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White House Announces New Precision Medicine Commitments

White House Announces New Precision Medicine Commitments | Healthcare and Technology news |

The Obama Administration has announced new commitments to its precision medicine initiative (PMI) that it unveiled six months ago.

The initiative, which President Barack Obama touched on in his State of the Union address in January, aims to pioneer a new model of patient-powered research to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

This week, the Administration launched new commitments, which include:

Guiding Principles for Protecting Privacy and Building Trust: The White House is unveiling draft PMI guiding principles that seek to build privacy into the design of the PMI research cohort, which will include one million or more Americans who agree to share data about their health. The White House is seeking public feedback on the privacy and trust principles online through August 7, 2015.

New Tools for Patients: In collaboration with federal partners, the Department of Health and Human Services Office of the National Coordinator for Health IT (ONC) and Office for Civil Rights (OCR) will work to address barriers that prevent patients from accessing their health data. OCR will develop additional guidance materials to educate the public and health care providers about a patient’s right to access his or her health information under the Health Insurance Portability and Accountability Act (HIPAA).

Research Awards to Unlock Data Insights: The Department of Veteran Affairs (VA) is announcing awards to support four research projects on key questions relevant to precision medicine using the rich data from the Million Veterans Program (MVP), the largest U.S. repository of genetic, clinical, lifestyle and military exposure data.

Additionally, private sector commitments related to the initiative launched this week include:

Duke Center for Applied Genomics and Precision Medicine: Duke has developed a platform called MeTree that helps individuals have challenging but necessary conversations with loved ones and care providers about family health histories, so that physicians can tailor care to patients’ unique risk profiles.

Flip the Clinic: Flip the Clinic, a project of the Robert Wood Johnson Foundation, is announcing a collaboration with more than 160,000 clinicians and staff practicing at sites across the United States, who have pledged to inform patients about their right to get digital copies of their medical records.

Genetic Alliance: Along with collaborators, such as Cerner, Genetic Alliance is launching new capabilities for Platform for Engaging Everyone Responsibly (PEER), a data registry that empowers participants to share their data with medical researchers, advocacy groups, and others.

GetMyHealthData: The GetMyHealthData campaign is pledging to help thousands of consumers over the next 12 months access and download their own clinical health data, so they can use it to understand and improve their health, their care, and the system as a whole—including donating their data for research.

Sage Bionetworks: Recognizing the importance of health-data liberation, and the role of data in driving research studies, Sage Bionetworks is announcing that it will support clinical studies that import electronic health-record information to its open source research platform and that it will release open-source informed-consent prototypes to support these studies.

The White House also is honoring "Champions of Change" in precision medicine, which includes nine individuals who are working to use data and innovation to improve healthcare.

Sophia Nguyen's curator insight, July 24, 2015 7:55 AM

I found this interesting because it shows how important the world of healthcare and how the president has taken notice that it's important for consumers to understand their health and take charge of it.!

'Precision Medicine': Privacy Issues

'Precision Medicine': Privacy Issues | Healthcare and Technology news |

Florence Comite, M.D., a pioneer in the evolving practice of "precision medicine," says extraordinary measures must be taken to protect patient privacy as more genetic and other sensitive data is collected to help personalize their care.

Precision medicine, also known as personalized medicine, involves the use of genomic, environmental, lifestyle and other personal data about patients so that clinicians can better tailor medical treatments that are potentially more effective based an individuals' characteristics.

To safeguard patients' sensitive data, Comite's New York-based endocrinology private practice had a developer build a custom electronic medical record system. The records system incorporates role-based access and encryption, as well as other features to protect patient privacy, she says in an interview with Information Security Media Group.

Comite keeps the most sensitive medical data - such as genetic data indicating that a patient potentially could develop a certain type of cancer or Alzheimer's disease - separate from other information in the patient's records, and often uses pseudonyms for patients to further protect this segregated information, she says.

Most healthcare is geared to mainstream, "one-size fits all" treatments that focus on treating illnesses rather than preventing them, the physician says. And most commercially available electronic records systems are built for those practicing this style of healthcare, she contends. "That's why I created my unique EMR, because I wanted to be able to collect data and equally be able to protect it in such a way that wouldn't undermine the kind of work we're trying to do."

Many patients are afraid of getting genetic testing done because of fear that sensitive data will be inappropriately released, she says. "That prevents a clinician from truly practicing what I see as the healthcare of the future."

In his recent State of the Union Address, President Obama unveiled a Precision Medicine Initiative. The White House calls the plan "a bold new research effort to revolutionize how we improve health and treat disease." In the Obama administration's fiscal 2016 budget, the Department of Health and Human Services is seeking a $215 million to launch the initiative.

In the interview, Comite also discusses:

  • The risks of hacker attacks targeting sensitive health information, such as genomic data;
  • The shortcomings in HIPAA privacy notices provided to patients;
  • The work that Comite's practice will be doing with employers, and how workers' health data privacy will be protected.

Comite is an endocrinologist with multidisciplinary training in internal medicine, pediatrics, gynecology and andrology. She is a graduate of Yale University School of Medicine, where she taught for 25 years as an associate clinical professor. An early practitioner in the emerging field of precision medicine, Comite has conducted clinical research at Yale and the National Institutes of Health in Reproductive Endocrinology and Metabolism. Comite maintains a private practice, ComiteMD, in New York City.

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Washington's Plan To End Private Practice Medicine

Washington's Plan To End Private Practice Medicine | Healthcare and Technology news |

In fixing the busted system that Medicare uses to pay American doctors, Congress has settled on a scheme that visits so many complexities on physicians, that it will inevitably stoke the continued demise of private, independent medical practices.

Many in Washington favor this outcome. Regulators at the Centers for Medicare and Medicaid Services have long preferred to deal with large entities and corporations that employ physicians, rather than try and enforce rules on a fragmented system of small, independent doctor offices.

Meanwhile, the “experts” on Capitol Hill, who are working to engineer the perfect solution to the nation’s healthcare system and its challenges around cost and quality, believe that large health systems modeled after Kaiser or the Geisinger Clinic are the optimal structuring. And that these models can be replicated nationwide.

For their part, the already big or near-big healthcare institutions, straining under declining reimbursement, see the leverage that comes with increasing their market share as a way to also improve operating margins and better control costs.

The result is a bipartisan package of “reforms” that visits so many new rules and complexities on doctors that individual physicians simply won’t be able to participate. They’ll face three choices. Refuse to see Medicare fee for service patients. Sell their practices and join a hospital or health system. Or ask their older patients to join Medicare Advantage plans, and see them under that arrangement. (Under Medicare Advantage, doctors won’t be directly responsible for adhering to many of the new payment conditions. The presumption is that these plans already enforce their own conditions to try and coordinate medical care.)

At issue is the framework that Medicare uses to set the rates doctors are paid by Medicare’s fee-for-service program on everything from thoracotomies to throat cultures. Referred to as the “sustainable growth rate” it’s part of a budget gimmick designed to cap what doctors are collectively paid and then let physicians fight amongst themselves over how that fixed pot of money gets allocated.

But the ploy never worked, and the price schedules are never properly adjusted for the rising cost of delivering medical care. Since private insurers adopt the prices, the malfunctioning system ends up having an outsized influence on medical care.

As I write in today’s Wall Street Journal Editorial Page, the major bipartisan, bicameral “reform” bill, set to advance in the next Congress, largely adopts many of the so-called doctor “payment reforms” already implanted in Obamacare. These changes are all variations on an old theme: capitation. The idea is to shift risk to providers with the goal of making doctors more discriminating about the cost and benefits of the treatments they prescribe. Rather than have the government ration care, or patients (through consumer directed health plans); the idea here is to have the providers do that reconciliation. The problem is that the new payment provisions come with their own alphabet soup of rules, reporting requirements, administrative procedures, and new bureaucratic infrastructures. Small doctor offices or medical groups simply won’t be able to participate, and will see their income under Medicare Fee for Service purposely reduced as a consequence. This is no accident. The architects of these provisions don’t believe that small medical practices are efficient, equipped to take risk, or comply with reporting requirements.

It isn’t any one single provision that will spell the demise of independent doctors. It’s the meshwork taken in its entirety, and the complexity if visits on providers.

Independent doctors practicing in smaller settings won’t be able to keep up with the requirements for overhead, reporting, and tracking. And the law makes it hard (illegal) for doctors to collaborate in loose associations to help them pool resources and buy these services. The end result is that collectively, the policies intentionally favor the consolidation of previously independent doctors into larger institutions.In the market, this is turning out to mean selling doctor practices to a local hospital.

When it comes to paying for doctors’ services, Washington has been setting prices for so long that it’s hard to envision another approach. But instead of dictating administered prices, it’s possible for Washington to measure them based on market surveys. One idea would simple be to survey prices paid by private Medicare plans, and use these as a barometer for setting rates in the fee for service program.

There’s a chicken and egg problem here. Medicare Advantage plans derive their own prices off the Medicare fee-for-service schedule. But if Washington were to turn the tables, and pay off a survey rather than its own rate setting, the market would quickly settle into a competitive equilibrium, with Medicare Advantage rates rising and falling to reflect supply, demand, and quality as plans compete to contract with the more popular medical practices. There would be new winners and losers. That is part of the problem. Many providers prefer the devil they know to the untried.

But right now, as the consolidation of once independent, privately practicing doctors accelerates it will also extinguish any semblance of local healthcare competition.

Obamacare is already leading to this desired outcome.

A 2014 survey of American docs that sampled 20,000 U.S. physicians found that 35% of doctors described themselves as independent, down from 49% in 2012 and 62% in 2008. These trends are becoming self-fulfilling by shaping expectations of newly minted docs. A new survey of 1,400 medical students conducted by Epocrates found that 73% plan to seek employment with a hospital or large health group when they graduate. Only 10% of students hope to work in a private practice.

Proponents of a market-based alternative to Obamacare will find that there’s not enough local rivalry between providers on which to eventually fashion a competitive structure to replace the Affordable Care Act.

All medical care is local. Once a single, large healthcare system or hospital controls all of the providers in an area, relying on market competition between separately contracting health plans won’t be possible. We will be dependent on administered pricing and increased regulation. For some in Washington, this is a fine outcome.

Many of our most pernicious problems in medicine don’t exist in spite of Medicare, but precisely because of the disorganized way that the Centers for Medicare and Medicaid Services buys doctors labor for seniors and other beneficiaries, and the outsized influence that the program exerts on the practice of medicine. If Congress passes this current bill, it might as well breath honesty into the law and repeal longstanding language saying that Medicare doesn’t regulate medical practice.

In a nutshell, the new legislation nixes the existing formula for capping the rate of growth in Medicare spending on doctors in favor of a new calculation. It ends the SGR, which was an attempt to tie Medicare’s budget to the inflation rate. In its place, the new plan limits total spending on physician services to .5% annual updates.

To give doctors a chance to earn more money, the legislation creates a new Merit-Based Incentive Payment System (MIPS). This plan basically consolidates three existing incentive programs, the bulk of which were already solidified under provisions established in the Affordable Care Act.

MIPS confer on doctors a score of 0-100 based on their adherence to different programs that purports to measure quality and outcomes based on information the doctors report. Those above certain numerical thresholds will get a raise. Those below it will get cut. To estimate their bottom line, doctors will have to track there performance against benchmarks they derive off of data that Medicare provides.

Mostly, the scores are tied to steps that doctors have to take in their medical practice that are believed to improve care. In other words, it measures inputs, not outcomes. The reporting requirements will be subject to audits, and civil penalties for mistakes. It doesn’t seem to matter that none of the programs that MIPS cements have reliably demonstrated that they actually improve outcomes, or lower costs.

The fee increases that the law enables (even baking in the bonus pools) are expected from the outset to fall far short of the real rise in medical practice costs. Physicians’ real income under Medicare will decline. It is another reason why the new scheme strongly favors the delivery of Medicare services through large, often hospital based systems. These bigger systems have more opportunity to enroll in the alphabet soup of legislative programs and inducements that will help goose reimbursement.

Over a short period of time, it’s likely that remaining office-based physicians will stop taking Medicare, or cap their Medicare patients at a small number. In fact the law explicitly exempts doctors that don’t treat a lot of Medicare patients from some of the penalties that are levied on doctors who don’t take part in MIPS. There’s little chance that smaller, independent medical groups (in particular, medical specialists) will be able to meet the multitude of provisions that this new law outlines, even with the help of some exemptions and special subsidies that the law provides.

Some doctors will just absorb the cuts to their rates (up to 9 percent a year). Others doctors will opt out entirely. The provision of services for the elderly will shift to the hospital outpatient setting. The law’s most significant payment bonuses are already reserved for doctors that practice as employees of hospitals and other integrated medical systems (which are referred to as Alternative Payment Models under the new law). In this way, the law furthers provisions in ObamaCare that favor the consolidation of medical practice around large hospitals and health systems and the movement of doctors from independent practices to salaried arrangements.

The law may also favor Medicare Advantage. These plans may have an easier time contracting with the doctors who cannot comply with the requirements, but still want to see some Medicare patients. Medicare patients, in turn, may favor Medicare Advantage if these plans are able to let them continue using outpatient practices.

But in the end, what the bipartisan plan really favors is Obamacare. It’s ironic that the only major healthcare reform measure likely to pass in 2015 is a bill that cements some of the most significant features of the Affordable Care Act. Republicans say they oppose Obamacare. They need to seize the opportunity to roll back some of its pernicious features. Or at least preserve enough of a medical marketplace to reserve for the future, a chance to come up with a better alternative.

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Why Hasn't Mobile Moved Medicine Further Yet?

Why Hasn't Mobile Moved Medicine Further Yet? | Healthcare and Technology news |

The advent of the smartphone and mobile "apps" has opened the floodgates in hospital and clinic settings. With the ease of communication and newfound ability to access the web in the palm of our hand, the world has grown smaller for everyday users. Given its current host of systemic predicaments, the medical industry has justifiably shifted its attention to these new technologies to rectify inefficiencies.

Mobile technology raises expectations for health care consumers with the obvious prospect of improved communication between providers and patients. From having your physician's prescriptions on-the-go to being able to rapidly authorize medical record transfers in emergent situations, a promising solution to chronic issues obstructing submaximal care is at our doorstep.

Why, then, have we not reached our full potential? StartUp Health reported a burgeoning digital health sector with $6.9 billion in funding over 551 deals in 2014. Mobile health savvy health insurance company Oscar has captured significant market share with a whopping $320 million of funding and 40,000 members to date. While these strides prove consumer and investor belief in mobile technology, few applications have proven valuable to stakeholders' stringent criteria despite the sheer number of available applications.

No single firm has demonstrated an intimate knowledge of the medical industry with delivery of high-quality tools that engage users. The lack of a clear winner in this noisy space has stunted broad adoption. For this reason, heavyweights in the technology industry like Google, Amazon, Facebook and Apple are exciting new entrants to the mobile health scene. In addition to the modular infrastructure offered by these established giants, the greatest value is their proven track record in customer validation and the user experience.

Established technology firms are by no means a shoe-in to win. The inherently low barrier to entry in the mobile health space is a double-edged sword. Though sparse quality control mechanisms are responsible for the sheer volume of subpar apps, they are also the reason why no innovator can be excluded from disrupting the space with the help of hired digital development shops. Excluding the fundamental challenges of operating within the health care industry (i.e. security and compliance standards), the delay in realizing the impact of mobile health technology can be distilled to four fundamental failures.

First, the end user is often forgotten. Often times, hospitals will excitedly reveal a mobile app that provides useful information but has such a poor interface that consumers fail to engage. Fewer apps have engaged users better than Instagram with over 300 million monthly active users. Instagram represents an exceptional product stakeholders in digital health care should not trivialize and learn from greatly. With two-thirds of the Americans owning a smartphone, the problem today is less so the access to digital tools than it is the actual engagement with them.

Second, the balance scale tilts heavily towards "wellness" and less towards "care." Though the return on investment for a mobile app may be greater for a healthy user willing to pay to track health and fitness metrics, those who actually need the increased vigilance in our health system are patients suffering from chronic disease or recovering from surgery. From the perspective of optimizing health outcomes and preventing frivolous costs, the attention needs to shift to vulnerable populations stressing the system. Furthermore, some insurance companies incentivize members by providing mobile apps under the moniker of "mHealth;" this terminology runs the risk of misleading individuals into skipping preventive care visits with their doctor. These apps should optimize medical management in the appropriate clinical context through physician supervision with appropriate FDA regulation as an "mCare" effort instead. The FDA already applies a risk-based approach for assessing mobile medical apps considered accessory to regulated medical devices or transformational into a regulated medical device. More of this patient-centered innovation is needed to solve our system's real issues.

Third, we fail to play to the strengths of smartphones in medicine. Smartphone technology is fundamentally advantageous because users have the freedom to move and communicate without restriction. Given that outcome metrics for the fields of orthopaedic surgery and rheumatology are predicated on physical mobility and patient-reported response to interventions, smartphone technologists should target these specialties first to realize benefits of afflicted patients in real-time. Joint replacement is one of the most common surgical interventions in the world, and being able to track steps taken, or the steps not taken, using the phone's native pedometer has the potential to alert a surgeon of post-operative complications in advance. The current strategy is focused on creating the best apps for the fittest individuals, but the most impactful technologies would be directed towards streamlining assurances of patient safety and physical activity for those with musculoskeletal conditions.

Finally, collaboration is lacking. Smartphones track and store the "small data" of millions of potential patients. When put together, the data tells a greater story. Numerous insidious diseases, from major depression to ovarian cancer, could be detected earlier and managed better when sharing our stored mobile data. While there do exist standout organizations like Fitbit which offer an open developer API, the current landscape is not set up to exchange user data. One such organization that recognizes the meaningful macroscopic conclusions that can be drawn from sharing mobile data is Open mHealth. Founded on the value of facilitating the sharing, storage, and processing of mobile data using an open infrastructure, Open mHealth has already made great strides among individuals with diabetes and veterans with PTSD.

Today, the smartphone is one of the greatest commercially available technologies. With emerging wearable devices like Apple Watch and Jawbone, who knows what our go-to device will be tomorrow? Thus, validation of mobile technology in medicine cannot hinge on today's version of devices. The evidence supporting application of mobile technologies to the medical workflow must maintain modularity and iterative capacity. One example of modular capacity is Apple's open source ResearchKit. Though in a perfect world Apple and Google would have partnered to cover nearly all smartphone users, ResearchKit has the laudable benefit of availability across all current and future iOS devices. Thus, validation is needed just once for survivorship of mobile technology in medicine to be ensured.

The potential for mobile technology in medicine is great, but the current landscape is not yet set up to transform the health care industry. There exists no reliable winner in the marketplace because either our goals are misaligned or our focus has been misplaced. If the objective is to help the well become more well, then we are thriving. However, if we choose to unbridle the capability of mobile technology in medicine by remembering the end user, helping the suffering, playing to the strengths of our resources, and enabling collaboration, we are on the precipice of a truly transformational era in modern medicine.

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Don’t look back to how medicine used to be

Don’t look back to how medicine used to be | Healthcare and Technology news |

Is it just me, or is the world of medicine getting way more complicated?

Sometimes I long for the good old days of practicing medicine.

First, the hospital switched over to electronic medical records, which required us to to attend Saturday morning classes to learn how to tell the nurses our patients could go home after surgery.

Next, our office got an insurance memo that said we must now add extra codes on our billing forms. The codes indicate that we’ve told our patients to quit smoking, warned them about the risks of our treatment, and offered them a follow-up appointment.

As if doctoring wasn’t time-intensive enough, now we must enter and re-enter data that has very little meaning to anyone except the pencil-pushers in insurance land.

It’s enough to make a doctor weary. Burned out. Aggravated.

It reminds me of a call I made 10 years ago to one of my mentors.

Here’s how it went down …

First, let me say that I’m just like you. I rarely reach out to call my mentor in the middle of a workday. He knows this about me. So, when he heard me on the other end of the phone, his first question was, “Are you calling from the operating room?”

We both laughed, relieved that my answer was no. Then we got on to the topic at hand. It went something like this.

I asked him why medicine had gone to hell in a hand basket, and how could I turn back the clock to the days when he was first in practice.

Here’s what he then asked me:

  1. When you go to a restaurant, do you feel like you can order pretty much whatever you want?
  2. Do you like where you live? Is the neighborhood safe?
  3. Does your car run OK, without you being fearful of it breaking down on your way to work every day?

Of course, my answers were yes, yes, and yes.

His response was, “Then quit your complaining.” (I believe he actually used a stronger word that rhymed with “itching.”)

He went on to remind me of all the things we all take for granted on a daily basis. That we are more fortunate than at least 90 percent of the world. And how we have the ability to help people, to know people more intimately and more authentically than in any other profession, and that we make a reasonable living doing it.

His take home message was: Don’t look back.

Don’t look back to how medicine used to be. Or how it looked when Marcus Welby, MD, was a not-so-unrealistic TV doctor. Or even how it was when we started medical school.

Instead, look forward at the innovations that have come to medicine that are helpful. Be grateful for the improvements in treatment for many diseases that used to have no hope. Appreciate the technology that, despite the overkill, allows us to Google medications we don’t know (even as it lets our patients Google symptoms that lead to their anxiety).

So, whenever I’m having the kind of day I had yesterday, where I have to pull myself up short and give myself a talking to … I remember my dear mentor’s words.

I remind myself to search for joy.

I remind myself to be grateful.

And I think about other words of wisdom that tell similar tales. Words from teachers such as Deepak Chopra, who said, “Each of us is like a millionaire with amnesia. We go through life feeling poor, having forgotten that in reality we are very rich. In other words, by being so convinced we are limited in mind and body, we have forgotten the truth that our soul knows no boundaries.”

Deepak wasn’t talking to doctors and health care providers.

But he could’ve been.

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