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US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence

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...

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Challenges and Opportunities in MedTech, Innovation and Digital Health

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...

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New Laws Expand Telehealth in California

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 health payers should consider the following key takeaways from these laws. Remote Prescribing Assembly Bill No. 1264 (codified at Cal. Bus. & Prof. Code § 2242(a)) took immediate effect on October 11, 2019. This provision alters the standard for prescribing, dispensing and furnishing dangerous drugs (including any prescription medication): Such drugs may be prescribed, dispensed and furnished as long as there is an “appropriate prior examination and a medical indication.” The law specifies that the appropriate prior examination “does...

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Vetting Relationships for Telemedicine Collaborations

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...

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Telemedicine Collaborations and Partnerships: Key Considerations for Success

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. Early-Stage Considerations 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...

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DOJ Continues Telemedicine Enforcement in Q2 2019

During the second quarter of 2019, DOJ continued its focus on enforcement activity in telemedicine. As reported in prior editions of the Quarterly Roundup, telemedicine is an expanding field, causing DOJ to pay particular attention to the industry. In April 2019, DOJ indicted the owner and operator of 1stCare MD and ProfitsCentric with one count of conspiracy to pay and receive kickbacks. The defendant’s arrest and federal indictment is part of a nationwide law enforcement action, as reported in the Q1 2019 Quarterly Roundup, that targeted 24 defendants involved in alleged extensive healthcare fraud schemes focused on telemedicine and durable medical equipment (DME) marketing. These schemes allegedly resulted in losses amounting to more than $1.2 billion. The indictment alleges that from 2016 to 2019 the defendant defrauded HHS in its administration and oversight of Medicare by conspiring with others by paying and receiving kickbacks and bribes in exchange...

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Dash to Digital Health? How the Regulatory Sprint to Coordinated Care Could Expand Access to Care

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 products. The US Department of Health and Human Services (HHS) launched the Regulatory Sprint to Coordinated Care in 2018 with the goal of reducing regulatory burden and incentivizing coordinated care. As part of this initiative, the Centers for Medicare and Medicaid Services and other agencies are scrutinizing a variety of long-standing regulatory requirements and prohibitions to determine whether they unnecessarily hinder the innovative arrangements policy-makers are otherwise hoping to see develop. While regulations such as the civil monetary penalty prohibition on...

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CMS Innovation Center Proposes Telehealth Solutions in ET3 Model

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...

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DOJ’s Enforcement Activity Against Individuals: Acute Focus on Telemedicine

DOJ’s focus on individual accountability is particularly important with respect to telemedicine. Telemedicine is a burgeoning field, with a projected market increase of 18 percent annually over the next six years, reaching $103 billion in 2024. In light of this recent surge in profitability, DOJ has begun paying extra attention to telemedicine, with at least one recent HHS-OIG report asserting that more than one-third of all telemedicine claims are improper. The report’s claim is further supported by a recent increase in telemedicine prosecutions. In April 2019, DOJ announced charges against 24 defendants, including owners of various telemedicine companies, for their alleged involvement in a health care fraud scheme resulting in $1.2 billion in loss. This scheme involved the payment of kickbacks and bribes by durable medical equipment (DME) companies to medical professionals working with telemedicine companies, in exchange for the referral of Medicare...

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Around the Corner in Digital Health: What’s Next for Care Coordination & Reimbursement?

The end of 2018 and the first months of 2019 brought a number of regulatory developments impacting care coordination and the adoption and reimbursement of digital health services. From the Centers for Medicare & Medicaid Services’ (CMS) Regulatory Sprint to Coordinated Care and Pathways to Success initiatives to the updated Physician Fee Schedule, speakers Dale Van Demark and Lisa Schmitz Mazur discuss the rules and regulations that have the potential to enhance or hinder access to digital health solutions and how digital health companies can position themselves for success in this evolving regulatory landscape. Click here to listen to this episode of the Of Digital Interest podcast. 

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