But the current chaos and resource challenges could hinder efforts to hasten release of pending final rules and guidelines in the closing days of the Trump administration, Market Pathways' editors report.
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It’s common for an outgoing White House to accelerate the release of regulations and guidance documents in the closing months of an administration to clear out the docket and maximize its policy legacy, but whether that will be possible this time around is under question.
Confusion surrounding President Trump’s refusal to concede, combined with reports of a greater-than-typical number of federal employees who are looking to leave their jobs before the end of the year and the continued pressures on HHS to direct its focus on the pandemic, might make it challenging to speed up policy document releases. That could make it less likely that measures anxiously anticipated from the administration by the device industry will be finalized by January 20, when Joe Biden’s administration will take the White House and the status of the pending rules becomes more ambiguous.
“I have questions about whether or not [the administration] may have the manpower to put out as many…final regulations and guidance documents as we've seen in the past” at the end of prior administrations, Sheldon Bradshaw, a partner with King & Spalding who served as chief counsel at FDA for several years of the George W. Bush administration, said during a November 10 panel discussion during the law firm’s virtual Medical Device Summit. “I would also note that issues related to the pandemic are sort of sucking all the air out of the room.”
Device firms are certainly hoping for some end-of-year HHS actions to finalize rules. Priority number one is CMS’ Medicare Coverage for Innovative Technologies. The MCIT proposal, which would give automatic, temporary national Medicare coverage to FDA Breakthrough Devices upon approval, came out at the end of August. (See “Medicare’s Breakthrough Coverage Proposal: Innovation, Evidence, and the Valley of Death,” Market Pathways, September 18, 2020.) At the time, both industry and CMS suggested they wanted to finalize the plan by the end of 2020. The public comment period ended November 2.
Another set of priority rules for industry are two linked proposals issued in 2019—one from the HHS Office of Inspector General expanding safe harbors to the federal Anti-kickback Statute and the other from CMS on reforms to the Stark self-referral regulations. (See “Feds Remain Circumspect on Role of Device Firms in Value Arrangements,” Market Pathways, October 22, 2019.) Final versions of those rules were apparently completed by the respective agencies in July, but they have both been stuck in review by the White House Office of Management and Budget since then, suggesting the administration has yet to resolve some internal concerns with the documents.
There are also some regulations that the agencies need to issue by law, including the annual payment rules. In that category, CMS has yet to issue the final 2021 Medicare outpatient payment rule (OPPS) and physician fee schedule (PFS), and industry stakeholders tell Market Pathways to expect those rules by December 1. The PFS could include significant cuts to specialty areas including radiology and orthopedic surgery, but analysts anticipate CMS may take steps to soften to slow those cuts in consideration of COVID-19 challenges to the healthcare sector. The fee schedule also is expected to clarify remote monitoring policies. The OPPS will likely move forward with a plan to phase-out the inpatient-only list for medical procedures. (See “Pathways’ Picks August 5: CMS Policy Picks, FDA Fee Rates, NICE News,” Market Pathways, August 5, 2020.) Individual companies are keeping a close watch on the rules for business-specific reimbursement impacts—one example is Digital Diagnostics Inc., which is pushing to maximize the reimbursement rate for its IDx-DR autonomous AI diagnostic system for diabetic retinopathy and macular edema. (See “Digital Diagnostics’ Autonomous AI Technology Clearing Reimbursement and Payor Hurdles,” Market Pathways, November 9, 2020.)
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