Telehealth Archives - Page 13 of 35

Telehealth

Florida’s Extension of its COVID-19 Out-of-State Provider Waiver: A Sign of the Times

by Adam J. Rogers, Dale C. Van Demark and Danielle N. Scheer | Apr 17, 2020 | General Interest, Telehealth

Background: Issuing Florida’s Emergency Order

On March 16, 2020, Florida Surgeon General Dr. Scott Rivkees signed, stamped and finalized Emergency Order 20-002. In doing so, Florida joined what would become the vast majority of states in modifying licensure requirements for physicians in response to the Coronavirus (COVID-19) emergency.

The surgeon general’s order waived licensing requirements for out-of-state healthcare professionals, advanced life support professionals and basic life support professionals so that they could render services in Florida for the purposes of preparing for, responding to and mitigating any effect of COVID-19. In addition to waiving licensing requirements for in-person services, the order exempted out-of-state physicians, osteopathic physicians, physician assistants and advanced practice registered nurses from licensing requirements governing the provision of telehealth. The order also impacted emergency medical services training programs, physical examination requirements for physician certifications, prescription drug distribution and controlled substance prescription renewals (including medical marijuana). The order was to expire 30 days after signing—April 15, 2020.

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$200 Million of Funding for COVID-19 Telehealth Program

by Dale C. Van Demark, Lisa Mazur, Marshall E. Jackson, Jr. and Rachel Stauffer | Apr 14, 2020 | Telehealth

On April 2, 2020, the Federal Communications Commission (FCC) launched the $200 million Coronavirus (COVID-19) Telehealth Program contemplated in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Telehealth Program is distinguishable from the broader Connected Care Pilot Program, which will make an additional $100 million in federal universal service funds available for telehealth over the next three years.

Telehealth Program

Notwithstanding telehealth’s advantages, most low-income Americans are unable to utilize telehealth services due to their lack of consistent, broadband internet connection. Furthermore, some providers are limited in their ability to treat patients via telehealth due to the substantial financial and IT investment in developing connected care programs (e.g., purchase of remote patient monitoring devices, telehealth software platforms). The purpose of the Telehealth Program is to support healthcare providers in urban and rural areas, that are responding to the ongoing coronavirus pandemic by maximizing their provision of connected care services and devices. The Telehealth Program will help eligible healthcare providers purchase telecommunications services, information services and devices necessary to provide critical connected care services.

For purposes of the Telehealth Program and Connected Care Pilot Program, “connected care services” are defined as a subset of telehealth that uses broadband internet access service-enabled technologies to deliver care to patients at their mobile location or residence. Only internet-connected devices are covered, not unconnected devices that require the patient to communicate the results to their provider.

Funding will be awarded on a rolling basis until funds are exhausted or the coronavirus pandemic ends. To maximize the $200 million, the FCC anticipates limiting each applicant to $1 million in funding. Further, the FCC has indicated an interest in prioritizing funding to areas especially hard-hit by the coronavirus.

Eligible Healthcare Providers

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Avoiding Confusion Over State Licensing Laws as CMS Further Loosens Telemedicine Restrictions

by Dale C. Van Demark, Dawn R. Helak, Lisa Mazur and Rachel Stauffer | Apr 10, 2020 | Telehealth

The Centers for Medicare & Medicaid Services (CMS) continues to loosen the conditions for participation in Medicare, as well as specific reimbursement requirements, to ensure facilities and practitioners are able to practice at the top of their license and across state lines without jeopardizing Medicare reimbursement. Unfortunately, as demonstrated when CMS took similar actions over the past few weeks in response to the Coronavirus (COVID-19) pandemic, headlines tend to overlook one fundamental component of the applicable regulatory regime: state law requirements.

Unlike the Veterans Affairs Administration’s (VA’s) action a few years ago, which preempted state licensing law for purposes of implementing a VA telemedicine program, the Department of Health and Human Services has limited its actions during the COVID-19 pandemic to modifications of federal regulations and rules. Secretary Alex Azar, in a letter to the Governors, instead encouraged the states to take action themselves to similarly loosen state laws to ensure maximum utilization of resources. The states have been doing so, in some instances since early March, with different approaches. These differences stem from a large number of variables that are implicated by state licensure laws.

Key Takeaways: The practical implication for the provider community is that new standards for Medicare need to be adopted in harmony with existing state laws requirements, which, unfortunately, are not uniform across the country. Nevertheless, nearly every state has taken action to loosen cross-border licensing restrictions for healthcare professionals and have modified other rules and regulations to help protect healthcare workers, maximize their numbers and help them practice at the highest level of their experience and training. There is a national movement in this direction, but it remains a patchwork.

For a deeper dive into telemedicine regulations during the COVID-19 pandemic, visit our Coronavirus Resource Center, which features articles, webinar recordings and videos on the telemedicine issues you need to know.

Telemedicine COVID-19 Briefing: March 16

by McDermott Will & Emery | Mar 13, 2020 | Telehealth

Government, media and industry have all pointed to the potential for telemedicine to assist in combating the COVID-19 pandemic. In addition, steps have been taken by the government to ease the burdens associated with the use of telemedicine during this crisis. Unfortunately, the complexity of the regulatory infrastructure has left a fair amount of confusion with respect to the extent to which rules have been, and may be, liberalized. At a time when our healthcare infrastructure is engaging with a health crisis that will get worse before it gets better, confusion about the requirements for care delivery needs to be reduced to a minimum.

Please join us on Monday, March 16 from 1 – 2pm ET for an update on:

Loosened Medicare reimbursement requirements
State emergency efforts
Related issues associated with the delivery of telemedicine services during the COVID-19 pandemic

CLICK HERE TO REGISTER

Bipartisan Bill Relaxes Federal Telehealth Requirements in the Wake of COVID-19

by Dale C. Van Demark, Lisa Mazur and Marshall E. Jackson, Jr. | Mar 5, 2020 | Telehealth

On March 4, 2020, the House passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, a bipartisan bill to aid in COVID-19 preparedness and response. The bill includes, among other things, provisions that waive certain telehealth requirements during the COVID-19 public health emergency to ensure Medicare beneficiaries can receive telehealth services at home to avoid placing themselves at greater risk of the virus.

Generally, Medicare beneficiaries may only receive telehealth services as a Medicare covered service if:

The beneficiary (patient) is located in a qualifying rural area;
The beneficiary is located at one of eight types of qualifying originating sites;
The services are provided by one of 10 categories of distant site practitioners eligible to furnish and receive Medicare payment for telehealth services;
The beneficiary and distant site practitioner communicate via an interactive audio and video telecommunications system that permits real-time communication between them—telephones, fax machines and email do not meet this requirement; and
The CPT/HCPCs code for the service is on the list of covered Medicare telehealth services.

The bill gives the secretary of the US Department of Health and Human Services (HHS) the authority to waive the originating site requirement for telehealth services provided to Medicare beneficiaries located in any identified emergency area during emergency periods by a qualified provider. An “emergency area” is a geographical area in which, and an “emergency period” is the period during which, there exists: (a) an emergency or disaster declared by the president pursuant to the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act; and (b) a public health emergency declared by the secretary. The bill also allows telehealth services to be provided to Medicare beneficiaries via phone, but only if the phone allows for audio-video interaction between the provider and the beneficiary.

The bill takes important steps to allow healthcare providers to deploy telehealth resources in response to COVID-19 and other public health emergencies, and allows Medicare beneficiaries to receive telehealth services from the comfort of their home (even via their smart phone) without risk of exposure. While the bill represents a further step in the expansion of the availability of telehealth services, we should be careful not to overstate its impact. The waiver of the originating site requirement and expansion of telemedicine modalities is limited to emergency areas identified by the president and secretary during emergency periods. Accordingly, as a practical matter, this expansion of availability of telehealth reimbursement is very limited. In addition, healthcare providers must still comply with state laws and regulations that govern telehealth, including, but not limited to, professional licensure, scope of practice, standard of care, patient consent and other reimbursement requirements for non-Medicare beneficiaries.

The bill offers a welcome relaxation of the rigid Medicare requirements for telehealth reimbursement during a time of stress within the healthcare industry. It also represents another, albeit small, step in the gradual acceptance of telehealth within the healthcare reimbursement sector.

Coronavirus Resource Center | Preparedness Planning for Businesses

by McDermott Will & Emery | Mar 5, 2020 | General Interest, Telehealth

In our global economy, Coronavirus (COVID-19) raises serious concerns for employers in all industries. Workers may be on the front lines caring for patients and developing vaccines, travelling for business, or in close contact with individuals who travel or may have been affected. At this time, there is no vaccine or medication approved to prevent or treat the COVID-19 disease. Therefore, preparedness and prevention are crucial. Frontline responders must be especially vigilant as they deliver care and anticipate the challenges this uncharted territory presents.

McDermott’s Coronavirus Resource Center, brought to you by a multi-disciplinary team, will keep you informed of the latest developments and provide comprehensive insight to help you navigate this crisis with your employees, including:

Frequently asked questions for US and multi-national employers
Recent news updates
Podcasts
Upcoming events

Click here to access the Resource Center.

The Role of Telehealth in COVID-19 Response Efforts

by Dale C. Van Demark, Lisa Mazur and Marshall E. Jackson, Jr. | Mar 3, 2020 | Telehealth

As the number of confirmed COVID-19 cases in the United States grows, healthcare providers are stepping up their response planning. To combat the spread of COVID-19, the Centers for Disease Control and Prevention (CDC) urged healthcare systems and providers to deploy all of the resources necessary to ensure health system preparedness. The CDC recommended the use of telehealth tools to help address COVID-19 preparedness and to assist in directing patients to the right level of healthcare for their medical needs.

Healthcare providers have a unique and pressing opportunity to offer telehealth services to potential COVID-19 patients. At the same time, healthcare providers’ response to the COVID-19 outbreak highlights some of the barriers to the provision of telehealth services. Providers considering using telehealth as part of their COVID-19 response efforts should take the following factors into consideration:

While healthcare providers cannot diagnose COVID-19 through a telehealth visit, they can perform a number of services without requiring a patient to visit crowded medical facilities where the virus might be present. These services include performing initial patient screenings, assessing and assigning risk categories to patients, determining if a patient needs to seek diagnostic testing, and answering patient questions and offering treatment recommendations.
Deploying telehealth services is not without its challenges. The varying reimbursement policies of private, state and federal payers, as well as differing state-based medical licensing requirements, may burden providers and patients with confusion, economic inefficiencies and onerous processes in a difficult engagement context.
As part of the COVID-19 response discussions, telehealth advocates propose that the Centers for Medicare and Medicaid Services reduce or eliminate its long-standing telehealth reimbursement restrictions. This change would allow Medicare to pay for virtual visits during national emergencies, regardless of originating site or geographic location. There is also a push to waive the lengthy enrollment process telehealth providers must undergo to be paid by Medicare.
While telehealth has the potential to assist in a healthcare system’s response to COVID-19, providers still must comply with state laws and regulations that govern telehealth, including but not limited to professional licensure, scope of practice, standard of care and patient consent, in addition to the reimbursement requirements and limitations put into place by third-party payers.
- Typically, telehealth providers must be licensed in the state in which the patient is located, although certain states have exceptions that telehealth providers may leverage in response to COVID-19.
- Telehealth providers must practice within the scope of practice of the profession in which they are licensed and within the standard of care set forth by the governing professional board in a given state.
- State telehealth laws may require a specific modality for telehealth consultations (e.g., audio-visual consultations). Likewise, third-party payers may require a specific modality for telehealth consultations for purposes of reimbursement.

Digital Health Business Strategy: A Careful Balance

by Dale C. Van Demark | Feb 19, 2020 | General Interest, Telehealth

When it comes to market success for digital tools in the health sector, business strategy can be far more complex than in other industries. Understanding customer-driven market trends is important, but healthcare’s complexity can camouflage customer demand and its regulatory ecosystem adds layers of additional considerations.

Customer Demand and Digital Solutions

The convenience, competitive pricing, answers-at-your-fingertips responsiveness and hyper-personalization delivered by top technology brands and their integration into other industry sectors has created an expectation for digital health solutions that deliver the same experience.

In some instances, consumers are finding the solutions. For example, telemedicine is gaining momentum as consumers discover that digital interactions with high-quality providers are oftentimes more convenient and less expensive than face-to-face encounters. Other tools are providing access to prescriptions, better health condition management solutions, better information sharing enabling smoother transitions among care settings, and more efficiency in everything from hospital operations to scheduling appointments to identifying in-network care options.

When it comes to business strategy, however, digital health solutions need to recognize that consumer pressures are frequently at odds with existing incentives within care delivery systems and, perhaps legal and regulatory requirements. Accordingly, it is critical not just from a compliance perspective but also from a business strategy perspective to navigate the healthcare industry’s unique market and regulatory dynamics.

Balancing Demand with Reality
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US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence

by Bernadette M. Broccolo | Jan 17, 2020 | Big Data, Consumer Protection, Data Privacy, Telehealth

On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory approaches to reducing barriers to the development and adoption of artificial intelligence (AI) technologies. Implementing agencies are agencies that conduct foundational research, develop and deploy AI technologies, provide educational grants, and regulate and provide guidance for applications of AI technologies, as determined by the co-chairs of the National Science and Technology Council (NSTC) Select Committee. To our knowledge, the NTSC has not yet determined which agencies are “implementing agencies” for purposes of the Memorandum.

Submission of Agency Plan to OMB

The “implementing agencies” have 180 days to submit to OMB their plans for addressing the Memorandum.

An agency’s plan must: (1) identify any statutory authorities specifically governing the agency’s regulation of AI applications as well as collections of AI-related information from regulated entities; and (2) report on the outcomes of stakeholder engagements that identify existing regulatory barriers to AI applications and high-priority AI applications that are within the agency’s regulatory authorities. OMB also requests but does not require agencies to list and describe any planned or considered regulatory actions on AI.

Principles for the Stewardship of AI Applications

The Memorandum outlines the following as principles and considerations that agencies should address in determining regulatory or non-regulatory approaches to AI:

Public trust in AI. Regulatory and non-regulatory approaches to AI need to be reliable, robust and trustworthy.
Public participation. The public should have the opportunity to take part in the rule-making process.
Scientific integrity and information quality. The government should use scientific and technical information and processes when developing a stance on AI.
Risk assessment and management.A risk assessment should be conducted before determining regulatory and non-regulatory approaches.
Benefits and costs. Agencies need to consider the societal costs and benefits related to developing and using AI applications.
Flexibility. Agency approaches to AI should be flexible and performance-based.
Fairness and nondiscrimination. Fairness and nondiscrimination in outcomes needs to be considered in both regulatory and non-regulatory approaches.
Disclosure and transparency. Agencies should be transparent. Transparency can serve to improve public trust in AI.
Safety and security. Agencies should guarantee confidentiality, integrity and availability of data use by AI by ensuring that the proper controls are in place.
Interagency coordination. Agencies need to work together to ensure consistency and predictability of AI-related policies.

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Challenges and Opportunities in MedTech, Innovation and Digital Health

by Stephen W. Bernstein and Sharon Lamb | Jan 10, 2020 | Big Data, Data Privacy, Telehealth

A recent McDermott roundtable on European health private equity generated key insights into the future of medtech, digital health, and data analytics, and identiﬁed opportunities for companies and investors.

Digital health solutions are widely considered to be the next big growth market. Healthcare lags signiﬁcantly behind other industries when it comes to digitization, but the potential opportunities are driving developers, healthcare providers, and investors to ﬁnd solutions.

PATIENT CARE
A key point to bear in mind about healthcare technology is that success and adoption may often be measured by the quality of the users’ experience, the resulting clinical outcomes, short and long term cost savings, and the resulting margin for both investors and the health care system at large. These multi-faceted goals are best illustrated by the demands for i) greater efficiency, and ii) better patient outcomes.

Efficiency is typiﬁed by, for example, streamlined bookings and appointment reminders, algorithms that triage patients to ensure they are seen by the right person at the right time, and in-home patient monitoring after patients are discharged. Patient take-up is also an excellent gauge of efficiency, for example, a high tech product that measures and reports blood sugar is of no value if the interface is too complicated for an older population.

Better outcomes result from clinicians gathering and using data to determine the right treatment in the fastest possible time, and are demonstrated, for example, by permanent lifestyle changes, improvements in self-care or care outside hospital,accurate drug dosage and use of medicines, and, in direct contrast with other sectors, reduced, rather than increased, service usage.

PRIVACY AND REGULATORY HURDLES
One of the most obvious challenges inherent in digital health is data privacy and security. Stemming from that are issues relating to control of the data, the right to use it, and ownership of the analysis. The most successful companies are those that, from the very beginning, understand the regulatory landscape in which they are operating; are transparent in terms of where their data comes from; make clear the type of data at issue, be that identiﬁable, pseudonymized, anonymized, or something in between; and identify who will control what data in what form. The ability to marry up these factors is a key part of any new entrant’s value proposition.

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