Sunday, June 2, 2013

Consumer-driven Healthcare Leads to Reform, Innovation

Even as the U.S. begins implementation of one of the most comprehensive healthcare policies ever passed, Regina Herzlinger, a professor at Harvard Business School and long-time advocate of consumer-driven healthcare, argues that policy cannot fix the broken healthcare system. According to Herzlinger, it will be consumer-focused entrepreneurial innovation that fixes the system -- providing that politicians, providers, insurers, and others with vested interests in the status quo get out of the way.
Speaking at the 2013 Mark McKenna Lecture, which was hosted by the Health Sector Supply Chain Research Consortium, a research group within the W. P. Carey School of Business, Herzlinger said that while the Affordable Care Act has expanded health insurance coverage, in terms of cost, quality, and access, healthcare in the U.S. is still poor. “And that’s not going to change unless we move out of the status quo healthcare system.”
“Innovation,” Herzlinger said, “can help us do that.”
The problem, part 1: Costs are still rising
Of the three issues Herzlinger identified as serious problems with the status quo healthcare system in the U.S., one is cost. The rate of growth of healthcare spending “vastly” outstrips growth in GDP. “We currently spend about 18 percent of GDP on healthcare, and we’re heading for 25 percent.”
More significantly, Herzlinger said, is the fact that labor productivity of healthcare is negative. “That means the more money we pour into healthcare, the less we get out of the system. And that is a very serious economic problem.”
Then there is the issue of huge unfunded Medicare liabilities. In 2009, Medicare unfunded liabilities totaled $89.3 trillion -- meaning that the government has promised almost $90 trillion in Medicare benefits that it has no way to pay for.
The problem of rapidly rising healthcare costs, negative labor productivity, and unfunded Medicare liabilities is compounded by how we pay for healthcare. “The primary payers of healthcare costs are employers,” Herzlinger said. In contrast, she advocates a “consumer-driven” system in which the consumers of healthcare are the ones who pay for it.
“Right now I am oblivious to the cost of care because my employer pays it. If I were to know and be able to control what I pay for healthcare, then I might not want every procedure under the sun. What's missing is real competition, and we won't see it as long as consumers are oblivious to the cost of their healthcare.”
The problem, part 2: Quality is still poor
In addition to the problem of the cost of healthcare is the quality of it. “The quality of healthcare in the U.S. is really unknown,” Herzlinger said. “As consumers of healthcare, we don’t know much about what we’re buying. Quality is reputational -- we go to one hospital or doctor because our neighbor said they were good.”
Even more problematic, Herzlinger said, is that current measures of healthcare quality are based on processes, not outcomes. “Entrepreneurial innovation has a hard time emerging in the science of medicine because we measure quality on whether A, B, and C procedures were done, not on the outcome of those procedures. So if someone thinks X, Y, and Z procedures would yield a better outcome, it’s very hard for them to break in.” In that way, Herzlinger said, “Medicine is notorious for obstructing innovation.”
The problem, part 3: Access is still limited
While the number of insured people in the United States has increased through the expansion of Medicaid, Herzlinger said, “It’s not clear that Medicaid is better than nothing.” Medicaid enrollees, she said, get worse care than patients with commercial insurance or enrollees in Medicare.
“The U.S. public healthcare system provides poor quality care,” Herzlinger said. That’s not a problem limited to America, but in other countries patients have something many Americans don’t: choice. “Brazil has universal coverage, but 45 percent of Brazilians have private insurance. In France and Spain, more than a third of people opt for private insurance over public insurance because they get better access.”
In those countries with national healthcare systems, Herzlinger said, “Public policy still doesn't provide the answer; it doesn't control cost, and it doesn't improve quality.”
Innovating the U.S. system
Controlling cost and improving quality and access, Herzlinger said, requires entrepreneurial innovation to completely overhaul the status quo healthcare system in the U.S. That means changing both the demand for and supply of healthcare, starting, she said, with giving consumers more choice.
One way to do that is to establish exchanges (just a fancy word, Herzlinger said, for markets). She said that such markets have been transformational for other industries. “As the air travel industry, for example, became more competitive and more consumerized -- as people could go online and choose from among a range of airlines -- the price of travel dropped,” Herzlinger explained.
Health insurance exchanges, Herzlinger said, will offer new types of policies. Those new policies will feature health promotion, high deductible options, medical travel, and bundled care.
“When we stay healthy, our healthcare costs are lower, so why shouldn’t we get paid for it?” Herzlinger asked. So new policies with health promotion features give insured individuals points for eating healthy, working out, and keeping chronic conditions like diabetes under control. “This type of health promotion changes behavior tremendously,” Herzlinger said. “It’s good for the individuals, and it’s good for the system.”
High deductible options, Herzlinger explained, have been shown to keep healthcare costs down, without sacrificing health. “They get the best value for the money.”
Health insurance policies with medical travel options will offer premium reductions to patients who choose to receive elective procedures in lower-cost locations (internationally and within the U.S.).
The most important feature of new health insurance policies, Herzlinger said, will be bundled care for chronic diseases. “Chronic heart failure, for example, has 34 common co-morbidities (co-occurring conditions like kidney disease, diabetes, and depression). The way it is now, that patient has to see 34 different doctors, all with records in systems that don’t talk to each other.”
In contrast, bundled care would provide all chronic heart failure-related care (including care for those related conditions) for a fixed price, within one system. “You could have a lot of competitive organizations focused on providing bundled care, and that would drive down the cost and improve the quality of care.” Herzlinger cited one study which found that if care were bundled, the cost of chronic heart failure care would be 2.5 times lower, and quality would be higher.
The second key to getting out of the status quo healthcare system in the U.S. is changing how healthcare is supplied, Herzlinger said. One supply change, she said, is to provide better-value alternatives, such as retail medical clinics, which offer much lower prices than doctor’s offices and urgent care centers.
Retail medical clinics typically treat patients who don’t have a primary care doctor -- those who are otherwise underserved. And, led by Walgreens, they’re moving into chronic disease management. “That’s a great idea from a public health perspective,” Herzlinger said, “because they’re providing management of self-care in a community setting” -- again, higher-quality care at a lower cost.
America’s global competitiveness is at stake
While Herzlinger had very little good news to share about the current state of healthcare in the U.S., she said that this is an “exciting time” in healthcare “because the system can’t stay the way it is, and there are great opportunities for smart people to make great changes in demand and supply.”
The importance of innovative change in the U.S. healthcare system is hard to overstate, Herzlinger said. It’s an issue of global competitiveness. “We need leaders with the spine to take on the oligopolistic hospitals, intent on maintaining the status quo, which are very dangerous to the U.S. economy. If our leaders don’t, then the U.S. economy doesn’t have much of a future. Healthcare costs will cripple business here.”
Bottom line:
1. The Affordable Care Act has expanded health insurance coverage but in terms of cost, quality, and access, healthcare in the U.S. is still poor.
  • Cost -- Healthcare consumes an increasingly large percentage of our income; the more we put into the system, the less we get out of it; huge unfunded Medicare liabilities will burden future generations; and consumers are insulated from cost because employers (or the government) pay for our healthcare.
  • Quality -- We don’t really know the quality of the medical providers we choose, our choices are largely based on the provider’s reputation; plus, current measures of the quality of healthcare are based on processes, not outcomes (which stifles innovation).
  • Access -- Medicaid enrollees get worse care than patients with commercial insurance or enrollees in Medicare.
2. Innovation in demand will include health insurance exchanges -- markets that will offer new types of policies, featuring health promotion, high deductible options, medical travel, and bundled care to reduce cost and improve quality and access.
3. Innovation in supply will include providing better-value alternatives, such as retail medical clinics, which offer much lower prices than doctor’s offices and urgent care centers.

The Power of Technology Can Transform Healthcare and Save Lives

Posted: 05/31/2013 9:16 am
Olivia "Bing Bing" Mann was a tiny infant with a complex, but treatable heart disease. From her home in a Chinese orphanage, it appeared virtually impossible for Bing Bing to receive the medical attention that she so urgently needed. But the London-based Swinfen Charitable Trust intervened and - utilizing the latest in telemedicine technology - was able to link baby Bing Bing with Dr. Karen Rheuben, one of the world's foremost experts in pediatric cardiology. From her offices halfway around the world, Dr. Rheuben, the director of the University of Virginia Center for Telehealth, virtually provided local caregivers with guidance on how to treat Bing Bing, who underwent the first in a series of life-saving surgeries. Today, Bing Bing is a thriving, happy three-year-old living a fuller and healthier life with her adoptive family in Pennsylvania.
Bing Bing's story reinforces that, despite the myriad of challenges facing our healthcare system today - including rising healthcare costs and the lack of quality and access to healthcare - there is a tremendous opportunity to use new technology tools to transform the way healthcare is delivered, especially to those most vulnerable - children, women and seniors - in remote or rural areas.

One of the ways we can speed this process is by putting next-generation technologies - like the power of cloud-based telemedicine - into the hands of innovative organizations, like the Swinfen Charitable Trust, who can help address these pressing social challenges.
Swinfen Charitable Trust has an established network of hundreds of renowned physicians around the world. These medical professionals volunteer their time to provide free consultations to healthcare workers in rural or remote parts of the world so these providers may, in turn, treat patients for an unfamiliar illness. And the Swinfen volunteers are able to deliver this expert care from anywhere in the world because of technology: mobile-based telemedicine and a secure, medical-grade cloud for the storing and exchange of patient health information and case referrals. And this is the tip of the technology iceberg.
It is important that companies continue to partner with innovative healthcare nonprofits and programs like these, to help them further expand telemedicine into developing countries where it can give patients like baby Bing Bing a chance to live.
Verizon's partnership with Swinfen Charitable Trust and the University of Virginia Health System allows healthcare workers to send patient information - including photos, X-rays and medical histories - through a secure, Internet-based messaging system to a network of more than 500 specialists across the globe to get more information and direction on care.
Telemedicine has been an effective healthcare resource for the last 25 years in countries with more developed healthcare infrastructure. In the last decade, the use of wireless networks and devices in telemedicine applications has become a critical link in reducing the tremendous disparities in global public healthcare access and delivery. These technologies are innovative in their simplicity and their potential. By utilizing existing networks and the cellular technology that is already in use by millions worldwide, we can deliver quality healthcare that is medically, culturally and socioeconomically relevant to patients. By delivering healthcare and health education via the same device that patients use to communicate with their loved ones and communities, we have the opportunity to improve health outcomes from the ground up by impacting the healthcare delivery system and its ability to scale to meet patient and disease demands.
By using existing wireless and broadband capabilities, we can lay the foundation for the medical experts who can really get this transformative work done. It is all about collaboration that steps outside of the research space into public-private partnerships to identify the most promising healthcare solutions and deliver the most powerful answers. Together, we can uncover new ways to use technology innovations to address society's deepest needs and continue to break through healthcare barriers.
This article is the second in a series covering the topics and initiatives discussed at the Social Innovation Summit, a private, invitation-only forum that explores "What's Next?" in the world of social innovation. For more information on the Social Innovation Summit please visit socinnovation.com. For real time updates on announcements and attendees follow us on Twitter at @socinnovation.

Parkland Memorial Hospital pays nearly $1.4 million to resolve allegations it submitted improper physical medicine and rehabilitation claims


By U.S. Department of Justice
Jun 2, 2013

DALLAS - Dallas County Hospital District d/b/a Parkland Health and Hospital System (Parkland) settled allegations it violated the civil False Claims Act and Texas Medicaid Fraud Prevention Act, announced U.S. Attorney Sarah R. Saldaña of the Northern District of Texas. The U.S. and Texas contend Parkland caused unallowable and “upcoded” physician consultations and other services to be submitted to Medicare and Texas Medicaid for certain physical medicine and rehabilitation (PMR) related items and services between 2007 and 2011. Parkland fully cooperated with the investigation, and by settling, did not admit any wrong-doing or liability.
When patients are admitted to a hospital, specialists, like PMR physicians, often consult with the attending physician on a variety of issues. At teaching hospitals, faculty physicians may bill for the supervision of residents, if present for the key or critical portions of the services. In both cases such consults, if medically appropriate, are reimbursed by Medicare and Texas Medicaid. The United States and Texas based their investigation on allegations that Parkland submitted or caused the submission of false and fraudulent PMR claims, and false statements in support of such claims, to the Medicare and Texas Medicaid programs between 2007 and 2011 for: (1)consultations that were never requested by a patient’s treating physicians and/or lacked medical necessity; (2) services related to the inappropriate supervision of residents and/or lacked medical necessity; (3) up-codeaninflated evaluation and management services; (4) inpatient rehabilitation stays that did not meet billing requirements; and (5) other unreimbursable costs.
The U.S. and Texas initiated the investigation in response to a March 2010 whistleblower suit brought by Lien Kyri, M.D., a former resident in the PM&R department, UTSW Medical Center at Dallas. Under the False Claims Act and Texas Medicaid Fraud Prevention Act, private individuals may bring actions alleging fraud on behalf of the U.S. and Texas and collect a share of any proceeds recovered by the suit. Dr. Kyri may receive up to 30% of the recovery under the settlement. U.S. Attorney Saldaña praised the efforts of the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) and the Texas Medicaid Fraud Control Unit. U.S. Attorney Saldaña also noted “this settlement demonstrates the Northern District of Texas, and the entire Department, remain committed to investigating allegations of health care fraud, regardless of provider or affiliation.” “Any time false claims are submitted for payment, the nation’s taxpayers and health insurance programs suffer,” said Special Agent in Charge Mike Fields of the OIG’s Dallas Regional Office. “Our agents will continue working to identify providers who manipulate the system to grab precious Medicare and Medicaid dollars to which they are not entitled.”
In addition to paying nearly $1.4 million, Parkland agreed to enter into with the OIG a five-year corporate integrity agreement (CIA) in exchange for release of the agency’s administrative remedies. The CIA requires Parkland to enact and report to the OIG its compliance with billing rules, but also will monitor Parkland to ensure patients receive appropriate care.
The case was handled by Assistant U.S. Attorney Sean McKenna and Assistant Texas Attorney General Paula Juba. The case is captioned United States ex rel. Kyri v. Dallas County Hospital District d/b/a Parkland Health and Hospital System, et al.; Civil Action No. 3:10-cv-0487-D (N.D. Tex.).

Medicine looks to industries for inspiration




 Connected coverage — selected articles on trends, challenges and controversies in the changing world of medicine.

Posted April 22, 2013
When physicians, hospitals and health systems encounter systemic problems that might lead to inefficient or substandard patient care, they don't always look within to find solutions. In some cases, the ways that nonmedical industries have changed their practices to boost quality, safety or efficiency can provide valuable examples that doctors and other health professionals can adapt to their own situations.
American Medical News has shed light on several instances in which the medical system has borrowed expertise and best practices developed by experts in other occupations that at first glance might appear to be completely unrelated. It might come as a surprise that the lessons learned by professionals overseeing car assembly lines, racing vehicle pit lanes and airplane cockpits can be used to improve medical care. Although they are not perfect analogies, champions of the approaches say the evidence is clear that adapting these solutions thoughtfully can save time, money and lives.

Cardiac treatment improves after taking page from Toyota playbook

The use of “lean management” principles, which focus on boosting productivity through reducing variation and waste, helped make the Toyota Motor Corp. the world's largest automobile manufacturer. New research shows that the principles also are working for hospital interventional cardiac care units, where lean management has entailed standardized admission order sets, immediate alerts for cardiac catheterization teams and regular monitoring of clinical procedures.

Doctors use Formula One pit crews as safety model

Racing pit crews help their drivers shave valuable seconds off their times through precision and near-perfect synchronization, with the overarching goal of keeping everyone at the track safe in the process. Following the crews' example, U.S. and British hospitals use similar elements of team leadership, situational awareness and data checklists to cut down on the rates of potentially harmful errors when handing off surgery patients to recovery settings.

Patient safety: What can medicine learn from aviation?

Many believe aviation safety principles such as adherence to checklists, crew resource management and anonymous incident reporting hold great potential for adaptation to the field of medicine — and in some ways they already have been adapted. But some experts caution that patients are not airplanes, and attempting to copy aviation's example without applying those skills to a particular process of medical care will not necessarily yield the results that everyone wants.

ACA data “dashboard” will track chronic conditions




NEWS IN BRIEF
The Centers for Medicare & Medicaid Services on March 28 announced that it was employing a new data tool to advance the health system reform goals of helping Medicare beneficiaries with multiple chronic conditions.
CMS said the new “dashboard” would make it easy for physicians and others in the health system to find current information on where these types of conditions take place, what services these beneficiaries need, and what Medicare spends on them. In 2011, the program spent about 93% of its funding, or $276 billion, on beneficiaries with two or more chronic health issues.
The dashboard is part of a larger initiative, begun in 2009, by the Dept. of Health and Human Services to improve the health of people with multiple chronic conditions.
The majority of Medicare beneficiaries have chronic diseases such as diabetes and heart disease, “and that number will rise with an aging population,” said Marilyn Tavenner, CMS acting administrator. “The Affordable Care Act addresses these health problems by making people with Medicare eligible for recommended preventive care without Part B deductibles or co-payments. The health care law also promotes better health care coordination and management of chronic conditions through analysis of current data.”

Will patients trade human imperfection for computerized perfection?


The Atlantic this week published a provocative article entitled “The Robot Will See You Now.”  Using the supercomputer Watson as a starting point, the author explored the mind-bending possibilities of e-care.  In this near future, so many aspects of medicine will be captured by automated technology that the magazine asked if “your doctor is becoming obsolete?”
The IT version of health includes continuous medical monitoring (i.e. your watch will check all vital functions), robotic surgery without human supervision, lifelong personal database with genetic code core and intensive preventive care modeled for each person’s need; all supervised by artificial intelligence with access to a complete file of medical research and findings.  The e-doctor will never forget, never get tired, never get confused, never take a day off and will give 24/7 medical care at any location, anywhere in the world, for a fraction of the cost. Perfect care, everywhere, at every moment, for a pittance.
While the transformation for doctors seems clear, a shift from being at the core of medicine to being what the article described as “super-quality-control officers,” what intrigues me is not how doctors will change (retire); the real question is how patients will adapt to this new healthcare world?  Particularly when experiencing extreme or life threatening illness, will patients accept that family, friends and a pumped up iPad are enough?
150 years ago doctors had little actual healing to offer, so what they gave was themselves at the bedside.  In our romantic memory of that time, patients expected professional compassion, gentle wisdom and personal support.  With the medical revolution of the past century, doctors now have a great deal more true care to offer.  However, that focus on science has resulted in patients expecting professional distance, fragmented communication and, no matter what passion a physician may hold in his heart, a lack of effective compassion at the bedside.
This next step in health evolution may completely remove the human provider from care and thus a vital question must be whether patients fighting extreme illness will trade human imperfection for computerized perfection?
It seems bizarre to consider a world where a patient dying of cancer, on hospice, would receive care supervised by machine.  But, once we trusted our hard won dollars to a person called a banker, thought the self-checkout-line at the market was insulting, actually shopped at stores, traveled in airplanes flown by men, bought or sold stock certificates representing value, could read a map and predicted the weather by the color of the sunset, not by satellites flying far above the sky. Once, the couple I saw get engaged on bended knee by the fire, spent the rest of the night dreaming and staring into each other’s eyes, not texting on smart phones.
Perhaps the privacy, freedom and quality promised by the e-hospice-doc, means its organic ancestor is doomed as the dinosaur.  Patients will get perfect care at home with the one’s they love, and avoid physician office waits and emergency room indignities, comforted by computer screen reassurance and synthetic GPS-like voice.  But, on that day, when that first patient dies with dignity, gently and quietly supervised by monitor’s glow, I will wonder whether doctors are the only thing that has become extinct.
James C. Salwitz is an oncologist who blogs at Sunrise Rounds.

How Are Visual Illusions Used In Medicine And Arts And What Was Their Role In History?

01 Jun 2013 

A conference at the University of Leicester will explore the medical, psychological, historical and religious uses of visual illusions

Experts from around the world are set to gather in Leicester to discuss how optical illusions have played an important part in medicine and art through the centuries.

A University of Leicester conference will assess visual illusions throughout history in light of recent findings which show that visual illusions can alter brain function and pain.

Visual Illusions - past, present and future use will be held at the University's Bennett Building on Friday, 7 June.

This conference will bring experts from around the world together to examine the medical, psychological, historical and religious use of visual illusions, and their influence on the arts and society.

Examples to be considered at the conference include:
  • Mirror therapy - where a mirror is used to help treat people with phantom limb pain. This occurs when patients feel pain in a limb after it has been amputated - and helps to ease the pain in their "phantom" limb. It also helps in other pain conditions and in stroke to improve movement
  • Rubber hand illusion - in which a dummy hand and a patient's own hand are stroked in the same way simultaneously, which can lead the person to feel that the dummy hand is their own
  • Hallucination and illusion theories in the 19th century - a period which gave rise to secular, psychical and spiritual theories about illusions that influenced the development of modern psychological and psychotherapeutic theories, and what the brain does when we look at art and architecture
The event has been organised by Professor Steven King, Acting Pro-Vice-Chancellor and Head of the College of Arts, Humanities and Law and Director of the Centre for Medical Humanities and Annegret Hagenberg, Research Fellow of the Centre.

The day will feature talks from academics from around the world - with keynote lectures from Dr Melita Giummarra, of Monash University, Australia, Professor Eric Altschuler, of New Jersey Medical School, USA and Dr Nick Holmes of the University of Reading.

It will also feature demonstrations of the illusions - which guests will be able to participate in.

There will be performances by the IMCO improvisational dance company, and the event will also feature an exhibition of artwork around the topic of visual illusions.

Annegret Hagenberg, Research Fellow of the Centre for Medical Humanities, said: "This conference aims to achieve a more complete understanding of Visual Illusions in the Arts and Science, and to point the way forward to research in this field.

"It brings together distinguished researchers in the fields from three different continents who are involved with Visual Illusions in Neuroscience, Psychology, History, Arts, Sociology and the Medical Humanities themselves, creating a network for progress in research and clinical application for the benefit of the public and people suffering from pain or motor impairment.

"We will hear, for example, how during the 19th century many theories about illusions emerged and influenced modern psychology and psychiatry as well as literature and the arts and how modern neuroscience was applied by Old Masters of Art.

"More recently, with the discovery of mirror therapy by Professor V.S. Ramachandran and the further use of mirrors to regain function in stroke by Professor Eric Altschuler who is a key speaker at our conference, the new understanding of the brain was accelerated: the brain is not hard-wired but very flexible and can be influenced with sometimes very simple tricks.

"This has opened new areas for research that are fascinating - such as the rubber hand illusion and transferring sensations to another person through the use of visual illusions. Dr Melita Giummarra and Dr Nick Holmes are expert researchers in this field and are both key speakers at the conference.

"Other speakers will tell us how the use of a simple mirror can have a huge effect in rehabilitation and modern technology takes this further into virtual reality and 3D set-ups to reduce pain and regain function.

"This conference will increase our understanding by looking at the topic from all these different areas. It is hoped that new insights will arise to benefit all: researchers, clinicians, and the interested public."

It will be held at the Bennett Building, University of Leicester, on Friday, 7 June. Bookings are taken up to 1 June here

References:
Source: University of Leicester
 Retrieved from

ENTREVESTOR: Exploring medical innovation

May 15, 2013 - 6:20pm BY PETER MOREIRA | ENTREVESTOR
In the midst of interviewing ABK Biomedical’s new CEO Pat O’Connor on the Halifax company’s direction, I realized that the story I should write was about O’Connor himself.
Last October, the company announced it had raised $1.25 million in funding from a variety of sources, and co-founder and chief scientific officer Daniel Boyd said, almost parenthetically, that it had also hired a new chief executive from Ireland, a man called Pat O’Connor, a former executive with Boston Scientific Corporation, a worldwide developer, manufacturer and marketer of medical devices.
When I finally interviewed him this month, I was astonished by his savvy and industry knowledge as he explained that ABK is at a critical juncture. The company, which is mainly focused on treating uterine fibroids, or benign tumours in a woman’s uterus, is now completing important development testing in preparation for applying for regulatory approval in Europe, the U.S. and/or Canada.
With the support of Springboard Atlantic, an organization that aids commercialization of university research, ABK a few years ago developed OccluRad — tiny bio-compatible glass beads that can treat uterine fibroids. About 40 per cent of women over 35 worldwide develop these tumours, and many require a hysterectomy. Yet radiologists are now tackling this problem in a minimally invasive manner by injecting beads into a target area and essentially blocking the area around the fibroid and starving it of blood.
The problem is that the beads now used in this procedure aren’t visible under fluoroscopy (an imaging technique that uses X-rays to obtain real-time moving images), so the radiologists have to introduce a dye that is visible to confirm that the right blood vessels are blocked.
ABK Biomedical’s innovation is the development of new particles, or to use the clinical term, radiopaque embolic beads, that are visible under fluoroscopy so the dye is no longer needed. That reduces costs, makes the procedure quicker and eliminates the risk of a toxic reaction from the dye.
O’Connor explained that the company now has its corporate structure in place, has lined up manufacturers and partners and is now assessing where it should first seek regulatory approval. The options being assessed are the U.S., Canada and the European Union, or any combination of the three.
The company will begin design verification testing, which includes such things as pre-clinical study, bio-compatibility testing and design verification bench testing, in August, for completion around January 2014.
Preliminary indications reveal the company may be able to receive approval for some applications with rigorous pre-clinical tests rather than full clinical trials. That means regulatory approval in whatever market it chooses first could come in mid-2014.
However, O’Connor added that that does not mean the company won’t proceed with clinical trials later in 2014 — depending on a couple of factors. “Even if you don’t need it (a clinical trial) for regulatory approval, it’s very powerful in gaining market approval,” said O’Connor. Also, patients with uterine fibroids are otherwise healthy and this will drive the requirement for ABK to generate clinical data for regulatory approval in some regions.
What O’Connor was displaying was a knowledge of the medical device development understood by few people — if any — in the Halifax medical device community. For example, when we discussed the continuing research that Boyd and his team was doing at Dalhousie University, and how this could lead to new products, O’Connor explained the challenges of bringing a product from the R&D stage to the market. These include not only safety and efficacy, but the market opportunity, the routes to market, the cost of making the product and what price it could bring in.
The trick, therefore, is not just to develop a device that improves health outcomes and is safe, but also one that can be manufactured and sold with acceptable margins. Any technology selected for development within ABK will be assessed with all those factors in mind.
O’Connor, who has worked for such medical device giants as Boston Scientific and Stryker Orthopaedics, is happy to share his knowledge with others in the medical device community. He hopes to be involved in a biotech mentoring session to be held by Springboard Atlantic and First Angel Network, June 12 and 13, at the Innovacorp Enterprise Centre in Halifax.

Saturday, June 1, 2013

Do You Practice in a "Virtual World"?

If you are involved in the “Digital Delivery” of Medicine in anyway, please share your thoughts, Ideas and Experiences on the following:

 

·        Patient Centered Care

·        Best Practices

·        Consumer Engagement

·        The Experience of Care

·        Frustrations / Inspirations

·        Further Integration

·        Lessons Learned

·        Future Resources Need

Consumers want an alternative. Taxpayers are tired. Patients want privacy.

How Do We Integrate Digital Health into America’s New Delivery System?

OIG: Flaws in CMS databases threatens integrity of Medicare

The inaccuracy, incompleteness, and inconsistency of provider data maintained by the Centers for Medicare & Medicaid Services (CMS) could put the integrity of the Medicare program at risk, according to findings from the Office of Inspector General (OIG).

The office with the Department of Health & Human Services (HHS) reviewed information of Medicare providers stored in the National Plan and Provider Enumeration System (NPPES) and Provider Enrollment, Chain and Ownership System (PECOS). As the OIG notes, providers are required to supply CMS with their National Provider Identifiers (NPIs), which are maintained in NPPES, in order to enroll in PECOS. Programs such as the EHR Incentive Programs require that eligible professionals and hospitals to have active NPIs to qualify and participate.
So what did OIG find?
First, nearly half of all records (48%) in NPPES contained inaccuracies with close to one-tenth (9%) of records being incomplete. The most common inaccuracies were found to be the provider’s or practice’s mailing address (34.1% and 33.3%, respectively). Based on a survey of 126 providers, most indicated that their mailing addresses were outdated (51; 53%), followed by those indicating that information was never correct at all (27; 28%) or only partially correct (18; 19%).
Second, PECOS was also plagued by inaccuracies, mostly in the area of address data with less than four percent of provider records missing data. Fifty-percent of Medicare-enrolled providers in PECOS had records that were inaccurate, with the most common inaccurate variable being their primary mailing address (46.8%). Similar to findings for NPPES, the largest number of the 126 providers surveyed reported that this information was outdated (60; 57%), followed by those reporting that their information was partially correct (25; 24%) and never once correct (21; 20%).
These findings in particular pose a significant threat to Medicare’s integrity. “Addresses, which are essential for contacting providers and identifying trends in fraud, waste, and abuse, were the source of most inaccuracies and inconsistencies,” writes the OIG.
Third, the OIG found that provider data between NPPES and PECOS were inaccurate for nearly all records, a whopping 97 percent:
Of the 987,266 records for providers listed in both NPPES and PECOS, 961,634 contained at least 1 variable that did not match. Only 11,682 records (1.2 percent of the mismatches) could potentially be attributed to the timelag between updates of the databases. Only 3 percent of records contained information that matched across all selected provider variables. More than half of the records were inconsistent between the databases for provider contact information, such as practice location address (89 percent), telephone number (59 percent), and mailing address (51 percent).
Fourth, the OIG is reporting that CMS fell short of properly verifying provider information in both NPPES and PECOS although the federal agency has processes in place to do so. “CMS had processes in place to verify the accuracy of provider data in NPPES and PECOS; however, the manner in which CMS implemented these processes impeded efforts to ensure that the databases contained accurate information,” states the report.
The OIG is recommending that CMS work closely with its Medicare Administrative Contractors to implement program integrity safeguards and require greater verification of NPPES enumeration data and PECOS enrollment data. Additionally, the federal agency should review and correct data for new and established records. CMS agreed with all the OIG’s recommendations.

Volunteering Benefits Patients, Communities and the Docs Who Do It

FRIDAY MAY 31, 2013

Are you safe?
Have you eaten today?
Did you take your medication?
Those questions can be heard every day in any primary care clinic in the country, but they stopped me in my tracks when I heard them recently on a sidewalk in Washington, D.C.
In town to lobby Congress about physician payment and in the shadows of the U.S. Capitol, I heard those words spoken by a primary care physician tending to a homeless man on the city streets. For Catherine Crossland, M.D., medical director for homeless outreach services at Unity Health Care, working the streets of Washington with a backpack full of medical supplies is a regular part of her job. My brief glimpse of her inspiring work brought to mind how much good primary care physicians do every week through volunteering.
The AAFP's vision is to transform health care to achieve optimal health for everyone. Health care reform has expanded coverage to millions of people who previously were uninsured or underinsured. But even after the Patient Protection and Affordable Care Act is fully implemented, the number of Americans without insurance will still stand at 15 million to 30 million, depending on how many states fail to expand Medicaid coverage.
In other words, there are people who are falling through the holes in our health care safety net today and who will continue to do so for our foreseeable future.
We still have a job to do, in D.C. and in all our communities.
The uninsured and underinsured receive primary care in three places: community health centers, free clinics and through the generosity of physicians in private offices. In fact, the average family physician provides free or discounted care to eight patients per week.
The years I spent volunteering at the Stout Street homeless clinic in Denver were tremendously challenging and rewarding. Caring for the homeless raises questions we never had to consider in my then suburban practice. How do you dose insulin when the next meal is uncertain?
Of course, volunteering doesn't have to be anything as time-consuming as providing care at a free clinic. Family physicians make a difference every day in their communities, from making time to see the extra uninsured patient to teaching medical students in the office or presenting Tar Wars in the local schools.
During my Academy travels, it always amazes me to meet the innumerable family docs who make a difference even beyond their medical expertise by coaching youth sports or getting involved with their local school boards.
And the interesting thing is, when we help others, we are also helping ourselves. Volunteering enriches our lives in many ways. It connects us to others, refreshes our souls and even has medical benefits. Research has shown that people who volunteer have less depression and less stress than those who do not volunteer.
Thank you for what you do every day. Your patients, your community and you are healthier for it.

CMS Estimates Medicare Physician Payment Cuts, Outlines Cost-Containment Steps

CMS estimates that Medicare payments to physicians will decline by 10.6% below current levels on July 1 and by 15.4% below current levels on Jan. 1, 2009, under the current payment formula, CQ HealthBeatreports. The estimates were released on Friday in a letter from Jeffrey Rich, director of the CMS Center for Medicare Management, to the Medicare Payment Advisory Commission. The cuts reflect an increase in the volume of services provided by physicians that exceeds growth targets. 

Nancy Nielsen, president-elect of theAmerican Medical Association, in a statement on Friday said that lawmakers should "replace 18 months of looming Medicare physician payment cuts ... with funded payment updates that reflect medical practice cost increases," adding, "This sensible approach will give Congress time to work with physicians to legislate a solution to the long-term Medicare physician payment problem." Nielsen said that if the 10.6% cut goes into effect on July 1, about 60% of physicians say they will have to limit how many new Medicare beneficiaries they can treat, and more than half say they will have to reduce office staff.

Congress is working on a Medicare package that would block the cuts, according to CQ HealthBeat. One plan by the Senate Finance Committee would block all cuts in 2008 and 2009.

Rich in the letter also outlined steps CMS is taking to improve quality and efficiency, including:
  • Continuing and expanding the Physician Quality Reporting Initiative, which pays physicians an additional 1.5% of their billed charges for reporting quality-of-care data;
  • Implementing "structural measures," which include purchasing and using electronic health record systems;
  • Intensifying efforts to collect and share data on physicians' comparative costs to improve efficiency; and
  • Testing pilot programs, which currently include one that pays for efficiency in treating chronic conditions and another that develops medical homes for beneficiaries.
Rich in the letter wrote, "The real issue is how Medicare can rapidly transform itself from a passive payer for services into an active purchaser of high-quality care by linking payment to the value of care provided" (Reichard, CQ HealthBeat, 3/3).
HHS Denies Request To Halt Competitive Bidding 
In related news, HHS last week denied a request by the American Clinical Laboratory Association to suspend a pilot program that tests competitive bidding for Medicare clinical laboratory services, CQ HealthBeat reports. The three-year program will be tested in the San Diego market and affects any laboratory that has Medicare revenues above $100,000. The trade group requested that the pilot be suspended for a minimum of 180 days. Meanwhile, a lawsuit brought by clinical labs that aims to halt the program is pending (CQ HealthBeat, 3/3).

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