The Medical Device Lobby
Washington insider website, The Hill, has an article on medical device lobbyists. They note that the medical device lobby has raised it's profile of late, tackling issues like reimbursement and the regulatory approval process. Following is the line up of lobbyists representing the interests of the medical device industry:
Advanced Medical Technology Association (AdvaMed): Stephen Ubl, Megan Ivory, Seth Radus
Ubl
took over last summer and set in motion plans to crank up AdvaMed’s
lobbying clout. A fellow lobbyist described Ubl as “a triple-A
superweight.” Ubl bolstered his policy shop with David Nexon, from the
office of Sen. Edward Kennedy (D-Mass.), and Ann-Marie Lynch, from the
House Ways and Means Committee.
Boston Scientific: Steven La Pierre
Boston
Scientific finally completed its acquisition of rival Guidant this
year. All the while it’s been capably represented in Washington by La
Pierre, who commands respect among his peers. La Pierre is “probably
the best shoe-leather lobbyist that the industry has,” one source
remarked.
Medtronic: Peter Slone
This experienced lobbyist
plays a leading role in the device industry’s efforts to get the U.S.
government to open overseas markets to new medical devices. Slone is a
former BKSH & Associates lobbyist.
Johnson & Johnson: Susan Reardon, Jane Adams
This
massive, diversified company is a leader in the device industry. Adams
is a “shining star” in a group of “top-tier lobbyists” at J&J, a
colleague said.
Edwards Lifesciences: Neleen Eisinger
Eisinger left a job with Sen. Kent Conrad (D-N.D.) to join Edwards and is viewed as a talented up-and-comer.
Medical Device Manufacturers Association (MDMA): Mark Leahey
Leahey
helms the MDMA, which represents smaller companies. The group was
founded in 1992 as a rift widened between the big and small factions of
the industry. That divide has recently begun to close, lobbyists said.
Alpine Group: Jay Hawkins
Hawkins, a former
senior aide to Sen. Jim Jeffords (I-Vt.), joined this small shop after
the breakup of Bergner, Bockorny, Castagnetti, Hawkins & Brain. He
represents AdvaMed.
Jeffrey J. Kimbell & Associates: Jeff Kimbell
The
energetic Kimbell was the MDMA’s first executive director. He moved on
to start his own firm a few years ago and has been adding clients at a
pace that has impressed colleagues. “He’s got a great book now,” one
person admiringly observed.
Walter Consulting: Sarah Walter
This former
senior aide to then-Sen. John Breaux (D-La.) left Venn Strategies last
year to launch a one-woman operation and brought along clients
including Boston Scientific and the MDMA.
McManus Group: John McManus
“He’s on every
list,” one source remarked. The former senior aide to the House Ways
and Means Committee works the GOP side for AdvaMed.
Capitol Hill Strategies: Chuck Brain
Brain is
newer to the medical-device industry than others on this list, but the
veteran Democrat is respected for his work ethic and quick
understanding of the issues, on both the policy and political sides.
Brain represents AdvaMed.
I expect to see a name associated with the Continua Health Alliance soon…
Remote Monitoring Market Adoption
I learned a new term yesterday, aging in place. This term describes the elderly living independently in their own homes. One of the chief tools to help folks “age in place” is remote monitoring. Yesterday, Christina Thielst had a nice column in Health IT World about remote monitoring and Gregg Malkary's recent market study on remote monitoring. (Gregg creates great market studies, and anyone interested in remote monitoring should have one – disclosure: sadly I don't get a penny if you actually buy one of Gregg's reports.)
The current top remote monitoring markets are congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), asthma, and diabetes. Christina nicely summarized Gregg's findings regarding barriers to adoption for remote monitoring:
- Little incentive in a fee-for-service environment, but a huge stimulus when providers have fiscal responsibility for patients. Providers such as the Veterans Administration (VA)
and home health agencies reimbursed per patient per month are attracted
to remote patient monitoring solutions for monitoring greater numbers of patients more efficiently. - The current healthcare model is focused on active care, not prevention. Clinicians
are not paid to prevent treatment, but they may become more interested
in solutions that help improve their patient outcomes for
pay-for-performance programs. - Professional licensure regulations are too restrictive. Patients
living in rural communities are usually prevented from utilizing
available solutions when their closest and chosen provider is located
across state lines. And these are often the patients with the most
significant transportation limitations. - According to 95 percent of those surveyed, the lack of healthcare payer reimbursement is the top barrier. Most
insurance plans are not reimbursing patients for the cost of the
equipment; however, the Centers for Medicare and Medicaid Services
(CMS) and the VA are conducting large demonstration projects that may
open the doors to increased payer reimbursement.
These are some of the structural health care issues that, in differing combinations, can stymie change of any kind in health care. The vendor side of the health care industry has it's own set of structural issues. As patient demands grow and reimbursement comes around, those that hope to succeed in remote monitoring will have to think outside the box – not only regarding connectivity and the whole product solution, but also regarding health care structural issues.
Pictured right is Health Hero Network's Health Buddy.
Continua Health Alliance
Yesterday, a new outfit called Continua Health Alliance held their first public event in San Francisco (press release).
rapid aging of the population, the methods of managing health will need to
shift from traditional institutional settings to peoples’ everyday
environments, including the home. To enable this shift, a group of
technology, healthcare and fitness companies have formed the Continua Health
Alliance, an open industry group that will establish an ecosystem of
connected personal health and fitness products and services, making it
possible for patients, caregivers and healthcare providers to more
proactively address ongoing healthcare needs.
Between the inexorable grind of demographics – the aging baby boomers and increases in chronic disease, and the shortage of nurses and physicians, our acute care focused health care delivery system will be running out of capacity in the foreseeable future. The solution is widely recognized – provide care outside of acute settings that emphasizes prevention and chronic disease management in order to minimize the burden on acute care.
The challenge is getting our quirky little health care industry to, you know, change the way we do things. Needed changes include reimbursement and the adoption of “new” technologies like email and the Internet by providers to better manage patients. The market opportunity is huge: 1 billion obese adults, 860 chronic disease patients, and 600 million people aged 60 or older. Currently 75-85% of health care spending goes to chronic disease management, and with 200,000 hospitals and 18 million acute care beds, this capacity gap can only grow.
There's a technology gap that exists as well. Current remote monitoring technology is too proprietary and too expensive, and the absence of open systems and interoperability aims to keep it that way. A while back, I met with Dave Whitlinger, director of health care device standards at Intel. We talked about the health care industry and how dysfunctional “unique” it is (I usually don't hold out much hope for outsiders trying to enter the health care market). Dave was particularly frustrated at the lack of open standards that could growth the market for all health care vendors. These standards exist in many other markets – manufacturing, automotive, aviation, telecommunications, the computer industry – but with the exception of DICOM, have been successfully resisted in health care. Also from yesterdays press announcement:
The alliance's members acknowledged they face plenty of hurdles. One
is the current “dog's breakfast” of technology interfaces on existing
devices, said Dave Watson, chief technology officer at Kaiser
Permanente, the country's largest health management organization.
Watson said it has been a slow and expensive process to connect to
Kaiser's network just some of the 300,000 biomedical devices it has in
its doctors' offices and hospitals.
“To place appropriate devices
in our members' homes takes us into billions of devices that are
outside our network,” said Watson. “If this is going to work, the
care-system people are going to have to put terms and conditions in our
contract. [They] must deliver a product that meets Continua input and
be a Continua-branded product.”
The Continua Health Alliance aims to close this technology gap by selecting existing industry standards and defining specific implementations of those standards to provide interoperability between vendors' products to create an end to end remote monitoring solution. Continua will not be creating standards; their role will be similar to the IHE developing guidelines for the implementation of standards that ensure interoperability. Continua will also certify compliant products and anoint them with a “consumer recognized” logo. Continua will also work with the world's major regulatory agencies to facilitate regulatory approvals (talk about a hybrid device classification) and the harmonization of regulations. Finally, the group will also work to extend reimbursement to this alternative health care model.
The alliance is targeting three initial market segments: health and fitness, chronic disease management, and elderly monitoring. The members of the Continua Health Alliance are an interesting bunch. I was struck by many non health care companies. Motorola, Sharp, Panasonic, Samsung – their strengths are consumer electronics and could contribute gateway devices like smart phones and PDAs, along with possibly commoditizing some sensors like NIBP and weight scales. It is nice to see Kaiser and Partners in the alliance representing providers. Medical device vendors were noticeable in their absence. Philips is in there based on their Motiva business. A cynic might think GE Healthcare is there because they can afford to be, and want to keep an eye on things. Welch Allyn is also a surprise since they currently don't target the remote monitoring market (although they have some great technology that could be used in that market). A number of companies with remote monitoring business round out the alliance roster.
Back to yesterday's event – during the Q&A, Matthew Holt brought up the elephant in the living room when he asked what role HIT vendors and payors might play in the alliance. Dave Whitlinger, who's also Continua's president and chair, said he expected them to be among the 100+ additional members he expects will join the alliance of the next several months.
Continua expects to have commercially available products some time in 2008. This will be a fun group to watch, and I'm expecting big things from the alliance and their member companies.
UPDATE: You can catch alliance member IBMer Sue Green's perspective on Continua Health Alliance on the HealthNex blog. IBM looking to advance remote monitoring with their “experience in helping to establish and leverage
standards, open systems and tools for interoperability between
communication devices and servers, as well as server to server and
application interoperability.”
The event was also covered by Red Herring and MedGadget – check 'em out.
