Smiths Medical lobbied the White House to boost Medicare reimbursement for its non-opioid pain pump in a private meeting May 9.
The effort seeks better payment for use of an ambulatory infusion pump through continuous peripheral nerve block (cPNB) for acute post-operative pain in CMS' Hospital Outpatient Prospective Payment System. The Trump administration has been working to broaden access to non-opioid pain management methods.
At issue is how Medicare provides payment for drugs and supplies to treat post-surgical pain. Hospitals receive the same payment if they provide more expensive non-opioid treatment under the current hospital outpatient rule instead of cheaper opioid treatment, according to letters in April from the Senate and House of Representatives to HHS Secretary Alex Azar.
A representative from Smiths Medical who attended the White House Office of Management and Budget meeting said it wants CMS to move toward a system that does not base payment for cPNB use of an ambulatory infusion pump on a bundled payment.
"The way the bundled payment is set up right now incentivizes use of opioids because they are on their face the cheapest thing if you don't look at addiction and other costs they are incurring," the representative, who asked not to be named, told MedTech Dive.
According to a PowerPoint presented at the meeting, Smiths Medical argued cPNB should receive payment outside of the bundled payment in both the ambulatory surgical center and outpatient settings. In its presentation, Smiths claimed many private insurers — including Aetna, Blue Cross, Cigna, Humana and United Healthcare — already cover cPNB use in home settings.
The Smiths Medical representative said HHS representatives at the Office of Regulatory Affairs meeting "asked a lot of great questions and they seemed really engaged on the topic."
The White House meeting is the result of years of lobbying by the Minneapolis-based medtech. Since 2017, the company has spent over $5 million lobbying on a number of issues including "medical device technology related to the opioid epidemic," according to lobbying disclosures.
Deaths from drug overdose deaths show no sign of abating. In 2017, 47,600 people died in the U.S. from a drug overdose involving an opioid, including prescriptions, heroin and other synthetic narcotics such as fentanyl, according to the Centers for Disease Control and Prevention.
CMS may be receptive to Smiths Medical's efforts this year.
"While CMS policy prevents us from commenting on the rulemaking process, we are deeply concerned about the magnitude of the opioid epidemic and its impact on our communities, and are committed to a comprehensive and multi-pronged strategy to combat this public health emergency," a CMS spokesperson told MedTech Dive in an email. "It is a top priority of this Administration to address the opioid epidemic and to that end we have engaged in stakeholder outreach to explore the full range of opioid alternative treatments."
AdvaMed is also lobbying for greater reimbursement for opioid device alternatives.
"While we have not specifically commented on issues related to infusion pumps, we have more broadly urged the Administration to support section 6082 of the SUPPORT Act and to cover devices and procedures which can help to reduce or alleviate the need to prescribe opioids," DeChane Dorsey, AdvaMed vice president of payment and healthcare delivery policy, told MedTech Dive in a statement.
The trade group recently sent feedback on the Pain Management Best Practices Inter-Agency Task Force's draft report urging the group to make recommendations to CMS and FDA to improve access to device-based opioid alternatives in the task force's final report. AdvaMed also is directly lobbying CMS Administrator Seema Verma.
"AdvaMed would ask CMS to consider payment system changes that will encourage providers to use these devices when needed without fear of negative financial impacts. We would also suggest that CMS consider other outpatient payment policy changes that will improve utilization of these devices, when needed, such as pass-through payments and new technology APC assignments," Donald May, AdvaMed executive vice president of payment and healthcare delivery, wrote to Verma April 11.
The Office of Information and Regulatory Affairs is currently reviewing the 2020 hospital outpatient proposed rule, which it received April 4. According to the Fall 2018 Unified Agenda the proposed rule is scheduled to be released in June and finalized by November 1.