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Lisa Schmitz Mazur advises health care providers and technology companies on a variety of legal, regulatory and compliance matters with a particular focus on digital health topics, including telehealth, telemedicine, mobile health and consumer wellness. Lisa advises a variety of health care providers and technology companies involved in “digital health,” including assisting clients in developing and implementing telemedicine programs by advising on issues related to professional licensure, scope of practice, informed consent, prescribing and reimbursement. Lisa helps clients identify and understand the relevant legal issues, and develop and implement practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape.  Read Lisa Schmitz Mazur's full bio.

This past fall, after months of speculation, President Trump declared the opioid crisis sweeping the United States a national public health emergency. Upon the president’s declaration, Acting Health and Human Services Secretary Eric D. Hargan made a formal declaration under Section 319 of the Public Health Service Act, making available an exception to the

The opioid epidemic is making the United States acutely aware of the horrors of substance abuse disorders and the limited means of treating the individuals suffering from addiction. Rural America is among the places hit hardest by opioid addiction while also having limited access to mental and behavioral health providers.

Telemedicine offers a viable solution

On February 9, 2018 after a brief shutdown, Congress passed and President Trump signed the Bipartisan Budget Act of 2018, a two-year budget agreement that includes funding for the operation of the federal government until March 23, 2018. The law includes significant health care policy changes impacting Medicare, Medicaid and other federal health agencies. In addition to raising federal spending caps enacted in the Budget Control Act of 2011, this legislation includes additional spending for health care priorities. Here we break down some of the changes affecting telehealth.

Expanded Access to Telehealth Stroke Services

The new law expands, beginning in 2019, the ability of patients presenting with stroke symptoms at hospitals or mobile stroke units to receive a timely telehealth consultation with a neurologist in order to determine the best course of treatment. The provision eliminates the current geographic restriction that limits originating sites to rural areas, meaning distant site providers delivering telestroke services could receive a professional fee for delivering the consultation to patients located anywhere in the United States, provided that the other Medicare telehealth coverage requirements are satisfied (e.g., type of provider, type of technology).
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As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to changing the landscape for product research, development and commercialization. Modernization of the existing legal framework has not kept pace with the rate of digital health innovation, leaving no shortage of obstacles, misalignment and ambiguity for those in the wake.

What did we learn in 2017 and what’s to come on the digital health frontier in the year ahead? From advances and investments in artificial intelligence (AI) and machine learning (ML) to the increasingly complex conversion of health care innovation and policy, McDermott’s Digital Health Year in Review details the key developments that shaped digital health in 2017, along with planning considerations and predictions for the health care and life science industries in 2018. 
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Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing

As the Federal Communications Commission repeals the Open Internet Order—more commonly known as the net-neutrality rules—health care consumers and providers have been left wondering how this change will affect their ability to receive and deliver health care using digital health tools. In this On the Subject, we outline how changes in internet access will

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.”
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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

The Senate’s unanimous passage of the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S.870) on September 26th is an encouraging step forward for modernizing telehealth access and reimbursement. The bipartisan, budget-neutral bill aims to improve health outcomes for Medicare beneficiaries living with chronic conditions and includes

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.
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