FWD:Medtronics Newsletter

Pain and Movement Disorder

Advocacy Newsbrief

November 15, 2006

Problematic Washington Proposed Regulation and Hearing on Pain Pump Cancelled!!! L&I Indicates Openness to Move toward Development of Reasonable Pain Pump Coverage Instead! As we reported last month, despite the comprehensive effort of many involved, Labor and Industries (L&I) announced their proposed pain pump rule which would again eliminate intrathecal drug delivery for the treatment of chronic, non-cancer pain for injured workers, and scheduled a related hearing on November 27th in Olympia. To respond to this threat, comprehensive lobbying (including with the Governor, Governor’s Chief of Staff, L&I Acting Director, and legislators) and grassroots work have been underway. And thanks to the help of many of you through the calls and letters you submitted, the agency announced on November 15th, their intent to stop the non-coverage rulemaking and to cancel the hearing! Instead, Judy Schurke, the new Acting Director, has indicated a willingness to review various reasonable Washington and national coverage policies, compare them to the case-by-case criteria L&I is otherwise using, and attempt to develop a more consistent and reasonable approach! This success is enormously important for injured workers in need and could not have been achieved without your involvement! Additionally, special thanks to both the Washington and Alaska Pain Initiative and the American Pain Foundation for their assistance in this effort! Now, we must keep the pressure on so that reasonable coverage policies are developed and put in place as soon as possible! We encourage you to send a thank you note or email to Acting Director Judy Schurke thanking her for the reasonable and responsible approach she is taking. Ms. Schurke can be reached at scju235@lni.wa.gov.

While coverage for pain pump appears headed in the right direction, it is far from complete. We of course first have to work with L&I to develop and implement a reasonable coverage policy on pain pump. Then, in the coming months, we also must continue working on securing appropriate patient access to spinal cord stimulation therapy as well. To that end, Medtronic Neurological’s outreach to physicians, staff, patients and their families to build a coalition to address these issues continues. The various advocacy components continue, including recruitment of public supporters of the “Consensus Statement” – now with approximately 150 supportive legislators, organizations, businesses and individuals! This statement asks the Gregoire Administration to change L&I policies so injured workers have appropriate access to both of these therapies. If you have not already done so and are a Washington resident, or a physician who treats Washington residents, please consider signing the Consensus Statement on our website today. Further, as a follow-up to other media stories regarding patients whose lives have been significantly improved due to these therapies, we are in the midst of sharing several more stories in key locations. And of course, we are still in need of additional patient stories to share! If you are interested in sharing your story publicly and have not yet notified us, please do so and we will have our public affairs firm contact you immediately! Together anything is possible!!

California Proposed Treatment Guideline Rule Lobbying Continues. As the Division of Workers’ Compensation (DWC) continues to consider further changes to their draft treatment guideline regulation, we continue to provide comment to them and lobby them directly on our thoughts and concerns. On November 1st, we again met with Carrie Nevans, Acting Director of the DWC, as well as with Herb Schultz, one of the Governor’s lead point people on health care and reform. We again worked to support the appointment of an interventional pain physician to the soon to be appointed Physician Advisory Committee, and also discussed the need to urgently “fill

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the coverage gaps within the ACOEM treatment guidelines” for interventional pain. Ms. Nevans confirmed that progress is expected shortly on several fronts. Stay tuned for important developments!

In addition to treatment guideline and coverage policy concerns, we also continue to work on attempting to resolve the issues of “silent PPOs” as described in previous newsbriefs. While legislation to address this issue stalled during this legislative session, during our November trip we met with several allied groups including the California Medical Association (CMA), California Hospital Association (CHA), and the California Society of Industrial Medicine and Surgery to discuss collaboration, and specifically this issue. All groups agreed that unless concerned physicians and hospitals contact their respective associations (CMA and CHA) encouraging them to address this issue, and become actively involved in programs such as “It’s Up to Us”, we will not likely be able to collaboratively address this unfair reimbursement issue. Please spread the word, ask others to consider joining the “It’s Up to Us” program, and please stay tuned for additional “Action Alerts” as they become necessary.

Massachusetts Medicaid Reimbursement Improvements Needed for Intrathecal Baclofen Therapy (ITB) and Other Implantable Therapies - - Advocacy Strategy Underway; Patient, Family, Physician and Hospital Help Needed Today!! As we reported last month, during the course of the past year, several concerns have been raised by patients, physicians and hospitals regarding low Massachusetts Medicaid reimbursement policies and how they are making it more and more difficult for hospitals to meet patients’ needs. Meanwhile, hospitals do an admirable job but continue to struggle with ensuring appropriate patient access to all needed services is maintained. After listening to these challenges, we recently hired a consultant who has developed and is implementing an advocacy and grassroots strategy with interested physicians, hospitals, patients and their families. Several “recruitment” trips have already occurred, and she has successfully signed up approximately 36 supporters of our public Consensus Statement asking MassHealth and the Legislature to increase payments to hospitals for these types of services. Meanwhile, she continues to identify and do outreach with various patient advocacy groups. She spent significant time strategizing with the Massachusetts Hospital Association (MHA) as well. While MHA is generally supportive, this effort will not become a priority for them unless they hear from their hospital members on this important issue! If you are a hospital, please have your CEO weigh in with MHA on this important issue!

As we proceed, we will no doubt need the grassroots involvement of any interested individual resident of Massachusetts, hospitals and others, who want to help preserve patient access to high-tech implantable and other therapies for Medicaid beneficiaries in Massachusetts. Please spread the word! We need all individuals interested to join our “It’s Up to Us” campaign today. We are also looking for Massachusetts residents who, in addition to joining “It’s Up to Us,” are willing to have their names used in public as a public supporter of ITB therapy and improving related MassHealth reimbursement to protect patient access. Finally, we are looking to identify approximately 30 patients (preferably, but not necessarily, on Medicaid) whose lives have been significantly improved by ITB (or other) implantable therapies. If you or someone you know is willing to allow us to use their name in public support, or to publicly share their story, please contact us immediately! Together we can and are making a difference for patients in need!! You can join some or all of these efforts at www.preservingtherapyaccess.com today!

Texas Workers’ Compensation Treatment Guidelines Final Rule Expected Shortly; Medtronic Pleased to Offer Complimentary Official Disability Guidelines (ODG) Subscriptions for Use in Prior Authorization Process; Hospital Fee Work Continues but Likely to Be Delayed Until Summer 2007! In late August, the Division of Workers’ Compensation (DWC) released the long awaited proposed “non-network” treatment guideline rule and good news related to spinal cord stimulation and intrathecal drug delivery coverage - - the proposal requires use of the recently updated ODG guidelines as promulgated by the Work Loss Data Institute (WLDI). A public hearing took place in early October where the various pros and cons of the proposal were debated. While no final decisions have yet been made by DWC, it is very likely that their final proposal will closely resemble the

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earlier draft and include the use of ODG guidelines as coverage criteria. We are pleased to remind you that these guidelines are now fully updated related to spinal cord stimulation and intrathecal drug delivery, include current clinical and cost effective literature, and also highlight the importance of the evidence gained by doing the individual patient trial for both of these therapies. Meanwhile, Medtronic Spinal continues to have concerns about use of ODG as it relates to other spinal therapies and is working with WLDI to submit current medical evidence related to other spinal procedures for their consideration and possible updating and improving of other guidelines contained within ODG.

While final decisions by DWC as to what treatment guideline will be used for “non-network” care will not occur until later this fall, we are pleased to offer free electronic subscriptions to pain physicians and their offices to help aid with prior authorizations whether or not ODG is officially adopted for non-network workers’ compensation care. Either way, we believe proactive use and citation of this guideline within the prior authorization process will significantly aid in ensuring appropriate patient access to these needed therapies - - both for in- and out-of-network care. If you would like to obtain your free subscription, please contact us directly or alternatively ask your Medtronic field representative who will be able to assist you, or contact us at preservingtherapyaccess@medtronic.com.

Further, work continues with DWC regarding promulgating new hospital in- and out-patient fee schedules for any care that does not fall within the newly established Provider Networks. Our lobbyist continues to work closely with DWC and the workgroup designated to discuss these issues. A draft proposal suggests Outpatient hospital reimbursement be set at 162% of Medicare rates, and Inpatient hospital reimbursement be set at 111% of Medicare reimbursement respectively. As the treatment of injured workers is widely understood to be much more complex, we are concerned that these facility payments may not be adequate. In order to help improve the reimbursement under this proposal we continue to lobby and work with hospital allies as well. Most recently, the agency indicated that due to challenges with pulling data together and doing analysis, that they would not likely be able to finish these rules prior to Session 2007 beginning in January, and as such will likely wait to do so until the summer of 2007. Meanwhile, work will continue on all fronts to positively influence same and preserve appropriate therapy access to needed therapies. Together we can - - and are - - making a difference for patients in need!

Ohio Bureau of Workers’ Compensation (BWC) Delays Implementation of New In-Patient Fee Schedule Until January 1, 2007; Work Underway to Meet with Consultant to Influence Development of All Fee Schedules. As we’ve reported, the Ohio BWC is working to implement a new fee schedule for in-hospital payments based on Medicare’s DRG payment system. Originally, the BWC planned to implement the new schedule on October 1 but has delayed implementation until January 1, 2007. The rule sets reimbursement for in-patient hospital services at 115% of the base Medicare rate, and where appropriate, the agency is considering including any “add-on” payments approved by Medicare for new technologies. As the treatment of injured workers is widely understood to be much more complex, we are concerned that these facility payments may not be adequate to ensure appropriate patient access to needed implantable therapies. To that end, Medtronic Neurological State Government Affairs (SGA) is working to meet with BWC staff in early December to make a case for separate device reimbursement in all facility settings. While we hope to change the inpatient rule before it’s implemented, we want to be sure to influence the development of the outpatient, Ambulatory Surgical Centers (ASCs), and physician fee schedules before draft proposals are released by the Bureau. The new fee schedules are to be implemented sometime in 2007. SGA staff has also asked to meet with the BWC consultant, Navigate Consulting, which will recommend the payment methodologies and reimbursement levels. Our goal, as always, is to help improve the reimbursement and therefore help to ensure appropriate patient access is maintained.

In late October, SGA staff traveled to Columbus and met with the Director of Managed Care for BWC, Joel Donchess. Our purpose was to educate the BWC about our pain therapies, ensure that the agency appropriately

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used ODG treatment guidelines, and to discuss our concerns about the in-patient fee schedule and its potential negative affect on patient access to needed therapies. Mr. Donchess assured us that all BWC managed care organizations should be using ODG guidelines and offered his help if any patients were experiencing any difficulties with prior authorizations because another treatment guideline was used. As mentioned above, we are pleased to offer free ODG electronic subscriptions to pain physicians and their offices to help aid with prior authorizations. If you would like to obtain your free subscription, please contact us directly or alternatively ask your Medtronic field representative who will be able to assist you, or contact us at preservingtherapyaccess@medtronic.com.