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Telehealth and Prescribing: What’s Permissible in Your State?

by McDermott Will & Emery | Mar 2, 2021 | Telehealth

Telehealth’s state-by-state regulatory patchwork means that healthcare providers must navigate a variety of regulations that govern which types of care can be provided by virtual means, and even what modalities can be used in different care settings.

Our new interactive map explores the standards and requirements that physicians and nurse practitioners must follow when prescribing non-controlled substances or ordering tests via a telemedicine encounter in all 50 states and the District of Columbia. Key issues addressed in the survey include:

In what states are asynchronous solutions permitted?
What are state rules governing prescriptions when a physician-patient relationship does not exist prior to the telehealth encounter?
What are state rules on prescribing via audio-visual encounters or audio-only encounters?
Under what state regulations can a questionnaire be sufficient to create a physician-patient or advance practice registered nurse-patient relationship?

Click here to access the map and download the full report.

Three Digital Health Trends Affecting Investors in 2021

by Lisa Mazur | Feb 23, 2021 | Telehealth

Private equity deal volume hit a low in the first half of 2020 as the pandemic slowed the US and global economies. But toward the end of the year, deals began picking back up, particularly in the digital health space.

COVID-19 forced healthcare providers to shift from in-person to virtual care, and technology was the vehicle to make that switch possible. Investors noticed, and more deals focused on companies specializing in telehealth, remote patient monitoring and other technology platforms that facilitate communication among specialists.

Expect this trend to continue in 2021, and keep these three factors in mind when evaluating the digital health landscape.

Easing of Laws and Regulations Surrounding Telehealth and Digital Health

Both telehealth and digital health are highly regulated, as every state has laws and regulations that govern how care is provided virtually and how those services are billed. In response to the pandemic, we’ve seen flexibility with these laws and regulations, and the Biden administration has signaled that it might make some flexibilities permanent.

Investment opportunities will likely increase as a result of the Biden administration’s willingness to lower some of the longstanding barriers to coverage and payment for virtual services, including telehealth, remote patient monitoring and other related services. That’s a positive sign for firms looking at healthcare through the lens of a technology solution.

Reallocation of Resources Due to Vaccine Rollout

Since the onset of the pandemic, labs have conducted a huge volume of testing and have had to ramp up personnel and other resources. Plus, the vast majority of COVID-19 tests must be ordered by a physician or nurse, further straining available resources.

While testing will likely continue in some capacity for a long time, the number of tests will presumably decline steadily as more people are vaccinated. That means capacity will open up, both for healthcare providers who were ordering the tests and for lab companies that were performing them. As a result, firms should begin asking themselves:

Where are there opportunities to shift focus and resources previously devoted to testing?
What other conditions lend themselves to at-home testing?
Where can companies shift efforts that were previously focused on reviewing orders?

Addressing Mental Health and the Other Epidemic

COVID-19 obviously emerged as the foremost health emergency of the past year. But it’s important to remember that the United States is still in the midst of an opioid addiction epidemic.

On top of that, COVID-19 has been hard on many people’s mental health. In response, many employers have made mental health a higher priority, and that trend is likely to continue, even as employees return to the workplace. In 2021, investors are likely to continue to emphasize digital health tools and service offerings that are focused on mindfulness and behavior health.

To learn more from Lisa and other thought leaders about the healthcare investing landscape heading into 2021, you can view a recording of The Deal’s webinar here.

National Telehealth Takedown Highlights Opportunity for Providers to Enhance Compliance Efforts

by James A. Cannatti III, Marshall E. Jackson, Jr., Tony Maida, Lisa Mazur, Dale C. Van Demark and Caroline Reigart | Oct 19, 2020 | Telehealth

The US Department of Justice and the US Department of Health and Human Services Office of Inspector General recently announced a significant healthcare fraud takedown involving $4.5 billion in allegedly false and fraudulent claims involving telehealth. The allegations involved telehealth executives paying healthcare providers to order unnecessary items and services, as well as payments from durable medical equipment companies, laboratories and pharmacies for those orders. While the alleged conduct is not representative of the legitimate and crucial telehealth services offered by the vast majority of healthcare providers, the government’s continued focus on telehealth arrangements, combined with the ongoing expansion of coverage for telehealth services, provides an important opportunity for healthcare providers to evaluate their telehealth service offerings and arrangements and to further enhance their related compliance activities.

In Depth

On September 30, 2020, the US Department of Justice (DOJ) issued a press release describing the largest national healthcare fraud and opioid enforcement action in the DOJ’s history (the Takedown). The Takedown involved coordination with the US Department of Health and Human Services Office of Inspector General (OIG) and other federal and state law enforcement agencies, and resulted in cases against more than 345 defendants in 51 judicial districts. The government charged the defendants with participating in healthcare fraud schemes involving more than $6 billion in alleged losses to federal health care programs, with the vast majority of alleged losses ($4.5 billion) stemming from arrangements involving alleged “telefraud.”

According to the DOJ press release, a recently announced National Rapid Response Strike Force led the initiative focused on telehealth. The National Rapid Response Strike Force is part of the Health Care Fraud Unit of DOJ’s Criminal Division Fraud section, and its mission is to “investigate and prosecute fraud cases involving major health care providers that operate in multiple jurisdictions, including major regional health care providers operating in the Criminal-Division-led Health Care Fraud Strike Forces throughout the United States.”

Background

In recent years, the government has increasingly focused on alleged healthcare fraud schemes involving telehealth services. In connection with the Takedown, OIG issued a fact sheet and graphic highlighting the increase in “telefraud” arrangements leveraging “aggressive marketing and so-called telehealth services.” The individuals charged in the Takedown included telehealth company executives, medical providers, marketers and business owners who allegedly used telemarketing calls, direct mail, and television and internet advertisements to collect information from unsuspecting patients.

Many of the cases involved telehealth executives who allegedly paid healthcare providers to order unnecessary durable medical equipment (DME), genetic and other diagnostic testing, and medications, either without any patient interaction or with only a brief phone call. The government alleged that the arrangements involved kickbacks to telehealth executives after the DME company, laboratory or pharmacy billed Medicare or Medicaid for items and services that the government asserts were often not provided to beneficiaries or were “worthless to patients . . . and delayed their chance to seek appropriate treatment for medical complaints.”

DOJ provided a [...]

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After the Curve Podcast: Focus on Digital Health

by McDermott Will & Emery | Oct 1, 2020 | Telehealth

COVID-19 has demanded a rapid shift in the world of telehealth and digital health, resulting in a global embracing of a telehealth and digital health system that is not yet fully developed. On this episode of the McDermott Health podcast, our digital health partners have joined to discuss the future of telehealth and use of digital tools to speed up care delivery and to improve outcomes in the wake of COVID-19, as well as the vital role of data readiness in reshaping the healthcare system. McDermott’s Chief Marketing Officer Leslie Tullio is joined by partners Stephen Bernstein and Lisa Mazur to examine current trends and potential changes to both telehealth as well as the broader digital health landscape, including:

The most impactful regulatory telehealth changes that have resulted from COVID-19
A look beyond telehealth to a paradigm shift in the broader digital health landscape
The impact that a more refined data exchange pathway could have on treatment during the next wave of COVID-19 or future pandemics
Meaningful collaborations that are currently happening in the digital health space
A look at innovations that are emerging from the demands of post-COVID-19 healthcare
Legal and regulatory compliance steps that still need to be taken to allow these telehealth programs to continue in the future

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Digital Health at Scale: The Payor Perspective

by Kate McDonald and Marshall E. Jackson, Jr. | Aug 20, 2020 | Telehealth, Uncategorized

The COVID-19 pandemic has catalyzed efforts by health insurers to expand reimbursement for telehealth services and digital health tools, and develop and invest in their own digital health technology. Health insurers, who increasingly play a hybrid role of payor, innovator and provider, have a vested interest in helping consumers manage chronic diseases and engage in preventive care from home, both during the public health emergency and after.

Joined by leaders from Humana, Oscar, and Medorion, we discussed the role of health insurers in the evolving digital health market, reimbursement pathways for digital tools and innovative partnerships between technology companies and health insurers. Click here to listen to the webinar recording, and read on for highlights from the program.

PROGRAM INSIGHTS

COVID-19 has accelerated the integration of digital health into the traditional health insurance framework. Pre-COVID-19, health insurers were using digital health tools to help their members find providers, access care and manage health conditions. COVID-19 has hastened health plans’ efforts toward vertical integration of digital health technology. Health insurers at the forefront of this effort are focused on creating a consumer-centric, digitally enabled and fully integrated healthcare ecosystem to enhance the member experience, bend the cost curve and carve out an essential (and expanded) role for themselves in the future of healthcare. As consumer behavior continues to change as a result of COVID-19, health insurers will have to be responsive to the way their members are getting care and interacting with the healthcare system.
Health insurers are uniquely situated to leverage digital health technologies. Data-driven technology is only as good as the data behind it. Due to the critical role health insurers play in paying for healthcare services, they have insight into member patterns of care and utilization that can be used to target interventions, influence member decision-making and improve health. Investments in digital tools and analytics, as well as strategic partnerships with technology companies, will allow for increased leverage of this valuable data, improved integration of member health information and enhanced member engagement.
Interoperability with existing health IT systems is crucial to break down barriers to digital health implementation. Healthcare has been grappling with data interoperability challenges for decades. To scale and make the information from digital tools actionable as part of a larger care plan, digital health platforms must also be interoperable with existing health IT systems. Interoperability will also allow insurers to gather a more complete picture of a member’s longitudinal health data and enable them to better support member health.
Health insurers and their legal teams will need to remain nimble amidst the rapidly changing regulatory environment. Keeping up with changing regulations during the COVID-19 public health emergency while planning to scale up in terms of technology implementations is a delicate balance. Though federal, state and local agencies appreciate that digital health tools and telemedicine have much potential in terms of patient care, health insurance companies remain vigilant of privacy and security risks and continue to be constrained in their [...]

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Remote Care Providers Await Final New Jersey Registration and Reporting Regulations

by Amanda Enyeart and Marshall E. Jackson, Jr. | Aug 17, 2020 | Telehealth

In 2017, the New Jersey legislature passed the New Jersey Telehealth and Telemedicine Act (codified at N.J.S.A. 45:1-61 et seq.), which established registration and reporting requirements for “telemedicine and telehealth organizations.” After a multi-year wait for details regarding the registration process, the New Jersey Department of Health (NJ DOH) published a proposed rule in April 2020 that brought providers of telehealth services in New Jersey one step closer to the implementation and enforcement of the registration requirements. A final rule is expected by April 2021.

New Jersey providers are also expecting the publication of a proposed rule detailing the reporting requirements for registered organizations. While the coronavirus (COVID-19) public health emergency has led many states to implement waivers and other measures to allow for the expansion of remote healthcare services within their states, telehealth and telemedicine organizations operating in New Jersey should prepare to comply with additional requirements and the outlay of annual registration fees if the state finalizes the registration requirements as proposed.

Background: The 2017 Telemedicine and Telehealth Act

For purposes of the Act, a “telemedicine or telehealth organization” is defined as a corporate entity “that is organized for the primary purpose of administering services in furtherance of telemedicine or telehealth.” The Act differentiates telemedicine from telehealth: “telehealth” is the use of information and communications technologies (including telephones, remote patient monitoring devices or other electronic means) to support clinical healthcare, provider consultation, patient and professional health-related education, public health, health administration and other services, whereas “telemedicine” is the delivery of healthcare services using electronic or technological means (not including the use, in isolation, of audio-only telephone, electronic mail, instant messaging, phone text or facsimile transmission) to “bridge the gap” between a healthcare provider located at a distant site and a patient located at an originating site.

In addition to establishing requirements for providers’ use of telemedicine and telehealth, the Act requires telemedicine or telehealth organizations to register with the NJ DOH annually, and to submit annual reports to the NJ DOH that include data elements established by the NJ DOH commissioner and, at a minimum, the following de-identified encounter data:

The total number of telemedicine and telehealth encounters conducted
The type of technology utilized to provide services using telemedicine or telehealth
The category of medical condition for which services were sought
The geographic region of the patient and the provider
The patient’s age and sex
Any prescriptions issued.

The Act did not establish any enforcement mechanism for the registration and reporting requirements, and because the NJ DOH has not yet implemented criteria for registering or reporting, New Jersey providers of remote health services have generally operated without regard to these statutory requirements.

Implementation of the Registration Requirement

The April 2020 proposed rule would implement the registration requirement for telemedicine or telehealth organizations and establish enforcement mechanisms available to the NJ DOH against any telemedicine or telehealth organization that fails to comply.

The proposed rule would require telemedicine and telehealth organizations to register with the NJ DOH [...]

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Preparing Your Data for a Post-COVID-19 World

by Stephen W. Bernstein, Bernadette M. Broccolo and Scott Weinstein | Jul 30, 2020 | Big Data, Data Transfers/Safe Harbor/Privacy Shield

The US healthcare system’s data infrastructure needs an overhaul to prepare for future health crises, streamline patient care, improve data sharing and accessibility among patients, providers and government entities, and move toward the delivery of coordinated care. With insights from leaders from Arcadia, Validic and McDermott, we recently discussed key analyses and updates on the interoperability and application programming interfaces (API) criteria from the 21st Century Cures Act, stakeholder benefits of healthcare data exchange and data submission facilitation for public health purposes. Click here to listen to the webinar recording, and read on for highlights from the program.

To learn more about the “Around the Corner” webinar series and attend an upcoming program, click here.

PROGRAM INSIGHTS

COVID-19 is reshaping healthcare through technology. Hospitals, clinicians and payors need to use digital health tools to address the challenges of the coronavirus (COVID-19) public health pandemic. How COVID-19 data and health information are captured, and then move through electronic systems, will form the foundation by which digital health tools can become effective in identifying cases, treating them and ensuring favorable outcomes.
API certification requirements under the 21st Century Cures Act are designed to enhance the accessibility of electronic health information. The 21st Century Cures Act’s purpose is to advance interoperability, address information blocking, support seamless exchange of electronic health information and promote patient access. Putting data from electronic health records (EHRs) into patients’ hands through consumer-facing apps will empower them to understand and take control of their health.
EHR vendors will be required to offer APIs that comply with the Fast Healthcare Interoperability Resource (FHIR) standard by May 1, 2022. The 21st Century Cures Act Final Rule will require EHR vendors to offer FHIR based APIs that make electronic health information more readily available to third-party applications (apps) of patients’ and providers’ choosing. API standardization will make it easier for third-party developers to build these apps, and for patients and providers wishing to use third-party apps to leverage their electronic health information for various purposes, including health information exchange and population health management.

Interoperability refers to the standards that make it possible for different EHR systems to exchange patient medical records and information between providers. Increased interoperability between EHR systems using harmonized standards allows for a more seamless transfer of patient data between providers. The interoperability requirements in the 21st Century Cures Act have the potential to advance patient access to their data and the use of information among physicians.
Both providers and patients can drive data exchange. One challenge impacting data exchange between patients and providers is that providers cannot always access or integrate data that patients have created with third-party tools (e.g., fitness trackers). However, there is emerging technology designed to aggregate and standardize consumer-generated health information, [...]

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Digital Delivery of Healthcare Services After COVID-19

by Sandra M. DiVarco and Jennifer S. Geetter | Jul 22, 2020 | Telehealth

The idea of keeping people healthy at home has become more relevant than ever during the COVID-19 public health emergency. The expansion of telemedicine during the pandemic is expected to serve as a catalyst that will permanently change the way providers deliver care and patients engage with their health. Joined by leaders from Cricket Health, Livongo and BehaVR, we discussed factors driving the shift towards expanding digital delivery of healthcare services and the challenges – technological, regulatory and cultural – that impact such expansion. Click here to listen to the webinar recording, and read on for highlights from the program.

To learn more about the “Around the Corner” webinar series and attend an upcoming program, click here.

Audience Perspective

This poll shows that 40% of digital health consider regulatory obstacles to be their biggest challenge.

Program Insights

A redoubled focus on preventative care will be key to bring about effective digital health delivery. The current US healthcare delivery system, built mainly on reimbursable, episodic care, is consistently indicted for being a “sick care” system, not a “healthcare” system. Patients, especially patients with chronic healthcare conditions such as diabetes, hypertension, behavioral health and acute kidney disease, need constant, real-time support and guidance, and need their providers to have access to accurate, actionable information to manage these conditions between real-time encounters. Digital health will play a vital role in this effort.
New care modalities open the door to structural changes, which will need to keep pace with the healthcare system. How emerging care modalities are integrated into and affect the healthcare system are still in development, and raise a variety of concerns, from staffing and technology needs to privacy safeguards. As the healthcare system adapts to these changes, the regulations that govern care delivery, licensing, and accreditation will need to adjust as well.
Positive regulatory changes have been implemented during the pendency of the national pandemic emergency, but those or similar regulatory changes must continue, and gain momentum and reach, for lasting changes to occur. The actions taken by regulators during the COVID-19 public health emergency show that the government can swiftly respond to new ideas and paths to care. However, these actions are temporary, and it will take time to implement lasting change. While there is an appetite to make some common-sense changes permanent, other areas, such as multi-state professional licensing, will likely take more time due to their complexity.
Reimbursement models based around episodic care are a major hurdle to the adoption of on-going remote monitoring and other digital health tools. Panelists agreed that when reimbursement structures are aligned with value-based care, such that providers are reimbursed for the outcomes and on-going care management they provide, digital health tools become a critical part of the provider’s toolbox. In [...]

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Future Forward: Data Arrangements During and After COVID-19

by Stephen W. Bernstein | May 12, 2020 | Big Data, Cybersecurity, Data Privacy, Data Transfers/Safe Harbor/Privacy Shield, General Interest, Mobile Apps, Telehealth

The need for speedy and more complete access to data is instrumental for healthcare providers, researchers, pharmaceutical, biotech and device companies and public health authorities as they work to quickly identify infection rates, disease trends, outcomes, including antibodies, and opportunities for treatments and vaccines for COVID-19.

A variety of data sharing and collaborations have emerged in the wake of this crisis, such as:

Requests and mandates by public health authorities, either directly or via providers’ business associates requesting real time information on infections and bed and equipment availability
Data sharing collaborations among providers for planning, anticipating and tracking COVID-19 caseloads
Data sharing among providers, professional societies and pharmaceutical, biotech and medical device companies in search of testing options, treatment and vaccine solutions, and evaluation of co-morbidities

CLICK HERE TO VIEW THE FULL INFOGRAPHIC.

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.

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