It depicts a tactic that coal miners used to use to detect when dangerous gases were present in the air. When a canary sent into the mine stopped singing, they knew toxic gases had leaked into the mine.

In this Mayo Clinic doctor’s mind, patients are the canaries, and when they stop singing – or in this case, when they stop complying with what their doctors have recommended or stop going to the doctor to begin with — the healthcare system has become toxic.

Non-compliance is frequently talked about as a cost and a burden put on the healthcare system by patients. But Montori’s theory is that really, it’s the healthcare system over-burdening the patient.

“We have to be very careful not to blame the patients,” Montori said during his closing keynote at MedCity’s ENGAGE on Thursday. “A lot of the conversation (around patient engagement) has been, how do we get them to do stuff? To me, that’s not engagement.”

When a patient doesn’t follow the treatment protocols issued by his doctor, the tendency today is for physicians to intensify the treatment. What’s really wrong, Montori said, is that the treatment wasn’t right for that patient to begin with, and asking him to do more of it is only going to make matters worse.

“Everyone has a given capacity to take care of your role in life,” he said. “If you are sick, you have that same capacity but you also have to deal with being sick.” Increasing the burden of treatment, then, isn’t the solution.

What happens so often now is that patients take the prescription the doctor gives them, fill it, read the information about the side effects when they get home and then decide they don’t want to take the medicine after all. Real patient engagement happens when doctors can give that information to patients before writing a prescription, help them understand all of their options, listen to what their priorities are and then help them choose to the solution that best fits their lifestyle.

That also shifts the dynamic of care from treating a disease to enabling the patient to achieve his number one goal, which is to be able to fully play the role he plays in his life.

Montori closed by asserting that the U.S. healthcare system will be the best in the world only when it begins to shrink. “Healthcare right now is all about itself. Healthcare right now is about how do we get bigger, more market share,” he said. “That means that patients have to take more medicine, have to monitor themselves more often [...] We will have the best healthcare system in the world when it becomes the first healthcare system that shrinks.”

Several dozen Minnesota hospitals and healthcare providers have focused efforts in five distinct areas to drive down avoidable readmissions by 20 percent over the past two years.

In Minnesota, nearly one in five Medicare patients is readmitted to a hospital within 30 days. The goal of the Reducing Avoidable Readmissions Effectively (RARE) Campaign was for hospitals to cut avoidable readmissions by 20 percent from their 2009 baseline. According to an announcement today, the campaign has exceeded its goal.

Spearheaded by the Institute for Clinical Systems Improvements, the Minnesota Hospital Association and Stratis Health, the RARE campaign has reported avoiding more than 4,500 preventable hospital readmissions in 2011 and 2012.  The campaign has been extended through 2013 with a focus on further engaging community partners beyond hospital walls to prevent an additional 2,000 avoidable readmissions this year.

These are the five key areas the campaign targeted:

Comprehensive discharge planning, or ensuring that the patient’s and the family’s input is considered in a comprehensive discharge plan. One approach taken by St. Luke’s Hospital in Duluth was use of a discharge advocate. In a pilot program, the advocate visited congestive heart failure patients at high risk for readmissions, who were receiving information and instructions from too many different sources. The discharge advocate streamlined that process and began the process of discharge education within the first 24 hours that the patient was admitted to the hospital.

Medication management, or making sure patients understand why they’re taking medication and that they are taking them in the correct manner at the correct time.

Transition care support, or coordinating care between different caregivers. Park Nicollet Methodist Hospital, for example, established a standardized process for making follow-up phone calls to patients 24 to 48 hours after they were discharged to answer questions, review medications and discuss the importance of attending scheduled follow-up appointments. The standardization process included developing evidence-based call questions, training staff to facilitate the calls and identifying patients who would require a follow-up call.

Patient and family engagement, or putting processes that emphasize the status of family caregivers as essential members of the team, and preparing them to help manage care at home.

Transition communications, or boosting communication between the sending and receiving caregivers. St. Gertrude’s Health and Rehabilitation Center is one of the facilities that uses a set of tools called INTERACT to improve early identification, assessment, documentation and communication about residents’ health statuses. For example, they would fill out a standardized form after noting a change in a resident’s condition that warranted follow up by an on-call physician or nurse practitioner.

RARE facilitates collaboration between the 83 participating hospitals and 93 community partners through monthly newsletters and recorded webinars. It also provides toolkits and other resources for participants.

Consumers buying health care coverage this fall on Minnesota's new insurance exchange likely will have more choices than are currently available, bringing a spark of competition as health reform rolls out in the months ahead.

UCare aims to offer a health plan for individuals for the first time in its history, according to documents filed Friday with the Minnesota Department of Commerce.

The state's other major health plans, including Blue Cross and Blue Shield of Minnesota, HealthPartners and Medica, also are seeking approval from the state to compete on the exchange, known as MNsure, when open enrollment begins Oct. 1.

Blue Cross and Medica will be offering plans for individuals and small businesses, while HealthPartners will offer an individual plan.

The Commerce Department is reviewing rate filings, and will have final say on what insurance choices will be available. A decision is expected in July.

UCare was started in 1984 by a group of family medicine doctors at the University of Minnesota Medical School and has previously only provided coverage for Minnesotans enrolled in public health programs -- families enrolled in MinnesotaCare and Medical Assistance, seniors eligible for Medicare and adults with disabilities.

It is seeking approval to offer a health plan that would simplify coverage for people whose financial and employment status changes, forcing them to move between individual coverage and Medical Assistance. Another UCare option is aimed at early retirees and families where one spouse is 65 or older and qualifies for Medicare but the other isn't yet eligible.

UCare is the fourth-largest plan in the state, with more than 300,000 people enrolled in plans in Minnesota and western Wisconsin. In the past year it has grown significantly, adding about 45,000 members after winning a competitive bidding process in the Twin Cities area.

Ghita Worcester, UCare's vice president of public affairs, said the expansion into the commercial market is a "logical extension" of work the Minneapolis-based insurer has been doing. About a third of its members are enrolled in one of its Medicare products.

Minnesota is one of 17 states that is building its own exchange, a new competitive marketplace created by the Affordable Care Act. The exchange is aimed at helping those who don't get coverage through the workplace as well as businesses with fewer than 50 employees shop for coverage using a website or toll-free phone number.

Officials say the MNsure exchange will be the gateway to insurance for more than 1 million Minnesotans when it is fully operational.

While consumers and small business owners can still buy insurance through a broker or directly from the plans in 2014, the MNsure exchange is the only place where those who are eligible can tap into federal tax credits and subsidies to make premiums affordable.

Little information about the Minnesota health plans' offerings has been made public, so it's unknown how much the premiums will cost.

They are expected to rise for some people, particularly young adults.

California earlier this week became the first state to release prices for health plans offered on its exchange, and the much-feared widespread "sticker shock" didn't happen, though some will face much higher premiums. More than three dozen California health plans submitted bids and 13 were selected.

Minnetonka-based United?Health decided not to offer a plan on the California exchange, as did two other national insurance players, Cigna and Aetna. ___

Now that next-generation DNA sequencing is fast enough, cheap enough and commercially available, the next challenging for innovators is finding ways to effectively apply it to everyday medicine outside of the research lab.

Mayo Clinic and personalized medicine firm Cancer Genetics Inc. (NASDAQ:CGIX) have formed a new company to do just that. OncoSpire Genomics, announced today, will discover and commercialize diagnostic products using next-generation DNA sequencing, starting in cancer.

OncoSpire will leverage clinical and research expertise from the Biomarker Discovery Program at Mayo’s Center for Individualized Medicine along with operating capital and commercial expertise from Cancer Genetics, a reference lab that offers products and services to enable development of cancer diagnostics and personalized treatments. Initially, it will focus on developing diagnostics for hematological and urogenital cancers.

The joint venture is another example of how hospitals, in search of fresh revenue streams, are increasingly turning to partners to commercialize the innovation they’re doing in-house. Mayo, in fact, has done this before in the form of mRemedy, a mobile health company created with DoApp Inc. to provide a patient engagement app.

Mayo also made a push to improve its approach to genome interpretation earlier this year when it initiated a strategic partnership with California diagnostics company Silicon Valley Biosystems.

The hospital and publicly traded Cancer Genetics will have equal ownership of the new Rochester-based venture, but other financial details were not disclosed.

Cancer Genetics CEO Panna Sharma said in a statement that the company wanted to work with Mayo because of its talented clinicians and thought leaders, who would help driving clinical value and adoption of products developed by OncoSpire. “We expect this will add value to our commercial offerings as next-generation sequencing becomes more widely accepted by the clinical community.”

[Photo from Flickr user andylepp]

One concern remains: Fewer physicians mean fewer mentors to train doctors in diagnosing and treating patients with chronic conditions that could lead to costly complications.

A joint venture between a health system and simulation developer called SiMCare Health has led to the development of Web-based patient simulators tapping thousands of patient experiences. The first of these focuses on diabetes.

HealthPartners Institute for Education and Research in Minneapolis worked with VitalSims and University of Minnesota to develop the platform. The research started in 2000 and the platform has undergone three randomized control trials. Health Partners has used the system for the past several years and now it’s making it available to providers and creating a new revenue stream for the health system.

SiMCare Diabetes is designed particularly for primary care physicians to help them better diagnose and manage diabetes, and the co-morbidities that can lead to complications that drive up healthcare costs. It has 18 patient profiles, derived from thousands of case studies, with underlying conditions such as sleep apnea, hyperlipidemia and patients who are on multiple medications for other conditions.

Here’s how it works. Users get about eight different patients with type 1 or type 2 diabetes and various co-morbidities outlined in their respective electronic medical records. They have to help patients set treatment goals for managing blood pressure, cholesterol and blood glucose levels. They review patient vitals, do a physical exam, particularly a foot exam, and based on that information can request tests or diagnostics, prescribe medications and work with patients to decide when they should take their medications. Users can also review lifestyle and potential adherence issues for each patient. Based on the actions and procedures taken for each patient, users get instant feedback. Each case ends when users successfully help them manage their condition over a six-month period.

“Primary care physicians have not had a simulated environment to treat diabetes,” said Chris Duncan, SiMCare Health CEO. “To give you a little perspective when in the simulator dealing with a patient they have access to therapies such as initiating and dosing insulin, ordering diagnostics, doing a foot exam, ordering lab tests. The simulator will tell them if the therapies are good or bad, things they may need to do.”

The Web-based platform is intended to offer an option for providers not located near a simulation center likes ones at teaching hospitals such as Harvard, Johns Hopkins and Penn Medicine. Think of simulators in the healthcare space and odds are high they are for surgery. But as Duncan sees it, the primary care and chronic care market have been largely ignored. Duncan also hopes providers will see a need for the simulator for nurse practitioners and pharmacists.

“Chronic disease represents 75 percent of healthcare costs…so better provider learning will be critical,” Duncan said. “It can be extremely helpful to newer clinicians so they can learn practices and therapies, but if you look at primary care physicians today, it can be used to provide updates on practices, medications, testing recommendations.”

Simulators focused on other conditions are in the works. Duncan expects one for hypertension will be available in the third quarter of the year and a simulator for treating asthma patients  will come on the market in 2014.

Lisa Suennen and John Stenson moderated a great discussion among three payers and one provider: Paulus. His needs were very different from the rest of the group, ranging from imminent cost cuts to the acceptable timeline for ROI. His comments show the pressure hospital systems are under to change almost every aspect of business from working with surgeons to implementing new technology to working with patients.

One of his most interesting comments was in reply to moderator Suennen’s question about how much doctors get involved in cost decisions. Paulus gave an example of how doctors are already stepping to the table on the cost side.

He said his hospital system works with an orthopedic practice of 75 doctors who have their own surgery centers and who also do surgery in the Allina hospitals.

“When they do hip-replacement surgery at one of our hospitals, they require us to offer 13 different hips,” he said.

He attended the group’s board meeting recently and asked how the surgery centers were doing.

“I asked them how they made any money on hip replacements because we can only break even,” he said.

The answer? By offering only one type of hip implant. Paulus renegotiated.

“Suffice it to say, I said, ‘We can’t make it with 13 hips, and if you don’t work with us, we’ll hire our own surgeons,’” he said. “We are now offering two hip implants.”

The group also talked about the return on investment for smoking cessation programs and weight-loss surgery. Most of the payers agreed that they could invest the money in patients now and wait for reduced healthcare bills several years later. Paulus said that the exact opposite is true with hospital systems.

“I’m looking for very quick turnaround, like 12 to 24 months, so if you have something that can do that, it will get a lot of attention,” he said. “We have to take $350 million to $500 million out of the system in the next couple years.”

Dr. Richard Migliori of UnitedHealth recommended everyone in the room read the IOM report on healthcare spending and high-value care. Paulus confirmed one of the report’s conclusions that saving money on drugs and devices is the low-hanging fruit of healthcare cost cutting.

“Folks could give away their devices at cost and it wouldn’t help because we can save money there without redesigning the system,” he said. “Anyone who can help us redesign will make a lot of money.”

[Image of the word NOW illustrated with a speedometer from BigStock]

Kate O'Reilly's spring allergy survival kit includes the usual stuff -- nasal sprays, allergy pills and a box of tissues. This season, she's added a new weapon to her line of defense: an app on her smartphone.

After waking up one recent morning with a stuffy nose and stinging eyes, she downloaded the WebMD Allergy app, which tracks pollen levels in the air.

"If there's a high level, I want to wake up knowing that," said O'Reilly, of Minneapolis.

The prolonged winter delayed the start of allergy season, which typically begins in March. While that gave allergy sufferers some relief, local allergists say their offices now are bustling as allergy season kicks into high gear.

Much like the trees and flowers causing problems for some Minnesotans, allergy apps are just starting to bloom. Many of them have been developed in the last year, said social media expert Christopher Lower, who contends that the new apps are a spinoff of the wildly popular weather apps.

These apps are beginning to change the way some people manage their seasonal allergies, which afflict up to 25 percent of the population. But some allergists are skeptical about the apps' usefulness.

Common features of the often-free allergy apps include a daily forecast of the pollen levels in your area and a description of the predominant allergens in the air -- tree pollen, grass, mold and ragweed, to name a few.

Many apps also allow users to log their symptoms and medications. For example, Zyrtec makes an AllergyCast app with a "Today I feel" dial that allows users to choose from "ugh" to "great." It also features a "products" tab that lists various medications, made by Zyrtec, of course.

Doctors divided

Dr. Ron Reilkoff, a pulmonologist and assistant professor at the University of Minnesota, said he sees benefits in using apps to measure air quality.

"All these allergies depend on the environment," he said, "so if you can be forewarned and be prepared that it's going to be a bad day ... I think it's beneficial."

Dr. Julia Montejo, an allergist with Fairview Clinics, agrees. She said the apps can be particularly helpful for people who don't recognize their symptoms.

"I think they're useful if they can help guide your therapy," she said. "For some people, if they have runny noses and sneezes, and they're wondering if they have a cold or an allergy, they can probably figure out that it's an allergy if they see pollen counts. So then they'll say, 'Oh, today is a Claritin day, not a Sudafed day.'?"

Catie Kennedy of Minneapolis has been using an allergy app for several months. "I find it incredibly useful," she said. "I'd rather know what I'm up against than not."

Her app sends her special alerts when pollen levels are especially high. "I take an allergy pill every day as soon as I start getting these alerts," she said.

But not everyone is so eager to welcome the apps. At the Allina Medical Clinic in Woodbury, Dr. Pramod Kelkar said that many factors beside pollen levels influence allergies.

"It's kind of intellectually satisfying to look at the apps and look at the pollen count," he said, but, "people should look at their body and their symptoms rather than looking at the apps."

Dr. Philip Halverson questioned the tool's usefulness as well. "I wonder about the clinical utility of pollen counts," he said. People with allergies who are seeing doctors already are treating their symptoms. "If it's a seasonal allergy, we typically have a plan," he said. "So, really, the treatment is pretty much symptom-based."

The search for a good app

Allergy apps aren't on most people's radar yet, said Lower, co-owner of Sterling Cross Communications in Maple Grove, but they're a natural outgrowth of mainstream apps. He cited a recent Pew Research Center report on smartphone apps, which found that weather-related apps top the list of mobile downloads. "That's typically where most of these [allergy] apps came out of -- they're gaining mass information from weather sites," he said.

O'Reilly had a weather app, but was looking for more information about pollen. So, she turned to what's become a reliable source: her smartphone. She tweeted: "I wish weather apps had an allergy component. Is there a seasonal allergy app?" She instantly received a half dozen responses on Twitter.

Kennedy chimed in, tweeting: "The Weather Channel App for iPhone does. There are even alerts!"

O'Reilly ultimately chose the WebMD Allergy app. It has bar graphs showing pollen levels, ranging from none to low to moderate to high and finally severe. "It's almost like a 'threat level green,' 'threat level orange' situation," she said, laughing. "I liked it right away."

Allie Shah --612-673-4488 ___

Doing more with less is one of the more derided phrases in a world where cost-cutting and downsizing have been the go-to strategy for many segments of corporate America.

But that approach may be a hero for healthcare’s future, which will thrive only if health systems and the larger medical industry can solve patient engagement and innovative around healthcare delivery.

For about four years now, Dr. Victor Montori’s go-to phrase is “minimally disruptive medicine,” which posits that healthcare should get more hands off with its most troublesome patients: those with multiple problems like diabetes, depression or heart disease.  Instead of check ups that require coming into the hospital, imagine appointments over the phone or in the home. Plus, think about how to treat patients in a way that empowers them to take better care of themselves (treat the depression so they’ll be better able to do what’s needed to help heart disease or diabetes).

Montori is the director of the Health Care Delivery Research Program at the Mayo Clinic and one of the keynote speakers at MedCity ENGAGE, MedCityNews.com’s summit on patient engagement and healthcare delivery on June 5-6 in Washington, D.C. Here’s a capsule of Montori’s vision, which you’ll hear about at ENGAGE.

Can it change healthcare for the better?

The premise. Treat patients in a way that also lets them get the treatment they need, treat themselves and let them continue to live their lives. The way healthcare is currently treating patients with chronic diseases can have as much to do with issues like making sure patients take their medications and the poor results of treatment of diseases like diabetes. Minimally disruptive medicine tailors treatment in a way that cuts down on multiple doctor visits, numerous medicines and complicated instructions that can make it harder for patients to treat themselves.

In short: stop focusing on phrases like on “controlling their blood sugar” and instead thinking about letting patients do what they want to do. “If I am a breadwinner of the family, I still need to be able to do that,”Montori says.

The principals

Montori and his colleagues think four steps are critical to make their idea work:

• “Establish the weight of burden.” Find a way to measure how much of a burden medical treatment puts on a patient’s daily life.
• “Encourage coordination in clinical practice.” Create incentives that encourage holistic approaches and coordinating care.
• “Acknowledge comorbidity in clinical evidence.” Develop approaches that will deal with the issues when a patient has more than one chronic disease (diabetes, heart failure, chronic obstructive pulmonary disease, etc.)
• “Prioritize from the patient perspective.” Get patients involve, including lettering them help decide which illness to treat and how deeply to treat it.

The promise

Suddenly, through this approach, patients will have more customized care that could include fewer medicines, be more straight-forward and offer easier-to-accomplish instructions at a lower cost. As Baby Boomers age the overall cost to healthcare becomes more manageable because patients are more likely to succeed with their treatment.

For many patients, it becomes less complicated to stay alive.

Dr. Victor Montori is one of the a diverse chorus of empowering and insightful speakers taking part in MedCity ENGAGE, MedCityNews.com’s summit on innovations in patient engagement and healthcare delivery on June 5-6 in Washington, D.C. Review the agenda, look at all the speakers and then join us in Washington D.C. in June.

MINNEAPOLIS - Weight was never a concern for Stephanie Brondani, 52, of Minnetonka. Until last year, when she hit menopause.

Suddenly, she noticed her midsection thickening. "I think everybody feels [like], 'I'm eating the same way I always have been and yet I'm getting this roll.' What is that about?" she said.

Scientists have long known that lower estrogen levels after menopause can cause fat storage to shift from the hips and thighs to the abdomen. Now, a groundbreaking study, co-authored by the Mayo Clinic, has determined why: Proteins, revved up by the estrogen drop, cause fat cells to store more fat.

The study also revealed a double whammy: These cellular changes also slow down fat-burning by the body.

Even though the research doesn't provide weight-loss solutions, it may bring a sense of relief to millions of middle-aged women who have been fighting an often losing battle against the dreaded "post-meno belly."

"It doesn't mean you're absolutely doomed," said Dr. Michael Jensen, an endocrinologist at the Mayo Clinic and one of the study's authors, "but it does mean it's going to be harder, probably" to lose weight.

That comes as welcome news to Brondani, who has tried a new exercise program, wears a pedometer and has cut back on sugar and junk food.

"There's that sense of 'Oh, this is just normal,' " she said. "While you don't have to just lay down and take it, you know you're not doing anything wrong. At least you feel like it's OK, everybody is going through this. Not just me."

Sudden changes

More than 50 million U.S. women are 50 or older; 75 percent of women age 50-55 are post-menopausal, according to the Menopause Center of Minnesota. Most -- if not all -- of them will have to confront post-menopausal weight gain.

How much weight a woman gains after menopause varies. According to a 2010 study in the International Journal of Obesity, women gain an average of 12 pounds within eight years of menopause. But even women who maintain the same weight say they notice their waistline expanding.

Cassandra Clay-Chapman started putting on pounds soon after she entered menopause a few years ago. Before she knew it, she was 10 pounds heavier.

"It just happens," she said. "You just blow up like a balloon."

Clay-Chapman, who now lives in Scottsdale, Ariz., is one of 24 women who participated in the Mayo study, the results of which were published recently. The group included Minnesota women who were both pre-menopausal and post-menopausal. They were all about the same age -- 49 to 50 -- and had the same body fat levels, Jensen said.

Beyond beauty

Weight gain, especially around the abdomen, is one of the top complaints women have when they come to the Menopause Center of Minnesota, said Sandy Greenquist, the center's director.

But beyond vanity concerns, there are health risks associated with having an extra layer of padding around the waist.

Belly fat is a sign of visceral fat around vital organs and increases a person's risk for obesity-related illness. According to the Mayo Clinic, a waist measurement of 35 inches or more can lead to a greater risk of problems such as heart disease, high blood pressure and diabetes.

That's why medical professionals focus on the health issues related to weight gain.

"We do a lot of counseling with our patients about nutrition and exercise," Greenquist said.

At one of the menopause chats she regularly gives, Greenquist said, she talks about ways to combat the muffin top, sleeplessness, hot flashes and other symptoms of menopause. She also talks about diet.

"We tend to overindulge on carbohydrates and not get nearly enough protein. Those two conditions contribute to fat on their bodies," she explained. "I give them some basics on changes that could be helpful. Exercise needs to be muscle-building exercise -- doing things that will increase their metabolism."

The Mayo research might lead to other strategies for maintaining a healthy weight after menopause. For example, Jensen said it raises questions about the kinds of dietary changes doctors might suggest. It also raises questions about whether hormone replacement therapy may play a role in offsetting weight gain.

"Those kinds of questions we weren't able to address with this study," he said, "but that's something we'll have to consider in the future."

Sylvia Santosa, an assistant professor of nutrition science at Concordia University in Montreal, Quebec, and the study's co-author, added that while science doesn't offer any fixes for the post-meno belly, the findings shed much-needed light on the issue. "It puts us one more step toward understanding how estrogen affects how and where we store fat," she said.

Mary Rossi, 64, of Minneapolis, used to take pride in her "marked waist."

Since menopause, she's watched her midsection grow five inches, despite the fact that she now eats less and is still active. She's healthy and her body is proportionate, but she says, "I've given up trying to go back to the waist I had when I was 50."

Allie Shah --612-673-4488 ___

That was confirmed at this week’s 10x Medical Device Conference in Minneapolis, Minnesota, during a panel on new sources for capital. It was a bone-jarringly frank conversation that featured two entrepreneurs including Steve Anderson, CEO of Preceptis Medical. Anderson was straightforward about early stage investing: Angels have money but the terms are typically bad (largely so angels can protect themselves in later rounds), while strategic investors are hesitant to come in on earlier rounds.

So what about crowdfunding for medical device companies?

“I don’t see how that works in devices–I don’t see one way it works,” he told the audience. It may be great in other sectors, such as consumer electronics, Anderson said. “But what are we going to give people–a medical device?”

That doesn’t mean the innovators aren’t trying to create a crowdfunding solution for medical device companies. MedStartr has a medical device section, a new site Liifmed is trying to focus on life sciences, and offshoots like PeerBackers, Poliwogg and TechMoolah are developing services too. But the amounts companies raise on these services are sub-$20,000 and the rewards for investing are quaint: blog posts written by the company you’re funding in exchange for a $500 investment or a customized key chain for a smaller investment.

Judging from the feedback at 10x, the medical device sector will need to see a company make Veronica Mars money from crowdfunding to make them believers.

Just like patient data is held in various silos through the health system, so is employee data siloed in large businesses. That poses some challenges when it comes to meeting administrative and communication requirements for employers mandated by the Patient Care and Affordable Care Act (for example, automatically enrolling qualified employees in the company’s health plan).

A Minnetonka, Minnesota software startup called HealthCare Impact Associates LLC has a solution it thinks can take the place of costly upgrades to existing human resources, payroll and benefits management systems that would help companies comply with the new requirements.

The product, called Health E(fx), integrates data from a company’s existing IT systems, provides historical and predictive cost analytics to support companies’ decisions about their health plans, and enables the necessary reporting. It also alerts companies when they are not being compliant with ACA measures, the company says.

HealthCare Impact Associates has just raised $2 million in preparation for the commercial launch of the cloud-based solution this June. Beta tests have been running since February, the company says, and will continue through the spring and early summer.

Minnesota doctors have been alerted to a new strain of influenza circulating in China and are urged to notify state health authorities if they have patients who traveled to the Asian nation and have flu-like symptoms.

An alert sent by the Minnesota Department of Health April 5 has already resulted in doctors finding a couple of patients who fit the profile and submitting lab samples to the state for testing.

The new strain, known as H7N9, migrated from birds to humans in China. So far there have been no cases in Minnesota -- or the United States.

"This is a new strain for the human population," said Kris Ehresmann, who directs the Health Department's influenza vaccination programs. "That's a concern."

The alert is the first sent to Minnesota doctors about a novel human influenza strain since the H1N1 pandemic of 2009. A second alert went out to doctors and clinics this week about the public health precautions they should take if they encounter patients who are potentially infected.

There are no signs yet that H7N9 could produce a pandemic on the scale of H1N1, which emerged months before the typical flu season in 2009 and was eventually linked to at least 63 deaths in Minnesota. There is no evidence that the new virus can pass from person to person. Most of the cases involved people who had contact with poultry, but 40 percent involved people who had no such contact.

Ehresmann said public health officials still need to be aware of the potential spread of the virus and prepared.

"It's time to dust off your plans from H1N1," she said.

On Wednesday, the World Health Organization reported 82 human cases, all in China, including 17 deaths. The figures might overstate the death rate from H7N9, Ehresmann said, because there could be mild cases that aren't reported.

Ehresmann said it was a relief that doctors reported a couple of potential cases, even if they turned out to be negative, because it means they are heeding the state's health alerts.

"You're casting this super-wide net. You want to make sure you don't miss anything." ___

MINNEAPOLIS, MN - Tisha Mette knew the autism therapy for her son, Ayden, would be expensive.

To pay for one month's treatment, her husband sold his $15,000 Harley. Then they took out a home-equity loan.

Since 2007, her husband has changed jobs three times trying to find an insurance plan that would cover the boy's treatment.

Now, state lawmakers are considering a proposal to require insurers to cover the intensive form of treatment, which can cost more than $100,000 a year.

It's a battle that has been playing out across the country as autism diagnoses have soared to record levels. Already, 32 states mandate some form of autism coverage.

This year, Minnesota legislators proposed one of the most generous mandates in the country, with no dollar or age limits on the coverage. But last week, in the face of growing cost concerns, a House committee scaled it back, setting a $50,000 annual limit per child.

Supporters have said they're more optimistic than ever about an autism mandate, which has support on both sides of the aisle. "People just understand that this is a growing problem that needs to be addressed," said Rep. Kim Norton, DFL-Rochester, one of the chief sponsors. "We're all there. It's just finding the funds."

The debate has pit desperate parents, who believe their children's futures depend on the most intensive treatment, against insurers and business groups that say the mandate will drive up health costs and lock in place a hotly contested brand of therapy.

Thanks to a quirk in federal law, the mandate also could cost Minnesota taxpayers millions of dollars at a time when the state budget is facing $150 million in health care cuts.

Initially, the mandate would affect only about a quarter of Minnesotans -- those in state-regulated insurance plans. (Most large employers, which are self-insured, are exempt from state mandates.) But under federal health care reform, any new mandate would apply to plans sold on the new health insurance exchange, and state taxpayers would have to subsidize it. Officials estimate that would cost $3.5 million next year, and $10 million by 2016.

But parents like Mette, who lives in Plymouth, say that families can't afford to shoulder the burden of autism alone. They believe society will save money in the long run by investing in early intervention.

Families swear by treatment

Mette, who has told her story at the Legislature, says her son was a "happy, verbal and loving little boy" until, at 15 months, he inexplicably stopped talking, stopped sleeping and started kicking, hitting and biting. His doctors recommended intensive behavior therapy, which drills children to help them learn basic skills, from talking to making eye contact, and shed autistic behaviors.

Most private insurers, the Mettes found, excluded the therapy.

The family borrowed the money to try it 25 hours a week. "Within the first two weeks we knew, oh my gosh, we have to keep doing this," Mette said. Her husband, Ryan, a telecommunications manager, switched jobs twice in search of better insurance coverage, only to learn it didn't cover Ayden's therapy. He eventually took a job as a truck driver at Schwan's, which does cover it.

Now Ayden, a bright-eyed boy with brown hair who turns 8 this week, gets 56 hours a week of home therapy. Last week, he hugged a red balloon as his therapist, Kristen Kissner, read him a book called "Bad Kitty." Moments later, on cue, he hopped to a desk to work on his writing. "Nice job, Mr. Ayden," she said. The positive reinforcement -- a key to this type of therapy -- comes in a constant stream. "Awesome job," she says.

Eventually, his parents hope Ayden will be able to attend regular school. "He's doing phenomenally," his mother said. "It's night and day from where we were."

But many families who have such insurance coverage are in danger of losing it, and that's why they're pushing for a mandate, says Eric Larsson, who runs the Minneapolis-based Lovaas Institute Midwest that provides Ayden's therapy.

Last year, the only large health plan in the state that covered it, Blue Cross and Blue Shield of Minnesota, announced it was stopping. Dozens of other families, who get coverage through the state's high-risk insurance pool, learned it will disappear under federal health reform. "Everybody's feeling like their coverage is at risk," said Larsson.

Larsson, whose institute has spent $387,000 on lobbying since 2008, says the insurance mandate is critical for those families. He points to studies describing this type of therapy, also known as Applied Behavior Analysis (ABA), as far and away the most effective.

Insurance industry is wary

The insurance industry, though, is skeptical. Glenn Andis, a psychologist at Medica, said that health plans cover many types of autism treatment, such as speech and physical therapy, but often draw the line at ABA. It's far more expensive than other types of treatment, he said, without proof that it's more effective.

Andis notes that an expert panel examined the scientific literature for the state of Minnesota, and concluded in February that the evidence was "far from robust." Yet the panel, called the Health Services Advisory Council, recommended that the state pay for an unlimited amount after supporters flooded the group with personal appeals. Andis called it a "political decision" rather than a scientific one. "Why should we pay 10 to 20 times more for something that shows no greater evidence?" he asks.

Andis said he's also troubled that parents have been led to believe that 40-hour-a-week treatment is their only hope. "Yes, they're going to get some behavior change, there's no doubt about it," Andis said. But "at what cost?... Is that the most effective and most efficient way?"

One autism advocate, in fact, has publicly criticized the proposed law. Idil Abdull of Burnsville, founder of the Somali American Autism Foundation, says that advocates sometimes exaggerate the need for intensive therapy, and a mandate like this would be a blank check.

"This bill asks unlimited hours for ABA, for unlimited age, forever," she testified in March. Abdull, who has complained about disparities in treatment for low-income children, said it would be fairer to put some limits on autism services, and make them equally available to rich and poor.

Supporters, though, say the fears about costs are overblown. Sen. Chris Eaton, DFL-Brooklyn Center, one of the chief sponsors, estimates that about a third of young children with autism might need intensive treatment, typically for about three years.

Michael Wasmer, of the national group Autism Speaks, says that autism mandates in other states have not been as expensive as some feared. On average, they cost health plans 31 cents per member per month. He acknowledges that most states have dollar caps -- typically $36,000 to $50,000 a year -- and age limits (from 6 to 21). But he cited a recent Missouri study that found a negligible impact on insurance premiums.

In any case, advocates argue that the cost pales compared to a lifetime of special education and support services.

"It would be really penny-wise and pound-foolish," said Eaton. "These people will cost millions of dollars over their lifetime if we don't give them treatment now."

Maura Lerner --612-673-7384 ___

NEW YORK (Reuters Health) - Despite lingering concerns that using fertility drugs might raise a woman's chances for later developing ovarian cancer, new research suggests the drugs don't contribute any added risk.

"One important message is women who need to use fertility drugs to get pregnant should not worry about using these fertility drugs," said Dr. Albert Asante, lead author of the study and a clinical fellow in the division of reproductive endocrinology at the Mayo Clinic in Rochester, Minnesota.

Research on fertility drugs and cancer risk has yielded conflicting results.

Some studies, especially in the 1990s, showed an increased likelihood of the cancer among women who took fertility drugs. And a Dutch report from 2011 found an increase in borderline tumors - those with abnormal cells that might not turn into cancer (see Reuters story of October 27, 2011 here: http://reut.rs/tn4n5t).

However, Dr. Bert Scoccia, a professor at the University of Illinois School of Medicine in Chicago who studies fertility medication and cancer, said numerous other studies have found no increased risk for women who take fertility boosting medications (see Reuters Health report of December 2, 2010 here: http://reut.rs/kA3Q3M).

The majority of studies have pointed to fertility drugs being safe, but many of them were conducted outside the U.S., Asante noted.

"It's difficult to translate what those findings mean for women in the U.S.," he told Reuters Health.

So Asante and his colleagues gathered medical information on 1900 women from an ongoing ovarian cancer study at the Mayo Clinic.

The researchers compared 1,028 women with ovarian cancer to 872 women of similar age who did not have cancer.

About 24 percent of the women who did not have ovarian cancer reported having used fertility drugs, while roughly 17 percent of women who had ovarian cancer had used fertility drugs, the team reports in the medical journal Fertility and Sterility.

After taking into account factors that can influence the risk for ovarian cancer, such as age and use of the birth control pill, the researchers found no difference in cancer rates between the groups.

"That is reassuring," said Scoccia, who was not involved in the research.

Scoccia said it's possible that the type of fertility drugs women used decades ago could explain why some earlier studies had found opposite results.

"Unfortunately, because the patients (in this study) were providing the information in a questionnaire, we don't know what drugs they took. Nevertheless...there was no increased risk in ovarian cancer," said Scoccia.

It's been difficult to tease out the effects of fertility drugs on ovarian cancer because women who are infertile are already considered to be at a higher risk for the cancer.

Infertility, defined as not getting pregnant after a year of trying, is experienced by about 15 percent of couples.

Asante's team looked specifically at whether women in the study who reported being infertile- whether or not they had taken fertility drugs - had a greater chance of developing ovarian cancer, and found no added risk.

Asante said one explanation for the result is that most of the women in his study had infertility issues, but eventually became pregnant. He would still expect to see a higher risk of ovarian cancer if he had included more women who never ended up having a baby.

Asante left open the possibility that long term use of fertility drugs - more than one year - could impact the chance of developing ovarian cancer, and to be safe these women might benefit from additional monitoring for tumors.

He said that because ovarian cancer is rare and develops later in life, there is a need for longer studies to thoroughly assess the effect of fertility drugs.

According to the National Cancer Institute, close to 13 out of every 100,000 women develop ovarian cancer, most commonly in their 60s. Family history of the disease or certain gene mutations raise a woman's risk considerably.

Scoccia said the recommendation for fertility drug use is that women use the lowest possible dose for the shortest amount of time.

SOURCE: http://bit.ly/10Jw6yl Fertility and Sterility, online April 2, 2013.

The maker of heart pacemakers, valves and other medical devices said European regulators approved its Brio, Kibra and LibraXP deep brain stimulation systems for managing symptoms of the incurable disease.

Dystonia causes a person's muscles to involuntarily contract and spasm, and can leave its victims wheelchair-bound.

“We’ve been viewed and viewed ourselves as simply a device provider as opposed to a healthcare solution provider which is what this is,” said Ishrak, who spoke on a panel on new healthcare collaboration with the likes of Mayo Clinic CEO Dr. John Noseworthy,  Duke University Health System CEO Dr. Victor Dzau, and Blue Cross Blue Shield of North Carolina CEO Brian Wilson.

These are thoughts he and other executives have discussed before. But it will be hard to find a more direct outline of the challenges for medical device companies that have to adjust to a system that will pay for the quality of care rather than the act of, say, implanting a stent.

Ishrak began his talk by describing Medtronic as a company with a history of innovation. But, he admitted, today’s innovation is different. What people pay for from Medtronic today is done during the medical procedure, Ishrak said. However, the true value of that procedure occurs after it’s complete and, today and in the future, that value will be realized over a longer period of time, Ishrak said.

To really get to the bottom of that value of a medical device and the procedure, Medtronic will need to leverage data and insights from hospital systems, health insurance companies and governments, among others. Through these efforts they’ll figure out the true cost of healthcare.

“This is brand new for us,” Ishrak said.

You can listen to an excerpt of his talk here.

MINNEAPOLIS - A disappointing setback in the federal rollout of the Affordable Care Act should help dispel lingering doubts about Minnesota's decision to build a homegrown version of the online health insurance marketplaces called for in the controversial health reform law.

Minnesota lawmakers in March approved legislation -- on mostly party-line votes -- that officially makes the state one of 17 to build and run a health exchange. Because of that, and because of the advance work done by Gov. Mark Dayton's administration, the part of the state exchange serving small businesses and their employees should be fully operational when enrollment begins this fall.

That will not be case in the 33 states that turned over the design and construction of their exchanges to the federal government -- often because of anti-Obamacare politics.

About a week ago, the U.S. Department of Health and Human Services announced that the part of the federally built exchange serving small businesses and their employees will not be fully operational this fall. Although few details were given about the delay, it's likely linked to the high and unexpected number of states that decided to rely on the federal government to build their health insurance marketplaces.

Small businesses and their workers still will be able to buy on the exchange in these states. But two key features of the small-business exchange will be delayed until 2015:

-- Employee choice: A fully functional exchange would let employers set a coverage contribution level for their employees, then allow employees to pick from competing plans using this contribution level. The delay means the status quo for employees for another year. Their employers will shop from competing plans, but employees are limited to what the boss picks.

-- Premium aggregation: This is a fancy way to say that the exchange website will be a one-stop shop for payment, easing employers' administrative burden by taking their payments for insurance and distributing them to the health plans their employees' choose.

In contrast, the Minnesota exchange is expected to have these features available this fall, making our state exchange both easy and attractive to use for businesses and their workers. It's clear that the state team working on the exchange's development put a high priority on meeting business needs. In turn, that should boost the confidence of the business community in this new marketplace as fall enrollment nears.

The attention to detail also bodes well for the consumers who will use the exchange -- now dubbed MNsure -- to buy individual policies and determine eligibility for tax credits and other assistance to obtain coverage.

"As a result of establishing MNsure, Minnesota controls its own destiny and is not tied to what the federal government chooses to deliver,'' Minnesota Management and Budget Commissioner Jim Schowalter said in a statement. "Independence from federal control was and continues to be a compelling reason for MNsure.'' ___

ST. PAUL - Increased spending on hospital care depressed operating profits for the state's nonprofit health insurance companies last year, according to a report released Monday, April 1, but financial reserves for health plans still increased to just over $3 billion.

Despite a 10 percent increase in hospital and emergency room patient care costs over 2011 levels, health insurers still posted an operating profit for 2012 of $120.1 million, according to figures from the Minnesota Council of Health Plans, a trade group based in St. Paul. That operating profit last year was down about 66 percent from 2011's figure of $355.7 million.

The operating profit figure was less than 1 percent of the $20.9 billion in premium revenue collected by the health insurers, according to the trade group, which represents seven companies, the largest being Eagan-based Blue Cross and Blue Shield of Minnesota, Bloomington-based HealthPartners and Minnetonka-based Medica.

During 2012, the health insurers collected $145.7 million in investment income. The operating and investment profits increased collective financial reserves to $3.02 billion at the end of last year from about $2.8 billion at the close of 2011, said Eileen Smith, a spokeswoman for the Minnesota Council of Health Plans.

"National and state standards exist to ensure that health plans have sufficient reserves for continuous payment of members' medical bills and for investing in technology and other improvements -- even when there are unexpected catastrophic claims, natural disasters or market instability," the trade group said in a statement.

The health plans operate insurance company subsidiaries, which primarily serve commercial customers, and HMOs that manage care for patients in the state's public health insurance programs.

Lawmakers increasingly have scrutinized HMO profits from the public programs in recent years.

The numbers released Monday show that HMOs ended 2012 with an operating margin of 1.4 percent from public programs, a figure that works out to $56.7 million.

"Managed care continues to demonstrate excellent value that allows the state to predict its budget and provide excellent coverage," said Julie Brunner, executive director of the Minnesota Council of Health Plans, in a statement. ___

NEW YORK (Reuters Health) - The number of Americans diagnosed with celiac disease continued to rise over the past decade but leveled off in 2004, according to a new study.

Researchers analyzed data on a small but representative sample of people living in Olmsted County, Minnesota, and found that between the years 2000 and 2010, the number of new cases of celiac disease increased from about 11 people per 100,000 to about 17 people per 100,000.

"We're finding a lot more celiac disease," said Dr. Joseph Murray, the study's senior author from the Mayo Clinic in Rochester, Minnesota.

"Some of that is probably that we're better at detecting it, but the fact that we're finding it all the time shows that there are a number of new cases," he added.

In people with celiac disease - which includes about 1 percent of Americans, according to most estimates - the immune system reacts to gluten, a protein found in wheat, barley and rye. Eating foods with gluten damages the small intestine and keeps it from absorbing nutrients.

Classic symptoms of celiac are diarrhea and weight loss, according to Murray's report.

Previous studies have shown that the number of people living with the condition increased over time, but few studies looked at the number of new cases being diagnosed in recent years.

The researchers used medical records for people living in Olmsted County, which is home to the Mayo Clinic and two affiliated hospitals, and where the health of most of the population is tracked through research projects.

Over the entire decade starting in 2000, some 249 people were diagnosed with celiac disease in the county. People as young as one year old and as old as 85 received a diagnosis, and about 63 percent of the new cases were women.

Between 2000 and 2001, 26 people were diagnosed with celiac disease, which works out to about 11 per 100,000 people at the time. By 2002 to 2004, that number had climbed to 67 - or about 18 people per 100,000, and remained about the same from then on.

"This study shows not only did it go up, but it kind of plateaued in 2004 and it remained stable at that elevated level," Murray said.

He and his colleagues write in The American Journal of Gastroenterology that the increased incidence of celiac disease may be partly due to doctors knowing about the signs and symptoms of celiac disease and screening people at risk, but not entirely.

"Something has changed in our environment that's driving an increased incidence of celiac disease," Murray said.

In their report, Murray and his colleagues note that gastrointestinal infections have been linked to the development of celiac disease. So has high consumption of gluten-containing foods, like breads, bagels and pizza.

Dr. Alessio Fasano, director of the Center for Celiac Research at MassGeneral Hospital for Children in Boston, agreed that something in the environment seems to be triggering the various genetic and biological factors that drive celiac disease.

"If you lead the lifestyle of three or four generations ago, you don't see this epidemic. I do believe what we're witnessing with celiac disease is that we're changing the environment way too fast for our body to adapt to it," said Fasano, who was not involved with the study.

"When we're born we are like a marble block. What carves this into a wonderful sculpture is the environment," Fasano added.

Murray told Reuters Health that people should see their doctors if they have a family history of celiac disease, or are experiencing its most common symptoms - including iron deficiency, weakness, tiredness, diarrhea, passing gas and weight loss.

SOURCE: http://bit.ly/YIl26a The American Journal of Gastroenterology, online March 19, 2013.

The Shriners Hospitals for Children-Twin Cities is now a part of the Mayo Clinic Care Network -- a partnership that doesn't involve any changes in ownership but gives Shriners easy access to Mayo's expertise.

"It's really an investment between the organizations," said Dr. David Hayes, medical director for the Mayo Clinic Care Network. The care network frequently delivers knowledge remotely to doctors working with a patient, he said. Shriners' doctors also will have access to the latest medical information through a Mayo database.

Mayo doctors have been doing work with the Shriners Hospital and its patients for 30 years, said Don Mattson, emeritus chairman for the hospital's board of governors. But the new agreement means improved care for patients and a better future for the hospital, he said.

"The challenges of medicine in this modern age demand that we seek and share knowledge in a way that has value to the patient," said Douglas Maxwell, president and chairman of Shriners Hospitals for Children. "Our participation is a continuation of that commitment."

The Twin Cities' Shriners hospital does pay to be part of the Mayo Clinic Care Network, though additional costs aren't passed on to patients, hospital officials said.

While the Mayo Clinic's reach has been expanding in southern Minnesota -- including a new hospital planned for Cannon Falls and its acquisition last year of the hospital and clinic in Red Wing for $64 million -- the care network's

presence in the Twin Cities isn't the same type of move.

"We think healthy, independent organizations should stay healthy and independent," Hayes said Wednesday, March 27, at the Shriners hospital, where the partnership was announced. "And the patients stay at their (home hospital) as much as they can."

If a patient needs to be referred for additional treatment, "there's no commitment to send them to Mayo. It's wherever is best for the patient," Hayes said.

Mayo's existing relationship with Shriners brought doctors to the hospital on the east side of the Mississippi River in Minneapolis, and that's expected to continue.

The Mayo Clinic Care Network, launched in 2011, has member organizations in 10 states and Puerto Rico.

The Shriners Hospital-Twin Cities, part of a Tampa, Fla.-based system of 22 hospitals, provides pediatric orthopedic care to people from seven states in the Upper Midwest and parts of Canada. So far, it's the only Shriners hospital that's part of the Mayo network.

John Welbes can be reached at 651-228-2175. ___

Following a small round of private financing in January, the company just raised another $500K, as disclosed in a new SEC filing. Company executives declined to comment on the funding.

BioDrain’s device, the Streamway System, plugs into an operating room’s existing plumbing, electrical and vacuum systems and automates the collection, measurement and disposal of surgical fluids. According to the company, the system virtually eliminates workers’ exposure to blood and other potentially infectious fluids in the OR, meanwhile making the process more efficient and cutting overhead costs.

With a new management team put in place last year, BioDrain appears to be making a push to gain U.S. market share from competitors in the surgical waste management space like Stryker and Cardinal Health. A recent press release touts sales of the device in hospital and surgical centers in New York, Michigan, Minnesota and Pennsylvania.

Stryker, for one, may actually be helping BioDrain’s cause, as it has recently encountered some regulatory hiccups with its Neptune Waste Management System. The FDA has recommended that providers use “alternative legally marketed devices” instead, a move that may open some doors for BioDrain in U.S.

The Minnesota-based company says it’s also planning meetings with distributors in Europe, Canada and Asia to being global expansion of the device.

[Photo from BioDrain]

As the health law marks its third anniversary, much of the action surrounding its implementation has shifted to the states.

Hot topics include creation of health exchanges, the on-line marketplaces where consumers will be able to shop for insurance coverage, and the law’s Medicaid expansion, a key mechanism by which the overhaul will extend health care to millions of people who currently lack health insurance.

We checked in with reporters on the ground in Colorado, Florida and Minnesota to find out what they view as the most significant developments to happen in their states since the law’s passage and what future challenges they see ahead.

LYNN HATTER, WFSU:  I’m Lynn Hatter from WFSU-FM in Tallahassee, Fla. One of the biggest developments in the past three years has been the state’s rejection of the Medicaid expansion under the Affordable Care Act. Florida lawmakers say they don’t want to move forward with that and are now proposing their own plan to submit to the federal government that would cover roughly the same 1 million Floridians who would have otherwise been eligible.  A plan should be coming on that within the next week.

One of the biggest challenges the state will face will be how to put it all together. Obviously, Florida is looking to do its own state-run program, and that’s going to come with getting approval from the federal government in order to take the Medicaid expansion money. The state is also looking at how to comply with the law in the area on insurance regulation, and Florida will be deferring to the federal government like premium increases, rate increases and other insurance regulations.

ELIZABETH STAWICKI, MINNESOTA PUBLIC RADIO: My name is Elizabeth Stawicki, and I’m a health care reform reporter at Minnesota Public Radio in St. Paul. The most significant issue that’s happened here since the law passed three years ago has been getting our legislation passed to create a state-based health insurance exchange. We’re one of the few states that actually has done this.

This began, though, three years ago. But, because Republicans were in control the first two years of the legislature, they wanted to block the creation of the health insurance exchange, because they were against the Affordable Care Act and thought that either the U.S. Supreme Court would strike it down or there would be a different president in the White House.

But, just this week our Legislature has passed this exchange legislation, and, as I am talking to you in mid-March, we believe that the governor will sign that legislation into law.

The challenges that I foresee in the coming year here again have to do mostly with the insurance exchange. Our state health plans that want to sell on the exchange have only until May 17 to get approval from the state -- which doesn’t leave them a whole a lot of time -- but that’s necessary in order for the state to begin enrolling Medicaid members and for people to start using the exchange to compare plans on Oct. 1.

ERIC WHITNEY, COLORADO PUBLIC RADIO: I’m Eric Whitney of Colorado Public Radio in Denver. The most significant thing to happen since the passage of the Affordable Care Act here was in 2011 when the state legislature passed a bipartisan health exchange bill that established the health insurance exchange in Colorado. There was a lot of debate over whether that was actually going to work or not, but the fact that it passed allowed the health insurance exchange to get started and go forward.

It did get a handful of Republican votes. The people who did vote for it – the Republican co-sponsors – took a lot of heat from more conservative members of their party. There was some concern over whether they would be ousted and whether Republicans would be able to muster the votes to derail the startup of the exchange in Colorado. The 2012 elections were also significant because that didn’t happen: The Republican supporters of the bill managed to survive their challenges. Also, the fact that the Obama administration kept the White House in 2012 meant that it was very clear that the exchange was going to be established and continue in Colorado.

Right now the most significant challenge for the exchange in Colorado – and I think the most significant thing for health reform going forward in Colorado – is finding an ongoing source of funding for the exchange’s operations. In 2015, state exchanges have to be self-sustaining, so right now the exchange board and the legislature are looking for ways to fund its ongoing operations. There’s been some work on that already – the exchange board has passed an administrative fee – but they have to go to the legislature to try to find some other funding mechanisms. And that debate is just starting up in Colorado, so that’s what I’m going to be watching closely.

Photo courtesy of Wikipedia Commons

ST. PAUL - Gov. Mark Dayton signed legislation Wednesday, March 20, creating a health insurance exchange in Minnesota, a move supporters call the state's most sweeping coverage reform in 50 years.

About 1.3 million state residents are expected to use the online marketplace for obtaining health insurance by 2016.

After weeks of contentious debate with Republicans and business groups criticizing the cost and leadership structure for the new marketplace, the Democratic-Farmer-Labor Party majority passed legislation for the health exchange without a single GOP vote in the state House and Senate.

Health insurance companies Wednesday predicted the exchange might not hit enrollment projections due to problems with the legislation. But in comments at the Capitol, Dayton focused on support from doctors, patient groups, unions and one organization that represents some small businesses.

"This is not meant to serve the insurance industry, or anybody else's industry," Dayton said. "It puts the people of Minnesota and their interests in charge of our health care system."

Individuals and small businesses can start shopping for coverage on the new marketplace beginning in October. The name "health exchange" is not popular, state officials have acknowledged, so they announced Wednesday that the marketplace will be called MNsure (pronounced Minn-sure).

The exchange is a key component of the federal health care overhaul law passed in 2010. Beginning next year, the law requires

almost all Americans to have health insurance, and exchanges are meant to be a key resource for consumers who have lacked coverage in the past.

In Minnesota, about 300,000 uninsured people are expected to gain coverage.

The federal health law has become a symbol for the partisan impasse in Washington D.C., and Dayton said Wednesday he regretted DFLers and Republicans in St. Paul couldn't find common ground on health policy, either.

Dayton blamed "exaggerations" put forward by Republicans and an "ugly" campaign last year to block the health law, both at the U.S. Supreme Court and through an election challenge to President Barack Obama. The health law survived both those challenges, Dayton said, and Minnesota is now moving forward on the state's own terms, rather than adopt a federal model.

But Rep. Jim Abeler, a Republican from Anoka, said DFLers in Minnesota had a chance to win Republican support. It didn't happen, he said, because the DFL wouldn't agree to limit the power of the health exchange's board of directors or allow insurance industry representatives on the board.

"We could have done better," said Abeler, the only Republican to serve on a conference committee that reconciled House and Senate versions of the exchange bill. "The weakness was, it was all passed on one side."

The exchange is supposed to be easier for consumers to use than the current health insurance market. The exchange also is the mechanism by which people can obtain federal tax credits that could significantly reduce out-of-pocket health insurance costs.

Dayton has tapped $110 million in federal grants during his more than a year of planning for Minnesota's exchange. It will consist of a website and call center for consumers to learn about health insurance options; help also will be available from health insurance brokers and a new group of advisors called "navigators."

"It's significant because for the first time in Minnesota history we put consumers on the same level playing field as the carriers from whom they are purchasing health insurance," said Rep. Joe Atkins, DFL-Inver Grove Heights, who sponsored the health exchange bill in the House. "Carriers will have to compete more fiercely than they ever have in the last 50 or 100 years for consumers' business."

The exchange will operate as a new state government entity with about 86 employees. It will withhold a portion of premiums from policies sold to cover $50 million per year in operating expenses.

A seven-person board of directors will lead the exchange. Six members will be appointed by the governor with ratification votes in the House and Senate; the state's human services commissioner holding the seventh slot.

It's not clear which health insurance companies will offer products on Minnesota's health exchange. Carriers have until May 17 to file plans.

Insurance companies have bristled at "active purchaser" powers in the law that will let the health exchange board exclude products that are deemed not in the best interest of consumers beginning in 2015.

"Consumers will feel the impact if a plan is on the exchange one year and not permitted to sell that product on the exchange the next year," Julie Brunner, executive director of the Minnesota Council of Health Plans, wrote in a letter to Dayton. Brunner's group represents nonprofit health insurers in the state.

"Lack of choice," she wrote, "will potentially make the exchange a less attractive option for consumers."

Dayton offered no clues Wednesday about whom he might appoint as board members for the exchange. His submissions are due in April.

By May, the state is scheduled to launch a public education and outreach campaign for MNsure. A call center should be open by September, and enrollment begins Oct. 1 for coverage taking effect Jan. 1, 2014.

The health exchange will be an option for people in the state's individual and small-group markets -- currently about 12 percent of the population -- as well as the roughly 9 percent of residents in Minnesota public health insurance programs.

It won't immediately be an option for people covered through larger employer groups, nor will it be used by Medicare beneficiaries.

Christopher Snowbeck can be reached at 651-228-5479. Follow him at twitter.com/chrissnowbeck and facebook.com/PioneerPressPolitics. ___

MINNEAPOLIS - University of Minnesota officials have investigated a concern raised by a bioethics professor -- that U psychiatrists might have "rubber-stamped" vulnerable schizophrenic patients into drug studies -- and concluded it is "completely false."

In a blog last month, professor Carl Elliott posted patient evaluation forms from the files of two mentally ill research subjects that contained responses that appeared to be identical. That raised the specter that the forms had been filled out in advance and that patients weren't actually evaluated for their wherewithal to consent to the risks and responsibilities of clinical research.

On Wednesday, university officials said they investigated Elliott's claim by reviewing all the "evaluation to sign consent" records from one of the studies he mentioned -- a project called CAFE, which compared the effectiveness and side effects of three antipsychotic drugs.

Each patient's folder contained an evaluation form with unique responses and markings, said Mark Rotenberg, the university's general counsel.

"There is no evidence that any of them contained predetermined, photocopied answers," Rotenberg said.

The dispute over consent evaluation records is the latest regarding Dan Markingson, who died by suicide at age 26 in 2004 while participating in the CAFE study. Markingson's mother, Mary Weiss, tried to keep her son out of the trial and questioned whether he was coerced into participating.

An investigation by the U.S. Food and Drug Administration after Markingson's death found no evidence of wrongdoing by the university, which also was dismissed from a lawsuit filed by Markingson's family. The recruiting of Markingson did draw concerns from Minnesota's mental health ombudsman, though, and resulted in legislation that prevents doctors from recruiting their own patients into their psychiatric drug studies.

The case also drew the attention of Elliott, who has since become an outspoken critic of his own university.

"Never in my life," Elliott said, "have I felt the kind of shame that I feel at the way my university has treated Mary Weiss."

Elliott posted two copies of evaluation records from Markingson's legal file and compared them with an identical record provided by the family of another research subject. That family has asked to remain anonymous.

Rotenberg said publicity surrounding the Markingson lawsuit resulted in many records from the case being distributed online, and perhaps that is how the duplicate came to exist with another family.

"The form, in our opinion, is simply another copy of the Markingson 'evaluation to sign consent' form," he said Wednesday.

Rotenberg said that families who believe they have questionable documents from the CAFE research should come forward with them.

"We absolutely want to see them and investigate," he said.

Petition seeks inquiry

The university's response has not caused Elliott to back off his criticism; he said he has asked to see the university's evaluation-to-consent records from the CAFE study for himself but so far has not been allowed to do so.

On Wednesday, an editorial from Elliott was published on Pharmalot, a blog that analyzes the drug industry, in which he encouraged people to sign a petition asking Gov. Mark Dayton to order an independent investigation of the Markingson case. The petition by the Markingson family has gained more than 1,000 signatures, including those of university faculty, two former editors of the New England Journal of Medicine and more than 100 experts in medicine and bioethics.

Jeremy Olson --612-673-7744 ___

(Reuters) ST. PAUL - A clinical trial evaluating St. Jude Medical Inc's implantable device used to prevent stroke in patients who have a common congenital heart defect failed to achieve its main goal.

St. Jude, which paid for the 980-patient study, said it used the trial data to file for U.S. regulatory approval and submitted an application to the U.S. Food and Drug Administration in the fourth quarter of 2012.

The device, a permanent implant, is used on people who have a hole in the wall that separates the left and right upper chambers, of the heart. Everyone has a hole present at birth, but it never closes in about one-quarter of the population, according to the National Institutes of Health.

The hole - called a patent foramen ovale, or PFO as it is more commonly known - raises the risk of stroke. It usually is not treated unless a blood clot causes a stroke, or if there are other heart problems. When relatively young people have a stroke without an identifiable cause, a PFO is often suspected.

Dr. Jeffrey Saver, director of the UCLA Stroke Center and one of the lead investigators of the study, dubbed RESPECT, said the trial demonstrated that implanting the device in the heart is likely a better strategy for reducing stroke than just using anti-clotting medication, such as aspirin or Warfarin.

"It's not formally a positive trial; it missed the primary endpoint," Saver said in a telephone interview.

Results of the trial were published in the New England Journal of Medicine.

The study showed a 51 percent reduction in stroke in the group of patients who got the device versus those who were treated with drugs.

The goal of the study had been to detect a 75 percent reduction in stroke, he said.

"That was an over optimistic goal to reach for," he added.

There is still evidence of superiority, and so some doctors might use the PFO closure device because it allows patients to rely less on anti-clotting drugs, which carry a risk of bleeding.

Saver said doctors estimate that medication alone cuts the risk of stroke by 20 percent to 60 percent in patients who have PFO. The risk is only an estimate because it never has been studied for ethical reasons.

In a prepared statement, St. Jude said the Respect study provides "compelling evidence" that its device, called AMPLATZER PFO Occluder, is superior to drugs.

"The totality of evidence from this study, including the strong performance and safety profile of the device, demonstrates the compelling clinical benefits of closure versus medical management in reducing the likelihood of recurrent stroke in this patient population," Frank Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division, said in an emailed statement.

The device won European regulatory approval in 1998. It is available in more than 60 countries outside the United States, including Canada, Latin America, Europe, Australia, Asia and the Middle East.

(Reporting By Debra Sherman; Editing by Kenneth Barry)