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March 25, 2015

NHIA's Legislative Advocacy Team Discusses Health Care Reform and Grassroots Activity

At no other moment has the home and specialty infusion industry been presented with truly extraordinary prospects for advancing our Medicare legislation. "With so much at stake, now is the time for all of us to further amplify our engagement in actions that will assure the meaningful recognition and success of our field," said NHIA's President & CEO Russ Bodoff as he opened the Annual Conference's Legislative Affairs General Session.  The session, supported by an educational grant by Integrated Medical Systems, Inc., is part of the Association's Annual Conference & Exposition being held in Phoenix this week.

Bodoff introduced NHIA's Outside Counsel Alan Parver, Esq., and Kendall Van Pool, NHIA's Vice President of Legislative Affairs who gave a joint presentation on the major legislative and regulatory issues we are facing in Washington that have the potential to impact the home infusion field and an update on Medicare legislation introduced earlier this year. "The Avalere report is making a difference with CMS and on the Hill," explained Van Pool, "and it ties in with other patient-centered health care initiatives that are building right now."

Parver discussed three possible vehicles for the Medicare Home Infusion Therapy Site of Care Act. "The so-called 'doc fix' is one option particularly because Congressional leaders are looking for a permanent fix this year," he said. "However, that legislation is moving very quickly and it has been made clear that Congressional leadership wants a bill that's free of extraneous provisions, making it more of a long shot."

NHIA's legislation could also fit into provisions of a budget reconciliation bill, according to Parver. "It's a good opportunity," he said. "Although the President could veto the resolution if it contains provisions he doesn't like, such as a repeal of Obamacare, it would be helpful later on since our provision would automatically be included in a subsequent resolution."

That's riskier in a partisan environment because the whole bill could be vetoed if it contains provisions that are distasteful to the president. However the fact that it passed would be helpful later on." The 21st Century Cures Act is a third vehicle, said Parver.  "That legislation covers a broad range of reforms governing the regulation of drugs and medical devices, and is moving swiftly through the House Energy and Commerce Committee."

"Currently, our Medicare legislation is under technical review by CMS at the request of Senate Finance Committee, which signals that the committee is serious," Van Pool explained, noting that the next step would be a Congressional Budget Office (CBO) score.  "This is where the grassroots efforts come in," added Van Pool. "Patient stories, site tours, letters to Congress, and op-eds are all tools you should employ and urge your team members to support," he said.

Parver and Van Pool also touched on a recent draft Memorandum of Understanding (MOU) circulated by the Food and Drug Administration (FDA) that is of concern to compounding pharmacies.  "The MOU reflects a provision in 503A regarding the interstate movement of compounded products," explained Parver, "and defines an 'inordinate amount' as 30% of all units of compounded and non-compounded products per month for states that sign the MOU and 5% for states that don't sign." 

NHIA has been advocating that patient-specific dispensing differs from distribution and that the document does not make allowances for pharmacies near borders, according to Parver.  "FDA and Congress need to know how it affects our industry."

Following the legislative and regulatory update, a panel of providers and others joined Parver and Van Pool on the stage to take a deeper dive into the Medicare Home Infusion Therapy Site of Care Act, Medicare Competitive Bidding, and FDA inspections of compounding pharmacies, among other issues. Participating on the panel were Logan Davis, PharmD, MBA, Director of Franchise Development for Vital Care, Inc.; Jennifer Charron, RN, Vice President of Clinical Operations at New England Life Care; Jeff Wills, President & COO of OptionOne, LLC; and Bill Noyes, Vice President of Health Information Policy.