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
Lisa Schmitz Mazur advises health care providers and technology companies on a variety of legal, regulatory and compliance matters with a particular focus on digital health topics, including telehealth, telemedicine, mobile health and consumer wellness. Lisa advises a variety of health care providers and technology companies involved in “digital health,” including assisting clients in developing and implementing telemedicine programs by advising on issues related to professional licensure, scope of practice, informed consent, prescribing and reimbursement. Lisa helps clients identify and understand the relevant legal issues, and develop and implement practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape. Read Lisa Schmitz Mazur's full bio.
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…
California Governor Gavin Newsom recently signed into law two bills that expand the delivery of telehealth services in the state. In particular, the legislation:
- Permits providers to prescribe medications without a synchronous interaction
- Requires payment parity of telehealth services under commercial plans
- Loosens restrictions on Medicaid coverage of store-and-forward services.
California healthcare providers and commercial…
As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology, opportunities for telemedicine collaborations are likely to grow. Like any collaboration, finding the right partner is crucial for success, particularly at the highly-scrutinized intersection of healthcare and technology. This post explores the factors to address when evaluating service providers and vendors for your next telemedicine collaboration.
Service Provider Evaluation
- Ask around “town” – What is the collaborator’s reputation? What independent feedback is provided in references?
- Determine if the service provider’s stage in the organizational “life-cycle” and its affiliated relationships are the best fit for the strategic goals of your partnership (e.g. should you partner with an early-stage company or a longstanding organization?)
- Assess the capabilities of potential collaboration partners for meeting your organization needs, and pressure test their ability to come up with back-up options, should the need arise throughout the course of the collaboration.
- Determine whether collaborator has state specific and service specific policies and procedures governing the provision of telemedicine services, including:…
Telemedicine collaborations, whether between technology companies and providers, health systems and patients, or other creative partnerships we have yet to see in the industry, can present numerous benefits to our healthcare delivery system and patient outcomes. However, such collaborations present a variety of regulatory, logistical and operational concerns that should be strategically addressed from the ideation stage of the collaboration onward.
The strategy behind the collaboration should be developed with an eye towards the duration of the relationship and the development of mutually beneficial goals and objectives that are clear and measurable. Each party should be transparent about their capabilities and strategic vision at the outset of the collaboration talks to avoid any surprises or disappointments deeper in the future. Questions for potential collaboration partners include:
- Is this an experimental partnership or a long-term plan?
- What do I bring to the table? How can this partner supplement or support my capabilities?
- How will this relationship be branded and marketed? Do I need greater visibility than my partner, or will we come together under a new brand?
- Do we have the IT infrastructure and vendor relationships in place to execute this collaboration? If not, how will secure what we need?
- Do we have the resources to meet the regulatory requirements of the partnership?
- How will we measure the success or failure of the collaboration?
Considerations in the RFP Stage
After the initial strategy discussions have taken place, the proposal period raises its own series of considerations. After ensuring that the arrangement proposed can address the goals and objectives of the collaboration, regulatory and transactional issues take center stage. Rights and responsibilities of each party, reporting and compliance mechanisms, fees, credentialing, licensing and privacy compliance and liability issues, to name a few concerns, are addressed at this point in the process. Fees structures and compliance with the evolving federal and state laws regulating telemedicine providers are particularly complex issues that should be addressed at this point.
Questions to address regarding fees include:
Certain long-standing laws, such as the civil monetary penalty provision prohibiting patient inducements, have hampered providers’ ability to fully leverage remote patient monitoring and other telehealth tools. Many stakeholders are hoping that developments in the Regulatory Sprint to Coordinated Care will begin the rulemaking process to enable greater access to digital health and virtual care…
Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital health companies faced intense scrutiny—not only from regulatory agencies, but in some cases from their own investors. While the regulatory framework for digital technology in health care and life sciences will continue to evolve, digital health enterprises can take key steps now to mitigate risk, ensure compliance and position themselves for success.
- Be accurate about quality.
Ensuring that you have a high-quality product or service is only the first step; you should also be exactingly accurate in the way that you speak about your product’s quality or efficacy. Even if a product or service does not require US Food and Drug Administration clearance for making claims, you still may face substantial regulatory risk and liability if the product does not perform at the level described. As demonstrated in several recent public cases, an inaccurate statement of quality or efficacy can draw state and federal regulatory scrutiny, and carries consequences for selling your product in the marketplace and securing reimbursement.
Tech companies and non-traditional health industry players should take careful stock of the health sector’s unique requirements and liabilities in this area, as the risk is much higher in this arena than in other industries.
As part of its efforts to provide patient-centered care and reduce costs for Medicare beneficiaries, the Centers for Medicare and Medicaid (CMS) have developed an Innovation Center model for ambulance care teams: Emergency Triage, Treat, and Transport (ET3). As part of this model, the agency has proposed two potential telehealth offerings: 1) An individual who calls 911 may be connected to a dispatch system that has incorporated a medical triage line to be screened for eligibility for medical triage services prior to ambulance initiation, and 2) telehealth assistance via audiovisual communications technologies with a qualified provider once the ambulance arrives.
Key participants in the ET3 model will be Medicare-enrolled ambulance service suppliers and hospital-owned ambulance providers. In addition, to advance regional alignment, local governments, their designees or other entities that operate or have authority over one or more 911 dispatches in geographic areas where ambulance suppliers and providers have been selected to participate in the ET3 model will have an opportunity to access cooperative agreement funding. As such, both state regulations and CMS regulations will apply to the use of telehealth offerings under ET3. This post explores early-stage questions of ET3 implementation and reimbursement, the intersection of state laws governing telehealth, and what potential participants and telehealth companies should know about the program.
How will CMS support the ET3 model implementation?
The key telehealth development for the ET3 program is that CMS expects to waive the telehealth geographic and originating site rules as necessary to implement the model, including waivers that will allow participants to facilitate telehealth at the scene of a 911 response. Additional information on these waivers is expected to accompany the ET3 Request for Applications (RFA), slated for release this summer. Overall, Medicare coverage requirements provide that the patient must be in an approved originating site at the time of the telehealth visit (e.g., hospital) and must be located within a rural area. CMS has waived these two requirements for other programs, such as the SUPPORT for Patients and Communities Act (the SUPPORT Act) in October 2018, which eliminated the originating site restriction for substance use disorder treatment, because doing so is necessary for these programs to succeed.
Last week, President Trump signed the SUPPORT for Patients and Communities Act (SUPPORT Act), a bipartisan piece of legislation designed to tackle the opioid crisis by, among other approaches, increasing the use of telemedicine services to treat addiction. Several key provisions are summarized below.
The package includes provisions to expand public reimbursement for telemedicine services…
On November 1, 2018, the Centers for Medicare and Medicaid (CMS) issued final rules for updating the 2019 Medicare Physician Fee Schedule to implement recent telehealth-related legislative reforms. As reported in our Digital Health Mid-Year Report: Focus on Medicare, these changes are expected to have a material impact on the ability of providers to…