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Access To Digital Health Applications And Digital Care Applications In Germany

On 20 January 2021, the German Federal Cabinet approved the draft law on the digital modernization of healthcare and nursing care. The draft has been criticized for not taking into account lessons learned from the implementation of the 2019 digital health applications law.

The legally enforceable right of patients insured in the Germany statutory healthcare system (SHI) to be able to access digital health applications (DiGAs) was included in the German SHI code (SGB V) at the end of 2019.

DiGAs are low-risk medical devices (risk class I and IIa) that are primarily based on digital technologies and support the detection, monitoring, treatment, or alleviation of diseases, injuries, or disabilities. Under the SGB V, DiGAs have to be approved by the German Federal Institute for Drugs and Medical Devices (BfArM) and included in the DiGA List before doctors can prescribe them to their patients on an individual basis and at the SHI’s expense. Among the DiGAs listed by BfArM since the first listing in October 2020, are those that support patients with light depression, insomnia, obesity, or tinnitus.

Read more in our latest edition of International News.




Top Takeaways | Cybersecurity & Insurance Coverage in the Age of Telehealth: Understanding and Mitigating Your Risk

With more frequent and more severe ransomware attacks against health care platforms and vendors and the increasing use of telemedicine, it is critical to understand how to proactively defend your organization using robust legal, regulatory and cyber-coverage strategies. In this webinar, McDermott partners Dale Van Demark and Edward Zacharias joined Brett Buchanan of Marsh & McLennan Agency and Larry Hansard of Gallagher USA to explore the intersection of telemedicine and cybersecurity. Our panelists offered attendees a road map for navigating this rapidly changing space, including practical strategies for shoring up their defenses and addressing potential risks to their businesses.

  1. Providers engaging in telemedicine should consider three critical areas of insurance coverage: medical professional liability, technology errors and omissions, and cyber/privacy liability. “Several carriers have packaged these three important coverages into a one-policy format, referred to as a virtual health program,” Hansard said.
  2. A medical professional liability program should include incident reporting, punitive damages, and sexual abuse and molestation. The latter may seem surprising in a telemedicine context, but is important given reports of inappropriate patient behavior during telemedicine encounters, Hansard said.
  3. New telehealth technologies, such as AI chatbots for patient intake, create new and more complex bodily injury exposures, Buchanan said. “Working with an insurance underwriter that understands these nuances is absolutely key,” he said. In addition to bodily injury, coverage should include technology errors and omissions, cyber liability and general liability.

Click here for the full list of highlights.
Click here to view the full webinar.




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

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

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.




Waiver of State Licensure Requirements for the Delivery of COVID-19 Countermeasures via Telehealth

In a fourth amendment to the March 17, 2020, Public Readiness and Emergency Preparedness Act (PREP Act), the US Department of Health and Human Services (HHS) has expanded access to COVID-19 Covered Countermeasures through telehealth and clarified the scope of liability protections provided by the PREP Act. In particular, the declaration is important to telehealth providers because it appears to preempt, under certain circumstances, state laws that have limited cross-border practice of medicine using telehealth. Healthcare providers should take note that the licensure exception and any immunity protections are limited to healthcare providers who are ordering or administering a Covered Countermeasure and there is no indication of intent to expand beyond these focused measures.

Access the article.




New Proposed CCPA Regulations Add Clarity to Process for Opting Out of Sale of Personal Information

On October 12, 2020, the California Department of Justice announced the release of a new, third set of proposed modifications to the California Consumer Privacy Act (CCPA) regulations. The proposed modifications amend a final set of regulations that were approved by the California Office of Administrative Law just two months earlier.

The Third Set of Proposed Modifications to the CCPA Regulations released on October 12 do not make substantial changes to the previously final set of CCPA regulations. The majority of the proposed modifications serve to clarify existing requirements rather than add new requirements or materially alter existing ones. As a result, the new proposed modifications should help businesses better understand what is expected to maintain compliance with certain aspects of the CCPA.

Process for Opting Out of Sale of Personal Information

The Department of Justice proposed to amend Sections 999.306(b)(3) and 999.315(h) to provide more detail about how a business should provide the right to opt out of the sale of personal information. Specifically, the Department of Justice:

  • Provides illustrative examples of how a business that collects personal information offline can provide its opt-out notice offline—through paper forms, posting signage directing consumers to an online notice or orally over the phone.
  • Makes clear that the methods for submitting opt-out requests should be easy for consumers to find and execute. For example, consumers should not have to search or scroll to find where to submit a request to opt out after clicking on the “Do Not Sell My Personal Information” link. A business should not use confusing language, try to impair a consumer’s choice to opt out or require a consumer to read through or listen to reasons why they should not opt out before confirming their request. In addition, the process for requesting to opt out shall collect only the amount of personal information necessary to execute the request.
Verifying Authorized Agent

The Department of Justice added language to Section 999.326(a) clarifying what a business may request to verify that an agent is authorized to act on a consumer’s behalf. Specifically, a business may require an authorized agent to provide proof of signed permission from the consumer for the agent to submit the request. In addition, the business may require the consumer to either verify their own identity directly with the business or directly confirm with the business that they provided the authorized agent permission to submit the request. Previously, a business had to go through the consumer to verify the authorized agent. Now, a business can verify the authorized agent directly.

Notices to Consumers Under 16 Years of Age

Finally, the Department of Justice clarified in Section 999.332(a) that all businesses that sell personal information about children must describe in their privacy policies the processes used to obtain consent from the child or parent (as applicable). Previously, the regulations were worded such that only a business that sells the personal information of both consumers under 13 and consumers between 13 [...]

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National Telehealth Takedown Highlights Opportunity for Providers to Enhance Compliance Efforts

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

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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Brazil’s LGPD Takes Effect—With Early Enforcement

Brazil represents over half of all IT spend in Latin America, has the largest regional market for software outsourcing, employs a sizable IT workforce, manufactures consumer goods (including commercial airplanes and cars) and has an active consumer market of social media operated by global data aggregators. At a time when data privacy is becoming increasingly important to consumers, it seems only fitting that Brazil would adopt comprehensive privacy legislation to protect data privacy rights.

The General Data Protection Law, the first law of its kind in Brazil, is now in effect, and we are already seeing enforcement. Streamlining the legal framework on data protection, the law sets forth a number of requirements addressing legal bases for processing, individual rights, governance and accountability and data transfers.

Access the article.




Digital Health at Scale: The Payor Perspective

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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