On April 10, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) published parallel proposed rules revising, respectively, the Stark exception and Anti-Kickback safe harbor concerning electronic health record (EHR) items and services. Highlights of the proposed rules include:
Sunset Provision. The EHR exception and safe harbor are scheduled to sunset on December 31, 2013. The proposed rules seek to extend the sunset provision to December 31, 2016.
Interoperability. Under the current EHR Regulations, a software is deemed interoperable “if a certifying body recognized by the Secretary has certified the software no more than 12 months prior to the date it is provided to the physician.” CMS and the OIG propose two changes to the requirement of interoperability.
First, CMS and the OIG propose to reflect that the Office of the National Coordinator for Health Information Technology (ONC) is responsible for recognizing certifying bodies and that entities must successfully complete an authorization process established by ONC.
Second, CMS and the OIG seek to amend the 12-month time period in which a donor has to furnish the EHR software to the recipient. The purpose of the current timeframe is to ensure that products have an up-to-date certification. Consistent with the current ONC regulatory process for adopting certification criteria and standards for EHRs, CMS and the OIG propose to amend the 12-month time frame to allow software to be eligible for deeming interoperability “if, on the date it is provided to the recipient, it has been certified to any edition of the electronic health record certification criteria that is identified in the then applicable definition of Certified EHR Technology in 45 CFR part 170.” This proposal allows for greater flexibility in determining interoperability without the 12-month deadline.
Electronic Prescribing Provision. The current EHR rules require the donated software to contain e-prescribing capability. The proposed rules seek to eliminate this condition because sufficient alternative policy drivers exist to support the adoption of e-prescribing capabilities.
Additional Proposals and Considerations.
Protected Donors. The EHR exception and safe harbor are currently available to a broad class of donors. The proposed rules seek to limit the availability of the EHR exception and safe harbor to cover only the original MMA-mandated donors: hospitals, group practices, Part D plan sponsors and Medicare Advantage organizations. In the alternative, the rules propose to exclude certain suppliers associated with a high risk of fraud and abuse in this context including laboratories, DME suppliers and independent home health agencies.
Data Lock-In and Exchange. Due to the concern of using the EHR exception and safe harbor to lock-in referrals, the proposed rules request comments on new or modified conditions that could be added to the rules to achieve the goals of: (a) preventing data and referral lock-ins, and (b) encouraging interoperability and the free exchange of data.
Covered Technology. The proposed rules seek comments on whether the regulatory text should be modified to explicitly reflect the items and services that fall within the scope of covered technology. The agencies consider the current regulatory text, when read in light of the preamble discussion, sufficiently clear but seek input from the public regarding this issue.
CMS and OIG are accepting comments on the proposed rules through June 10, 2013.
The Bipartisan Policy Center (BPC), Heritage Provider Network (HPN), and The Advisory Board Company have launched the Care Transformation Prize Series, a national contest to address the most daunting data problems US health care organizations face as they implement new delivery system and payment reforms. This challenge will will examine the most difficult questions facing health care organizations today, and will engage the nation’s best and brightest data scientists to develop solutions.
The Care Transformation Prize Series is the latest competition sponsored by Dr. Richard Merkin, President and CEO of HPN, in an ongoing effort to spur innovations that improve quality and reduce inefficiencies as organizations work to implement new delivery system and payment reforms. Prizes will be awarded to the teams that develop the best solutions and the winning algorithms will be made widely available to the public and health care organizations. A Prize Board made up of prominent leaders from many sectors of healthcare will determine which challenges will be addressed by competing teams of leading data scientists.
Heritage Provider Network and The Advisory Board Company will offer at least three quarterly prizes of $100,000 to the teams that develop the best solutions to the selected challenges. The winning algorithms will then be made available to health care organizations and the public. For more information about The Care Transformation Prize Series or to submit a question, please visit http://www.caretransformationprize.com
You can watch the video from the announcement below:
“In addition to the expanding marketplace and corresponding increase in workload for ONC, much of the work to date has been funded using Recovery Act funds scheduled to expire at the end of FY 2013. Consequently, a new revenue source is necessary to ensure that ONC can continue to fully administer the Certification Program as well as invest resources to improve its efficiency," the ONC explains in the budget proposal appendix.
In particular, the fee could be used to fund:
Development of implementation guides and other forms of technical assistance for incorporating standards and specifications into products
Development of health IT testing tools that are used by developers, testing laboratories and certification bodies
Development of consensus standards, specifications and policy documents related to health IT certification criteria
Administration of the ONC Health IT Certification Program and maintenance of the Certified Health IT Product List
Post-market surveillance, field testing and monitoring of certified products to ensure they are meeting applicable performance metrics in the clinical environment
If approved the collections will likely begin late in fiscal year 2014 and would be gradually phased in. According to the proposal "user fees would be collected from Health IT vendors," and then "would be collected on ONC’s behalf by ONC-Authorized Certification Bodies (ONCACBs)" which already certify EHR systems as part of the meaningful use program. A fee structure would be established by the Secretary and published in the Federal Register, but a tiered system is being proposed where EHR modules would likely be assessed at a lower rate than a complete EHR system.
The HIMSS EHR Association opposes ONC's proposal. "EHR developers are already devoting extensive resources to successful implementation of the EHR Meaningful Use Incentive Program and other healthcare delivery reform efforts, including the significant fees associated with EHR product certification," the group said in a statement. I'm not automatically opposed to fees, however it is not the vendors that would ultimately bear the cost. My biggest issue with the EHR Incentive Program is that it should be more accurately called the EHR Vendor Incentive Program since these companies are making record profits and any payments to providers are simply a pass through to the vendors.
I would like to see steeper requirements for certification as future stages of meaningful use are developed. There are WAY too many products on the Certified Health IT Products List (CHPL) for small practices, community and critical access hospitals to make sense of and choose an appropriate vendor. When this program first launched a software developer friend reviewed the standards and certification criteria and claimed that she could design a product that would meet all of the certification requirements and yet be completely unusable in actual practice. I told her not to waste her time since it appeared that some companies had already done that...
Over ten years ago Intel launched the Proactive Health Research Project, a multiyear effort to bring ubiquitous computing to eldercare. Since that time Eric Dishman, an Intel Fellow and now general manager of the Health Strategy & Solutions Group, has been promoting healthcare innovation with a specific emphasis on home and community-based technologies and services for chronic disease management and independent living. He has often expanded on the concept initially proposed by Andy Grove in Fortune magazine where he described the "mainframe" era of healthcare. He said at the time, "It took us 50 years to move from the mainframe to personal computing, but health care needs to go through a similar transformation in ten years or less."
I riffed off of this a bit at the recent Dell Healthcare Think Tank entitled "The Future of Information Driven Healthcare," where I also described the launch of the HIMSS project within the Clinton Global Initiative, the Healthcare Transformation Project. With cloud services, mobile health technology and telemedicine advances, we may just be seeing a similar revolution in healthcare that the computer industry underwent. I think the Healthcare Transformation Project will help to spur this revolution...
Here is a TED Talk of Eric's where he discusses some of the ideas I referenced:
In the fall of 2012 the ONC decided that now is not the time for regulations on health information exchange governance. They decided to instead implement an approach that provides a means for defining and implementing nationwide trusted exchange with higher agility, by working in concert with the private market in a collaborative manner. On December 20, 2012 ONC released the Exemplar Health Information Exchange Governance Entities Program Funding Opportunity Announcement. Two organizations have now been awarded a cooperative agreement by the ONC to participate in the program. This work will support and advance the efforts of these existing governance entities which will benefit consumers and providers by allowing health information to flow securely between unaffiliated healthcare organizations.
DirectTrust (I am a member of the Board of Directors of DirectTrust) is one of the awardees in the program. they will work with ONC to develop and adopt policies, interoperability requirements and business practices that align with national priorities, overcome EHR interoperability challenges, reduce implementation costs for providers and patients, and assure the privacy and security of health information exchange. DirectTrust will work with ONC to implement the technical mechanism and process for trust anchor exchange to enable Directed exchange more easily across vendor boundaries, as well as to develop and implement a federated agreement among accredited participants that avoids the need for one to one legal agreements. They will also continue development of the national accreditation program for health information service providers (HISPs), certificate authorities (CAs), and registration authorities (RA) who act as trusted agents on behalf of users of Directed exchange. The accreditation program, launched in November 2012 in partnership with the Electronic Healthcare Network Accreditation Commission (EHNAC), is targeted to achieve wide scale participation by the end of 2013.
"The work that will be done by DirectTrust will be crucial in promoting good governance practices and enhancing the exchange of patients’ health information," said ONC’s Claudia Williams, program director, State Health Information Exchange Program. "I encourage ONC grantees, vendors, providers and health information exchange initiatives to work closely with DirectTrust in an effort that will help to improve the care and health of patients."
The New York eHealth Collaborative (NYeC) will also participate in the Exemplar HIE Governance Program on behalf of the EHR/HIE Interoperability Workgroup (IWG). In partnership with the ONC the workgroup will continue its efforts in developing robust implementation specifications for ‘plug and play’ interoperability. The IWG will attempt to address the implementation challenges facing the exchange of health information including patient matching and querying provider directories. The IWG recently selected the Certification Commission for Health Information Technology (CCHIT) to carry out compliance testing against the workgroup’s agreed upon specifications. "We are thrilled that the ONC has recognized the significant contributions of the EHR/HIE Interoperability Workgroup in driving the development and implementation of plug and play exchange standards," said Dave Whitlinger, Executive Director of the New York eHealth Collaborative.
April 2, 2013 at the White House, President Obama unveiled the BRAIN Initiative — a new research effort to revolutionize our understanding of the human mind and uncover new ways to treat, prevent, and cure brain disorders like Alzheimer’s, schizophrenia, autism, epilepsy, and traumatic brain injury.
The BRAIN Initiative — short for Brain Research through Advancing Innovative Neurotechnologies — promises to accelerate the invention of new technologies that will help researchers produce real-time pictures of complex neural circuits and visualize the rapid-fire interactions of cells that occur at the speed of thought. Such cutting-edge capabilities, applied to both simple and complex systems, will open new doors to understanding how brain function is linked to human behavior and learning, and the mechanisms of brain disease.
The BRAIN Initiative is launching with approximately $100 million in funding for research supported by the National Institutes of Health (NIH), the Defense Advanced Research Projects Agency (DARPA), and the National Science Foundation (NSF) in the President’s Fiscal Year 2014 budget. Foundations and private research institutions are also investing in the neuroscience that will advance the BRAIN Initiative. The Allen Institute for Brain Science, for example, will spend at least $60 million annually to support projects related to this initiative. The Kavli Foundation plans to support BRAIN Initiative-related activities with approximately $4 million dollars per year over the next ten years. The Howard Hughes Medical Institute and the Salk Institute for Biological Studies will also dedicate research funding for projects that support the BRAIN Initiative.
Remarks by the President on the BRAIN Initiative and American Innovation
THE PRESIDENT: Thank you so much. (Applause.) Thank you, everybody. Please have a seat. Well, first of all, let me thank Dr. Collins not just for the introduction but for his incredible leadership at NIH. Those of you who know Francis also know that he’s quite a gifted singer and musician. So I was asking whether he was going to be willing to sing the introduction -- (laughter) -- and he declined.
But his leadership has been extraordinary. And I’m glad I’ve been promoted Scientist-in-Chief. (Laughter.) Given my grades in physics, I’m not sure it’s deserving. But I hold science in proper esteem, so maybe that gives me a little credit.
Today I’ve invited some of the smartest people in the country, some of the most imaginative and effective researchers in the country -- some very smart people to talk about the challenge that I issued in my State of the Union address: to grow our economy, to create new jobs, to reignite a rising, thriving middle class by investing in one of our core strengths, and that’s American innovation.
Ideas are what power our economy. It’s what sets us apart. It’s what America has been all about. We have been a nation of dreamers and risk-takers; people who see what nobody else sees sooner than anybody else sees it. We do innovation better than anybody else -- and that makes our economy stronger. When we invest in the best ideas before anybody else does, our businesses and our workers can make the best products and deliver the best services before anybody else.
And because of that incredible dynamism, we don’t just attract the best scientists or the best entrepreneurs -- we also continually invest in their success. We support labs and universities to help them learn and explore. And we fund grants to help them turn a dream into a reality. And we have a patent system to protect their inventions. And we offer loans to help them turn those inventions into successful businesses.
And the investments don’t always pay off. But when they do, they change our lives in ways that we could never have imagined. Computer chips and GPS technology, the Internet -- all these things grew out of government investments in basic research. And sometimes, in fact, some of the best products and services spin off completely from unintended research that nobody expected to have certain applications. Businesses then used that technology to create countless new jobs.
So the founders of Google got their early support from the National Science Foundation. The Apollo project that put a man on the moon also gave us eventually CAT scans. And every dollar we spent to map the human genome has returned $140 to our economy -- $1 of investment, $140 in return. Dr. Collins helped lead that genome effort, and that’s why we thought it was appropriate to have him here to announce the next great American project, and that’s what we're calling the BRAIN Initiative.
As humans, we can identify galaxies light years away, we can study particles smaller than an atom. But we still haven’t unlocked the mystery of the three pounds of matter that sits between our ears. (Laughter.) But today, scientists possess the capability to study individual neurons and figure out the main functions of certain areas of the brain. But a human brain contains almost 100 billion neurons making trillions of connections. So Dr. Collins says it’s like listening to the strings section and trying to figure out what the whole orchestra sounds like. So as a result, we’re still unable to cure diseases like Alzheimer’s or autism, or fully reverse the effects of a stroke. And the most powerful computer in the world isn’t nearly as intuitive as the one we’re born with.
So there is this enormous mystery waiting to be unlocked, and the BRAIN Initiative will change that by giving scientists the tools they need to get a dynamic picture of the brain in action and better understand how we think and how we learn and how we remember. And that knowledge could be -- will be -- transformative.
In the budget I will send to Congress next week, I will propose a significant investment by the National Institutes of Health, DARPA, and the National Science Foundation to help get this project off the ground. I’m directing my bioethics commission to make sure all of the research is being done in a responsible way. And we’re also partnering with the private sector, including leading companies and foundations and research institutions, to tap the nation’s brightest minds to help us reach our goal.
And of course, none of this will be easy. If it was, we would already know everything there was about how the brain works, and presumably my life would be simpler here. (Laughter.) It could explain all kinds of things that go on in Washington. (Laughter.) We could prescribe something. (Laughter.)
So it won't be easy. But think about what we could do once we do crack this code. Imagine if no family had to feel helpless watching a loved one disappear behind the mask of Parkinson’s or struggle in the grip of epilepsy. Imagine if we could reverse traumatic brain injury or PTSD for our veterans who are coming home. Imagine if someone with a prosthetic limb can now play the piano or throw a baseball as well as anybody else, because the wiring from the brain to that prosthetic is direct and triggered by what's already happening in the patient's mind. What if computers could respond to our thoughts or our language barriers could come tumbling down. Or if millions of Americans were suddenly finding new jobs in these fields -- jobs we haven’t even dreamt up yet -- because we chose to invest in this project.
That's the future we're imagining. That's what we're hoping for. That’s why the BRAIN Initiative is so absolutely important. And that’s why it’s so important that we think about basic research generally as a driver of growth and that we replace the across-the-board budget cuts that are threatening to set us back before we even get started. A few weeks ago, the directors of some of our national laboratories said that the sequester -- these arbitrary, across-the-board cuts that have gone into place -- are so severe, so poorly designed that they will hold back a generation of young scientists.
When our leading thinkers wonder if it still makes sense to encourage young people to get involved in science in the first place because they're not sure whether the research funding and the grants will be there to cultivate an entire new generation of scientists, that's something we should worry about. We can’t afford to miss these opportunities while the rest of the world races ahead. We have to seize them. I don’t want the next job-creating discoveries to happen in China or India or Germany. I want them to happen right here, in the United States of America.
And that's part of what this BRAIN Initiative is about. That’s why we’re pursuing other “grand challenges” like making solar energy as cheap as coal or making electric vehicles as affordable as the ones that run on gas. They’re ambitious goals, but they’re achievable. And we’re encouraging companies and research universities and other organizations to get involved and help us make progress.
We have a chance to improve the lives of not just millions, but billions of people on this planet through the research that's done in this BRAIN Initiative alone. But it's going to require a serious effort, a sustained effort. And it’s going to require us as a country to embody and embrace that spirit of discovery that is what made America, America.
They year before I was born, an American company came out with one of the earliest mini-computers. It was a revolutionary machine, didn't require its own air conditioning system. That was a big deal. It took only one person to operate, but each computer was eight feet tall, weighed 1,200 pounds, and cost more than $100,000. And today, most of the people in this room, including the person whose cell phone just rang -- (laughter) -- have a far more powerful computer in their pocket. Computers have become so small, so universal, so ubiquitous, most of us can't imagine life without them -- certainly, my kids can't.
And, as a consequence, millions of Americans work in fields that didn't exist before their parents were born. Watson, the computer that won “Jeopardy,” is now being used in hospitals across the country to diagnose diseases like cancer. That's how much progress has been made in my lifetime and in many of yours. That's how fast we can move when we make the investments.
But we can't predict what that next big thing will be. We don't know what life will be like 20 years from now, or 50 years, or 100 years down the road. What we do know is if we keep investing in the most prominent, promising solutions to our toughest problems, then things will get better.
I don't want our children or grandchildren to look back on this day and wish we had done more to keep America at the cutting edge. I want them to look back and be proud that we took some risks, that we seized this opportunity. That's what the American story is about. That's who we are. That's why this BRAIN Initiative is so important. And if we keep taking bold steps like the one we’re talking about to learn about the brain, then I’m confident America will continue to lead the world in the next frontiers of human understanding. And all of you are going to help us get there.
So I’m very excited about this project. Francis, let’s get to work. God bless you and God bless the United States of America. Thank you.
