Medical Device Link.

Originally Published MX January/February 2006

EDITORIAL ADVISORY BOARD

The first members of the MX editorial advisory board offer guidance in two rapidly changing areas of importance to medtech executives.

In the medical device industry, keeping track of change is an ongoing challenge. To keep their companies on track, medtech executives must continually be watching over changing market conditions, competitive developments, finance trends, and public policy issues that could affect their business planning.

Over the past five years, MX has endeavored to cover major developments in these and other areas of importance to medical device executives. Along the way, the MX family of offerings has grown to include significantly expanded content available via the publication's Web site (www.devicelink.com/mx) as well as a business news supplement, MX: Issues Update, which is delivered to e-mail subscribers each month.

With this issue, MX marks the beginning of its sixth year of publication and a new era for the magazine. Throughout 2006, MX will be announcing members of an editorial advisory board that will help to guide the overall direction and content of the publication. Members of the board will include a variety of experts drawn from industry, government, finance, legal affairs, and academic organizations, each with specialized expertise in the business of medical technology.

The overall advisory board will encompass a series of councils, each dedicated to a separate area and including several experts in the field. In this issue, MX is pleased to present the first members of the advisory councils for two rapidly changing areas of critical importance to medtech executives: information technologies (IT) and reimbursement affairs.

Information Technologies

Dillione

Janet Dillione serves as chief operating officer of the healthcare information technology division of Siemens Medical Solutions USA (Malvern, PA). In her current position, Dillione is responsible for profitability, market-share growth, and customer satisfaction.

With more than 20 years of experience in the healthcare IT industry, she is part of a senior executive team responsible for ensuring that Siemens' global healthcare IT offerings enable Siemens customers to achieve optimal results in patient safety, operational efficiency, and clinical outcomes. Dillione has worked in both the financial and clinical solutions arenas, as well as in technical and management positions.

One area in which Dillione and Siemens have been particularly active is the ongoing quest in the United States for widespread adoption of interoperable electronic health records (EHRs). Several government initiatives, including the development of a national health information network (NHIN) and the establishment of regional health information organizations (RHIOs), are driving toward this goal.

"Since the pivotal discussions regarding the action plan for building an NHIN first began, Siemens has been proud to be a part of these deliberations," Dillione says. "As a significant provider to the industry and a member of the EHR Vendors Association of the Healthcare Information and Management Systems Society (HIMSS), we look forward to continuing to collaborate and contribute to the activities of our participating customers in the selected markets. It is through the industry's ongoing commitment to EHR- and RHIO-enable the nation's healthcare providers that the communities they serve will indeed benefit from the power and promise of a connected, secure, and patient-centric healthcare system."

A frequent speaker at industry forums, member of the HIMSS advisory board, and HIMSS fellow, Dillione passionately espouses the need for technology to support the local delivery of healthcare. She comes from a long line of nurses, which gives her firsthand knowledge of the challenges in delivering personal patient care. One of Dillione's goals is to ensure that her company's customers implement technology to improve patient care.

Dillione holds a BA degree in biomedical ethics from Brown University and is a graduate of the Wharton School of the University of Pennsylvania's executive management program. She lives in West Chester, PA, with her husband and two daughters.

Gee

Tim Gee is the principal of Medical Connectivity Consulting (Beaverton, OR), a firm that specializes in the application of technology and process reengineering for hospitals and medical product manufacturers. For more than two decades he has focused on hospital connectivity, creating products to automate work flow for cardiology, the emergency department, radiology, and most patient-care areas.

Gee is skeptical about the prospects for federal support of healthcare IT initiatives to produce meaningful results, at least in the short term. "Federal support for healthcare IT will generate much publicity, result in some interesting pilot projects (usually at the few well-funded healthcare providers), and ultimately do little to affect healthcare IT in the United States," he says. "In the coming year, the truism that 'you must have something to share before you can share it,' will become increasingly pertinent as hospitals struggle to bring their internal IT capabilities up to a level that could connect with regional health information organizations and other federal IT schemes."

According to Gee, the costs involved in implementing healthcare IT remain a major obstacle for most healthcare institutions. "At $20 million for a hospital electronic health record application, price will continue to be the biggest barrier to progress in healthcare IT initiatives," he says. "Over the next 12 to 18 months, hospital budgets will continue to be squeezed by falling reimbursement rates, driving interest in open source software and other schemes to commoditize software."

Prior to his work at Medical Connectivity Consulting, Gee held various management positions at companies including Welch Allyn, Pointshare Corp., Philips Medical Systems, Corometrics Medical Systems, and Baxter International Inc. Based on his experience, Gee says that both medtech manufacturers and their customers are continuing to struggle with medical device connectivity. "Most manufacturers are struggling with business strategy, planning, and execution issues more than any particular technology," he says. "Better supporting the emerging IT-rich environment means shifting from an embedded-system business model to a general-purpose computing platform business model. Most medtech manufacturers resist rather than embrace this transition, creating insufficiently flexible products and minimal capabilities in network integration, IT troubleshooting, and IT product life-cycle issues such as frequent operating system patches and rapid obsolescence."

Gee is a member of the HIMSS work group on medical device security and contributed to several articles in the 2005 MX series on IT in Healthcare.

Rudolph

Harvey Rudolph, PhD, is the global program manager for medical devices at Underwriters Laboratories Inc. (UL; Northbrook, IL), an independent, not-for-profit product-safety testing and certification organization. Rudolph's work at UL involves developing a global regulatory conformity assessment program, as well as a new regulatory services portfolio.

Prior to joining UL, Rudolph served FDA in a variety of capacities over 25 years. During that time, he worked on a wide variety of regulatory projects, including the establishment of the accredited-persons program for premarket notification (510(k)) review, the recognition of consensus standards for satisfying regulatory requirements, and the evolution of FDA's software policy.

Among the many positions he held at FDA, Rudolph was most recently deputy director of the Office of Science and Technology in FDA's Center for Devices and Radiological Health. In that role, he was responsible for guidance on premarket notification submissions, pilot-testing third-party review mechanisms, coordination of standards recognition activities, and technology forecasting.

Rudolph is widely published and has given numerous invited talks on medical device regulatory issues. He has also served on the joint working group on risk management of the International Organization for Standardization and International Electrotechnical Commission since its inception, and he cochairs the U.S. technical advisory group.

Rudolph received his PhD in nuclear physics from the State University of New York at Stony Brook.

Reimbursement Affairs

Bostic

Robin R. Bostic is vice president of reimbursement for ventricular assist device manufacturer Thoratec Corp. (Windham, NH), and has spent the past 15 years managing reimbursement departments and national accounts for medical device companies.

Over the years, Bostic has successfully worked with the Centers for Medicare and Medicaid Services (CMS; Baltimore) and private payers to create national and regional coverage, coding, and payment for new, innovative technologies, as well as managed reimbursement departments for medical device companies. Her involvement in reimbursement issues also includes obtaining positive technology assessments and educating case managers, medical directors, hospitals, and physicians regarding payment.

While at Thoratec, Bostic has secured CMS national coverage for end-of-life support with ventricular assist devices (VADs) and obtained 26 CMS healthcare provider codes. She has also established 69 CMS left ventricular assist device centers that are reimbursed by Medicare, and facilitated the funding, creation, and implementation of the CMS-National Institutes of Health (NIH) postmarket registry. She served as an industry representative on the NIH mechanical circulatory system registry.

According to Bostic, CMS requirements for the creation of postmarket registries in connection with national 'coverage with evidence development' determinations is a trend to be watched. "CMS has already given us indicators of what will be required for a positive national coverage decision. Rather than a snapshot of evidence, CMS is basically requiring ongoing clinical validation to establish and maintain coverage," she says.

"Three recent national coverage decisions (lung volume reduction surgery, left ventricular assist devices for destination therapy, and cardiac resynchronization therapy) have stipulated that patient outcomes must be reported to a nationally audited registry," Bostic adds. "Manufacturers should plan strategically to provide a broad view of ongoing evidence—especially for innovative procedures and devices."

Prior to joining Thoratec in June 2003, Bostic served as director of global reimbursement for the orthopedic division of Smith & Nephew Inc. (Memphis) and has also had stints at Exogen (Piscataway, NJ) and Orthofix (Dallas). Before entering the realm of medical manufacturing, she worked in the insurance industry for eight years.

Bostic is on the speaker faculties of the Institute for International Research (New York City) and industry association AdvaMed (Washington, DC), through which she has presented reimbursement and outcome strategies for medical devices to audiences throughout the United States.

Of recent CMS initiatives to permit gainsharing relationships between healthcare organizations and their providers, Bostic notes that the concept is in some ways a result of 'pay for performance' proposals, which have also driven the agency to require reporting of patient outcomes in many key coverage decisions. "The pay for performance concept embraces the idea of delivering technologies that enhance patient outcomes into the hands of those who are accomplished at the procedure, and rewarding those who are successful," she says. "But the question becomes, 'Who is to judge patient benefit?'"

Bostic holds a BS in political science from Baylor University. She and her husband reside in Windham, NH, with their two children.

Mannen

Ted R. Mannen, JD, is managing director of the consulting firm of ContentHealth LLC (Washington, DC) and has more than 25 years of experience in counseling medical device, diagnostics, and pharmaceutical companies on Medicare and other third-party reimbursement matters. He has advised dozens of medical technology companies on coverage, coding, and payment policies affecting new product introductions.

Mannen notes that medtech companies frequently make erroneous choices that can hurt their chances of appropriate reimbursement for their products. "Manufacturers are sometimes tempted to view their product strategies through a prism that is exclusively regulatory. For example, it will often be concluded that speed to market and ease of regulatory burden trump the market differentiation that can result from a premarket approval (PMA) or a more nuanced premarket notification (510(k))," he says. "The fastest regulatory route may be the best one for many products. But for others, getting to market quickly, but doing little to differentiate the product from competitors' products, may lead to disappointment in reimbursed markets."

Mannen began his career as a lawyer in the Office of the Legislative Counsel of the U.S. House of Representatives, where he drafted legislation for the judiciary committee. Later, in the Senate, he served as an adviser to Senator Adlai E. Stevenson (D–IL) on banking committee matters.

In the private sector, Mannen has held senior management positions at the Health Industry Manufacturers Association, now AdvaMed. His positions there included general counsel and executive vice president responsible for technology reimbursement and Medicare policy.

Mannen's experience spans every major Medicare payment system introduced since 1980, and he has assisted device and drug companies and their trade associations in addressing a number of Medicare national and local coverage issues. His work with Medicare officials has included participation in a negotiated rule making committee that drafted national coverage policies for more than 20 clinical laboratory tests. In 1999, when Congress approved legislation on Medicare's hospital outpatient prospective payment system, Mannen helped draft provisions that created transitional pass-through payments for certain types of new devices, pharmaceuticals, and biologics.

Of the emerging CMS policy on coverage with evidence development, Mannen says that one trend to watch is how much the agency decides to base decisions on the mining of Medicare claims data and information from other "jumbo" databases. "The theory is that volume of information on a product—albeit information that is sometimes a bit raw—can be more revealing than a randomized trial," he says. "In the future, it will be interesting to see how much CMS relies on coverage with evidence development and how much on data mining. Also interesting will be FDA's approach as it enters agreements with health insurers to mine their databases for postmarket insights."

Mannen adds that CMS policy on coverage with evidence development may mean different things to different manufacturers. "There will definitely be pitfalls, but their seriousness will depend on whether a particular manufacturer sees the policy glass as half full or half empty," he says.

"It will be half empty for those products that have a broad regulatory clearance. In those cases, a coverage with evidence development determination will exert a constricting effect, necessitating data production in order to achieve the broad market acceptance the manufacturer seeks," says Mannen. "However, for a new product with little supporting data, the glass may be half full. That is, such a determination will offer the chance to secure reimbursement for some services as needed data is produced. There will be distasteful consequences in either case, but if the glass is half full, they will be easier to swallow."

In 2004, Medical Device & Diagnostic Industry magazine named Mannen one of 100 notable people in the device and diagnostics industry. The American Bar Association Journal has described Mannen as one of a "new breed of lawyer-lobbyist" that offers Congress "sophistication and expertise."

Internationally, Mannen has served as expert industry advisor in health policy talks with the governments of Germany, Japan, Taiwan, China, and South Korea. He is a frequent writer and speaker on reimbursement and health policy, and he blogs on these topics at www.healthhombre.com.

Mannen is a cum laude graduate of the Northwestern University School of Law (Chicago), where he served as notes and comments editor of the Northwestern University Law Review.

Slurzberg

Jo Ellen F. Slurzberg is vice president of reimbursement and health policy at Almyra Inc. (Boxborough, MA), the holding company for a variety of firms trying to bring new therapeutic and implantable cardiac and obesity-related products to market.

In her role, she leads the reimbursement and health policy initiatives for a portfolio of about 12 medical device and diagnostics companies. The therapeutic product categories of the companies include cardiovascular surgical implants, devices used in bariatric surgery and diabetes management, rehabilitation therapeutics, durable medical equipment, radiology, and therapeutic monitoring equipment.

Prior to joining Almyra in June 2004, Slurzberg was vice president of consulting services at Boston Healthcare Associates (Boston), a consulting firm specializing in strategic planning for the healthcare industry. There her clients included drug discovery, medical device, pharmaceutical, biotechnology, and in vitro diagnostics manufacturers, as well as venture capital firms, investment banks, and provider groups.

Slurzberg has spent more than a decade working on reimbursement policies for a variety of companies, including Schering-Plough Corp. (Kenilworth, NJ), which hired her as a sales representative right after her graduation from the University of Virginia. She eventually helped develop Medicare coverage policies for such Schering staples as Procrit and Leustatin. She has also performed similar tasks for Ortho Biotech (Raritan, NJ), Advanced Tissue Sciences Inc. (San Diego), Cypress Bioscience (San Diego), and Circe Biomedical (Lexington, MA).

Slurzberg has been working in the pharmaceutical, biopharmaceutical, and biotechnology device industries since 1983. She has focused on Medicare coverage, coding, and payment issues and related health policy as part of her work to gain coverage and reimbursement for novel biotechnology devices and biologic therapies. She has participated in industry-related policy and reimbursement committees and has conducted training programs on these topics.

In addition to her regulatory and reimbursement work, Slurzberg cochairs the Medical Device Manufacturers Association reimbursement committee and is the common procedural terminology (CPT) coding subcommittee chair.

MX looks forward to the contributions of these editorial advisers and will continue to announce members of additional councils throughout 2006. In the March/April issue, MX will present its advisory board members in the areas of business planning and finance. To nominate medtech industry experts in these or other fields, contact MX editor-in-chief Steve Halasey at 310/445-4274 or via e-mail at steve.halasey@cancom.com.

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