 and provided relevant background on telemedicine in Texas. The Board is accepting public comments on the Proposed Rules. A public hearing regarding the Proposed Rules will be held at a later date to be determined.
In addition, the Texas Health and Human Services Commission (HHSC) recently adopted final rules regarding the reimbursement of telemedicine in Texas Medicaid (Final Rules) on October 6, 2017. The Final Rules are effective as of December 1, 2017. Continue Reading Texas Continues to Embrace Telemedicine
On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the legislation in early 2016 and referred to the Senate Committee on Finance. As we previously reported on February 29, 2016, this iteration of the proposed bill also focuses on promoting cost savings and quality care under the Medicare program through the use of telehealth and remote patient monitoring (RPM) services, and incentivizing such digital health technologies by expanding coverage for them under the Medicare program—albeit using different terminology. Chiefly, the CONNECT Act of 2017 serves as a way to expand telehealth and RPM for Medicare beneficiaries, makes it easier for patients to connect with their health care providers and helps reduce costs for patients and providers. As with the previous iteration, the CONNECT Act of 2017 has received statements of support from over 50 organizations, including the American Medical Association, American Telemedicine Association, Healthcare Information and Management Systems Society, Connected Health Initiative, Federation of State Medical Boards, National Coalition on Health Care and an array of vendors and health systems. Continue Reading Round Two: Significant Telehealth Expansion Re-Proposed in Bipartisan Senate Bill
Late last month, Senator Cory Gardner (R-CO) and Senator Gary Peters (D-MI) introduced Senate Bill 787, the Telehealth Innovation and Improvement Act (Telehealth Improvement Act), which is focused on expanding Medicare’s currently limited coverage of telehealth services and opportunities for innovation.
The Telehealth Improvement Act would require the Center for Medicare and Medicaid Innovation (CMMI) to test the effect of including telehealth services in Medicare health care delivery reform models. More specifically, the Act would require CMMI to assess telehealth models for effectiveness, cost and quality improvement, and if the telehealth model meets these criteria, then the model will be covered through the Medicare program. Continue Reading More Federal Legislation Aimed at Expanding Medicare Coverage of Telehealth Services
Utah is one of the many states that started off 2017 with proposals to change its existing telehealth laws and regulations. Proposed Utah HB 154 (the Proposed Bill), endorsed by Ken Ivory and Allen Christensen, amends the regulatory infrastructure for telehealth, with a focus on mental health. Two of the key components of the Proposed Bill are listed below:
- The Proposed Bill creates a scope of telehealth practices within the Utah Health Code. Under the scope of practice requirements, any provider using telehealth to provide care will be held to the same standard of care as that applicable to in-person care. In addition, the Proposed Bill stipulates that a provider may not prescribe using telehealth unless the provider has obtained the patient’s relevant clinical history and documented the relevant clinical history and current symptoms. The provider must also be available for follow-up care and familiar with available medical resources near where the patient was located during the telehealth consult.
- The Proposed Bill enacts a new provision to the Utah Medical Assistance Act specifically enabling the provision of mental health services—treatment of mental conditions that are approved in the DSM-V—via telehealth technologies. This provision of the Proposed Bill is Utah’s attempt to increase access to behavioral and mental healthcare services in Utah. In particular, the DSM-V addresses substance abuse disorders as mental health disorders, and the telehealth provision will enable providers to help treat addiction using telehealth services where treatment facilities may not otherwise be available. Importantly, the Proposed Bill’s Medical Assistance Act amendment applies to any managed care organization that contracts with Medicaid, or any provider who is reimbursed under the Medicaid program, and requires insurers to disclose whether they provide coverage for telehealth services for mental health as part of the price and value comparison requirement under Utah law.
The Proposed Bill was passed by both the Utah House of Representatives and Senate and was enrolled on February 24, 2017. The Proposed Bill now awaits Governor Gary Herbert’s signature. If approved, the Proposed Bill will greatly expand access to health care for the mentally ill in Utah, and additionally provide more guidance to assist in the expanded use of telehealth and telemedicine services within the state.
Texas telehealth requirements will significantly change in the near future if Texas Senate Bill 1107 is passed into law, as it removes the controversial “face-to-face” or in-person consultation requirement to establish a physician-patient relationship and lawfully provide telehealth and telemedicine services within the state. This bill comes after a six-year-long battle between telemedicine stakeholders and the Texas Medical Board, and will better align Texas’ regulations with those found in other states.
Arkansas currently has one of the most restrictive telemedicine environments in the country, and was one of the last states to require an in-person examination to form a provider-patient relationship. Prior to September 2016, Arkansas telemedicine laws required an initial in-person encounter to establish a valid physician-patient relationship. In September 2016, the state expanded the formation of a provider-patient relationship to include a face-to-face examination using both real time audio and visual telemedicine technology that provides information at least equivalent to the information that would have been obtained through an in-person examination.
Then, early last month, Arkansas Senate’s Public Health, Welfare and Labor Committee approved Senate Bill 146, which was signed by the Governor and became Arkansas Act 203 on February 20th, which further amended the state’s telemedicine laws to, among other things, enable patients to access telemedicine services from their home or other remote locations. The Act modified the “originating site” location requirement, redefining “originating site” to permit services to be provided wherever the patient is located at the time of the consult. While this change has the potential to expand the use of telemedicine in Arkansas, the Act added more to its restriction on the formation of a professional relationship through telemedicine, as it states that a professional relationship cannot be formed through an internet questionnaire, email message, patient-generated medical history, audio-only communication, text messaging, fax machine or any combination of these technologies. This provision reaffirms that a patient relationship can only be formed in Arkansas with an Arkansas-licensed provider utilizing both real time audio and visual technology.
Notably, the Act also has implications for school-based telemedicine programs, which are increasing in popularity across the country. Arkansas requires school-based telemedicine programs that treat Medicaid recipients to utilize either the minor’s regular pediatrician or other primary care physician; a physician with a cross-coverage arrangement with the regular pediatrician or primary care physician; or have authorization from the regular pediatrician or other primary care physician of the minor. (In most cases, school-based telemedicine programs require a parent’s consent for telemedicine services, and a child’s pediatrician or other primary care provider is notified after the child treated via telemedicine.) This specific provision is particularly protective of the role of treating physicians, but does not include the requirement that a parent or guardian have the power to consent to the formation of a physician-patient relationship with a minor, which is ordinarily expected.
In sum, while the law will not make Arkansas a leader in expanded access to telemedicine, it will help bring Arkansas into line with the rest of the US.
On December 6, 2016, the House passed the Expanding Capacity for Health Outcomes Act (S. 2873) (the ECHO Act), which was unanimously passed by the Senate on November 29, 2016. The ECHO Act seeks to expand the use of health care technology and programming to connect underserved communities and populations with critical health care services.
The ECHO Act builds upon the University of New Mexico’s world-renowned Project ECHO by encouraging the broader development and use of technology-enabled collaborative learning and care delivery models by connecting specialists with multiple other health care professionals through simultaneous interactive videoconferencing for the purpose of facilitating case-based learning, disseminating best practices, and evaluating outcomes.
The ECHO Act requires the Secretary of the Department of Health and Human Services (HHS) to study technology-enabled collaborative learning and capacity building models, and the impact of those models on (1) certain health conditions (i.e., mental health and substance use disorders, chronic diseases, prenatal and maternal health, pediatric care, pain management, and palliative care), (2) health care workforce issues (e.g., specialty care shortages) and (3) public health programs.
Within two years of the enactment of the ECHO Act, the Secretary of HHS must submit a publically available report to Congress that:
- Analyzes the impact of technology-enabled collaborative learning and capacity building models, including, but not limited to, the impact on health care provider retention, quality of care, access to care and barriers faced by healthcare providers;
- Lists the technology-enabled collaborative learning and capacity building models funded by HHS over the past five years;
- Describes best practices used in adopting these models;
- Describes barriers to adoption of these models and recommends ways to reduce those barriers and opportunities to increase use of these models; and
- Issues recommendations regarding the role of technology-enabled collaborative learning and capacity building models in continuing medical education and lifelong learning, including the role of academic medical centers, provider organizations and community providers in such education and lifelong learning.
The recommendations made in HHS’s report may be used to integrate the Project ECHO model into health systems across the country.