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Shelby Buettner advises pharmaceutical, medical device manufacturers, healthcare technology companies and healthcare providers on FDA regulatory and compliance matters. She regularly counsels clients on regulatory and policy considerations associated with mobile medical technology, telehealth, telemedicine, digital health and clinical research. Shelby assists clients, including academic medical centers and biotechnology manufacturers, with regulatory, transactional and compliance issues related to clinical research, manufacturing and quality issues and legislative initiatives affecting the healthcare industry. Shelby’s transactional practice focuses on advising investors on FDA regulatory and business considerations in pharmaceutical, medical device and clinical research transactions and contractual arrangements. She also assists investors and companies to conduct due diligence on FDA regulatory matters for mergers and acquisitions and other transactions. Read Shelby Buettner's full bio.

The Centers for Medicare & Medicaid Services (CMS) reiterated its commitments to expanding access to telehealth services and paying “appropriately” for services that maximize technology in the Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program Final Rule published on November 15, 2017 (the Final Rule). Among many other developments, the Final Rule expands allowable telehealth reimbursement under the calendar year (CY) 2018 Physician Fee Schedule, List of Medicare Telehealth Services (list) and permits virtual sessions in certain circumstances under the Medicare Diabetes Prevention Program Expanded Model (MDPP, or the Program). The regulations are effective January 1, 2018.

“New” and “Add-On” Telehealth Services Slated for Reimbursement

CMS evaluates requests for the addition of telehealth services on the basis of two categories: (1) services that are similar to services already on the list and (2) services that are not similar to services already on the list. An evaluation of a category (2) service requires CMS to assess, based on the submission of evidence, whether the use of a telecommunications system to furnish the service “produces demonstrated clinical benefit to the patient.” Continue Reading Slow and Steady – CMS Expands Telehealth Reimbursement Opportunities in 2018

Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities.

The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar. Continue Reading FDA Outlines the New Digital Health Innovation Action Plan and Software Precertification Pilot Program

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

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.

Read the full article.

Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held devices—is empowering the innovation needed to meet the imperative for a transition from payment based on volume to payment based on value that is evaluated in terms of measurable improvements in care delivery and population health.

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One prominent example is the use of digital health solutions to implement the payment innovation contemplated by the Medicare Access and CHIP Reauthorization Act (known as MACRA)—which directly ties both payment increases and reductions to various, specific efficiency and value measures. The Merit-Based Incentive Payment System (MIPS), one of the two available payment pathways under MACRA, assigns points to clinicians in different performance categories, several of which promote the adoption of digital health solutions. To illustrate:

  • The Quality category requires six measures to be reported, many of which may be leveraged through the use of digital health tools. For example, the Maternity Care: Post-Partum Follow-Up and Care Coordination measure tracks the percentage of patients who were seen for post-partum care within eight weeks of giving birth who received particular evaluations, screening and education. Obstetricians, gynecologists and family medicine practitioners could earn points under this measure by using telemedicine technologies, like videoconferencing platform, to engage in virtual patient visits with post-partum patients to answer the patient’s questions, provide education on the recovery process and assess the patient’s physical and mental health status, including the performance of mandatory post-partum depression screenings.
  • The Advancing Care Information category requires the use of certified electronic health record technology to coordinate care through patient engagement (g., secure messaging). The implementation of patient portals with integrated messaging platforms facilitate communication between the patient and health care practitioner, providing additional functionalities like sending reminders, engaging in dialogue about follow-up care, encouraging preventative action and distributing educational materials. These portals typically also give the patient access to timely and informative data, like test results, that allow the patient to play a role in decision making and (hopefully) empower the well-informed consumption of care.
  • The Clinical Practice Improvement category is perhaps the best opportunity for digital health integration. Activities that improve beneficiary engagement, population management, expanded practice access and care coordination—among others—are assigned points and weighted. Here, mobile apps have the capability to enable e-visits via videoconference as an alternative method to an in-person visit; facilitate questionnaire reporting; and send reminders, materials and other notifications to alert and educate patients about services due. The apps also provide opportunities to generally inform the delivery of care for the specific patient by sending alerts to providers to indicate that it’s time for a visit or that a problematic symptom was noted on a questionnaire. Further, clinical practices could leverage app-sourced data to gain information about patient trends, clinical areas of concern or successes related to digital health tool utilization.

For additional examples and insights on how digital health tools will be necessary for a successful transition to alternative payment schemes, please read Managing the Transition to Transformation: Digital Health Solutions: Essential Ingredients in Alternative Health Care Delivery and Payment Innovations.

Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the numerous regulatory bodies responsible for overseeing different aspects of digital health. The following illustration identifies the numerous regulatory bodies that have been increasingly focused on the use of technology in healthcare and are expected to continue their focus and enforcement activities in the coming years.

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Because innovation is moving faster than the law in this area, in-house counsel and compliance officers must be prepared to identify and manage the myriad compliance and liability risk considerations arising from participation in and use of digital health tools. This will require an understanding of how each of these regulatory bodies oversees and regulates digital health today and close monitoring of how that evolves and changes in the future.

Health care providers, patients and consumers should approach the selection and use of digital health advancements with a reasonable degree of caution. As AMA CEO James L. Madara, MD, advised in his address at the recently concluded 2016 AMA Annual Meeting, “…. Appearing in disguise among these positive products are other digital so-called advancements that do not have an appropriate evidence base … or that just do not work well or that actually impede care, confuse patients and waste our time … from ineffective electronic health records to an explosion of direct-to-consumer digital health products to apps, some of which are of poor quality.” In this regard, providers would be well served by performing sufficient “due diligence” to determine whether the functionality of the digital health tool effectively meets their specific clinical and operational needs, as well as the needs of their patients, and to evaluate the developer’s compliance with applicable laws and regulations.

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:

  1. 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;
  2. Lists the technology-enabled collaborative learning and capacity building models funded by HHS over the past five years;
  3. Describes best practices used in adopting these models;
  4. Describes barriers to adoption of these models and recommends ways to reduce those barriers and opportunities to increase use of these models; and
  5. 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.

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 care.

The FTC did recommend the clarification of the Proposed Regulation on the scope of practice of Occupational Therapist Assistants.  The determination of the appropriateness of remote care and decisions about the amount and level of supervision during a telehealth encounter are expressly restricted to Occupational Therapists, while all other requirements also apply to Occupational Therapist Assistants.  The FTC noted that the ambiguities regarding the role of Occupational Therapist Assistants in telehealth evaluations and the determination of whether to use telehealth could discourage their participation in telehealth care.

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory requirements for low risk products that promote a healthy lifestyle—coined “general wellness products.” In the Final Guidance, the FDA makes minimal substantive changes to the policies articulated in its January 2015 draft guidance. Notably, however, the Final Guidance added and refined several examples to illustrate the products that are subject to FDA’s enforcement discretion and ultimately outside FDA’s intended scope of regulatory oversight.

Read the full article, FDA Finalizes Guidance on Low Risk General Wellness Devices here.