DICOM Standard Flaw Could Compromise Medical Device Security
CMS is taking several actions to achieve that goal.
For one thing, the agency has proposed bringing telehealth services, remote communication services and monitoring, and care management into the physician fee schedule for Medicare beneficiaries.
Seema Verma
Source: CMS
In addition, CMS has redesigned the local coverage determination (LCD) process as part of its Patients over Paperwork initiative, which is an effort to get feedback from stakeholders on policies that are outdated, redundant, or burdensome. The redesign is intended to clarify and simply the process to enable manufacturers to get innovative medical devices to patients faster.
CMS has proposed changes to payment policies for medical devices that are granted FDA Breakthrough Devices Program designation to speed their entry into the market. One change is to waive the requirement for “substantial clinical improvement,” a criterion that must be met for CMS to make additional payments.
“Waiving this requirement would provide additional Medicare payment for the technologies for a period while real-world evidence is emerging, so Medicare beneficiaries don’t have to wait for access to the latest innovations. After devices have been on the market for two years, they would still have to demonstrate evidence of “substantial clinical improvement” to receive the third year of add-on payment,” Verma explained.
CMS is soliciting comments on what should constitute “substantial clinical improvement.”
CMS is working with the FDA even before devices are approved to speed Medicare coverage opportunities. One result of this cooperation is the CMS-FDA Parallel Review Program that grants FDA approval and CMS coverage for medical devices on the same day.
CMS Reforms Code Process to Speed Innovation, Ensure Coverage In addition, CMS is changing the current process for issuing Healthcare Common Procedure Coding System (HCPCS) codes. Instead of being restricted to applying once per year for Level II codes, device makers can apply two times per year and drug makers four times per year.
“We expect this will greatly improve the ability of innovators to accelerate through the adoption curve,” she said.
Verma added that her agency had been getting feedback that Medicare contractors are making decisions to automatically not cover devices with Current Procedural Terminology (CPT) Category III codes, which are temporary codes for emerging technologies.
In response, CMS has posted a clarification which says that contractors must follow the new local coverage determination (LCD) process for decisions they make, meaning that they cannot decide to automatically not cover an item or service because it has a Category III code.
She noted that CMS is working with Congress on legislative changes to address the challenges faced in adapting the Medicare program to modern devices and technology. For one thing, the President’s FY 2020 budget proposes expanding coverage of disposable devices, such as glucose monitors and insulin pumps that substitute for a durable device, for use in the management and treatment of diabetes.
“Taken together, these steps represent several key components of a comprehensive CMS strategy to address barriers to medical innovation in the Medicare program. 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,” Verma concluded.
