- A bipartisan bill reintroduced in the U.S. House on Friday would pave the way for faster CMS coverage of devices and diagnostics deemed a breakthrough technology by FDA.
- The bill would require Medicare to cover all products approved through FDA's breakthrough pathway for a three-year transitional period. During the three years, CMS would assess whether additional data would be needed to make a permanent coverage determination.
- The legislation also would make coding available for new devices and diagnostics. Medicare does not cover many FDA-approved or -cleared breakthrough devices because they do not fit within a benefit category.
FDA's Breakthrough Devices Program gives priority review to technologies with potential to become a more effective treatment for a life-threatening or debilitating condition, but there is no equivalent CMS pathway to facilitate coverage, coding and payment. The lag in reimbursement can sometimes delay for years a Medicare patient's access to a new device treatment.
Newer types of devices that did not exist when Medicare was created, such as software or prescription digital therapeutics, do not have a benefit category and therefore no coverage for beneficiaries, legislative backers said in a press release.
The new House bill would let HHS make coverage determinations for products that have FDA breakthrough status but no benefit category. Called the Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5333), the legislation would amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program. It was first introduced in 2018 by Reps. Suzan DelBene, D-Wash., Jackie Walorski, R-Ind., Tony Cardenas, D-Calif., Gus Bilirakis, R-Fla., and Terri Sewell, D-Ala.
Rep. Roger Marshall, R-Kan., joined the original five sponsors in reintroducing the bill.
Prospects for moving the bill forward don't seem immediate, as no current corresponding legislation in the Senate is listed on Congress.gov.
AdvaMed applauded the House bill, saying it will give both Medicare patients and physicians access to breakthrough medical technology in a timely matter.
CMS Administrator Seema Verma has argued that coding regulations have restricted access to new medical technologies. In May, Verma announced an overhaul of the agency's policies for new technologies. Changes include allowing medical device companies to apply for a new permanent Healthcare Common Procedure Coding System code twice a year instead of annually. The local coverage decision process also was revised to prevent contractors from automatically not covering a device.
The Outpatient Prospective Payment System and Inpatient Prospective Payment System rules for 2020 build on those steps. In November, CMS finalized the OPPS rule, including a provision to allow breakthrough devices to bypass a requirement for demonstrating substantial clinical improvement to qualify for the agency's pass-through payment status.
Also last month, the White House included a proposed rule, Medicare Coverage of Innovative Technologies, to address the need for a swift coverage mechanism to allow beneficiary access to new technology in its Fall 2019 Unified Agenda for regulatory actions.