Legislative Updates for the Medtech Community

Congressional Outlook: The latest Continuing Resolution funding the government is set to expire at the end of the week. The House is expected to take up a new CR early in the week, likely funding the government until March 22. As of now, the expectation is that the Senate will pass the House CR once it is received, although negotiations around budget caps, immigration, tax extenders and other policies continue.  If a deal on caps and other items comes together, the likely scenario for passage of such a deal would be for the Senate to generate the legislation and send it to the House. Even in the case that a broader deal on caps and other items is reached, Congress would still have to pass a separate omnibus spending bill using the new caps numbers to fund the government for the remainder of the fiscal year, and any such omni would be several weeks away. We will keep you posted on any developments.

Device Tax: AdvaMed’s activities this week have focused on limited “thank you” activities for our congressional champions and leadership for the recent two year suspension. We are running a series of digital ads in select states and districts through at least February 8. These ads are running in California, Illinois, Indiana, Kentucky, Minnesota, New York, Pennsylvania, Texas, Utah, Washington, and Wisconsin. Please refer to Riley’s note from yesterday for further details on the ads and related activities. AdvaMed also continues to explore opportunities for further action on the tax this year, including in connection with tax extenders legislation or the possibility of moving stand-alone legislation. We are also regrouping with our association partners to discuss next steps and explore broadening our base of champions. Another element of our advocacy for this year is framing how we discuss the value of the suspension as an important step, but not equivalent to long-term relief. We’ve spoken with several of you already about your company’s budget cycle, how you will plan for the device tax in the future, and the financial impact of short- versus long-term relief. Please share any examples that you can provide of projects, budgeting, or investments that you are able or unable to pursue given the short-term nature of the device tax relief with Angie Comte ([email protected]). We are happy to collect these examples on an ongoing basis as decisions are made. If you have any questions, please contact Riley at [email protected].

Diagnostics Regulatory Reform: This week, AdvaMed met with staff for Senators Hatch and Bennet staff to discuss their progress on a diagnostics regulatory reform proposal. As with the House, the Senate offices have not yet advanced any proposal as they await FDA comments on the draft proposal from Reps. Buschon and DeGette. Senate staff indicated that this is a priority issue for both offices, and that while they are in the very early stages of meeting with stakeholders, they believe they can advance legislation this year. AdvaMed will stay in close contact with staff as this process evolves. To that end, we will discuss this feedback and other priority items on February 13th during a Dx Washington Representatives strategy meeting. If you have any questions, please contact Duane at [email protected].

Breakthrough Pathway: We continue to anticipate near-term introduction of legislation in the House reflecting the Breakthrough Pathway payment proposal by Reps. Suzan DelBene (D-WA), Jackie Walorski (R-IN), Tony Cardenas (D-CA), Gus Bilirakis (R-FL) and Terri Sewell (D-AL).

VA Procurement: Riley held a call of our working group to review current work on legislation to create a new clinical program office for device procurement at the VA, and a Hill letter on continued industry issues with purchase order backlogs. We have finalized both a draft letter on the backlog issue and a concept paper on the program office, and AdvaMed will coordinate with member companies on outreach to our Hill leaders on this issue, starting with Reps. Peters (D-CA) and Banks (R-IN).

Third Party Servicing: The Hill letter to FDA regarding the pending report on third party servicing of medical technologies has been finalized, led by Reps. Costello (R-PA) and Peters (D-CA), with a total of 18 signatories (9 Republicans and 9 Democrats). Please see attached. In addition, AdvaMed will host a briefing for our patient group alliance partners on the topic on Tuesday.

Opioids: The Senate Finance Committee is requesting input from health care industry groups on potential policy changes to Medicare and Medicaid as part of efforts to address the opioid crisis. In their letter, bipartisan committee leadership asks for comments on whether program incentives can be used to promote pain management that minimizes the risk of becoming addicted to opioids. They also ask for recommendations that could expand access to treatment and prevention. AdvaMed’s payment and regulatory work groups continue to try to generate legislative proposals relevant to this issue, but so far we have not seen a robust response. If you have any concepts to share, please follow up with Elizabeth at [email protected]. Also, we have begun planning for a March Hill showcase to demonstrate technologies that are relevant to the opioids crisis. We will follow up with additional details.

Right to Try: In his State of the Union address, the President called for congressional action on right to try legislation. The Senate moved related legislation last year, and included a provision exempting medical devices, as requested by AdvaMed. The House Energy & Commerce Committee is working behind the scenes to prepare their own proposal, which we may see in the coming weeks. We will pursue a similar exemption in the House, and are also in touch with FDA to share our concerns.

SMTA Fly In: The 2018 State MedTech Alliance Fly-In will take place on February 27-28. We expect attendees from state associations from across the country, and will host a welcome reception the evening of February 27.  We will be reaching out directly to several of you to determine your interest in participating alongside your state associations in these visits.


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