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Category Archives: ObamaCare

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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The Innovation Center Will Now Demonstrate.

There are many provisions in the Affordable Care Act that people don’t know about.  Everybody is familiar with the health insurance part of it, but did you know the Centers for Medicare and Medicaid services (CMS) is giving $10 billion dollars to an organization called “The Innovation Center”?  The Innovation Center is charged with researching ways to most effectively deliver health care. Good goal.   The center’s website says “The Innovation Center develops new payment and service delivery models”. Oh.  Well, still good goal.

Here’s what the definition of a “model” is, according the the free online dictionary: A schematic description of a system, theory, or phenomenon that accounts for it’s known or inferred properties and may be used for further study of its characteristics.  So a model is not the thing.  It’s a smaller or schematic representation of the thing.  So what the Innovation Center is supposed to do is find or come up with schemes of payment and service delivery and try them out.  It has been doing this, so far, largely with “demonstration projects”.  A demonstration project tests an idea or group of ideas that might improve either payment systems or delivery systems, and then uses some complicated math to determine if things were better or worse before and after the idea is implemented.  Therefore, CMS is not looking for proven methods of improving payment or services, but testing ideas that might work.

There’s nothing wrong with this, by itself.  My 2-year-old does this all the time.  She peers up at the kitchen counter, determines she can’t see, drags a chair over, gets on it, and compares the view with the chair vs. the view without the chair.  Over time this has allowed her to develop a policy of always getting a chair if she wants to see what I’m doing.  She wouldn’t go get the chair if I just said “be a good girl and go get a chair”  and then praise her and give her a cookies if she does it.  If you go the the Innovation Center website what you mostly see is incentive programs for good behavior.  For example: The Comprehensive Primary Care Initiative is one of the Innovation Center’s projects.  This is how CMS describes this program:

“The Comprehensive Primary Care (CPC) initiative is a multi-payer initiative fostering collaboration between public and private health care payers to strengthen primary care. Medicare will work with commercial and State health insurance plans and offer bonus payments to primary care doctors who better coordinate care for their patients. Primary care practices that choose to participate in this initiative will be given resources to better coordinate primary care for their Medicare patients.”

Here’s another:  The Physician Group Practice Transition Demonstration:

‘The PGP Demonstration was the first pay-for-performance initiative for physicians under the Medicare program. Under the PGP Demonstration, physician group practices continued to be paid under regular Medicare fee schedules, but earned incentive payments for offering patients high-quality, coordinated healthcare that resulted in Medicare savings for the patient population they served.”

Another, the Medicare Health Care Quality Demonstration, goes straight to performance measures.  Three hospital/physician care systems in the US are being given money to test ideas that will improve performance measures.  Performance measures are not “performance” measures.  They are “quality” measures.  Doctor’s get up on stage and perform certain things, and judges evaluate whether their performance is a quality one.  As I have said before, measures of quality are things that are easily measured, quantifiable, and easy to find in an electronic medical record.

OK, to summarize so far:  CMS, i.e the federal government, is funding the Innovation Center, which is supposed to find better ways to pay for and deliver health care, but which is mostly doing pay-for-performance stuff.  Fine.  There are some people doing some fine work in health care delivery who could use the funding.  Some people are complaining that all the studies that the Innovation center are doing are demonstration studies, not randomized controlled trials (RCT).  RCT’s are the medical gold standard for proof, essentially.  It’s not true until an RCT says it is.  Why isn’t the Innovation center doing more RCTs?

I postulate several reasons: 1.  RCTs take a lot of time.  CMS, under the gun from ACA opponents, wants quicker results.  2. A good RCT has a very narrow research question, usually one or maybe two interventions compared to no change.  The researchers have to settle on a promising intervention and follow it up long-term.  It’s hard to decide what promising intervention is going to give the best results given how long the question will take to answer.  3. There are so many moving parts in health care.  It’s very hard to control for everything.  Some large RCTs that have affected national policy, such as the Tennessee study in the 1980’s, which found that smaller class sizes in early childhood translated into better long-term outcomes, changed only one variable and kept everything else the same.  Tennessee public schools are a closed system with relatively little short-term variability and relatively predictable human behaviors.  An RCT that, for instance, studies the effect of a specific intervention on re-admission rates to hospitals has to deal with the variability of disease process and progression, human behavior, emergency situations, dubious quality measures, record-keeping inconsistencies, the list goes on and on.

So, should the Innovation center be doing RCTs?  Absolutely.  Is CMS funding the way to get that done?  Probably not.  But you have to give the ACA an A for effort on this one.

 

 

 
 

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The meaning of success

How should we define the success of the Affordable Care Act (ACA)? In recent months, news reports focused on the number of new enrollees as a key test of the law. Although the troubled performance of the healthcare.gov website during October and November delayed enrollment for hundreds of thousands of potential subscribers, Obama administration officials and Congressional Democrats hailed a surge in enrollment at the end of the year as proof that the law would fulfill its promise of providing affordable coverage to millions of uninsured Americans.

To date, enrollment numbers paint a decidedly mixed portrait of the ACA’s impact. Speaking on September 30, 2013, HHS Secretary Kathleen Sebelius declared that “success looks like at least 7 million people having signed up by the end of March 2014.” By late December, however, Sebelius hailed the fact that 2.1 million people had signed up for coverage through the new exchanges as evidence that the law was now working well. Earlier in the month, President Obama cited the increased pace of enrollment as proof that “the demand is there, and the product is good.” Even the most optimistic estimates, however, suggest that signups continue to lag far behind the administration’s own goals.

Obama administration officials responded to criticism about the widespread cancellation of individual insurance market policies in late 2013 by exempting millions of Americans who faced “unexpected natural or human-caused events” that prevented them from obtaining coverage from the individual mandate. Ironically, this decision, which sought to mollify Congressional critics and their outraged constituents, further undermines the prospects for meeting its enrollment targets and exacerbates an already serious credibility gap for Democratic candidates in the upcoming Congressional elections. Democrats continue to emphasize a “moving average” approach to measuring the success of the health insurance exchanges, pointing out that the pace of enrollments increased steadily once the website’s “glitches” were ironed out in late November. However, a failure to meet the administration’s own goal of 7 million new enrollees by the end of March 2014 will provide Republicans with a new policy story just in time for the 2014 campaign season.

Unfortunately for Congressional Democrats, increased enrollments did little to rehabilitate the image of the ACA in the eyes of the public. In a CNN poll released in on December 23, support for the law fell to 35% – a new low – despite significant improvements to healthcare.gov as a result of the “tech surge” in late November. The new polls highlight a troublesome trend for Democratic candidates who heed President Obama’s call to close ranks behind the ACA. Core Democratic constituencies now oppose the law, including 60% of women. Furthermore, in an ironic twist, 63% of those polled expected to pay more for health care after the implementation of the Affordable Care Act. In its current form, the ACA promises to be a millstone around the necks of vulnerable Congressional Democrats in 2014. Unless the Obama administration and other supporters of reform can reassure a doubtful public about the problem-solving capacity of American political institutions, the ACA may prove to be a classic Pyrrhic victory. In short, administration officials may win small battles over improving the performance of website, but lose the larger war over public support for government-led health care reforms.

The continued unpopularity of ObamaCare more than three and a half years after its enactment reflects a much deeper concern than simply website snafus or insurance cancellations. As I’ve argued elsewhere, ObamaCare has done little to restore public faith in the ability of government to solve social problems. Unless and until the administration begins to meet its own targets, the political fallout of the ACA will cast a long shadow over the 2014 elections … and beyond.

 

Sometimes, Even If You Like Your Insurance, You Can’t Keep It

Perhaps one of the most frustrating parts of being President is that your every waking moment is documented. Consequently, when you say something, and it subsequently turns out not to be quite true, you can expect that your opposition will take advantage of the opportunity to make you look like the American people can’t trust you. That’s precisely what has happened in the last week or two as some 3.5 million individuals report receiving cancellation notices from their insurance company, despite President Obama’s assurance early in the health reform debate that if you like your coverage, you can keep it.

There’s no disputing that the President overstated things and that his words are being used against him, but the issue is a bit more complex than that, and that’s what I’m going to address here. In particular, I want to move past the idea of broken Presidential promises and focus instead on the details of why insurance companies have been cancelling policies and what it means for the individuals affected.

The simple explanation is that the plans that were cancelled did not meet federal requirements under the ACA. This could happen for a number of reasons, but the primary one is that the plans did not meet the minimum actuarial value of 60% and/or did not cover all of the essential health benefits outlined in the law. That means, to put it even more simply, that individuals covered by these plans would be underinsured. But to people who were fortunate enough not to have to test the limits of their coverage, the inadequacy of their benefits isn’t apparent. In fact, one might argue that the coverage was perfectly adequate in practice, if not in theory.

So what’s happening now? The ACA is making these less than adequate plans illegal, and requiring individuals to obtain more robust coverage. Of course, the big concern among consumers is that this may be more expensive. Whether or not that’s the case will depend on numerous factors like where the individuals live, how much money they earn, and whether affordable coverage is available to them through an employer. Depending on the answers to those questions, individuals may find that they are eligible for Medicaid at no cost to them, eligible to purchase heavily subsidized private coverage through the health insurance exchange, or able to obtain affordable coverage through their employer. For many individuals, the price they’ll pay for insurance will go down. Of course, for others it will increase. But in all cases, the individuals will have substantially better coverage that will be there for them in the event that they ever need it, and that’s the true purpose of having insurance.

For those who want a more detailed understanding of the issue, I highly recommend two pieces by Jonathan Cohn. The first will provide you an overview. The second will give you some anecdotal insight into the complexities of the issue.

 

 

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Mental Health Loses Funding As Government Continues Shutdown

In the months leading up to World Mental Health Day, DC has been shaken by a series of violent events that ended with innocent lives lost and our country’s mental health services called into question. During this same time period, Washington, DC has been consumed by a government shutdown, with lawmakers and policymakers trying to determine how to rein in our country’s financial burdens and overspending. Unfortunately, as federal and state governments look to cut budgets at every turn, mental and behavioral health services are often on the chopping block first. Financial cuts, compounded with US stigma often applied to mental health troubles and disparate access to services across the county, mean that those who need services most are often those left without proper care.

August though October brought DC into the spotlight for many reasons, the saddest of which is the violence that was covered by mass media as two shootings occurred. In one case, Aaron Alexis, a 34-year-old, perpetrated a mass shooting that left 12 people dead, in Washington’s Navy Yard. Previous to the shooting, it was reported that Mr. Alexis was treated at the VA for mental health issues including sleep disorders and paranoia, but had not lost clearance.

Miriam Carey, also 34, reportedly had an unhealthy obsession with the White House when she drove her car into the White House gates and led police on a chase around DC before being killed. Although she had no reported psychosis or supposed violent intent, it was noted in the months leading up to the incident she believed that the President had beenstalking her and might have suffered from postpartum depression. When killed by authorities on Pennsylvania Avenue, she had her 18-month-old child in the car.

Budget Cuts

Although societal stigma and knowledge of where to access behavioral and mental services are often barriers to care, budget cuts continue to make seeking care more difficult. Whether this be through decreases in available services, lack of providers due to poor reimbursements or less preventative actions in communities, the impact of mental health funding shortages is great. According to the National Alliance on Mental Illness, “increasingly, emergency rooms, homeless shelters and jails are struggling with the effects of people falling through the cracks due to lack of needed mental health services and supports.”

In the last five years, significant budget cuts have befallen mental health programs and services. From 2009 to 2011, states cut mental health budgets by a combined $4 billion- the largest single combined reduction to mental health spending since de-institutionalization in the 1970s. In Chicago alone, state budget cuts combined with reductions in county and city mental health services led to shutting six of the city’s 12 mental health clinics. These closures, along with other public and private center closures in Chicago, have eliminated vitally needed services, especially on the south and west sides where they are indispensable.

Threats of sequestration in 2013 had a significant impact on people’s ability to access mental health services and programs, including children’s mental health services, suicide prevention programs, homeless outreach programs, substance abuse treatment programs, housing and employment assistance, health research, and virtually every type of public mental health support. The Substance Abuse and Mental Health Services Administration(SAMHSA) claimed it alone would be cutting $168 million from its 2013 spending, including areduction of $83.1 million in grants for substance abuse treatment programs.

Consequences

Despite the need to balance budget and make all health care services more efficient, many argue that society has better long-term outcomes if more federal and state dollars are allocated to mental and behavioral health care. This includes preventative services as well as mental health testing and treatment.

Because individuals with untreated mental illness often find themselves in emergency rooms, homeless shelters and prisons, the societal cost of prevention and treatment may be exponentially less than funding those other outlets and catchment areas. This is especially true in the case of children, who face cycling in and out of the system throughout their lives if left untreated.

These costs can be exceptionally large over the lifetime given that the National Institute of Mental Health (NIMH) estimates that two-thirds of children with lifetime mental health problems never receive treatment. This takes substantial emotional and financial tolls on individuals and families, as well as the broader society. However, programs that address the mental health needs and provide services for youth show better outcomes in health and education that carry over the lifetime. For example, in the University of Chicago’s Crime Lab, therapy is being used to curb youth violence, especially amongst those with behavioral and mental health care needs.

Additionally staining on the mental health care system is that during times of recession and budget cuts the caseload for mental health actually increases. It has been estimated that during this most recent recession, the caseload of community mental health services alone has increased almost 50 percent. This increase has most notably been seen in the Native American community, where suicide prevention is an essential part of the cultural health care demands.

Everyone Benefits

The NIMH contends that one in 17 people suffer from a “seriously debilitating mental illness,” we as a society are accountable for ensuring that those in need have resources for care. Not only does access to quality mental and behavioral health care ensure that individuals are being properly treated, but that America as a whole saves money and resources caring for those in need in other, more expensive settings. It may further prevent violent acts like those in DC from happing.

On this World Mental Health day think about the ways in which access to and support of mental and behavioral health care can be improved in your community.

 

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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.

 

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Making Sense of the Technical Difficulties in ObamaCare Implementation

October 1st is now a week in the past, but it was an awfully big day politically and in the lives of millions of Americans. Of course, it was the start of the 2014 fiscal year and, without a budget bill, the government shut down. That’s never good news, but the even worse news is that the deadline to raise the debt ceiling is fast approaching, and it appears that a number of members in Congress consider defunding ObamaCare worth the risk of an unprecedented federal default. Just take a look at this, this, and this if you feel like losing whatever shred of faith you have in our elected leaders.

And speaking of ObamaCare, October 1st was also the day that individuals across the country could go online and start signing up for health insurance coverage on the state-based exchanges. The early feedback is that the websites–including both the state exchanges and the main portal healthcare.gov–experienced some pretty serious glitches. The federal government claims that the site functions just fine, but was simply overwhelmed by “up to five times as many users as it was designed to handle.” Critics, of course, contend that this is merely the latest evidence of the failures of a terrible policy. Just watch this piece from Fox News.

The truth is, the task being demanded of the exchanges is actually a terribly complex series of tasks that have to be carried out essentially in real time. That, when combined with a tremendous amount of volume, was–at times–enough to overwhelm the systems the government had put in place. But it is far too soon to make a judgment about the exchanges. Of the more than 8 million people who visited healthcare.gov the week of October 1st, we don’t know yet how many actually signed up for coverage and how many were just curious individuals–including reporters, academics, and others who have no intention of enrolling in a plan.

What we do know is that the options available to people through the exchanges vary widely. And that is actually really good news. Why? Because for the first time in quite a long time, if not ever, insurance companies are having to go head-to-head publicly with each other. This is a grand experiment in whether the free market can work for health insurance.

It will be some time before we ought to make much ado about the performance of the exchanges. I think that some wrinkles were certainly to be expected, but the federal government is not shying away from the glitches. They are openly admitting that they are not satisfied with the initial roll out, and they are acting quickly to resolve the problem. Meanwhile, there is at least some indication that millions of people are interested in what the exchanges have to offer: affordable health insurance options. People still have nearly six months to get signed up for a plan before facing a penalty. That should be plenty of time for the kinks to get worked out and for people to get signed up. So, let’s take a collective breath and revisit this question of evaluating the exchanges in March 2014. It will be much clearer by then whether the grand experiment has succeeded or failed.

 

 
 
 
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