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 affect digital health and what the regulatory landscape will look like in the coming months and years.
Disruption of traditional health care is inevitable and poses a central challenge for health care governance. While the size and complexity of the health care industry have slowed the process of business disruption, its high costs and lack of convenience make it highly vulnerable to innovative, nontraditional competitors.
To make sure boards are well-prepared to address this challenge, McDermott Will & Emery and Kaufman Hall have partnered on a new thought leadership series designed to help you identify the signs of disruption, learn how to prepare your organization, and understand the implications for health care governance.
Get critical insights on how to spot, prepare for and manage disruption in your organization now:
Subscribe to the Surviving Disruption podcast on iTunes, SoundCloud and Pocket Casts, and keep an eye on the Resource Center for Episode 2: The Path Through Disruption and Episode 3: A Governance Foundation, being released on December 27 and January 10.
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.” (more…)
In September, the Office of the National Coordinator for Health Information Technology (ONC) announced that it is scaling back requirements for third-party certification of criteria related to certified electronic health record (EHR) technology (CEHRT). Going forward, ONC will allow health developers to self-declare their products’ conformance with 30 of the 55 certification criteria.
ONC will also exercise discretion and not enforce the requirement that certification bodies conduct randomized surveillance of two percent of the health IT certifications they issue.
Read “ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria.”
Copyright 2017, American Health Lawyers Association, Washington, DC. Reprint permission granted.
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.
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 key provisions expanding access to telehealth. A summary of the key telehealth provisions under the CHRONIC Care Act can be found here.
The bill now moves to the House Subcommittee on Health and may be adopted in its current form or integrated into existing House bills. The House has already advanced three separate bills this year with telehealth provisions similar to those included in the CHRONIC Care Act: expanding telehealth services under Medicare Advantage (HR 3727), expanding telehealth for stroke patients (HR 1148), and expanding the use of telehealth to facilitate the use of home dialysis (HR 3178). With seemingly aligned goals between the two chambers, the House may accept the remaining provisions of the CHRONIC Care Act, or negotiate minor changes and incorporate the CHRONIC Care Act into another priority health care related bill, such as extending federal funding for the Children’s Health Insurance Program, as a vehicle for passage this calendar year.
The recent momentum of federal legislation focused on expanding telehealth services to Medicare beneficiaries signals Congress’ continued consideration of telehealth’s ability to improve patient health and lower the costs of health care delivery. In light of this increased legislative activity, health care providers, commercial payers and telehealth technology companies should be mindful of the following.
On September 29, the Federal Trade Commission (FTC) formally announced a December 12th workshop on informational injury—the injury a consumer suffers when information about them is misused. The workshop will address questions such as, how to characterize and measure such injury and what factors businesses and consumers should consider the benefits and risks of collecting, using and providing personal information so as to gain further perspective for how the FTC should apply its legal framework for privacy and security enforcement under 15 USC § 45 (Section 5). In her September 19th remarks to the Federal Communications Bar Association, Commissioner Maureen Ohlhausen, the Acting Chairman of the FTC, metaphorically characterized the workshop’s purpose as providing the next brushstrokes on the unfinished enforcement landscape the FTC is painting on its legal framework canvas. The full list of specific questions to be addressed may be accessed here.
Background. The FTC views itself as the primary US enforcer of data privacy and security, a role it recently assumed. While the FTC’s enforcement against practices causing informational injury through administrative proceedings goes back as far as 2002, its ability to pursue corporate liability for data security and privacy practices under its Section 5 “unfair or deceptive trade practices” jurisdiction was only ratified in 2015 by the US Court of Appeals for the Third Circuit in FTC v. Wyndham Worldwide Corporation. The FTC has actively invoked its enforcement authority but, in doing so, has been selective in determining which consumer informational injuries to pursue by questioning the strength of evidence connecting problematic practices with the injury, examining the magnitude of the injury and inquiring as to whether the injury is imminent or has been realized. (more…)
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. (more…)
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. (more…)
A recent article in Kaiser Health News highlights the health risks associated with the increased effort to get patients home—namely, the need for families to gain and effectively deploy the skills needed to care for themselves and family members. The article highlights the risks (and increased rates) of infections, particularly in relation to catheters. However, it does not take much imagination to identify other conditions where at home care is critical.
Concise and easy to follow instructions are key, of course, but information technology can play a role here as well. While the business plan for this type of digital health strategy may not be as clear as others, this is the type of sector that could demonstrate the digital health opportunity in the effort to increase value in health care delivery.
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