Articles

Cook Group President Hawkins plans retirement

Kem Hawkins, who has been president of Cook Group Inc. since 2001, will retire on July 1. He will be replaced by Pete  Yonkman, who since 2013 has been president of Cook Medical, the Cook subsidiary that makes medical devices.

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People

Bloomington-based Cook Medical Inc. promoted Pete Yonkman to president, replacing Kem Hawkins, who will continue as president of Cook Group Inc., the parent of Cook Medical. Yonkman joined Cook Medical 12 years ago as corporate counsel. He was most recently executive vice president, overseeing the company’s 10 strategic business units. Yonkman earned bachelor’s degrees in psychology and philosophy from Indiana University in Bloomington and a law degree from the IU Maurer School of Law in Bloomington.

OurHealth, which operates employer health clinics, has hired Kendra Stewart as director of wellness. Prior to joining OurHealth, she served as health behavior coordinator for Richard L. Roudebush VA Medical Center. Stewart is a clinical health psychologist who earned her doctoral degree from Ohio University.

Susan Waschevski has been appointed director of Franciscan St. Francis Health’s PACE initiative—Program of All-Inclusive Care for the Elderly. She most recently was deputy director of home and community-based services with the state Division of Aging. Prior to that, Waschevski was a program manager for CICOA Aging & In-Home Solutions. Waschevski earned a bachelor’s degree in sociology from Monmouth College in Illinois.
 

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Health care has priced itself out of its own market

It’s no secret the growth of the U.S. economy slowed in the 2000s after the go-go decade preceding it. But the U.S. health care system—hospitals, doctors, drug companies, device makers and health insurers—apparently didn’t get that memo.

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Company news

Indianapolis-based Eli Lilly and Co., already the promoter of the leading anti-impotence pill Cialis, will now try to speed up development of a drug to treat premature ejaculation. Canada-based TVM Life Sciences Ventures VII, which manages funds supplied by Lilly, invested in Ixchelsis Ltd., a new company created in the United Kingdom to develop the experimental drug, which is called IX-01. The drug was originally discovered at a research facility in the United Kingdom operated by New York-based Pfizer Inc., the company that brought the anti-impotence pill Viagra to market. Lilly’s Chorus unit will oversee development of the drug to determine if its proposed concept of action appears to work. “TVM’s strategic relationship with Lilly enables its project-focused companies, like Ixchelsis, to reach clinical proof of concept efficiently and cost-effectively,” said Darren Carroll, Lilly’s vice president of corporate business development, in a prepared statement. If and when the drug’s proof-of-concept is verified, Lilly will have the option to acquire the drug for further development. Lilly and TVM estimate that as many as 30 percent of men worldwide suffer from premature ejaculation.

Warsaw-based Zimmer Holdings Inc., which lost a February trial against Stryker Corp. over a surgical device, was told to pay more than $228 million—three times the jury award plus other costs—and stop selling certain products. According to Bloomberg News, the increase in the jury award was appropriate because Zimmer intentionally infringed Stryker patents to build its business for pulsed lavage, a technique that removes damaged tissue and cleans bones during joint-replacement surgery, U.S. District Judge Robert Jonker said in an order issued Wednesday. He also ordered Zimmer to stop selling its Pulsavac Plus device. A federal jury in Grand Rapids, Mich., in February sided with Stryker and awarded $70 million in damages. The dispute is over devices that use pulsing liquid, such as water or saline solution, to loosen debris from a surgical site and remove it by suction. The $228 million figure is more than the second-quarter profit for either company. Kalamazoo, Mich.-based Stryker reported $213 million in earnings on sales of $2.2 billion. Zimmer, based in Warsaw, reported $152 million in earnings on $1.2 billion in sales.

Three months after the recall of its Zilver PTX stent to prop open peripheral arteries, Bloomington-based Cook Medical Inc. put the device back on the market around the globe, according to MassDevice.com, an industry trade publication. Cook voluntarily recalled the stents in April after getting reports of one patient death and one injury when the equipment that delivers the stent into patients broke off during surgery. In late May, the U.S. Food and Drug Administration slapped its “deadly” warning on Cook’s recall of its stent, which props open arteries in the legs and arms to prevent serious blood clots. Millenium Research Group has estimated that Cook derives $2,750 from each Zilver stent it sells in the United States. Since it first hit foreign markets in 2009, the Zilver stent has been deployed in more than 30,000 patients, according to data from Cook. The Zilver, which is the first stent covered with an inflammation-reducing drug, was introduced to the U.S. market in December 2012. The Zilver recall did not affect stents that were already placed in patients.
 

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Company news

The Indiana Family and Social Services Administration will hold two public hearings this week on using the Healthy Indiana Plan to expand Medicaid coverage in Indiana. The hearings must be held before the federal government will consider Indiana’s special request to use the Healthy Indiana Plan as opposed to expanding its traditional Medicaid program. "After completing a preliminary review of your extension request, we have determined that the state's extension request has not met the requirements for a complete extension request," wrote Diane Gerrits, director of the CMS' division of state demonstrations and waivers, in a Feb. 25 letter to Gov. Mike Pence. That response sparked criticism of Pence from Democratic lawmakers, who said Pence’s strategy makes it unlikely the state Legislature will have a decision from the feds before they have to adopt a two-year budget at the end of April. “We have considerable concerns as to whether this will hamper the state’s ability to inject billions of dollars of federal funds into Indiana’s economy, create tens of thousands of jobs and give hundreds of thousands of Hoosiers a plan to receive affordable health care services,” wrote House Minority Leader Scott Pelath, D-Michigan City, and Senate Minority Leader Tim Lanane, D-Anderson, in a letter to Pence. They even asked if Pence would call a special session of the Legislature to deal with the Medicaid expansion. Pence spokeswoman Christy Denault said the administration always knew they had to hold public hearings but was trying to get an approval as soon as possible because of a June deadline.

Bloomington-based Cook Medical Inc. launched a new set of minimally invasive products to treat obstructive salivary gland disease and, it's hoped, stave off the need for open surgeries. The most prevalent obstructive salivary gland disease is obstruction by salivary duct stones. It’s a disease that affects twice as many men as women. Cook, which launched the products as part of its newly formed division for otolaryngology and head and neck surgery, said physicians can use its products to perform outpatient surgeries to remove salivary stones.

Fishers-based Nexxt Spine LLC, a designer and manufacturer of spinal implants, is consolidating operations and moving its headquarters and manufacturing facility to Noblesville. The city of Noblesville announced Monday that its Common Council approved a three-year tax abatement for Nexxt Spine, which is expected to add 44 jobs by 2018. The company currently has 11 employees split between its headquarters in Fishers and a manufacturing facility in Indianapolis.  Nexxt Spine was founded in 2009 by Andrew Elsbury, who previously had served as a contract manufacturer for several large medical-device companies.

St. Vincent Indianapolis Hospital recently earned verification as a trauma center by the American College of Surgeons. It is now the fourth trauma center in Indianapolis designated by the American College of Surgeons and the ninth in Indiana. To prepare for the verification, St. Vincent renovated space for trauma, surgical and neuroscience intensive care units and added CT scan imaging equipment. The hospital also dedicated one of its operating rooms for trauma and added in-house physician coverage for trauma surgery, anesthesia, critical care and radiology. To ensure air transportation was readily available, St. Vincent Health arranged an affiliation agreement with PHI Air Medical called St. Vincent StatFlight. The service has five medical helicopters in Anderson, Danville, North Vernon, Rushville and West Lafayette.

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Q&A

Dave Reed is president of the Healthcare Business Solutions group inside Bloomington-based Cook Medical Inc. Since 2007, his team of 18 full-time people—aided by about 60 others throughout Cook’s organization—has worked with hospital systems, distributors of medical products and group purchasing organizations to improve the efficiency of the business side of health care and to make sure new products contribute to that efficiency, as well as solving unmet medical needs.

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Cook wins approval for new stent

Bloomington-based Cook Medical won approval for the first drug-coated stent for clogged leg arteries in the United States, which accounts for 40 percent of the soon-to-be $3 billion market.

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Growing ENT market attracts Cook

Bloomington-based Cook Medical announced a new division to capitalize on the growing market for minimally invasive procedures to fix problems in ears, noses and throats, as well as other maladies of the head and neck.

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Company news

Employee benefits provider Apex Benefits Group Inc. said Monday that it plans to expand in Indianapolis, creating up to 25 jobs by 2016. The company, now based at Keystone in the Crossing, plans to invest $1 million to lease and equip a new facility for its headquarters at 3755 E. 82nd St. As part of the project, the company will purchase new furniture, computer hardware and software for the 7,329-square-foot office building. The company plans to begin hiring additional sales and professional workers in Indianapolis this September. The jobs will earn an average wage of $44 an hour. Apex is one of a handful of central Indiana benefits brokers that has grown rapidly in recent years without acquiring other firms. Founded in 2003, Apex has 27 employees and operates satellite offices in Tippecanoe and Owen counties. Indiana Economic Development Corp. offered Apex up to $400,000 in tax credits and up to $45,000 in training grants based on the company's job-creation plans. The city of Indianapolis plans additional incentives.

Cook Medical Inc. had been planning to open five new manufacturing plants over five years in small communities around the Midwest, including Indiana, but shelved those plans because of the hit it will take from a new U.S. tax on medical devices. The Bloomington-based medical device maker estimates it will pay between $20 million and $30 million once the tax takes effect in January, said Pete Yonkman, executive vice president of strategic business units at Cook Medical. The 2.3-percent tax on sales of all medical devices was created as part of President Obama’s 2010 health reform law to help pay for its expansion of health insurance coverage to as many as 30 million more Americans. The tax is projected to raise about $2.9 billion per year. Yonkman referred to a plant Cook opened last year in Canton, Ill., renovating a plant abandoned by International Harvester Corp. Cook has invested $30 million in the plant, which eventually will employ 300 or more people, Yonkman said. Canton is the hometown of the late Bill Cook, who founded Cook Medical. Yonkman said Cook had planned to open a similar facility each year for the next five years. The Center for Budget Policies and Priorities, a liberal think tank in Washington, D.C., said in a March report that medical device makers are blowing the tax’s impact out of proportion. It noted that the new tax does not apply to medical devices made in the United States but then exported for sale overseas.

The Indiana Medicaid program will receive $3.3 million from a multi-state settlement with a drug wholesaler that was accused of inflating prices, according to the Associated Press. San Francisco-based McKesson Corp. agreed to a $151 million settlement with 29 states last week, just three months after it agreed to a similar $187 million settlement with the federal government. McKesson, one of the nation’s largest drug wholesalers, was accused by a whistleblower lawsuit of deliberately inflating price information it reported to First Data Bank, which many state Medicaid programs use to set payment rates for pharmaceutical reimbursement. Prices for such drugs as Allegra, Ambien, Lipitor, Prozac and Ritalin were inflated as much as 25 percent, according to the attorneys general that struck the settlement. McKesson admitted no guilt in the settlement and a company spokesman said the whistleblower lawsuit’s claims were without merit.

Shares of WellPoint Inc. shed 10 percent of their value last week after the Indianapolis-based health insurer’s second-quarter profit missed analyst estimates and the company trimmed its full-year forecast. Earnings excluding one-time items were $2.04 a share in the quarter, compared with the $2.08 average profit expected by analysts, according to Bloomberg News. Overall, net income fell 8.3 percent to $643.6 million, or $1.94 a share, from $701.6 million, or $1.89, a year earlier. Revenue increased to $15.4 billion from $15.1 billion. WellPoint, along with its competitors, benefitted from lower medical costs last year, as Americans stayed away from the doctor amid unemployment rates that topped 9 percent. Those costs have stabilized this year, making it harder to increase profit, said Ana Gupte, a Sanford C. Bernstein & Co. analyst in New York. Membership in WellPoint medical plans fell 2.3 percent, to 33.5 million. The declines came in the insurer’s commercial accounts, where WellPoint raised fees for some policies. That eclipsed gains among government-backed Medicare and Medicaid plans. Full-year profit is expected to be $7.30 to $7.40 a share, the company said.Just two weeks earlier, it had predicted full-year profit of $7.57 per share.

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Cook Medical shelves Midwest expansion plans

Life Sciences Cook Yonkman watch videoCook Medical Inc. had been planning to open five new manufacturing plants over the next five years in small communities around the Midwest, including Indiana, but has shelved those plans because of the hit it will take from a new U.S. tax on medical devices.

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Company news

Executives at Bloomington-based Cook Group have never been fans of the $2.3 billion-a-year tax on medical-device manufacturers included in the 2010 health reform law. Late company founder Bill Cook even once said the tax could kill 1,000 jobs in Bloomington. Cook Chairman Steve Ferguson won’t go that far, but he insists the law is forcing Cook to grow outside the United States instead of at home. “You don’t want to say to your work force that you’re going to lay people off,” Ferguson told Bloomberg News. “The tax is going to result in growth in another location and not in the U.S.; that’s the way I see the impact on Cook.” The tax will be levied based on each company’s U.S. market share—regardless of how profitable the company is. Supporters of the tax have argued that it will indirectly help medical-device manufacturers do more business, because the 2010 health law uses that money to subsidize insurance coverage for an extra 30 million Americans. But Ferguson said Cook expects to receive no new business from the law. He noted that a large chunk of the newly insured will be young people, who most likely will have no need of Cook’s products. Also, Cook sells to hospitals not to consumers, and in many cases, previous laws have already required hospitals to provide medical devices to uninsured people who need them. “So it doesn’t increase the number of devices sold,” Ferguson said.

Chamberlain College of Nursing is opening a campus in Indianapolis with classes scheduled to begin Feb. 27. It is the first Indiana location for Illinois-based Chamberlain, which operates nine other campuses around the country. “Indiana will not be able to build a strong nursing work force if prospective nurses do not have adequate access to quality nursing education,” said Susan Groenwald, national president of Chamberlain. In Indiana, more than 12,000 additional nurses will be needed by 2018, according to the Indiana Department of Workforce Development. The Indianapolis campus, at 9100 Keystone Crossing, will offer a three-year bachelor’s program in nursing. The local campus will be led by Margaret Harvey, who previously served as interim dean of nursing at Davenport University in Iowa.

Indianapolis-based Healthx Inc., a provider of online health care portals to health insurers, medical providers and employers, has received a $22 million investment from a private-equity firm in Charlotte, N.C. Frontier Capital announced the investment on Jan. 5 and said the funding will support the company’s continued expansion. Founded in 1998, Healthx develops self-service communication and data integration portals for the health care and human resources industries. The company, in The Precedent Office Park on the north side, has 65 employees. Healthx President and CEO Greg Bell will continue to lead the company, Frontier Capital said. The transaction closed on Dec. 28.

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Company news

Franciscan St. Francis Health entered an exclusive-provider agreement with Greenwood-based Indiana Internal Medicine Consultants, one of the largest physician groups working at Franciscan’s hospitals. The practice has 37 doctors specializing in family practice, internal medicine, infectious disease and sleep medicine. The tighter relationship, which took effect Oct. 1, is designed to help Franciscan function as an accountable care organization. That concept, promoted in the 2010 health reform law, calls for hospitals and doctors to work together to care for a specific population of patients—and have some of their pay hinge on how well they maintain the health of that population. Hospitals around Indianapolis and the nation have been acquiring physician practices or entering tight contractual relationships, such as Franciscan’s exclusive-provider agreement, which will not allow Indiana Internal Medicine’s doctors to practice at hospitals outside the Franciscan chain. Franciscan operates hospitals in Beech Grove, Indianapolis and Mooresville.

The pain isn’t ending for the Warsaw-based makers of orthopedic implants. Democrats from the House Energy and Commerce Committee have asked Republican leaders to hold hearings on metal-on-metal hips, saying they have caused "significant harm to human health". The FDA is conducting its own review of metal-on-metal, having requested post-market data from about 20 companies, including Warsaw-based DePuy Orthopaedics, Zimmer and Biomet, as well as New Jersey-based Johnson & Johnson.

Bloomington-based Cook Medical Inc.’s drug-coated stent to treat blocked femoral arteries is sailing toward approval. The Zilver PTX got an 11-0 approval vote from a panel of outside advisers to the U.S. Food and Drug Administration, according to Bloomberg News. The FDA does not have to follow the recommendations of its advisory panels, but it usually does. The device would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg. It would be an alternative to bypass surgery, angioplasty or the use of a stent without a coating of a drug, paclitaxel, which is designed to reduce the build-up of new fatty deposits. Peripheral arterial disease affects 8 million to 12 million people in the U.S., according to the Peripheral Arterial Disease Coalition, and can lead to heart attacks and strokes.

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Gloomy outlook for medical device makers

The next four years could be rough for makers of medical devices and orthopedic implants, including Bloomington-based Cook Medical Inc. and Warsaw-based Zimmer Holding Inc. and Biomet Inc.—and not because of the 2010 health reform law.

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