Busy BIO Legislative Day Fly-In: Critical Issues Abound
Monday, April 25, 2016
Posted by: Kate Oesterle
18 miles on the FitBit was the result of attending 14 out 16 Michigan Congressional office meetings, along with three other business meetings over a day and a half – that sums up the 2016 BIO Legislative Day Fly-In: Exhaustion and sore feet.
The Fly-In occurred April 12-13, 2016, and it was another great opportunity of engaging with Members of Congress and their senior staff on the most important legislative issues facing the biotechnology industry. I was joined by member company representatives, Patrick Conley, Director of Alliance Development, Johnson & Johnson (based in Bay City), and Harold Cash, Director of Government Affairs, NSF International (headquartered in Ann Arbor), as well as by Peter Pellerito, Special Advisor on Economic Development & University Affairs, BIO (and a Michigan resident).
The two most critical issues on the advocacy agenda – recently CMS-issued draft rule for Medicare Part B coverage of drugs and physician reimbursement and a federal GMO food labeling law – dominated discussions with Michigan offices.
On March 8, 2016, CMS proposed a rule that would implement a new “Medicare Part B Payment Model” and in essence result in further reimbursement cuts to Medicare Part B products through changes in the Average Sales Price (ASP) + % payment system to physicians. Currently, the model allows for ASP+6% reimbursement. However, due to sequestration triggered for Medicare providers, that rate is effectively ASP+4%. Now, CMS has proposed an ASP+2.3%, which effectively translates to ASP+0.8% once sequestration is applied. Such a dramatic slash is alarming. Already, physicians are opting out of Medicare and forcing patients to seek treatment at clinical/hospital settings where costs are higher. This is particularly burdensome for patients in rural settings who will now have to travel longer distances to seek treatment. MichBio and BIO is seeking a full retraction of the proposed CMS payment model rule. Letters have been sent to CMS, HHS, and Congressional leadership in support of that retraction.
The U.S. Senate has been jostling with instituting a federal GMO food labeling uniformity legislation that would provide consumers with more consistent information about GMO food. Sen. Debbie Stabenow, ranking on the Senate Agriculture Committee, and her colleagues have been opposed to the bipartisan legislation (H.R. 1599) passed overwhelmingly by the House due to heavy push-back by a coalition of non-GMO activists groups. Federal legislation is needed to provide manufacturers with a singular set of guidelines that moves beyond a state-by-state patchwork of labeling challenges. The latter scenario will greatly impact supply chains, and ultimately cost to consumers, and increase confusion over the meaning of labeling information.
Other issues of importance to MichBio that were shared with Congressional offices included: Funding for NIH and FDA, Fostering Innovation Act (would provide a temporary exemption for SOX for companies after IPO), and Small Company Disclosure Simplification Act (seeks exemption for emerging companies regarding XBRL reporting), among others.
Many thanks to all the Michigan delegation for their engagement. MichBio greatly welcomed the opportunity to meet directly with Reps. Bishop, Dingell, Kildee, Lawrence, Levin, Moolenaar, and Wahlberg. Additionally, the meetings with staff from Sens. Stabenow and Peters, and Reps. Conyers, Huizenga, Miller, Trott and Upton were most appreciated.