May 03, 2019 - CMS is working with other federal agencies and lawmakers in Congress to modernize its approach to coverage for data-driven medical devices and other innovative technologies.
As digital tools, companion apps, and analytics technologies become more commonplace across the industry, CMS hopes to speed up the process of determining payment rates for breakthrough advances in patient care, CMS Administrator Seema Verma said in a speech at the Medical Device Manufacturers Association Annual Meeting this week.
“Our vision is ambitious yet achievable: to protect and secure Medicare and ensure beneficiaries have access to the latest medical technologies,” said Verma.
“The advent of novel medical technologies requires CMS to remove barriers to ensure safe and effective treatments are readily accessible to beneficiaries without delaying patient care. In essence, keeping new technologies and treatments moving from bench to bedside—and into the hands of those who need them most.”
CMS is anticipating the continued development of medical devices and other products that incorporate advanced analytics, data interoperability, and machine learning to offer actionable insights for patients and providers at the point of care.
Integrating new products and services into the Medicare fee schedule can be a lengthy and complex process, however, said Verma.
CMS and its Medicare Administrative Contractors (MACs) must first make coverage decisions on a national or local level. Then the agency must determine if the new technology can be coded for payment with existing codes or if new codes are needed.
Lastly, the agency makes a payment determination, taking into account the site and purpose of use in addition to other criteria.
Medicare can take years to make these decisions. Oftentimes, coverage for a “new” technology or device can lag behind commercial coverage by as much as a decade.
As the pace of innovation accelerates as the healthcare industry enters the age of artificial intelligence, this snail’s pace is simply no longer acceptable, said Verma, especially as other agencies such as the FDA take proactive steps to modernize their processes.
“With the remarkable number of transformative technologies coming to market — many with unprecedented price tags — Medicare must develop new frameworks that will support tomorrow’s innovations and endure the test of time,” she said.
“Simply put, our goal is to get new innovations to our beneficiaries concurrent with FDA approval by removing government barriers to innovation and harmonizing CMS coverage, coding, and payment processes.”
CMS has proposed several changes to payment policies for medical devices that receive “breakthrough device” designations from the FDA.
“This includes waiving the requirement for ‘substantial clinical improvement,’ which is one of the criteria that must be met for CMS to make additional payments,” said Verma. “For devices granted Breakthrough-designated FDA approval, real-world data regarding outcomes in different patient populations is often limited at the time of approval, making it hard for innovators to meet this requirement.”
“Waiving this requirement would provide additional Medicare payment for the technologies for a period of time while real-world evidence is emerging, so Medicare beneficiaries don’t have to wait for access to the latest innovations.”
Medical devices on the market for two years would still have to demonstrate substantial clinical improvement to qualify for a third year of payment, but putting products into the market more quickly will allow patients to benefit from innovations immediately, she added.
By collaborating more closely with the FDA, CMS is repositioning Medicare as an innovation leader instead of a barrier to bringing new devices and technologies to some of the nation’s neediest patients.
“We are also working with Congress on a raft of legislative changes to address the challenges we face in adapting the Medicare program to modern technology,” Verma continued. “For example, the President’s Budget proposes expanding coverage of disposable devices, such as innovative glucose monitors and insulin pumps that substitute for a durable device, for use in the management and treatment of diabetes.”
“If we implement all of these changes, we will ensure beneficiaries have access to the latest technologies in a timely manner; improve the innovator experience with Medicare; create predictable coverage pathways; enhance opportunities for coverage for transformative technologies; reduce wait times for permanent codes; and modernize payment for innovative services.”
These efforts align with Verma’s signature Patients Over Paperwork initiative, which aims to reduce unnecessary complexity for beneficiaries and providers.
“Patients over Paperwork is an agency-wide effort to solicit input from stakeholders on policies that are outdated, redundant, or overly burdensome, and to make updates in response,” she explained.
“We believe these changes clarify and simplify the process, helping to ensure that manufacturers get appropriate therapies and medical devices to patients more efficiently. These improvements respond to stakeholders’ suggestions for more transparency, including multiple opportunities for engagement with CMS and our MACs.”
Making widespread changes to such a large and influential government entity isn’t easy, Verma acknowledged, but collaborating with industry stakeholders and other agencies will help to advance the adoption of cutting-edge analytics and innovative medical devices in a safe and effective manner, she concluded.
“A modernized CMS, with stronger inter-agency collaborations with FDA and NIH, will unleash innovation for years to come, and be a catalyst for improving quality, enhancing access, increasing efficiency, and lowering costs.”