Designed to provide business leaders and their key advisors with the knowledge and insight they need to grow and sustain successful digital health initiatives, we are pleased to present The Law of Digital Health, a new book edited and authored by McDermott’s team of distinguished digital health lawyers, and published by AHLA.
Visit www.mwe.com/lawofdigitalhealth to order this comprehensive legal and regulatory analysis, coupled with practical planning and implementation strategies. You can also download the Executive Summary and hear more about how Digital Health is quickly and dynamically changing the health care landscape.
As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been actively monitoring Texas’ approach to telemedicine regulation and the related Teladoc case. Texas has eliminated its most restrictive requirement for delivering care via telemedicine in Texas, increasing opportunities for providers to reach patients using technology. Senate Bill 1107 was passed on May 11, 2017, and the House added an amendment in passing Senate Bill 1107, which was approved in the Senate on May 18. The bill was signed into law by Governor Abbott last weekend.
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. (more…)
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.
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.
Collaborative efforts between congressional offices and various health care stakeholders, as well as the feedback provided in response to the Bipartisan CHRONIC Care Working Group Policy Options Document released in December of 2015, have driven the Senate Finance Committee to introduce a draft of bipartisan legislation known as the CHRONIC Care Act, which seeks to modernize Medicare payment policies to improve the management and treatment of chronic diseases using telehealth.
On August 3, 2016, the Federal Trade Commission (FTC) staff submitted public comments regarding the Delaware Board of Occupational Therapy Practice’s proposed regulation for the provision of occupational therapy services via telehealth in Delaware (the Proposed Regulation). The FTC’s comments to the Proposed Regulation follow its comments to Alaska’s telehealth legislation earlier this year and evidence its continued focus on telehealth’s ability to foster flexibility in health care delivery by increasing practitioner supply; encouraging competition; and improving access to affordable, quality health care.
By way of background, in 2015, Delaware amended its Insurance and Professions and Occupations Code (the Code) to include the regulation of telehealth and telemedicine services, including the delivery of occupational care remotely under existing, in-person standards of care. Consistent with the Code, the Delaware Board of Occupational Therapy Practice (the Board) revised its rules and regulations to address telehealth services. The Proposed Regulation defines telehealth as “the use of electronic communications to provide and deliver a host of health-related information and health care services, including occupational therapy related information and services, over electronic devices. Telehealth encompasses a variety of occupational therapy promotion activities, including consultation, education, reminders, interventions, and monitoring of interventions.”
The Proposed Regulation gives Occupational Therapist and Occupational Therapist Assistant licensees’ (Licensees) discretion in assessing and determining the appropriate level and type of care for an individual patient, provided that certain requirements are satisfied. Specifically, under the Proposed Regulation, Licensees that provide treatment through telehealth must have an active Delaware license in good standing to practice telehealth in the state of Delaware. In addition to obtaining informed consent and complying with confidentiality requirements, the licensee must also: (1) be responsible for determining and documenting that telehealth is an appropriate level of care for the patient; (2) comply with the Board’s rules and regulations and all current standards of care requirements applicable to onsite care; (3) limit the practice of telehealth to the area of competence in which proficiency has been gained through education, training and experience; (4) determine the need for the physical presence of an occupational therapy practitioner during any interactions with patients, if he/she is the Occupational Therapist who screens, evaluates, writes or implements the plan of care; (5) determine the amount and level of supervision needed during the telehealth encounter; and (6) document in the file or record which services were provided remotely. (24 Del. Admin. Code § 2000-4.2.)
Staff of the FTC’s Office of Policy Planning and its Bureaus of Competition and Economics, responding to the Board’s request for public comments, stated that by not imposing rigid and unwarranted in-person care and supervision requirements, the Proposed Regulation could have various positive impacts, including: (1) improving access to cost-effective, quality care, especially for patients with limited mobility; (2) reducing Medicaid’s transportation expenditures as well as individuals’ pecuniary and time costs; (3) addressing anticipated workforce shortages in the health care sector by increasing practitioner supply and facilitating care of an aging population; and (4) enhancing competition, consumer choice and access to [...]
The integration of technology into health care delivery is exploding throughout the health industry landscape. Commentators speculating on the implications of the information revolution’s penetration of the health care industry envision delivery models rivaling those imagined by celebrated science fiction authors, and claim that the integration of information technology into even the most basic health care delivery functions can reduce cost, increase access, improve quality and, in some instances, fundamentally change the way health care is delivered.
These visions are difficult to refute in the abstract; the technology exists or is being developed to achieve what just a few years ago seemed the idle speculation of futurists. But delivering this vision in an industry as regulated as health care is significantly harder than it may seem. While digital health models have existed for many years, the regulatory and reimbursement environment have stifled their evolution into fully integrated components of the health care delivery system.
Recent comments linking digital health tools to so-called “snake oil” has the channels of social media atwitter. (Add this post to the noise!) While some may decry the comparison, there is a lot we can learn from that perspective.
One of the challenges of broad digital health adoption is the simple fact that digital health encompasses such a broad array of technologies, usages and purposes. There is no one tonic that will cure a list of ailments; rather we are presented with shelves of solutions to even more shelves of challenges waiting to be addressed. Digital health includes, by my definition, the application of social media tools to preventative health and chronic disease management measures, as well as highly sophisticated data analytics applied to massive amounts of population health data to identify important health trends. It also includes home monitoring devices that keep health care providers informed of their patient’s at-home health condition, as well as telestroke programs that allow physicians to access needed expertise. The list is potentially endless, as new technologies created to address health issues and existing technologies are being put to use in the health care context. (more…)
On June 13, the American Medical Association (AMA) adopted a new ethical guidance policy governing the practice of telemedicine that will be published in the coming months. The policy is based on a report from the AMA Council on Ethical and Judicial Affairs and builds upon the AMA’s 2014 telemedicine guidance.
Consistent with past guidance from AMA and other professional organizations, the AMA notes that the ethical responsibilities of physicians are the same – regardless of whether the physician communicates with a patient in-person or remotely – and encourages providers to recognize the potential uses and limitations of technology when delivering care. “Telehealth and telemedicine are another stage in the ongoing evolution of new models for the delivery of care and patient-physician interactions,” said AMA Board Member Jack Resneck, MD. “The new AMA ethical guidance notes that while new technologies and new models of care will continue to emerge, physicians’ fundamental ethical responsibilities do not change.”
The 2016 policy recommends that once a patient-physician relationship is established, physicians who engage in telemedicine by responding to individual health queries electronically or providing clinical services through telemedicine:
Must disclose financial or other interests in certain telemedicine applications or services
Must protect patient privacy and confidentiality
Should inform patients of the limitations of the telemedicine encounter
Should encourage patients to inform their primary care doctor about the encounter
Should advise patients how to arrange follow-up care
Should, when necessary, recommend the use of a telepresenter or other health care professional at the originating site (e., the patient’s physical location)
Notably, the 2014 guidance required that a patient-physician relationship be established prior to the provision of telemedicine services. The relationship could be established during a face-to-face examination, through a consultation with another physician, or by meeting the evidence-based practice guidelines developed by major medical specialty societies. While the 2014 guidance did not specify whether the face-to-face examination must occur in-person, rather than digitally, many interpreted this requirement to be satisfied via an interactive telemedicine encounter.
In addition, the 2016 policy formally recognizes the importance of a “coordinated effort across the profession,” which includes clarifying standards and promoting access to technology. That said, the 2016 policy still requires the licensure of physicians in the state in which the patient is located. (As a general rule, physicians that practice telemedicine are subject to the licensure rules of both the state in which their patient is physically located and the state in which the provider is practicing.) One potential avenue for facilitating multi-state licensure is the Federation of State Medical Boards’ Interstate Medical Licensure Compact, which offers a streamlined licensure process in each Compact state. The Compact has been adopted by 17 states thus far and more are expected to join this year and in 2017.
In sum, the AMA’s new ethical guidance should help physicians to better understand how their fundamental ethical responsibilities may play out differently when patient interactions occur through technology, and how this technology can [...]
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