Vents: More legislative activity to come

YARMOUTH, Maine - If two major manufacturers have their way, there will be other ventilator-related bills introduced in Congress.

Bills known as The BREATH Act have already been introduced in the House of Representatives and the Senate—they would establish policies and standards for determining appropriate use for vents, and would increase Medicare reimbursement for the product category by 20% on Jan. 1, 2017. The bills have zero co-sponsors in the House (H.R. 6012) and three co-sponsors in the Senate (S. 3195).

“While appropriate payment is important, we believe coverage issues should be prioritized,” said Liesl Cooper, vice president of market access for ResMed. “We expect to see other bills in the near future that better address these issues.”

Both ResMed and Philips Respironics, along with AAHomecare, have supported efforts by several pulmonary groups to get CMS to reconsider its national coverage determination for vents. In particular, the groups want the agency to clinically define respiratory failure and mechanical ventilators/ventilation; and create objective, consistent criteria for providing the products.

Legislation needs to be more “broad and farther-reaching than the topic of a temporary reimbursement increase tied to a decreases in utilization,” said Jim Doty of Philips Respironics. Per the existing bills, if utilization for vents doesn't go down 20% in 2017, the government has the authority to cut reimbursement the following year by the difference between 20% and the actual decrease in utilization.

“From our perspective, the proposed legislation will not effectively focus on the best outcomes for patients, nor will it ensure future reimbursement coverage at sustainable levels,” said Doty, senior director of field marketing. “We will continue to work with all stakeholders, including clinical, patient and industry policy advocates to ensure appropriate access and reimburse, which could involve comprehensive legislation that addresses patient and stakeholder needs in this changing healthcare environment.”

In the wake of CMS's recent announcement that it will continue to defer to the existing NCD, a legislative fix may be the only way forward, Doty says.

“In light of CMS's response, Philips will support a legislative route seeking to clarify coverage guidelines,” he said.

CMS, by refusing to reconsider the NCD for vents and instead tweaking coding and pricing, isn't getting to the core of the issue with the product category, Cooper says.

“Changes have followed a spike in vent prescriptions over the past few years, partly because backup rate devices can help patients with COPD exhale carbon dioxide and it's currently easier to prescribe a vent than a bilevel PAP with backup rate,” she said. “Passing national coverage policies that clearly define who can quality for a bilevel with backup rate, and how to document that, will benefit CMS, providers and, most importantly, patients.”