An Engineering Feat Gives Hearts Extra Life

With the release of their new HeartAssist5 heart pump, ReliantHeart is making real-time, personalized feedback possible for the millions of Americans suffering from heart failure. The new technology allows for real-time, remote monitoring of implantable devices, years of added life for patients, and flexibility to travel without a physician nearby. With a staggering projected 46% growth in heart failure by 2030, advances in heart failure innovation are on the forefront of changing medical treatment, policy, device research and physician reimbursements. Further, with heart failure and disease disproportionately affecting minorities in the US, advances in length and quality of life could be huge strides for medical equality.

Heart Failure In America

Approximately 7.5 million people in the United States currently suffer from heart failure, a figure that is increasing over time as more people survive heart attacks and various other heart conditions. According to the Heart Failure Society of America, an estimated 400,000 to 700,000 new cases of heart failure are diagnosed each year, with deaths averaging 250,000 annually, more than double since 1979. Even worse, an estimated one half of heart failure patients die within five years of diagnosis and 20% within the first year.

With a waiting list for heart transplants at an overwhelming 3,736 at publication, and less than 2,500 hearts donated annually, the need for a bridge between heart failure and transplant is literally life and death.

LVADs

Left ventricular assist devices (LVAD) are implantable heart pumps that were created to temporarily support patients with advanced heart failure as the bridge between diagnoses and transplant. However, with new scientific advancements, LVADs are becoming a long-term tool for improving heart function without transplant.

The right ventricle pumps blood to the lungs, but the left ventricle is responsible for pumping blood to the rest of the entire body, making it much more susceptible to failure. Therefore, LVADs have been the focus of most modern research to prolong and improve life saving implants.

Patient-Centered Care

Reliant’s system acts like your car’s dashboard. “If a patient’s pump has any sign of a challenge, like dehydration or low flow, the remote monitoring system signals the change to a data-collection center that notifies the transplant center as well as the individual,” ReliantHeart CEO Rodger Ford says. This is what makes the HeartAssist5 unique; at the first sign of a problem the right people are notified immediately.

Essentially, if the engine light goes on, the heart center and patient are notified to get the engine checked.

He also notes that the patients can set monitors to send text message notifications, thus making changes in blood flow, speed and power truly personalized. Individual blood flow is collected and transmitted every 5 minutes, making one’s own body the standard comparator.

The greatest importance to Founder and CTO Bryan Lynch is his ability to use his background as an engineer to, “Get involved in a project where you can actually see how you saved a life. While the docs and nurses are the real lifesavers, we give them the tool to make it possible.” He continues that it is vitally important for engineers and innovators to gain a patient-centered approach to get a real reduction in cost burden and improve quality of life.

Sailesh Saxena, CFO, continues highlighting the patient focus of the company by telling about the origination of the design of the VAD pack. “Bryan and I used to go to Schlotsky’s Deli ($BUNZ) for lunch,” he said, “and we used to see this man wearing a coat although it wasn’t cold out. Bryan noticed immediately that he was attempting to hide an LVAD controller and batteries. Well, this happened more than once, and we recognized that he was always concealing the VAD controller. So we decided that we needed to create a unique insert so that our LVAD control system could slip right into a Louis Vuitton ($LVMH) or Gucci ($GUC) bag unnoticed. It’s the small things that make the patient feel like we understand what they really want.”

Expanding The Geography Of Care

Remote monitoring, like other methods of telemedicine, is a key to expanding the geography of health care. “As technology matures, with the help of remote monitoring, the cardiologist and patient will feel safer with greater distances between them,” says Saxena.

This growth in telemedicine as a whole, and specifically in heart care, has major implications for the Centers for Medicare & Medicaid Services (CMS) as well as health care policy and reform. Because CMS is beginning to assign reimbursements and penalties based on patient outcomes instead of traditional fee-for-service metrics, it will become more and more important to have reimbursements reflect remote monitoring and its likely benefits.

Reimbursement codes also need to be reworked to genuinely target geographic discrepancies in care, which are fundamentally important for transplant centers. However, at present, CMS is slowly beginning to take growth rates of heart implants seriously based on the agency’s continued increases in payments, including their slight variations in geographic differences.

An Engineering Feat

In a recent study, researchers found that platelets flowing through the HeartAssist5 are exposed to significantly lower cumulative shear stress levels than in competitive devices tested. Ultimately, this means that the ReliantHeart product allows for what the CTO calls “a more physiologically normal cardiac output, including the pulse.”

What Bryan means is that people with failing hearts have low blood flow throughout the body, which is why they are so sick. When an LVAD is implanted, patients return to a more normal flow, but they also need blood flow that is as natural as possible. With the HeartAssist5, blood is not damaged and any pulse that the recovering heart produces is naturally transmitted to the body.

The LVAD and heart now work together to help the patient recover.

Although there are two other continuous flow LVADs on the market (THOR and HTRW), the ReliantHeart team claims their careful design capitalizes on working with the natural ventricle to the benefit of the patient, almost like a gym trainer for your heart.

Their “implantable flow probe” is also a revolutionary aspect of the HeartAssist5. This ultrasonic probe measures the blood flow from the LVAD in real-time providing critical feedback that is a one-of-a-kind technology providing data that makes the aforementioned remote monitoring so valuable. Ford says this ability to see patient-specific trends remotely in real time not only helps all patients improve quality of life, but the longevity of the HeartAssist5 creates a life support system, far beyond the “bridge” that the LVAD was originally created to be.

So this month, for American Heart Month, think about what innovation really is. It might be the ability to prolong and add quality of life for individuals and families across the nation, to share more time with loved ones.

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President Obama Fails To Explain Tech Glitches And Solutions In ACA Speech

Monday at 11:30am EST, President Obama spoke in the Rose Garden about the recent troubles with health insurance exchange enrollment and websites. With a team of young people standing behind him and Janice Baker at his side, the first person in the state of Delaware to successfully enroll in the exchange, President Obama said he was speaking to every American wanting to get affordable health insurance. He claimed that in the last three weeks, despite the horrific technological problems with the websites, that “half a million consumers across the country have submitted application through federal and state marketplaces.” He further touted that the “federal site alone has been visited 20,000,000 times” in the last three weeks. Unfortunately for those American’s who are really interested in signing up on the exchange sites, he glossed over the depth and breadth of the current troubles, giving a speech that sounded more like a State of the Union address with small-business examples and reading letters written to the White House.

President Obama also alleged that no one wants to see the exchange sites improve more than the federal government, noting that, “the website has been to slow, and people have been getting stuck during the process.” He also said that it is the mission of the administration to make them “more better,” with visible cringing from the audience, but claimed failures were due to response rates. He said the public response was “overwhelming, which has aggravated the underlying problems.”

However, he failed to go any further to explain what those other underlying problems were or when specifically they will be fixed. He did say that while HHS and contractors such as CGI Federal are working out the “kinks,” American’s should be patient. He claimed that “if the product is good, [American people] are willing to be patient,” suggesting that there will not be a delay for the individual mandate.

Nevertheless, he followed this by assuring the public that unlike Black Friday sales, the insurance plans will not run out like purchasing a new PlayStation – adding to the list of items the administration has compared exchange sites to, including iPhones and travel websites.

Despite his promises of improvements and putting the “best and brightest” on the job, CNN and other sites have insisted that the inherent technological and platform problems with Healthcare.gov will not be resolved anytime soon. This begs the question, that if the federal government is now searching for the best and brightest to correct the estimated 5,000-5,000,000+ lines of coding that need to be fixed on the federal site alone, who was working on the original platforms?

As he continued his speech, the President reminded the American public that although the websites for enrollment are not as, “quick, consistent or efficient as we want,” that the exchange sites are far more than “just a website.” He noted that many pieces of the Affordable Care Act (ACA) are already in place and being utilized by millions of Americans. He addressed pre-existing conditions, youth under the age of 26 and several other provisions that are already being rolled out by federal law, and the successes they have seen there.

He noted more examples of ACA triumph in Oregon, where he maintained that the exchange, “has cut the number of uninsured people by 10% in three week,” which is about “56,000 more Americans” with health insurance coverage.

During the speech, President Obama also tried to clarify the exchanges or marketplaces by describing them to the public as becoming part of a “big group plan… that bargains on your behalf for the best deal in health care.” He said that by doing so, insurance companies have created new products and options that strengthen market forces, leading to better deals.

He went on to say that without a doubt, “prices have come down,” further claiming that “when you add the next tax credits (those not yet implemented)… then the prices come down even further.”

The President rounded out his talk by noting the Republican party’s opposition to the ACA and how willing they were to “shut down the global economy” to fight against the ACA. A move, he claimed, that shows just how unwilling Republicans are to negotiate on legislation intended to, “free families from the pervasive fear that one illness one injury will cost you everything.”

While that may be the goal of the Affordable Care Act, the underlying technological and coding problems may prove to make that impossible.

 

Closing Racial And Ethnic Disparity Gaps: Implications Of The Affordable Care Act

For all intents and purposes, the Affordable Care Act (ACA), the President’s signature piece of legislation, will provide more health care coverage to poor and underserved populations. Persistently disadvantaged communities have much further to go than those with insurance, and new means of accessing and paying for care will benefit them disproportionately. Nevertheless, with more than 20 percent of the nation’s Black population uninsured, more than 30 percent of Hispanics uninsured and a country still grappling with understanding and properly addressing disparities, just how far does the ACA take us?

By mandating individual health insurance coverage and expanding the list of covered preventative services, ACA legislation should, theoretically, improve the quality of health care for those populations at disproportionate risk of being uninsured and having low incomes. In advance of the January 2014 start of major health reform initiatives, some estimate that more than half of the uninsured will gain insurance coverage.

However, research has shown that having health insurance itself does not have a substantial impact if people cannot find a doctor to see them, do not have proper information about accessing resources, or are not treated in a culturally and environmentally competent manner. Moreover, when the number of uninsured could be decreased by more than half, but being uninsured is not equitable across racial and ethnic groups in the US, what happens to our countries most vulnerable?

It has been well documented that low-income individuals and those without employee-sponsored insurance (ESI) are more likely to be people of color. Kaiser and US Census estimates indicate that there are significant differences in insurance rates by race and ethnicity, with national averages approximating there are almost three times as many uninsured Hispanics as Whites. In Louisiana, for example, it is believed that more than 50% of the state’s Hispanics are uninsured, while only 18% of Whites are. In the same state, it is estimated that 30% of Blacks are uninsured, reiterating just how unbalanced our country remains and how terribly far we have to go to eliminate inequalities.

The oft-cited example of health reform success is Massachusetts, where Blue Cross Blue Shield 2013 estimates indicate that about 97 percent of the state’s population has health insurance thanks to health reform. While this is a grand feat for gaining an insurance card, insurance alone does not constitute affordable, quality care, or improved long-term health and equity. The real successes come from improved statistics on accessing care, preventative care and disease reduction.

For those looking to Massachusetts, data does support a slight improvement in overall access to care by showing that Whites, Blacks and Hispanics all had increases in the number of insured, and further that the percentage of the state’s population that had “any doctor visit in prior year” between 2006 and 2009 rose by more than five percent.

Unfortunately, as many have argued, those for and against health reform, Massachusetts is not necessarily a good representation of other US states or populations, as anyone who has been to Massachusetts knows that the state population looks and behaves very differently from places such as southern California or the Southside of Chicago. Furthermore, even in Massachusetts the number of Blacks and Hispanics that remain uninsured is two and three times that of Whites, respectively.

Many of those who will be left uninsured will be Blacks, immigrants and Hispanics, who will continue to use Emergency Departments for critical care or, worse, go untreated.

Additionally, there are those who are lower middle class (a growing group in this nation) who fall into the economic gap where they cannot afford the employer/exchange insurance offered to them, but earn too much to receive subsidies for offsetting the mandatory cost of insurance, which are often people of color.

Other groups of concern are those minorities who do not have the knowledge of where to access care, do not have the financial or transportation means to access care or still distrust the system due to systemic problems with culturally competent care.

Although the ACA takes us a step forward in giving many of the countries uninsured an insurance card, the US must address what to do about probable provider shortages that will result from a lack of primary care physicians and different utilization in care. We must be prepared to understand both to cultural differences in demand and pent-up demand of the previously uninsured, as well as start to really face how to deal with persistent racial and ethnic inequality in this nation that shows itself in our health care system every day.

In the coming weeks, months and years the US citizens have to do more than champion or attempt to repeal the ACA. Party lines and moderate attempts at change will never fix our broken health care system. We have to start addressing the real issues our country faces, those of injustice, unequal access and treatment and how we properly care for and address the needs of those who are not White and wealthy.

 

High-Risk Pools and Reinsurance: Potential Shock Waves to Insurers

Due to poorer health, higher cost services and pent up demand for health care, there are numerous concerns about high-risk and expensive individuals. These are people who were previously uninsured or enrolled in high-risk plans that will soon be covered by exchanges. Further, there is concern that premiums could skyrocket in 2014 if the unhealthy disproportionately move to exchanges for coverage while younger, healthier individuals slowly and cautiously join.

The Affordable Care Act was partially designed to mitigate these concerns. One method in particular is aimed at spreading the risk amongst the individual market for the first three years through “reinsurance”.

The initial description of reinsurance was that all insurers would be responsible for paying into the program.  Insurers were eligible to get funds in return, if a large portion of their enrollees were high-risk and expensive. The plan was designed to pay out $10 billion in year one, $6 billion in year two and $4 billion in year three to insurers of high-risk plans, incentivizing them to phase in their high-risk (and higher cost) individuals onto the exchanges.

The goal was to keep the individual market premiums low by balancing out costs in the exchanges, so that the young and healthy would equally participate. The gradual transition would give further funding to insurers to support their high-risk population, hopefully, mitigating the obvious discrimination of not allowing those high-risk persons equal, free market participation in the individual market.

Recent changes made by the federal government however, now have states and insurers concerned about the program they are required to pay into and get funding from, once the health care law takes effect.

The Department of Health and Human Services (HHS) has released regulation clarifying that state high-risk pools are no longer eligible for the return of funds, and that the government money will not be given for anyone with medical costs  around$60,000 per year. This shifting of incentive has many health policy analysts worried that states now have no reason not to dump their high-risk pools onto the exchanges on opening day.

Under the new regulations it actually makes sense for insurers to move high-risk enrollees as quickly as possible to get larger shares of the reinsurance funds. Therefore, insurers like the Blue Cross Blue Shields of the world will most likely have to ask HHS for more flexibility, and perhaps assistance during the transition period.

Reinsurance was anticipated to slowly maneuver high-risk people from the state’s pre-existing condition plans and high-risk pools plans onto the exchanges in a manner that prevented a substantial jolt to the individual market. However the recent clarification may actually have the opposite effect on its intended goal, forcing insurers to quickly move high-risk individuals en masse to the exchanges. This drastic shift in health care dollars may in fact destabilize the individual market, rather than slowly coaxing a change.