‘The traditional model of patients interacting with their health care providers has become outdated’
YARMOUTH, Maine – As the home health care industry continues to adapt to advancing technologies and the regulatory issues surrounding how to use them, attorney Lisa Schmitz Mazur has been helping industry leaders make sense of it all.
A partner at the McDermott, Will & Emery law firm, Mazur advises health care providers and technology companies on a variety of legal, regulatory and compliance matters with a particular focus on digital health, including telehealth, mobile health and consumer wellness.
Mazur will present an important overview of the home health technology regulation and reimbursement space at next week’s Home Health Technology Summit in New Orleans. Here’s a preview.
HHTN: How is technology impacting the delivery of health care today?
MAZUR: The traditional model of patients interacting with their health care providers within the four walls of a medical facility—with minimal or no interaction between scheduled patient visits (unless a medical emergency occurs)—has become outdated. Technology has enabled health care providers to interact with their patients on a more regular basis, and empowered patients and consumers to track and manage their health conditions, share information with health care providers and receive health care services and resources when needed. When used appropriately, these tools promise to improve the health and wellness of users and to reduce health care costs.
HHTN: How is this advancement of technology forcing changes in regulation and reimbursement?
MAZUR: Although there is great recognition among accrediting bodies, payers, regulators, providers and patients that digital health tools offer solutions to improve health and lower health care spending, health care providers and technology companies are still faced with navigating the complex, and, at times, overwhelming laws and regulations that govern digital health solutions, many of which were drafted for a different time, sometimes many decades ago. For example, the hundreds, perhaps thousands, of state and federal privacy laws can be daunting to identify, let alone navigate. In addition to state and federal regulatory schemes, digital health providers are also required to meet payer standards if they want the service to be covered and reimbursed by payers. That said, there is increased recognition of the value of these solutions by payers and regulatory bodies, which has created some efficiencies and lowered certain burdens in very recent years. The recent guidance offered by the U.S. Food and Drug Administration is a great example of this change.
HHTN: Are the FDA’s recent guidelines and efforts around digital health good news for the home health care industry?
MAZUR: Absolutely. The Digital Health Innovation Action Plan and other FDA guidance statements greatly clarified how digital health technology developers should approach development, classification and post-market product decisions and surveillance. These clarifications have encouraged innovation while still maintaining FDA oversight where it’s merited.
HHTN: What are some of the biggest challenges to wider reimbursement of home health care technology?
MAZUR: The biggest challenge continues to be effectively confronting the concern that these technologies will result in more services and, therefore, additional costs to payers. Until such time as there is clear and overwhelming evidence that these tools result in cost savings, payers will continue to express fiscal concerns and expand reimbursement at a slow pace.
HHTN: What is your vision of home health care in 10 years?
MAZUR: While the hype of artificial intelligence is more significant than what is currently happening today, there is no doubt that AI-powered health care has proven itself to have great potential. Clinical decision support tools are already being used as a way to focus the role of human health care providers in care delivery and have been found clinically appropriate in certain care settings. The potential of AI to address a myriad of different health care issues—ranging from increased access to care by helping providers to better leverage resources to lowering the cost of health care delivery—will continue over the next 10 years.