Dive Brief:

• Medicare Administrative Contractors (MAC) tasked with deciding what medical technologies qualify for Medicare coverage in local geographical areas will now be required to publish a summary of clinical evidence supporting their decisions, include a beneficiary representative and non-physician healthcare workers on advisory committees, and ensure that Contractor Advisory Committee meetings are open to the public.
• The changes, promulgated by CMS on Wednesday, come in response to Section 4009 of the 21st Century Cures Act. Separately, the House passed legislation in September aiming to change how Local Coverage Determinations are made, with strong backing from the medical device industry.
• CMS Administrator Seema Verma says that the changes will help speed new medical technologies to patients, but AdvaMed and key Republican lawmakers say more should be done.

Dive Insight:

Local Coverage Determinations are made by MACs when a national coverage determination has not yet been made or when a national policy needs to be clarified to address local differences in the practice of medicine.

“Coverage decisions will be made more transparently with an explanation of the clinical evidence that supports them, and with input from beneficiaries who are affected,” Verma said in a statement.

AdvaMed praised CMS for implementing the changes, saying they would “improve transparency and consistency.”

“Having a more open LCD meeting process for MACs and requiring them to provide rationales for their decisions will help allow for greater stakeholder engagement and a fairer process, and ensure that no Medicare beneficiaries are denied access to life-changing innovations because of bureaucratic impediments,” Don May, AdvaMed EVP of payment & healthcare delivery policy, told MedTech Dive in a statement.

The recently passed House bill, the Local Coverage Determination Clarification Act of 2018, would require local private insurers to undertake feedback processes before issuing a determination and post a rationale for a final determination online.

Companion legislation in the Senate, sponsored by Sen. Jonny Isakson, R-Ga., has yet to gain traction in the Finance Committee. It appears Isakson is not satisfied with the changes CMS is undertaking.

“Senator Isakson feels there is more work to be done in this space, and the bill he introduced is still needed to create a fair and transparent process for the issuing of Local Coverage Determinations (LCDs). We were pleased to see the U.S. House move on their version of the bill, and we are working closely with the Senate Finance Committee on a path forward for Senator Isakson’s legislation,” Isakson's Communications Director Amanda Maddox told MedTech Dive in a statement.

Finance Committee Chairman Orrin Hatch, R-Utah, will work with Isakson and other lawmakers to consider if the CMS policy may affect the legislation and solicit stakeholder feedback on the CMS policy changes, committee spokesperson Nicole Hager told MedTech Dive.

AdvaMed CEO Scott Whitaker said that while the CMS actions are commendable, more should be done.

The MedTech community has been hopeful to see even more in this space to unleash the power of breakthrough technologies. We are ready to work with CMS to find additional solutions to ensure America’s seniors have improved access to new innovations. @SeemaCMS @CMSGov

— Scott Whitaker (@ScottWMedTech) October 3, 2018

Industry is lobbying CMS to quickly speed Medicare coverage of breakthrough devices that are cleared by FDA. CMS and the Office of Management and Budget both appear to be open to the idea, but a concrete timeline for a pilot program or other action remains unclear.