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Telehealth

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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CMS Takes a Preliminary Step to Make Certain COVID-19 Waivers Permanent

by Lisa Mazur and Rachel Stauffer | Aug 14, 2020 | Telehealth, Uncategorized

On August 4, 2020, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to update its payment policies under the Medicare Physician Fee Schedule (PFS) for calendar year 2021. The proposed rule was issued in tandem with a presidential executive order, which directed the Secretary of the US Department of Health and Human Services (HHS) to propose regulations expanding telehealth services covered by Medicare. CMS stated that the proposed rule “is one of several proposed rules that reflect a broader Administration-wide strategy to create a health care system that results in better accessibility, quality, affordability, empowerment, and innovation.”

In response to the coronavirus (COVID-19) public health emergency (PHE), CMS has issued several temporary waivers and flexibilities that expand telehealth reimbursement under Medicare, Medicaid and the Children’s Health Insurance Program for the duration of the COVID-19 PHE. CMS issued these waivers under authorities granted pursuant to HHS’s public health declaration, as well as legislation passed in response to the pandemic. Many of these waivers have substantially altered the Medicare telehealth reimbursement landscape and, as we detailed in our prior On the Subject, many can be made permanent via regulatory action. The proposed rule represents the first official word that CMS will take such action to make certain of its waivers permanent. These policy changes have the potential to greatly increase the availability of telehealth to Medicare beneficiaries around the country.

CMS will accept comments, either electronically or by mail, on the proposed rule until 5 pm EDT on October 5, 2020.

Changes to Medicare Telehealth Services

CMS proposed to add several services, listed below, to its list of services that may be delivered via telehealth. Many of these were previously added on an interim final rule basis for the duration of the PHE. The proposed rule would keep them on the Medicare telehealth services list even after the PHE ends.

CMS also proposed a new method for adding or deleting services from the Medicare telehealth services list. Currently, CMS evaluates new services for inclusion based on two categories: Category 1 is for services that are similar to professional consultations, office visits and office psychiatry visits that are already on the Medicare telehealth services list, while Category 2 is for services that are not similar to those already on the list, but that would still be appropriate to include because the service is accurately described by the corresponding code when delivered via telehealth and providing the service via a telecommunications system results in clinical benefit for the patient. Because of the COVID-19 PHE, CMS has proposed to add a Category 3, which would include services that would be temporarily on the Medicare telehealth services list. CMS proposed this third category because, while CMS currently has the authority to waive or modify Medicare telehealth payment requirements during the PHE, that authority will expire once the PHE [...]

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TREATS Act Aims to Expand Use of Telehealth to Treat Substance Use Disorder

by Marshall E. Jackson, Jr. | Aug 14, 2020 | Telehealth

A bipartisan pair of US senators have proposed legislation that would allow certain controlled substances to be prescribed via an initial telehealth encounter and—under certain conditions—expand Medicare reimbursement of audio-only substance use disorder treatment services. The proposed TREATS Act has been referred to the Senate Committee on Health, Education, Labor, and Pensions, and could significantly reduce the regulatory burdens associated with the remote prescribing of controlled substances.

For more than a decade, healthcare providers in the United States have been largely prohibited from prescribing controlled substances via telehealth without having previously performed an in-person medical evaluation of the patient. Although Congress created the framework for a “special registration” pathway that has the potential to more broadly permit the practice, the Drug Enforcement Administration (DEA) has not issued regulations to implement it. This has been a significant roadblock for the treatment of substance use disorder, which is often treated with controlled substances. Recently, Senators Rob Portman (R-OH) and Sheldon Whitehouse (D-RI) proposed the Telehealth Response for E-prescribing Addiction Therapy Services Act (the TREATS Act), which would allow certain controlled substances to be prescribed via telehealth. The TREATS Act also proposes to expand Medicare reimbursement of audio-only substance use disorder treatment services, if certain conditions are met. The TREATS Act was introduced on June 30, 2020, and has been referred to the Committee on Health, Education, Labor, and Pensions.

Remote Prescribing of Schedules III and IV Controlled Substances

The remote prescribing of controlled substances has been stymied by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), which typically requires providers to perform an in-person medical evaluation of the patient prior to prescribing controlled substances. The Ryan Haight Act does incorporate seven pathways by which practitioners can prescribe controlled substances via telemedicine without a prior in-person examination, but these exceptions are extremely narrow and it is difficult for most providers to meet their requirements. One of the pathways, however, called for a “special registration process” that had the potential to more broadly permit providers to prescribe controlled substances via telemedicine. Congress left the implementation of the special registration process up to the DEA—and the DEA never issued regulations to implement it. After ten years of silence, Congress again pushed the DEA to act, imposing a second deadline for the DEA to implement regulations regarding the special registration process by October 24, 2019, under the SUPPORT for Patients and Communities Act. While there were rumblings that the DEA was prepared to act in late 2019, it is still yet to issue a proposed rule regarding the special registration process.

As we explained in a prior On the Subject, the COVID-19 public health emergency ushered in a significant, albeit temporary, change to the Ryan Haight Act, permitting providers to prescribe controlled substances via telehealth without a prior in-person medical evaluation during the pendency of the public health emergency declared [...]

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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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Around the Corner: The Future Of Telehealth After COVID-19

by Jennifer S. Geetter, Marshall E. Jackson, Jr. and Lisa Mazur | Jun 26, 2020 | Telehealth

Prior to the pandemic, health providers and stakeholders were quickly moving to develop and expand existing telehealth programs. Now we are seeing an adoption of telehealth solutions that far surpasses all of the activity we saw in the past five years combined.

Joined by leaders from BDO, Babylon Health, Crossover Health and the Illinois Bone & Joint Institute, we discussed what the future of digital provider/patient engagement may look like after COVID-19 and the legal factors that influence implementation. Telehealth is the new normal and there is no turning back.

Bar graph with poll results.

PROGRAM INSIGHTS

There is now recognition that telehealth can, in fact, replace in-person visits in many situations. Patients and healthcare providers have quickly turned to telehealth to provide care for existing and new healthcare conditions during the pandemic. This increase in use has provided additional data demonstrating the value of telehealth. In addition to telehealth visits, patients are looking to patient care navigators and wellness advisors for basic healthcare information that can empower them to manage their healthcare needs before seeking treatment from a licensed healthcare professional.
The regulation of telehealth on a state-by-state basis is an ongoing hindrance to telehealth providers in the United States. While the state waivers on professional licensure and care delivery during the COVID-19 public health emergency have temporarily lowered some of these barriers, these waivers have or will soon expire in many states, once again leaving telehealth providers with the burden of developing complex compliance strategies that differ from state to state.
For telehealth to achieve its full potential, it needs to be freed from the constraints that apply to in-person episodic care. In doing so, remote monitoring can meaningfully engage patients in real time to actively manage care on an ongoing basis, without interruptions or the need for a pre-scheduled visit.
The COVID-19 pandemic is digital health adrenaline – forcing people rapidly and without warning to pivot to telehealth. But when technology works well and effectively, demand will persist well beyond the catalyzing event. If patients receive superior quality care through digital technologies and superior convenience, this improved experience will force the traditional healthcare delivery process to continue its changed approach.
The healthcare transactional business model is a challenge that holds back widespread adoption of telehealth. Now that lawmakers have data that demonstrates the value of telehealth, reimbursement codes for different delivery modalities will need to be reevaluated. This reevaluation will future catalyze greater adoption of telehealth by providers as payments will align more appropriately with the services delivered.

For a deeper dive into these topics, please listen to our webinar recording, available here.

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.

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