Lawmakers, industry urge CMS to push breakthrough payment rule as May 15 deadline looms

Dive Brief:

The medtech industry and members of Congress have stepped up pressure on CMS to push through a breakthrough device payment rule amid reports of a further delay.
Thirty-seven Democratic members of Congress wrote to acting CMS administrator Liz Richter to voice their support for the Medicare Coverage for Innovative Technology rule and call for the agency to "move forward with implementation as soon as possible."
Separately, AdvaMed rounded up comments from politicians, investors, medtech companies and other stakeholders to show the support for MCIT. At the same time, the rule faces strong pushback from some healthcare professionals, the Medicare Payment Advisory Commission and a patient safety group.

Dive Insight:

MCIT is due to come into effect on May 15. CMS delayed implementation by 60 days as part of a Biden administration review of regulations pushed through in the waning days of the Trump presidency. However, with feedback received during the reopened comment window confirming the depth of opposition against MCIT in some quarters, analysts at Cowen predicted a further delay.

Faced with that pushback, a range of groups are pushing to ensure the rule takes effect on May 15 as planned. Four members of Congress wrote to Richter in February to ask CMS to stick with the original March 15 implementation date. With that letter failing to have the desired effect, the four lawmakers have persuaded 33 of their colleagues to sign a second letter to Richter.

In the letter, the lawmakers make the case for MCIT, arguing, as AdvaMed has done, that it is right to provide seniors with timely access to breakthrough devices that have been through the "rigorous, science-based FDA approval or clearance process."

Opponents of MCIT argue differences in the FDA and CMS evidence requirements will mean the rule forces Medicare to pay large sums for products with unproven benefits. Cancer doctors, insurers and patient safety group ECRI have all come out against the MCIT.

ECRI has warned it would take away the incentive for manufacturers to conduct further safety trials of their products.

As well as trying to prevent a further delay, the lawmakers are seeking to ensure MCIT applies to any breakthrough devices that win FDA approval or clearance between the original implementation date of March 15 and whenever the rule finally takes effect.

Separately, AdvaMed published a roundup of comments people have made in support of MCIT in recent weeks. The quotes include an extract from an op-ed by two members of the Minnesota state senate, who expressed their support in near-identical terms to the words used by AdvaMed CEO Scott Whitaker, calling MCIT "good government, good policy, and good common sense."