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Curbside Consult with Dr. Jayne 4/28/14 | HIStalk

Curbside Consult with Dr. Jayne 4/28/14 | HIStalk | Healthcare and Technology news |

Death of a Practice

I wanted to be a physician from a very young age. Most people find that interesting because no one in my family is a physician or even in the healthcare field.

Going into junior high school, my best friend (who eventually became a nurse) and I became candy stripers, starting our healthcare careers. My first memory of a physician who didn’t make me cry was the kindly general practitioner my parents took me to after our pediatrician retired. He was the kind of doctor who kept his patient records on index cards (they were 4×6 inches) and wore a reflector on his head – old school.

Flash forward to second year of residency, when most primary care trainees start looking for a job. I had a potential offer from the medical group affiliated with the hospital where I was training. I had seen too much from the inside, though, to really want to work for them, so I decided to investigate whether that hospital where I first started was hiring any physicians.

In a stroke of luck, they were looking for someone interested in solo practice. I was offered a start-up in the small town where I grew up.

Their deal looked pretty good. Although technically employed during the first couple of years, the group allowed their sites to run like private practices and the physicians were on a largely eat-what-you-kill model. They were allowed autonomy over their practice except for certain office processes, which were paid for through a management fee taken off the top. Compared to hiring separate billing, compliance, OSHA, legal, HR, and other services, the management fee was extremely competitive.

I had rotated in one of their practices as a student and had seen first-hand how things ran. Two trainees ahead of me had taken jobs with them and everything was on the up-and-up. The non-compete was such that physicians could actually buy their practices and go private, staying in the same location, once they got off the ground. Coupled with the fact that they were willing to install an EHR at no cost to me and the fact that as a solo doc I wouldn’t have to deal with anyone else’s baggage, it was a done deal.

I had a lot of input on the office itself since construction had just started in a local strip mall. It was built for electronic health records from the beginning and was large enough to eventually house three physicians. The sponsoring hospital had done its homework and knew there was primary care demand in the community. We had people trying to make appointments more than a month before we were set to open.

I completed residency at the end of June, sat for the Board exam two weeks later, and opened the practice the following Monday. I saw nine patients that first day and never looked back.

I was proud to be part of the community. I had my own branding, Most people didn’t realize we were affiliated with the hospital. That was a big draw for some and gave us a certain pride of ownership I don’t think we would have had if we were visibly under the hospital umbrella.

Patients loved us being in the strip mall near a high-traffic intersection, glad they could park 20 feet from the door rather than having to use a parking garage or large lot at one of the hospital-based practices. I threw candy from a float in the Founders’ Day parade. It many ways, it was a dream come true.

My little office grew by leaps and bounds (“local girl comes home” is a powerful marketing statement.) Before long, I was ready to add another physician and eventually a nurse practitioner. The hospital sponsored several other start-up primary care practices, hiring a couple of my residency colleagues to help them build a troop of primary care docs to stay ahead of the community’s needs.

As for my site, since we were piloting the EHR system that the hospital’s parent health system planned to implement for all owned practices, I became pretty visible as an EHR champion. Eventually I was hired as part-time medical director for ambulatory EHR. One half-day a week at the IT office became two, then four, to the point where several years later I was only in the practice one day a week.

Eventually, patients’ lack of access to me became the topic of every office visit. Realizing it wasn’t good for the practice or my morale, one of our IT directors figured out a way for the hospital and IT to buy me out. It was a bittersweet decision to leave my little start-up, which wasn’t so little any more. We never turned an enormous profit, but we did break even and I had the opportunity to recruit my own replacement. It seemed like things were in good hands, so off I went to the land of IT.

The practice thrived until the recession started, the auto industry failed, and other heavy industry went to states with cheaper costs of labor. I had moved on career-wise, but still had enough connections to hear the updates on “my” practice. The staff was a little less busy, the bad debt write-offs grew, and the finances moved into the red.

The hospital president believed in primary care, though, and continued to subsidize the practice, knowing there was a need in the community (I’m not naïve — he also knew how many million dollars in ancillaries the average primary care doc drives to his or her preferred hospital.) And so the office stayed open.

Fast forward, and the hospital (now a major part of the regional safety-net rather than a community resource that drew patients through innovation and excellence) posted several major losses, sending its president to greener pastures elsewhere. Then one of the providers left for a higher salary, followed by another who took a maternity leave and never came back.

The hospital had a hard time finding a physician who wanted to care for patients with difficult socioeconomic challenges, especially when affluent practices with richer payer mixes beckoned. They weren’t willing to guarantee a salary that would have convinced someone to stay. I had last heard the practice was running with a single nurse practitioner who was supervised by a physician 20 miles away.

I found out today that the office is closing. Once I stood on the sidewalk with the mayor of our small town, cutting the “Grand Opening” ribbon with his giant gold-painted scissors. Now that sidewalk will lead people to yet another vacant quasi-retail space.

The provider who remains is being “consolidated” into a shared office on the hospital grounds, where physicians seem to land when they can’t get along with their partners or their practice loses too much money. Any trace of the office we worked so hard to build will soon be gone.

The economic reality is that no one wants to own small primary care practices any more. The work is hard, the hours are long, and the pay is less than other specialties. Hospitals stepped in hoping to lure primary care docs to their communities and solidify their slices of the revenue pie. Once they stop making money, though (which is often the reality of primary care in our current model,) it’s the beginning of the end.

Perhaps new payment models could have saved my little practice, but we will never know. Rather than having a family physician down the street or around the corner, patients will drive half an hour and navigate the maze of the hospital campus. They’ll probably be subject to a facility fee now, as I’m sure the remaining provider will be set up as a hospital outpatient department to try to eke out as much revenue as possible.

Even though I haven’t practiced there in years, I feel bad about it. I’m sorry that primary care doesn’t get the respect or compensation it deserves. I’m sorry that the hospital is no longer willing or able to subsidize valuable community services.

But most of all, I’m sorry for the patients. I’m grateful, though, for the time we had together, for the times I was able to help, and most of all, for the memories.

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CrowdMed « Healthcare Economist

Last week, I had an interview with Jared Heyman, Founder of the CrowdMed website. What is CrowdMed? Here is the website in the firm’s own words

CrowdMed ( is harnessing “the wisdom of crowds” to help solve the world’s most difficult medical cases quickly and accurately. On CrowdMed, a patient with an undiagnosed medical condition can post his or her case and CrowdMed’s community of ‘Medical Detectives’ collaborate on solving it — using a patented prediction market system that collects their “bets” on the most likely diagnoses and solutions. Using this methodology, CrowdMed members have solved 200+ challenging medical cases that have stumped individual physicians for years.

The CrowdMed states why this is a great idea. I was more interested in how it works. For instance, who solves these cases?

Mr. Heyman calls the medical experts on his site “Medical Dectectives.” Medical detectives can be physicians, medical students, nurses, patients with the disease, or just about anyone. Empirically, a large share of the Medical Dectectives are medical students, foreign doctors, and other health care professionals.

If there is no screening, why would anyone listen to the advice of an unlicensed Medical Detective?
One word: Reputation. The CrowdMed algorithm solicits advice from any Medical Detectives that want to participate. However the opinions of Medical Detectives that have a better track record of solving cases have their guesses given more weight that Medical Detectives that are novices or who do not have a good diagnosis track record.

Why would any Medical Detective want to participate?
There are a number of reasons. First is altriusm. Second is cash rewards. To incentivize Medical Detectives to solve their case, patients offer up a reward. The Medical Detectives who diagnose the disease correctly get to split the reward. The Medical Detectives place bets. Larger bets entitle you to a larger share of the winnings. However, if you place a large be and lose, your reputation on CrowdMed will suffer.

How is a winning diagnosis decided?
The winning diagnosis is determined by the patient. The patient receives trend statistics on which diagnoses are most likely. The patient can take these suggestions in-person to a new doctor to see if any of the proposed diagnoses hit the mark. Originally, CrowdMed required patients to get a confirmed diagnosis from a doctor but this delayed the process and now all “winners” are selected by patients.

Who is the typical patient that uses CrowdMed?
These are patients generally with serious, difficult-to-diagnose chronic illnesses. Patients using CrowdMed have annual medical costs of $55,000. According to company statistics, 80% of patients say they receive better diagnosis on CrowdMed than through their physician.

CrowdMed will not replace in-person diagnosis–particularly for acute conditions. However, using prediction markets to identify patient diagnoses is one way to have the internet help improve patient health.

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What does it take to get beyond hype in health IT and focus on valuable, actionable, practical, relevant content?

What does it take to get beyond hype in health IT and focus on valuable, actionable, practical, relevant content? | Healthcare and Technology news |

My friend John Lynn was kind enough to cover the new HealthIMPACT Conference that I’m chairing in Houston on April 3 in his recent piece entitled “Getting Beyond the Health IT Cheerleaders, BS, and Hype Machine“. While the article was great, Beth Friedman’s comment was priceless:

What are the criteria to be considered part of the cheerleader squad? This PR agency wants to be sure we are providing valuable, actionable, [practical], relevant content….NOT HYPE! And we’re open to your guidance.

John gave her a great reply:

It’s interesting how in high school you always wanted to be a cheerleader, but in marketing you don’t want to be seen as the cheerleader;-)

I think your description describes what you need to do to avoid hype. You have to focus on what really matters to the customers. Provide value to the customer as opposed to trying to sale your product. A deep understanding of the domain will create a relationship where people trust your views and then can talk about what you’re doing to solve their problems which you understand deeply.

Since Beth posted a great question I wanted to do it justice by answering more specifically. By the way, we’ll be covering a lot similar material at the inaugural Health IT Marketing Conference taking place in Vegas on the 7th and 8th of April. Join us!

Health IT “Cheerleaders” in my mind are those that push technology without considering deep value, return on investment, return on assets, and productivity loss. The hype machine is built around technology when health IT “cheerleaders” focus more on the gadgetry itself rather than the value proposition. If content is built around workflows, workflow optimization, and those tasks within existing or new workflows that optimize patient care through the use of technology then that’s real value.

This morning a college student sent a great question around health IT related productivity loss:

I am currently working on a capstone project for my MBA and my team is required to address a set of challenges as well as opportunities. One of the challenges they seem to be concerned the most [about] is the reduction in productivity of the physicians during and after the implementation of the EHR platform (they are currently working on a paper-base workflow). Since EMR requires doctors to type in the information which eventually takes significantly larger amount of time compared to their traditional method of handwriting, they are asking about ideas what they should do.

I replied that this sounds like a great project – and promptly advised them to conduct an analysis on whether the concern or productivity loss is warranted. I suggested they do a current workflow analysis to figure out their efficiency of existing steps and how those steps would change after an EHR is installed. If such an analysis is not done, evidence-driven technology choices cannot be made.

For a great example of how to build content around clinical workflows, check out HRSA’s guidanceIt’s still surprising to me how many of us in the tech business suggest usage of technology without a deep understanding of workflow. Progress will come, and cheerleading will be reduced, when tech meets workflow in a measurable way.

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What the Shift to Mobile Means for Blind News Consumers

What the Shift to Mobile Means for Blind News Consumers | Healthcare and Technology news |

If a website is designed haphazardly, it doesn’t just look messy; it can be messy for someone who can’t see, too.

"News apps are just completely frustrating," said Christopher Danielsen, spokesman for the National Federation of the Blind. "Blind people, the way we deal with this, is we share information about what apps tend to work, so I don't tend to download something unless I have a pretty good sense that I'm going to be able to deal with it." 

The problem with much of the web—and, in particular, its newsier corners—is that it's designed without consideration for people who aren't navigating by sight. In many cases, the busier a website looks, the harder it is for people who use tools like audio screen-readers to get where they want to go, or even figure out where to go in the first place.

But Danielsen says design for accessibility is getting much better, albeit largely by accident. "The mobile world is taking over where the web used to be dominant," he told me. "For blind people as well as for sighted people in many cases, that's a good thing."

A World Without Flash

It makes sense that the shift to mobile—and the stripped down, sparse aesthetic that in many cases comes with it—makes web navigation easier for someone using screen readers and other tools designed to help people with varying levels of sightedness. Mobile sites often mean a more pleasant experience for sighted users, too. 

Retailers like Amazon and grocery-delivery service Peapod have great mobile sites, Danielsen says, where most news organizations are still lagging. He’ll often log onto a website's mobile iteration as a way to cut through the clutter. (Check out, for instance.)

Things have also improved as designers move away from Adobe Flash and toward HTML5, which allows for more labeling coded into the designs that screen readers can identify for someone who can't clearly see what's on the screen. 

"If you're using a screen reader, you can often tell there are buttons there, but you can't necessarily tell what they do," said Danielsen. "With Flash, the screen reader will say something like 'unlabeled button zero,' and I'm like, 'Great. I have no idea what that does.' I could hit that button and blow up the world."

There are still plenty of obstacles. Danielsen says he "routinely" visits a news site where a video is posted but there's no way to tell how to control the player. And the web has inherited an ambiguity problem from television, where people on screen are identified with text on the screen but not verbally. For someone who can't read printed text, that kind of labeling can be "very frustrating," Danielsen says.

At the same time, the Internet has provided everyone a content smorgasbord. If someone's annoyed by one site's functionality, there are plenty of other places they can go to get their information fix. This should be a cautionary reminder to news organizations who aren't thinking proactively about accessibility, but there are all kinds of realities about journalism that journalists are more reluctant to acknowledge than anyone else. (See also: futility of paywalls, death of print, the newspapers not worth saving, etc.) 

"I'm a news junkie," said Bryan Bashin, director of LightHouse for the Blind and Visually Impaired and a former journalist. "I don't need a special blind-ghetto news site. We're swimming in news now. There has never been a more golden age for blind people."

Bashin says he's found that many news organizations may not think about accessibility from the beginning, but some are willing to make improvements when alerted to their limitations. 

"I'm a fan of Frontline, and the PBS website had this really pretty selector page at one time," he said. "You could select a cover image of a documentary or a program, but there were no labeled graphics... I actually emailed PBS and they fixed the problem."

Available Everywhere—but Not Always Accessible

It's not always so easy. The Internet, of course, isn't just where people consume information, but also a place where they can produce it. Yet many publishing systems are designed without blind or visually impaired people in mind. 

Twitter is pretty good because of its relative simplicity—though it can be annoying to click on a link expecting an article and have it turn out to be an unlabeled GIF or photo, several people told me. Facebook, on the other hand, is harder to navigate.

"There's an awful lot of work that goes into accessing Facebook," Bashin said."Most blind people use the mobile app of Facebook, but depending upon what week it is and [founder Mark] Zuckerberg's whims, sometimes it's better and sometimes its worse."

For those who have watched content-based industries sometimes flail in an era of communications driven largely by technology companies, it is perhaps no surprise that platforms are less reliably accessible than the devices we use to get to them. The iPhone has robust accessibility settings that many blind people praise. Yet even though Apple has accessibility guidelines for app developers, they're often ignored. 

Meanwhile, advocates for inclusivity in design argue that it's not about catering to one population of web users—it's not about a "blind ghetto," to use Bashin's term—but about creating a more dynamic and functional Internet for everyone. The way anyone interacts with information online ought to be dictated by her individual needs and preferences, says Sara Hendren, an artist and researcher focused on inclusive design. 

"Even if it's just changing your font size really easily, or changing your contrast really easily, a lot of web users don't realize you don't have to accept the defaults of your web browser," Hendren said. "There's no reason we should accept the web should be primarily visual, or even visual with accommodations for visuality."

Even the way we talk about accessibility can change the way developers approach it, Hendren says. She likes to remind people that "all technology is assistive technology," and that the "assistive" part is why we love technology in the first place. 

"What we need is a big turn in the tone of the conversation about accessibility from, 'Eat your spinach,' to 'Wow, this is a real design opportunity.'"

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E-cigarettes are being hawked by Jenny McCarthy, and that may not change under the new FDA rules

E-cigarettes are being hawked by Jenny McCarthy, and that may not change under the new FDA rules | Healthcare and Technology news |

The Food and Drug Administration has proposed the first-ever regulations to tame the “Wild West” of electronic cigarettes, as some tobacco-control groups have called it.

After a 75-day comment period, the new rules are expected to set the age limit for buying e-cigs at 18, ban their sale in vending machines, and introduce labels warning of the potential for addiction to nicotine. E-cig manufacturers would also have to register their products and report their ingredients to the FDA. The proposed measure would also affect pipes, hookahs, and cigars.

For those unfamiliar, e-cigarettes are those things that make it look like their user is sucking on a very cold ball-point pen. They’re filled with a water, nicotine, and propylene glycol solution, which gets heated by a battery and inhaled.

U.S. students who have tried e-cigarettes. (CDC)

There are now more than 250 varieties of e-cigs, and their manufacturers netted sales of over $2 billion in 2013. The percentage of high school students who have tried e-cigs doubled from 4.7 to 10.0 percent between 2011 and 2012, according to the CDC. Only about 6 percent of adults have tried them.

One reason e-cig sales had time to skyrocket like this—other than their rising stature among hipsters—was that the FDA has only had the power to regulate tobacco products since 2009. They’ve spent the intervening years battling tobacco companies in court over other rules the agency has attempted to enact.

Related Story

The Electronic Future of Cigarettes

Meanwhile, anti-smoking groups have been worried that even as the devices have spiked in popularity, we still don’t know how safe they are. E-cigs have only been around for six or seven years, not enough time for a longitudinal public health study.

“Seven years is a nanosecond in scientific terms,” said Thomas Glynn, director of cancer science at the American Cancer Society. “We don’t even know what the long-term effects of inhaling heated propylene glycol are,” not to mention the nicotine component.

The FDA has previously studied e-cig samples and detected toxins like diethylene glycol and nitrosamines in some brands. The nicotine in them is addictive and can be harmful to pregnant women and teens. Some smokers think “vaping” can help them quit smoking actual cigarettes, and there’s some evidence they work about as well as nicotine patches, but it's far from conclusive.

Importantly, the new regulations won't limit the ability of e-cig manufacturers to sell fruity flavors, like "Cherry Blast" or "Gummy Bear," which critics say hooks kids on the devices.

Screenshot: Staff of Sen. Dick Durbin

Young people tend to be drawn to flavored tobacco products more than adults are. In a report released in April, Democratic policymakers expressed alarm that e-cig company Eonsmoke used Facebook polls to ask fans what flavors should be released next.

And companies will still be able to advertise the products on TV, something cigarette manufacturers haven’t been able to do for decades. In one TV ad for blu eCigs, for example, notable “science expert” Jenny McCarthy touts their advantages over regular tobacco.

"It doesn't make my hair smell or my teeth turn yellow," she says. "And no going outside in the rain or freezing my butt off just to take a puff."

According to the Wall Street Journal, the ads "have aired on cable networks including ESPN, Comedy Channel and Spike TV and local affiliates of broadcast networks; [e-cig maker] NJOY reached about 10 million viewers during this year's Super Bowl." In 2012, 40 state attorneys general urged the FDA to ban the TV spots, saying they glamorized smoking among young audiences.

The FDA says it can't do away with the flavors and TV ads until it has the scientific evidence to prove e-cigs are harmful—and that evidence will only come with the rules the agency is trying to establish today.

“You can’t get to the flavors until you have regulatory authority over them,” Mitchell Zeller, director of the Center for Tobacco Products at the FDA, told the New York Times.

According to Glynn and others, though, the FDA's "getting" to that other stuff can't come soon enough.

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Obamacare's Exchange Signups, Expanded Medicaid Boost Aetna

Obamacare's Exchange Signups, Expanded Medicaid Boost Aetna | Healthcare and Technology news |

Health insurance giant Aetna AET +6.63% (AET), buoyed by growth of newly insured government- subsidized subscribers under the Affordable Care Act and the Medicare program, expects to double operating revenues by the end of the decade, company executives said today in announcing the company’s first-quarter earnings.

Aetna chief executive officer Mark Bertolini said the company has more than 230,000 paid health plan members from public exchanges created under the health law and expects that to grow to 450,000 “paid public exchange members” by the end of the year. Aetna executives also say they enrolled 50,000 new health plan members in the first quarter from the expanded Medicaid health insurance program for the poor and expect another 50,000 by the end of the year.

In all, Aetna is projecting an increase of 800,000 to 1 million new health plan members, which will increase the company’s medical membership to more than 23 million.

Aetna and its Coventry subsidiary sell health insurance on public marketplaces known as exchanges in all or parts of 17 states. Health plans are benefitting in part by the rush of Americans who signed up in March, the last month of open enrollment for people who wanted coverage this year. Under the health law, the uninsured can get subsidies to pick a range of health plan options via state or federally-operated exchanges.

In addition, Aetna and Coventry contract with state Medicaid health insurance programs for the poor. Under the health law, more than two dozen states expanded their Medicaid programs to millions of Americans and insurers like Aetna have generated tens of thousands of new customers from that business.

Bertolini is now projecting 2014 revenue to jump to a range of $56 billion to $57 billion from about $54 billion.

“Our strong membership growth in the quarter came from both our commercial and government businesses and we project this momentum will continue,” Bertolini told Wall Street analysts and investors on the company’s first-quarter earnings call, which lasted an hour.

In Aetna’s first quarter, revenue jumped 47 percent to nearly $14 billion thanks in part to the company’s acquisition last year of Coventry Health Care CVH NaN%. Net income soared 36 percent to  $665.5 million, or $1.82 a share, from $490.1 million, or $1.48, a year earlier.

Aetna joins the parade of health insurance companies that have raised their profit forecasts at least once in the last few months. Others benefitting from the health law include Wellpoint (WLP), UnitedHealth Group UNH +1.9% (UNH) and Humana (HUM).

English: President Barack Obama’s signature on the health insurance reform bill at the White House, March 23, 2010. The President signed the bill with 22 different pens. (Photo credit: Wikipedia)

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Too Much Codeine Still Prescribed to U.S. Kids: Study – WebMD

Too Much Codeine Still Prescribed to U.S. Kids: Study – WebMD | Healthcare and Technology news |

MONDAY, April 21, 2014 (HealthDay News) -- Emergency room physicians still hand out hundreds of thousands of codeine prescriptions for children every year, despite warnings that kids' responses to codeine vary wildly and the drug can cause an accidental overdose, a new study finds.

ER doctors issued about 560,000 to 880,000 prescriptions for codeine to kids each year between 2001 and 2010, according to an analysis of hospital survey data collected annually by the U.S. Centers for Disease Control and Prevention.

"We have hundreds of thousands of children still getting codeine, even though there are better and safer alternatives available," said study author Dr. Sunitha Kaiser, an assistant clinical professor of pediatrics at the University of California, San Francisco (UCSF).

The study was published online April 21 in the journal Pediatrics.

Continue reading below...

These prescriptions continued to be handed out despite repeated warnings from the American Academy of Pediatrics (AAP) that differences in children's metabolisms can cause the effects of codeine to swing from ineffective to toxic.

Codeine is classified as a narcotic drug.

Doctors prescribe codeine to kids for pain relief and as a cough suppressant, Kaiser said.

The human body must metabolize codeine for the drug to have any effect, essentially converting it into morphine, said Dr. Alan Woolf, a pediatrician at Boston Children's Hospital, who wrote an accompanying commentary to Kaiser's study.

But kids' ability to metabolize codeine varies wildly. About a third are not able to metabolize codeine well, and thus receive no pain relief from taking it. At the same time, as many as one in 12 rapidly metabolize codeine, accumulating toxic amounts of morphine in their systems that could harm or kill them, according to a UCSF news release.

"You'd have to know a child's genetics to predict for sure how they're going to metabolize the drug," Woolf said.

"This is not a drug that is so safe or effective, and maybe it's time we move on because we have an array of therapies that are effective," he added.

Concerns over codeine have led drug regulators in Canada and the European Union to restrict its use to people older than 12. And in 2012 the World Health Organization removed codeine from its list of essential drugs, the study authors noted in background information.

The AAP warned doctors twice -- in guidelines issued in 1997 and 2007 -- to avoid prescribing codeine to children.

This is the first study to attempt an estimate on the number of children being prescribed codeine in U.S. emergency rooms and to see if those warnings made any difference, Kaiser said.

She and her colleagues used a nationwide survey on hospital and outpatient care, performed annually by the U.S. National Center for Health Statistics, to determine the frequency of codeine prescriptions to children aged 3 to 17 during ER visits from 2001 through 2010.

quick's comment, June 21, 6:25 AM
quick's comment, June 21, 6:25 AM!

How to Prevent Healthcare Data Breaches (and What to Do If You're a Victim)

How to Prevent Healthcare Data Breaches (and What to Do If You're a Victim) | Healthcare and Technology news |

Data breaches are unfortunately not uncommon in the healthcare industry. In the last three years, more than 500 breaches affecting 500 or more patient records have been reported to the Office for Civil Rights (OCR)within the U.S. Department of Health and Human Services. OCR estimates that close to 60,000 smaller breaches have occurred in the same timeframe.

Most data breaches begin with a moment of, "You're not going to believe what just happened," says Robert Belfort, a partner with Manatt, Phelps & Phillips LLP. It could be a CD with patient data that goes missing from a storage firm when the employee who signs for it suddenly resigns, or it could be a laptop taken from a car parked in an otherwise nondescript residential neighborhood.

Facebook and Physicians: Not Good Medicine

Both incidents are real; the latter occurred in 2011 and involved the Massachusetts eHealth Collaborative (MAeHC), a small nonprofit that's nonetheless active in influencing national healthcare IT policy. Given the organization's role, "It was no small embarrassment to find out that we had make some critical mistakes," CEO Micky Tripathi says.

What to Do If You're a Victim of a Healthcare Data Breach

Tripathi, Belfort and others spoke at last week's Privacy & Security Forum, presented by Healthcare IT News and the Healthcare Information and Management Systems Society (HIMSS).

Once an incident is discovered, the first step is determining if a breach actually happened. That's no small task, Belfort says, as there are differences between data breaches and system vulnerabilities or violations of an organization's security policy. Vulnerabilities and violations should be noted, both for auditing purposes and to educate employees about data security, but they don't automatically constitute breaches.

Even if a breach has occurred, Belfort continues, there are two additional questions to consider: Did unauthorized or improper access to personal health information (PHI) occur, and if so, is there any risk to the organization? If an unencrypted laptop containing PHI was in a car that was stolen and subsequently dumped at the bottom of a lake, then the risk of anyone having seen that PHI is low, he says.

Commentary: Who Should Be At the Root of Protecting the Nation's Healthcare Data?

The MAeHC incident was a data breach, Tripathi says. Neither the laptop nor the data was encrypted, and although the files were password-protected, it was determined that an "enlightened amateur" could access the data. Of the nearly 15,000 patient records on the laptop, 1,000 put patients at a significant risk of harm, he says, as they contained a patient's name and one of three other pieces of information: date of birth, Social Security number or reason for the appointment.

 The next step was notifying those 1,000 patients. Here differing state and federal laws complicated matters. Federal law puts a HIPAA-covered entity at fault. In this case, that would have been the practices for which the MAeHC was a contractor. (The agency was studying error logs for electronic data submissions.) Under Massachusetts law, though, the MAeHC, as the entity that lost the data, was responsible. To avoid confusion, Tripathi says, the eight affected covered entities sent the letters (to meet federal law) but mentioned MAeHC in the first sentence (to cover the state law).

In the end, data breach mitigation cost MAHC about $289,000. More than half went to legal fees and the bulk of what was left went to pulling staff from other tasks to focus on breach mitigation. "Basically, you have to sweep everything aside and focus on this," Tripathi says.

A breach involving one specific covered entity had to be reported to the Office for Civil Rights, as it affected more than 500 patients. The OCR concluded that MAeHC was "in substantial compliance" with federal rules and did not fine the organization; the federal agency even went so far as to tell Tripathi that overlapping state and federal laws left the OCR unsure if it even had jurisdiction over the incident.

Lessons Learned: How to Prevent a Healthcare Data Breach

Tripathi decided to use the incident as an educational experience for others, as a lengthy post on the HIStalk Practice blog and subsequent interview with The New York Times suggest. "This kind of detail just doesn't get out there," he says.

It should. A recent analysis of healthcare data breaches by the Health Information Trust Alliance (HITRUST) finds that incidents such as the MAeHC breach—involving lost or stolen and unencrypted laptops—remain all too common in the healthcare industry despite new rules that dramatically increase fines for data breaches.

All told, theft and loss account for 66 percent of the breaches of 500 or more patient records, and 82 of the total records lost, that have occurred since September 2009, the HITRUST report notes. Small physician practices, which make up the vast majority of healthcare organizations in the United States, are particularly vulnerable, the report says: "This industry segment is struggling and requires significant assistance due to a lack of available expertise and resources."

In an interview, Christopher Hourihan, principal research analyst with HITRUST, says small practices should focus on the basics, including training, encryption, firewalls and antivirus software—the same technology that savvy users have on their home networks. "Don't try to do anything all at once," he says. "Focus on the critical areas first and expand the program that way."

Speaking at the Privacy Security Forum, Leon Rodriguez, director of the Office for Civil Rights, agrees that encryption technology is key to avoiding breaches. (Under 2009's HITECH Act, the loss of encrypted PHI, or of encrypted hardware that contains PHI, is not considered a data breach.) Training matters, too, he adds, as there is always "some human frailty" to a data breach that's unrelated to technological vulnerabilities.

The HITRUST report notes that data breaches involving HIPAA business associates—which, as noted, HIPAA-covered entities are responsible for—have accounted for 21 percent of breaches in the last three years and 58 percent of the records lost. This points to a need for "proactive due diligence," Hourihan says. It's been a problem, and it will continue to be a problem, because businesses sign a contract and then don't do anything else."

To combat this issue, healthcare organizations should first ask for a business associate's most recent security audit and risk analysis and then work with the BA to fill the gaps that could result in a data breach. Since some providers have hundreds, if not thousands, of BAs, Hourihan suggests giving the most attention to electronic health record vendors, vendors that support critical business functions and other companies that interact with customer data.

Healthcare organizations also need to be aware of hackers. While hacks account for only 8 percent of reported data breaches, Hourihan thinks the actual number is higher, as HITRUST has seen PHI for sale on underground message boards that often can't be tied to a reported breach. With PHI worth up to 50 times more to hackers than credit card or Social Security numbers, Hourihan and HITRUST expect to see a "pretty significant rise" in hacks in years to come.

David Harlow, principal of The Harlow Group LLC, acknowledges that the industry "collectively need[s] to do a better job cracking down on those exploits."

Doing so requires a mix of technology, education and leadership. For Rodriquez, it's that final point that matters most—not just for preventing hacks but also for preventing data breaches and doing the sort of due diligence that MAeHC did in order to avoid an OCR fine. "It comes down to leadership owning compliance issues and doing so consistently. It's that leadership that makes all the difference," he says.

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Medicaid paid $12 million for Illinois dead

Medicaid paid $12 million for Illinois dead | Healthcare and Technology news |

(AP) — An internal state government memo says auditors have found the Illinois Medicaid program has paid an estimated $12 million for medical services for people listed as deceased in other state records.

The Associated Press obtained the memo through a Freedom of Information Act request. The memo, dated Friday, says the state auditor compared clients enrolled in the Medicaid database with state death records dating back to 1970. Auditors identified overpayments for services to roughly 2,900 people after the date of their deaths.

The heads of the departments of Healthcare and Family Services and Human Services outline steps to fix the problem in the memo to their senior staffs.

The memo states that more than $7 million has been recovered and the rest is expected to be recouped by year's end.

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Personal Connected Health Alliance

Personal Connected Health Alliance | Healthcare and Technology news |
The Personal Connected Health Alliance Launches with Goal to Improve Health and Wellness through Connected Technologies

Continua Health Alliance, mHealth Summit and HIMSS partner to enable individuals to better manage their health and wellness, anytime and anywhere 

WASHINGTON D.C. – (APRIL 22, 2014) – The Personal Connected Health Alliance, an international non-profit organization established by Continua Health Alliance, mHealth Summit and HIMSS to represent the consumer voice in personal connected health, formally launched today. PCHA will build upon the global reach, leadership and resources of its founding organizations, to ensure that personal connected health technologies, such as smartphones, mobile apps, sensors and personal health tracking devices, are user-friendly, secure and can easily collect, display and relay personal health data. The Alliance's work will generate greater awareness, availability and access to plug-and-play consumer-friendly personal health technologies that empower people to better manage their health and wellness, anytime and anywhere, in an increasingly connected world.
“As healthcare delivery evolves and brings care beyond hospital walls to where we live, work, learn and play, individuals are being called upon to engage more intimately with their own health and wellness,” said Jeremy Bonfini, Executive Vice President, PCHA. “The Personal Connected Health Alliance aims to facilitate the development and widespread availability of user-friendly personal health devices, mobile apps, sensors and other connected health technologies, putting consumers in the driver’s seat when it comes to their own health.”
The mission of PCHA is to promote the adoption, standardization and appropriate regulation of personal connected health devices and systems in order to empower individuals to better manage their health and wellness from anywhere, at any time, with stronger links between consumers, their social networks and providers. Additionally, PCHA aims to nurture the technology ecosystem necessary to facilitate “big data” in healthcare. PCHA will continue to develop and publish industry standards for interoperability of personal connected health devices, via the Continua Design Guidelines and certification programs.
“Our Board of Directors is very pleased to join with mHealth Summit and HIMSS to create a strong and dynamic voice to advance personal connected health technologies,” added Clint McClellan, Board President Chair, Continua Health Alliance. “The International Telecommunication Union (ITU), the United Nations specialized agency for information and communication technologies, recently ratified the Continua family of standards as the defacto global connected health standard for plug-and-play interoperability to create an easily accessible, user-friendly and secure network of personal connected health devices and systems. We are currently working with governments around the world, including Denmark, Abu Dhabi, Singapore and the UK, that are developing implementation plans for groundbreaking national connected health initiatives for their citizens based on Continua's Design Guidelines.”
The Personal Connected Health Alliance will unite the continuum of care across the healthcare ecosystem, and bring together a unique combination of domestic and global expertise, along with resources focused on personalized health solutions that meet individuals’ lifestyle needs. Each participating organization – Continua Health Alliance, mHealth Summit and HIMSS – will bring a unique perspective to the Alliance, providing a holistic view and approach to promoting the advancement of healthcare technologies that focus on consumers. 
“The Personal Connected Health Alliance, in cooperation with the mHealth Summit and Continua, will continue driving the industry forward by generating a new knowledge base around the personal connected health space, providing a strong and united voice on policy, regulatory issues and government relations, and advancing education and awareness for the widespread adoption of personal connected health technologies,” said Rich Scarfo, Vice President, Personal Connected Health Alliance  and Director, mHealth Summit. “The mHealth Summit – the industry’s leading event focused on mobile and personal health topics – will continue to provide an important platform for the industry, and will be expanding its presence to Europe, Asia and the Middle East.”
To learn more about the Personal Connected Health Alliance, visit:
About the Personal Connected Health Alliance
The Personal Connected Health Alliance (PCHA), a global, non-profit organization, is a collaboration between Continua Health Alliance, mHealth Summit and HIMSS, focused on engaging consumers with their health via interoperable personalized health solutions that meet their lifestyle needs. PCHA is an independent HIMSS organization, combining the dynamic membership and expertise of Continua, and the networking and reach of the mHealth Summit and global mhealth events, with the global access and leadership of HIMSS to bring greater focus on personal connected health technology. Representing the consumer voice in personal connected health, PCHA brings together a unique combination of domestic and global resources focused on personalized health solutions that meet the needs of consumers throughout their lives. Visit 
About Continua Health Alliance 
Continua Health Alliance (Continua), an international not-for-profit industry group, is the leading organization convening global technology industry standards to develop end-to-end, plug-and-play connectivity for personal connected health. Continua is dedicated to the development of Design Guidelines and test tools to expedite the deployment of personal connected health devices and systems that will empower information-driven health self-management and facilitate the incorporation of health and wellness into the day-to-day lives of individuals. Continua is a pioneer in establishing standards-based guidelines and security for connected health technologies such as sensors, remote monitoring devices, tablets, gateways and smart phones as well as networked and cloud solutions through its Guideline releases. The Alliance’s activities include a certification and brand support program, events and collaborations to support technology and clinical innovation, and outreach to employers, payers, governments and care providers. With over 200 member companies reaching across the globe, Continua's Board of Directors feature leading technology, medical device and health care industry leaders and service providers: Fujitsu, Intel, Oracle, Orange, Partners HealthCare Center for Connected Health, Philips, Qualcomm Life, Roche Diagnostics, Samsung Electronics, Sharp and UnitedHealth Group. For more information visit: 
About the mHealth Summit
The 2014 mHealth Summit, the global convener of the expanding mobile health ecosystem, explores the disruptions, challenges and opportunities of the expanding integration of mobile and wireless technologies into the healthcare system, and in consumer and patient engagement, for the delivery of better health outcomes. The 6th Annual mHealth Summit will take place December 7-11, 2014, in Washington, D.C. Focusing on four fundamental platforms – technology, business, research and policy, the mHealth Summit is presented by HIMSS, in partnership with the National Institutes of Health, the mHealth Alliance and the Foundation for the NIH. For more information, visit; and follow at @mhealthsummit or #mHealth14.
HIMSS is a global, cause-based, not-for-profit organization focused on better health through information technology (IT). HIMSS leads efforts to optimize health engagements and care outcomes using information technology.
HIMSS is a cause-based, global enterprise producing health IT thought leadership, education, events, market research and media services around the world. Founded in 1961, HIMSS encompasses more than 52,000 individuals, of which more than two-thirds work in healthcare provider, governmental and not-for-profit organizations across the globe, plus over 600 corporations and 250 not-for-profit partner organizations, that share this cause.  HIMSS, headquartered in Chicago, serves the global health IT community with additional offices in the United States, Europe, and Asia.
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ObamaCare signups: More than just the exchange numbers

ObamaCare signups: More than just the exchange numbers | Healthcare and Technology news |

President Obama just announced that 8 million people signed up for coverage on federal and state health insurance exchanges during the initial open enrollment period for the Affordable Care Act, aka ObamaCare. That’s higher than originally projected, and much higher than how things looked when the glitch-filled sputtered out of the gate. Cynics will pick at that accomplishment, claiming that it overstates the law’s impact by counting people who already had insurance, and those who don’t end up paying their premiums.

ObamaCare is a complex law (remember the big excitement about how many pages it takes to spell out) and it’s much more than just the exchange websites.

Focusing just on the 8 million who have signed up through the exchanges actually seriously underestimates ObamaCare’s impact on the number of people with insurance. Consider:

  • Close to 4 million people have signed up for Medicaid since October. It would have been more if opponents hadn’t blocked Medicaid expansion in so many states
  • Millions have signed up for private health insurance outside of exchanges: through brokers or directly with the health insurers
  • Many formerly uninsured young adults are insured through their parents up to age 26 instead of being dropped

There’s also another way to look at the folks who already had insurance who have signed up on the exchange. ObamaCare opponents have made a big deal out of people having their plans canceled because those plans didn’t meet the new law’s requirements. We’re suddenly told how everyone loves their existing plan –something I never heard touted prior to ObamaCare. Considering the hassle involved in getting a policy through an exchange, one could reasonably assume that people are getting better, cheaper coverage than what they had before. Even if that doesn’t increase the number of insured people, it improves the overall level of insurance within the population.

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Is There A Link Between Prostate Cancer And Chronic Inflammation?

Is There A Link Between Prostate Cancer And Chronic Inflammation? | Healthcare and Technology news |
Is There A Link Between Prostate Cancer And Chronic Inflammation?

Based on data from a new study from the Johns Hopkins Kimmel Cancer Center, men who demonstrate evidence of chronic inflammation seen in prostate biopsies stemming from chronic prostatitis may have close to twice the risk of developing prostate cancer compared to those without inflammation.

Prostate cancer is the second most common cancer in men in the US.

The link between developing cancer and having chronic inflammation was even more striking for men with aggressive or high-grade prostate cancer, reflected in a Gleason score between 7 and 10. The Gleason score is a numeric scale for assessing risk of developing invasive or high-grade prostate cancer based on microscopic evaluation of prostate tissue.

The research was published April 18 in the Journal Cancer Epidemiology, Biomarkers & Prevention.

The data from the current study is derived from information about men in the placebo arm of the Prostate Cancer Prevention Trial by the Southwest Oncology Group. The goal of the trial was to evaluate if the drug finasteride could prevent prostate cancer. Regardless of whether there were any concerning signs of cancer such as high prostate specific antigen (PSA) levels, the protocol called for biopsies to check for prostate cancer at the conclusion of the trial.

English: Micrograph showing prostatic acinar adenocarcinoma (the most common form of prostate cancer) Gleason pattern 4 (left of image) and Gleason pattern 5 (right of image). H&E stain. Prostate currettings. See also Image:Prostate cancer with Gleason pattern 4 low mag.jpg (Photo credit: Wikipedia)

“What we’ve shown in this observational study is a clear association between prostate inflammation and prostate cancer, although we can’t prove that inflammation is a cause of prostate cancer,” said Elizabeth A. Platz, Sc.D., M.P.H., a professor in the Department of Epidemiology at the Johns Hopkins University Bloomberg School of Public Health and the School of Medicine.

Dr. Angelo M. De Marzo, Professor of Pathology at Johns Hopkins’ School of Medicine and associate director of cancer research pathology explained that inflammation is much too prevalent in men to have any value as way to evaluate men for prostate cancer. But, as De Marzo explained, investigators are trying to understand the factors responsible for prostate inflammation, specifically how it may lead to prostate cancer, and ultimately if it can be prevented. “I think there will be strategies going forward for either preventing inflammation or intervening when it occurs,” Platz added.

Platz explained that previous research has evaluated potential links between inflammation and prostate cancer. However, earlier research studied tissue from men who had a specific reason to undergo a biopsy. “Our study was designed to rule out the bias that would ordinarily exist between the way we detect prostate cancer and the presence of inflammation.”

“Because inflammation makes PSA levels go up, men with inflammation are more likely to have higher PSA and, with a rising PSA, they’re more likely to be biopsied,” said Platz. “By doing more biopsies on these men, prostate cancer is more likely to be detected, even if inflammation is not a cause of prostate cancer.”

In their study, Platz, De Marzo and their co-investigators studied benign tissue samples taken from the biopsies of 191 men with prostate cancer and 209 men without cancer, examining the samples for the prevalence and extent of immune cells that indicate inflammation. They found that 86.2 percent of the prostate cancer patients had at least one tissue sample with signs of inflammation, compared to 78.2 percent of men without cancer.

“We knew going into this research that inflammation in the prostate is very common in men who have biopsies because of the higher PSA levels and other indicators of prostate cancer, but we did not anticipate the high prevalence of prostate inflammation in men who didn’t have an indication for biopsy,” explained DeMarzo.

Men with at least one biopsy showing signs of chronic inflammation had 1.78 times higher risk for having prostate cancer, and 2.24 times higher risk of having an aggressive cancer, according to their results.   This particular association was also seen in men with low PSA levels at the time of their biopsies.

It is quite clear, based on this study that more investigation will be necessary to definitively link inflammation to increased risk of prostate cancer.  Inflammation can be the result of not only infection, but also diet and autoimmune disease.

It turns out that a diet which promotes cardiovascular health also results in improved prostate function. Lower amounts of meat–especially burnt or overcooked meat–is integral for ensuring good prostate health and well as heart health.  Getting more aerobic exercise, losing weight and smoking cessation are important measures to ensure a healthy prostate.

Drugs such as statins, which are prescribed for patients with elevated cholesterol and coronary artery disease, may also help reduce the risk of rapidly proliferating prostate cancers. Statins have anti-inflammatory properties which may reduce inflammation which could be leading to high grade prostate cancers.

Other areas to explore include a potential relationship between a history of sexually transmitted diseases and the level of inflammation in the prostate. Whether this may play a role in chronic low grade inflammation is unclear.

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Even After Doctors Are Sanctioned or Arrested, Medicare Keeps Paying

Even After Doctors Are Sanctioned or Arrested, Medicare Keeps Paying | Healthcare and Technology news |

This story was co-published with NPR

In August 2011, federal agents swept across the Detroit area, arresting doctors, pharmacists and other health professionals accused of running a massive scheme to defraud Medicare.

The following month, several of those arrested —including psychiatrist Mark Greenbain and podiatrist Anmy Tran — were suspended from billing the state's Medicaid program for the poor.

"Health care fraud steals funds from programs designed to benefit patients, and we all pay for it," U.S. Attorney Barbara McQuade said in a press release at the time of the arrests. "We hope that the strength of our efforts will have a deterrent effect."

But the indictment and Medicaid suspensions didn't deter Medicare from continuing to allow the doctors to treat elderly and disabled patients — and billing taxpayers for their services.

In 2012, Medicare paid Greenbain more than $862,000, according to newly released data on Medicare payments to physicians. Tran received $155,000.

Greenbain and Tran were among dozens of doctors identified by ProPublica who Medicare kept paying after they were suspended or terminated from state Medicaid programs, indicted or charged with fraud, or had settled civil allegations of submitting false claims to Medicare.

Outlays to these doctors amounted to more than $6 million in 2012, ProPublica's analysis shows. That's a small fraction of the $77 billion Medicare has publicly reported paying that year for doctors' visits and outpatient services in its Part B program, but it signifies a hole in regulators' ability to protect the program — and patients — against fraud and abuse, said current and former government officials and fraud experts.

The total dollars paid to sanctioned doctors is likely much higher. Only a handful of states post online the names of doctors terminated from Medicaid programs in a way that can be accurately matched to Medicare Part B payments.

"If you've been suspended or terminated in one of the federal programs...I would think that you'd be suspended in the other programs, just as a basis of good practice," said Louis Saccoccio, chief executive of the National Health Care Anti-Fraud Association.

Part B payments to doctors were released last week for the first time. A court injunction that had kept the information secret for 35 years was lifted last year as a result of a lawsuit by Dow Jones & Co., parent company of the Wall Street Journal.

But Medicare has long had access to the information. "They're the ones doing the paying," Saccoccio said.

Aaron Albright, a spokesman for the Centers for Medicare and Medicaid Services, said he could not discuss the status of individuals, such as Greenbain and Tran, both of whom were finally barred from billing Medicare this month.

By that time, Greenbain had pleaded guilty and been sentenced to four years in prison. Tran had been found guilty and trial and was sentenced to five years. She is appealing her conviction.

Albright said the Medicare payment data may not reflect money already recovered by his agency or held back from providers suspended from billing the program.

Preventing improper payments is a top priority for CMS, Albright said. The agency has employed new enrollment screening techniques to prevent high-risk providers from getting into the system and is using advanced data analytics to spot fraudulent billing before payments are made, he said. "Already, we have cracked down on tens of thousands health care providers suspected of Medicare fraud," he said in an email.

Medicare's fraud-fighting efforts have been criticized repeatedly in recent years. In an audit released last month, the inspector general of the U.S. Department of Health and Human Services found that about one-third of states hadn't told CMS when they terminated providers from Medicaid and others had provided incomplete information, hobbling regulators' ability to flag sanctioned professionals.

In December, the inspector general faulted Medicare for not systematically reviewing the billings of the program's top-paid doctors and said it should be doing more to spot aberrant claims.

Last year, ProPublica reported that doctors who had been terminated from Medicaid or had been disciplined by state medical boards were able to continue prescribing medications to beneficiaries in Medicare's drug program, prompting Sen. Charles Grassley (R-Iowa) to push for better coordination.

Medicare has more direct responsibility for overseeing activities in Part B than in the drug program, which is administered by private insurers. The drug program doesn't even require that prescribers be enrolled in Medicare and payments go to pharmacies, not doctors. By contrast, in Part B, it's up to Medicare to monitor services and payments, which go to clinicians or their employers.

"There's been a disconnect between Medicaid and Medicare on problem providers," wrote Grassley, ranking Republican on the Senate Judiciary Committee, in an email to ProPublica. "The release of Medicare billing data should help force better communication between Medicaid and Medicare on these providers. The new transparency makes it harder to ignore when doctors who harm patients or defraud taxpayers in one program face no consequences in the other program."

Sen. Tom Carper, (D-Del.), chair of the Senate Homeland Security and Governmental Affairs Committee, credited Medicare with ramping up efforts to verify the credentials of those treating its beneficiaries. "But there is still much work to be done," he said in a statement.

Among the physicians ProPublica found who continued to collect Medicare payments after being flagged by law enforcement or other oversight agencies:

Dr. Lawrence Eppelbaum, a Roswell, Ga., pain doctor convicted last year of inducing patients to be treated at his Atlanta pain clinic by paying their travel fees through a purported charity he controlled. He was indicted on the charges in March 2011, but Medicare paid him $500,000 to treat 80 patients the following year. This February, Eppelbaum was sentenced to 50 months in prison and fined $3.5 million. He is appealing.

In a sentencing memorandum, Eppelbaum's lawyer maintained that Medicare did not lose any money because of the doctor's conduct. "Virtually every patient would have received treatment somewhere, by some doctor," he wrote. "Thus, Medicare would have paid the exact same amount of money, albeit possibly to another provider."

Michigan ophthalmologist Matthew Burman was suspended by the state's Medicaid program in 2009 after he was convicted of a misdemeanor count of criminal sexual conduct arising from a patient's accusation against him. He subsequently surrendered his medical licenses in Texas and California and agreed not to activate his registration in New York. He was paid $379,000 by Medicare in 2012. (Medicare has not released payment data for prior years.)

Burman, who continues to practice in Michigan, said he could have re-enrolled in Medicaid but chose not to. "One has nothing to do with the other," he said. "I didn't violate any Medicare rules. Medicare has nothing to do with why I'm not a Medicaid provider."

Las Vegas pain doctor Steven Kozmary agreed in December 2011 to pay the federal government $1 million to settle health care fraud allegations involving Medicare and other programs. The government could have moved to terminate him from Medicare, according to the settlement. Instead, in 2012, Medicare paid him $563,000. He was disciplined by Nevada's medical board in 2013 related to the 2011 settlement. He did not return a phone call.

Louisville Dr. Steven Stern and his practice paid $350,000 to settle allegations of overbilling Medicare in September 2011. He and his practice were accused of overbilling Medicare for infusing Infliximab, a drug used to treat rheumatoid arthritis. Specifically, they were accused of splitting vials of the drug across multiple patients but billing as if a whole vial was used for each. In 2012, Stern received more than $3 million in payments from Medicare, including $2 million for infusing Infliximab. He did not return a phone call seeking comment.

Eight of 14 New Jersey health providers arrested in December 2011 on charges of receiving kickbacks for referring Medicare and Medicaid patients to a specific MRI center continued to be paid by Medicare in 2012. At the time of the arrests, Tom O'Donnell, special agent in charge for the HHS inspector general said, "The audacity of these physicians should offend honest taxpayers, especially at a time when our taxpayer resources are stretched thin."

Even a guilty plea sometimes wasn't enough for Medicare to cut off payments. Dr. Anthony Jase of New Orleans pleaded guilty to two counts of health care fraud in October 2011. He still collected $97,460 for Medicare billings in 2012. Last fall, he was sentenced to 15 months in prison and ordered to pay $360,293 in restitution.

"It certainly looks like there is a need for more attention," said Mark McClellan, former administrator at CMS who is now at the Brookings Institution. "One important consequence of the release of this information at the physician level is that it will lead to some further analysis and actions against these truly outlier physicians who are clearly billing improperly."

ProPublica's analysis also found payments to doctors who were subsequently barred from billing the program by the HHS inspector general, mostly because of fraud convictions. Medicare paid 135 of them more than $18 million in 2012, before they were kicked out.

Some doctors have been indicted post-2012, including Michigan oncologist Farid Fata, a Michigan oncologist who was paid $10 million in 2012, ranking him among Medicare's top-paid providers that year. Last year, Fata was accused of misdiagnosing patients with cancer so he could give them unnecessary, expensive treatments. Fata has pleaded not guilty; his lawyer did not respond to a request for comment.

In a conference call last week with reporters, CMS' principal deputy administrator Jonathan Blum said the agency knows it can do more to find fraud. "We know that there's waste in the system. We know that there's fraud in the system. We want the public's help" to review the physician payment data and report suspected wrongdoing.

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Small Business and the Affordable Care Act: How Has Your Business Been Affected?

Small Business and the Affordable Care Act: How Has Your Business Been Affected? | Healthcare and Technology news |

The Affordable Care Act is having a lasting impact on small businesses, affecting how owners make decisions about hiring and managing staff, upgrading equipment and more.

Among them are entrepreneurs being profiled by the Journal as part of its “Faces of the Affordable Care Act” multimedia feature—Tommy Cain, owner T. Cain Grocery Inc., of Fairhope, Ala., and Erin Patinkin and Agatha Kulaga, co-owners of retail and wholesale bakery Ovenly LLC of Brooklyn, N.Y.

The grocer is concerned that he’ll be forced to raise prices if more of his 240 employees sign onto his company’s insurance plans next year. And while the bakers have a staff of just 27, and are therefore exempt from the law’s employer mandate, they’re challenged with finding a way to continue offering coverage despite rising insurance premiums under the law.

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CDC Would Sacrifice Kids To Cut Healthcare Costs

CDC Would Sacrifice Kids To Cut Healthcare Costs | Healthcare and Technology news |

The U.S. Centers for Disease Control and Prevention (CDC) appears to have assumed a role that was never intended: reducing the ability of vaccines to save lives.  At their past two meetings, the CDC’s vaccine advisory committee, the Advisory Committee on Childhood Vaccines (ACIP), has debated whether to eliminate the fourth (and last) dose of the pneumococcal vaccine given to infants, although there is evidence showing this would cause more disease and even deaths.

Pneumococcal disease is caused by infection of bodily fluids and various organs by a bacterium called Streptococcus pneumoniae, or pneumococcus.  It can be relatively harmless, such as when it causes the self-limited ear infections that occur in hundreds of thousands of children annually, but it can also be extremely dangerous.  It can infect the lungs and cause pneumonia, and if it enters the blood stream, pneumococcus can cause invasive disease, resulting in infections of the blood, internal organs, brain or spine.  (Its presence in the blood is known as bacteremia and inflammation of the membranes that cover the brain and spinal cord is called meningitis; both are life-threatening illnesses.)

English: This is CDC Clinic Chief Nurse Lee Ann Jean-Louis extracting Influenza Virus Vaccine, Fluzone® from a 5 ml. vial. (Photo credit: Wikipedia)

For years, the CDC has recommended four doses of pneumococcal vaccine — at 2, 4, 6 and 12–14 months of age (referred to as the “3+1” schedule — three primary doses, plus a booster) — as the way to protect children optimally against these infections.  Recently, however, the agency’s bureaucrats have favored eliminating the last dose, although it is known to boost children’s immunological response, making them better able to resist infection.  The primary reason cited is cost savings.  (The federal government is by far the largest purchaser of pediatric vaccines.)  Fortunately, the ACIP has remained skeptical.

Removing the fourth dose would result in savings of about $500 million a year, but consider that just over $100 per dose for the four-dose schedule provides lifetime protection against covered strains of pneumococcus.  Another benefit is the “indirect effect” of the vaccine – “herd immunity” protection of the recipient’s friends and family contacts.  And compare this penny-wise, pound-foolish approach to the absence of cost-benefit considerations in other areas of health care: A single 18-week regimen of a certain new lung cancer drug costs $80,000 to prolong a patient’s life just 1.2 months.

The prospective cost savings would not come without risk; eliminating the last dose of pneumococcal vaccine would result annually in at least two deaths, 44 cases of invasive pneumococcal disease, 12,000 cases of pneumonia and 261,000 ear infections.  Moreover, the cost-savings calculation assumes that drug companies would not simply raise the price of the vaccine in order to compensate for fewer doses being purchased.

According to Dr. Michael T. Brady, chair of the American Academy of Pediatrics infectious diseases committee and an ACIP liaison representative, the reduced schedule may particularly put black children at increased risk of disease.  He noted at the last meeting that he “would hate to find that we actually do need higher levels of antibody to protect African American children.  If we went to a schedule that was either 2+1 or 3+0, and we now returned to having a disparity, I would be very uncomfortable.”

Disparities among those who fall below the poverty line already exist, regardless of race.  Children whose families live in poverty are currently more likely to receive only three doses of the vaccine.  According to the latest CDC data, at least three doses are necessary to fully protect most children.  If the official schedule is reduced to three doses it is probable that many of these children will then receive fewer than the prescribed number of doses, further increasing their risk of contracting pneumococcal disease.

This is not the first time the CDC has chosen to leave infants vulnerable in order to save money.  As I pointed out in 2011, the CDC at that time refused to recommend a meningococcal vaccine for infants in spite of the proven effectiveness of the vaccine, because of its high cost.  Clearly, fiscal considerations are beginning to trump public health at one of the nation’s premier public health agencies.

In an attempt to obscure their focus on cost, the CDC claims that removing a dose of pneumococcal vaccine will increase parental confidence in immunizations by decreasing the number of vaccines on the schedule.  That argument is weak.  If a parent is concerned about the safety or number of vaccines, the CDC’s eliminating a dose of pneumococcal vaccine – which would make infections more likely — should serve to boost, not dispel, skepticism about vaccines.

Under the CDC’s rationale, why not remove poliovirus vaccination from the schedule?  After all, we haven’t seen a case in this country in years, so arguably it is just overloading the vaccination schedule.  But that would be a terrible and irresponsible strategy.  We know that a resurgence of polio – the cause of dreaded “infantile paralysis” – could be just a plane ride away.  Pneumococcal disease is even closer.  Children can be killed or permanently disabled if they aren’t properly vaccinated.

CDC officials should go back and read the agency’s mission statement, which includes this commitment: “As the nation’s health protection agency, CDC saves lives and protects people from health threats.”  And then they should rethink weakening the schedule for pneumococcal vaccine.

Henry I. Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution; he was the founding director of the FDA’s Office of Biotechnology. 

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Facebook Acquires Fitness And Activity Tracking App Moves | TechCrunch

Facebook Acquires Fitness And Activity Tracking App Moves | TechCrunch | Healthcare and Technology news |

Facebook has acquired the motion tracking app for Android and iPhone ‘Moves,‘ the startup announced today via a blog post. The company’s founders say that the Moves crew will join Facebook’s team to “work on building and improving their products and services” and that the Moves app will continue to operate on its own as a standalone experience. Currently, Moves says that there aren’t any plans to bring Moves data to Facebook’s social graph directly, or change how it operates, so this sounds like it could be another case similar to that which Facebook employs with running WhatsApp and Instagram. Facebook founder and CEO Mark Zuckerberg recently revealed his company’s broader app strategy in an interview with the NYT, and in that discussion, he acknowledged that the company would be building a number of experiences, some of which would carry FB branding and some of which would not. No price was disclosed for the acquisition, but it buys Facebook entry into the emerging fitness and activity tracking market. Moves is an app-only solution in this space, which seems to be a wise move for Facebook at this stage, as Nike has recently shown signs of exiting the hardware portion of the business, and there are broader indications that the fitness gadget market has been slow to start so far. The fitness and health software market seems poised to explode, however, especially as major tech companies like Apple and Google continue to build platforms and devices designed to better track user activity and translate that into health-related data. Companies like Moves differentiate themselves based on their own unique movement data interpretation algorithms, which turn info gathered from sensors built into devices like accelerometers into user-friendly stats like steps taken, calories burned and more. According to the WSJ, Moves has racked up more than four million downloads across Android and iOS since its launch last January. The app also offers an API for third-party devs to build software using its data, and the catalog of apps employing that access now numbers above 40. Access to the API will remain open under the new ownership.

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Scientists Think Your Body Clock Was Set Before You Were Born

Scientists Think Your Body Clock Was Set Before You Were Born | Healthcare and Technology news |

There's a tiny but critical collection of neurons in your brain that tells you what to do and when to do it. 

It's only the size of a mustard seed, but the suprachiasmatic nucleus, or SCN, regulates when you eat, when you sleep, when you feel thirsty, along with a litany of functions related to social and sexual behaviors. 

This little mustard seed is the master clock that keeps your brain and your body synced up. It's what what makes one person a night owl and the next a morning lark. And those characteristics appear to be genetic, decided before you were even born, says Seth Blackshaw, an associate professor of neuroscience at Johns Hopkins.

Blackshaw is the author of a new study about the development of the SCN, and his team's findings represent a major step toward better treatments for sleep disorders, even jetlag.

Sleep problems are considered a "public health epidemic," according to the Centers for Disease Control and Prevention. And people's sleeping habits change as they age, a fact that's well established but little understood. 

"The shift toward later bedtimes in teenagers, that's really not understood at all at a molecular level," Blackshaw told me. "Teenagers tend to be night owls and as you age you generally tend to shift to being a lark. Nobody really knows why. But it's known that cellular synchronicity within the SCN deteriorates as you age."

We also know that messing with our body clocks feels bad. But being awake when your body wants to sleep is also bad for you. 

Studies show that people who work graveyard shifts never completely adapt to their nocturnal schedules. Those workers often have problems with high cholesterol, obesity, and diabetes. Some studies have found working overnight may even increase a person's risk of getting cancer or having a heart attack. 

Here's the crazy thing: The clock that keeps you on track isn't just in your brain, but all over your body. Every cell is its own timekeeper rigged up to the SCN master clock, and all those cells have to be properly connected to the SCN to stay in sync. Blackshaw knows this because he tried disrupting the connection. 

What he found in the mice was "remarkable" disruption when his team removed a key gene that helps the SCN communicate with other cells. Instead of going about their day on a normal 24-hour schedule, mice started operating as if they had two or even three body clocks governing their behavior at the same time. 

"When we take a close look at their rhythms, we start to see real problems," Blackshaw said. "So the clock is still running but it's not as well synchronized. It looks like light can still synchronize their activity rhtyms. But if we put them in the dark... and just examine the core circadian oscillator, we find that it's just massively disrupted."

This matters for humans because we know that there are people out there who have altered circadian rhythms—people who are severe night owls, or those might call themselves both morning people and night owls depending on the day. 

Looking more closely at a person's suprachiasmatic nucleus could also help explain why some people who work regular day-time hours develop health problems. If there's a mismatch in synchronicity between someone's master clock and the rhythms in the rest of his cells, that may be a clue that there's something bigger wrong with the SCN or its proteins. 

"This tiny little structure controls many, many things," Blackshaw said. "We're talking about a very broad range of physiological processes including not only metabolism but also mood, cognitive function as well, memory, depression, and also reproduction."

All of this raises a question about all those other clocks—the rhythms in every cell that take cues from the SCN on timing. If the master clock is so important, why do we even have all those mini clocks?

Scientists aren't really sure.

But Blackshaw suspects it may be a matter of redundancy. Cell-level clocks—which can keep time without the SCN working for a matter of hours or days after a disruption—are "gyroscopic stabilizers, training wheels on a bike, actually many sets of training wheels."

But your body's clockwork may instead be something simpler and more profound. It may have to do with where all humans begin—as single cells. 

"Because if you think about it, single-celled organisms like blue-green algae maintain their own clocks, too," Blackshaw said. "It could well be that the whole process starts with a single-cell oscillator, or clock, that's really baked into the cake when you start to evolve multi-cellularly. It's engineered really deep into the system."

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What Surgeons Know About Picking Doctors (And You Don't)

What Surgeons Know About Picking Doctors (And You Don't) | Healthcare and Technology news |

This is Part Two of my interview with Dr. Marty Makary, author of Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care. Yesterday, he talked about how patients can make decisions about their care. Today, he discusses something a bit more personal: how he helped his Dad choose a surgeon and how we need much more transparency.

LB: Pretend for a moment you didn’t know the physicians in your community. How would you pick one if someone in your family needed surgery? Where would you get information?

MM: It’s funny you say that because my father recently needed his gallbladder removed, and it’s an operation that I do frequently. He doesn’t live near me, so I didn’t know the doctors personally. I checked out the hospital, checked out the surgeon, talked to people there. Turns out sometimes an emergency room nurse knows more about quality than any metric out there, because they know which doctors respond to their pages, see their complications in the ER, and which surgeons take a personal interest in their patients’ problems instead of dishing them off to the covering doctor. I felt that he was in a group that performed well (Geisinger in Pennsylvania), and it went very well, thank goodness.

LB: Many of us aren’t going to call around to the physicians and nurses at the hospital we are considering for surgery. Are there other options for getting information?

MM: I would probably look at everything and then decide what makes sense and what doesn’t: Medicare’s website, Leapfrog*, the Hospital Safety Score*, the Society of Thoracic Surgeons results, patient satisfaction results, the credentials of the surgeon, and online reviews with a critical mass.  Beware of sporadic reviews, as they can be misleading. I don’t know that any doctor or hospital has perfect performance across every measurement system. But that’s okay. Some aspects of being a good doctor are not measureable.

LB: Some hospital leaders say the information they collect is very sensitive and might be interpreted the wrong way if it’s made public.

MM: When someone walks in to the ER, they will trust me to put a knife to their skin within seconds of meeting me – because I’m the doctor and they’re at the hospital. Patients give us this enormous trust, and the question is whether they deserve to see our performance. I think it’s reasonable to expect transparency from a nonprofit institution that’s dedicated to serving a community, with the noble and important mission of caring for the sick and injured.

These days, we have many great ways to measure quality in the hospital, and the data are actively being collected, but it’s kept totally confidential. Why is the data proprietary? That’s an important ethical dilemma facing our society right now as the data is being collected: Does the public have a right to know?

Surgeons (Photo credit: libertygrace0)

LB: Is that message about transparency the reason you wrote Unaccountable?

MM: The book was my attempt to share personal experiences and call out the great success stories in American transparency that have revolutionized health care. As a matter of fact, the title I loved the most of the prospective titles is what’s now in the subtitle: “How transparency can revolutionize health care.”

In my opinion, the book is a series of positive stories about the amazing work of a lot of people, and I’m the observer. For example, I learned about open notes where patients get an instant copy of their notes after the doctor’s visit, and how that increased the trust between these doctors and their patients. I learned about video-based peer review, where doctors who knew that a colleague was going to review their procedure and provide feedback suddenly changed the way they did that procedure so that it complied with best practices. I learned about how the University of Utah and Cleveland Clinic publish patient satisfaction scores, and that has driven near-universal improvement in physician performance.

This movement for transparency in health care parallels the movement for transparency in American society. We expect transparency from the White House or in the way bills are written in Congress. I can see where cabs are in my area and hail one on my cellphone. The students at Johns Hopkins Medical School demand transparency with their grades. That’s not the sort of experience we had when I was growing up.

For one, I’m privileged to be part of the dialogue. It’s very refreshing, very exciting. I have a great deal of hope for the future.

*Disclosure: The Leapfrog Group administers The Hospital Safety Score. Dr. Makary has no official or financial relationship with Leapfrog.

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America's Broken Health Care System: The Role of Drug, Device Manufacturers

America's Broken Health Care System: The Role of Drug, Device Manufacturers | Healthcare and Technology news |

Health care costs are dramatically higher in the U.S. than in the rest of the world. Yet our health care outcomes – from life expectancy to infant mortality – are average at best. There is little dispute over these facts.

The real debate comes when we ask why. While there isn’t one single answer, the rapidly rising cost of drugs and medical devices is a significant factor.

And the magnitude of this problem is likely to spike in the future if not properly addressed.

Pharmaceutical and medical device manufacturers have been criticized for their role in health care for over a decade. Little has changed. Americans pay significantly more for prescription drugs and medical devices than patients in the rest of the world.

The justifications for these extraordinarily high prices vary, but the industry is well aware that most patients have no choice but to pay whatever they charge.

The rising cost of American health care has close ties to the rapidly rising cost of prescription drugs and medical devices. (Photo credit: Wikipedia)

Pricing Not Always Justified, Even For Better Products

Pharmaceutical pricing has long been a point of contention among manufacturers, patients and payers of health care (including insurers, employers and unions).

The U.S. drug patent system allows a drug discoverer to exclusively sell the new drug for an extended time period. Theoretically, this protection is designed to encourage new medical discoveries and enable a drug or device company to recoup its R&D investment.

Because the theory makes sense, drug manufacturers use it to defend their prices. Certainly, those higher prices could be justified for developing clinically superior products but, all too often, the added cost far exceeds the incremental benefit.

How does drug pricing work? It’s hard to say. Pharmaceutical pricing is opaque. Drug manufacturers aren’t asked to quantify their costs or compare them to projected sales and profits. Business school students learn that the price of a product isn’t determined by what’s reasonable but what the market will bear. A wide array of drug pricing examples would indicate that pharmaceutical and medical device companies hire a lot of business school graduates.

How One Drug Might Earn It’s Maker A 2,500% ROI

Take sofosbuvir, a new drug used to treat Hepatitis C. It’s marketed as Sovaldi by Gilead Sciences.

As a more effective treatment of Hepatitis C than those available today, this drug will be a positive addition to the physician’s armamentarium. Its effectiveness at ridding the body of this virus justifies a higher price than the treatments available today.

But at $1000 a pill, its pricing is exorbitant, monopolistic, and disrespectful to the purchasers and patients who will bear the brunt of the massive cost.

It is estimated that total treatment costs will range from $84,000 to $200,000 per patient, depending on treatment length. That’s 10 to 20 times the cost of today’s approach. Is this a reasonable return for the company?

Drugs this expensive are typically produced for those with rare conditions. These “orphan drugs” should cost more per patient because of the limited treatment population. But Hepatitis C is a very common disease. It affects nearly 4 million Americans, according to the American Liver Foundation. So, this can’t be the reason.

High development costs are another oft-cited explanation for extremely high drug pricing. Typically, manufacturers don’t disclose exact R&D costs but Gilead is reported to have paid $11 billion for Pharmasset, the drug company that developed the medication that led to Sovaldi. From this purchase price, we can estimate the R&D costs of this drug.

At Sovaldi’s price-point, Gilead is estimated to recoup its total investment in less than 18 months with revenue estimates of $269 billion over the drug’s lifespan.

That would be a 2,500 percent return on investment.

Manufacturers of luxury cars or yachts can rightfully charge wherever they choose, but when patients in need have no alternative option, that’s just wrong. Interestingly, two other drugs with similar therapeutic responses will be available in the near future. It will be fascinating to see how they’re priced.

Compounding the high price of many medications is the reality that patients in others countries don’t pay nearly as much as those in the United States. The reason is that most governments across the globe regulate drug prices. To date, the U.S. Congress has prohibited the practice here.

The result is that drug sales in the U.S. subsidize a disproportionate share of a drug company’s research costs and contribute to much of the company’s margin, regardless of where in the world it is headquartered. If we want our businesses to be globally competitive, this needs to change.

Aggressive Advertising Gives Manufacturers An Edge

Clinically superior products may very well warrant incrementally higher prices. But what of the increasing prices for products that don’t add much value?

Let’s compare the laparoscope to the prostate robot. First, the laparoscope.

In the past, removing a patient’s gallbladder required a large abdominal incision. Then along came a new technologically enhanced laparoscopic removal with remarkably better results. Suddenly, rather than making an incision under the entire right rib cage and cutting through the abdominal muscles, surgeons could remove the gallbladder with two tiny punctures and a telescope-like device.

Before, the surgeon would have to leave large rubber drains in place for several days to reduce the risk of infection. Average recovery times took up to six weeks. In contrast, gallbladder removal today is a routine, minimally invasive outpatient procedure that most people recuperate from in a week.

Laparoscopic surgery was a miracle advancement. Hardly the same story as the prostate surgery robot.

Mention “robot” to most patients and they’ll assume it’s a space-age advancement with major clinical benefits. It sounds sexy and, intuitively, its approach to prostate surgery makes sense. After all, the robot has steady hands and requires a smaller incision.

The problem is the outcome data doesn’t support the hype or the cost. The results – in terms of both cancer eradication and surgical complications – are similar to traditional alternatives, according to most studies. And for most surgeons, the robot-assisted procedure takes longer.

The price tag for this device is over $1 million, but that’s just the beginning. The company behind the robot designed it with disposable “arms” and built in an obsolescence factor that forces the hospital to replace each arm after 10 uses. The motivation isn’t safety. It’s profit. The manufacturer could have built a robot that could complete 100 procedures. But that would reduce profits dramatically.

If the robots add little clinical value yet significantly increase costs, why do so many hospitals tout them? The answer: Aggressive advertising.

By simultaneously marketing to consumers and hospitals, these devices were strategically positioned to help hospitals lure patients from their competitors. And, of course, it worked. Big billboards helped early adopting hospitals attract patients with the promise of a new “high-tech wonder.” Once a few hospitals jumped on board, others had no choice but to follow.

Since the robot’s introduction, academic medical centers (university hospitals) train their surgical residents almost exclusively in its use. Gone or going are the more traditional methods. Unless patient expectations change or expanded competition is permitted, this will ensure that the manufacturer sees a large revenue stream for decades to come.

The result: This device will drive up health care costs significantly in the future, while clinical outcomes remain relatively unchanged.

Minimally Different Drugs Launched At Maximum Prices  

Even when a new product is essentially the same as an old one, manufacturers use their patent protections and market control to drive up revenues. A great example is an injectable drug for a medical problem called “wet macular degeneration.”

Manufactured by Genentech, Avastin is an FDA-approved drug for cancer treatment. It slows the growth of new blood vessels that feed a tumor.

A while back, a thoughtful group of ophthalmologists recognized that if this drug could limit blood-vessel proliferation to stop tumor growth, it might also be useful in slowing the overgrowth of blood vessels inside the back of the eye – the cause of wet macular degeneration.

These physicians tried injecting a very small dose of Avastin at about $60 per treatment with excellent clinical results.

But here’s where it gets interesting. Genentech recognized the same opportunity at about the same time. And instead of recommending Avastin as an effective treatment, Genentech created Lucentis, a new drug with a biologically active component identical to Avastin.

Once Genentech received FDA approval, it priced Lucentis at $2,300 a dose, never showing that it was superior to Avastin at $60 a treatment.

Ophthalmologists across the country were outraged. Adding insult to injury, Genentech tried to embargo sales of Avastin for non-oncology practices. Not surprisingly, when the National Eye Institute tested Lucentis against Avastin, it found essentially no difference for a drug priced 40 times higher.

Change Is Possible, Not Easy

There are legitimate reasons why some drugs and devices are very expensive. But it’s common for manufacturers to hike up prices even when the magnitude of improvement is minimal.

If we’re serious as a nation about making health care more affordable while increasing quality outcomes, we’ll need to rein in these practices.

We can begin by demanding that drug companies disclose the true cost of development as part of the FDA approval process. Regulatory agencies could then use that information to evaluate the appropriateness of the price.

The FDA could also require all new agents and devices to be tested against existing approaches so that pricing and incremental value can be measured. Finally, we can make all of this information available and transparent to patients, so they can make the best decisions for themselves.

Health Care Is Different From Retail, Needs To Be Treated As Such

Outside of health care, people can choose whether to pay inflated prices for a patent-protected technology or minimally better products. But patients don’t have that same choice – at least not without facing potentially serious health consequences.

No doubt, patent protection for drugs and devices needs to protect the company and the investments it has made. But their economic gain must be balanced against a certain level of social responsibility. Unfortunately, that balance doesn’t exist today and change will be hard to accomplish in this current political environment.

Elected officials receive large campaign contributions from “Big Pharma,” preventing legislative change. Hospitals hype new technologies to attract more patients, even when the benefit is marginal and cost is exceedingly high. And at the first sign of resistance, drug companies spend millions on direct-to-patient advertising while continuing to wine and dine doctors (even with the implementation of the Sunshine Act, which is designed to prevent these practices).

However, there may be a flicker of hope. Recent public disclosures of new Hepatitis C medication prices have sparked national debate. Congressional leaders are starting to question drug manufacturers’ pricing schemes. And maybe this time, greed has exceeded reason. Maybe there will be regulatory backlash. But patients and employers will need to demand it.

Americans should understand that these exorbitant health care costs are not free. They come out of their paychecks and reduce the amount of public services the government can provide.

Our health care system is broken and – given the drug pipeline aimed at maximizing prices and profits – the problems will get worse if change doesn’t happen soon.

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The Case for Seeing a Nurse Instead of a Doctor

The Case for Seeing a Nurse Instead of a Doctor | Healthcare and Technology news |

America is changing—it’s getting grayer, fatter, and more medicated. But luckily, it’s also getting a lot more insured.

A few days ago, the Obama administration announced that eight million people signed up for health insurance under the Affordable Care Act, but that’s just the beginning.

Partly as a result of the ACA’s expansion of Medicaid, the health insurance program for the poor, Medicaid enrollment is projected to grow by 11 or 12 million each year until 2024.

So who is going to treat these people?

There’s no way to know how doctors will respond to the surge in demand. Some pundits are predicting bread lines for biopsies, particularly in areas that already face a shortage of doctors. Others think more doctors will refuse to see new Medicaid patients, as already about a third do. Another theory is that doctors will increasingly assign routine tasks to nurses and physician assistants, thereby freeing themselves up to do more complicated procedures.

According to a new study, that third option might be the best way to go.

We don’t know which of these paths any given doctor will choose when faced with a wave of newly insured Obamacare patients. But a new study from the National Bureau of Economic Research tracked what happened when dentists in several states were faced with the same quandary.

Dental insurance isn’t a mandatory benefit for adults under Medicaid, but some states provide it anyway. The NBER paper looked at the way dentists adjusted to an influx of Medicaid patients in states where the program was expanded to include dental care for adults, using responses from the Survey of Dental Practices collected between 1999 and 2011.

What they found should come as a relief for those worried that the ACA will lead to long waits for doctors or fewer doctors participating in Medicaid.

As it turns out, in states that added the dental benefit, more dentists started participating in Medicaid—there was an average increase of about 15 percent. 

Medicaid dental coverage by state (dark gray) and year (NBER)

As we might expect, more people also wanted to see the dentist in those states. To squeeze everyone in, dentists worked an extra half hour per week, their appointments with each patient became about a minute shorter, and patients had to wait an average of an extra half-day for an appointment. The dentists also made more money—between $15,477 and $20,480 more a year.

But the study also found that while the dentists saw about three additional patients per week, their hygienists saw four or more extra patients. And that’s the key to how the dentists managed the uptick in patients: They just relied on their assistants more.

Even though dental hygienists are trained to do everything from teeth cleanings to x-rays to, in some cases, diagnosing tooth problems, only about two-thirds of the dentists in the authors’ sample employed a hygienist. In states that added the Medicaid dental benefit, however, dentists were more likely to have hygienists working for them.

What’s more, states that allowed the hygienists to practice more like regular providers—with greater autonomy and with the ability to bill Medicaid directly—were less likely to see an increase in wait times with the Medicaid expansion. It seems like dentists were simply shuttling some of their new patients directly to the hygienists, and the states that made that process easier had the smoothest adjustment.

This study presents a strong argument for more liberal “scope of practice” regulations. Allowing physician assistants and nurses to take on more responsibility would help ease the burden on primary care physicians when Americans take their brand-spankin new insurance cards for a spin. Nurse practitioners, for example, can already practice independently in 16 states, but others require them to get sign-offs from doctor-supervisors as they treat their patients.

Attempts at streamlining the state laws have gotten tangled in fights between nurse lobbying groups, who say nurse practitioners are just as competent as doctors, and doctor lobbying groups, who say that their advanced medical training makes them better providers. We’ll see if doctors’ groups stick to that position when faced with more patients, less time, and too few other doctors available.

The surge in insured people from Obamacare very well might strain doctors’ ability to see everyone. But if the experience of these dentists is a guide, that might simply mean we’ll start getting our basic medical needs met by nurses, physician assistants, and other non-doctor doctoring types.

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Healthcare IT Security Brings Challenges, Opportunities, but No Big Surprises

Healthcare IT Security Brings Challenges, Opportunities, but No Big Surprises | Healthcare and Technology news |

Few contest the notion that healthcare IT security needs to improve. The sensitivity (and black-market value) of patient data makes the industry a frequent target of thieves, while the age and usability of technology in many facilities makes healthcare professionals seek portability of data, paper or otherwise, with occasional unintended consequences.

Several recent reports shed some light on healthcare IT security, noting where the industry faces its biggest challenges and highlighting what it can do to better prevent data breaches. Admittedly, few of the findings are surprising, though the advice certainly can't hurt.

Verizon Business' Data Breach Incident Report (DBIR), which examines data breach information from 50 global organizations, finds that 46 percent of healthcare data breaches are the result of loss or theft. Insider misuse (15 percent) and "miscellaneous errors" such as publishing errors or improper disposal (12 percent) round out the top three causes.

Across all industries, not just healthcare, loss is 15 times more likely than theft. The main challenge, the DBIR says, is mitigating the impact of lost devices. "That suggests simply having sensitive information 'behind locked doors' isn't enough; there are still a lot of people inside those locked doors," the report says, adding that, when it comes to thieves, 86 percent either disable or bypass controls to get behind those doors.

Backing up and locking down data will help, as will encouraging users to keep mobile devices on them at all times, but encryption represents the easiest way to thwart this challenge. In fact, the DBIR says, "Encryption is as close to a no-brainer solution as it gets for this incident pattern." It's easier said than done, though, since healthcare notoriously resists encryption.

Kevin Haley, director of Symantec Security Response — which recently issued its own 2014 Internet Security Threat Report — says healthcare may eschew device encryption due to concerns about viability, deployment, the need to update desktop software and the cost. On top of that, he says, measuring return on investment is difficult.

Symantec's report found that, of all reported breaches, 37 percent came from healthcare. Haley cautions against reading too much into that, though. HIPAA regulations require healthcare to report every breach involving more than 500 individuals, whereas "many industries are less forthcoming when a breach occurs," according to the Symantec report. "For instance, if a company has trade secrets compromised, which doesn't necessarily impact clients or customers directly, they may not be quite as forthcoming with the information."

In addition, while healthcare was responsible for 37 percent of all reported breaches, these incidents constituted only 1 percent of all identities exposed in 2013, which Symantec calls "The Year of the Mega-Breach" thanks to Target and others. "Clearly [healthcare is] experiencing a lot of breaches, but they are generally small in nature," Haley says.

Insider misuse of data — the second most common cause of healthcare data breaches, according to the Verizon DBIR — most often results from the abuse of privileged access to desktop computers, databases and servers. "Most insider misuse occurs within the boundaries of trust necessary to perform normal duties," the report says. "That's what makes it so difficult to prevent."

To prevent this from happening, healthcare organizations need to intimately know their data and who has access to it, the DBIR says. They need to watch for data exfiltration, regularly review user accounts and publish the results of any audits they conduct.

Any employee accessing data that's not required of his or her job or department needs to be flagged, says Suzanne Widup, a senior analyst with Verizon Business and DBIR author. "It's all about knowing who has access to sensitive data," she says. Better that you discover fraud and nip it in the bud, she adds, than to have patients learn the hard way that they're victims of fraud.

The third most common cause of data breaches is almost unique to healthcare and government — so much so that the Verizon DBIR categorizes it as "miscellaneous errors" — and is all too familiar to industry observers. Think paper records that aren't shredded, CD-ROMs that aren't destroyed, X-rays that are nabbed by opportunistic crooks who want the silver that's inside, and mass mailings where a single mistake means thousands receive the wrong record.

Here, again, the solution isn't difficult: Data loss prevention software to monitor email or USB drives, for example, or a policy that treats old hardware like hazardous waste that only IT can dispose of properly.

Cyberattacks, Point-of-Sale Vulnerabilities Still Matter

Though neither point-of-sale (POS) hacks nor cyberattacks rank among healthcare's top data breach causes, Verizon Business and Symantec deem these respective vulnerabilities worthy of healthcare's attention.

Hospitals may use POS systems, for example, to collect copays or let cafeteria patrons pay for food. Many such systems are managed by third-parties; this makes them attractive to thieves, Widup says, as it gives them access to all of that vendor's customers.

To keep POS systems safe, the Verizon DBIR report recommends restrictions on remote access, enforced password policies, robust antivirus software and limits on additional uses — that means no social media sites or games.

As for cyberattacks, Symantec points to several, including the "professionalization" of zero-day threats (23 reported in 2013, more than 2011 and 2012 combined), ransomware (500 percent more prevalent in 2013 than 2012) and, of course, website vulnerabilities such as Heartbleed, which Haley already expects to be a focal point of Symantec's 2014 report.

Across industries, 78 percent of websites had vulnerabilities. Haley says "One in eight [sites] had a very critical vulnerability that would make it trivial for a criminal to get on there and host malware." The overall industry response to Heartbleed was "great," he adds, but "website owners need to step it up to make sure their sites are safe."

To that end, the preliminary findings of the CyberRX exercise, led by the Health Information Trust Alliance and overseen by Booz Allen Hamilton, give healthcare organizations six recommendations for preventing cyberattacks. First and foremost: Participating in a cyberexercise will enhance preparation, no mature an entity's level of technical maturity.

Identify Data That's Most Critical and Guard It With Your Life

Along with the various security measures outlined above, healthcare organizations need to identify the data that's most critical to them and make sure their security and privacy policies place a priority on protecting that, Haley says.

Encryption, as noted, is a great place to start. As Haley sees it, a large number of breaches caused by lost and stolen devices could be prevented if laptops, mobile phones and thumb drives are encrypted. (Under the HIPAA Breach Notification Rule, encryption is one of several ways to render protected health information "unusable, unreadable, or indecipherable." The loss of such data does not constitute a data breach.)

Of course, device encryption would be less of a priority if those darn users wouldn't lose their stuff. However, as the Verizon DBIR report puts it, "If there's anything we know to be true about human nature, it's that losing things and stealing things seem to be inherent predispositions."

Plus, as Haley points out, users can serve as another line of defense against data breaches — provided that they undergo extensive security training and aren't simply handed "a bunch of rules they need to follow."

As Widup puts is: "We'd love to see change. We'd love to see this get better."

Technical Dr. Inc.s insight:

Is your practice secure?  If you haven't had a HIPAA Risk Assessment done in the last 12 months, you aren't.  Contact us at or call 877-910-0004 today to schedule your assessment.

- The Technical Doctor Team

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Medicare chief Jonathan Blum leaving Obama administration

Medicare chief Jonathan Blum leaving Obama administration | Healthcare and Technology news |
April 22, 2014

The Obama administration's top Medicare official is stepping down from his post.

CMS Principal Deputy Administrator Jonathan Blum has been with the agency for more than five years.

CMS Administrator Marilyn Tavenner announced Blum's resignation, effective May 16, in an e-mail to staff.

“Under Jon's leadership, the Medicare program has served as one of our primary drivers to shift our healthcare system to reward quality, care improvement and value,” Tavenner wrote. “The Medicare team's accomplishments are too many to list, but include developing the ACO regulations, implementing our quality framework for Medicare Advantage plans, implementing our competitive bidding program for durable medical supplies, and developing many of our value-based payment strategies.”

Blum helped oversee the unprecedented release earlier this month of detailed Medicare payment data for 880,000 physicians.

Blum was the Obama administration's first political appointee to the CMS in March 2009. Before that he worked on Medicare issues at the Office of Management and Budget. He also served as a top healthcare staffer for then-Sen. Max Baucus (D-Mont.).

Tavenner's e-mail cited unspecified “new opportunities” as the reason for Blum's departure.

(This story first appeared on the website of Crain's sister publication Modern Healthcare.)

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Quarter of Prostate Cancer Patients May Abandon 'Watchful Waiting' Approach – WebMD

Quarter of Prostate Cancer Patients May Abandon 'Watchful Waiting' Approach – WebMD | Healthcare and Technology news |

THURSDAY, April 17, 2014 (HealthDay News) -- Doctors often recommend no treatment at all when a man is diagnosed with prostate cancer, opting instead to keep a close eye on the slow-growing tumor and acting only when it becomes aggressive.

But a new, long-term European study says this strategy, called "active surveillance," has a major flaw -- if men don't come back for regular checkups, doctors won't be able to tell if their prostate cancer becomes life-threatening.

A quarter of prostate cancer patients participating in a Swiss active surveillance study didn't bother showing up for their recommended appointments, lead researcher Dr. Lukas Hefermehl reported to the annual meeting of the European Association of Urology, held this month in Stockholm.

"These findings leave us with a practical and ethical dilemma," Hefermehl, a urologist at Kantonsspital Baden, in Switzerland, said in an association news release. "We often recommend that men go onto an active surveillance program, but these results indicate that more than a quarter of men will disappear from the system."

Active surveillance -- also known as "watchful waiting" -- is a pragmatic treatment strategy derived from two known facts about prostate cancer.

First, prostate cancer grows so slowly in most men that they are likely to die from other causes. Second, the surgery and radiation therapy used to treat prostate cancer often cause impotence, incontinence and other side effects that affect the man's quality of life.

Prostate cancer is the most common cancer in American men other than skin cancer, according to the American Cancer Society, but the 15-year survival rate for prostate cancer is an impressive 94 percent.

As a result, many doctors have concluded it's better to leave the prostate cancer alone and only act if it accelerates.

This new study followed 157 men during 13 years of active surveillance.

Researchers found that after 13 years, about 28 percent of all patients required treatment because their prostate cancer flared up. Nearly all the men were cured of their prostate cancer, with an overall group survival rate of 94 percent.

However, another 27 percent of the men in the study didn't bother coming back for check-ups after being placed on active surveillance, leaving themselves potentially vulnerable to a prostate cancer flare-up.

Researchers also found that about 19 percent of the men refused to undergo a second biopsy three months after their diagnosis, to confirm the results of their first prostate cancer biopsy.

"We don't know exactly what the reasons are," Hefermehl said. "It may be that once the patient was told that this cancer is probably 'not immediately threatening,' he might downplay the importance of another test.

"On the other hand, some men might have real concerns about the risk of there being a more severe cancer," he said. "Or it may be to do with the risk of incontinence or impotence after treatment, the idea of having cancer, a sense that nothing will really happen to them or it may be due to another reason which we just don't know about."

European study tracked how many men came back for regular checkups over 13 years
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Potential Impact On R&D Of A Pfizer Takeover Of AstraZeneca

Potential Impact On R&D Of A Pfizer Takeover Of AstraZeneca | Healthcare and Technology news |

Employees of Pfizer and AstraZeneca were jarred on Easter Sunday morning with The Sunday Times story that Pfizer is mulling a takeover of AstraZeneca (AZ).  For those Pfizer PFE +2.21% folks who have been with the company since 2000, they have already weathered the major acquisitions of Warner-Lambert, Pharmacia and Wyeth, each time dealing with integration, reorganization, and the inevitable “synergies” i.e., the drastic reductions in staff and infrastructure needed to justify the billions spent in each acquisition. AZ is no stranger to this behavior, itself being formed by the merger of Astra and Zeneca in 1999. In addition AZ has made significant acquisitions such as their addition of Medimmune in 2007.

In all major mergers, there are good reasons given by the principals for the business case justifying such a move. However, my own experience teaches that such mergers have a debilitating impact on R&D, the engine of any biopharmaceutical company.  Thus, it is interesting to speculate what might happen if such a takeover would occur.

In 2008, the year before Pfizer’s $68 billion purchase of Wyeth, Pfizer spent close to $8 billion and Wyeth $5 billion on R&D. In 2013, Pfizer spent $6.55 billion. Effectively, Pfizer eliminated 50% of what the individual organizations had spent five years earlier. This massive cut did not come purely from elimination of duplications and improved processes. Clearly, drastic cuts in personnel and closure of research sites had to occur to make this happen. In 2013, AZ Invested $4.82 billion in R&D, almost 19% of its pharmaceutical sales of $25.7 billion. Percentage-wise, Pfizer invested less in R&D with only 13.7% of its biopharmaceutical sales of $47.9 billion. It is likely that Pfizer will take a similar hard line on a new R&D organization should this acquisition occur. Thus, both organization can expect a major round of cost cutting.

Where might these occur? An investigation of AZ’s pipeline, particularly the early and mid-stage assets, could provide some answers. AZ has one of the most transparent pipelines in the industry with every compound, its disease indication/mechanism of action and development stage all listed on its website. The website is pretty current as it was last updated in January. Most interesting is AZ’s oncology pipeline with 24 compounds in phase 1/2 including a number of compounds in the exciting area of immuno-oncology, the hottest area of cancer research right now. There is some overlap in each pipeline and so some compounds will be discontinued. But, for the most part, these are assets that Pfizer will covet. The question in oncology will be where will the future work be carried out? Pfizer consolidated all of its oncology R&D in LaJolla, California back in 2007. It is unlikely that Pfizer would return to a situation where oncology research was split in multiple sites around the globe, particularly as this adds R&D costs. Thus, researchers in both companies will wonder about their future should such a merger happen.

The next major area of emphasis in AZ is in the respiratory disease area. Pfizer discontinued its R&D in respiratory diseases back in 2007, when it decided to work in fewer disease areas. However, two of AZ’s biggest products are for the treatment of asthma and COPD: Symbicort ($3.5 billion in sales in 2013) and Pulmicort ($867 million in 2013). Furthermore, AZ has a dozen early stage candidates in this general area. Suddenly, Pfizer could have a new franchise in respiratory diseases. Both companies, however, have efforts in inflammation/autoimmunity research. Again, this is an area ripe for consolidation with the prioritization of some programs and the discontinuation of others. It is unlikely that Pfizer would simultaneously progress five compounds for Lupus, five compounds for Crohn’s Disease, etc. Again, it would be expected that these research efforts would be centralized in one location further paring infrastructure costs.

As for other AZ areas of research, based on the pipeline, it appears CNS (which follows a largely outsourced model), infectious diseases, and cardiovascular can all be absorbed into existing Pfizer groups. Thus, the facilities where these groups exist could be eliminated in order to provide savings.

Clearly, all of the above is speculation. It is based on a high level analysis made on the assumption that, if such an takeover were to occur, cost savings would be demanded across the new company, including R&D. If such a deal were to be announced, the type of speculation offered here would be rampant in the R&D organizations of both companies. Given that it would be close to a year before the merger would be finalized and approved by regulatory authorities, such speculation will weigh down an R&D organization. In this type of an atmosphere, a lot less science gets discussed. Rather, one worries about whether they will have a role in the new company, whether they will have to move their family to a new site, whether they will be able to work on the same program, whether they will have the same boss, etc. It is not fun. For the sake of the scientists in both organizations, I hope that it doesn’t happen.

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Just say yes? The rise of 'study drugs' in college

Just say yes? The rise of 'study drugs' in college | Healthcare and Technology news |

(CNN) -- Around this time of year, you're more likely to find college students in the library cramming for final exams than out partying. In an environment where the workload is endless and there's always more to be done, a quick fix to help buckle down and power through becomes very tempting.

Prescription ADHD medications like Adderall, Ritalin, and Vyvanse are becoming increasingly popular for overworked and overscheduled college students -- who haven't been diagnosed with ADHD.

Experts reevaluate ADHD drug study

"Our biggest concern ... is the increase we have observed in this behavior over the past decade," says Sean McCabe, research associate professor at the University of Michigan Substance Abuse Research Center.

FDA warns of fake Adderall sold online

Full-time college students were twice as likely to have used Adderall non-medically as their counterparts who were not full-time students, according to a National Survey on Drug Use and Health report released in 2009.

The numbers vary significantly by school, with the greatest proportion of users at private and "elite" universities. Some researchers estimate about 30% of students use stimulants non-medically.

More students think marijuana is OK

"When we look at upperclassmen, the number really begins to jump," says Alan DeSantis, professor of communications at the University of Kentucky who has conducted research on stimulant use in college. "The more time you stay on campus, the more likely you are to use."

Of course, by and large the most common use is to concentrate while studying, with more than 90% of users doing it for this purpose.

ADHD stimulants "strengthen the brain's brakes, its inhibitory capacities, so it can control its power more effectively," said Dr. Edward Hallowell, a psychiatrist and ADHD expert. "They do this by increasing the amount of certain neurotransmitters, like dopamine, epinephrine, and norepinephrine."

Students say they take these stimulants for the "right reasons," to be more productive in classes and to stay afloat in the sea of intense competition.

In a 2008 study of 1,800 college students, 81% of students interviewed (DeSantis 2008) thought illicit use of ADHD medication was "not dangerous at all" or "slightly dangerous." While the picture of a methamphetamine user has hollowed cheeks, rotting teeth, and skin sores, an amphetamine-dextroamphetamine (Adderall) user looks just like anybody else.

"It helps me stay focused and be more efficient, which is very helpful with the chaos of college," says one university student who takes Adderall anywhere from once a month to a few times a week, depending on her schedule and workload. Students did not want to be identified because of their illegal use of the prescription drugs.

Yet these drugs are Schedule II substances, sitting pretty on the Drug Enforcement Administration's list right next to cocaine, meth and morphine.

"College students tend to underestimate the potential harms associated with the nonmedical use of prescription stimulants," McCabe says.

Students may not know the stimulant's documented contraindications (situations in which a drug might be harmful) or recommended precautions or how it may interact with other drugs, McCabe says. Hallowell is also concerned that students taking controlled substances without prescriptions and physician supervision, noting that they may not know the dosage.

How will I handle this course load?

WATCH: ADHD meds don't work long-term

Short-term adverse consequences include sleep difficulties, restlessness, headaches, irritability and depressed feelings. Other side effects include loss of appetite, nervousness, and changes in sex drive.

The long term risk of psychological and physical dependence is of concern for routine users that may find they do not feel they can function optimally without it. Schedule II substances are classified by the DEA as having a high potential for abuse.

While students' knowledge of the health dangers are limited, even less consideration is given to the illegality of use. Obtaining stimulants from friends with prescriptions, as the vast majority of college students do, seems less dangerous and illegal than buying drugs off the street.

"The fact that it's illegal really doesn't cross my mind," one student says. "It's not something that I get nervous about because it's so widespread and simple."

The biggest barrier to changing attitudes is the effectiveness of stimulants on campuses where the ends justify the means, researchers believe. After those late library nights, many students praise the little pill that got them through their hefty textbooks and into the morning.

After taking Adderall, says one university student, "I just feel very alive and awake and ready for challenges that come my way."

"I'm on page 15 (of my paper) in just a few hours ... and I'm very confident in it."

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