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As hospitals are rapidly adopting acute care telemedicine it is easy to see why healthcare organizations are reaching out to attorneys well versed in telemedicine law.

The Office of the Inspector General (OIG) vigorously enforces the Anti-Kickback (AKB) Statute intended to root out fraud and abuse in the healthcare system. It is worthwhile noting that the OIG issued an advisory statement that recognized the cost-saving potential of telemedicine and indicated they would not prosecute any hub/spoke relationship that balances what each party contributes. Nonetheless, these hub/spoke contracts must be carefully constructed with regard to federal AKB law.

When properly structured based on legal advice and appropriate intention, a hub hospital can in most cases subsidize a significant portion of a spoke hospital’s acute care telemedicine program with very low AKB risk.

Healthcare organizations should be very careful in crafting these contracts since a violation of AKB law is a criminal offense that can result in fines and even jail sentences. Every detail of a hub/spoke contract should be thoroughly evaluated by legal professionals with expertise in telemedicine and e-health law.

And please remember: this is NOT legal advice. It’s just a blog letting you know that the AKB waters can be successfully navigated. But please don’t make that journey without legal counsel.

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In a recent blog, Dr. Joseph Kvedar from the Center for Connected Health discussed how three “megatrends” are combining to give new impetus and immediacy to telemedicine.

The first trend is the sea change in healthcare reimbursement – from volume to value. For decades, many patients seeking treatment for severe heartburn were put through a dizzying array of tests and scans to rule out possible heart problems. Those tests were obviously of little value in determining the root cause of the problem. We now have a healthcare system that’s moving steadily toward a more sensible reimbursement paradigm.

The second trend is that consumers are getting increasingly smarter about healthcare costs, provider options, and ways to get personally involved in their own well-being. Thanks to the Internet, patients are much more engaged in the process rather than being passive participants.

Finally, most patients are now completely comfortable with mobile technology, which makes them much more receptive to innovations in connected health. Smartphones, tablets and touch screens are now commonplace – and most patients have no problem with a specialist on the East Coast assessing their condition in the Pacific Northwest. Most patients now readily agree that a provider’s time zone is far less important than the timeliness and quality of treatment.

When powerful megatrends merge, the world is forever transformed. For instance, when cheap oil and modern logistics came together, FedEx and Walmart became pioneers in the global supply chain. In similar fashion, the confluence of three megatrends is fueling telemedicine. Like the rivers that feed the Mississippi, these trends are creating a movement that can’t be stopped.

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It’s very easy to be on the wrong side of history. When IBM dismissed the personal computer as a passing fad, it lost its chance to be an enduring player in that market. And the same is true for physician organizations that take a short-term view of telemedicine’s transformative power.

Case in point: the Florida Medical Association staunchly opposes the Florida Telemedicine Act, a proposed bill that would allow physicians licensed in other states to treat Florida patients via telemedicine. In fact, the FMA recently conducted a statewide patient survey to try to bolster its position.

More than half of the 600 patients surveyed were “strongly opposed” to letting out-of-state physicians treat them. But it’s highly unlikely that any of those patients have had a life-saving encounter with a remote physician. If you were to survey stroke patients in rural Idaho who have been administered tPA by a physician thousands of miles away, you’d get a much different story.

The FMA is obviously taking the myopic stance that physicians in Boston or Chicago might take business away from Florida doctors – or might deliver inferior care. That’s absurd, of course, and it overlooks telemedicine’s long-range potential.

The FMA’s line-in-the-sand opposition reminds us of the roadblocks faced by early proponents of laparoscopic surgery, which is now a worldwide standard of care. One of the pioneers in that field, Dr. Erich Mühe, was nearly hounded out of the medical profession in the 1980s.

Like Dr. Mühe, telemedicine advocates are on the right side of history, even though they’re facing many obstacles at the moment. Twenty years from now, medical students will scratch their heads and wonder why telemedicine had its critics in 2014. Some breakthroughs – like personal computers, laparoscopic surgery, and telemedicine – are too pivotal and important to resist.

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Last year, a Montana hospital filed a lawsuit against its EHR vendor for failing to meet Meaningful Use deadlines. It’s believed to be the first lawsuit of its kind – and Modern Healthcare recently noted that this may be the first of many such cases.

In this litigation, the company being sued happens to be one of the most experienced EHR vendors in the country – an organization that focuses solely on healthcare. So just think how many lawsuits are waiting to happen when hospitals partner with healthcare novices.

Billions of dollars are still pouring into health IT projects, and that’s enough to attract companies that have little or no healthcare expertise. Let’s take the example of videoconferencing companies. If something goes wrong with a normal videoconference (such as a quarterly call to investment analysts), no one is likely to sue. But when people’s lives are in the balance, it’s another story.

Attorneys are also likely to pounce if a hospital has unforeseen problems treating patients using freeware like Skype. The question becomes: Could they have done more to safeguard the well-being of their patients?

At this year’s annual HIMSS conference, you’ll hear endless talk about mobile health technologies, many of which are not FDA cleared and have been developed by healthcare newcomers. For acute care applications, that’s an open invitation to costly lawsuits.

Most patients have two basic expectations when it comes to telemedicine. First, they expect to be treated by an expert, not an intern. Secondly, they assume that the technology connecting doctor to patient is also the work of acute care experts. When those expectations aren’t met, it’s just a matter of time until lawyers get involved.

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In his recent State of the Union speech (SOTU), President Obama used his considerable powers as “persuader-in-chief” to reposition the Affordable Care Act in citizens’ minds.

The president devoted more SOTU time to healthcare than in any address since 2010. He noted that despite the botched rollout of www.healthcare.gov, some 9 million Americans have signed up for the new private health plans or Medicaid coverage. And he cited the ACA innovations that people in both red and blue states are excited about, including no coverage denials for pre-existing conditions and the ability to keep kids on a parent’s health plan until age 26.

Opinion polls show that Americans are increasingly fed up with partisan gridlock – and Mr. Obama warned that voters would frown on more efforts to “repeal a law that’s already helping millions of Americans.”

Lawmakers at the state level are finally starting to admit that the ACA offers major advantages. The president praised efforts by Kentucky governor Steve Beshear to ensure that his state’s health insurance exchange is successful. “Kentucky’s not the most liberal part of the country,” said the president, “but Governor Beshear’s like a man possessed when it comes to covering his commonwealth’s families.”

As memories of the awkward launch fade, the public is starting to realize that health reform truly is improving access, raising quality and lowering costs. We applaud the president for having the courage to reframe the health reform debate, even though many members of his own party feel that it’s a losing issue.

Americans are willing to be patient with health reform because it promises so much. To quote an old song by The Eagles: Will health reform make it? We’ll find out in the long run.

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Any company involved in robotics owes a special thanks to Amazon’s Jeff Bezos and Google’s Larry Page and Andy Rubin. All three are widely recognized as visionaries in the tech community – and what they say gets the immediate attention of their peers and the media.

So when Bezos appeared recently on 60 Minutes to unveil Amazon’s long-range plan for delivery drones, the world took notice. There was also a big splash when Google leaders revealed that they’ve acquired eight robotics companies in recent months. Google’s Rubin refers to these robotics ventures as “moonshots” that will require a decade of R&D to bear fruit.

It’s great when corporate titans endorse the long-range viability of robotics, but it sometimes obscures the fact that robotics innovation is delivering real-world results right now.

While Amazon experiments with drone-delivery technology, the company is already deploying more than 1,000 robots in its distribution warehouses.

In the healthcare field alone, there are many companies where robotics is currently the centerpiece, including NASDAQ-traded Intuitive Surgical, Mako Surgical (now part of Stryker) and, of course, InTouch Health.

In short, people don’t have to wait until 2024 to be amazed by what robotics innovation can do. The prospect of a drone delivering your holiday packages pales in comparison to an RP-VITA helping remotely diagnose and treat a stroke patient. It’s the difference between a life-enhancing application and a life-saving one.

It’s always fun to envision an astonishing future, but it’s also important to realize that robotics technology is producing marvels, even as we speak.

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The 2013 Congressional agenda was marked by gridlock and disagreement on many fronts. That’s why it’s encouraging that 2014 is starting in a more gracious, bipartisan spirit – especially when it comes to telemedicine.

A lot of the credit goes to Sen. John Thune, the South Dakota Republican who could be a surprise contender for the 2016 Presidential nomination. But Thune is getting a lot of help from Senate Democrats like Oregon’s Ron Wyden and Michigan’s Debbie Stabenow.

Early this year, the Senate Finance Committee took two bold and unexpected moves: approving Thune-authored amendments that would improve Medicare coverage for telemedicine services. The first lifts restrictions on the use of telemedicine for any health system using an alternative payment model (such as ACOs) beginning in 2017. The second establishes a Medicare demonstration program for remote patient monitoring by home health agencies and other entities.

The proposed lifting of restrictions on ACOs and medical homes is a huge victory for telemedicine advocates because it would allow those entities to have the same telemedicine flexibility enjoyed by Medicare’s managed care plans.

The two amendments ensure that Sen. Thune’s Fostering Independence Through Technology Act (S.596) and other measures can move forward this year. It’s heartening that legislators from both sides of the aisle are becoming ardent telemedicine supporters. So here’s the Bipartisanship Honor Roll with regard to telemedicine:

Republicans – Thune, Roberts, Enzi.

Democrats: Wyden, Stabenow, Rockefeller, and Casey.

Telemedicine advocates have worked tirelessly to advance these amendments, and we salute the Senate’s “Magnificent Seven” for working together as colleagues, not combatants.

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Sometimes it takes real courage to stay the course. The Affordable Care Act has stumbled badly out of the gate, but we need to keep repeating its core mission like a mantra: “Improve access, improve quality, lower costs.”

Telemedicine aligns perfectly with those goals, so we think it’s wise not to overreact to the recent mistakes and miscues in health reform. There are many historical precedents for programs that launched poorly but fulfilled their promise.

Perhaps the best example is the interstate highway system. President Eisenhower signed the Federal Aid Highway Act in 1956, which provided the funding for our present-day network of coast-to-coast highways. By 1961, the program had a cost overrun of $11 billion and there were fierce battles over where to build – especially in urban areas. One newspaper even called the project “our great highway bungle.” Sound familiar?

With all the media pundits calling health reform a fiasco, it’s time to take a deep breath and remember that even landmark programs like our federal highway system had many major hiccups and delays. You don’t hear many complaints today from people cruising on America’s freeways. And it’s likely that the health reform uproar will end when the program starts to deliver.

It’s important to remember that health reform is a necessity, regardless of the setbacks and adjustments that will surely take place. We have no choice but to improve access, improve quality and lower costs. We’re confident that health reform will ultimately achieve those goals – and that telemedicine will play a major role.

 

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One of the joys of the holiday season is that we become more aware of the magic and miracles that surround us 365 days a year.

A century ago, Ashley Graber would have described her encounter with Dr. Jennifer Needle as a visit from an angel. Today, it’s just one of the everyday miracles made possible by telemedicine.

In 2011, Graber’s daughter MaLea was diagnosed with a high fever and virus and sent home for rest. When her condition worsened, a physician at Columbia Memorial Hospital in Astoria, Oregon requested a teleconsultation with Dr. Needles, a pediatric intensivist at Oregon Health & Science University’s Doernbecher Children’s Hospital in Portland.

Needle determined that MaLea had meningococcemia, a life-threatening bacterial infection. Her doctors inserted a breathing tube before airlifting her to the OHSU hospital.

It took 111 days for MaLea to recover. “I think telemedicine is the greatest thing ever invented,” says Graber. “I don’t think she’d be alive if not for that.”

This holiday season, think of all the people like MaLea – including thousands of stroke and cardiac patients – who are home celebrating with their families thanks to telemedicine. Like the angel in It’s A Wonderful Life, telemedicine offers a special gift: a second chance.

 

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Mobile apps in healthcare have become so ubiquitous that there are now several magazines that cover nothing else. They contain little or no news about hospitals and providers – just info on the latest healthcare apps for your smartphone. It leaves people with the impression that tomorrow’s healthcare will be delivered entirely on the run, with doctors making clinical decisions on the golf course or at a rock concert.

Fortunately, the FDA recently took steps to mute some of the exuberance about healthcare mobile apps. The organization has ruled that these apps fall into two broad categories: passive ones (used mainly for education and information-sharing) and active ones that require FDA Class II medical device clearance.

In the FDA’s view, apps that are designed for things like surgery training or patient education don’t have anything to do with real-time patient care. The same is obviously true for the vast array of business and administrative apps that perform things like billing or physician scheduling.

Even in the active category, most mobile apps are pretty limited tools compared to the Class II devices used in telemedicine. Most of these apps are designed for doctors who are already physically en route to the hospital. For example, there are now smartphone apps that let obstetricians view a baby’s fetal heart rate in real-time as they head for the delivery room. Likewise, a cardiologist can get a real-time look at a patient’s ECG transmitted from an ambulance. But that’s a far cry from the peri-operative and post-surgical precision that telemedicine brings to high-acuity environments.

The FDA has made it crystal clear that most healthcare apps are not – and never will be – worthy of medical device clearance. And those that do meet the criteria fall far short of delivering what’s needed for active patient monitoring in high-acuity settings. There’s no danger of tablets replacing telemedicine networks anytime soon.

 

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